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The quality of a drug has an impact on its efficacy and safety. Quality is determined by proper manufacturing and storage: high-quality medications are available when rational purchasing procedures are followed and suppliers are dependable. Additionally, it is critical to maintaining ideal transportation and storage conditions.
One of the most serious difficulties facing the pharmaceutical business is protecting medications from unwanted interactions with the environment while also keeping their potency during shelf life.
Primary packaging materials, in particular, must meet stringent regulatory requirements, such as those set forth in US regulations: "Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products are not reactive, additive, or adsorptive in such a way that the safety, identity strength, quality, or purity of the drug product is not altered beyond the official or other established requirements.
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Norms of excellence
Each medicine is distinguished by specific pharmacopoeia or manufacturer-supplied files that are recognised by competent authorities in each nation. These standards cover colour, odour, physicochemical qualities, analysis processes, shelf life, and storage conditions, among other things.
Analysis certifications ensure that products from a single batch (from the same production cycle) meet official quality standards in the country of origin. Manufacturers issue these certificates for each product.
Every unit (box and bottle) should be correctly labelled, with each label indicating the following:
– INN,
– form and dosage,
– number of units (tablets, ampoule, etc.) or the volume (syrup, etc.),
– name and address of the manufacturer,
– batch number,
– expiry date.
Conditions of storage
Drug stability is affected by both environmental elements like temperature, air, light, and humidity, as well as drug-specific characteristics including the active component, dosage form (tablet, solution, etc.) and manufacturing method. If the recommendations are not identical, it is required to follow the storage instructions provided in this guide or by manufacturers (on notices and labels).
The temperature in the store should not exceed 25 degrees Celsius.
The following are the storage temperatures as established by the European Pharmacopoeia:
freezer - 15 to 0 °C
refrigerator + 2 to + 8 °C
cool + 8 to + 15 °C
ambient temperature + 15 to + 25 °C
Temperatures within vehicles, shipping containers, and ports may reach 50 to 60 °C during transit and shipment, and shelf life and expiry dates may no longer be guaranteed.
Freezing can be harmful, especially for solutions, since it can cause active components to deteriorate or precipitate, as well as ampoules and vials to crack.
Vaccines, immunoglobulins, and antisera are heat and light-sensitive compounds. Vaccines that are less susceptible to heat (referred to as "thermostable") must nevertheless be stored in the refrigerator between 2 and 8 degrees Celsius, and the cold chain must be properly followed during shipment.
A heat-sensitive monitor could be included in the vaccine containers (VVM). When exposed to heat over time, the square on the monitor changes colour: if the square is lighter than the circle, the vaccine can be used. The vial must be discarded if the square is the same colour or darker than the circle. The metre keeps track of how much heat you've been exposed to overtime.
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Controlled temperature chain (CTC)
Certain vaccines licenced for use in a CTC can only be transferred and used outside of the cold chain during certain mass vaccination programmes.
To be used in a CTC, the vaccine must be able to withstand temperatures of up to 40 °C for at least 3 days after being removed from the cold chain (2 °C to 8 °C). A peak threshold indicator in each vaccine carrier used for transport and vaccination in the field monitors the maximum temperature of 40 °C.
Humidity and air
The relative humidity in a store should not exceed 65 per cent (there are several devices for humidity measurement).
Because of its oxygen and humidity concentration, the air is a deteriorating component. All containers should be kept closed at all times. Drugs are shielded from air and light in airtight and opaque containers (hospital type). It is best to avoid opening medicine containers too soon before using them.
Patients should be advised that tablets should not be taken out of blisters until just before they are administered.
Light
The light should be kept away from drugs, especially solutions. Parenteral forms should be kept in their original containers. Coloured glass may provide false light shielding.
Deterioration
It's critical to be familiar with each drug's normal characteristics (colour, odour, solubility, consistency) in order to spot alterations that could suggest deterioration. It's crucial to remember that deterioration does not necessarily result in visible exterior changes.
The most common symptom of deterioration is a decrease in therapeutic activity, which can have serious ramifications for the individual and/or community.
Using expired antibacterials, for example, does not cure an infection and promotes the emergence of resistant strains.
It is not suggested that a random increase in the regular dose be used to compensate for a probable fall inactivity, as there is a real risk of overdosing when utilising harmful medications.
Certain medications deteriorate with time, resulting in the formation of far more harmful chemicals and consequently an increase in toxicity. Tetracycline is the most common example: the pale yellow powder turns dark and viscous, making it harmful to use even if it is past its expiration date.
Certain medicines, such as penicillins and cephalosporins, have shown a rise in allergen strength.
Suppositories, pessaries, lotions, and ointments should not be used if they have been melted in the heat. The active substance is no longer evenly distributed throughout the body.
Oral rehydration salts can be utilised as long as they maintain their white powder appearance. Humidity turns them into a dense mass that is brownish in colour and intractable. They are thus unfit for ingestion, regardless of their expiration date.
Expiration
Even if maintained properly, drugs decay with time and according to a variety of factors. Manufacturers must investigate the stability of their products in standardised settings and guarantee a minimum shelf lifetime in most countries, according to legislation. Manufacturers' expiry dates designate the period up to and including which the therapeutic effect remains unaltered (at least 90 percent of the active ingredient should be present and with no substantial increase in toxicity).
The expiration date on the label is based on the drug's stability in its original, sealed container. Currently, 3 to 5 years of shelf life is routinely assured. Substances that are less stable are only guaranteed for one or two years.
The expiration date, as well as storage directions, should be printed on the label.
Disposal of outdated or no longer useful medications and materials
Throwing out or burying outdated or useless drugs without proper precautions might be deadly. Interagency Guidelines For Safe Disposal of Unwanted Pharmaceuticals in and After Emergencies, WHO/99.2, contains more information on drug and material destruction.
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Reference pharmaceutical UCGconferences press releases and blogs
https://ucgconferences.tumblr.com/post/679327062370238464/how-to-store-highly-sensitive-drugs
https://kikoxp.com/posts/10171
https://www.linkedin.com/pulse/how-store-highly-sensitive-drugs-dr-richard-raven/?published=t
https://medium.com/@luciferellisucg/how-to-store-highly-sensitive-drugs-e24447784f27
https://luciferellis.blogspot.com/2022/03/how-to-store-highly-sensitive-drugs.html
https://hubpages.com/health/How-To-Store-Highly-Sensitive-Drugs
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