Understanding the Introduction Components:

The initial slides of the presentation serve as the introduction to the entire MOM chapter training. They establish the context and purpose of the information being presented. Let's break down each component:

1. NABH 6th Edition:

   • NABH (National Accreditation Board for Hospitals & Healthcare Providers): NABH is the leading accreditation body for healthcare organizations in India. It sets standards for quality and patient safety. It's crucial to understand that this training is based on NABH standards, meaning the content is driven by the requirements of this accreditation body.

   • 6th Edition: This explicitly states that the training is based on the latest edition of the NABH standards, the 6th Edition. This is important because NABH standards are periodically updated to reflect advancements in healthcare, evolving best practices, and lessons learned from implementation. Mentioning the 6th Edition right at the start signals that this is current and up-to-date information for hospitals aiming for NABH accreditation.

2. ACCREDITATION STANDARDS FOR HOSPITALS:

   • Focus on Hospitals: This clarifies the target audience and scope of the standards being discussed. NABH has different accreditation programs for various types of healthcare organizations (e.g., small healthcare organizations, blood banks, etc.). This introduction specifically points to the standards designed for hospitals. This is important for professionals in hospitals as it directly relates to their work environment and accreditation goals.

   • Accreditation Standards: These are not just suggestions or guidelines, but rather standards that hospitals are assessed against during the accreditation process. Meeting these standards is a requirement for achieving and maintaining NABH accreditation, which has implications for a hospital's reputation, patient trust, and potentially payer contracts.

3. CHAPTER 3: MANAGEMENT OF MEDICATION (MOM):

   • Chapter 3: This places the topic within the broader structure of the NABH standards document. The standards are organized into chapters covering different functional areas of a hospital. Knowing it's Chapter 3 helps orient individuals familiar with the NABH manual and quickly locate this section within the larger document.

   • MANAGEMENT OF MEDICATION (MOM): This clearly defines the specific topic of this chapter and training. "Management of Medication" is a critical function in any hospital. It encompasses all processes related to medications, from procurement and storage to prescription, dispensing, administration, and monitoring. The acronym "MOM" is introduced, which is used consistently throughout the presentation for brevity. This immediately signals that the training will be centered around medication safety and effective medication management practices.

Changes from 5th to 6th Edition in the Introduction Context:

Looking specifically at the slides and OCR text provided, there are no explicit changes mentioned for the introduction itself between the 5th and 6th Editions. The titles, headings, and overall components (NABH, Accreditation Standards, MOM chapter, CAHO) remain consistent.

However, the presentation does highlight general changes within the MOM chapter for the 6th Edition compared to the 5th. These changes, while not direct alterations to the introductory text, are crucial to understand as they set the stage for the entire chapter's update:

• "Summary of Changes (6th edition Vs. 5th edition)" slides are presented early. This signifies that the 6th Edition is not just a minor revision, but incorporates important updates. The fact that changes are being summarized right after the introduction indicates their significance and that the training will specifically address these updates.

• Intent of MOM is elaborated in a new slide. This could be seen as an enhancement of the introduction. While the core intent of MOM likely remained consistent between editions, explicitly outlining the "Intent of MOM" at the beginning of the training (as shown on Page 2 of the OCR) is a notable improvement in the 6th edition training material. It provides a clearer and more structured starting point for understanding the chapter's objectives. This helps participants grasp the why behind the MOM standards before diving into the specifics of what the standards are.

• Modifications to Intent specifically mention new elements for the 6th edition: "Modified to include: Medication safety officer, Reconciliation of medication at transition points and patient care areas." These modifications, while related to the "Intent," are highlighted immediately after the introduction. This implicitly signals that the 6th Edition has broadened or emphasized these specific aspects of medication management that were potentially less prominent or newly added compared to the 5th edition.

In Summary Regarding Introduction Changes:

• The basic introductory elements (NABH, Accreditation Standards, MOM, CAHO) remain largely the same in terms of structure and focus.

• No explicit textual changes to the initial introductory headings are mentioned or apparent.

• The key change in the "introductory context" is the emphasis on the updates for the 6th Edition right from the start. This is achieved through:

  • Clearly labeling the training for the 6th Edition.

  • Presenting "Summary of Changes" slides early on.

  • Elaborating the "Intent of MOM" explicitly, including new elements for the 6th edition like the Medication Safety Officer and Medication Reconciliation at transition points.

Therefore, while the basic introductory components are consistent, the 6th Edition introduction in the training material is enhanced by immediately highlighting the updates and the core purpose of the MOM chapter in a more structured manner. The emphasis is on the evolution and improvement reflected in the 6th Edition standards, particularly in areas like medication safety officers and reconciliation, which are introduced as key updates early in the presentation.

MOM1: Pharmacy services and medication management is done safely. 

This overarching standard is the cornerstone of medication safety in the NABH framework. It’s not just a statement of intent; it's a guiding principle that should permeate every aspect of how a hospital handles medications. The core idea is to minimize the risk of medication-related harm to patients. Let's break down each sub-element to see how this overarching goal is achieved.

1. MOM 1a: Pharmacy services and medication usage are implemented following written guidance. * (C) - Expanded Detail

• Rationale: Imagine a hospital where medication procedures are passed down verbally, change based on individual preferences, or are inconsistently applied across departments. Chaos and errors are inevitable. Written guidance brings consistency, predictability, and accountability to medication processes. It acts as a standardized playbook, ensuring everyone is on the same page and follows established best practices.

• Practical Implementation Examples:

  • Formulary Guidance: The written guideline wouldn't just list the formulary drugs, but also detail how the formulary is created and maintained. For example, it could specify:

    • The process for adding new drugs to the formulary (including criteria for selection, review process, committee approval).

    • How often the formulary is reviewed and updated (at least annually, as per MOM 2b).

    • How clinicians are informed of formulary changes.

  • Procurement Guidance: This guidance would outline:

    • Vendor qualification and selection criteria (ensuring reliable and reputable suppliers).

    • The process for placing medication orders (who is authorized, how orders are documented).

    • Receipt and inspection procedures (checking for damage, expiry, batch numbers).

    • Managing medication shortages and backorders.

  • Storage Guidance: This is crucial for maintaining drug integrity and safety. Examples in the written guidance would include:

    • Temperature requirements for different medications (including specifics for refrigerated drugs and vaccines).

    • Guidelines for storage security (preventing unauthorized access, theft, diversion).

    • Protocols for managing expired medications (segregation, proper disposal).

    • Arrangements for storing medications outside the central pharmacy (ward stock, crash carts - ensuring pharmacy oversight, as per Intent of MOM).

  • Prescription Guidance: This focuses on promoting rational and safe prescribing habits, addressing:

    • Hospital policy on using generic names where appropriate to promote cost-effectiveness.

    • Guidelines on restricted medications or those requiring specialist authorization.

    • Processes for medication reconciliation at admission, transfer, and discharge (as updated in 6th edition intent).

    • Strategies for minimizing polypharmacy and drug interactions.

  • Dispensing Guidance: Ensuring accurate medication provision to patients:

    • Steps for prescription verification by a pharmacist before dispensing.

    • Double-checking processes to prevent dispensing errors (right drug, right strength, right patient).

    • Labeling requirements for dispensed medications (patient information, dosage instructions, expiry).

    • Procedure for handling medication recalls (as per MOM 6b).

  • Administration Guidance: The cornerstone of the "5 Rights" (Right Patient, Right Drug, Right Dose, Right Route, Right Time) and beyond:

    • Patient identification procedures before administration (using at least two identifiers, as per MOM 7c).

    • Verification processes at the point of administration (checking against the medication order, physical inspection - MOM 7d).

    • Techniques for different routes of administration (IV, oral, IM etc.), ensuring safety and efficacy.

    • Protocols for administering high-risk medications (independent double-checks, as per MOM 7d).

    • Guidelines for documentation of medication administration (MOM 7i).

  • Monitoring Guidance: Ensuring patient safety post-administration:

    • Protocols for routine monitoring after medication administration (assessing therapeutic effect, observing for side effects).

    • Specific monitoring guidelines for high-risk medications or those with narrow therapeutic indices.

    • Procedures for reporting and managing adverse drug reactions (ADRs – as per MOM 8c onwards).

  • Usage Guidance: Overall framework for responsible medication use:

    • Hospital's commitment to antimicrobial stewardship and responsible antibiotic use.

    • Policies on self-administration of medications (MOM 7j) and patient-brought medications (MOM 7k).

    • Guidelines for managing medication samples (prohibition of selling, appropriate handling).

2. MOM 1b: A multidisciplinary committee guides the formulation and implementation of pharmacy services and medication management. (C) - Expanded Detail

• Rationale: Medication management is complex, crossing departmental lines and involving diverse professional expertise. A multidisciplinary committee ensures that decisions are well-rounded, consider various perspectives, and are not solely driven by one department. This collaborative approach is vital for creating a system that is safe, efficient, and patient-centered.

• Importance of Committee Composition:

  • Clinical Department Representatives: Physicians from key specialties (Internal Medicine, Surgery, Pediatrics, etc.) bring clinical insights into medication needs, prescribing patterns, and therapeutic issues specific to their patient populations.

  • Administration: Management representatives ensure that medication management initiatives are aligned with overall hospital goals, are financially sustainable, and are practically implementable within the hospital's resources and infrastructure.

  • Pharmacist/Clinical Pharmacologist: Pharmacy professionals provide specialized knowledge about pharmacology, drug interactions, formulary management, dispensing systems, and medication safety. Clinical pharmacologists bring expertise in the rational use of drugs and optimizing medication therapy.

  • Nurses: Nurses are at the front line of medication administration and patient monitoring. Their input is crucial for practical considerations in medication administration workflows, identifying potential error-prone areas, and ensuring patient-centered care.

  • Quality Department: Quality personnel ensure that medication management processes are aligned with quality improvement principles, are regularly audited, and contribute to overall patient safety goals and accreditation standards.

• Benefits of the Committee's Responsibilities:

  • Developing Processes: The committee's collaborative nature ensures processes are practical, clinically sound, and address the needs of all stakeholders.

  • Formulary Management: The multidisciplinary input leads to a formulary that is evidence-based, considers cost-effectiveness, and meets the diverse therapeutic needs of the hospital's patient population, avoiding being driven purely by cost or single-specialty preferences.

  • Evaluating Medication Use: The committee can analyze medication usage data from different perspectives (clinical, pharmacy, cost) to identify patterns, areas for improvement in prescribing practices, and potential cost savings opportunities, while always prioritizing patient safety and outcomes.

  • Monitoring Safety Incidents: The committee can collectively analyze medication errors and ADRs from different viewpoints to identify root causes that might be missed by a single department and develop more effective system-wide corrective actions.

3. MOM 1c: A multidisciplinary committee update medication management processes. (A) - Expanded Detail

• Rationale: Healthcare is not static. New medications, guidelines, technologies, and safety concerns constantly emerge. A stagnant medication management system will become outdated and potentially unsafe. Continuous improvement through regular updates is essential to maintain a safe and contemporary system.

• Importance of "Monitor and Use Information":

  • Monitor Literature Reviews and Best Practices: This is proactive learning. The committee doesn't just react to problems; it actively seeks out new knowledge to prevent problems and improve proactively. This could involve:

    • Subscribing to pharmacy journals and safety newsletters.

    • Attending conferences and webinars on medication safety and best practices.

    • Reviewing alerts and guidelines from organizations like ISMP (Institute for Safe Medication Practices), FDA, WHO, and relevant national bodies.

    • Benchmarking against best-performing hospitals or healthcare systems in medication safety.

  • Use Information to Update Processes: The gathered information isn't just for knowledge; it's for action. This step involves:

    • Translating new guidelines or best practices into concrete revisions of hospital policies, procedures, and protocols.

    • Disseminating updated information to relevant staff through training, memos, or electronic communication.

    • Implementing changes in workflows or systems based on new safety recommendations or technological advancements.

• Real-World Update Examples:

  • Example 1: Look-Alike Sound-Alike (LASA) Medications: If new LASA drug pairs are identified nationally or internationally, the committee should update the hospital's LASA drug list, review storage strategies (as per MOM 3e), and update staff training to emphasize awareness of these new pairs.

  • Example 2: High-Risk Medication Updates: If national guidelines for safe use of a particular high-risk medication category (like concentrated electrolytes) are updated, the committee should review the hospital's protocols for prescribing, dispensing, administering, and monitoring these medications and make necessary revisions to align with the latest recommendations.

  • Example 3: Medication Error Trends: If the committee’s medication error analysis (as per MOM 8e) reveals a recurring type of error (e.g., wrong dose calculations in pediatric patients), they should proactively review and update relevant processes, potentially implement double-check systems for pediatric doses, or provide focused training to staff on pediatric medication safety.

4. MOM 1d: There is a procedure to obtain medication when the pharmacy is closed. * (C) - Expanded Detail

• Rationale: Patients' medical needs don't adhere to pharmacy opening hours. Emergencies can occur at any time, and inpatients require continuous medication access. Ensuring 24/7 medication availability is a patient safety imperative. A procedure for after-hours access bridges the gap when the regular pharmacy is unavailable.

• Components of a Robust After-Hours Procedure:

  • Clear Trigger: The procedure needs a clear definition of "pharmacy closed" – is it nights only? Weekends? Holidays? This defines when the after-hours procedure kicks in.

  • Designated Access Points: Are there designated individuals who can access a limited after-hours medication supply? Is there a secure medication cabinet or dispensing system for after-hours access?

  • Authorized Personnel: Who is authorized to access and dispense medications after hours? Usually, this would be senior nurses, on-call physicians, or a designated on-call pharmacist (if available).

  • Limited Formulary: After-hours access often involves a limited formulary of essential emergency medications, not the full range of the hospital formulary. This limits risk and complexity while still meeting urgent needs. The procedure should define this limited formulary.

  • Documentation and Accountability: Every medication dispensed through the after-hours procedure must be carefully documented (patient name, medication, dose, time, person dispensing) to maintain accountability, inventory control, and ensure accurate billing.

  • SOP Details: The SOP itself should outline step-by-step instructions:

    1. Confirmation of pharmacy closure.

    2. Authorization process for accessing medications (who needs to approve).

    3. Location of after-hours medication stock.

    4. Dispensing and documentation steps.

    5. Procedure for replenishing after-hours stock when the pharmacy reopens.

• Why 24-Hour Pharmacy is Preferable: While an after-hours procedure is a minimum requirement, a 24-hour pharmacy offers significant advantages:

  • Full Pharmacist Oversight: 24/7 pharmacy ensures continuous pharmacist review of prescriptions, dispensing accuracy, and drug information support, minimizing errors and maximizing patient safety at all times.

  • Wider Medication Availability: A 24-hour pharmacy can maintain a broader range of medications readily available, not just a limited emergency stock.

  • Improved Efficiency and Workflow: Reduces reliance on complex after-hours procedures and designated personnel, streamlining medication access for staff and patients around the clock.

5. MOM 1e: The organisation has a mechanism to inform relevant staff of key changes in pharmacy services and medication management to ensure uninterrupted and safe care. (C) - Expanded Detail

• Rationale: Information is power, especially in a complex system like medication management. If staff are unaware of crucial changes, errors and unsafe practices are more likely. Timely and effective communication is a critical safeguard.

• Characteristics of an Effective Communication Mechanism:

  • Designated Responsible Person/Team: Clearly identify who is responsible for initiating and disseminating these communications (e.g., Pharmacy In-charge, Medication Safety Officer, Pharmacy Committee).

  • Multiple Communication Channels: Utilize various methods to reach all relevant staff. Examples include:

    • Email alerts: For broad announcements and updates.

    • Intranet postings: For detailed information, policies, and procedures.

    • Department meetings/huddles: For face-to-face communication, discussions, and Q&A, especially for critical or complex changes.

    • Notice boards/bulletin boards: For visual reminders and quick updates in key areas like pharmacy, nursing stations.

    • Training sessions/workshops: For more in-depth education on significant changes or new protocols.

  • Defined Content and Format: Standardize the communication format to ensure clarity and consistency. Information should be concise, accurate, actionable, and easily understandable.

  • Targeted Communication: Ensure that communication reaches the relevant staff. Not every change needs to be communicated to every single employee. Identify the staff groups who need to be informed about each specific type of change.

  • Documentation of Communication: Keep records of communications sent (e.g., email logs, meeting minutes) as proof of compliance and for future reference.

• Examples of Communication Scenarios:

  • Medication Shortages: When a drug goes into shortage:

    • Pharmacy informs prescribers about the shortage and recommends therapeutic alternatives (via email, intranet).

    • Pharmacy staff updates dispensing system to reflect the shortage and guide substitutions.

    • Nursing staff is informed about potential changes in medication orders and alternative options.

  • Drug Recall: For a Class I recall (serious risk):

    • Pharmacy immediately issues a hospital-wide alert (email, urgent intranet posting).

    • Pharmacy and nursing staff are tasked with identifying and removing the recalled product from all storage locations (pharmacy, wards, crash carts).

    • Prescribers are notified to immediately discontinue use of the recalled drug and consider alternatives.

    • Patients who may have received the recalled drug may need to be identified and contacted (depending on the nature of the recall).

  • Serious Adverse Medication Event Trends: If analysis reveals a concerning trend in ADRs with a particular drug or drug class:

    • The Pharmacy Committee/Medication Safety Officer might issue an alert to prescribers about the trend, recommending more cautious prescribing or specific monitoring strategies.

    • Nursing staff might be alerted to be especially vigilant for signs of ADRs with that drug.

    • Pharmacy may review dispensing procedures to ensure appropriate patient counseling about potential side effects.

MOM2: The organisation develops, updates and implements a hospital formulary.

This standard focuses on the crucial role of a hospital formulary in ensuring rational, safe, and cost-effective medication use. A formulary is essentially a list of medications approved for use within a hospital. It's a dynamic document that reflects the hospital's clinical needs, evidence-based practices, and safety considerations.

Let's break down the objective elements (sub-sections) of MOM 2:

1. MOM 2a: A list of medications appropriate for the patients and as per the scope of the organisation's clinical services is developed collaboratively by the multidisciplinary committee. (CO)

• Key Phrase: "Developed collaboratively by the multidisciplinary committee" and "appropriate for patients and scope of services."

