This site is intended for health professionals only

Patient Group Directions: a step in the right direction

Alison Martin
MB ChB MSc
Medical author
JB Medical Ltd
Sudbury, Berks
E:alison@carsmartin.me.uk

The Medicines Act of 1968 established that only doctors, dentists and vets were allowed to prescribe. Medicines classified as prescription-only (POMs) could be sold or dispensed only via a registered pharmacy with a prescription from an appropriate prescriber. Certain exemptions were added to cover the prescribing and dispensing of medicines by doctors and dentists in hospitals or health centres and their administration or supply by chiropodists, midwives and ambulance paramedics.(1)
At the time of the Crown Report in 1999, patients were often being treated nominally under "group protocols", documents designed to cover the supply or administration of medicines by nonprescribers without the direct instruction of a doctor. The Crown Report found that the development, use and review of group protocols was inconsistent and may have contravened the Medicines Act. New legislation was introduced to clarify these legal uncertainties and improve standards of care nationally.(1)
Patient Group Directions (PGDs), introduced in 2000, allowed certain types of health professional to supply or administer specified licensed medicines to groups of patients who may not be individually identified before presentation, under the guidance of a formal document, with the intention of assisting a doctor or dentist in providing primary medical or dental care for the patient. This must be developed and agreed locally by a named senior doctor or dentist and pharmacist, and must be authorised by the relevant NHS trust or primary care trust (PCT). A representative of the health professions to which the PGD applies should be involved with the development and should sign the PGD. For the first time, the supply or sale of medicines could occur at sites distant from a pharmacy or hospital, and POMs could be supplied or administered without a prescription from an appropriate practitioner. However, most medical care is, and will continue to be, performed for specific patients who have been identified in advance or who are treated by a doctor or dentist, and PGDs will not apply in these situations.(2)
PGDs applied originally to health professionals employed by NHS organisations, funded by the NHS and caring for NHS patients.(2) Subsequent legislation has extended this to certain independent sector healthcare providers in the private, charitable and voluntary sectors and certain UK Crown establishments such as police stations, prisons and armed forces premises.(3,4)

Who is allowed to administer or supply drugs under a PGD?
Only health professionals from an approved list are allowed to supply or administer medicines under a PGD. These include:

  • Registered nurses.
  • Registered midwives.
  • Registered health visitors.
  • Pharmacists.
  • Registered chiropodists/podiatrists.
  • Orthoptists.
  • Physiotherapists.
  • Radiographers.
  • Ambulance paramedics.
  • Optometrists.

Discussions are underway to extend the list to include dietitians, occupational therapists, prosthetists, speech and language therapists and orthodontists. No specific training is required, but all health professionals using the PGD must be named in advance and must be able to demonstrate appropriate competencies in the understanding and skills required to implement the PGD safely and appropriately.(2)

[[nip13_box1_58]]
 
In what situations should PGDs be used?
PGDs do not permit prescribing of medicines - any health professional able to prescribe the required medication does not need to do so under a PGD. They should be used only in situations where they will benefit patients, such as by reducing delay in acquiring appropriate treatment or increasing the options for where to access treatment. They should not be used merely to make life simpler for health staff or to save money!
The situations in which PGDs tend to be used come under three main categories:

  • Emergency treatment, where delay could be ­dangerous; for example:
    • Administration of adrenaline in anaphylaxis.
    • Administration of thrombolytic drugs by ambulance paramedics.
    • Supply of emergency contraception by practice nurses, school nurses and pharmacists.
    • Treatment of acute exacerbations of asthma or COPD.
  • Routine tasks regularly carried out by nonmedical staff in the past, or to improve access to services by patients; for example:
    • Childhood vaccinations.
    • Influenza immunisation.
    • Catheter maintenance.
    • Nicotine replacement therapy.
    • Treatment of head lice infestation.
  • Tasks carried out by nonmedical staff in specialist clinics or situations; for example:
    • Chlamydia treatment in sexual health clinics.
    • Mydriasis in retinal screening clinics.

