40 Use and Supply of Drugs or Medicines in Optometric Practice

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1 40 Use and Supply of Drugs or Medicines in Optometric Practice Guideline The optometrist has a duty to take due care in the use of drugs in optometric practice and to only supply drugs when it is appropriate to do so. It is good practice for the supply of drugs to normally be made by a pharmacist. Advice General Optometrists are exempt from some of the general rules laid down in the Medicines Act. Two exemptions levels have been established for medicinal products (POMs) that can be sold in the course of professional practice and in an emergency (or supplied via a signed order from the pharmacist 1 ). By virtue of their registration, all optometrists are able to access the basic exemption list. Optometrists who have undergone a further course of training approved by the GOC ( additional supply optometrists ) are able to access an additional list of drugs. Full details of the drugs available on each list are available in the Optometrists Formulary If an optometrist is writing a signed order for supply of the drug by a pharmacist the optometrist must include his/her GOC number on the order. This helps the pharmacist check whether the optometrist is an additional supply optometrist. Optometrists are reminded to use standard abbreviations. Examples are provided in the Optometrists Formulary Practitioners must always act in accordance with the current medicines legislation controlling the use and supply of drugs in optometric practice. Use of drugs in optometric practice Practitioners should ensure they maintain the necessary knowledge and skills to use the drugs they need in optometric practice To protect the patient an optometrist has a duty to maintain a reasonable level of knowledge of drugs e.g. actions, interactions, cautions and contraindications through a commitment to appropriate continuing professional development (see also section below.) Practitioners are encouraged to support adverse drugs reactions reporting schemes (see Information section below). The patient s General Medical Practitioner should be informed of any suspected adverse reaction When using any diagnostic drug, patients should be made aware of the effects and possible side effects of the drug. If the practitioner will not be available to deal with any emergency that may arise following instillation of the drug, he or she should instruct the patient to attend the local Accident and Emergency department should an adverse reaction occur. The College has produced information leaflets that practitioners may wish to give to their patients 3. The College of Optometrists Members Handbook. Pub Jan 08 Revised Jan

2 40.09 Optometrists should record the batch number and expiry date of drugs that are used in their professional practice. This will facilitate verification that the drug is in date and also - in the case of a drug recall makes it easier to trace all patients who may have been affected. The details may be recorded on the patient record, or other suitable log. Supply of drugs in optometric practice Practitioners using or supplying therapeutic drugs should maintain their competence to do this. The competencies are identified in the Competency Framework for Prescribing Optometrists available from the GOC or the National Prescribing Centre In order to separate prescribing and supply, it is good practice for the supply of therapeutic agents to be made by pharmacists wherever possible. Optometrists should not supply therapeutic drugs to patients unless it is in the patient s best interests for them to do so If it is necessary, pharmacy (P) or prescription only (POM) medicines can be supplied to patients but only if this is done by or under the supervision of the optometrist 5. The optometrist should be asked before the drug is sold or supplied to the patient, so that s/he can intervene if this is not appropriate. One way to do this would be to have the supply of drugs only in the consulting room If they are supplying therapeutic drugs to their patients, practitioners have a duty to ensure that this drug is appropriate for the patient. This will mean the optometrist has to make a diagnosis of the patient s condition. Supply should normally only be made following an eye examination, or within a reasonable time afterwards. Patients should be made aware of the need to have their condition periodically reassessed to determine whether or not the drug is still appropriate. This is particularly important if the patient has already sought treatment elsewhere. All actions and advice should be noted on the patient record Optometrists should be aware of the indications, cautions, contraindications and side effects of any medicinal products supplied. Patients should be made aware of how to use the drug and what to do in the case of an adverse event occurring Patients should be asked about any previous drug-induced adverse event and known drug allergies. Self-prescribing and treatment Optometrists should avoid self-prescribing or treatment wherever possible. Exceptions may be when treating minor ailments or taking suitable action in an emergency. Optometrists should not normally prescribe or prepare written orders for POM drugs for their own personal use or that of members of their close family. This is to avoid any lack of objectivity which might arise or potential litigation if things go wrong or relationships break down. Exceptions to this could be where an optometrist was treating minor ailments, or was required to take appropriate action in an emergency. The College of Optometrists Members Handbook. Pub Jan 08 Revised Jan

