Policy responses and statements
Background: The MHRA wrote to the College to consult on proposals to allow dispensing opticians to order stocks of specified POMs. The proposals would also allow dispensing opticians to administer these medicines in certain circumstances. The proposals are intended to address a practical difficulty whereby dispensing opticians are unable to order stocks of medicines for use in their own practices by visiting optometrists. They are also intended to enhance patient care by reflecting developments in contact lens practice. This consultation was made available in Wales, Scotland and Northern Ireland. The proposed changes to legislation would apply throughout the United Kingdom. Under the Medicines Act 1968, medicines classed as prescription only (POM) and pharmacy (P) medicines may only be sold or supplied through registered pharmacy premises by or under the supervision of a pharmacist. POMs are subject to the additional requirement that they may only be sold or supplied against an appropriate practitioner’s prescription. An appropriate practitioner is a doctor, dentist, and, within the terms of the legislation covering their prescribing, a supplementary prescriber, nurse independent prescriber or pharmacist independent prescriber. Legislation is also being introduced to allow optometrists to gain independent prescribing status. There are exemptions from these restrictions for registered optometrists which allow them to sell or supply specified lists of POM and P medicines in the course of their professional practice. Optometrists are also allowed to obtain wholesale supplies of P medicines and specified POMs for administration in the course of his/her business. Registered optometrists engage in the testing of sight and may or may not fit and supply optical appliances. Dispensing opticians are trained to dispense and fit spectacles and other optical aids, working from prescriptions written by optometrists and ophthalmologists. Around 900 are sole practitioners working from their own premises. Both optometrists and dispensing opticians may fit contact lenses but dispensing opticians must be registered as a specialist in the practice on the General Optical Council (GOC) register. The GOC has an established competency framework for the speciality of contact lens practice. Specialist contact lens practice includes involvement in the management of certain eye conditions where contact lenses are especially beneficial or may be the only management option. The most appropriate type of lens is usually complex in form and fitting process. The use of anaesthetics may be required in the assessment and fitting of such contact lenses. Proposals: The proposals outlined were developed in consultation with the General Optical Council (GOC), which is the statutory body for the regulation of the optical professions. Dispensing opticians in sole practice often work with optometrists who attend their premises on a consultancy basis and use certain POMs - generally for diagnostic purposes and to treat a limited range of ocular conditions. Other POMs are used in contact lens practice which is undertaken by optometrists and dispensing opticians who are registered specialists. The Agency understands that for many years it has been customary for dispensing opticians to order stocks of these POMs. However, under medicines legislation they are not actually entitled to receive stocks of POMs. An increasing awareness of the legal position means that suppliers are now requiring that orders for POMs are signed by an optometrist. There are practical difficulties around obtaining the optometrist’s signed order because he or she may not attend the dispensing optician’s premises frequently. This impacts on ensuring stocks are kept up to date. There is also an impact on those specialist dispensing opticians who engage in fitting contact lenses but cannot obtain medicines used in the course of their practice in their own right. It is therefore proposed to allow registered dispensing opticians to obtain wholesale supplies of the following POMs for use by optometrists attending their practices:
It is also proposed to allow registered dispensing opticians who are also registered as contact lens specialists on the GOC register to obtain wholesale supplies of the following POMs for administration in the course of their professional practice:
COMMENTS ONMEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)MLX 351: PROPOSALS FOR AMENDMENTS TO MEDICINES LEGISLATION TO ALLOW DISPENSING OPTICIANS ACCESS TO CERTAIN PRESCRIPTION ONLY MEDICINES (POMS)
The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on consultation MLX 351: Proposals for Amendments to Medicines Legislation to allow Dispensing Opticians access to certain Prescription Only Medicines (POMs). These proposals directly address the practical difficulties that arise from medicines legislation which does not currently allow dispensing opticians to stock medicines in their own premises for use by visiting optometrists. The proposals would allow dispensing opticians who are registered as contact lens specialists with the General Optical Council (GOC) to obtain the Prescriptions Only Medicines necessary for their professional practice. This College supports the proposals and agrees that they should maintain and enhance patient care. It is recognised that the GOC sets high standards for practice in terms of practitioner competencies and patient safety, and it is in this context that the proposals are given broad support. In response to the consultation, the College has canvassed opinion from a number of our Fellows who are practising Ophthalmologists, and there is general agreement with the proposals. There is an assumption that any changes to legislation would be accompanied by appropriate attention to the details of patient safety. This might include high level specification of how the changes will be implemented, instruction on storage facilities including refrigeration for drugs, use of single dose units, production of standard operating procedures and making patient information leaflets available. This College suggests consultation with the Royal College of Ophthalmologists over determining any contraindications to the use of these medicines by dispensing opticians and optometrists. The College received some detailed comments from our Fellows on the individual medicines covered by the proposed change in legislation. There was support without reservation on the use of the mydriatic medications tropicamide and cyclopentolate. Similarly, the inclusion of chloramphenicol is agreed. But chloramphenicol is on the one hand available over the counter from pharmacists but, on the other, there is concern about its use long-term because of the risk (albeit extremely low) of causing aplastic anaemia. So it may be appropriate to give guidance on maximum duration of therapy that is instigated by optometrists and dispensing opticians e.g. one week. Finally, the use of local anaesthetic agents is also agreed, but with some comment on detail. Proxymetacaine alone and in combination with fluorescein was endorsed, and proxymetacaine was cited as particularly useful in children. Lignocaine use is decreasing but still used alone and in combination with fluorescein. Amethocaine was described as longer acting (more suitable for surgical procedures) and as causing more discomfort for the patient, and so its inclusion was questioned. Oxybuprocaine was described as short acting but causing more irritation than proxymetacaine so, again, the latter agent was favoured.
Copies of this response are available from: Lesley Lockhart, Tel: 0131 225 7324 ext 608 [1 December 2008]
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