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Glossary

All definitions in Medicines, Ethics and Practice, July 2007, National Prescribing Centre, March 2004 and NMC Standards of Proficiency for Nurse and Midwife Prescribers, NMC Standards for Medicines Management

Patient Group Direction (PGD)

A written instruction to sell, supply and/or administer a named medicine in an identified clinical situation. A PGD applies to groups of patients who may not be individually identified before presenting for treatment.

Patient Specific Direction (PSD)

A written instruction from a qualified and registered prescriber to supply or administer a medicine or appliance to a named patient. The PSD to state the dose, route and frequency of administration.

Competence

Relates to the need for the practitioner to demonstrate their "capability" in certain skill areas to a required standard at a point in time.

Competencies

Component skills which contribute to being competent and achieving the standards of proficiency for professional registration. Competencies might include skills arising from learning outcomes or other requirements.

Dispensing

To label from stock and supply a clinically appropriate medicine to a patient/carer/client, usually against a written prescription. For self-administration or administration by another professional, and to advise on safe and effective use.

Dispensed Medicinal product

This includes a medicinal product prepared or dispensed by a practitioner (doctor, dentist or veterinarian) or prepared or dispensed in accordance with a prescription given by a practitioner and a medicinal product prepared or dispensed in a registered pharmacy by or under the supervision of a pharmacist, either in accordance with a specification furnished by the purchaser (for example, a customer's recipe) or in accordance with the pharmacist's own judgement as to the treatment required for a person present in the pharmacy (i.e. counter-prescribing).

General Sale List (GSL) Medicine

A medicine for which all active ingredients are listed in the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984 or are so classified in their marketing authorisation. All GSL medicines, except those that have been designated as foods or cosmetics, must be licensed products.

Link: http://www.rpsgb.org.uk/pdfs/MEP31s1-2a.pdf

Medicinal Product

Any substances or article (not being an instrument, apparatus or appliance) which is manufactured, sold, supplied, imported or exported for use wholly or mainly in either or both of the following ways, that is to say:
(a) use by being administered to one or more human beings or animals for a medicinal purpose;
(b) use as an ingredient, by a practitioner or in a pharmacy or in a hospital or in a business comprising the sale of herbal remedies, in the preparation of a substance or article which is to be administered to one or more human beings or animals for a medicinal purpose.

Medicinal Purpose

This means any one or more of the following purposes, that is to say:
(a) treating or preventing disease;
(b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition;
(c) contraception;
(d) inducing anaesthesia;
(e) otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by ways of terminating, reducing or postponing, or increasing or accelerating, the operation of that function or in any other way.

Parental administration

Means administration by breach of the skin or mucous membrane.

Nurse independent prescriber

Means a person:
(a) who is a registered nurse or a registered midwife, and
(b) against whose name is recorded in the professional register an annotation signifying that he/she is qualified to order drugs, medicines and appliances as a nurse independent prescriber or a nurse independent/supplementary prescriber.

Pharmacist independent prescriber

Means a person:
(a) who is a pharmacist, and
(b) against whose name is recorded in the register maintained under the Pharmacists and Pharmacy Technicians Order 2007 an annotation signifying that he/she is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber.

Prescription only (POM) medicine

Prescription-only medicines are those medicinal products described as such in the POM Order. There are a number of exemptions from prescription-only control and you should refer to the alphabetical list of medicines for human use to determine the category of medicine, and whether any particular exemption applies.

Link: http://www.rpharms.com/support/mep.asp

Pharmacy (P) medicine

Any medicinal product other than those designated as GSL or POM products. Pharmacy medicines can be sold or supplied only from a registered pharmacy by or under the supervision of a pharmacist, subject to certain exceptions.

Link: http://www.rpharms.com/support/mep.asp

Expiry date

Means the date after which, or the month and year after the end of which, the medicinal product should not be used, or the date before which or the month and year before the beginning of which, the medicinal product should be used.

Off-label/Off-license

Where prescribing or supply of a licensed medication is outside the indications named in their license or summary of product characteristics (SPC). There are a number of circumstances where medicines may be prescribed or supplied for the purposes for which they are not licensed e.g. children.

Product license

Marketing Authorisation

Licensed medication

The Medicines and Healthcare products Regulatory Agency (MHRA) operates a system of licensing before medicines are marketed (see Marketing authorisation). However, the Medicines Act allows certain exemptions from licensing which include:

  • the manufacture and supply of unlicensed relevant medicinal products for individual patients/clients (commonly known as "specials")
  • the importation and supply of unlicensed relevant medicinal products for individual patients/clients
  • herbal remedies exemption

Marketing authorisation

Previously known as a "product licence". This normally has to be granted by the MHRA before a medicine can be prescribed or sold. This authorisation, which confirms that medicines have met standards for safety, quality and efficacy, considers all of the activities associated with marketing medicinal products.

Medicines Act Exemptions

Allows certain groups of healthcare professionals including occupational health schemes and midwives to sell, supply and administer particular medicines directly to patient/clients. Provided the requirements of any conditions attached to those exemptions are met, a PGD is not required.

Patient information leaflet (PIL)

Data sheets found in all dispensed medicinal products which should be brought to the patient's attention on administering the medicinal product.

Summary of Product Characteristics (SPC)

This forms an integral part of the marketing authorisation and is the basis of information for health care professionals. It describes the properties and effects as of the medicine as well as warnings about it.

Supply under a Patient Group Direction (PGD)

When supplying under a PGD, this should be from the manufacturers' original packs or over labelled pre-packs so that the patient details, date and additional instructions can be written on the label at the time of supply.

Transcribing (Transposing)

Any act by which medicinal products are written from one form of direction to administer to another is "transcribing". This includes discharge letters, transfer letters, copying illegible patient administrations chart onto new charts, (whether hand written or computer generated).

Unlicensed medicines

This term refers to medicines that do not have a `Marketing Authorisation` for any indication or age group.