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Prescribing and Patient Group Direction

Legal Framework for PGDs (including HDL)

The Medicines Act 1968 and associated secondary legislation limited prescribing of Prescription Only Medicines (POMs) to doctors and dentists

In 1998 a report on the Supply and Administration of Medicines under Group Protocols was published. The Group was chaired by Professor June Crown and resulted in a report in her name. The Crown Report recommended that the legal position of such protocols required clarification. This resulted in relevant medicines legislation to encompass the national health services (NHS) and those services funded by the NHS but were provided by the private, voluntary or charitable sector. (Ref: MHRA)

The legislation was updated in 2000 to permit the sale, supply or administration of medicines under a Patient Group Direction (PGD) throughout the UK. The legislation was further extended to include certain groups of controlled drugs and the addition of specific health care professionals. Legislation includes the following groups who are registered by their professional and/or regulatory body: Nurses, Midwives, Pharmacists, Paramedics, Physiotherapists, Chiropodists or Podiatrists, Dietitians, Optometrists, Orthoptists, Radiographers, Prosthetists, Orthotists, Speech and Language Therapists, Occupational Therapists, Dental Hygienists and Dental Therapists.

The Prescription Only Medicine Human Use Order 1997 known as the POM Order contains some specific exemptions which allow for the sale or supply and administration of certain POMs directly to patients, without the directions of a doctor or dentist. These exemptions, which continue to apply, relate to midwives, ambulance paramedics, optometrists, podiatrists, chiropodists and occupational health nurses and a selection of medicines given in emergency situations to save life. In some emergency situations, pharmacists are able to supply medicines to patients without a prescription. Further details of exemptions to the Medicines Act and emergency supply by pharmacists is available. (Ref: Medicines, Ethics and Practice, a guide for pharmacists; July 2009 Number 33).

Approved Practitioners

Those registered health care practitioners, who are listed as approved in the legislation can operate under the PGD. The individual must be named and have signed the PGD, which has been approved and is within expiry date, for use within their area of practice. Practitioners agree when signing the PGD to operate under the directions contained within the PGD and that they will follow the professional codes of their registering body. Practitioners should be deemed competent to operate under the PGD by their line manager or professional lead who also signs the PGD authorising the named individuals.

Exemptions

The changes in legislation and the introduction of PGDs did not amend current exemptions to the original legislation for specified groups of healthcare practitioners. Such exempted individuals may continue to supply or administer these defined medicines as part of their normal professional practice. The exemptions apply to a number of health professionals and enable them to sell, supply and administer medicines directly to patients without a prescription from a doctor or independent prescriber. For further information see  exemptions section.

PGD Framework

The legislation specifies that each PGD must contain the following
information:

  • the name of the business to which the Direction applies;
  • the date the Direction comes into force and the date it expires;
  • a description of the medicine(s) to which the Direction applies;
  • class of health professional who may supply or administer the medicine;
  • signature of a doctor or dentist, as appropriate, and a pharmacist;
  • signature by an appropriate health organisation;
  • the clinical condition or situation to which the Direction applies;
  • a description of those patients excluded from treatment under the Direction;
  • a description of the circumstances in which further advice should be sought from a doctor (or dentist, as appropriate) and arrangements for referral;
  • details of appropriate dosage and maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration, and minimum and maximum period over which the medicine should be administered;
  • relevant warnings, including potential adverse reactions;
  • details of any necessary follow-up action and the circumstances;
  • a statement of the records to be kept for audit purposes.

Ref: HDL (2001)07

Authorisation of PGD

All those involved in the development of a PGD must sign it.  The development groups must include a doctor (or when appropriate, a dentist), a pharmacist, and a professional from the group to whom the PGD will apply (e.g. nurse if PGD applies to nurses). Additionally the PGD must be authorised by the relevant appropriate body as set out in the legislation. In Scotland NHS Health Boards have usually assigned this process to the local Area Drug and Therapeutics Committee (ADTC) or one of its sub-committees.  It is recommended that the process within your own Health Board area is reviewed before proceeding with PGD development. It is advisable to follow the local process as defined by each Health Board.