• Requirement: The hospital's formulary isn't just created in isolation by the pharmacy department. It must be a product of collaborative effort by the multidisciplinary committee (as established in MOM 1b). The selection of medications for the formulary must be directly tied to the patient population served by the hospital and the range of clinical services it offers. It's about aligning the available medications with the actual needs of the hospital's patients.

• Rationale: A collaboratively developed formulary ensures:

  • Clinical Relevance: Medications included are those genuinely needed by the hospital's patient population, considering the diseases treated and services offered.

  • Evidence-Based Practice: Selection can be based on clinical guidelines, efficacy data, and expert consensus, rather than solely on cost or pharmaceutical company promotions.

  • Multidisciplinary Input: Input from clinicians, pharmacists, and administration ensures a balanced approach, considering clinical needs, pharmacy operations, and cost-effectiveness.

  • Rational Use: A well-defined formulary promotes more rational prescribing, as clinicians are guided towards a pre-approved list of effective and safe medications.

• Practical Implementation - Developing the Formulary:

  • Develop Based On:

    • Organisation's mission: The formulary should align with the hospital's overall mission and values. For example, a mission focused on specialized care for cardiac patients would necessitate a strong cardiology section within the formulary.

    • Patient's need: The formulary should prioritize medications commonly used to treat the conditions prevalent in the hospital's patient population. Consider epidemiological data for the region.

    • Scope of services: The range of clinical services offered by the hospital directly dictates the required medication categories in the formulary. A hospital with a robust oncology department will need a comprehensive chemotherapy section.

  • Include: The essential components to be specified for each medication in the formulary list:

    • Name of the molecule (Generic name): Using generic names promotes consistency and cost-effectiveness. Brand names might be listed alongside for clarity, but generic names should be primary.

    • Formulation: Specify the available dosage forms (tablets, injections, creams, solutions, etc.). The formulary might list multiple formulations if clinically relevant (e.g., both oral and IV forms of an antibiotic).

    • Strength(s): Detail the available strengths for each formulation (e.g., amoxicillin 250mg capsules, 500mg tablets). This helps guide prescribing and dispensing and standardizes available options.

  • Consider: Factors the committee must deliberate upon during formulary development:

    • Harm potential of a medication: Evaluate the risk-benefit profile. Medications with a higher potential for serious adverse events (high-risk medications – see MOM 3c) might require stricter formulary inclusion criteria, usage guidelines, or even restriction.

    • Interaction with other medications: Consider common drug interactions, especially if the hospital patient population is likely to be on multiple medications (e.g., elderly patients). The formulary could prioritize medications with fewer interaction concerns or include guidelines on managing interactions.

    • Likelihood of patient safety incidents: Medications known to be associated with a higher rate of medication errors (e.g., LASA drugs) might require special consideration in formulary inclusion and necessitate extra safety measures.

  • Limit: A crucial aspect of formulary management:

    • Number of drug concentrations of a drug: Limiting the number of strengths and formulations of a drug is a key formulary management strategy. Too many options can increase complexity, confusion, and the risk of medication errors. Standardizing to a clinically sufficient but limited range of strengths simplifies processes and reduces errors.

  • Points to Remember:

    • Organisation can have system wise/speciality wise formulary: Hospitals can choose to have a hospital-wide formulary or develop specialty-specific formularies (e.g., a cardiology formulary, an oncology formulary) if their services are highly specialized. However, a central, overarching formulary system is usually beneficial for consistency and overall management.

    • Implants and devices are considered as drugs: For the purpose of NABH MOM standards, implantable prosthesis and medical devices are also considered under the umbrella of "medications" or items to be managed within the medication management system. This is important for MOM 10 specifically.

2. MOM 2b: The list is reviewed and updated collaboratively by the multidisciplinary committee at least annually. (C)

• Key Phrase: "Reviewed and updated collaboratively...at least annually." Emphasizes dynamism and regular review.

• Requirement: The formulary is not a static document. It needs to be reviewed and updated at least once a year by the multidisciplinary committee. This ensures it remains current with the latest medical advances, safety information, and changing patient needs. "Collaboratively" is reiterated, emphasizing that updates should also be a committee decision.

• Rationale: Regular review and update is critical because:

  • Medical Advancements: New, more effective, or safer medications are continuously being developed. The formulary needs to incorporate these advancements to provide patients with the best possible care.

  • Safety Updates: New safety information, drug recalls, or adverse event reports may necessitate changes in formulary inclusion, usage guidelines, or even removal of certain medications.

  • Changing Disease Patterns: The prevalence of diseases within the hospital's patient population might shift over time, requiring adjustments to the formulary to reflect current needs.

  • Cost-Effectiveness Considerations: Generic medications become available, or the cost of certain medications might change significantly. Formulary updates can consider these factors to promote cost-effective yet clinically appropriate medication use.

  • Resistance Patterns: In areas like antibiotics, emerging resistance patterns require formulary updates to ensure the hospital is using the most effective agents while minimizing the development of further resistance.

• Practical Implementation - Reviewing and Updating:

  • Review and update: The scope of the review can be:

    • All medications: A comprehensive annual review of the entire formulary.

    • Only certain medication categories: Focused reviews on specific therapeutic areas (e.g., antibiotics, anticoagulants, pain medications) based on emerging issues, new guidelines, or usage data.

  • Include in revised list: Important source of input for formulary updates:

    • Non-formulary drugs procured previous year: If there's a pattern of frequently procuring medications that are not on the formulary (through non-formulary drug request processes – see MOM 2f), it indicates a potential gap in the current formulary. The committee should review these non-formulary drugs to assess if some should be added to the regular formulary in the next revision.

  • Discuss: Key aspects to be discussed during the review and update process:

    • Aspects of patient safety including adverse drug reactions: Review ADR reports, medication error data, and any safety concerns related to formulary medications. This could lead to removing certain drugs, adding warnings, or tightening usage guidelines.

    • Changing disease pattern and changing resistance pattern: Analyze hospital epidemiological data, antibiotic resistance trends in the community and within the hospital, and update the formulary to align with these patterns. For instance, if resistance to a certain antibiotic class is rising, the formulary might need to favor alternative classes.

    • Cost: Consider the cost implications of formulary changes. Evaluate the cost-effectiveness of newer medications versus existing ones, explore generic alternatives, and assess the overall budget impact of formulary decisions.

  • Note: "The multidisciplinary committee should review and update the list at least annually." Reinforces the minimum frequency. More frequent reviews might be necessary if there are rapid changes in medical practice or significant safety alerts.

3. MOM 2c: The current formulary is available for clinicians to refer to. (C)

• Key Phrase: "Available for clinicians to refer to." Emphasis on accessibility and point-of-care use.

• Requirement: The formulary is only useful if it is easily accessible to the clinicians who need to prescribe medications. This standard mandates that the current version of the formulary must be readily available for reference by treating doctors and clinicians.

• Rationale: If clinicians don't have easy access to the formulary:

  • They might prescribe medications not on the formulary, leading to increased costs, potential stock-out issues for non-formulary drugs, and deviation from rational prescribing.

  • They may not be aware of formulary restrictions, preferred agents, or updated guidelines.

  • The intended benefits of having a formulary (rational prescribing, cost-effectiveness, safety guidance) are diminished if it's not easily used in practice.

• Practical Implementation - Ensuring Formulary Availability:

  • Who should have access to current version of formulary?

    • Treating doctors and clinicians: Anyone authorized to prescribe medications needs ready access. This includes physicians, residents, and in some settings, authorized advanced practice providers.

  • How can it be made available? Flexible options for access:

    • Physical form (Printed formulary): Traditional printed formulary booklets can be placed at key locations like nursing stations, clinics, and pharmacies. However, printed versions can quickly become outdated.

    • Electronic form (e-Formulary): Electronic access is generally preferred for easier updating and broader availability. Options include:

      • Hospital Intranet: Hosting the formulary on the hospital's intranet for access from any computer within the network.

      • Electronic Health Record (EHR) integration: Ideally, the formulary should be integrated into the EHR system, allowing prescribers to easily check formulary status and preferred medications directly within their prescribing workflow. This is the most seamless and effective approach.

      • Mobile Apps/Web-based Access: Providing web-based or mobile app access for clinicians to check the formulary from hospital devices or even their personal devices (following hospital security policies).

    • Regular Updates and Communication: Regardless of the format, it's vital to ensure that the formulary is always current and that any updates are promptly communicated to clinicians.

4. MOM 2d: The clinicians adhere to the current formulary. (A)

• Key Phrase: "Clinicians adhere to the current formulary." Emphasis on compliance and appropriate prescribing.

• Requirement: Having a formulary and making it available is not enough. This standard requires that clinicians actively adhere to the current formulary when prescribing medications. The expectation is that clinicians should primarily prescribe medications that are listed in the formulary, promoting rational use and cost-effectiveness.

• Rationale: Adherence to the formulary:

  • Promotes Rational Prescribing: Guides clinicians towards using medications that have been vetted by the multidisciplinary committee, ensuring they are evidence-based and appropriate for the hospital's patient population.

  • Enhances Patient Safety: Formulary decisions often incorporate safety considerations, promoting the use of safer alternatives or establishing guidelines for medications with higher risk.

  • Controls Costs: Formularies often prioritize cost-effective medications and generic alternatives, helping to manage hospital medication expenditure.

  • Streamlines Pharmacy Operations: A well-adhered-to formulary simplifies pharmacy inventory management, procurement, and dispensing processes.

• Practical Implementation - Promoting Clinician Adherence:

  • Clinician Action:

    • Prescribe drugs as per current formulary: The primary expectation is to prescribe formulary medications unless there is a compelling clinical reason to use a non-formulary drug for a specific patient.

  • Organisation Action: Monitoring and feedback mechanisms to track adherence:

    • Monitor frequency of prescription being rejected/local purchase done as it contained non-formulary drugs: Pharmacy systems should track prescriptions that are for non-formulary medications and require manual intervention (rejection or local purchase - meaning buying outside of regular contracts). A high frequency of these can indicate poor formulary adherence or gaps in the formulary.

    • Feedback and Education: If monitoring reveals low adherence, the multidisciplinary committee should investigate the reasons. It may require:

      • Education for clinicians: Reinforcing the importance of formulary adherence, explaining formulary policies, and highlighting the availability of the formulary resource.

      • Addressing Formulary Gaps: If clinicians are frequently requesting non-formulary medications because the formulary is missing essential drugs for specific clinical situations, the committee needs to reconsider formulary inclusions during the next review.

      • Streamlining Non-Formulary Request Process: While formulary adherence is the goal, there should be a clear and efficient process for clinicians to request non-formulary medications when clinically justified (MOM 2f addresses this). This ensures that patient needs are met while maintaining a degree of control over non-formulary use.

  • Objective element changed from excellence to achievement: In the 5th edition, this might have been considered an "excellence" level indicator. Shifting it to "achievement" in the 6th edition suggests that demonstrable formulary adherence is now considered a more fundamental expectation for accreditation, highlighting its importance for quality and safety.

5. MOM 2e: The organisation adheres to the procedure for the acquisition of formulary medications. * (C)

• Key Phrase: "Procedure for the acquisition of formulary medications." Focus on a structured procurement process.

• Requirement: The hospital must have a well-defined procedure and actively adhere to it when acquiring medications that are listed in the formulary. This ensures a reliable, safe, and cost-effective medication supply chain for formulary drugs.

• Rationale: A structured acquisition process for formulary drugs is essential for:

  • Consistent Supply: Ensuring that formulary medications are consistently available when needed, preventing stock-outs that could disrupt patient care.

  • Quality Assurance: Selecting reliable vendors and following quality control steps during procurement helps ensure the medications purchased are of good quality, authentic, and meet required standards.

  • Cost Management: A well-defined process can incorporate strategies for vendor negotiation, bulk purchasing, and competitive bidding to optimize medication costs.

  • Regulatory Compliance: Procurement procedures must comply with relevant regulations and legal requirements for purchasing, storing, and handling pharmaceuticals.

• Practical Implementation - Acquisition Procedure Steps:

  • Vendor selection:

    • Establish criteria for vendor selection (reputation, reliability, quality certifications, regulatory compliance, price competitiveness, service).

    • Maintain a list of approved vendors.

    • Conduct periodic vendor evaluations (MOM 2e itself mentions "Vendor evaluation" again, likely referring to initial selection and ongoing performance monitoring).

  • Vendor evaluation: Ongoing assessment of vendor performance, including:

    • Timeliness of deliveries.

    • Quality of products.

    • Responsiveness to issues.

    • Compliance with agreements.

  • Reorder levels:

    • Establish appropriate reorder levels for each formulary medication based on usage patterns, lead times from vendors, and desired stock levels. This prevents stock-outs while avoiding excessive inventory.

  • Indenting process:

    • Define a clear process for departments to "indent" or request medications from the pharmacy. This might involve electronic requisition systems, standardized order forms, and authorized personnel for placing orders.

  • Generation of purchase orders:

    • Outline the steps for generating purchase orders based on indent requests, ensuring proper authorization, budget approvals, and documentation of orders placed with vendors.

  • Receipt of goods:

    • Establish procedures for receiving medication deliveries:

      • Verifying quantities against purchase orders.

      • Inspecting for damage, expiry dates, and batch numbers.

      • Properly documenting receipt of goods.

  • Stock-outs management:

    • Have a plan to manage medication stock-outs if they occur despite good procurement practices. This might involve:

      • Identifying therapeutic alternatives.

      • Expedited procurement from alternative vendors if possible.

      • Communicating stock-out situations to prescribers and relevant clinical staff.

6. MOM 2f: The organisation adheres to the procedure to obtain medications not listed in the formulary. * (C)

• Key Phrase: "Procedure to obtain medications not listed in the formulary" - Balancing formulary adherence with patient needs.

• Requirement: While formulary adherence is important (MOM 2d), there will be legitimate clinical situations where a clinician needs to prescribe a medication that is not on the formulary. This standard requires a clear procedure for obtaining these non-formulary medications. The procedure should ensure that non-formulary use is justified, controlled, and potentially informs future formulary updates.

• Rationale: A non-formulary drug request procedure:

  • Balances Formulary Adherence with Patient Needs: A rigid formulary could hinder optimal patient care in specific circumstances. A mechanism to access non-formulary drugs ensures flexibility for unique clinical scenarios.

  • Controls Non-Formulary Use: The procedure should have built-in checks to ensure non-formulary drug requests are clinically justified and not simply due to clinician preference or lack of formulary awareness.

  • Informs Formulary Updates: Tracking non-formulary requests provides valuable data to the formulary committee. Frequent requests for certain drugs may indicate a need to reconsider their inclusion in the regular formulary in future revisions (MOM 2b).

  • Maintains Documentation and Accountability: Properly documenting non-formulary requests provides a record of why these drugs were used, ensuring accountability and enabling review for appropriateness.

• Practical Implementation - Non-Formulary Drug Request Procedure:

  • Flowchart of Steps (as shown in the slide):

    • Local purchase outside the formulary (Trigger): A clinician identifies a need for a non-formulary medication for a specific patient.

    • Evaluate: The request is evaluated. Who evaluates it? This is crucial. It could be:

      • Pharmacist review: Pharmacist can review for drug interactions, appropriateness, formulary alternatives, and potential safety issues.

      • Peer review (e.g., by a senior clinician or departmental head): For high-cost or unusual requests, peer review can add another layer of clinical justification.

    • Authorise: Authorization step. Who authorizes?

      • Pharmacy authorization: Pharmacy can authorize based on clinical justification from the prescriber and their own review.

      • Designated authority authorization: For very expensive or restricted non-formulary drugs, a designated authority (e.g., Head of Department, Pharmacy Committee chair, or a senior administrator) might be required to authorize.

    • Ratify: Ratification step. This might involve:

      • Pharmacy documentation: Pharmacy documents the non-formulary drug dispensing, cost, and reason.

      • Committee review (periodic): The formulary committee periodically reviews a summary of non-formulary drug use (perhaps quarterly or annually) to identify trends and inform formulary updates.

    • Decide subsequent inclusion in formulary: Based on the pattern and justification for non-formulary drug use, the formulary committee decides whether to include the medication in the regular formulary during the next review cycle (MOM 2b). If a particular drug is frequently requested and clinically justified, it's a strong indicator for potential formulary inclusion.

Overall Summary of MOM 2:

MOM Standard 2 is all about establishing and managing a robust hospital formulary system. It highlights the importance of:

• Collaborative Development and Updating (MOM 2a & 2b): Ensuring the formulary is clinically relevant, evidence-based, and continuously improved through multidisciplinary input.

• Accessibility (MOM 2c): Making the formulary a practical tool for clinicians at the point of care.

• Adherence and Monitoring (MOM 2d): Promoting formulary compliance and tracking non-formulary use to inform improvements.

• Structured Acquisition (MOM 2e & 2f): Having defined procedures for both formulary and non-formulary drug procurement to ensure supply, quality, cost-effectiveness, and appropriate usage.

MOM3: Medications are stored appropriately and are available where required.

This standard emphasizes two crucial aspects of medication management:

1. Appropriate Storage: Medications must be stored under conditions that maintain their quality, safety, and efficacy throughout their shelf life. This includes considerations for temperature, light, humidity, security, and organization.

2. Availability Where Required: Medications must be accessible at the right locations (pharmacy, wards, emergency areas) and in sufficient quantities to meet patient needs promptly.

Now, let's dissect each objective element within MOM 3:

1. MOM 3a: Medications are stored in a clean, safe and secure environment and incorporating the manufacturer's recommendation(s). (CO)

• Key Phrases: "Clean, safe and secure environment" and "manufacturer's recommendation(s)."

• Requirement: This objective element mandates that medication storage environments within the hospital must meet stringent criteria:

  • Clean: Storage areas must be clean and hygienic to prevent contamination of medications.

  • Safe: Storage must be safe for both the medications themselves (protecting their integrity) and for the personnel handling them.

  • Secure: Storage must be secure to prevent unauthorized access, diversion, theft, and loss of medications, especially controlled substances and high-value drugs.

  • Manufacturer's Recommendation(s): Hospitals must adhere to the storage instructions provided by the medication manufacturers. These recommendations are based on scientific stability studies and are critical for maintaining drug quality.

• Rationale: Proper storage is paramount to:

  • Maintain Medication Efficacy: Incorrect storage (e.g., temperature excursions) can degrade active pharmaceutical ingredients, reducing the drug's intended therapeutic effect, potentially leading to treatment failure.

  • Ensure Patient Safety: Degraded medications can not only be ineffective but also potentially produce harmful byproducts, posing a direct risk to patient safety.

