numbers of people. d. healthy human volunteers. 3. The generic name of a drug is a. the name assigned to the drug by the pharmaceutical company developing it. CHECK YOUR UNDERSTANDING http://www.nhsdirect.nhs.uk The NHS Direct service provides patients with information and advice about health, illness and health services. http://www.nice.org.uk The National Institute for Health and Clinical Excellence provides guidance on public health, new and existing treatments within the NHS and also information on the most appropriate care for patients. http://www.nmc-uk.org The Nursing and Midwifery Council sets standards for training and education and ensures that those standards are maintained This database provides travel health information for health care providers. This site can be accessed only by registered NHS users..org.uk This site for the Research Defence Society provides information on the use of animals in research. http://www.yellowcard.gov.uk Health care professionals and the public are encouraged to report unwanted or unexpected adverse reactions using the yellow card system. Points to Remember • All nurses must abide by the standards set by the Nursing and Midwifery Council for the safe administration of drugs. • Drugs are chemicals that are introduced into the body to bring about some sort of change. • Drugs can come from many sources: plants, animals, inorganic elements, synthetic preparations and biopharmaceuticals. • Preclinical testing of potential drugs involves the use of laboratory animals to determine their therapeutic and adverse effects. • Phase I studies test potential drugs on healthy human subjects to assess safety. • Phase II studies test potential drugs on patients who have the disease the drugs are designed to treat. • Phase III studies test drugs in the clinical setting to determine any unanticipated effects or lack of effectiveness. • Phase IV studies assess the safety and effi cacy of the newly approved drug on a wider population. • The MHRA regulates the development and marketing of drugs to ensure safety and effi cacy. • Generic drugs are sold under their chemical names, not trade names; they may be cheaper but are not necessarily as safe as trade name drugs. OTC drugs are available without prescription for the self-treatment of various complaints. preparations SAMPLE chapter may be found in in the back Choice most appropriate answer to the following. 1. Clinical pharmacology is the study of a. the biological effects of chemicals. b. treat, prevent plant components that can be d. binders and other vehicles for 2. Phase I drug studies involve of laboratory patients with the to treat. mass marketing SAMPLE DERSTANDING by the Nursing the Nursing inistration of inistration of potential drugs involves the potential drugs involves ermine their therapeut ermine their therape t potential drugs on healthy human ential drugs on healthy h assess safety. ies test potential drugs on patients who have rugs on patients who have disease the drugs are designed to treat. III studies test drugs in the clinical setting to deter II studies test drugs in the clinical setting to dete ne any unanticipated effects or lack of effectiveness y unanticipated effects or lack of effectivenes Phase IV studies assess the safety and effi dies assess the safety and effi cacy of th approved drug on a wider population. • The MHRA regulates the development and drugs to ensure safety and effi cacy. • Generic drugs are sold under their trade names; they may be cheaper ily as safe as trade name drugs. ily as safe as trade without prescription for t without pr complaints. 12 PART I — Introduction to Nursing Pharmacology 6. A patient has been taking fl uoxetine for several years, but when picking up the prescription this month, found that the tablets looked different and became concerned. The nurse, checking with the pharmacist, found that fl uoxetine had just become available in the generic form and the prescription had been fi lled with the generic product. The nurse should tell the patient that a. the new tablet may not work and the patient should carefully monitor response. b. generic drugs are available without a prescription because they are very safe. c. the law requires that prescriptions be fi