Registered pharmacies and medicines related regulatory issues

Hugh Simpson

Director of Policy and Communications

Update on MHRA’s human medicines legislation consolidation

• Timetable

• What we have done

• Section 10(7)

• Optimisation of medicines use

• Next steps

REGISTERED PHARMACIES UPDATE

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

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

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

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

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

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)

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

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

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

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

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.

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

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

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