Committee on safety of medicines Health Dictionary

Committee On Safety Of Medicines: From 1 Different Sources


The Committee for safety of medicines was set up in 1963 after the thalidomide disaster. It is an advisory committee which examines drugs before clinical trials, before a product licence is granted, and when passed for marketing. A product cannot be tested in the human body without the company holding a clinical trial certificate. A product licence is renewable after five years. 
Health Source: Bartrams Encyclopedia of Herbal Medicine
Author: Health Encyclopedia

Ethics Committee

A committee that can have a number of roles in relation to ethics. For example, it may develop policy relative to the use and limitation of treatment; serve as a resource for individuals and their families regarding options for terminal illness; or assess research projects with respect to the appropriate application of ethical principles.... ethics committee

Safety

A judgment of the acceptability of risk (a measure of the probability of an adverse outcome and its severity) associated with a given situation or setting.... safety

Approved Names For Medicines

The term used for names devised or selected by the British Pharmacopoeia Commission for new drugs. European Union law (1992) requires the use of a Recommended International Non-proprietary Name (rINN) for medicinal substances. In most cases the British Approved Name (BAN) and rINN were the same when the legislation was introduced; where there were di?erences, the BAN was modi?ed to meet the new requirements.

Pharmaceutical manufacturers usually give proprietary (brand) names to the drugs they develop, though doctors in the NHS are expected to prescribe using approved – nonproprietary or generic – titles. Most nonproprietary titles are those in the European Pharmacopoeia, British Pharmacopoeia Commission or the British Pharmaceutical Codex. The USA has its own legislation and arrangements covering the naming and prescribing of medicines. (See PROPRIETARY NAME; GENERIC DRUG; PATENT.)... approved names for medicines

Committee On Safety Of Medicines (csm)

An independent advisory committee – launched in 1971 in the United Kingdom – composed of doctors, pharmacists and other specialists. It advises the MEDICINES CONTROL AGENCY in the UK on the safety, e?cacy and pharmaceutical quality of MEDICINES for which licences are sought and also reviews reports of ADVERSE REACTIONS TO DRUGS, including spontaneous ‘Yellow Card’ reports from doctors or pharmacists who suspect that a patient has suffered an adverse reaction from a medicine. Its predecessor, the Committee for Safety of Drugs, was set up in 1963 in response to the THALIDOMIDE disaster.... committee on safety of medicines (csm)

Health And Safety Executive (hse)

The statutory body in Britain responsible for the health and safety of workers. The address of the HSE can be found in APPENDIX 7: STATUTORY ORGANISATIONS.... health and safety executive (hse)

Lifestyle Medicines

Drugs used for non-health problems or for disorders that are in the grey area between a genuine health need and a desire to change a ‘lifestyle failing’ by the use of medication. Examples are: SILDENAFIL CITRATE, which is prescribed for men unable to achieve penile erection (erectile dysfunction); and ORLISTAT, a drug used to combat OBESITY.... lifestyle medicines

Safe Disposal Of Unwanted Medicines

Unwanted medicines are a form of ‘controlled waste’ under the Environmental Protection Act 1990 and must be disposed of in an appropriate way. The best thing is to take any extra or unwanted medicines to a registered pharmacy. Syringes and needles (used by diabetic patients, for example) pose problems: devices exist to cut o? and retain the needle, and some local authorities in the United Kingdom arrange for collection and safe disposal. There are also local ‘needle exchange’ schemes for intravenous drug abusers.

Safe use of medicines All medicines can have unwanted effects (‘side-effects’ or, more strictly, adverse effects) that are unpleasant and sometimes harmful. It is best not to take any medicine, prescribed or otherwise, unless there is a clear reason for doing so; the possible adverse effects of treatment, and the risk of their occurring, have to be set against any likely bene?t. Remember too that one treatment can affect another already being taken. Many adverse events depend upon the recommended dose being exceeded. Some people – for example, those with allergies (see ALLERGY) to a particular group of drugs, or those with kidney or liver disease – are more likely to suffer adverse effects than otherwise healthy people.

When an individual begins a course of treatment, he or she should take it as instructed. With ANTIBIOTICS treatments especially, it is important to take the whole course of tablets prescribed, because brief exposure of bacteria to an antibiotic can make them resistant to treatment. Most drugs can be stopped at once, but some treatments can cause unpleasant, and occasionally dangerous, symptoms if stopped abruptly. Sleeping tablets, anti-EPILEPSY treatment, and medicines used to treat ANGINA PECTORIS are among the agents which can cause such ‘withdrawal symptoms’. CORTICOSTEROIDS are a particularly important group of medicines in this respect, because prolonged courses of treatment with high doses can suppress the ability of the body to respond to severe stresses (such as surgical operations) for many months or even years.... safe disposal of unwanted medicines

Health And Safety Executive

(HSE) (in Britain) a statutory body responsible for health and safety in the workplace (including factories, offices, and farms). See also COSHH.

