Medicines commission Health Dictionary

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

See HEALTHCARE COMMISSION.... commission for health improvement

The process of drawing up contracts with service providers to provide care.... commissioning

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)

An o?cial, responsible to the United Kingdom’s parliament, appointed to protect the interests of National Health Service patients in matters concerning the administration of the health service and the delivery of health care (excluding clinical judgements). Known colloquially as the health ombudsman, the Commissioner presents regular reports on the complaints dealt with.... health service commissioner

Launched in 1999 in England and Wales as CHI, this is an inspectorate charged with protecting patients from ‘unacceptable failings in the National Health Service’. A statutory body under the 1999 Health Act, it evaluates and re?nes local systems designed to safeguard standards of clinical quality. Working separately from the NHS and the health departments, it o?ers an independent safeguard that provides systems to monitor and improve clinical quality in primary care, community services and hospitals. As of 2004 it became responsible for dealing with patients’ complaints if they could not be settled by the trust concerned. The board members include health professionals, academics and eight lay members. Scotland has set up a similar statutory body. (See APPENDIX 7: STATUTORY ORGANISATIONS.)... healthcare commission (commission for health improvement)

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

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

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. ... committee on safety of medicines

(CCGs) self-governing bodies set up by the Health and Social Care Act 2012, following the abolition of *primary care trusts and *strategic health authorities, to commission most NHS services in England. CCGs are formed of all GP practices within a given geographical area, and all GP practices must belong to a clinical commissioning group. All CCGs have their own constitution and governing body, which (in addition to GPs) must include at least one registered nurse and at least one secondary care specialist doctor. There are currently 195 CCGs in England.... clinical commissioning groups

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

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

This was set up under the CARE STANDARDS ACT 2000 as an independent regulator in respect of homes for the elderly, the disabled and children in the state and private sectors in the UK.... national care standards commission

see Equality and Human Rights Commission.... disability rights commission

a nondepartmental public body set up in 2007 to promote human rights and equality in regard to age, disability, gender, race, religion and belief, pregnancy and maternity, marriage and civil partnership, sexual orientation, and human rights. It replaced the Commission for Racial Equality, the Disability Rights Commission, and the Equal Opportunities Commission.... equality and human rights commission

identifying services required to meet population health-care needs and obtaining such services from an appropriate service provider via allocation of resources and contracting arrangements. Commissioners monitor the quality of commissioned services, including adherence to any appropriate national standards. Most NHS commissioning is undertaken by *clinical commissioning groups or *NHS England.... health-care commissioning

(CQC) a publicly funded independent organization established in 2009 and responsible for regulation of health and social care in England; it replaced the Healthcare Commission, the Commission for Social Care Inspection, and the Mental Health Act Commission. The responsibilities of the commission include publication of national health-care standards; annual assessment of the performance of NHS and social-care organizations; reviewing other (i.e. private and voluntary) health- and social-care organizations; reviewing complaints about the services when it has not been possible to resolve them locally; and investigating serious service failures.... care quality commission

the person in charge of the independent public agency set up to regulate the use and storage of personal data under the Data Protection Act 1998 (see data protection). The office of the Information Commissioner both regulates the use of data under the Act and takes any enforcement action required as a result of noncompliance with the principles of the statute. The Information Commissioner’s office also promotes public access to official information under the Freedom of Information Act 2000.... information commissioner

(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

a regulating body in England and Wales, governed by the Mental Health Act 2007, that was responsible for regularly visiting psychiatric hospitals, reviewing psychiatric care, giving second opinions on the need for certain psychiatric treatments, and acting as a forum for the discussion of psychiatric issues. It was subsumed under the *Care Quality Commission in April 2009.... mental health act commission