2. Update on MHRA’s human medicines
legislation consolidation
• Timetable
• What we have done
• Section 10(7)
• Optimisation of medicines use
• Next steps
4. Contents
1. Context and approach
2. Licensed medicines
3. Extemporaneous preparation of (unlicensed)
methadone
4. Manufacturing by registered pharmacies
5. Supervision of the sale of Pharmacy ‘P’ category
medicines
5. Context and approach
1. Development of new standards (and new inspection
model) has enabled us to take a fresh look at a range
of medicines related issues
2. Focus on patient safety, principle-based approach and
the need to be consistent with wider regulatory and
legal framework
Principle based approach:
• Council’s vision and strategy
• Our policy in relation to standards setting
• Consistent with the legal framework
• That we need to consider the role of others
6. Licensed medicines - background
• Directive 2001 /83/EC on medicinal products for
human use
• GPhC interim standards based on RPSGB policy
• General Medical Council guidance – update and
position of MHRA
• Novartis Judicial Review of the NHS in relation to use
of Avastin
7. Licensed medicines – ad hoc group
discussions
• We have to be consistent with the legal position in
Directive 2001/83/EC on medicines for human use
• It is not for the GPhC to allow ‘exemptions’ to law
• As it is not a GPhC standard, but interpretation of the
law, our position could sit outside our standards but
would need to be explicit
• We need to ensure consistency, where possible, with
the GMC and other regulators
8. Statements for consideration
1. The direction of travel would mean that a GPhC
position on supply of licensed medicines should not
be set out in standards
2. We would need to provide clear and unequivocal
guidance to registrants about the legal position and
how to meet our (professional) standards
3. Given the forthcoming judicial review and legal advice
received by the GMC, we should ensure that we are
consistent with the legal interpretation and any high
court decisions
9. Extemporaneous preparation -
background
• Longstanding ‘exemption’ in RPSGB standards adopted
on an interim basis by the GPhC
• Extemporaneously prepared methadone is an
unlicensed medicine
• Call for evidence issued to understand better
motivation and practice (rather than consult on
proposition)
10. Extemporaneous preparation – ad hoc
group discussions
• Consensus view that neither RPSGB nor GPhC could
provide an ‘exemption’ to the law
• Directive seems explicit that only exceptions to
supplying medicines with a marketing authorisation
are where one is not available or where there is a
‘special need’
• Need to consider impact and timing of change, but not
appropriate to allow something which goes against
legal framework
11. Statements for consideration
1. If cost is not an acceptable reason for supplying
unlicensed medicines, the GPhC would need to be
explicit that extemporaneous preparation is not
consistent with the law
2. If the practice is deemed inconsistent with law and
our standards we would need to commission/carry
out research to ascertain the scale of the practice and
have a reasonable implementation timetable
12. Manufacturing by registered
pharmacies - background
• Medicines can only be manufactured/prepared by
holders of appropriate licences (Medicines Act 1968)
• S10 exempts pharmacists from a registered pharmacy
(and some other settings such as hospitals) enabling
preparation against a prescription for a named patient
• Challenge has been at an operational level with
confusion arising when registered pharmacies also
holding a manufacturers/specials licence from MHRA
13. Manufacturing by registered
pharmacies – ad hoc group discussions
• Noted discussions executive have had with MHRA
• Not an issue about size/volume – about preparation
against a prescription for a named patient.
• Some early discussions for a new protocol at
operational level where MHRA license holder claims to
be working under a s10 exemption
14. Statements for consideration
1. We need to pursue clear and consistent
communication from ourselves and the MHRA
2. Operational protocols should be developed to ensure
joint decision making can take place consistent with
the legal and policy positions of MHRA and GPhC
3. Ultimately it is for the licensor (MHRA) to determine
whether a registered pharmacy requires a
manufacturers licence.
15. Supervision of the sale of Pharmacy ‘P’
category medicines - background
• Pharmacy medicines must be sold under the supervision of a
pharmacist from a registered pharmacy (Medicines Act 1968)
• The GPhC adopted, as an interim measure, the standard that
P medicines cannot be made available for self selection
• Our consultation set out a desire to be outcome focussed and
encourage pharmacists to use their professional judgement
• Current categorisation process for medicines not explicit
about the influence of the ‘professional’ interpretation
supervision in the registered pharmacy context
16. Supervision of the sale of ‘P’ medicines
– ad hoc group discussions
• Heard strong opinions from representative bodies and
from some of the patient/public participants
• Broad agreement within ad hoc group that it should be
the owner/superintendent who decides how best to
fulfil legal requirements of supervision in this context
• Some discussion about the need for professional
leadership bodies in provide advice to their
members/profession
17. Statements for consideration
1. Models of delivery and supervision have changed in
pharmacy and will continue to do so; we should
maintain and focus on outcomes in relation to supply
of P category medicines
2. Our inspection model should take into account, and
we should communicate, the sorts of risk assessment
and decision making processes we think owners and
SI’s should undertake before allowing any self-
selection