  • Prevent Contamination: Unclean storage areas can harbor microorganisms or contaminants that could compromise medication sterility and safety, particularly for injectables and sterile preparations.

  • Control Diversion and Abuse: Secure storage, especially for controlled substances like narcotics and psychotropics, is legally mandated and ethically essential to prevent diversion, misuse, and abuse.

  • Meet Regulatory Requirements: Accreditation standards (like NABH) and regulatory bodies mandate proper medication storage practices as a fundamental aspect of patient safety and pharmaceutical quality assurance.

• Practical Implementation - Creating a Compliant Storage Environment:

  • Storage Space: Clean, Safe, Secure and Organised:

    • Cleanliness: Implement regular cleaning schedules for medication storage areas, shelves, and refrigerators. Use appropriate cleaning agents that are compatible with pharmaceutical environments.

    • Safety:

      • Ensure adequate ventilation and appropriate temperature and humidity control in storage areas.

      • Provide adequate lighting for visibility and accurate medication selection.

      • Storage areas should be free from pests, rodents, and other potential contaminants.

      • Implement measures to prevent spills and breakages.

    • Secure:

      • Restrict access to medication storage areas to authorized personnel only (pharmacy staff, designated nurses, etc.).

      • Use locked cabinets, rooms, or automated dispensing systems, especially for controlled substances and high-value medications.

      • Implement inventory tracking systems and regular audits to detect and prevent medication diversion.

    • Organised:

      • Implement a systematic storage arrangement (e.g., alphabetical order by generic name, therapeutic category).

      • Use clear labeling and signage for shelves, bins, and drawers to facilitate easy medication identification and retrieval.

      • Separate different dosage forms and strengths of medications to minimize mix-ups.

  • Storage requirements: Adhere to manufacturer's instructions/develop and implement guidelines:

    • Manufacturer's Instructions are Key: The first and most important step is to always consult the medication's packaging insert or manufacturer's prescribing information for specific storage instructions (temperature range, light sensitivity, humidity, etc.).

    • Develop Hospital Guidelines: Translate manufacturer's recommendations into practical hospital-wide guidelines and Standard Operating Procedures (SOPs). These guidelines should specify:

      • Temperature monitoring frequency and documentation in medication storage areas, especially refrigerators and temperature-controlled rooms.

      • Actions to take in case of temperature excursions (out-of-range readings).

      • Procedures for handling light-sensitive medications (storage in light-protective containers or areas).

      • Humidity control measures, if relevant (especially in areas with high humidity).

      • Protocols for managing power outages that could affect temperature-controlled storage.

  • Storage of beyond expiry date drugs (before disposal): Store these drugs away from drugs intended for patient use:

    • Expired medications pose a risk of being inadvertently dispensed or administered. Therefore, expired drugs must be:

      • Immediately removed from active medication stock upon expiry.

      • Segregated and stored in a separate, clearly marked area that is physically distinct from medications intended for patient use.

      • Stored in a designated "quarantine" area pending proper disposal according to hospital policy and regulatory requirements.

2. MOM 3b: Sound inventory control practices guide storage of the medications throughout the organisation. (C)

• Key Phrase: "Sound inventory control practices." Focus on organized and efficient storage management.

• Requirement: Effective inventory control practices must guide how medications are stored throughout the hospital – not just in the central pharmacy, but also in wards, clinics, and other areas where medications are stored. This is about organized storage that supports efficient stock management and minimizes waste and errors.

• Rationale: Sound inventory control in medication storage is crucial for:

  • Preventing Stock-Outs: Effective inventory management ensures that essential medications are consistently available when patients need them, avoiding treatment delays or interruptions.

  • Minimizing Expiry and Waste: Proper inventory control, especially using "First-Expiry, First-Out" (FEFO) principles, reduces the risk of medications expiring before use, minimizing drug waste and associated costs.

  • Optimizing Stock Levels: Sound practices help maintain appropriate stock levels – neither too high (leading to expiry and storage space issues) nor too low (leading to stock-outs).

  • Improving Efficiency: Organized storage facilitated by inventory control makes it easier and faster for pharmacy staff and nurses to locate and retrieve medications, improving workflow efficiency.

• Practical Implementation - Inventory Control Methods for Storage:

  • Always, better and control (ABC) (Based on cost):

    • ABC analysis categorizes inventory items based on their annual consumption value (cost).

    • "A" items: High-value medications (typically 70-80% of total drug expenditure) - require tight control, frequent monitoring, and precise inventory management. Examples: expensive biologics, specialized cancer drugs.

    • "B" items: Medium-value medications (around 15-20% of expenditure) - moderate level of control and monitoring. Examples: commonly used antibiotics, antihypertensives.

    • "C" items: Low-value medications (around 5-10% of expenditure) - simpler inventory control methods, less frequent monitoring. Examples: common analgesics, multivitamins.

    • Storage strategies can be tailored based on ABC category. "A" items might have more secure, closely tracked storage, while "C" items might have simpler stock management.

  • Vital, essential and desirable (VED) (Based on criticality):

    • VED analysis classifies medications based on their clinical criticality.

    • "Vital" drugs: Life-saving medications, absolutely essential for patient survival in critical conditions (e.g., epinephrine, emergency cardiac drugs). Must always be in stock.

    • "Essential" drugs: Medications needed for managing common conditions, important for routine patient care (e.g., commonly used antibiotics, analgesics). Should be readily available.

    • "Desirable" drugs: Supportive medications or those used for less critical conditions or as adjunct therapy. Stocking levels can be more flexible, and temporary stock-outs are less critical.

    • "Vital" medications, by their nature, should have robust storage and inventory control to guarantee constant availability.

  • Fast moving, slow moving and non-moving (FSN):

    • FSN analysis categorizes medications based on their rate of consumption.

    • "Fast-moving" drugs: High consumption, frequently used medications. Require larger stock levels and frequent replenishment. Should be stored in easily accessible locations for quick retrieval.

    • "Slow-moving" drugs: Lower consumption rate. Smaller stock levels, less frequent ordering. Can be stored in less prime storage locations.

    • "Non-moving" drugs: Very low or no consumption over a defined period. Need careful review. May indicate overstocking, formulary changes, or potential expiry. Need to minimize stocking to prevent waste.

    • FSN analysis helps optimize storage layout. Fast-moving drugs should be readily accessible, while slow-moving or non-moving items can be stored in less convenient locations.

  • First expiry, first out (FEFO):

    • FEFO is a fundamental principle of medication storage and dispensing. Medications with the earliest expiry dates should always be stored in front and dispensed first to minimize expiry and waste.

    • Implement FEFO by:

      • Organizing shelves so that earlier expiry medications are placed in the front and are easily accessible.

      • Training pharmacy and nursing staff to always check expiry dates and pick the medications with the soonest expiry first.

  • Lead time analysis:

    • "Lead time" is the time interval between placing an order for a medication and receiving it from the vendor.

    • Lead time analysis involves:

      • Tracking the typical lead times for different medications from various vendors.

      • Incorporating lead time information into inventory management systems and reorder point calculations.

    • Accurate lead time data helps in setting appropriate reorder levels to prevent stock-outs while minimizing overstocking.

3. MOM 3c: The organisation defines a list of high-risk medication(s). * (CO)

• Key Phrase: "Defines a list of high-risk medication(s)." Proactive identification of dangerous medications.

• Requirement: Hospitals must proactively define and maintain a list of "high-risk" or "high-alert" medications. These are medications that have a heightened risk of causing significant patient harm if used in error. This list is the basis for implementing enhanced safety strategies throughout the medication use process.

• Rationale: Identifying high-risk medications is a cornerstone of medication safety because:

  • Prioritization of Safety Efforts: Focuses resources and attention on the medications that pose the greatest potential for harm, allowing hospitals to implement targeted safety strategies.

  • Error Prevention: Knowing which medications are high-risk allows hospitals to implement extra layers of safety measures at each step of the medication use process (prescribing, dispensing, administration, monitoring) to minimize the chance of errors.

  • Standardization and Awareness: A defined high-risk medication list promotes staff awareness and consistent application of enhanced safety protocols across the hospital.

• Practical Implementation - Defining the High-Risk Medication List:

  • High-risk/high alert medications carry heightened risk for adverse outcomes: The definition of high-risk medications is based on their inherent properties and potential for harm.

  • Cause catastrophic harm in case of error: Errors with these medications can have severe, even life-threatening consequences for patients.

  • Examples (Points to Remember): The slide provides examples of common high-risk medication categories, but each hospital needs to develop its own list based on its patient population, services, and medication usage patterns. Common categories include:

    • Medications with low therapeutic window: Drugs where the difference between a therapeutic dose and a toxic dose is small, increasing the risk of toxicity if dosage errors occur. Examples: digoxin, warfarin, lithium, theophylline.

    • Controlled substances (Narcotics and psychotropic agents): High potential for abuse, diversion, and respiratory depression if misused or overdosed. Examples: opioids (morphine, fentanyl, hydromorphone), benzodiazepines.

    • Psychotherapeutic medications: Medications used for psychiatric conditions that can have significant side effects, drug interactions, and require careful monitoring. Examples: antipsychotics, antidepressants, mood stabilizers.

    • Look-alike, sound alike (LASA) medications: Drug names or packaging that are easily confused with each other, leading to medication mix-ups. Hospitals should develop their own LASA lists specific to their formulary.

    • Concentrated electrolytes: Highly concentrated solutions of electrolytes (potassium chloride, sodium chloride, magnesium sulfate, etc.) which can cause severe electrolyte imbalances and cardiac arrest if administered undiluted or incorrectly.

    • Chemotherapeutic agents: Potent cytotoxic drugs used in cancer treatment with narrow therapeutic windows and significant toxicity.

    • Insulin: Crucial for diabetes management but dosage errors can lead to hypo- or hyperglycemia, both of which can be dangerous.

    • Anticoagulants: Medications that prevent blood clotting (warfarin, heparin, enoxaparin, etc.). Over-anticoagulation can lead to bleeding complications; under-anticoagulation can increase the risk of thromboembolism.

  • Process for Developing the List: The multidisciplinary committee (MOM 1b) should be responsible for creating and regularly reviewing the high-risk medication list. The process should involve:

    • Reviewing national and international lists of high-alert medications (e.g., ISMP High-Alert Medication List).

    • Analyzing the hospital's own medication error data and ADR reports to identify medications frequently involved in errors or causing harm.

    • Considering the hospital's formulary, patient population, and services offered.

    • Regularly reviewing and updating the list (at least annually or more frequently as needed) to reflect new safety information and changes in medication usage.

4. MOM 3d: High-risk medications are stored in areas of the organisation where it is clinically necessary. (A)

• Key Phrase: "Stored in areas...where it is clinically necessary." Controlled and targeted availability.

• Requirement: While high-risk medications must be available for legitimate clinical needs, their storage should be controlled and targeted to areas where they are truly needed for patient care. This element aims to balance accessibility with enhanced security and control.

• Rationale: Controlled storage of high-risk medications:

  • Enhances Security: Limiting storage locations reduces the number of places where these potent drugs are accessible, making it easier to implement enhanced security measures and inventory control, especially for controlled substances prone to diversion.

  • Focuses Safety Efforts: Concentrating high-risk medication storage in specific areas allows for more focused implementation of error prevention strategies and specialized storage conditions in those locations.

  • Minimizes Unnecessary Distribution: Prevents the widespread distribution of high-risk medications throughout the hospital, reducing potential exposure and the risk of errors in areas where they are less frequently needed and staff might be less familiar with their specific handling requirements.

• Practical Implementation - Controlled Storage Areas:

  • Store high-risk medications in pre-determined areas: Identify specific locations within the hospital where high-risk medications will be routinely stored. Examples could be:

    • Central pharmacy: For bulk stock and controlled dispensing.

    • Intensive Care Units (ICUs): For critical care medications, including concentrated electrolytes and vasoactive drugs, often stored in automated dispensing cabinets with restricted access.

    • Operating Rooms (ORs): For anaesthetic agents and emergency medications.

    • Designated areas in wards (with secure access): If high-risk medications are routinely used on certain wards (e.g., oncology, cardiology), consider designated, secure storage (locked medication carts, automated dispensing units) within those wards rather than scattered throughout general ward stock.

  • Determine their availability in these areas based on clinical needs: The quantity and type of high-risk medications stored in each designated area should be based on a clinical need assessment:

    • ICUs would require a broader range and larger quantities of certain high-risk medications (e.g., vasoactive drugs, concentrated electrolytes) compared to general medical wards.

    • Ward stock of high-risk medications should be minimized and only include those routinely required on that specific ward, with most high-risk drugs dispensed from the pharmacy on a patient-specific basis.

  • Adhere to regulations, where applicable (storing narcotics): For controlled substances (narcotics and psychotropics), storage must strictly comply with all applicable legal and regulatory requirements, which often mandate:

    • Securely locked, substantially constructed cabinets or rooms.

    • Double-locked storage for Schedule II controlled substances in some regions.

    • Strict inventory records, dispensing logs, and perpetual inventory tracking.

    • Specific personnel authorized to access controlled substance storage.

  • Adopt safety measures to prevent inadvertent administration: In designated storage areas, implement additional safety measures, such as:

    • Visual cues and warning labels to clearly identify high-risk medications within storage.

    • Segregation strategies (e.g., storing concentrated electrolytes separately from other IV solutions).

    • Restricting access to automated dispensing cabinets using multi-factor authentication for high-risk drug drawers.

    • Regular audits of high-risk medication storage areas to ensure compliance and identify any potential security vulnerabilities.

5. MOM 3e: High-risk medications including look-alike, sound-alike medications and different concentrations of the same medication are stored physically apart from each other. * (CO)

• Key Phrase: "Stored physically apart from each other" and specific examples of medication types needing separation.

• Requirement: To minimize medication errors, especially mix-ups involving high-risk medications, hospitals must store specific categories of high-risk drugs physically separate from one another. The slide highlights two key categories needing separation:

  • Look-alike, sound alike (LASA) medications: Medications with similar names or packaging.

  • Different concentrations of the same medication: Different strengths of the same drug (e.g., heparin 1000 units/mL vs. heparin 10,000 units/mL).

• Rationale: Physical separation is a powerful error-prevention strategy because:

  • Reduces Confusion: Separation visually cues staff to the distinct nature of these medications, reducing the chance of picking the wrong one due to name or package confusion.

  • Minimizes Proximity Errors: If LASA drugs or different concentrations are stored right next to each other, the chance of grabbing the incorrect one increases significantly. Physical distance reduces this proximity-related risk.

  • Reinforces Awareness: Purposeful physical separation serves as a constant visual reminder to staff to be extra vigilant when handling these specific medication categories.

• Practical Implementation - Physical Separation Strategies:

  • LASA medications:

    • Make a list: Develop a hospital-specific LASA medication list (MOM 3c).

    • Place the list in all drug storage units: Display the LASA list prominently in pharmacies, nursing stations, automated dispensing cabinets, and any location where medications are stored or dispensed. This serves as a constant visual reminder for staff.

    • Physical Separation in Storage: Implement significant physical separation in storage locations:

      • Store LASA pairs on different shelves or in different drawers.

      • Ideally, store them in different areas of the pharmacy or ward (e.g., opposite ends of a shelf, different sections of a medication cart).

      • Use visual aids like color-coded bins or labels to further distinguish LASA pairs in storage.

  • Different concentration of same medication:

    • Develop a list from hospital formulary: Identify medications that come in multiple concentrations in the formulary. Examples: heparin, insulin, concentrated electrolytes.

    • Revise the list at regular intervals (Changes in formulary and changes in packaging): The list of different concentrations needs periodic review as formularies change and manufacturers may alter packaging.

    • Physical Separation in Storage: Implement physical separation for different concentrations:

      • Store different strengths of the same medication on different shelves or in distinctly labeled bins.

      • Use auxiliary warning labels on packaging to highlight different strengths (e.g., "1000 units/mL - LOW DOSE," "10,000 units/mL - HIGH DOSE").

      • In automated dispensing cabinets, ensure different strengths are in completely separate pockets/drawers that are clearly labelled.

  • Points to Remember:

    • Keep the two identified LASA drugs and different concentrations of same drug far apart (such as in opposite ends of the pharmacy): Emphasize that "physical separation" is not just putting them on adjacent shelves; it means creating meaningful spatial distance to truly minimize the risk of proximity errors.

    • In addition to pharmacy, follow storage practices in patient care areas as well: These separation strategies should be implemented in all medication storage locations within the hospital, not just the central pharmacy. This includes ward medication rooms, nursing stations, automated dispensing cabinets in patient care areas, and procedure areas where medications are stored.

6. MOM 3f: The list of emergency medications is defined and is stored uniformly. * (C)

• Key Phrases: "List of emergency medications is defined" and "stored uniformly." Standardization for rapid access in emergencies.

• Requirement: Hospitals must have a defined list of "emergency medications" (drugs used in life-threatening situations) and ensure these medications are stored in a standardized and easily identifiable manner in designated emergency locations (e.g., crash carts). Uniformity is key for rapid and error-free access during emergencies.

• Rationale: Standardized emergency medication storage is critical for:

  • Rapid Access in Emergencies: In critical situations, time is of the essence. Standardized storage ensures that staff can quickly locate and retrieve needed emergency drugs without delay or confusion.

  • Error Reduction under Stress: Emergency situations are high-stress. Uniformity in storage and presentation reduces the cognitive load on staff and minimizes the chance of errors when selecting medications under pressure.

  • Efficiency and Teamwork: Standardized crash carts and emergency medication sets enable all trained personnel to quickly and effectively respond to emergencies, regardless of their specific department or usual work area, fostering better teamwork in crisis situations.

• Practical Implementation - Standardizing Emergency Medication Storage:

  • Prepare a list: The multidisciplinary committee (MOM 1b) should define a standard list of emergency medications to be included in crash carts and other emergency medication sets. This list should be:

    • Based on hospital's patient population and common emergencies: Tailored to the specific needs of the hospital's patient mix and the types of emergencies typically encountered.

    • Developed with input from relevant specialists (ER physicians, intensivists, cardiologists, pharmacists, nurses): Ensures the list is clinically appropriate and reflects the medications most likely to be needed in emergencies.

    • Regularly reviewed and updated: To reflect changes in emergency medicine guidelines and best practices.