If a nonprescriber is supplying or administering medication in situations such as those given above without a PGD, they are at risk of criminal prosecution under the Medicines Act 1968. A survey in East Lancashire in April 2001 found that only half of practices had protocols for vaccination administration, and none complied with PGD legislation.(5)

How are PGDs developed?
PGDs must be developed locally by a multidisciplinary team including at least a senior doctor and a pharmacist. Input from a local microbiologist is required for any PGD that involves antimicrobial agents, due to concerns about resistance. It is considered good ­practice to involve the Drugs and Therapeutics Committee, Area Prescribing Committees or similar organisations.(2) However, other agencies may help in compiling the information to be included, usually found in the British National Formulary, the summary of product characteristics of the relevant drugs and, for vaccines, the "Green Book".(7)
Once the PGD has been approved and signed, a copy should be kept in the clinical site where it will be used. PGDs should be numbered as they are updated and old versions kept for 10 years in case of a complaint or litigation relating to their use.
Procedures must be in place to ensure the principles of the Duthie Report on handling medicines(8) and COSHH Regulations are met,(9) in particular:(10)

  • Storage of the medicines (is a refrigerator required or just a locked cupboard?).
  • Secure systems to record exactly what medicine has been supplied or administered to which patient.
  • Stock reconciliation.
  • Disposal of out-of-date medication.
  • Labelling of medicines - patient packs should be used wherever possible.
  • Patient information leaflets should be given with details of possible side-effects and other ­consequences from taking the medication.

What are the financial issues around PGDs?
Prescription charges apply to medicines supplied or dispensed under a PGD, so systems are needed to collect the fee or a signed declaration of exemption. Reimbursement for vaccine administration is by the usual method. However, there is still uncertainty about reimbursement for medicines supplied in GP surgeries. While nondispensing GPs are allowed to supply medication to their patients for free, they are not allowed to sell drugs or charge a dispensing fee.
 
Conclusion
PGDs set out clear instructions for nonprescribers to administer or supply medicines to patients not identified already by a doctor. While their development can be time-consuming, and there are uncertainties still about financial aspects of their use, it is clear that undertaking these tasks without the protection of a PGD could lead to legal consequences and may be jeopardising patient safety.

[[nip13_box1_60]]

References

  1. DoH. A report on the supply and administration of ­medicines under group protocols (Crown Report). London: The Stationery Office;1999. Available from URL://www.doh.gov.uk/pub/docs/ doh/ protocol.pdf
  2. DoH. Patient Group Directions. (England only.) Health Service Circular HSC 2000/026. London: DoH; 2000.
  3. Medicines (Pharmacy and General Sale Exemption) Amendment Order 2003 (SI 2003 No. 697).
  4. Medicines (Sale and Supply) (Miscellaneous Provisions) Amendment (No. 2) Regulations 2003 (SI 2003 No. 698).
  5. Primary Care Secondary Care Interface. No. 49; April 2001. Available from URL: http://www.bprpct.nhs.uk/ issue_49.pdf
  6. Public consultation - patient group directions (PGD) - proposal to permit the supply of certain controlled drugs by health professionals under the PGD system. Home Office; 2003. Available from URL:http://www.homeoffice.gov.uk
  7. DoH. Immunisation against infectious disease. London: HMSO; 1996.
  8. NHS Executive. Guidelines for the safe and secure handling of medicines (Duthie Report). London: NHSE; 1988.
  9. Health and Safety Executive. Control of substances hazardous to health (COSHH) regulations. London: The Stationery Office; 1999.
  10. DoH. Medicines management (safe and secure handling). London: DoH; 2003.

Resources
JB Medical An independent medical publishing company ­specialising in the field of evidence-based medicine. Offers a ­development ­service to ­individual PCTs
W:www.jbmedical.com
Approved Group Protocols Contains ­examples of PGDs submitted by trusts
W:www.groupprotocols.org.uk
Department of Health guidance on supply and potential future prescribing of medicines by allied health professionals W:www.doh.gov.uk/chpo/prescribing.htm
Health Service Circular 2000/026
W:www.doh.gov.uk/coinh.htm
British National Formulary
W:www.bnf.org