HSE website: provides guidance on a wide range of health and safety topics... health and safety executive

Local Medical Committee

(LMC) a group of representatives of the general practitioners working in a defined geographical area. There are separate LMCs for each area, and the members speak on behalf of the local practitioners by whom they are elected. Similar arrangements and responsibilities apply for dentists, pharmacists, and optometrists practising in the NHS outside hospitals.... local medical committee

Medical Committee

see local medical committee.... medical committee

Medicines And Healthcare Products Regulatory Agency

(MHRA) a UK government agency that regulates the use of medicinal drugs and medical devices. The agency regulates and issues *licences for the clinical trial, manufacture, and marketing of new products. It also applies the regulations governing the collection, storage, and use of human blood and blood products.

MHRA section of the website... medicines and healthcare products regulatory agency

Medicines

Medicines are drugs made stable, palatable and acceptable for administration. In Britain, the Medicines Act 1968 controls the making, advertising and selling of substances used for ‘medicinal purposes’, which means diagnosing, preventing or treating disease, or altering a function of the body. Permission to market a medicine has to be obtained from the government through the MEDICINES CONTROL AGENCY, or from the European Commission through the European Medicines Evaluation Agency. It takes the form of a Marketing Authorisation (formerly called a Product Licence), and the uses to which the medicine can be put are laid out in the Summary of Product Characteristics (which used to be called the Product Data Sheet).

There are three main categories of licensed medicinal product. Drugs in small quantities can, if they are perceived to be safe, be licensed for general sale (GSL – general sales list), and may then be sold in any retail shop. P (pharmacy-only) medicines can be sold from a registered pharmacy by or under the supervision of a pharmacist (see PHARMACISTS); no prescription is needed. P and GSL medicines are together known as OTCs – that is, ‘over-thecounter medicines’. POM (prescription-only medicines) can only be obtained from a registered pharmacy on the prescription of a doctor or dentist. As more information is gathered on the safety of drugs, and more emphasis put on individual responsibility for health, there is a trend towards allowing drugs that were once POM to be more widely available as P medicines. Examples include HYDROCORTISONE 1 per cent cream for skin rashes, CIMETIDINE for indigestion, and ACICLOVIR for cold sores. Care is needed to avoid taking a P medicine that might alter the actions of another medicine taken with it, or that might be unsuitable for other reasons. Patients should read the patient-information lea?et, and seek the pharmacist’s advice if they have any doubt about the information. They should tell their pharmacist or doctor if the medicine results in any unexpected effects.

Potentially dangerous drugs are preparations referred to under the Misuse of Drugs Act 1971 and subsequent regulations approved in 1985. Described as CONTROLLED DRUGS, these include such preparations as COCAINE, MORPHINE, DIAMORPHINE, LSD (see LYSERGIC ACID

DIETHYLAMIDE (LSD)), PETHIDINE HYDROCHLORIDE, AMPHETAMINES, BARBITURATES and most BENZODIAZEPINES.

Naming of drugs A European Community Directive (92/27/EEC) requires the use of the Recommended International Non-proprietary Name (rINN) for medicinal substances. For most of these the British Approved Name (BAN) and rINN were identical; where the two were di?erent, the BAN has been modi?ed in line with the rINN. Doctors and other authorised subscribers are advised to write titles of drugs and preparations in full because uno?cial abbreviations may be misinterpreted. Where a drug or preparation has a non-proprietary (generic) title, this should be used in prescribing unless there is a genuine problem over the bioavailability properties of a proprietary drug and its generic equivalent.

Where proprietary – commercially registered

– names exist, they may in general be used only for products supplied by the trademark owners. Countries outside the European Union have their own regulations for the naming of medicines.

Methods of administration The ways in which drugs are given are increasingly ingenious. Most are still given by mouth; some oral preparations (‘slow release’ or ‘controlled release’ preparations) are designed to release their contents slowly into the gut, to maintain the action of the drug.

Buccal preparations are allowed to dissolve in the mouth, and sublingual ones are dissolved under the tongue. The other end of the gastrointestinal tract can also absorb drugs: suppositories inserted in the rectum can be used for their local actions – for example, as laxatives – or to allow absorption when taking the drug by mouth is di?cult or impossible – for example, during a convulsion, or when vomiting.