  • Use crash cart to store medications in a standardised manner: Crash carts (emergency carts) should be used as the primary standardized storage system for emergency medications:

    • Uniform Cart Design and Contents: Use the same type of crash cart throughout the hospital. Standardize the layout of drawers, compartments, and the location of specific medication categories within the cart across all carts.

    • Consistent Labeling and Color-Coding: Use standardized labeling (drug names, concentrations) and color-coding for medication containers and drawer labels within all crash carts. This visual uniformity helps rapid identification.

    • Standardized Medication Boxes/Trays: Consider using standardized medication boxes or trays within the crash cart drawers to further organize medications into categories (cardiac drugs, vasopressors, anticonvulsants, etc.) and maintain uniformity.

  • Point to Remember:

    • Do not store other drugs with emergency medications: Crash carts and designated emergency medication sets should only contain the defined list of emergency medications and related supplies (syringes, needles, IV sets, etc.). Avoid cluttering them with routine medications or non-emergency items as this can cause confusion and delay in emergencies.

7. MOM 3g: Emergency medications are available all the time and are replenished promptly when used. (CO)

• Key Phrases: "Available all the time" and "replenished promptly when used." Ensuring constant readiness of emergency drugs.

• Requirement: Emergency medications must be consistently available whenever and wherever they are needed in the hospital. This means both:

  • Maintaining adequate stock levels at all times.

  • Having a system for promptly replenishing emergency medications and supplies in crash carts and emergency locations after they are used. Readiness is ongoing, not just initial setup.

• Rationale: Consistent availability and prompt replenishment are essential for:

  • Ensuring Immediate Response in Emergencies: Stock-outs or depleted crash carts render emergency medication protocols useless. Reliable availability ensures that staff can always access critical drugs when seconds count.

  • Maintaining Readiness: Emergency situations can arise unpredictably. Continuous availability and prompt replenishment ensure that the hospital is always prepared to respond effectively to medical crises.

  • Preventing Delays and Errors: Delays in finding or retrieving emergency medications due to stock-outs or unreplenished carts can lead to adverse patient outcomes. Prompt replenishment eliminates these delays.

• Practical Implementation - Ensuring Constant Availability and Replenishment:

  • Stock adequate quantity of emergency medicines:

    • Determine appropriate stock levels for each emergency medication based on:

      • Hospital size and patient volume.

      • Frequency of emergencies encountered (historical data, if available).

      • Recommended stock levels in emergency medicine guidelines.

      • Lead time for replenishment.

    • Maintain stock levels that are sufficient to meet anticipated emergency needs, but avoid excessive overstocking that could lead to expiry.

  • Perform inventory check at least daily: Regular inventory checks of crash carts and emergency medication locations are essential:

    • Implement a daily checklist for designated staff (pharmacy technicians, nurses, assigned ward personnel) to verify the presence, quantities, and expiry dates of all emergency medications and supplies in each crash cart and emergency medication location.

    • Document the date, time, and name of the person performing the check.

    • Promptly address any identified deficiencies (missing medications, expired drugs, low stock levels) through replenishment procedures.

  • Note: "If the organisation follows a system of sealing the emergency cart, then the emergency cart should be checked after each use/once in a month."

    • Sealed Crash Carts: Some hospitals use a sealing system for crash carts (using a numbered seal). When a cart is used in an emergency, the seal is broken.

    • Post-Use Check is Mandatory: If sealed carts are used, a mandatory check and replenishment of the entire cart must be done after each use (when the seal is broken). This ensures that the cart is fully restocked and ready for the next emergency.

    • Periodic Check if Unused (Monthly): Even if a sealed cart is not used during a month, a periodic check (at least monthly) is still required to verify medication expiry dates, integrity of supplies, and overall readiness of the sealed cart.

Overall Summary of MOM 3:

MOM Standard 3 provides a comprehensive framework for medication storage, emphasizing:

• Maintaining a Quality Storage Environment (MOM 3a): Cleanliness, safety, security, and adherence to manufacturer's recommendations.

• Sound Inventory Control (MOM 3b): Using methods like ABC, VED, FSN, and FEFO to optimize storage and minimize waste.

• Proactive High-Risk Medication Management (MOM 3c & 3d): Identifying, defining, and controlling the storage locations of high-risk medications for enhanced safety and security.

• Error Prevention through Physical Separation (MOM 3e): Separating LASA medications and different concentrations to reduce mix-ups.

• Standardized Emergency Medication Storage (MOM 3f & 3g): Defining emergency medication lists, ensuring uniform storage in crash carts, and guaranteeing constant availability and prompt replenishment for effective emergency response.

MOM4: Medications are prescribed safely and rationally.

This standard emphasizes that medication prescriptions must be generated in a way that minimizes errors, promotes patient safety, and ensures that medications are used appropriately and effectively. It goes beyond just having a prescription order; it's about the quality and rationality of the prescribing process itself.

Let's dissect each objective element within MOM 4:

1. MOM 4a: Medication prescription is in consonance with good practices/guidelines for the rational prescription of medications. * (C)

• Key Phrase: "Rational prescription" and "good practices/guidelines."

• Requirement: Medication prescribing within the hospital must align with established principles of "rational medication use." This means prescriptions should be guided by evidence-based guidelines and reflect good clinical practice, ensuring medications are used appropriately and effectively.

• Rationale: Rational prescribing is fundamental to:

  • Patient Benefit: Ensuring patients receive medications that are truly appropriate for their clinical needs, leading to better health outcomes.

  • Minimizing Harm: Rational prescribing avoids unnecessary medication use, reduces the risk of adverse drug reactions (ADRs), and minimizes drug interactions.

  • Cost-Effectiveness: Promotes the use of cost-effective medications when clinically appropriate, optimizing resource utilization.

  • Antimicrobial Stewardship: Rational antibiotic prescribing is crucial in combating antibiotic resistance, ensuring these vital drugs remain effective for future patients.

• Practical Implementation - Implementing Rational Prescription Practices:

  • Follow good practice: This is a broad directive, urging prescribers to embrace sound clinical judgment and evidence-based approaches in their prescribing decisions. It means going beyond just writing a prescription and considering the broader context of patient care.

  • Adhere to guidelines for rational prescription of medications: Hospitals should actively adopt and promote the use of evidence-based guidelines to guide prescribing practices. These guidelines can come from:

    • National and international clinical practice guidelines: Guidelines developed by reputable medical societies or organizations for specific diseases or conditions.

    • Hospital-developed guidelines: The multidisciplinary committee (MOM 1b) can adapt national/international guidelines or develop their own hospital-specific guidelines for common conditions or high-priority areas like antibiotic use.

    • Formulary guidance: The formulary itself (MOM 2) is a tool for rational prescribing, directing clinicians to use preferred medications.

    • Therapeutic protocols: Standardized treatment protocols for common conditions can guide rational medication choices.

  • WHO Definition of Rational Use (Quoted in slide): The slide provides the WHO definition of rational drug use:
    "Rational use of medicines requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community."

    • Deconstruct the WHO Definition:

      • Appropriate to clinical needs: Medication is truly indicated for the patient's diagnosis and condition, not just for convenience or patient demand.

      • Doses that meet individual requirements: Dosage is individualized based on patient factors (age, weight, renal function, etc.) and the specific medication, not just a "one-size-fits-all" approach.

      • Adequate period of time: Duration of treatment is appropriate for the condition being treated; avoiding unnecessarily prolonged or overly short courses.

      • Lowest cost to them and their community: Considering cost-effectiveness, using generic alternatives where possible, and avoiding expensive medications when equally effective and cheaper options exist.

  • Points to Remember:

    • Written guidance should address both OP and IP prescriptions: Rational prescribing guidelines should be applicable to both outpatient (OP) and inpatient (IP) settings. While principles are similar, specific contexts might require nuances.

    • Clinicians should be trained/sensitized on rational prescription of medications: Education is essential. Hospitals need to provide training to prescribers on rational prescribing principles, relevant guidelines, and the hospital's formulary and therapeutic protocols. This can be through workshops, continuing medical education (CME) sessions, online modules, and regular communication about best practices.

2. MOM 4b: The organisation adheres to the determined minimum requirements of a prescription. * (CO)

• Key Phrase: "Minimum requirements of a prescription." Focus on essential prescription elements.

• Requirement: The hospital must define and enforce the minimum information that must be included in every medication prescription. This ensures that prescriptions are complete, legible, and contain all the necessary details for safe dispensing and administration.

• Rationale: Incomplete or illegible prescriptions are a significant source of medication errors. Standardizing minimum requirements:

  • Reduces Ambiguity and Errors: Ensures all crucial information is present, reducing the chance of misinterpretation or omissions that can lead to wrong drug, dose, or patient errors.

  • Enhances Communication: Provides clear and standardized communication between prescribers, pharmacists, and nurses.

  • Improves Legibility: Guidelines on writing prescriptions, like using capital letters, enhance legibility and reduce errors due to handwriting.

  • Facilitates Traceability and Accountability: Requiring prescriber details and signatures makes prescriptions traceable and accountable.

  • Regulatory Compliance: Meeting minimum prescription requirements often aligns with legal and regulatory mandates for prescription content.

• Practical Implementation - Defining and Enforcing Minimum Requirements:

  • Adhere to national/international guidelines and regulatory bodies: Hospitals should consider national drug regulations, pharmacy practice standards, and guidelines from organizations like ISMP or WHO when defining their minimum prescription requirements.

  • Write in capital letters: Promoting the use of capital letters for drug names and instructions improves legibility, especially for handwritten prescriptions (though electronic prescribing is preferred – see MOM 5a).

  • Initialise prescription errors or illegible prescriptions after single strikethrough and rewrite: If an error is made on a paper prescription, the recommended method of correction is a single strikethrough of the incorrect information, initialing the change, and then writing the correct information clearly. Overwriting or using correction fluid should be avoided.

  • Avoid using error-prone abbreviations: Hospitals must develop a list of prohibited abbreviations and ensure prescribers are trained to avoid using them. Error-prone abbreviations are those that are commonly misinterpreted and lead to medication errors. Organizations like ISMP provide lists of these abbreviations. Use full drug names, units (e.g., "units" not "U"), and dosage terms.

  • Points to Remember: Minimum requirements of a prescription (IPD, OPD and emergency): The slide lists the essential elements that must be on every prescription, regardless of whether it's for inpatients (IPD), outpatients (OPD), or emergency situations:

    • Name of the patient: Essential for patient identification.

    • Unique hospital number: More robust patient identifier than just name, especially for patients with common names.

    • Name of the drug: Clearly written, preferably using generic name.

    • Strength: Specify the drug strength (e.g., 250mg, 500 units/mL).

    • Dosage instruction: Clear directions on how to take or administer the medication (e.g., "Take one tablet twice a day," "IV infusion over 30 minutes").

    • Duration: Specify the length of treatment or when to stop the medication (e.g., "for 5 days," "until discharge," "continue as per OPD follow-up").

    • Total quantity of medicine: For outpatient prescriptions, specifying the total amount dispensed (e.g., "dispense 30 tablets").

    • Name, signature and registration number of prescribing doctor: Identifies the prescriber and makes the prescription accountable and traceable.

  • Note: "For more information, refer 'Drugs and Cosmetics Act' and 'Code of Medical Ethics'." These Indian legal and ethical frameworks provide further context for prescription requirements in India.

3. MOM 4c: Drug allergies and previous adverse drug reactions are ascertained before prescribing. (C)

• Key Phrase: "Drug allergies and previous adverse drug reactions are ascertained." Proactive allergy assessment.

• Requirement: Before prescribing any medication, clinicians must make a reasonable effort to ascertain (find out and document) if the patient has any known drug allergies or a history of previous adverse drug reactions (ADRs). This is a fundamental patient safety step.

• Rationale: Drug allergies and previous ADRs are critical patient safety information. Failing to ascertain this information:

  • Can Lead to Preventable ADRs: Prescribing a drug a patient is allergic to can trigger severe allergic reactions, including anaphylaxis, which can be life-threatening.

  • Increases Risk of Recurrent ADRs: Patients with a history of ADRs to a specific drug or drug class are at higher risk of experiencing the same or similar ADRs upon re-exposure.

  • Violates Patient Rights: Patients have a right to be treated safely, and preventing allergic reactions and known ADRs is a core element of safe medication practices.

• Practical Implementation - Ascertaining Allergies and ADR History:

  • Timing of Assessment:

    • During initial consultation: Allergy history taking should be a routine part of the initial patient assessment, both in outpatient and inpatient settings.

    • At any point in time during care: Allergy status should be re-verified before prescribing any new medication, even if allergy history was taken earlier, as patient history may change or previous information might have been missed or forgotten.

  • Methods of Ascertainment:

    • Direct questioning of the patient (or family/caregiver if patient is unable to communicate effectively): Ask open-ended questions about known allergies to medications, foods, latex, and other relevant allergens. Specifically probe for drug allergies and ask about reactions experienced in the past (e.g., "What happens when you take [drug name]?").

    • Review of medical records: Check past medical records, allergy lists in EHRs, previous discharge summaries, and allergy bracelets/identification cards if available. However, reliance solely on records without patient confirmation is insufficient.

  • Documentation: It is essential to document the allergy history (or lack thereof) clearly and prominently in the patient's medical record:

    • Note: "Both in OP and IP, drug allergies should be documented in the medical record." This applies to both outpatient and inpatient settings.

    • Document the specific allergen (drug name, class, etc.).

    • Document the type of reaction experienced (e.g., rash, itching, anaphylaxis).

    • Date of allergy assessment.

    • Location of allergy documentation (allergy list in EHR, medication chart, etc.).

    • Highlight allergies prominently (e.g., use allergy alert stickers in paper charts, electronic allergy flags in EHRs).

  • Note on "allergy vs. intolerance/side effect": Clinicians should be trained to distinguish between a true drug allergy (immune-mediated reaction) and a drug intolerance or expected side effect. True allergies require strict avoidance, while intolerances or manageable side effects might not always preclude drug use. Accurate documentation of the type of reaction is important.

4. MOM 4d: The organisation has a mechanism to assist the clinician in prescribing appropriate medication. (E)

• Key Phrase: "Mechanism to assist the clinician in prescribing." Providing tools for informed prescribing.

• Requirement: The hospital must provide clinicians with tools and resources that assist them in making informed prescribing decisions, specifically in areas that are complex and prone to errors, like drug interactions, food-drug interactions, therapeutic duplication, and dose adjustments.

• Rationale: Prescribing medications is a complex task. Clinicians need readily available information to:

  • Avoid Drug Interactions: Prevent harmful interactions between multiple medications a patient is taking, which can reduce drug efficacy or increase ADRs.

  • Manage Food-Drug Interactions: Inform patients about potential food restrictions or modifications needed while taking certain medications to ensure proper drug absorption and avoid adverse effects.

  • Prevent Therapeutic Duplication: Avoid prescribing multiple medications from the same therapeutic class or with the same mechanism of action unnecessarily, which increases risk and cost without added benefit.

  • Ensure Correct Dose Adjustments: Facilitate appropriate dose adjustments based on patient factors like renal or hepatic function, age, weight, and co-morbidities, ensuring safe and effective dosing.

• Practical Implementation - Mechanisms to Assist Prescribers:

  • Provide clinicians with mechanisms to identify: The slide specifically lists types of assistance mechanisms should address:

    • Drug interactions:

      • Electronic drug interaction checkers: Integrate drug interaction software into the EHR/CPOE (Computerized Physician Order Entry) system. These systems automatically check for potential interactions when a new medication is prescribed and provide alerts and information.

      • Pharmacist consultation: Make clinical pharmacists readily available for consultation with prescribers to review medication regimens for potential interactions and provide recommendations.

      • Drug information resources: Provide clinicians with access to reliable drug information databases (electronic or printed) that include drug interaction information.

    • Food-drug interactions:

      • Food-drug interaction databases: Integrate databases into the EHR or make them easily accessible to prescribers to check for food-drug interactions.

      • Dietary counseling resources: Provide access to registered dietitians or nutrition resources who can provide dietary advice to patients, especially for medications with significant food interactions (e.g., warfarin and vitamin K-rich foods).

      • Patient education materials: Develop and provide patient-friendly materials on food restrictions or modifications for medications known to have food interactions.

    • Therapeutic duplication:

      • Therapeutic duplication alerts in CPOE: Integrate CPOE systems to alert prescribers if they are prescribing a new medication that has the same therapeutic effect as a medication the patient is already on.

      • Formulary guidance: A well-designed formulary can help minimize therapeutic duplication by preferentially listing one or two agents within a therapeutic class, rather than multiple redundant options.

      • Pharmacist review: Pharmacists reviewing prescriptions can identify and flag potential therapeutic duplication issues.

    • Dose adjustments:

      • Renal/hepatic dose adjustment guides: Provide easily accessible guides (printed charts, electronic resources within EHR) that provide dose adjustment recommendations for medications based on renal function (creatinine clearance) or hepatic impairment.

      • Pharmacokinetic/pharmacodynamic resources: Provide access to drug information resources that include pharmacokinetic and pharmacodynamic data to help guide dose adjustments in complex cases.

      • Clinical decision support tools: More advanced EHR systems can incorporate clinical decision support tools that automatically calculate adjusted doses based on patient parameters.

  • Note: "This could be in electronic or physical form." The assistance mechanisms can be delivered through various means – electronic (EHR integration, online databases, software) is generally preferred for accessibility and ease of updating, but physical resources (printed guides, charts) can also be useful, especially in areas without consistent electronic access.

  • Compliance Level: (E) - Excellence level. Providing robust mechanisms to assist prescribing is considered an indicator of excellence, signifying a hospital's commitment to going above and beyond basic requirements to promote truly safe and rational medication use.

5. MOM 4e: Reconciliation of medications occurs at transition points of patient care. (CO)

• Key Phrase: "Reconciliation of medications occurs at transition points." Emphasis on continuity of medication information across care settings.

• Requirement: Medication reconciliation must be performed at key transition points in a patient's care within the hospital. This means systematically creating a complete and accurate list of the patient's medications, comparing it to the physician's admission, transfer, and/or discharge orders, and resolving any discrepancies.

• Rationale: Medication reconciliation at transitions of care is crucial to:

  • Prevent Medication Errors at Transitions: Transitions are high-risk points for medication errors. Patients often have multiple medications, and changes in care settings can lead to omissions, duplications, drug interactions, or dosing errors if medication lists are not accurately and consistently managed.