3 Co-management schemes Optometrists may be involved in co-managing patients, such as those who have undergone surgical procedures. This may involve the optometrist being asked to modify the patient s ocular medication that is not on the list of drugs optometrists can use or supply under the entry level or additional supply level exemptions described above. This may be done under the authority of a Patient Group Direction (see below), or delegated authority from the responsible medical practitioner. Optometrists must ensure that they work within the law and should also ensure that appropriate local protocols are in place. It is important that the optometrist can contact the responsible medical practitioner when needed. Storage and disposal of drugs Optometrists should ensure that all diagnostic and therapeutic drugs are stored according to the manufacturers instructions. They should be out of patients reach Legislation is in place to cover the disposal of hazardous waste. Optometrists must ensure that drug waste is disposed of in accordance with the regulations. This may be via the local pharmacist or GMP surgery or dedicated local service. Information Reporting schemes on adverse drugs reactions From 1 April 2003, the Medicines and Healthcare products Regulatory Agency (MHRA) replaced the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA). The MHRA is an Executive Agency of the Department of Health with trading fund status Two reporting schemes exist, operated by the MHRA. These are the Yellow Card scheme which covers systemic adverse reactions to ocular medicines and ocular reactions to systemic medication and the Medical Devices Reporting Form (covering adverse events to mainly contact lenses and care products) Since the beginning of 1995 certain ophthalmic products such as contact lens care solutions (including contact lens comfort drops), ophthalmic viscoelastic devices, ocular irrigating solutions and ocular endotamponades (used in retinal detachment surgery) have come within the definition of a medical device and therefore are subject to provisions of the Medical Device Regulations (1994) which came fully into force on 14 June Contact lens care products are defined as accessories to contact lenses and therefore are included within the Device Regulations. Products such as artificial tears, diagnostic stains such as fluorescein and rose bengal are not considered devices Full details of the reporting schemes are included in the Optometrists Formulary. Patient Group Directions Optometrists are named as professionals who can supply or administer drugs to patients under a Patient Group Direction (PGD). PGDs are written instructions for the supply or administration of medicines to groups of patients The College of Optometrists Members Handbook. Pub Jan 08 Revised Jan

4 who may not be individually identified before presentation for treatment. Information can be found on the MHRA website 6. The Royal Pharmaceutical Society has produced an information pack for pharmacists 7. Self-prescribing The GMC 8, BMA 9 and RPSGB 10 advise against self-prescribing or treatment wherever possible. Pharmacists Code of Ethics relating to the supply of pharmacy medicines The RPSGB Code of Ethics relating to the sales of pharmacy medicines states that 11 : All staff whose work regularly includes the sale of pharmacy medicines must be competent and instructed to refer customers to the pharmacist where appropriate. (a) Pharmacists or assistants asked for advice on treatment must obtain sufficient information to allow an assessment to be made that self-medication is appropriate, and to enable a suitable product or products to be recommended. Advice on the use of products must be provided. (b) Pharmacists must ensure that when a product is requested by name the procedures for sales of medicines provide for professional advice and intervention whenever this can assist in the safe and effective use of pharmacy medicines. Pharmacists or assistants must provide any advice relevant to the product and the intended consumer. (c) Pharmacists must be personally involved whenever this is necessary to provide an acceptable standard of pharmaceutical care. Assistants must be trained to know when the pharmacist should be consulted. (d) Procedures must ensure that the particular care needed is provided when supplying products for children, the elderly and other special groups or individuals or where the product is for animal use. (e) Pharmacists must ensure that they are involved in the decision to supply any medicine, which requires their intervention. Such medicines may include those that have recently become available without prescription, that may be subject to abuse or misuse, or where the marketing authorisation for nonprescription use is restricted to only selected conditions. Pharmacists and their staff must be aware of the abuse potential of certain over the counter products and should not supply where there are reasonable grounds for suspecting misuse. Additional information The following information is relevant to this section: Royal Pharmaceutical Society of Great Britain, Code of Ethics and standards (accessed 23/3/07) References 1 Guidance on the content of a signed order is available from the AOP _feb04_v5.pdf 2 Optometrists Formulary Accessed 20/12/04 The College of Optometrists Members Handbook. Pub Jan 08 Revised Jan

5 4 Competency framework for prescribing optometrists, General Optical Council & National Prescribing Centre, May and 5 Guidance on Supervision is contained in section 7 of this Guidance para 24 (b) 11 Part 3, service specification 10. The College of Optometrists Members Handbook. Pub Jan 08 Revised Jan