Medicines Control Agency: From 1 Different Sources
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.
A study that starts with the identification of persons with the disease (or other outcome variable) of interest, and a suitable control (comparison, reference) group of persons without the disease. The relationship of an attribute to the disease is examined by comparing the diseased and non-diseased with regard to how frequently the attribute is present or, if quantitative, the level of the attribute, in each of the groups.... case control study
See CONTRACEPTION.... birth control
Use of natural, indigenous predators or organisms to control medically important insects.... biological control
The set of actions taken to ensure that spending is in line with budgeted amounts and the regulations for spending them.... budgetary control
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)
The control of disease caused by infectious agents or their toxic products. Successes in the 19th and 20th centuries in the treatment and control of communicable diseases such as SMALLPOX, CHOLERA, TUBERCULOSIS, gastrointestinal infections, POLIOMYELITIS and SEXUALLY TRANSMITTED DISEASES (STDS) resulted in an erroneous conception that they no longer posed a serious threat to public health, and certainly not in developed countries. As a consequence, the maintenance of e?ective public health strategies steadily lost out in the competition for resources to the more ‘glamorous’ developments in medicine, such as improved CANCER treatments, HEART surgery, kidney DIALYSIS and organ TRANSPLANTATION. However, in recent decades the dangers of this approach have become increasingly apparent. Rapidly expanding urban populations, more complex lifestyles, new and resurgent infections (some linked to a spread of antibiotic resistance) such as AIDS/HIV and variant CREUTZFELDT-JAKOB DISEASE (CJD), and the ease with which infection can be spread by the enormous growth of long-distance travel and population migrations are severely straining existing public health measures. The supply of clean water, e?ective waste- and sewage-disposal measures, the hygienic production and delivery of food and early detection and subsequent prevention of infectious diseases can no longer be taken for granted. Governments will need to strengthen the provision of workable, properly resourced public health facilities, and developing countries will need ?nancial support and expert help from developed nations to achieve this objective. Timely recognition of new and resurgent infectious diseases requires national and international early-warning mechanisms to ensure rapid investigation and implementation of e?ective control measures. Otherwise, serious breakdowns in public health will occur, and international co-operation is vital to provide and support control measures. (See also COMMUNICABLE DISEASE; NOTIFIABLE DISEASES.)... communicable diseases control
A control group that is observed by investigators at the same time as the treatment group but that was not established using random assignment of participants to control and treatment groups. Differences in the composition of the treatment and control groups may result.... concurrent nonrandomized control
A group of participants that serves as the basis of comparison when assessing the effects of the intervention of interest that is given to the participants in the treatment group. Depending upon the circumstances of the trial, a control group may receive no treatment, a ‘usual’ or ‘standard’ treatment, or a placebo. To make the comparison valid, the composition of the control group should resemble that of the treatment group as closely as possible.... control group
All the measures designed to prevent or reduce as much as possible the incidence, prevalence and consequences of disease, such as the control of disease vectors, the removal or reduction of the influence of predisposing factors in the environment, immunization and curative care.... disease control
An independent agency recently set up by the UK government. The aim is for the agency to protect consumers’ interests in every aspect of food safety and nutrition. The agency advises ministers and the food industry, conducts research and surveillance, and monitors enforcement of food safety and hygiene laws.... food standards agency
A public or private organization that provides home health services supervised by a licensed health professional in a person’s home, either directly or through arrangements with other organizations.... home health agency (hha) / home health care agency
An organization offering advice and practical assistance to older people who need to repair, improve or adapt their homes.... home improvement agency
A combination of biological and insecticidal methods of control, e.g. the introduction of predacious fish to breeding places which are also sprayed with insecticides that have minimum effect on the fish.... integrated control
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
An executive agency of the Department of Health in the UK. Set up in 1994, it is responsible for regulating and advising on the sale or use of any product, other than a medicine, used in the health-care environment for the diagnosis, prevention, monitoring or treatment of illness or disease. Equipment ranges from pacemakers (see CARDIAC PACEMAKER) to prostheses (see PROSTHESIS), and from syringes to magnetic resonance imaging (see (MRI).... medical devices agency
the control of disease due to infectious agents or their toxic products. See Consultant in Health Protection.... communicable disease control
(HPA) formerly, a nondepartmental public body set up as a special health authority in 2003 to protect the health of the UK population via advice and support to the NHS, local authorities, the Department of Health, emergency services, and others. The HPA was abolished in April 2013; its responsibilities were largely passed to *Public Health England. See Consultant in Health Protection.... health protection agency
the ability to make moral judgments and to take responsibility for choices and actions.... moral 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
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
A government-appointed expert advisory body on the use of MEDICINES in the UK.... medicines commission
A National Health Service body intended to combat the increasing threat from infectious diseases and biological, chemical and radiological hazards. Covering England, the agency includes the Public Health Laboratory Service, the National Radiological Protection Board, the Centre for Applied Microbiology and Research, and the National Focus Group for Chemical Incidents.... national infection control and health protection agency
The sum of all the activities which prevent unwanted change in quality. In the health care setting, quality control requires a repeated series of feedback loops which monitor and evaluate the care of the individual (and other elements in the health care process). These feedback loops involve checking the care being delivered against standards of care, identification of any problems or opportunities for improvement, and prompt corrective action, so that the quality is maintained.... quality control (qc)
A process within society which both formally, through law, and informally, through customs, norms and mores, attempts to influence and order the actions of social groups and their members and thus maintain public order.... social control
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
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