  • Ensure Accurate Medication History: Creating an accurate "best possible medication history" (BPMH) at admission is the foundation for safe medication management throughout the hospital stay.

  • Improve Communication: Reconciliation improves communication about medications between different healthcare providers involved in a patient's care across different settings.

  • Reduce ADRs and Readmissions: By minimizing medication errors at transitions, reconciliation contributes to reducing ADRs and potentially preventing medication-related hospital readmissions.

  • Patient Safety Goal: Medication reconciliation is often a core patient safety goal for hospitals and is emphasized by organizations like The Joint Commission and WHO.

• Practical Implementation - Implementing Medication Reconciliation:

  • What is the purpose of medication reconciliation?

    1. To ensure list of medications is complete and up-to-date with past clinical conditions and current care plan: The goal is to create the most accurate and comprehensive medication list possible, considering all medications the patient is taking (prescription, OTC, herbal, supplements), previous conditions, and current treatment plan.

  • When should it be done? (Transition points):

    1. At transition points (At the time of admission, transfer of patient or at the time of discharge): Key transition points where reconciliation is most important:

       • Admission: Creating the BPMH upon hospital admission is crucial.

       • Transfer of patient (Between units within the hospital, e.g., from ER to ward, ward to ICU): Medication regimens may need to be re-evaluated and reconciled when patients move between care units.

       • At the time of discharge: Ensuring patients have an accurate and understandable discharge medication list is critical for safe medication management at home and in the outpatient setting.

    2. After cross-consultation: If a patient has a consultation with a specialist, reconciliation might be needed to integrate any new medication recommendations into the overall medication plan.

    3. During handover: During shift changes or when care is handed over between healthcare providers, medication reconciliation can help ensure accurate communication of the medication regimen.

  • Process for Reconciliation: A typical medication reconciliation process involves:

    1. Collect BPMH: Gather the most complete list of the patient's medications. Sources include:

       • Patient interview.

       • Patient's medication containers brought from home.

       • Outpatient pharmacy records (with patient consent).

       • Primary care physician records.

       • Previous hospital records (if available).

    2. Compare BPMH to current orders: Compare the BPMH to the medications prescribed upon admission, transfer, or at discharge by the hospital physician.

    3. Identify discrepancies: Note any differences between the BPMH and the new orders (omissions, additions, changes in dose, route, frequency, etc.).

    4. Resolve discrepancies: Investigate and resolve any discrepancies. This often involves:

       • Consulting with the prescriber to clarify intended orders and rationale for changes.

       • Verifying if omissions are intentional or unintended.

       • Ensuring any unintended discrepancies are corrected.

    5. Communicate and document:

       • Communicate the reconciled medication list to all relevant healthcare providers (physicians, nurses, pharmacists).

       • Document the reconciled medication list in the patient's medical record.

       • Document any changes made or discrepancies resolved during the reconciliation process.

  • Note: "The process should be documented." The entire medication reconciliation process, including roles and responsibilities, steps involved, documentation procedures, and training should be documented in a hospital policy or procedure.

6. MOM 4f: Verbal orders are implemented by ensuring safe medication management practices. * (CO)

• Key Phrase: "Verbal orders...safe medication management practices." Controlling risks of verbal orders.

• Requirement: Verbal medication orders (orders communicated orally, usually by phone) are inherently more error-prone than written or electronic orders. This standard requires that if verbal orders are used (which should ideally be minimized), they must be implemented with stringent safety practices in place to mitigate the associated risks.

• Rationale: Verbal orders increase the risk of errors due to:

  • Mishearing or Misunderstanding: Oral communication is prone to mishearing, especially over the phone or in noisy environments.

  • Lack of Written Record at the Time of Ordering: No immediate written confirmation of the order increases the chance of forgetting details or discrepancies in what was intended and what was heard.

  • Potential for Ambiguity and Incompleteness: Verbal orders may be less detailed than written orders, increasing the risk of omissions or ambiguity.

  • Lack of Verification: Verbal orders might bypass standard verification steps that are built into written or electronic ordering processes.

• Practical Implementation - Implementing Safe Verbal Order Practices:

  • Written guidance: The slide emphasizes the need for written guidelines addressing key aspects of verbal orders:

    • Who can give verbal orders?: Clearly define who is authorized to give verbal medication orders. Typically, this should be restricted to licensed independent practitioners (physicians, dentists, etc.) and only when direct written or electronic ordering is not immediately possible.

    • When can it be given?: Define when verbal orders are permissible. Verbal orders should ideally be limited to:

      1. Urgent situations: Emergencies or situations where immediate medication administration is crucial, and waiting for a written or electronic order would cause unacceptable delay in patient care.

      2. Situations where immediate written or electronic communication is not practical: For example, during a code situation, in areas with limited electronic access, or when a prescriber is urgently needed to give an order remotely.

    • How to authenticate these orders?: Define the procedure for authenticating verbal orders to create a written record and ensure accuracy.

  • Points to Remember: Verbal orders:

    • Limit to urgent situations where immediate written or electronic communication is not practical: Stress that verbal orders should be the exception, not the rule. Encourage written or electronic orders as the primary method whenever feasible.

    • Order only approved list of formulary drugs. This list can be defined either by inclusion/exclusion: Consider limiting verbal orders to a pre-defined, restricted list of medications. This list could be:

      1. Inclusion list: A list of drugs that can be verbally ordered (e.g., emergency medications, frequently used IV medications).

      2. Exclusion list: A list of drugs that cannot be verbally ordered (e.g., high-risk medications, chemotherapy, controlled substances – unless in genuine emergency with stringent safeguards). This approach is more restrictive and generally safer.

    • Follow repeat back/read back: The "repeat back/read back" (or "hear back and verify") technique is essential for verbal orders. The person receiving the verbal order must:

      1. Write down the order as they hear it.

      2. Read back the entire order verbatim to the prescriber. (e.g., "Doctor, I have written down: [Drug name] [Dose] [Route] [Frequency] for [Patient name]. Is this correct?").

      3. Wait for the prescriber to confirm that the read-back is accurate.

    • Doctor should countersign (within 24 hours): Crucially, a written and signed (or electronically signed) prescription must be obtained from the prescriber to authenticate the verbal order as soon as practically possible, ideally within 24 hours. This provides a permanent written record and formal authorization.

    • Documentation of Verbal Order: Document the verbal order in the patient's medical record, including: date, time, drug, dose, route, frequency, prescriber's name, name of person receiving the order, and indication that it was a verbal order. Note when the countersigned written order was obtained.

7. MOM 4fg: Audit of medication orders/prescription is carried out to check for safe and rational prescription of medications. (A)

• Key Phrase: "Audit of medication orders/prescription...safe and rational prescription." Proactive monitoring of prescribing quality.

• Requirement: The hospital must conduct periodic audits (reviews) of medication orders/prescriptions to proactively assess and ensure that prescribing practices are safe and rational. This is a quality improvement activity to identify areas for improvement in prescribing.

• Rationale: Regular prescription audits:

  • Identifies Potential Prescribing Errors or Issues: Audits can detect patterns of prescribing errors, irrational medication choices, deviations from guidelines, or potential areas of overuse or misuse.

  • Provides Data for Quality Improvement: Audit findings provide data that the multidisciplinary committee (MOM 1b) can use to identify system weaknesses, educational needs, and areas for process improvement in medication management.

  • Promotes Adherence to Guidelines and Formulary: Audits can assess the extent to which clinicians are adhering to hospital guidelines, formulary policies, and rational prescribing principles.

  • Enhances Patient Safety: By identifying and addressing prescribing issues, audits contribute to overall medication safety and better patient outcomes.

• Practical Implementation - Conducting Prescription Audits:

  • Audit Points (What to check): The slide suggests points to consider during an audit, ensuring a focus on safety and rationality:

    • Legibility and use of capital letters in written orders: Check for compliance with hospital guidelines on prescription legibility (MOM 4b and 5c).

    • Appropriateness of drug, dose, frequency and route of administration: Assess if the prescribed drug, dose, frequency, and route are clinically appropriate for the patient's diagnosis, condition, and relevant patient factors (age, renal function, etc.). This involves reviewing a sample of patient charts and prescriptions.

    • Presence of therapeutic duplication: Check for instances of potential therapeutic duplication, where patients are prescribed multiple medications with similar therapeutic actions unnecessarily.

    • Possibility of drug interaction, food-drug interactions and steps taken to avoid them: Assess if the audit sample reveals prescriptions where potential drug-drug or food-drug interactions are likely and if appropriate steps (dose adjustments, monitoring, patient counseling) are documented.

    • Requirements of this standard (safe and rational prescription of medications): The audit should generally assess overall compliance with the principles of safe and rational prescribing as outlined in MOM 4 and related standards.

  • Points to Remember:

    • Perform an audit once in a month: Regular, at least monthly, audits are recommended to provide ongoing monitoring and feedback.

    • Use representative sample size: Audits do not need to review every single prescription every month. A representative sample of prescriptions should be selected for audit. The sample size should be large enough to provide meaningful data (e.g., a random sample from different departments or patient populations).

    • Staff in-charge: Clinical pharmacologist/clinical pharmacist/multi-disciplinary committee: The audit should be overseen or conducted by qualified personnel. This could be:

      • Clinical Pharmacologist or Clinical Pharmacist: Bring specialized expertise in pharmacology and rational drug use to the audit process.

      • Multidisciplinary committee (or a subcommittee): The MOM 1b committee can delegate audit activities or review audit findings and recommend actions.

      • Collaboration between pharmacists, physicians, and nurses in the audit process can provide a more comprehensive assessment.

8. MOM 4h: Corrective and/or preventive action(s) is taken based on the audit, where appropriate. (A)

• Key Phrase: "Corrective and/or preventive action(s) is taken based on the audit." Audit is not just data collection, it's for action.

• Requirement: The audit process is not complete with just data collection and identification of issues (MOM 4fg). This objective element requires that the hospital must take appropriate corrective actions to address identified prescribing issues and preventive actions to avoid future recurrence of similar issues. The audit findings must drive improvement.

• Rationale: Without follow-up action, audits become just exercises in data collection without any real impact on patient safety or quality. Implementing corrective and preventive actions closes the quality improvement loop and ensures that audits lead to tangible improvements in prescribing practices.

• Practical Implementation - Action Cycle Based on Audit Findings:

  • Perform root-cause analysis: If the audit identifies significant or recurrent prescribing issues, perform a root-cause analysis (RCA) to understand the underlying system factors contributing to those issues, rather than just blaming individual prescribers. RCA helps identify systemic weaknesses in processes, training, communication, or systems that need to be addressed.

  • Take CAPA (Corrective and Preventive Action): Based on the root-cause analysis and audit findings, develop and implement a CAPA plan. This plan should outline:

    • Corrective actions: Actions taken to fix the immediate problem identified in the audit (e.g., provide feedback to individual prescribers on errors, revise a specific policy, improve a workflow).

    • Preventive actions: Actions taken to prevent the recurrence of similar problems in the future and improve the overall system (e.g., implement new training programs, update clinical guidelines, modify electronic prescribing system alerts, enhance communication processes).

    • Assign responsibility: Clearly assign responsibility for implementing each CAPA action item to specific individuals or departments.

    • Set timelines: Establish realistic timelines for completing CAPA actions.

  • Maintain records of action(s) taken: Document all corrective and preventive actions taken in response to audit findings. This documentation provides evidence of the hospital's quality improvement efforts and is important for accountability and future review.

  • Re-audit/Follow-up: After implementing CAPA actions, conduct a re-audit or follow-up review (after a reasonable period) to assess the effectiveness of the actions taken. Did the issues identified in the initial audit improve? Were the corrective and preventive actions successful? This completes the cycle and may lead to further refinements if needed.

Overall Summary of MOM 4:

MOM Standard 4 emphasizes a holistic and proactive approach to medication prescription, encompassing:

• Rationality (MOM 4a): Prescribing guided by evidence-based practices and WHO principles of rational drug use.

• Completeness (MOM 4b): Ensuring prescriptions contain all essential information for safe use.

• Patient Safety (MOM 4c): Proactively assessing for drug allergies and ADR history.

• Decision Support (MOM 4d): Providing tools to assist prescribers in complex prescribing decisions.

• Continuity at Transitions (MOM 4e): Implementing medication reconciliation to prevent errors at care transitions.

• Controlled Verbal Orders (MOM 4f): Minimizing and safely managing the risks of verbal orders.

• Proactive Audit and Improvement (MOM 4fg & 4h): Regularly auditing prescribing practices and taking action based on findings to drive continuous improvement in medication safety and rationality.

MOM5: Medications orders are written in a uniform manner.

This standard aims to ensure consistency and clarity in how medication orders are documented across the hospital. Uniformity in medication orders is a fundamental error prevention strategy, making it easier for all healthcare professionals involved (prescribers, pharmacists, nurses) to interpret and act upon the orders accurately and safely.

Let's break down the objective elements within MOM 5:

1. MOM 5a: The organisation ensures that only authorised personnel write orders. * (C)

• Key Phrase: "Only authorised personnel write orders." Controlling who can prescribe.

• Requirement: The hospital must have a policy and system in place to ensure that only individuals who are legally and organizationally authorized are allowed to write medication orders. This prevents unauthorized prescribing, which can lead to significant safety risks and legal liabilities.

• Rationale: Restricting order writing to authorized personnel is crucial to:

  • Ensure Competency and Accountability: Authorized prescribers are those who have the necessary medical training, licenses, and hospital-granted privileges to prescribe medications safely and responsibly.

  • Prevent Unqualified Individuals from Prescribing: Unauthorized individuals (e.g., medical students without supervision, non-physician staff not legally authorized to prescribe) writing orders could lead to clinically inappropriate, unsafe, or even illegal prescriptions.

  • Maintain Legal and Regulatory Compliance: Prescription writing is a legally defined activity. Hospitals must comply with laws and regulations that dictate who can legally prescribe medications.

• Practical Implementation - Ensuring Authorised Personnel Only:

  • Medication order card (Paper-based systems):

    • Only Doctor (MBBS) should write the medication order (includes transcribing verbal/consultant orders, OP record/admission note): In traditional paper-based systems, establish a clear policy that only physicians with a recognized medical degree (MBBS or equivalent) are authorized to write medication orders on medication order sheets. This includes:

      • Initial orders: For new admissions, consultations, and routine prescriptions.

      • Transcribing verbal orders: If a verbal order is received (MOM 4f), it must be transcribed onto the written order sheet only by an authorized physician and then properly authenticated (countersigned).

      • Outpatient prescriptions: For patients being discharged or seen in outpatient clinics.

      • Admission notes and OP records: Medication orders documented within admission notes or outpatient records should also be written by authorized physicians.

    • Verify credentials: Pharmacy and nursing staff should be trained to recognize and verify that the person writing a paper-based order is indeed an authorized physician (e.g., checking for a physician's stamp, signature and credentials).

• • Electronic medical record (EMR) (Electronic systems):

    • Doctor should enter the prescription in the hospital information system (HIS) using his/her unique login: In EMR systems, restrict access to the medication ordering module to authorized prescribers. This is typically achieved through:

      • Unique login and password: Each authorized prescriber has their individual login credentials to access the EMR and prescribe.

      • Role-based access control: Within the EMR system, user roles and permissions are configured so that only users with the "physician" or "prescriber" role have access to the medication ordering function.

    • The entry made by an assistant should be verified and authorised by doctor: In some settings, a physician might delegate the data entry of medication orders into the EMR to an assistant (e.g., a medical scribe, a nurse). However, even if data entry is delegated, the final authorization and prescribing decision must always be made by the authorized physician themselves. The EMR system should have features to:

      • Clearly distinguish between "entered by" and "authorized by" fields for prescriptions.

      • Require the physician to log in separately and electronically sign to authorize and finalize the prescription entered by an assistant.

    • System audits: Regularly audit EMR system access logs to ensure that only authorized personnel are accessing and using the medication ordering module.

  • Note: "The medication order written by other authorised staff should be backed by a legislation or government order." In very specific circumstances, and only if legally permitted by local legislation or government regulations, other healthcare staff (e.g., advanced practice nurses, physician assistants, specially trained pharmacists under collaborative practice agreements) might be authorized to prescribe medications within a defined scope of practice. If such exceptions exist, the hospital's policy must be strictly aligned with and backed by the relevant legislation or government order. This should be clearly documented and communicated to all staff. However, the general rule is physician-led prescribing.

2. MOM 5b: Medication orders are written in a uniform location in the medical records, which also reflects the patient's name and unique identification number. (C)

• Key Phrase: "Uniform location" and "reflects patient's name and unique identification number." Standardization for order location and patient ID.

• Requirement: Medication orders must always be documented in a consistent and designated location within the patient's medical record, and this location must clearly display the patient's name and unique identification number. This standardization makes it easier to find and manage medication orders and ensures proper patient association.

• Rationale: Uniform location and patient identification in medication orders:

  • Facilitates Easy Location and Review: Standardized location allows all healthcare team members (nurses, pharmacists, physicians) to quickly find and review medication orders in the medical record without searching through different sections or notes.

  • Reduces Errors from Misidentification: Clearly associating the patient's name and unique ID (medical record number, patient ID band number) directly on the medication order reduces the risk of orders being misinterpreted as belonging to the wrong patient, especially when dealing with patients with similar names.

  • Improves Organization and Clarity: A designated medication order section keeps medication-related information organized and separate from other clinical notes, enhancing clarity and reducing the chance of overlooking medication orders.

• Practical Implementation - Uniform Location and Patient ID:

  • Write in uniform location of medical record:

    • Paper-based charts: Designate a specific section within the paper chart solely for medication orders. This could be:

      • A dedicated medication order sheet or section at a consistent place in every patient chart (e.g., always the first or last section).

      • Using pre-printed medication order sheets that are consistently inserted into the chart.

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    • Electronic medical record (EMR): In EMR systems:

      • Designate a specific tab or section within the patient's electronic chart dedicated to medication orders.

      • Ensure that the medication order section is prominently and easily accessible from the main patient chart view.

  • Administer only medications that are written in this location: Enforce a strict rule that nursing and pharmacy staff should only administer medications based on orders documented in this designated uniform location for medication orders. Orders written in other parts of the chart (e.g., progress notes, consultation reports, discharge summaries) should not be acted upon directly unless they are officially transcribed into the designated medication order section.

