These are written instructions from a doctor or dentist for a medicine or appliance that is to be administered or supplied to a named patient.

In primary care these may be written in the patient’s notes, and in hospital this may include instructions on a patient’s ward drug chart.

There is no need for a patient group direction where a patient-specific direction exists.

This is a written instruction for the supply or administration of medicines to groups of patients who may not be identified individually before presenting for treatment.

It is not a form of prescribing, and no specific training needs to be undertaken by health professionals before they can work under a PGD.

The law restricts the use of PGD to the NHS or organisations providing care for NHS patients as part of an NHS contract.

Those using PGD in non-NHS settings should seek guidance from their professional organisation/insurer.

PGD should be drawn up by a multidisciplinary group and must be signed by a senior doctor and senior pharmacist who should both have been involved in the group.

The multidisciplinary group should have representation from all professional groups expected to supply or administer medicines under the PGD.

Only fully competent, qualified and trained professionals should operate within PGD.

The law allows chiropodists, ambulance paramedics, midwives and occupational health nurses to administer specified parenteral medicines on their own initiative without the directions of a doctor. These exemptions are found in Schedule 5 of the Prescription Only Medicine (Human Use) Order 1997 No. 1830.

The prescriber is responsible for the clinical assessment of the patient, establishing a diagnosis, and the clinical treatment needed. Where necessary, he/she will prescribe appropriate medication.

Currently, only doctors, dentists and some nurses are independent prescribers.

Doctors may delegate responsibility to nurses for immunisation if the following conditions apply:

• the nurse agrees to be professionally accountable as described in the NMC guidance ‘Scope of Professional Practice’
• the nurse has received training and is competent in all aspects of immunisation including contraindications to specific vaccines
• adequate training has been given in the recognition and treatment of anaphylaxis. (www.resus.org.uk)

In 1964 the Yellow Card Scheme for reporting suspected adverse drug reactions (ADRs) was introduced. From October 2002 the scheme was extended to include all nurses, midwives and health visitors as recognised reporters along with doctors, dentists, pharmacists, coroners and pharmaceutical companies. At the same time, an electronic version of the Yellow Card Scheme was also introduced and is the preferred method of reporting. www.yellowcard.gov.uk

An extension to the scheme is the HIV Adverse Drug Reactions Reporting Scheme launched in October 1997, which manages the reporting of suspected ADRs in those infected with HIV.

Further information about the scheme can be obtained by email info@mhra.gsi.gov.uk

An adverse drug reaction is a reaction, or a suspected reaction, related to taking a drug or a combination of drugs. The Yellow Card Scheme relies upon voluntary reporting of these events, and if in doubt report.

Areas of special interest include:

• adverse reactions in children
• adverse reactions in the elderly
• delayed drug effects
• congenital anomalies
• herbal remedies.

A black triangle is given to newer drugs and vaccines. Reporting adverse drug reactions (ADRs) provides an increase in knowledge of the safety profile of new medicines, and previously unrecognised side-effects are identified as quickly as possible. No standard time is given for a black triangle to be displayed, but assessment at two years' post-marketing is usual. The symbol is not removed until the drug’s safety has been well established.

A black triangle is given to the following products if the drug:

• is a new active substance
• has a new combination of active substances
• is administered by a novel route or drug delivery system
• has a significant new indication which may alter the established risk/benefit profile of the drug.

Most medicines are designed for and tested on adults but are widely prescribed for children. However, children and adults respond very differently to medicines and therefore a new paediatric medicines strategy is being developed around:

• paediatric clinical trial data for new and current medicines
• better information on the use of medicines in patient information leaflets
• separate British National Formulary for children
• the promotion of research into medicines for children.

Information on EU regulations, the UK strategy document and other useful reference websites and research papers, can be found at the following link:
http://medicines.mhra.gov.uk/ourwork/licensingmeds/children/children.htm

Medicines and Healthcare products Regulatory Agency www.mhra.gov.uk
The Green Book, Immunisation against Infectious Disease www.dh.gov.uk

Guidance on the use of PGDs, Health Service Circular 2000/026

Schedule 5 of the Prescription Only Medicine (Human Use) Order 1997 No. 1830