The issues have been set out as the MHRA sees them together with preliminary
proposals for the future regulation of PGDs. Views were invited on
these proposals as well as comments on any other issues relating to
PGDs and the other matters raised.
PGDs arose from the 1997 Review of Prescribing, Supply and Administration
of Medicines (the Crown Review). The Review found that various group
protocols (the earlier term for PGDs) were being used to enable nurses
(usually) to supply/administer prescription only medicines to groups
of patients thereby removing the need for the doctor to see each patient.
The principle of such protocols were regarded as good practice but
there was some concern that the Medicines Act could be interpreted
as requiring "patient-specific" directions. Also the quality
of the protocols varied throughout the country. The Crown Review’s
first report advised that the majority of clinical care should continue
to be provided on an individual, patient-specific basis and the use
of PGDs should be reserved for those limited situations where this
offers a distinct advantage for patient care and where it is consistent
with appropriate professional relationships and accountability.
However, they recognised that PGDs could work well in certain situations.
As well as recommending criteria for the development, implementation
and review of such protocols, the report also recommended that the
law should be clarified to ensure that health professionals who supply
or administer medicines under approved group directions are acting
within the law and that all such directions comply with specified legal
criteria.
The Royal College of Physicians of Edinburgh (the College) is pleased to respond
to the Medicines and Healthcare Products Regulatory Agency’s (MHRA) consultation
on provisions for Patient Group Directions (PGDs) and other matters.
General comments on Patient Group Directions
The College agrees with the positive and negative aspects of PGDs set out
by the MHRA. Although a valuable concept, PGDs have been used increasingly
to convey the power to prescribe more widely and in circumstances where a trained
individual should be making patient specific decisions.
The College is concerned that, under medicines legislation, directions for
administration are only required for parenteral preparations and suggests that
directions should apply equally to all forms of prescription medicine.
-
Article 12
- 12E of the Prescriptions Only Medicines (Human Use) Order 1997 and
corresponding provisions in the Pharmacy and General Sale (Exemption)
Order 1980
Health Centres (Article 12)
The College notes that Article 12 allows medicines to be sold or supplied
for the purpose of being administered to a particular person in the course
of the business of a hospital in accordance with the written directions of
an independent prescriber. This patient-specific direction (PSD) does
not have to comply with all of the usual prescription requirements and there
is no requirement for the sale or supply to take place on registered pharmacy
premises under the supervision of a pharmacist.
There is some ambiguity surrounding whether this exemption also applies to “health
centres”. The College notes the MHRA’s discussion of the
now expanded meaning of “health centres” and believes that the
reference to “health centres” should be deleted to remove any
uncertainty.
Supply by Independent Non-Medical Prescribers (Article 12A)
It is noted that the MHRA is considering amending this exemption to allow
supply for the purposes of administration in accordance with the written directions
of other independent non-medical prescribers. The College has major concerns
about such an extension and considers that the groups who are already permitted
under the legislation are adequate.
Health Professionals authorised to supply and administer (Article 12B)
The College concurs with the MHRA’s view that only registered health
professionals should be authorised to supply or administer medicines under
PGDs. This ensures that such professionals are identifiable, must achieve
measurable standards of competency and are subject to a fitness to practice
framework.
It is noted that amongst the Emergency Medicine community, there is concern
about the use of drugs by ambulance paramedics, particularly the variations
in usage between ambulance trusts, and the lack of appropriate audit and feedback
regarding the use of these drugs.
Cross-border recognition (Article 12C)
The College does not believe that the law should be amended so that an independent
provider entering into arrangements with a pharmacy must be registered in the
country where that pharmacy is registered and where those services are offered. The
College considers that cross recognition between devolved administrations should
be maintained.
Independent Hospitals, Clinics and Medical Agencies
(Article 12D)
It is noted that Article 12D provides exemptions which allow independent hospitals,
clinics and medical agencies registered with the Care Quality Commission (CQC)
to develop and authorise their own PGDs. The implementation of the Health
and Social Care Act 2008 means that providers of health and social care
across the NHS and independent sectors will be registered by the CQC.
In assessing whether the Article 12D should be expanded to include other providers
who will now be registering with the CQC, the College considers that all PGDs
should be scrutinised by a Drug & Therapeutics Committee with an appropriate
constitution whatever the healthcare provider.
Prisons, Police and Armed Forces (Article 12E)
It is agreed that the legal position regarding the authorisation and delegation
of powers within PGDs in prisons, police and armed forces should be absolutely
clear.
Particulars
required to be contained in PGDs
The College supports the inclusion of a specific requirement for review dates
in PGDs. Many drugs are given according to protocols and algorithms,
for example, cardiac arrest guidelines of the Resuscitation Council (UK) and
the European Resuscitation Council. These and other similar guidelines
are regularly reviewed and changed. Without review dates, there is the
very real risk of drugs being administered under old guidelines.
-
Unlicensed medicines
The College considers that unlicensed medicines should remain excluded from
the scope of PGDs, although there may be a special case for relaxation in relation
to paediatric medicines where there is a demonstrated need.