  • Transcribe orders written in different location to this location: If, for legitimate reasons, a medication order is initially written in a non-standard location (e.g., in an emergency note), it must be promptly transcribed into the designated medication order section of the medical record by authorized personnel. The original note should be referenced for context, but the actionable order must be in the uniform location.

  • Include patient's name and unique identification number: On every medication order sheet (paper) or in the header of the electronic medication order section, clearly display:

    • Patient's full name: Legibly written and consistently formatted.

    • Unique identification number: Medical record number, patient ID band number, or other unique hospital identifier to ensure correct patient association.

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  • Ensure prescription and administration record are written on same sheet or use "Drug Kardex": For efficient workflow and error reduction, consider:

    • Combined prescription and administration record (paper): Using medication order sheets that are designed to also serve as medication administration records (MARs) on the same sheet. This allows nurses to directly document administration on the same form where the order is written, improving traceability and reducing transcription errors.

    • "Drug Kardex" (paper or electronic): A "Kardex" is a summarized patient care plan or medication profile. If using a Kardex (paper or electronic summary of medication orders), ensure it accurately reflects the medication orders from the uniform location in the chart and is used for administration documentation.

    • Electronic MAR integration: In EMRs, ensure that the electronic medication administration record (eMAR) is directly linked to the electronic medication orders, so that nurses administer and document against the electronic orders.

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  • Write fresh order for change in existing order: When there is a change to an existing medication order (change in dose, frequency, route, discontinuation, adding a new medication), a fresh, new medication order should be written. Avoid altering or overwriting previous orders. This maintains a clear audit trail and prevents confusion about current vs. previous orders.

  • Note: Electronic orders should also follow these principles: Even in fully electronic systems, the principles of uniform location and clear patient identification are still vital. Ensure the EMR system is configured to enforce these principles.

  • Points to Remember:

    • Phrases like "CST"/continue same treatment/"repeat all"/"repeat 1,4,5,8" should not be accepted: Avoid using vague or ambiguous phrases like "CST" (continue same treatment), "repeat all," or "repeat 1,4,5,8" in medication orders. These phrases are prone to misinterpretation and errors. Each medication order should be written out completely and specifically. If continuing previous medications, list each one out individually with details.

    • A strike-through or over-writing the previous order is not acceptable: Altering or overwriting previous medication orders, whether on paper or electronically, should be strictly avoided as it can obscure the original order, create confusion, and compromise the audit trail. Use the "write a fresh order for change" principle instead.

3. MOM 5c: Medication orders are legible, dated, timed and signed. (C)

• Key Phrase: "Legible, dated, timed and signed." Essential elements for a valid and traceable order.

• Requirement: All medication orders, whether paper-based or electronic, must be:

  • Legible: Easily readable and understandable to prevent misinterpretation.

  • Dated: Date of when the order was written or issued is essential for tracking order history and ensuring order currency.

  • Timed: Time of when the order was written is also important, particularly for PRN (as needed) medications or for tracking medication timing in relation to other interventions.

  • Signed: Identified and authenticated by the prescriber through their signature (or electronic signature in EMRs). This establishes accountability for the order.

• Rationale: Legibility, dating, timing, and signing of orders are critical for:

  • Preventing Misinterpretation and Errors: Legible writing reduces the chance of pharmacy or nursing staff misreading the medication name, dose, or instructions.

  • Establishing Order Validity and Currency: Dating and timing confirm when the order was issued, allowing staff to determine if it is a current and valid order. Undated or untimed orders are ambiguous.

  • Ensuring Accountability and Traceability: Prescriber signature (or electronic signature) clearly identifies the person responsible for the order, making the order traceable and accountable. Essential for audit trails and error investigations.

  • Legal and Regulatory Compliance: Legible, dated, timed, and signed orders are often legally required components of a valid prescription.

• Practical Implementation - Enforcing Legibility, Dating, Timing, and Signing:

  • Write in capital letters: As mentioned in MOM 4b, encouraging the use of capital letters for drug names and instructions improves legibility of handwritten orders.

  • Use list of approved standardised abbreviations: Hospitals should develop and enforce the use of a standardised list of approved medical abbreviations. This helps promote consistent understanding of common medical terms while prohibiting the use of error-prone abbreviations (MOM 4b). Train staff on the approved abbreviation list.

  • Avoid using error-prone abbreviations: Strictly prohibit the use of error-prone abbreviations (as identified by organizations like ISMP) on medication orders.

  • Ensure traceability of identity of person (Write name/state employee code against every order or have master signature list having name of the person against signature.): To ensure traceability and accountability:

    • Option 1: Write name/state employee code against every order: Require prescribers to legibly write their printed name and employee code/identification number along with their signature on every paper prescription. In electronic systems, the EMR system automatically logs the user (and thus their identity) when an order is created.

    • Option 2: Have master signature list having name of the person against signature: Maintain a master signature list (paper or electronic) that contains the signatures of all authorized prescribers along with their printed names and employee codes. Pharmacy and nursing staff can refer to this list to verify the signature on a prescription and identify the prescriber. This is more cumbersome than Option 1, so Option 1 is generally preferred.

  • Note: "For more information, refer ‘Institution for Safe Medication Practices' guidelines." ISMP provides excellent resources and guidelines on improving prescription legibility and reducing errors related to handwriting and abbreviations. Hospitals should consult ISMP guidelines to inform their policies.

4. MOM 5d: Medication orders contain the name of the medicine, route of administration, strength to be administered and frequency/time of administration. (C)

• Key Phrase: "Name of medicine, route, strength, frequency/time of administration." Core elements of a complete medication order.

• Requirement: Every medication order must contain, at minimum, these four essential components:

  • Name of the medicine: Clear and unambiguous identification of the drug to be administered.

  • Route of administration: How the medication is to be given (oral, IV, IM, subcutaneous, topical, etc.).

  • Strength to be administered: The dosage strength (e.g., milligrams, units, micrograms per mL).

  • Frequency/time of administration: How often and when the medication should be given (e.g., "twice daily," "every 6 hours," "stat," "once a week," "at bedtime," "before meals").

• Rationale: These four components are absolutely essential for a complete and actionable medication order. Missing any of these:

  • Creates Ambiguity and Risk of Errors: Without all four components, there is significant ambiguity and increased risk of administering the wrong drug, wrong dose, wrong route, or at the wrong time.

  • Makes Order Incomplete and Unactionable: Pharmacy cannot accurately dispense, and nurses cannot safely administer, a medication if the order lacks these fundamental details.

  • Violates Safe Medication Practices: Administering medication based on incomplete orders is a serious deviation from safe medication practices and can directly harm patients.

• Practical Implementation - Ensuring Complete Medication Orders:

  • Write name of medicine, route of administration, strength to be administered and frequency/time of administration: Prescribers must be trained and expected to include all four of these components in every medication order. Use standardized templates or prompts in paper forms or EMR systems to remind prescribers to include all essential information.

  • Write strength of individual drugs (tablet/capsule/injection) of same medicine: When ordering a medication that comes in multiple strengths, the specific strength to be administered must be explicitly written in the order (e.g., "Amoxicillin 250mg capsules," not just "Amoxicillin capsules"). This is crucial to avoid dispensing or administering the wrong strength.

  • Record separately, if the strength differs for each time of administration: If the intended dose or strength of a medication varies at different times of the day (e.g., a tapering dose regimen), each dose and its corresponding strength must be clearly and separately recorded in the order. Avoid using a single order line that attempts to describe varying strengths over time, which can be confusing. Use separate order lines for each distinct dose/strength.

  • Points to Remember:

    • Strength of individual drugs need not be written for preparations having combination of vitamins and/or minerals: In cases of fixed-dose combination products, particularly for vitamins and minerals (where strengths are usually standardized within the combination product), it may be acceptable to write just the brand name or combination name, as long as the hospital formulary clearly defines the exact composition and strengths of each ingredient in that combination product. However, if there is any ambiguity or multiple combination product options, specifying the individual component strengths is still safer. For most single-entity drugs, always specify the strength.

    • Have a mechanism to take actions in case of incomplete medication orders: Pharmacy and nursing staff should be trained and empowered to question and clarify any medication order that is incomplete (missing any of the four essential components). Establish clear procedures for:

      • Pharmacy to reject incomplete prescriptions: Pharmacists should not dispense medications based on incomplete prescriptions and should contact the prescriber to obtain the missing information.

      • Nurses to clarify with prescriber before administration: Nurses should not administer any medication if the order is incomplete or ambiguous and should contact the prescriber to get clarification before administering the drug.

      • Documenting clarification efforts: Document all attempts to clarify incomplete orders and the resolution in the patient's medical record and/or pharmacy system.

Overall Summary of MOM 5:

MOM Standard 5 emphasizes the importance of uniformity and completeness in medication orders as a foundational element of medication safety. It focuses on:

• Authorised Prescribing (MOM 5a): Ensuring only qualified and authorized individuals write orders.

• Uniform Order Location (MOM 5b): Standardizing where orders are documented and associating them with patient identifiers.

• Order Legibility and Traceability (MOM 5c): Requiring orders to be legible, dated, timed, and signed for clarity and accountability.

• Essential Order Components (MOM 5d): Mandating that every medication order contains the drug name, route, strength, and frequency/time, ensuring completeness and actionability.

MOM6: Medications are dispensed in a safe manner.

This standard emphasizes that the dispensing process, which is the critical step between a medication order and its administration to the patient, must be conducted with the utmost care and adherence to safety protocols to prevent dispensing errors and ensure patients receive the correct medications.

Let's dissect each objective element within MOM 6:

1. MOM 6a: Dispensing of medications is done safely. * (C)

• Key Phrase: "Dispensing of medications is done safely." Overarching emphasis on safety during dispensing.

• Requirement: This objective element is the overarching principle for MOM 6. It requires that the entire medication dispensing process, from receiving the prescription to handing the medication to the patient (or nurse), must be conducted with a primary focus on safety and minimizing the risk of dispensing errors.

• Rationale: Safe dispensing is crucial because dispensing errors can lead to:

  • Wrong Medication Errors: Dispensing the wrong drug to a patient, potentially causing harm, lack of therapeutic effect, or adverse reactions.

  • Wrong Dose Errors: Dispensing the wrong strength or dosage form, leading to under-dosing or over-dosing, with potentially serious consequences.

  • Wrong Patient Errors: Dispensing medication for one patient to another, leading to treatment errors and potential harm to both patients.

  • Expired Medication Errors: Dispensing medications that are expired, leading to reduced efficacy or potential degradation products.

  • Contaminated Medication Errors: Dispensing medications that have been compromised or contaminated due to improper handling or storage during the dispensing process.

• Practical Implementation - Ensuring Safe Dispensing Practices:

  • Written guidance: The slide emphasizes the importance of written guidelines to ensure safe dispensing. These guidelines should cover:

    • Dispense medication only against valid prescription/medication order (except for over the counter drugs): Establish a strict policy that medications should only be dispensed by the pharmacy upon receipt of a valid medication order (prescription) written by an authorized prescriber (as per MOM 5a). This excludes over-the-counter (OTC) drugs, which are typically self-selected by patients and do not require a prescription for dispensing in retail pharmacies (but hospital pharmacies may still have policies for managing OTC medications within the inpatient setting). "Valid prescription" implies that the prescription meets the minimum requirements as per MOM 4b (patient ID, drug name, dose, route, frequency, prescriber details, etc.).

    • Check medication before dispensing. For example: Check generic composition, formulation, expiry date and strength of medication: Implement a robust verification process that pharmacists (or trained pharmacy technicians under pharmacist supervision, depending on regulations) must follow before dispensing any medication. This verification process should include, at minimum, checks for:

      • Generic composition: Verify that the medication being dispensed matches the generic name specified in the prescription and aligns with the hospital formulary (MOM 2).

      • Formulation: Confirm that the dosage form (tablet, capsule, injection, solution, etc.) being dispensed is the correct formulation as per the prescription (and clinically appropriate).

      • Expiry date: Always check the expiry date of the medication container before dispensing. Dispense only medications that are well within their expiry date. Apply the FEFO principle (MOM 3b). Do not dispense expired medications.

      • Strength of medication: Critically verify that the strength (dose concentration) of the medication being dispensed exactly matches the strength prescribed. Errors in strength selection are a common source of medication errors.

    • Do not sell physician's samples: Establish a policy that strictly prohibits the sale of physician's samples by the hospital pharmacy (if the hospital even receives or manages physician's samples at all). Physician's samples are meant to be provided free of charge to patients for specific purposes (e.g., initial dose, titration pack, patient assistance programs) and should not be sold or commercialized. Selling physician's samples is generally unethical and in some jurisdictions, illegal.

  • Note: Both bulk and retail pharmacy should ensure safe dispensing of medications: This note emphasizes that the principles of safe dispensing apply to all pharmacy dispensing areas within the hospital, whether it's the main inpatient pharmacy (bulk dispensing to wards) or a retail/outpatient pharmacy serving patients directly. Safety is paramount in all dispensing settings.

2. MOM 6b: Medication recalls are handled effectively. * (C)

• Key Phrase: "Medication recalls are handled effectively." Proactive management of drug recalls.

• Requirement: The hospital must have a well-defined procedure in place to effectively handle medication recalls, ensuring that recalled medications are promptly identified, removed from use, and appropriate actions are taken to protect patients.

• Rationale: Medication recalls are issued by regulatory authorities (like FDA in the US or CDSCO in India) or manufacturers when there are concerns about the safety, quality, or efficacy of a particular batch or product. Effective handling of recalls is essential to:

  • Prevent Patient Harm: Ensure patients are not exposed to potentially unsafe or ineffective recalled medications.

  • Maintain Patient Trust and Safety: Demonstrates the hospital's commitment to patient safety and responsiveness to safety alerts.

  • Legal and Regulatory Compliance: Promptly acting on recalls is often a regulatory requirement for healthcare organizations.

• Practical Implementation - Effective Medication Recall Process:

  • Based on: The trigger for initiating the recall process:

    1. Communication from regulatory authorities: This is the most common trigger. Regulatory bodies (like FDA, CDSCO) issue official recall notices. The hospital pharmacy must have a system to promptly receive, monitor, and act upon these official recall communications (e.g., subscribing to email alerts from regulatory agencies, monitoring agency websites).

    2. Communication from manufacturer's: Pharmaceutical manufacturers may also initiate voluntary recalls. The hospital pharmacy must have channels to receive recall notices directly from manufacturers (e.g., through distributor networks, direct manufacturer communications).

    3. Internal feedback (eg: visible contaminant in IV fluid bottle): In some cases, a recall might be initiated based on internal feedback within the hospital. For example, if pharmacy or nursing staff observe a visible quality defect in a medication batch (e.g., particulate matter in an IV solution, discoloration, or packaging defect), this internal feedback can trigger an investigation and potential recall action, even before an official external recall is issued.

  • Inform: Actions to take upon receiving recall information:

    1. Appropriate regulatory authority in case of recall due to internal feedback: If a recall action is initiated based on internal feedback, and if the issue appears to be significant or affects a larger batch, it is important to inform the appropriate regulatory authority. This might involve reporting the quality defect to the local drug regulatory agency. This is important for transparency and to contribute to broader drug safety surveillance.

  • Steps in a Recall Procedure: A comprehensive recall procedure should typically include steps like:

    1. Prompt receipt and verification of recall notice: Ensure recall information is received from reliable sources and is accurately understood.

    2. Immediate cessation of dispensing: Immediately stop dispensing the recalled medication from the pharmacy inventory and inform all dispensing locations within the hospital to do the same.

    3. Identify and quarantine recalled medication: Locate all stocks of the recalled medication throughout the hospital (pharmacy, wards, clinics, crash carts, automated dispensing cabinets). Physically remove the recalled medication and place it in a designated quarantine area to prevent accidental dispensing.

    4. Review dispensing records: If possible, review dispensing records to identify patients who might have already received the recalled medication.

    5. Patient notification (if necessary): Depending on the severity of the recall and the potential harm, consider if patient notification is needed. This is usually directed by the regulatory recall notice and may involve contacting patients, sending letters, or issuing public notices.

    6. Manufacturer communication and return: Contact the manufacturer or distributor to arrange for the return of the recalled medication as per recall instructions.

    7. Documentation: Document all steps taken during the recall process, including receipt of recall notice, inventory removal, quarantine, patient notification (if done), return to manufacturer, and disposal. Maintain records for audit trails and regulatory compliance.

    8. Staff training: Ensure all relevant pharmacy and nursing staff are trained on the hospital's recall procedure and their roles in implementing it.

3. MOM 6c: Near-expiry medications are handled effectively. * (C)

• Key Phrase: "Near-expiry medications are handled effectively." Managing medications approaching their expiry date.

• Requirement: The hospital must have a defined procedure for managing "near-expiry" medications to minimize wastage and ensure that medications are dispensed before they expire and lose efficacy.

• Rationale: Effective management of near-expiry medications is important for:

  • Minimizing Medication Waste: Medications expiring on shelves represent a significant financial loss for the hospital. Proactive management can reduce wastage and optimize medication inventory.

  • Preventing Dispensing of Expired Medications: Ensuring that expired medications are not accidentally dispensed to patients is a patient safety imperative.

  • Cost-Effectiveness: Reducing wastage contributes to more cost-effective pharmacy operations.

• Practical Implementation - Near-Expiry Medication Management Procedure:

  • Define near-expiry: The first step is to clearly define what "near-expiry" means for the hospital's context. The slide note suggests: "Note: Near-expiry may constitute three months before expiry date." This is a common timeframe, but hospitals can define their own timeframe based on their inventory turnover rates and dispensing practices. Common definitions are 3-6 months before expiry, but it depends on medication type and typical usage patterns.

  • Withdraw near-expiry drugs: Implement a system to proactively identify and withdraw medications that are approaching their defined "near-expiry" date from the active dispensing stock. This involves:

    • Regularly monitoring medication expiry dates (e.g., through pharmacy software reports, physical shelf checks using FEFO principles).

    • Identifying medications that are nearing their near-expiry timeframe.

    • Physically removing these medications from regular dispensing shelves or automated dispensing cabinets.

  • Ensure non-availability of beyond expiry date medication: The withdrawn near-expiry medications should be managed to ensure that they do not become "beyond expiry" (expired) and are never dispensed to patients after they expire. Management options for near-expiry drugs (after withdrawal from active dispensing) include:

    • Prioritized dispensing (if still usable): If the "near-expiry" timeframe is still within a reasonable period before actual expiry, consider implementing strategies to prioritize dispensing these medications first (while still ensuring they are dispensed before they truly expire) to use them before they are wasted. This might involve:

      • Using pharmacy software to flag near-expiry batches and prioritize them for dispensing for appropriate prescriptions.

