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Background note for ad hoc group on med


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Background note for ad hoc group on med

  1. 1. Briefing note: Modernising Pharmacy Regulation: Ad hoc group on medicines relatedstandardsPurpose of the meetingTo ensure all relevant issues are identified and considered to enable the executive topresent suitable information and advice to Council as part of their consideration andapproval of standards for registered pharmacies, particularly in relation to medicines safetyand the interaction with medicines legislation and the medicines regulator, MHRA.ContextThe draft of the standards issued for consultation was developed with a number of keyunderlying 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 registrantsOverarching principlePatient safety comes first. If there is a risk to patient safety which is so serious it requiresregulatory activity we should do so if it is within our remit. If not, we should make clearour views to others who do have a role, either at a local or national level.Background and approachIn attempting to provide clarity about out role and the way in which we wish to regulate, anumber of specific issues have arisen, particularly in relation to how we interpret theMedicines Act 1968 which is both complex and dated. 1
  2. 2. In some areas (for example, the supply of medicines) the previous regulator was veryprescriptive about what was required. In areas where there was a regulatory interface withthe MHRA we have identified a need for much greater clarity about how we each interpretlegislation and apply policies in an operational context (not least inspections of sites whichare both registered pharmacies and MHRA licensed sites).We see it as critical to the confidence of patients, the public and registrants that we meetour commitment to the five core principles for good regulation (proportionate; accountable;consistent; transparent and targeted). It is important, however, to note that there may becircumstances (see overarching principle above) where an activity or practice is notprohibited in law but a proportionate response may still be to create a rule or standardwhich has the effect of a blanket prohibition.Specific issuesHaving considered the above principles and approach in drafting the consultation documentthere are a number of specific issues which have been identified as needing furtherdiscussion now that our consultation, Modernising Pharmacy Regulation, has closed (theCouncil will receive a report of the consultation and engagement feedback at their meetingin 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 outcomefocussed do not seek to impose a blanket prohibition (or in the case of extemp. preparationof methadone, enable it). 2
  3. 3. Each of the issues has been raised as part of our consultation and in considering how best toresponse 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? 3
  4. 4. 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 standardsEnsure products with a marketing authorisation are supplied where such products exist in asuitable form and are available, in preference to unlicensed products or food supplementsexcept where an exemption has been authorised (the GPhC has granted an exemption forthe extemporaneous preparation of methadone).Background InformationAll 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 beenassessed before marketing, together with its efficacy.Some licensed medicines are prescribed ‘off label’ this means that the medicine is used foran 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 prescribingdoctor 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 authorisationand 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 bebecause a licensed medicines does not exist.LegislationThe 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 anMA. (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 themanufacture or assembly of a stock of relevant medicinal products with a view to dispensing 4
  5. 5. them in accordance with a bona fide unsolicited order formulated in accordance with thespecification of a doctor or dentist and for use by his individual patients on his directpersonal 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 toa prescription from a doctor or dentist.GMC GuidanceThe General Medical Council has recently reviewed its guidance on prescribing. Details ofthe issues it considered and the interim position they have recently agreed are set out intheir Council Paper attached separately.2. The extemporaneous preparation of methadoneGPhC interim standardsThe GPhC has granted an exemption from the standard that requires products with amarketing authorisation are supplied where such products exist in a suitable form and areavailable, in preference to unlicensed products or food supplements.BackgroundThe Council agreed an exemption to its standards to enable the extemporaneouspreparation of methadone. The Council agreed at that time that the exemption would besubject to review. Since then, we issued has held a call for evidence recognising that therehad been anecdotal concerns raised about the practice (See separate call for evidence). Wealso raised this issue with the NPSA to ascertain if there is any further empirical evidenceabout the safety of this practice.Extemporaneously prepared methadone is an unlicensed version of the product which isprepared in the pharmacy. There is a licensed version, however it has been a longestablished practice within some pharmacies to prepare it on site, rather than purchase thelicensed version.There is no detailed quantitative evidence to set out why, however our call for evidencewould suggest that there are two main motivations: the lack of storage space in somepharmacies; and the reduced cost associated with the extemporaneously prepared version.(The pharmacy is reimbursed at the same rate by the NHS Business Services Authority foreither version of the methadone). 5
  6. 6. 3. The manufacturing of medicines by pharmacies (under an exemption set out in section 10 of the Medicines Act)BackgroundMedicines must be manufactured by holders of the appropriate licences. This is a legalrequirement 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 besupplied at a later date for individual patients against a prescription.Pharmacists can obtain stocks of both licensed and unlicensed medicines manufacturedelsewhere by holders of the appropriate licences and supply them to patients againstprescriptions.The Act also allows pharmacists in registered pharmacies to manufacture certain medicinesand sell them over the counter to patients.In our experience, there has been difficulty in working with the MHRA at an operationalwhich would benefit from greater clarity in supplementary guidance. We have, through aseries of meetings with the MHRA in recent months, received helpful verbal confirmation oftheir view that if the manufacture is for a named patient, then the pharmacy is exempt fromthe requirement to have an MHRA license. They further confirmed that they scale of themanufacture is not a relevant criterion.4. The display of Pharmacy (P) medicinesBackgroundPharmacy medicines must be sold under the supervision of a pharmacist from a registeredpharmacy. 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 madeavailable for self selection.In a physical building that patients visit, this means that no P medicines can be accessed bypatients and the public without first speaking to a member of the pharmacy team. Some 6
  7. 7. pharmacies may place dummy packs on the shop floor but the patient would need to speakto 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 arethose medicines that you can buy from any retail outlet) and P medicines. The patient can ineffect ‘pick’ which medicines they wish to purchase. For P medicines, as is the case for aphysical pharmacy a pharmacist would need to supervise the sale and the sale would needto take place from a registered pharmacy.What we have heardAlthough we are still analysing the responses from the consultation, we are aware that anumber of representative bodies from pharmacy have expressed concerns that this mightbe 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 bythe MHRA, but they appear unlikely to be able to give us a definitive view as to whether adifferent interpretation of the legal requirement for supervision (such as self-selection)would have led to different decisions on categorisations of medicines which have movedfrom POM to P. 7