In the third article in this series, Dr Gerard Panting, of the MPS, discusses medico-legal issues around the drawing up and implementation of patient group directions

Clause 60 of the Health and Social Care Bill will, if enacted, extend prescribing rights beyond doctors, dentists and midwives. The Secretary of State will be able to grant prescribing rights to a host of healthcare workers, including pharmacists, anyone registered under the Professions Supplementary to Medicine Act 1960, ophthalmic opticians and registered osteopaths.

What this may mean in practice is clarified to some extent in the explanatory notes accompanying the Bill. One example cited is that of physiotherapists, who may be given rights to prescribe certain drugs including anti-inflammatory agents.

The note goes on to state:

'One of the effects of this policy might be to remove the need for routine visits to the GP for continuing care.'

The Health and Social Care Bill is a priority for Government and is therefore likely to reach the statute book before the election. We will then have to wait for the Secretary of State to publish regulations allowing registered professional groups to prescribe, in most cases, a restricted range of drugs. So even when the Bill becomes law there will be an interval before eligible groups are granted their new rights piecemeal.

In the meantime, some health professionals in England can supply or administer medicines under a patient group direction (PGD). Such health professionals include nurses, midwives, health visitors, optometrists, pharmacists, chiropodists, radiographers, orthoptists, physiotherapists and ambulance paramedics.

PGDs are merely written instructions from a senior doctor (or in some cases dentist) and a pharmacist to provide prescription-only medicines to groups of unnamed patients meeting certain criteria.

The PGD must be authorised by the responsible primary care group/trust (PCG/T) or health authority.

The legal authority for PGDs is to be found in three Statutory Instruments (see Table 1, below). It is important to note that it applies only to NHS treatments, including NHS-funded treatment in the private and voluntary sectors.

Table 1: Statutory Instruments

The Medicines Act 1968 is amended by:
The Prescription Only Medicines (Human Use) Amendment Order 2000
The Medicines (Pharmacy and General Sale – Exception) Amendment Order 2000
The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No.2) Regulations 2000
All changes came into force on 9 August 2000

How should it work in practice?

Within each NHS unit where PGDs are to apply, a multidisciplinary team should be established to include a doctor, pharmacist, and representatives of each professional group who are involved in the scheme. Individuals from other relevant groups may also be involved.

But a PGD need not apply to every individual within a professional group. Selection of personnel is clearly a key issue.

Everyone involved in patient care has a duty to provide care and treatment that lies within their own expertise, but equally anyone delegating a duty must be satisfied that the person taking on the task can do it to a reasonable standard. It is therefore essential that only those professionals who can demonstrate sufficient competence operate within the scheme. It is recommended within HSC 2000/0261 that a senior person for each professional group oversees selection.

What information should be included in a PGD?

It is important that the PGD is unambiguous and sets clear limits to the authority it grants.

The specific information that must be included in a PGD is set out in Table 2 (below).

Table 2: Legal requirements for PGDs1

Each patient group direction 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 senior doctor or dentist, 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 or 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

The requirements amount to a template for a strict protocol effectively covering indications, absolute and comparative contraindications for seeking further advice from the supervising professional, and a limited time for one individual to receive treatment.

The circular governing the PGD states that appropriate documentation should be signed by each member of the multidisciplinary group responsible for generating each PGD.

In addition, each healthcare professional to whom it applies should sign a document confirming that he/she has read and understood the direction and will abide by the limits of authority within the direction.

Many will include restatement of the general professional responsibility not to undertake treatments that lie beyond the individual's personal level of experience and skill.

PGDs may include all drugs, except controlled drugs, although even this may change in the future. They can therefore include the use of drugs for indications outside their product licence.

In these situations it is important to ensure that the management is in keeping with accepted medical practice, and that in the event of any challenge to that management the professionals concerned can demonstrate that the management is in accordance with accepted medical practice.

Authoritative guidelines from national institutions or guidance from the National Institute for Clinical Excellence (NICE) are examples of appropriate authority.

It is important that those involved in setting up and operating under a PGD get it right. The Statutory Instruments modify the requirements of the Medicines Act 1968, but failure to comply with the regulations or the modified provisions of the Act can render the transgressor vulnerable to criminal prosecution.

Where should you start?

A good starting point is the website www.groupprotocols.org.uk where an increasing number of protocols are available for downloading.

As pointed out on the website, PGDs are locality specific and should not be used in localities other than those for which they have been developed.

Although some adaptation may be required, there is no point in agonising over the basic draft when a model is readily available. If nothing else, examples from the website set out the basic template to be followed.

PGDs provide a means of extending the roles of some non-medical healthcare workers.

The golden rules are to ensure that:

  • The protocol complies with the regulations
  • It accommodates relevant local factors
  • Any person named within the PGD will be able to complete the task to a reasonable standard
  • There are systems in place within the practice to ensure that relevant information about patient care will be recorded and accessible to other healthcare workers who may need it when providing care to the patient.

References

  1. Patient Group Directions (England Only). Health Service Circular 2000/026.

Guidelines in Practice, March 2001, Volume 4(3)
© 2001 MGP Ltd
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