Embedded Files
effects associated with drugs they The MHRA continually evaluates this info The MHRA continually evaluates t drugs cause unexpected effects that a drugs cause unexpected effects tha wide distribution occurs. Sometim therapeutic. For example, patient sonism drug amantadine were found sonism drug amantadine were infl uenza than other patients, other patients, amantadine is an effective other instances, the the diet drug only SAMPLE d Unlicensed Drugs ensed Drugs ions when an unlicensed drug, that is a drug ons when an unlicensed drug, that is a drug t completed the entire clinical trials programme, completed the entire clinical trials programme, treat a patient. For example, an unlicensed drug eat a patient. For example, an unlicensed dru e used as drug treatment as part of a clinical tr s drug treatment as part of a clinical t rnatively, the doctor may consider that the patie atively, the doctor may consider that the pa enefi t from the new treatment because other t t from the new treatment because other approaches have failed. The doctor must apply approaches have failed. The doctor must apply maceutical company to use the drug on wha maceutical company to use the drug on wh ‘named patient’ basis. The doctor takes res ‘named patient’ basis. The doctor takes re unlicensed drug treatment and the patient aware of the potential risks associate aware of the potent Drugs that have successfully p Drugs that ha ing are granted a product licence are granted a product permits the pharmaceutic permits the pharmac for the treatment of specifi ered by the license. If could be useful in could be use to treat anothe treat anoth pany will need another license another doctors patient SAMPLE 17,21-dipropionate CHAPTER 1 — Introduction to Drugs 9 Legal Regulation of Drugs The Medicines Act (1968) controls the manufacture and supply of medicine. Newly marketed drugs can be allocated to one of four categories: 1. Prescription-only medicine controlled drugs (POM CD) can be supplied only by authorized individuals. 2. Prescription only medicine can be sold only by a pharmacist in receipt of a prescription from a doctor. 3. Pharmacy-only drugs (P) can be sold without the need of a prescription by pharmacists. 4. General sales list drugs can be sold without a prescription in any shop. Controlled Substances Drugs with abuse potential are called controlled substances. The Misuse of Drugs Act (1971) regulates the manufacturing, distribution and possession of drugs that are known to have abuse potential. This act established categories for ranking the abuse potential of various drugs, where Class A drugs are considered to be the most harmful. Examples of drugs in each class include: • Class A – ecstasy, lysergide (LSD), diamorphine (heroin), morphine, opium, pethidine, cocaine, crack, magic mushrooms, methylamphetamine (crystal meth) and other amphetamines if prepared for injection. • Class B – oral amphetamines, barbiturates, codeine, pholcodine, ethylmorphine, glutethimide, pentazocine and phenmetrazine. • Class C – drugs related to amphetamines, cannabis (including resin), most benzodiazepines and androgenic and anabolic steroids. A second act, the Misuse of Drugs Regulations (2001) specifi es those individuals who are authorized to supply drugs from these categories to their patients. The Home Offi ce is responsible for the enforcement of these regulations. Generic Drugs When a pharmaceutical company has synthesized and carried out some preclinical testing it applies for a patent. A patent is usually valid for 20 years and only that company can sell the drug during that time. When the patent runs out on a trade name drug, the drug can be produced by other manufacturers. Generic drugs are medicines that are produced by companies that just manufacture drugs. These companies do not have the research or the advertising that pharmaceutical companies have and can, therefore, produce the generic drugs more cheaply. In the past, some quality control problems were found with generic products. For example, the binders used in a generic drug might not be the same as those used in the trade name product; as a result, the way the body absorbs and uses the drug may differ. In that case, the bioavailability of the
Report abuse