CLINICAL PHARMACOLOGY 2003 (PART 7)

This chapter describes the background to why it became necessary to regulate the use and supply of drugs, and the ways in which these processes are managed. • Basis for regulation: safety, efficacy, quality, supply • Present medicines regulatory system • Present day requirements • Counterfeit drugs • Appendix: the thalidomide disasterchange the safety information e.g. add new warnings, or contraindications. The quality aspects may also need to be revised as manufacturing practices change. MAHs have strong profit motives for making claims about their drugs. Only governments can provide the assurance about all those aspects in the life of...
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CLINICAL PHARMACOLOGY 2003 (PART 7) 5 Official regulation of medicines SYNOPSIS change the safety information e.g. add new warn- ings, or contraindications. The quality aspects may This chapter describes the background to why also need to be revised as manufacturing practices it became necessary to regulate the use and change. MAHs have strong profit motives for supply of drugs, and the ways in which these making claims about their drugs. Only governments processes are managed. can provide the assurance about all those aspects • Basis for regulation: safety, efficacy, quality, in the life of a medicine, (in so far as it can be supply provided). • Present medicines regulatory system The principles of official (statutory) medicines regu- • Present day requirements lation are that • Counterfeit drugs • No medicines shall be marketed without prior • Appendix: the thalidomide disaster licensing by the government. • A licence shall be granted on the basis of scientific evaluation1 of: — safety, in relation to its use: evaluation at the point of marketing is provisional in the sense Basis for regulation that it is followed in the community by a pharmacovigilance programme — efficacy (now often including quality of life)Neither patients nor doctors are in a position to — quality, i.e. purity, stability (shelf-life)decide for themselves across the range of medicinesthat they use, which ones are pure and stable, and 1effective and safe. Except in the case of traditional herbal medicines (which They need assurance that the medicines they are can be ineffective and/or hazardous), as well as otheroffered fulfil these requirements and are supported substances used in the legitimate practice of complementary medicine, for which this requirement cannotby information that permits optimal use. The be met. Official regulators, finding themselves between theinformation about and the usage of medicines gets rock of maintaining scientific principles and the hard placeout of date, and there is an obligation on licence of banning complementary medicines that are popular withholders continually to review their licence with the public (a political impossibility), have reacted in accordance with the highest traditions of their calling as civilparticular regard to safety. Marketing Authorisation servants. They have produced a compromise mix ofHolders (MAH), i.e. pharmaceutical companies, reinterpreted regulations with circumspect labelling that willcan also change the efficacy claims to their licence, allow these products to continue to be sold without, it ise.g. new indications, extension of age groups, or hoped, misleading the public. 73 5 OFFICIAL REGULATION OF MEDICINES — supply: i.e. whether the drug is suitable to be ation of synthetic drugs in the early 20th century unrestrictedly available to the public or when the traditional and familiar pharmacopoeia4 whether it should be confined to sales expanded slowly and then, in mid-century, with through pharmacies or on doctors enormous rapidity. prescriptions; and what printed information The first comprehensive regulatory law that should accompany its sale (labelling, required premarketing testing was passed in the USA leaflets). in 1938, following the death of about 107 people due• A licence shall specify the clinical indications to the use of diethylene glycol (a constituent of anti- that may be promoted and shall be for a limited freezes) ...