VETERINARY PHARMACY Elizabeth Shipley

Content Background legislative documents and bodies The Cascade Withdrawal periods Legal categories RQPs Controlled Drugs Prescriptions/Labels Record keeping Adverse reactions Veterinary Pharmacy bodies/courses

The Veterinary Medicines Regulations Until October 2005 Veterinary Medicines regulated under the Medicines Act New legislation came into force on 30th October 2005 called The Veterinary Medicines regulations Replaces all pre-existing legislation including the Medicines Act 1968 (except controlled drug legislation) Aim to have all legislation covered under one document Reviewed on an annual basis (October each year)

Administration Manufacture Record keeping Marketing Disposal Veterinary Medicines Regulations 2009 Controls all aspects pertaining to veterinary medicinal products including…. Administration Record keeping Disposal Importation Prescriptions Manufacture Marketing Advertising Classification Supply and possession

Veterinary Medicines Directorate (VMD) Executive agency of DEFRA (Department for Environment, Food and Rural Affairs) Operate the licensing system for animal medicines Safe guard public health, animal health and the environment Ensure the safety, quality and efficacy of medicines within the UK Veterinary Products Committee Committee of experts advising the VMD on new and renewal of marketing authorisations SARSS Suspected Adverse Reaction Surveillance Scheme MAVIS Medicines Act Veterinary Information Service Veterinary Residues Committee Committee of experts advising the VMD and Food Standards Agency on residue surveillance programmes etc

Overview of control VMD (agency of DEFRA) RCVS BVA Interpretation Legislation Interpretation and the provision of guides Additional guidelines, filling in the gaps RPSGB/GPhC Guidelines for Pharmacists

Cascade for selecting drugs – Non food animal If there is no medicine authorised in the UK for a condition affecting a non food-producing species, the veterinary surgeon responsible for treating the animal(s) may, in particular to avoid unacceptable suffering, treat the animal(s) in accordance with the following sequence: (a) a veterinary medicine authorised in the UK for use in another animal species or for a different condition in the same species; or, if there is no such product: (b) either: (i) a medicine authorised in the UK for human use; or (ii) in accordance with an import certificate, a medicine authorised for veterinary use in another Member State; or, if there is no such product: (c) a medicine prepared extemporaneously, by a veterinary surgeon, a pharmacist or a person holding an appropriate manufacturer’s authorisation, as prescribed by the veterinary surgeon responsible for treating the animal.

Cascade for food producing species If there is no medicine authorised in the UK for a condition affecting a food producing species, the veterinary surgeon responsible for treating the animal(s) may use the cascade as for non-food animals except that: the treatment in any particular case is restricted to animals on a single holding; any medicine imported from another Member State (option b(ii)) must be authorised for use in a food-producing species in the other Member State; the pharmacologically active substances contained in the medicine must be listed in Annex I, II or III to Regulation (EEC) No. 2377/90; the veterinary surgeon responsible for prescribing the medicine must specify an appropriate withdrawal period; the veterinary surgeon responsible for prescribing the medicine must keep specified records. Annex I MRLs have been established Annex II no MRL required Annex III provisional MRLs have been set

If withdrawal period not specified Withdrawal Periods Withdrawal periods are set for food-producing animals to protect consumers. Time before which meat or animal products from that animal may not be used in the food chain If withdrawal period not specified Not less than 7 days for eggs and milk Not less than 28 days for meat Not less than 500 degree days for meat from fish

Veterinary Medicines – Legal categories All Veterinary Medicinal Products require a product licence Legally classified into four different categories Prescription Only Medicine – Veterinarian (POM-V) Prescription Only Medicine – Veterinarian, Pharmacist, SQP (POM-VPS) Non-Food Animal – Veterinarian, Pharmacist, SQP (NFA – VPS) Authorised Veterinary Medicine – General Sales List (AVM-GSL)

“Animals under his/her care” For prescribing POM-V medicines RCVS definition: Vet has responsibility for the animal(s) Real and not nominal Seen at prescribing or recently or often enough Vet must keep the clinical records of this animal or group of animals