Small amounts of drug can be absorbed through the intact skin, and for very potent drugs like OESTROGENS (female sex hormones) or the anti-anginal drug GLYCERYL TRINITRATE, a drug-releasing ‘patch’ can be used. Drugs can be inhaled into the lungs as a ?ne powder to treat or prevent ASTHMA attacks. They can also be dispersed (‘nebulised’) as a ?ne mist which can be administered with compressed air or oxygen. Spraying a drug into the nostril, so that it can be absorbed through the lining of the nose into the bloodstream, can avoid destruction of the drug in the stomach. This route is used for a small number of drugs like antidiuretic hormone (see VASOPRESSIN).

Injection remains an important route of administering drugs both locally (for example, into joints or into the eyeball), and into the bloodstream. For this latter purpose, drugs can be given under the skin – that is, subcutaneously (s.c. – also called hypodermic injection); into muscle – intramuscularly (i.m.); or into a vein – intravenously (i.v.). Oily or crystalline preparations of drugs injected subcutaneously form a ‘depot’ from which they are absorbed only slowly into the blood. The action of drugs such as TESTOSTERONE and INSULIN can be prolonged by using such preparations, which also allow contraceptive ‘implants’ that work for some months (see CONTRACEPTION).... medicines

Medicines Commission

A government-appointed expert advisory body on the use of MEDICINES in the UK.... medicines commission

Medicines Control Agency

An executive agency of the Department of Health with the prime function of safeguarding the public health. It ensures that branded and non-branded MEDICINES on the UK market meet appropriate standards of safety, quality and e?cacy. The agency applies the strict standards set by the UK Medicines Act (1968) and relevant European Community legislation.... medicines control agency

National Patient Safety Agency

(NPSA) formerly, a special health authority that led and coordinated work to improve all aspects of patient safety in England. The NPSA comprised three divisions: the National Reporting and Learning Service, the National Research Ethics Service, and the National Clinical Assessment Service. It closed in 2012, with its key functions transferred to *NHS England. In 2016 the same functions were transferred from NHS England to the newly formed *NHS Improvement.... national patient safety agency

Research Ethics Committee

see ethics committee.... research ethics committee

Uk National Screening Committee

(NSC) the body responsible for advising the NHS, the ministers of the UK government, and the three devolved governments in the UK about all aspects of screening. The NSC also has responsibility for overseeing all noncancer screening programmes in the NHS in England and monitoring their quality and effectiveness. It was formed in 1996 and became part of *Public Health England in 2013. See screening test.

National Screening Committee website: contains detailed notes on all screening programmes the committee has considered and the rationale for the decisions the committee has made... uk national screening committee

Safety Of Drugs

The COMMITTEE ON SAFETY OF MEDICINES (CSM) has the function of scrutinising the e?cacy, quality and safety of new DRUGS before clinical trials and before marketing, as well as the surveillance of each drug after marketing so that adverse reactions are monitored and documented, and warnings issued as required. Early clinical trials of a drug can only be carried out after a clinical-trial certi?cate has been issued by the licensing authority.

The major defect in this system is the dif?culty in obtaining reports of adverse reactions. Evidence suggests that at most, about 10 per cent of such reactions are reported. One method of trying to obtain this information is the ‘yellow card’ system. It is so called because it is based on the distribution of yellow cards to all doctors, pharmacists and dentists, on which they are asked to report any adverse reaction happening to someone taking a drug, whether or not they think it is the cause. Alternatively the CSM has a Freephone line and on-line computer facilities (ADROIT) for practitioners to use. Even though the annual number of adverse reactions reported in this way has risen from around 5,000 in 1975 to more than 18,000, this is probably fewer than the number actually occurring.

Two further committees in this safety screen are the Joint Committee on Vaccination and Immunisation and the Adverse Reactions to Vaccines and Immunological Substances Committee.... safety of drugs

British Herbal Medicine Association, Scientific Committee, 1995

Peter R. Bradley MSc CChem FRSC (Chairman). Whitehall Laboratories.

Sheila E. Drew BPharm PhD MRPharms. Deputy Head of Technical Services, William Ransom & Son plc.

Fred Fletcher-Hyde BSc FNIMH. President Emeritus, British Herbal Medicine Association. President Emeritus, National Institute of Medical Herbalists.

Simon Y. Mills MA FNIMH. Director, Centre for Complementary Health Studies, University of Exeter. Hugh W. Mitchell MNIMH (Hon). President, British Herbal Medicine Association. Managing Director, Mitchfield Botanics Ltd.

Edward J. Shellard BPharm PhD DSc(Hon) (Warsaw Medical Academy) FRPharmS CChem FRSC FLS. Emeritus Professor of Pharmacognosy, University of London.

Arnold Webster CChem MRSC. Technical Director, English Grains Ltd.

Peter Wetton BSc LRSC. G.R. Lane Health Products Ltd.

Hein Zeylstra FNIMH. Principal. School of Phytotherapy, Sussex. ... british herbal medicine association, scientific committee, 1995




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