      • Using color-coded labels or physical separation to visually identify near-expiry stock for pharmacy staff to preferentially dispense.

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    • Return to supplier (if applicable): Check if there are agreements with medication suppliers or manufacturers that allow for the return of near-expiry medications for credit or exchange.

    • Donation (if permitted and appropriate): In some settings, if medications are still usable before expiry and meet quality standards, consider donating them to charitable organizations or healthcare facilities in need, if legally permissible and ethically sound.

    • Proper disposal (if expiry date passed or no other option): If near-expiry medications cannot be dispensed, returned, or donated before they actually expire, ensure they are disposed of properly according to hospital policy and relevant waste management regulations for pharmaceutical waste.

4. MOM 6d: Dispensed medications are labelled. * (CO)

• Key Phrase: "Dispensed medications are labelled." Importance of clear and informative labeling.

• Requirement: All medications dispensed by the pharmacy must be appropriately labelled to ensure accurate identification, safe use, and provide necessary information to patients and healthcare staff. The labeling requirements depend on whether it's for outpatient or inpatient use and the dispensing format.

• Rationale: Proper labelling of dispensed medications is crucial for:

  • Patient Safety: Clear labels help patients and nurses correctly identify the medication, dose, and administration instructions, reducing medication errors.

  • Accurate Administration: Labels provide nurses with essential information needed for safe medication administration (patient name, drug name, dose, route, timing, etc.).

  • Patient Understanding and Adherence: For outpatients, clear dosage instructions and other label information are crucial for patients to understand how to take their medications correctly at home, improving medication adherence.

  • Legal and Regulatory Requirements: Labeling requirements for dispensed medications are often mandated by pharmacy laws and regulations.

• Practical Implementation - Medication Labelling Standards:

  • All medications (For OP) -> Write dosage instructions: For all outpatient dispensed medications, at a minimum, the label must include clear and easily understandable dosage instructions for the patient. This should specify:

    • How much to take (e.g., "Take one tablet").

    • How often to take it (e.g., "twice a day").

    • When to take it (e.g., "with meals," "at bedtime").

    • Route of administration (if not obvious from the dosage form, e.g., "apply to skin," "eye drops").

    • Any special instructions (e.g., "shake well," "take with plenty of water").

    • Use simple and non-technical language that patients can easily understand. Consider providing instructions in the patient's preferred language if possible.

  • Medications dispensed as cut strips or from bulk containers (For IP, OP and reconstituted drugs) -> Write drug name, strength, dosage instruction and expiry date: For medications that are dispensed in formats other than original manufacturer packaging, or for reconstituted medications, the label requirements are more extensive. This applies to:

    • Cut strips/unit doses (often for inpatients): If tablets or capsules are dispensed in cut strips or unit dose packaging (e.g., from bulk bottles), they need a new label.

    • Medications dispensed from bulk containers (for both IP and OP): If liquids, ointments, or other medications are dispensed from larger bulk containers into smaller dispensing containers, they must be relabeled.

    • Reconstituted drugs (e.g., powdered antibiotics reconstituted into solutions): Reconstituted medications always require new labels as they are prepared by the pharmacy.

    • For these types of dispensed medications, the label must include, at minimum:

      • Drug name: Generic name (and brand name if relevant and helpful).

      • Strength: Strength per unit dose or per mL (e.g., "Amoxicillin 250mg," "Potassium Chloride 40mEq/20mL").

      • Dosage instruction: As described above for outpatient labels.

      • Expiry date: Crucial for tracking expiry, especially for reconstituted drugs which often have shorter expiry dates after reconstitution. The label should state the reconstituted expiry date if different from the original product expiry. If dispensing from bulk, consider using a shortened "beyond-use date" (BUD) if the stability data for dispensing container is shorter than the original expiry date.

    • Additional Labeling Considerations (Best Practices): Beyond the minimum requirements, consider adding other elements to dispensed medication labels for improved safety and patient information:

      • Patient name and medical record number (especially for inpatient labels and often for outpatient as well).

      • Route of administration (if not oral).

      • Special warnings or precautions (e.g., "May cause drowsiness," "Take with food").

      • Hospital name and pharmacy contact information.

      • Barcode or QR code for medication identification and verification if using technology systems.

5. MOM 6e: High-risk medication orders are verified before dispensing. (CO)

• Key Phrase: "High-risk medication orders are verified." Extra verification for dangerous drugs.

• Requirement: For orders of "high-risk medications" (as defined by the hospital in MOM 3c), a mandatory extra verification step must be implemented before dispensing. This adds a layer of safety to minimize dispensing errors for these particularly dangerous drugs.

• Rationale: High-risk medications have a greater potential to cause significant patient harm if errors occur. Therefore, adding a robust verification step before dispensing is a critical safety strategy to:

  • Catch Potential Prescribing Errors: Pharmacist verification can identify prescribing errors in dose, drug selection, route, or frequency.

  • Prevent Dispensing Errors: Even with a correct prescription, there's still a chance of dispensing the wrong medication or strength. Verification aims to catch these dispensing errors specifically for high-risk drugs.

  • Enhance Overall Safety: Adding a verification step for high-risk medications significantly reduces the likelihood of patients receiving these drugs in error.

• Practical Implementation - Verification Process for High-Risk Medications:

  • Verify written order before dispensing: For all orders of medications on the hospital's high-risk medication list (MOM 3c), implement a mandatory verification step before dispensing. This verification step typically involves a pharmacist review (or a trained senior pharmacy technician under pharmacist supervision, depending on local regulations). The verification should include:

    • Independent review of the original medication order: The pharmacist should review the original prescription or medication order (not just the dispensed medication container) to confirm:

      • Patient identification (name, MRN).

      • Drug name, strength, dosage form.

      • Dose, route, frequency, duration.

      • Prescriber details.

      • Clinical appropriateness for the patient (within the pharmacist's scope of practice).

    • Verification of dispensing process: Pharmacist should also verify that the dispensing process itself was performed correctly by pharmacy technicians, confirming:

      • Right medication was selected from the shelf.

      • Correct strength and dosage form was picked.

      • Labeling is accurate and complete.

      • Expiry date is checked.

      • Final dispensed product matches the prescription.

  • Adhere to statutory requirements: In some jurisdictions, there may be specific legal or regulatory requirements for verifying prescriptions of certain high-risk medication classes (e.g., controlled substances, chemotherapy). Ensure that the hospital's verification procedure is compliant with all applicable regulations.

  • "Second Check" Approach: Often, verification for high-risk medications involves a "second check" approach – meaning two qualified individuals (e.g., two pharmacists, or a pharmacist and a senior pharmacy technician) independently verify the prescription and dispensing process for extra safety redundancy. This is strongly recommended for high-risk drugs.

  • Documentation of verification: Document the verification process (who verified, when, that verification was completed) in the pharmacy system or medication record.

6. MOM 6f: Return of medications to the pharmacy is addressed. * (C)

• Key Phrase: "Return of medications to the pharmacy is addressed." Managing returned medications safely and appropriately.

• Requirement: The hospital must have a policy and procedure to address the return of medications to the pharmacy. This is about managing medications that are returned from patient care areas or from patients themselves (e.g., unused medications after discharge, discontinued medications) in a safe, controlled, and compliant manner.

• Rationale: Addressing medication returns is important for:

  • Medication Safety: Preventing the re-dispensing of returned medications that might be compromised or pose a safety risk if re-issued.

  • Inventory Control: Managing returns properly helps maintain accurate pharmacy inventory records and prevents confusion.

  • Waste Management: Provides a system for appropriate disposal of returned medications that cannot be reused.

  • Regulatory Compliance: Regulations may dictate how returned medications should be handled.

• Practical Implementation - Medication Return Policy and Procedure:

  • Written guidance: The slide emphasizes the need for written guidance on medication returns.

  • Make a list of medications which would be accepted for return: Define which types of medications the pharmacy will accept for return. Common categories for acceptable returns might include:

    • Unopened, manufacturer-sealed medications: Often, only medications returned in their original, unopened, tamper-evident manufacturer packaging can be considered for potential reuse (after careful pharmacist inspection).

    • Specific dosage forms: Return policies might be limited to certain dosage forms (e.g., oral solids like tablets and capsules) and exclude others (e.g., injectables, opened liquids, creams).

    • Exceptions for specific drugs: Controlled substances, refrigerated medications, compounded preparations, and certain other high-risk or temperature-sensitive drugs are often not accepted for return or reuse due to safety and regulatory concerns.

  • Define minimum conditions for returning medication: Establish minimum conditions that must be met for a returned medication to be considered for potential acceptance and review by the pharmacy. These conditions might include:

    • Drug name: Clearly identifiable.

    • Strength: Clearly identifiable.

    • Batch number: Present and legible (for traceability in case of issues).

    • Expiry date matching bill: Expiry date must be clearly visible and preferably verified against original dispensing records or invoice.

    • No visible damage: Packaging must be intact, not damaged, tampered with, or compromised in any way (no tears, openings, discoloration, etc.). Medication inside must appear in good condition (no discoloration, clumping, etc.).

  • Ensure non-return of drug having specific temperature storage requirement: Strictly prohibit the return or reuse of medications that require specific temperature storage (e.g., refrigerated medications, frozen medications). These medications, once removed from controlled storage, cannot reliably be guaranteed to have maintained their required temperature throughout the return process, potentially compromising their efficacy and safety.

  • Points to Remember:

    • Minimum conditions for return of medications: Reiterate the minimum conditions (Drug name, Strength, Batch number, Expiry date matching bill, No visible damage). Emphasize that all conditions must be met for a return to even be considered for review.

    • Create awareness regarding the return of medication: Communicate the hospital's medication return policy to all relevant staff (nurses, physicians, pharmacists, patients – if outpatient returns are considered in the policy). Educate staff on the types of medications accepted for return, the conditions for return, and the process for returning medications to the pharmacy. This promotes consistent implementation of the policy.

    • Pharmacist review of returned medications: Even if a medication meets the minimum return conditions, a pharmacist should always inspect the returned medication before it is considered for potential reuse (if policy allows reuse in very specific and limited circumstances for unopened, sealed packages of low-risk drugs - this is generally not recommended practice for most hospitals due to risk). In most cases, and particularly for high-risk hospitals, a safer and more common practice is that returned medications are generally NOT reused or re-dispensed to other patients. Returned medications are typically segregated and disposed of according to pharmaceutical waste disposal procedures. The emphasis is on safe disposal, not reuse, in most modern hospital settings.

Overall Summary of MOM 6:

MOM Standard 6 is dedicated to ensuring medication dispensing is performed with a primary focus on safety at every step. Key themes include:

• Verification and Accuracy (MOM 6a & 6e): Robust checks to confirm prescription validity and prevent dispensing errors, especially for high-risk medications.

• Recall Management (MOM 6b): Effective procedures to handle medication recalls promptly and protect patients.

• Expiry Date Management (MOM 6c): Proactive handling of near-expiry medications to minimize waste and prevent dispensing of expired drugs.

• Clear Labeling (MOM 6d): Mandating informative labeling for dispensed medications to ensure safe use and patient understanding.

• Controlled Medication Returns (MOM 6f): Addressing the management of returned medications to prevent unsafe reuse and ensure proper disposal.

MOM7: Medications are administered safely.

This standard is at the very heart of medication safety because it addresses the final step before a medication reaches the patient – administration. It emphasizes that every aspect of the medication administration process must be designed and executed to minimize errors and ensure patient safety during this crucial step.

Let's dissect each objective element within MOM 7:

1. MOM 7a: Medications are administered by those who are permitted by law to do so. (C)

• Key Phrase: "Permitted by law to do so." Focus on legal authorization for administration.

• Requirement: Medications must be administered only by healthcare professionals who are legally authorized and competent to perform medication administration within the scope of their practice and according to hospital policy. This prevents unauthorized individuals from administering medications, which could be unsafe and illegal.

• Rationale: Restricting medication administration to legally authorized personnel is fundamental for:

  • Patient Safety: Ensuring medications are administered by trained and qualified individuals who understand medication administration principles, techniques, and potential complications.

  • Legal Compliance: Medication administration is a legally defined healthcare practice. Hospitals must adhere to laws and regulations that specify who is authorized to administer medications in different healthcare settings.

  • Professional Accountability: Assigning responsibility to legally authorized personnel ensures accountability for safe medication administration.

• Practical Implementation - Defining and Ensuring Authorized Personnel:

  • Registered nurse: In most hospital settings and jurisdictions, Registered Nurses (RNs) are legally authorized and trained to administer a wide range of medications across various routes of administration. The slide explicitly lists "Registered nurse" as authorized personnel. This assumes the RN has the required education, licensure, and hospital-granted competencies for medication administration.

  • Doctor with minimum MBBS qualification: Physicians (Doctors with MBBS or equivalent degrees) are also legally authorized to administer medications and often do so in specific situations (e.g., IV push medications, emergency medications, procedural sedation). The slide lists "Doctor with minimum MBBS qualification" as authorized personnel.

  • Note: "Medication administration by other authorised staff should be backed by a legislation or government order." In very specific circumstances, and only if permitted by law and regulations, other healthcare staff beyond RNs and MBBS doctors might be authorized to administer certain limited categories of medications (e.g., in some regions, trained Licensed Practical Nurses (LPNs) or Licensed Vocational Nurses (LVNs) may administer specific oral medications under RN supervision). However, such authorization must be explicitly backed by relevant legislation, government orders, or specific regulatory frameworks, and should be clearly defined in hospital policy and scope of practice documents. This should be an exception, not the rule, and carefully controlled. The core expectation is RNs and MBBS-qualified physicians as primary medication administrators in most hospital settings.

  • Hospital policy and scope of practice: Hospital policies should clearly define:

    • Who is authorized to administer medications in different roles (RN, physician, and any other legally permitted categories).

    • Scope of practice for each authorized category (types of medications, routes of administration they are competent and permitted to administer).

    • Competency assessment and training requirements for medication administration.

    • Supervision requirements, if any (e.g., for less experienced staff or in specific clinical areas).

  • Verification and education: Nursing and pharmacy leadership should ensure that all staff involved in medication administration are:

    • Aware of the hospital's policy on authorized personnel for medication administration.

    • Properly trained and competent in medication administration techniques and safety procedures.

    • Regularly assessed for competency maintenance.

    • Supervised and mentored appropriately, especially newly hired or less experienced staff.

2. MOM 7b: Prepared medication is labelled before preparation of a second drug. (C)

• Key Phrase: "Prepared medication is labelled before preparation of a second drug." Immediate labelling to prevent mix-ups.

• Requirement: When preparing medications, especially in settings where multiple medications might be prepared sequentially (e.g., operating rooms, procedure areas, compounding areas), the first medication prepared must be fully labelled before the preparation of a second, different medication is started. This sequential preparation and immediate labelling reduces the risk of medication mix-ups and unlabeled syringes.

• Rationale: Sequential preparation and labelling:

  • Prevents Mix-Ups of Prepared Medications: In busy clinical settings, it's easy to get distracted or misidentify unlabeled syringes or prepared medications if multiple preparations are done at once. Labelling immediately after preparing each medication minimizes this risk of confusion.

  • Ensures Correct Identification: Immediate labelling prevents the risk of forgetting what medication is in an unlabeled syringe or container, especially if preparations are interrupted or staff is called away.

  • Maintains Order and Organization: Sequential preparation and labelling promotes a more organized and controlled medication preparation workflow, reducing potential for errors and interruptions.

• Practical Implementation - Sequential Preparation and Labelling:

  • Prepare and load first medication: When preparing a medication for administration (e.g., drawing up a medication into a syringe, reconstituting a powder, preparing an IV admixture), focus only on that one medication at a time.

  • Attach label: Immediately after preparing the first medication (e.g., once the syringe is filled or the admixture is compounded), apply a complete and accurate label to the prepared medication container (syringe, IV bag, etc.). The label should include all essential information (drug name, strength, concentration, patient name, date/time of preparation, preparer's initials – hospital policy will specify required elements).

  • Then, prepare second drug: Only after the first prepared medication is fully labelled, start the process of preparing a second, different medication, if needed. Do not prepare multiple medications simultaneously without labelling each one sequentially.

  • Points to Remember/Examples:

    • Anaesthetic drug preparation in OTs: This is a prime example. In operating rooms, anaesthesia personnel often prepare multiple medications for induction, maintenance, and emergencies. Following sequential preparation and labelling is crucial in the fast-paced OT environment to avoid mix-ups of potent anaesthetic agents.

    • Chemotherapy drugs: Compounding of chemotherapy drugs requires meticulous accuracy and labelling. Sequential preparation and labelling is essential in compounding areas to prevent errors and cross-contamination between different chemotherapy agents.

    • General principle for all medication preparation: This principle should ideally be applied to all medication preparation in all clinical settings, not just in specialized areas. Any time a medication is prepared (drawing from a vial, reconstituting, etc.) it should be labelled immediately before moving on to prepare another, different medication.

3. MOM 7c: The patient is identified before administration. (C)

• Key Phrase: "Patient is identified before administration." Fundamental step of patient identification.

• Requirement: Before administering any medication to a patient, the healthcare professional administering the medication must positively and reliably identify the intended recipient. This is the cornerstone of the "Right Patient" principle and a critical step to prevent wrong-patient medication errors.

• Rationale: Patient identification is the single most important step to prevent wrong-patient medication errors. Failure to properly identify the patient:

  • Leads to Wrong-Patient Errors: Administering medication to the wrong patient can have severe consequences, including allergic reactions, adverse drug reactions, lack of therapeutic effect, and incorrect treatment for the actual intended patient.

  • Undermines All Other Safety Steps: Even if all other aspects of medication management are correct (right drug, dose, route, time), if the medication is given to the wrong patient, it is a serious and preventable error.

  • Violates Basic Patient Safety Principles: Correct patient identification is a fundamental patient right and a core expectation in healthcare.

• Practical Implementation - Patient Identification Protocol:

  • At a minimum, two identifiers shall be used: The standard of care for patient identification requires using at least two different, acceptable patient identifiers to reliably verify patient identity. Relying on just one identifier is not considered sufficiently robust and increases the risk of errors (e.g., two patients with the same last name in the same ward).