What is a RQP? POM-VPS and NFA-VPS products can be prescribed by a RQP which may be a Vet Registered pharmacist SQP – In some cases this may be a veterinary nurse May be an animal feed merchant Trained by Animal Medication Training Regulatory Authority (AMTRA) Registered with the VMD for some or all classes of POM-VPS and NFA-VPS

Controlled Drugs Veterinary controlled drugs legislated under the Misuse of Drugs Regulations Legal requirements the same as for human drugs except no requirement for private prescriptions to be on a standardised form

Written prescriptions- legal requirements the name, address and telephone number of the person prescribing the product; the qualifications enabling the person to prescribe the product. It is good practice to cite MRCVS or the SQP registration number. This is a legal requirement when prescribing controlled drugs; the name and address of the owner or keeper; identity (including the species) of the animal or group of animals; the premises at which the animals are kept if this is different from the address of the owner or keeper; the date of the prescription; the signature or other authentication of the person prescribing the product; the name and amount of the product prescribed; the dosage and administration instructions; any necessary warnings; the withdrawal period, if relevant; if it is prescribed under the cascade, a statement to that effect. Extra requirements for CDs the same as for human prescriptions

Labelling the name and address of the pharmacy, veterinary surgery or approved premises supplying the veterinary medicinal product; the name of the veterinary surgeon who has prescribed the product; the name and address of the animal owner; the identification (including the species) of the animal or group of animals; the date of supply; the expiry date of the product, if applicable; the name or description of the product, which should include at least the name and quantity of active ingredients; dosage and administration instructions; any special storage precautions; any necessary warnings for the user, target species, administration or disposal of the product; the withdrawal period, if relevant; and the words “Keep out of reach of children” and “For animal treatment only”

Record Keeping Records must be kept for receipts and supplies of POM-V and POM-VPS products. In addition to the record you would make when supplying against a private prescription for a human you must record the Batch number (if for a non-food-producing animal, you only need to make a record of this either on the date you received it from your supplier or the date when you first supplied the product). The pharmacist can either keep all documents that show all the required information or make a record in their private prescription book. Records can be kept electronically. Records and documents must be kept for at least 5 years. Pharmacies which stock veterinary medicines must undertake an annual stock audit of their veterinary medicines.

Adverse reactions Should be reported to the Veterinary Medicines Directorate (VMD) under the Suspected Adverse Reaction Surveillance Scheme (SARSS) Also report adverse effects on humans administering the product and reactions to human products prescribed under the cascade Use yellow card from back of NOAH compendium (form MLA 252A) or on VMD website VPC advises on problems identified by VMD

Veterinary Pharmacy Courses The Veterinary Pharmacy Education Programme, in conjunction with Harper Adams College run a number of courses Professional Certificate in Companion Animal & Equine Health Care Professional Certificate in Large Animal Health Care HAUC University College Diploma in Veterinary Pharmacy (UCDip) HAUC Postgraduate Diploma in Veterinary Pharmacy (PgD) HAUC Masters in Veterinary Pharmacy (MSc)

The Veterinary Pharmacists Group Scope: “The Veterinary Pharmacists Group is open to all pharmacists interested or involved in the supply of veterinary medicines to pet owners and the keepers of livestock.   The group promotes the practice of veterinary pharmacy and plans to hold an annual conference and convene periodic webinars.”   Aims and objectives: “to advise and represent the Society on professional interests of pharmacists involved in the supply of veterinary medicines, to act as a source of information and education (including CPD) to represent the profession with external stakeholders including VMD, BVA, RCVS, NOAH, AMTRA, AHDA, RUMA, PHC and others”

Publications Pharmacists can apply to get the Vet Times and Veterinary Record Other reference sources: Veterinary Pharmacy (Pharmaceutical Press) BSAVA Small Animal Formulary (BSAVA) Veterinary Formulary (Pharmaceutical Press)

Useful Websites http://www.rpharms.com/law-and-ethics/veterinary-medicines.asp http://www.harper-adams.ac.uk/press/article.cfm?ID=3060&archive=true&year=2010 http://www.vpep.net http://www.bsava.com http://www.rcvs.org.uk http://www.beva.org.uk/home www.vmd.gov.uk