Medicines Act 1968

Last updated

Medicines Act 1968
Act of Parliament
Royal Coat of Arms of the United Kingdom (variant 1, 1952-2022).svg
Long title An Act to make new provision with respect to lolllll medicinal products and related matters, and for purposes connected therewith.
Citation 1968 c. 67
Territorial extent  England and Wales
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]

Contents

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 actual Commission on Human Medicines.

Related Research Articles

<span class="mw-page-title-main">Thalidomide</span> Immunomodulatory drug known for its ability to cause birth defects

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. While thalidomide has been used in a number of HIV-associated conditions, such use is associated with increased levels of the virus.

<span class="mw-page-title-main">Over-the-counter drug</span> Medication available without a prescription

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) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

<span class="mw-page-title-main">Pharmacist</span> Healthcare professional

A pharmacist is a healthcare professional who specializes in the preparation, dispensing, and management of medications and who provides pharmaceutical advice and guidance. Pharmacists often serve as primary care providers in the community, and may offer other services such as health screenings and immunizations.

<span class="mw-page-title-main">Pharmacy</span> Clinical health science

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.

<span class="mw-page-title-main">Prescription drug</span> Medication legally requiring a medical prescription before it can be dispensed

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.

<span class="mw-page-title-main">Regulation of therapeutic goods</span> Legal management of drugs and restricted substances

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.

<span class="mw-page-title-main">Standard for the Uniform Scheduling of Medicines and Poisons</span> Australian legal instrument

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 2023, the most recent version is the Therapeutic Goods Instrument 2023.

<i>British National Formulary for Children</i>

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.

<span class="mw-page-title-main">Compounding</span> Preparation of a custom medication

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.

<span class="mw-page-title-main">Pharmacists' Defence Association</span> UK insurance company

The Pharmacists' Defence Association is a not-for-profit membership organisation that supports the needs of individual pharmacists, pharmacy students and pharmacy undergraduates in the United Kingdom. Membership of the PDA includes insurance, union membership and defence association benefits, which all aim to assist and support pharmacists in their working lives. In June 2022, the PDA reported having more than 34,000 members. in the United Kingdom. The National Association of Women Pharmacists became a semi-autonomous network within the association in 2019 and the PDA subsequently launched the LGBT+ Pharmacists network, BAME Pharmacists network and the Ability Network for pharmacists with a disability.

<span class="mw-page-title-main">Codeine</span> Opiate and prodrug of morphine used to treat pain

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 or adults. 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 habituation 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.

<span class="mw-page-title-main">Pharmacy (shop)</span> Shop that provides pharmaceutical drugs

A pharmacy is a retail shop 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.

<span class="mw-page-title-main">Thalidomide scandal</span> Medical condition

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.

<span class="mw-page-title-main">Drug disposal</span> Safe disposal of unused drugs

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.

References

  1. "Medicines Act 1968". www.Legislation.gov.uk. Her Majesty's Government of the United Kingdom . Retrieved 7 November 2016.
  2. Kayne, Steven B; Jepson, Michael H, eds. (2004). Veterinary Pharmacy. Pharmaceutical Press.
  3. "The Prescription Only Medicines (Human Use) Order 1997". www.Legislation.gov.uk. Her Majesty's Government of the United Kingdom . Retrieved 7 November 2016.
  4. http://www.rpharms.com/mep/legal-classification-of-medicines.asp (subscription required)
  5. Conroy, S.; McIntyre, J.; Choonara, I.; HULL, P. S. D. (1 March 1999). "Unlicensed and off label drug use in neonates Commentary". Archives of Disease in Childhood: Fetal and Neonatal Edition. 80 (2): F142–F145. doi:10.1136/fn.80.2.F142. PMC   1720896 . PMID   10325794.
  6. Royal Pharmaceutical Society (2011). "The evolution of pharmacy, Theme E, Level 3 Thalidomide and its aftermath" (PDF). Archived from the original (PDF) on 9 October 2014.
  7. Griffin, J. P. (1998). "The evolution of human medicines control from a national to an international perspective". Adverse Drug Reactions and Toxicological Reviews. 17 (1): 19–50. PMID   9638280.
  8. Shah, R. R. (2001). "Thalidomide, drug safety and early drug regulation in the UK". Adverse Drug Reactions and Toxicological Reviews. 20 (4): 199–255. PMID   11770171.

Further reading