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Briefing note: Modernising Pharmacy Regulation: Ad hoc group on medicines related

standards

Purpose of the meeting

To ensure all relevant issues are identified and considered to enable the executive to

present suitable information and advice to Council as part of their consideration and

approval of standards for registered pharmacies, particularly in relation to medicines safety

and the interaction with medicines legislation and the medicines regulator, MHRA.

Context

The draft of the standards issued for consultation was developed with a number of key

underlying principles:

Council’s vision and strategy: including the desire to regulate in a way which is

proportionate and allows innovation which is consistent with high quality practice

Our policy in relation to standards setting: which endorsed the principle of outcome

focussed standards (and the need to consider additional supportive information and

guidance)

Consistent with the legal framework: The recognition that registered pharmacies will

need to comply with the law, but just because they are operating within the law, does

not mean that they are necessarily meeting our standards

That we need to consider the role of others: In some specific areas there is likely to be a

role for others areas of practice, as with professional standards, where leadership or

representative bodies may be better placed to provide guidance to registrants

Overarching principle

Patient safety comes first. If there is a risk to patient safety which is so serious it requires

regulatory activity we should do so if it is within our remit. If not, we should make clear

our views to others who do have a role, either at a local or national level.

Background and approach

In attempting to provide clarity about out role and the way in which we wish to regulate, a

number of specific issues have arisen, particularly in relation to how we interpret the

Medicines Act 1968 which is both complex and dated.

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In some areas (for example, the supply of medicines) the previous regulator was very

prescriptive about what was required. In areas where there was a regulatory interface with

the MHRA we have identified a need for much greater clarity about how we each interpret

legislation and apply policies in an operational context (not least inspections of sites which

are both registered pharmacies and MHRA licensed sites).

We see it as critical to the confidence of patients, the public and registrants that we meet

our commitment to the five core principles for good regulation (proportionate; accountable;

consistent; transparent and targeted). It is important, however, to note that there may be

circumstances (see overarching principle above) where an activity or practice is not

prohibited in law but a proportionate response may still be to create a rule or standard

which has the effect of a blanket prohibition.

Specific issues

Having considered the above principles and approach in drafting the consultation document

there are a number of specific issues which have been identified as needing further

discussion now that our consultation, Modernising Pharmacy Regulation, has closed (the

Council will receive a report of the consultation and engagement feedback at their meeting

in June ).

1. The requirement to supply of medicines with a marketing authorisation (MA) in

preference to a medicine that does not (i.e. the supply of a licensed medicine where one

exists in preference to an unlicensed medicine)

2. The extemporaneous preparation of methadone (which was specifically ‘allowed’ by the

RPSGB despite being an unlicensed medicine)

3. The manufacturing of medicines by pharmacies (under an exemption set out in section

10 of the Medicines Act)

4. The display of pharmacy medicines (P) which the RPSGB stated should not be available

for ‘selection’ by a patient.

The current draft of our standards do cover each of the issues above, but by being outcome

focussed do not seek to impose a blanket prohibition (or in the case of extemp. preparation

of methadone, enable it).

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Each of the issues has been raised as part of our consultation and in considering how best to

response Council will need to consider each of the following questions:

I. Do our standards comply with our own policy in relation to regulatory standards and

approach to regulation more generally?

II. Do our standards, as they are currently drafted, contradict the current legal

framework for medicines?

III. On these specific medicines related issues:

a. Is it the GPhC or the MHRA who is the lead regulatory body?

b. Do we need to defer to, or reference, expert advice from another

organisation?

c. If not, and we decide that the GPhC needs to provide clear and definitive

advice or requirements to its registrants, does that best sit with individual

registrants through CEP or associated guidance or to owners and SI’s through

registered pharmacy standards?

d. What should the standard, or guidance, say?

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Appendix (factual information in relation to the three identified issues)

1. The supply of medicines with a marketing authorisation where these exist (i.e. the

supply of a licensed medicine in preference to an unlicensed medicine where one

exists)

GPhC interim standards

Ensure products with a marketing authorisation are supplied where such products exist in a suitable form and are available, in preference to unlicensed products or food supplements except where an exemption has been authorised (the GPhC has granted an exemption for the extemporaneous preparation of methadone).

Background Information

All medicinal products placed on the UK market require a ‘marketing authorisation’

(formerly known as a product licence). They are generally referred to as licensed medicines.

The authorisation is intended to provide assurance that a product’s safety has been

assessed before marketing, together with its efficacy.

Some licensed medicines are prescribed ‘off label’ this means that the medicine is used for

an indication outside of the terms of its marketing authorisation. An example is 1%

hydrocortisone cream. This is a licensed medicine, but it is not licensed for use on the face.

However, some doctors will prescribe it for use on the face. This is lawful. The prescribing

doctor and supplying pharmacist must both be satisfied that it is appropriate for the patient.