Other restrictions

The administration of radiopharmaceuticals continues to be regulated by the Medicines (Administration of Radioactive Substances) Regulations 1978 and should not be included in  Patient Group Directions.

Controlled Drugs

There are only certain controlled drugs that can be administered or supplied under a PGD. This has list has been updated by changes to the Misuse of Drugs Regulations.
https://www.gov.uk/government/publications/nurse-and-pharmacist-independent-prescribing-mixing-of-medicines-possession-authorities-under-patient-group-directions-and-personal-exemption-provisions-for-schedule-4-part-ii-drugs

Present legislation allows the following use of controlled drugs in PGDs in certain circumstances and by specific practitioners.

  • Schedule 2, Morphine and Diamorphine can be included in PGDs only be Nurses and Pharmacists for the immediate and necessary treatment of a sick or injured person
  • Schedule 3, Midazolam
  • Schedule 4, all drugs, including benzodiazepines and ketamine, anabolic steroids and any injectable preparation used for treating addiction must not be included in a PGD
  • Schedule 5, All drugs, including codeine

(Ref: http://www.legislation.gov.uk/uksi/2001/3998/contents/made)

Antimicrobials

Caution is required in the development of PGDs related to antimicrobial agents. A local microbiologist should be involved in drawing up these PGDs to ensure their development will not jeopardise strategies to combat resistance to antimicrobial agents. Local health boards will have their own process for the approval of antimicrobial PGDs. It is advised to check the local processes which are in place prior to proceeding.

The Scottish Government has requested the co-operation of each Health Board in delivering the recommendations set out in the publication `Antimicrobial prescribing policy and practice in Scotland` a guidance document on the prudent use of antibiotics and other antimicrobial drugs in acute hospitals (Ref CMO(2005)08) Each Scottish Health Board is required to ensure a local framework is in place to implement the associated recommendations. One of the twenty recommendations includes the setting up of a local multidisciplinary antimicrobial management team. It specifies that this team should include a lead Doctor and Pharmacist, a microbiologist and / or infectious disease physician, and a senior management representative (normally the Infection Control manager. http://www.sehd.scot.nhs.uk/cmo/CMO(2005)08.pdf

Labeling of medicines for supply under a PGD

The EC Labeling and Leaflet Directive 2001/83 (Ref: Dale and Appelbe's Pharmacy Law and Ethics, Eight Edition, 2005 and MHRA) applies to all medicinal supplies including those under PGDs. It is a legal requirement that the manufacturer's patient information leaflet is provided each time a medicine is supplied.

Medicines for direct supply to a patient, without a prescription, should therefore be prepared and labelled with the relevant details by pharmacy staff. The professional supplying the medicine can then add the patient's name and date. The patient information leaflet (PIL) must be included with the supply. If the PIL is not available in the pack it can be found on the electronic medicines compendium and printed to be included with the supply of the medicine.

When administering under a PGD the patient should be informed about the medicine and provided with a PIL where necessary.

Statutory Instruments

These Statutory Instruments related to PGDs can be accessed by clicking on the links to HMSO detailed below. This is a list that we have found helpful but is not inclusive.

  • The Prescription Only Medicines (Human Use) Amendment Order 2000
  • The Medicine (Pharmacy and General Sale - exemption) Amendment 2000
  • The Medicines (Sale and Supply) (Miscellaneous Provisions) Amendment Regulations 2000
  • The Prescription Only Medicines (Human use) Amendment Order (Statutory Instrument 2003 No 696)

  • The Medicines (Sale and Supply) (Miscellaneous Provisions) Amended Regulations 2003 (Statutory Instrument 2003 No 698)
    Home Office circular 009/2012 Nurse and pharmacist independent prescribing, 'mixing of medicines', possession authorities under patient group directions and personal exemption provisions for Schedule 4 part II drugs. 

Private PGDs

Information on Private PGDs can be accessed at the following MHRA website (external link).