Act of Parliament | |
Long title | An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith. |
---|---|
Citation | 1968 c. 67 |
Territorial extent | United Kingdom |
Dates | |
Royal assent | 25 October 1968 |
Commencement | 1968 |
Status: Amended | |
Text of the Medicines Act 1968 as in force today (including any amendments) within the United Kingdom, from legislation.gov.uk. |
The Medicines Act 1968 (c. 67) is an act of Parliament of the United Kingdom. Its official long title is "An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith." [1] It governs the control of medicines for human use and for veterinary use, which includes the manufacture and supply of medicines, and the manufacture and supply of (medicated) animal feeding stuffs. [2]
The act defines three categories of medicine: prescription only medicines (POM), [3] which are available only from a pharmacist if prescribed by an appropriate practitioner (including, but not limited to doctors, dentists, optometrists, prescribing pharmacists and nurses); pharmacy medicines (P), available only from a pharmacist but without a prescription; and general sales list (GSL) medicines which may be bought from any shop without a prescription.
The act controls supply of the drugs it covers, but does not define any offence of simple possession. Possession of a prescription only drug without a prescription is only an offence if the drug is also controlled under the Misuse of Drugs Act 1971 and possession is thus specified as an offence. Therefore, for example, possession of a prescription only antibiotic without a prescription is not an offence.
For description of the legal classification of medicines in the UK see the Royal Pharmaceutical Society web site, and the publication Medicines Ethics and Practice. [4]
The act was introduced following problems with the off-label use of thalidomide. [5] [6] [7] [8]
The act established the forerunner to the current Commission on Human Medicines.
Pharmacology is the science of drugs and medications, including a substance's origin, composition, pharmacokinetics, pharmacodynamics, therapeutic use, and toxicology. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals.
Thalidomide, sold under the brand names Contergan and Thalomid among others, is an oral medication used to treat a number of cancers, graft-versus-host disease, and many skin disorders. Thalidomide has been used to treat conditions associated with HIV: aphthous ulcers, HIV-associated wasting syndrome, diarrhea, and Kaposi's sarcoma, but increases in HIV viral load have been reported.
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) and strengths of final products.
A pharmacist, also known as a chemist in Commonwealth English, is a healthcare professional who is knowledgeable about preparation, mechanism of action, clinical usage and legislation of medications in order to dispense them safely to the public and to provide consultancy services. A pharmacist also often serves as a primary care provider in the community and offers services, such as health screenings and immunizations.
Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links health sciences with pharmaceutical sciences and natural sciences. The professional practice is becoming more clinically oriented as most of the drugs are now manufactured by pharmaceutical industries. Based on the setting, pharmacy practice is either classified as community or institutional pharmacy. Providing direct patient care in the community of institutional pharmacies is considered clinical pharmacy.
A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
The Pharmaceutical Benefits Scheme (PBS) is a program of the Australian Government that subsidises prescription medication for Australian citizens and permanent residents, as well as international visitors covered by a reciprocal health care agreement. The PBS is separate to the Medicare Benefits Schedule, a list of health care services that can be claimed under Medicare, Australia's universal health care insurance scheme.
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), also known as the Poisons Standard for short, is an Australian legislative instrument produced by the Therapeutic Goods Administration (TGA). Before 2010, it was known as the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The SUSMP classifies drugs and poisons into different Schedules signifying the degree of control recommended to be exercised over their availability to the public. As of 2024, the most recent version is the Therapeutic Goods Instrument 2024.
BNF for Children (BNFC) is the standard UK paediatric reference for prescribing and pharmacology.
The United Kingdom Misuse of Drugs Act 1971 aimed to control the possession and supply of numerous listed drugs and drug-like substances as a controlled substance. The act allowed and regulated the use of some Controlled Drugs by various classes of persons acting in their professional capacity.
An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the Internet and sends orders to customers through mail, shipping companies, or online pharmacy web portal.
The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.
In the field of pharmacy, compounding is preparation of custom medications to fit unique needs of patients that cannot be met with mass-produced products. This may be done, for example, to provide medication in a form easier for a given patient to ingest, or to avoid a non-active ingredient a patient is allergic to, or to provide an exact dose that isn't otherwise available. This kind of patient-specific compounding, according to a prescriber's specifications, is referred to as "traditional" compounding. The nature of patient need for such customization can range from absolute necessity to individual optimality to even preference.
Codeine is an opiate and prodrug of morphine mainly used to treat pain, coughing, and diarrhea. It is also commonly used as a recreational drug. It is found naturally in the sap of the opium poppy, Papaver somniferum. It is typically used to treat mild to moderate degrees of pain. Greater benefit may occur when combined with paracetamol (acetaminophen) or a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen. Evidence does not support its use for acute cough suppression in children. In Europe, it is not recommended as a cough medicine in those under 12 years of age. It is generally taken by mouth. It typically starts working after half an hour, with maximum effect at two hours. Its effects last for about four to six hours. Codeine exhibits abuse potential similar to other opioid medications, including a risk of addiction and overdose.
A veterinary pharmacist is a specially trained pharmacist who dispenses veterinary drugs and supplies or products and advice to owners of companion animals and livestock. In addition, they advise the regulatory bodies and are involved in the formulation of veterinary drugs. Veterinary pharmacy is a field of pharmacy practice, in which veterinary pharmacists may compound medications, fill prescriptions, and manage drug therapies for animals. Veterinary pharmacists are licensed pharmacists who specialize in the distribution of medications for animals.
In Denmark, pharmaconomists are experts in pharmaceuticals who have trained with a 3-year tertiary degree. Pharmaconomy describes either their professional practice or their training courses.
A pharmacy is a premises which provides pharmaceutical drugs, among other products. At the pharmacy, a pharmacist oversees the fulfillment of medical prescriptions and is available to counsel patients about prescription and over-the-counter drugs or about health problems and wellness issues. A typical pharmacy would be in the commercial area of a community.
In the late 1950s and early 1960s, the use of thalidomide in 46 countries by women who were pregnant or who subsequently became pregnant resulted in the "biggest anthropogenic medical disaster ever," with more than 10,000 children born with a range of severe deformities, such as phocomelia, as well as thousands of miscarriages.
Drug disposal is the discarding of drugs. Individuals commonly dispose of unused drugs that remain after the end of medical treatment. Health care organizations dispose of drugs on a larger scale for a range of reasons, including having leftover drugs after treating patients and discarding of expired drugs. Failure to properly dispose of drugs creates opportunities for others to take them inappropriately. Inappropriate disposal of drugs can also cause drug pollution.