Some medicines are unlicensed. This means that they do not have a marketing authorisation

and have not been subject to clinical trials and the same regulatory oversight by the MHRA.

A lot of children’s medicines are either unlicensed or of label – however often this will be

because a licensed medicines does not exist.

Legislation

The Medicines for Human Use (Marketing Authorisation etc) Regulations 1994 (‘the Regs)

explain that no relevant medicinal product should be placed on the market unless it has an

MA. (Reg 3 (1) of the Regs).

This does not apply to anything done in a registered pharmacy, a hospital or health centre,

that is done there by or under the supervision of a pharmacist, and consists of procuring the

manufacture or assembly of a stock of relevant medicinal products with a view to dispensing

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them in accordance with a bona fide unsolicited order formulated in accordance with the

specification of a doctor or dentist and for use by his individual patients on his direct

personal responsibility (as set out in the MHRA guidance note 14).

This means that it is lawful for a pharmacist to supply an unlicensed medicine in response to

a prescription from a doctor or dentist.

GMC Guidance

The General Medical Council has recently reviewed its guidance on prescribing. Details of

the issues it considered and the interim position they have recently agreed are set out in

their Council Paper attached separately.

2. The extemporaneous preparation of methadone

GPhC interim standards

The GPhC has granted an exemption from the standard that requires products with a marketing authorisation are supplied where such products exist in a suitable form and are available, in preference to unlicensed products or food supplements. Background The Council agreed an exemption to its standards to enable the extemporaneous

preparation of methadone. The Council agreed at that time that the exemption would be

subject to review. Since then, we issued has held a call for evidence recognising that there

had been anecdotal concerns raised about the practice (See separate call for evidence). We

also raised this issue with the NPSA to ascertain if there is any further empirical evidence

about the safety of this practice.

Extemporaneously prepared methadone is an unlicensed version of the product which is

prepared in the pharmacy. There is a licensed version, however it has been a long

established practice within some pharmacies to prepare it on site, rather than purchase the

licensed version.

There is no detailed quantitative evidence to set out why, however our call for evidence

would suggest that there are two main motivations: the lack of storage space in some

pharmacies; and the reduced cost associated with the extemporaneously prepared version.

(The pharmacy is reimbursed at the same rate by the NHS Business Services Authority for

either version of the methadone).

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3. The manufacturing of medicines by pharmacies (under an exemption set out in section

10 of the Medicines Act)

Background

Medicines must be manufactured by holders of the appropriate licences. This is a legal

requirement and is set out in the Medicines Act.

Under the supervision of a pharmacist in a registered pharmacy, (and some other settings,

including hospitals), medicines can be manufactured / prepared against a prescription,

without the need for a licence. This can happen under an exemption detailed in the Act.

The Act also allows pharmacists in registered pharmacies to prepare stock in advance to be

supplied at a later date for individual patients against a prescription.

Pharmacists can obtain stocks of both licensed and unlicensed medicines manufactured

elsewhere by holders of the appropriate licences and supply them to patients against

prescriptions.

The Act also allows pharmacists in registered pharmacies to manufacture certain medicines

and sell them over the counter to patients.

In our experience, there has been difficulty in working with the MHRA at an operational

which would benefit from greater clarity in supplementary guidance. We have, through a

series of meetings with the MHRA in recent months, received helpful verbal confirmation of

their view that if the manufacture is for a named patient, then the pharmacy is exempt from

the requirement to have an MHRA license. They further confirmed that they scale of the

manufacture is not a relevant criterion.

4. The display of Pharmacy (P) medicines

Background

Pharmacy medicines must be sold under the supervision of a pharmacist from a registered

pharmacy. This is a legal requirement and is set out in the Medicines Act.

The GPhC adopted, as an interim measure, the standard that P medicines cannot be made

available for self selection.

In a physical building that patients visit, this means that no P medicines can be accessed by

patients and the public without first speaking to a member of the pharmacy team. Some

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pharmacies may place dummy packs on the shop floor but the patient would need to speak

to a member of the pharmacy team before they could access the medicines themselves.

If a patient visits an internet pharmacy, they can browse all general sale list (GSL – these are

those medicines that you can buy from any retail outlet) and P medicines. The patient can in

effect ‘pick’ which medicines they wish to purchase. For P medicines, as is the case for a

physical pharmacy a pharmacist would need to supervise the sale and the sale would need

to take place from a registered pharmacy.

What we have heard

Although we are still analysing the responses from the consultation, we are aware that a

number of representative bodies from pharmacy have expressed concerns that this might

be a risk to patient safety and may undermine the categorisation process for medicines.

We are awaiting receipt of any relevant documentation about this process carried out by

the MHRA, but they appear unlikely to be able to give us a definitive view as to whether a

different interpretation of the legal requirement for supervision (such as self-selection)

would have led to different decisions on categorisations of medicines which have moved

from POM to P.