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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
The new Council for Healthcare Regulatory Excellence will help to promote the interests of patients and to improve co-operation between the existing regulatory bodies – providing, in e?ect, a quality-control mechanism for their activities. The government and relevant professions will nominate individuals for this overarching council. The new council will not have the authority to intervene in the determination by the eight regulatory bodies of individual ?tness-to-practise cases unless these concern complaints about maladministration.... council for healthcare regulatory excellence
Maintaining an up-to-date evidence base of ‘what works’ in public health and health improvements.
Providing useful information to health practitioners.
Commissioning research to remedy the gaps in the evidence base for medical practice.
Improving health promotion and advising on the standards for (and implementation of) public-health activities.
(See APPENDIX 7: STATUTORY ORGANISATIONS.)... health development agency (hda)
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
1. Name of the patient.
2. Name and address of the herbal practitioner.
3. Directions for use of the remedy.
4. Liquid preparations for local or topical use to be clearly marked: For external use only.
Statutory Instruments: Medicine (Labelling) Regulations 1976 No. 1726. Medicines (Labelling) Regulations 1977 No. 996. ... labelling of herbal products by a practitioner
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
Misleading claims and the use of such words as “organic”, “wholesome”, “natural” or “biological” cannot be accepted on product labels. The Licensing Authority treats herbal manufacturers no differently than manufacturers of allopathic products for serious conditions.
The Advertising Standards Authority does not allow quotation of any medicinal claims, except where a Product Licence (PL) has been authorised by the Licensing Authority.
All labels must include: Name of product (as on Product Licence), description of pharmaceutical form (tablet, mixture etc), Product Licence No., Batch No., quantity of each active ingredient in each unit dose in metric terms; dose and directions for use; quantity in container (in metric terms); “Keep out of reach of children” or similar warning; Name and address of Product Licence Holder; expiry date (if applicable); and any other special warnings. Also to appear: excipients, method/route of administration, special storage instructions, and precautions for disposal, if any.
Where licences are granted, the following words should appear on the label of a product: “A herbal product traditionally used for the symptomatic relief of . . .”. “If symptoms persist see your doctor.” “Not to be used in pregnancy” (where applicable). “If you think you have . . . consult a registered medical practitioner before taking this product.” “If you are already receiving medical treatment, tell your doctor that you are taking this product.” These warnings are especially necessary should symptoms persist and be the start of something more serious than a self-limiting condition.
Herbal preparations should be labelled with the additives and colourings they contain, if any. This helps practitioners avoid prescribing medicines containing them to certain patients on whom they may have an adverse reaction.
Labels of medicinal products shall comply with the Medicines (Labelling) Regulations 1976 (SI 1976 No. 1726) as amended by the Medicines (Labelling) Amendment Regulations 1977 (SI 1977 No. 996), the Medicines (Labelling) Amendment Regulations 1981 (SI 1981 No. 1791) and the Medicines (Labelling) Amendment Regulations 1985 (SI 1985 No. 1558).
Leaflets issued with proprietory medicinal products shall comply with the requirements of the Medicines (Leaflets) Regulations 1977 (SI 1977 No. 1055).
See also: ADVERTISING: CODE OF PRACTICE. BRITISH HERBAL MEDICINE ASSOCIATION. ... labelling of herbal products
Platelets may be given in transfusions for people with blood-clotting disorders. Patients who have life-threatening infections may be treated with granulocytes, a type of white blood cell. Fresh frozen plasma is used to correct many types of bleeding disorder because it contains all the clotting factors. Albumin, prepared from the plasma of whole blood, is used mainly to treat shock resulting from severe blood loss until compatible whole blood becomes available. Purified albumin preparations are used to treat nephrotic syndrome and chronic liver disease.
Concentrates of blood clotting factors and are used in the treatment of haemophilia and Christmas disease.
Immunoglobulins (also called antibodies), which are extracted from blood plasma, can be given by injection (see immunoglobulin injection) to protect people who are unable to produce their own antibodies or have already been exposed to an infectious agent, or to provide short-term protection against hepatitis A.
Immunoglobulins are given in large doses to treat certain autoimmune disorders.... blood products
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