  • Check unique identification number: One of the two identifiers must be a unique identification number that is specific to the patient and their medical record. Acceptable unique identifiers include:

    • Medical record number (MRN): The hospital-assigned unique MRN is an excellent identifier.

    • Patient ID band number: The unique number printed on the patient's wristband. Visual check of the ID band against the medication order/MAR is essential.

  • Check patient's name: The patient's name should be used as a second identifier. However, name alone is not a sufficient identifier because multiple patients can have the same or similar names. It must always be used in conjunction with a unique identifier. Verify the name by:

    • Asking the patient to state their full name: If the patient is conscious and able to communicate, ask them to state their full name.

    • Comparing the name on the patient's ID band to the medication order/MAR: Visually confirm that the name on the ID band matches the name on the medication order/MAR.

  • Acceptable Patient Identifiers (Hospital Policy should define): Hospital policy should specify the approved two patient identifiers that must be used for medication administration. Commonly accepted identifiers (beyond name and MRN/ID band number, if needed) could include:

    • Date of birth (DOB).

    • Another patient-specific identifier (e.g., unique visit number).

  • Unacceptable Identifiers (to be avoided as sole identifiers):

    • Room number or bed number (patients can be moved, rooms can be misidentified).

    • Patient's medical condition or diagnosis (can be shared by multiple patients).

  • Patient Unable to Respond: If the patient is unconscious, confused, or unable to communicate, the identification process must still be performed using the patient's ID band and verifying with a second qualified staff member if possible.

  • Document patient identification: In some settings (e.g., for high-risk medications, or per hospital policy), documentation of patient identification verification may be required in the medication administration record.

4. MOM 7d: Medication is verified from the medication order and physically inspected before administration. (CO)

• Key Phrase: "Verified from medication order" and "physically inspected." Two-pronged verification before administration.

• Requirement: Immediately before administering a medication to a patient, the healthcare professional must perform a "double-check" process, involving both:

  • Verification against the medication order (or Medication Administration Record - MAR): Confirming that the medication being prepared is consistent with the prescribed order.

  • Physical inspection of the medication: Visually examining the medication itself for any signs of issues or discrepancies before administering it.

• Rationale: Two-pronged verification:

  • Catches Prescription Errors: Verification against the medication order ensures that the medication being administered is actually what was prescribed. It acts as a final check for potential prescribing errors in drug, dose, route, or frequency.

  • Catches Dispensing Errors: Verifying against the order also helps catch any dispensing errors – if the wrong medication or strength was dispensed by the pharmacy, this verification step can identify the discrepancy before it reaches the patient.

  • Detects Medication Quality Issues: Physical inspection can reveal obvious medication quality problems (e.g., discoloration, precipitation, particulate matter, damaged packaging, expiry).

  • Ensures "5 Rights" Compliance: This verification process helps confirm key elements of the "5 Rights of Medication Administration" (Right Drug, Right Dose, Right Route, Right Time, Right Patient).

• Practical Implementation - Verification and Physical Inspection:

  • Verify medication order: Compare the prepared medication against the information in the medication order (or MAR). The comparison should include verifying:

    • Right drug: Confirm that the name of the medication being prepared matches the name on the order. Check both generic and brand names.

    • Right dose: Verify that the dose (strength and quantity) being prepared is exactly what is prescribed. Pay close attention to units of measurement.

    • Right route: Confirm that the route of administration (oral, IV, etc.) is consistent with the order and is appropriate for the medication and patient.

    • Right time (for scheduled medications): Verify that it is the correct time to administer the medication based on the frequency and timing in the order.

  • Check general appearance of medication (melting and clumping): Physically inspect the medication itself before administration for any signs of quality issues:

    • Visual appearance: Check for any unusual discoloration, cloudiness (for solutions), precipitation, or presence of particulate matter (especially in injectables).

    • Physical integrity: Check for damage to tablets or capsules (crushing, breaking, melting, clumping).

    • Package integrity: Inspect the packaging for any tears, leaks, or signs of tampering.

  • Check expiry dates: Always re-verify the expiry date of the medication container immediately before administration, even if it was checked at dispensing. Expiry dates can sometimes be missed earlier in the process. Do not administer expired medications.

  • Defer administration in case of missing/incomplete parameters (Name, strength, route or frequency/time): If any of the essential information is missing or incomplete on the medication order, or if there's any ambiguity or discrepancy during verification or physical inspection, do not administer the medication.

    • Defer administration: Hold the medication administration.

    • Clarify with prescriber: Contact the prescriber to clarify any ambiguities, get missing information, or resolve discrepancies.

    • Document clarification efforts: Document the reason for deferring administration and the steps taken to clarify the order in the patient's medical record and/or medication administration record.

  • Points to Remember:

    • Verbal confirmation: "Adhere procedure for verbal order." If the medication order is based on a verbal order (MOM 4f - which should be minimized), it is even more critical to follow a rigorous "repeat back/read back" process and perform careful verification before administration.

    • High-risk medication(s): "At least two staff (nurse-nurse or nurse-doctor) should verify independently and document the process." For high-risk medications (MOM 3c), implement a double-check or independent verification process. This usually requires two qualified healthcare professionals (e.g., two nurses, or a nurse and a physician) to independently:

      • Verify the medication order.

      • Verify the prepared medication against the order.

      • Physically inspect the medication.

      • Document both of their verifications in the medication administration record.

    • Empower nurses to highlight prescription errors: Create a culture where nurses are empowered and encouraged to question prescriptions, highlight potential errors, and defer administration if they have any concerns about the order or the medication, without fear of reprisal. Nurses are often the last line of defense in catching medication errors before they reach the patient.

5. MOM 7e: Strength is verified from the order before administration. (C)

• Key Phrase: "Strength is verified from the order." Specific focus on verifying medication strength.

• Requirement: Specifically and explicitly, the strength of the medication to be administered must be verified against the medication order before administration. This is a focused subset of the broader verification in MOM 7d, highlighting the critical importance of dose and strength accuracy.

• Rationale: Strength errors are a frequent and potentially serious type of medication error. Highlighting strength verification as a separate objective element underscores its significance:

  • Dose Errors are Common: Errors involving incorrect medication strength or concentration are a significant portion of medication errors reported.

  • Strength Errors Can Have Major Impact: Wrong strength administration can easily lead to under-dosing (treatment failure) or over-dosing (toxicity, ADRs), especially for medications with narrow therapeutic indices.

  • Multiple Strengths Available: Many medications are available in multiple strengths and concentrations. It's crucial to verify that the correct strength is being administered as per the order.

• Practical Implementation - Strength Verification:

  • Verify strength from medication order: When performing verification before administration, place particular emphasis on confirming that the strength written on the medication order exactly matches the strength of the medication being prepared and is ready for administration. This should be a conscious and deliberate step in the verification process.

  • Defer medication administration in case of discrepancy: If there is any discrepancy identified between the ordered strength and the strength of the prepared medication, defer administration immediately. Do not administer the medication until the discrepancy is fully investigated and resolved by clarifying with the prescriber and/or pharmacy.

6. MOM 7f: The route is verified from the order before administration. (C)

• Key Phrase: "Route is verified from the order." Specific focus on verifying administration route.

• Requirement: Specifically and explicitly, the route of administration (oral, IV, IM, subcutaneous, topical, etc.) must be verified against the medication order before administration. This is another focused element highlighting the importance of correct route selection.

• Rationale: Route errors are also a serious type of medication error, and selecting the wrong route can have significant clinical consequences:

  • Wrong Route Can Lead to Ineffectiveness: Administering a medication via the wrong route can render it ineffective (e.g., giving an IV medication orally).

  • Wrong Route Can Cause Serious Harm: Administering a medication via the wrong route can cause severe tissue damage, systemic toxicity, or even death (e.g., giving an IV medication intended for IM use, giving intrathecal medication intravenously).

  • Route Errors Can Be Subtle but Dangerous: Mix-ups between IV and subcutaneous routes, or between different types of topical preparations, can occur if route verification is not meticulous.

• Practical Implementation - Route Verification:

  • Check route and site of administration with medication order: When performing verification before administration, explicitly check and confirm that the intended route of administration written in the medication order (e.g., "IV," "oral," "IM," "topical") matches the route you are about to use for administration and is appropriate for the medication and patient. Also, for certain routes (e.g., IM, subcutaneous, topical), verify the intended site of administration (e.g., "deltoid muscle," "left thigh," "affected area of skin") as specified in the order or standard protocol.

  • Clarify any ambiguity: If the route of administration is unclear, ambiguous, or seems inappropriate based on the medication, patient, or clinical situation, always clarify with the prescriber or pharmacy before administering the medication. Do not assume or guess the intended route.

7. MOM 7g: Timing is verified from the order before administration. (C)

• Key Phrase: "Timing is verified from the order." Specific focus on verifying correct administration time.

• Requirement: Specifically and explicitly, the timing of medication administration (when the medication is due to be given) must be verified against the medication order (or MAR) before administration. Administering medications at the correct time is crucial for therapeutic effectiveness and patient safety.

• Rationale: Correct timing of medication administration:

  • Maintains Therapeutic Blood Levels: For many medications, especially those given multiple times a day, maintaining consistent blood levels within the therapeutic range is important for efficacy. Giving doses too early or too late can disrupt these levels and reduce effectiveness.

  • Optimizes Drug Action: For some medications, timing is critical for optimal drug action (e.g., medications given before meals for better absorption, medications given at bedtime to minimize daytime sedation).

  • Prevents Errors Related to Frequency: Verifying timing helps ensure that medications are given at the correct intervals (e.g., every 6 hours vs. twice daily) as prescribed, avoiding over or under dosing due to incorrect frequency interpretation.

  • Minimizes Interactions: Proper timing can be important in managing drug interactions, e.g., separating administration times of medications known to interact.

• Practical Implementation - Timing Verification:

  • Scheduled timing: "Verify with medication order." For medications with scheduled administration times (e.g., "every 6 hours," "twice daily," "morning," "evening"), verify that it is the correct time window to administer the dose based on the prescribed schedule and the hospital's medication administration timing policies. Check the MAR to see when the last dose was given and when the next dose is due.

  • Suggested timing: "Documentation of actual timing should be available when timing is not written in the medication order." For medications prescribed "PRN" (as needed) or with less specific timing instructions, document the actual time of administration in the medication administration record. This provides a record of when PRN medications were given and helps track frequency and effectiveness.

  • Points to Remember:

    • ISMP Acute Care Guidelines for Timely Administration of Scheduled Medications: The slide references ISMP guidelines, highlighting their importance. ISMP provides excellent resources on medication timing, including:

      • Provides guidance on scheduled medication: ISMP guidelines offer practical guidance on establishing hospital policies for medication administration timing windows, defining "on-time," "early," and "late" administration.

      • Classifies them into time-critical and non-time-critical: ISMP categorizes scheduled medications into "time-critical" (where even small delays in administration can be harmful – e.g., insulin, anticonvulsants) and "non-time-critical" medications. This categorization helps hospitals prioritize timing for different medication categories.

      • The organisation can adopt/adapt the same: Hospitals are encouraged to review and adopt or adapt ISMP guidelines for timely medication administration to develop their own timing policies that best suit their setting and patient needs.

8. MOM 7h: Measures to avoid catheter and tubing mis-connections during medication administration are implemented. * (CO)

• Key Phrase: "Avoid catheter and tubing mis-connections." Preventing dangerous misconnections.

• Requirement: Hospitals must implement specific measures to prevent dangerous misconnections between different types of catheters and tubing used for medication administration and other medical purposes (e.g., IV lines, feeding tubes, epidural catheters). Misconnections can lead to administering medications or fluids into the wrong route, with potentially catastrophic consequences.

• Rationale: Catheter and tubing misconnections can result in severe and often preventable patient harm, including:

  • Intravenous administration into non-IV lines: Accidental IV infusion into feeding tubes, epidural catheters, or other non-vascular lines can cause severe tissue damage, infection, or systemic complications.

  • Enteral administration into IV lines: Accidental enteral feeding into IV lines can lead to serious systemic infections (sepsis) and death.

  • Medication administration into wrong route (e.g., IV medication into epidural space): This is extremely dangerous and can cause paralysis, neurological damage, or death.

  • Under-treatment or over-treatment: If fluids or medications are delivered to the wrong system, the intended therapeutic effect will be missed, and the patient may be under-treated. Conversely, if high-concentration medications are misconnected to a wrong route, it can cause overdose.

• Practical Implementation - Measures to Prevent Misconnections:

  • Avoid inadvertent administration of a drug through a wrong route: The overarching goal of these measures is to eliminate or minimize the possibility of accidentally administering a medication or fluid into the wrong catheter or tubing route.

  • Use design features to prevent misconnections: Utilize specialized connectors and tubing designs that are route-specific and physically incompatible with connectors for other routes. Examples include:

    • Enteral-specific connectors (ENFit connectors for feeding tubes): Standardize the use of ENFit connectors for all enteral feeding tubes and devices. ENFit connectors are physically incompatible with standard IV connectors, making it impossible to connect IV tubing to an enteral feeding tube and vice versa.

    • Epidural-specific connectors: Utilize specialized connectors for epidural catheters that are also incompatible with IV connectors.

    • Regional anesthesia connectors (e.g., NRFit connectors for neuraxial regional anaesthesia): Adopt NRFit connectors for regional anesthesia catheters that are incompatible with both IV and enteral connectors.

  • Prompt user to take correct action: Implement systems and workflows that prompt users to double-check connections and route compatibility before making connections. Examples:

    • Pre-use checks and visual inspection: Train staff to always visually inspect connectors and tubing before making connections to ensure they are compatible and route-appropriate.

    • "Independent double-check" for high-risk connections: For connections involving high-risk routes (epidural, intrathecal, arterial lines), require a second qualified staff member to independently verify the correct connector and tubing are being used before connection.

    • "Line reconciliation" process: Implement a process of "line reconciliation" during patient handovers, shift changes, and at key points in care to systematically trace and verify all lines and connections.

  • Avoid using IV extension tubes for epidurals, irrigation, drains, central lines and to extend enteric feeding tubes: Strictly prohibit the routine use of standard IV extension tubing for routes other than IV administration. This is because standard IV extension sets can mistakenly be connected to various types of catheters and tubing, creating misconnection hazards. Use route-specific tubing whenever possible. If extension sets are absolutely needed for non-IV routes, use clearly labelled, route-specific extension sets that are distinct from standard IV extension sets (e.g., enteral extension sets with ENFit connectors).

  • Position functionally dissimilar tubes away from each other: In patient care areas, physically position and organize different types of tubing and catheters (IV lines, feeding tubes, drainage tubes) in a way that they are visually distinct and are less likely to be confused with each other. Avoid coiling them together or running them in parallel if possible. Use distinct labels and color-coding for different types of lines to further enhance visual differentiation.

  • Trace all lines from origin to connection port to verify attachments: Train staff to always trace lines from their origin to the connection port before administering any medication or fluid or making any connection. This involves physically following the tubing from the fluid/medication source, tracing it along its entire path to the patient's catheter or access port, to verify that it is connected to the intended and correct route and port. This is a critical step to ensure correct attachments and rule out misconnections before administration.

9. MOM 7i: Medication administration is documented. (C)

• Key Phrase: "Medication administration is documented." Complete and accurate documentation of administration.

• Requirement: Every instance of medication administration must be accurately and completely documented in the patient's medical record. This documentation serves as a legal record of administration, aids in patient care continuity, and is essential for medication safety monitoring.

• Rationale: Documentation of medication administration is vital for:

  • Legal Record: The medication administration record (MAR) is a legal document that verifies that medications were administered as prescribed and is often required for regulatory compliance and medico-legal purposes.

  • Patient Care Continuity: Accurate MARs provide a clear and up-to-date record of the patient's medication history, allowing all members of the healthcare team to know what medications have been given, when, and by whom. This is essential for coordinating care and making informed treatment decisions.

  • Error Tracking and Prevention: MARs can be reviewed to track medication administration patterns, identify potential missed doses or errors, and analyze administration timing. This data can be used to improve medication administration processes.

  • Billing and Reimbursement: Accurate documentation is essential for billing purposes and for hospital reimbursement for medication costs.

• Practical Implementation - Medication Administration Documentation:

  • Documentation Elements: The medication administration record (MAR) should, at a minimum, document the following essential elements for each medication administration:

    • Name of medication: Generic and/or brand name.

    • Strength: Strength of the administered dose.

    • Route of administration: How it was given (oral, IV, etc.).

    • Timing: Date and exact time of administration.

    • Name/employee ID number, signature of authorised person: Identify the healthcare professional who administered the medication (typically a nurse). Include their printed name, employee ID, and signature (or electronic signature in EMRs).

    • Infusions: Start time, rate of infusion and end time: For intravenous infusions, document the start time, infusion rate (mL/hour or units/hour), and the end time of the infusion. This is important for tracking complete infusions and calculating total doses given.

  • Points to Remember:

    • Document in uniform location: Use a standardized medication administration record (MAR) form (paper or electronic) that is consistently used across the hospital. This ensures all documentation is in a predictable location and format.

    • Document each dose of the same medication separately: Record each individual dose of a medication on a separate line in the MAR, even if it is the same medication given multiple times a day. Do not group multiple doses on a single entry, as this can obscure timing details and make tracking individual doses difficult.

    • Record should reflect actual administration: The MAR must accurately reflect what was actually administered to the patient. Document any deviations from the original order, medication refusals, or reasons for non-administration.

    • Examples:

      • If brand Y was given instead of brand X (same generically), then documentation should be done for brand Y: If, due to formulary substitution or availability issues, a different brand (Brand Y) was dispensed and administered instead of the originally ordered Brand X (but both are the same generic drug), document exactly what was administered (Brand Y) in the MAR. Do not document Brand X if that was not what the patient received.

      • If order was for tablet of 250mg, but ½ tablet of 500 mg was administered, then document the latter: If a dose adjustment is made (e.g., splitting a 500mg tablet to administer 250mg), document the actual dose administered (250mg, or "½ of 500mg tablet") in the MAR. Do not just document the originally ordered dose if the administered dose was different.

    • Document patient's refusal to take medication: If a patient refuses a scheduled medication, document this refusal in the MAR, including the time, the medication refused, and the reason for refusal (if known and documented). Follow hospital policy on managing medication refusals (e.g., notifying physician, offering alternatives).