CONTROLLED

DRUGS

VETERINARY MEDICINES GUIDANCE NOTE

No 20

Last updated June 2014

www.gov.uk

VMGN No 20

2

QUICK START GUIDE This Veterinary Medicines Guidance Note (VMGN) is aimed primarily at veterinary surgeons and pharmacists and is intended to provide guidance on the prescribing and supply of controlled drugs (CDs) and the additional requirements which must be met under misuse of drugs legislation. The quick start guide is a summary of the provisions of the misuse of drugs legislation, detailed information is found in the body of the VMGN. The Home Office has overall responsibility for CDs and associated legislation which relates to both veterinary and human medicines. In Northern Ireland this responsibility (excluding imports and exports) falls to the Department of Health, Social Services and Public Safety (DHSSPS). All CDs are listed in one of five Schedules contained in the Misuse of Drugs Regulations (MDR) 2001 and the Misuse of Drugs Regulations (Northern Ireland) (MDR(NI)) 2002. The substances are scheduled according to their therapeutic usefulness and need for legitimate access, as well as potential for misuse and the harms caused by that misuse, to both the individual and society. Schedule 1 CDs are subject to the greatest restrictions and Schedule 5 the least. All veterinary medicines, regardless of whether they contain a CD, must meet the requirements laid out in the Veterinary Medicines Regulations (VMR). The requirements contained in the misuse of drugs legislation are in addition to those in the VMR for medicines that contain a CD. The following is a summary of the main additional legislative requirements: Prescriptions – There are special requirements for prescriptions for any CDs listed in Schedule 2 or 3 (excluding temazepam). It is also an offence to supply any Schedule 2 or 3 drug against a faxed or e-mailed prescription. Validity of a prescription – A written prescription for a CD in Schedule 2, 3 and 4 is valid for 28 days only. Supply of a CD – If you are supplying a Schedule 2 or 3 CD against the prescription from another veterinary surgeon you must first ascertain that the address specified in the prescription as the prescriber’s address is an address within the UK. You must also be satisfied that the signature in the prescription is genuine. Record keeping – a Controlled Drugs Register (CDR) should be kept for Schedule 2 CDs. There are very specific legislative requirements for the format of a CDR which are detailed in the body of the VMGN. Storage requirements – Schedule 2 and certain Schedule 3 CDs (those containing Buprenorphine, Diethylpropion, Flunitrazepam and Temazepam) must be securely stored in a locked receptacle to which only authorised persons may have access. Destruction and disposal of CDs – Schedule 2 CDs may only be destroyed in the presence of authorised persons. These drugs must be rendered irretrievable before disposal, for example, by using a commercially available denaturing kit. Alternatively

VMGN No 20

3

injectable solution may be placed into sawdust, or cat litter and tablets may be crushed and mixed with soapy water. Please see body of the VMGN for further information. There are also a number of good practice requirements which are detailed in the body of the VMGN. FURTHER INFORMATION For more information on the requirements of CDs please contact the VMD’s

Legislation team on 01932 338312 or alternatively contact VMD reception on 01932 336911 and quote “controlled drugs”.

VMGN No 20

4

TABLE OF CONTENTS Contents Paragraph Page Introduction and Summary 1 5 Controlled drugs schedules 5 5 Prescriptions 7 6 Instalment prescriptions 16 7 Supply of a Controlled Drug 18 8 Errors on a prescription 22 8 Wholesale supply 23 8 Collection of a Controlled Drug 27 9 Supply against a prescription via the internet 28 9 Record Keeping Requirements 30 10 Requirements for Product Literature and SPC 36 11 Storage Requirements 37 11 Veterinarian’s bag 43 12 Returning/Destruction/Disposal Requirements Return of medicines that are used or part-used 45 12 Disposal of waste product 49 13 Destruction 51 13 Controlled Drug Liaison Officer (CDLO) or a Single Point of Contact (SPOC) for Controlled Drugs 58 15 Import and Export 60 15 Restriction on the export of Controlled Drugs to specific destination countries 62 15 Further Information 69 16 List of Abbreviations 17

VMGN No 20

5

Introduction and Summary 1. This is one of a series of Veterinary Medicines Guidance Notes (VMGNs) explaining

the requirements under the Veterinary Medicines Regulations (VMR). The VMR are revoked and replaced on a regular basis, so the references to them should be read as referring to the ones that are currently in force. Therefore, the date and number of the Statutory Instrument are not shown in this VMGN. The VMGN will be updated as necessary and the date of the most recent update is shown on the front cover.

2. The VMR set out the UK controls on veterinary medicines, including their manufacture, advertising, marketing, supply and administration. VMGN 1 Controls of Veterinary Medicines, which is published on the Veterinary Medicines Directorate’s (VMD) website: http://www.vmd.defra.gov.uk/public/vmr_vmgn.aspx gives basic information about the scope of the VMR and the requirements for Marketing Authorisations (MAs). This note details the requirements for veterinary surgeons regarding the storage, supply and administration of controlled drugs (CDs).

3. The Home Office has overall responsibility for CDs and associated legislation which

relates to both veterinary and human medicines. In Northern Ireland this responsibility (excluding imports and exports) falls to the Department of Health, Social Services and Public Safety (DHSSPS). The purpose of this VMGN is to provide guidance on requirements that specifically relate to veterinary medicines.

4. All veterinary medicines, regardless of whether they contain a CD, must meet the

requirements laid out in the VMR. The misuse of drugs legislation requirements are in addition to those in the VMR for medicines that contain a CD.

Controlled drugs schedules 5. All CDs are listed in one of five Schedules in the Misuse of Drugs Regulations

2001(MDR) and the Misuse of Drugs Regulations (Northern Ireland) (MDR(NI)) 2002. A list of commonly encountered CDs can be found on the GOV.UK website (https://www.gov.uk/government/publications/controlled-drugs-list) and requests to establish the control status of other drugs can be sent to Home Office licensing enquiries at licensing_enquiry.aadu@homeoffice.gsi.gov.uk. A list of all current veterinary medicines that are CDs is also available on our website (www.vmd.defra.gov.uk).

6. The substances are scheduled according to their therapeutic usefulness and need for

legitimate access, as well as potential for misuse and the harms caused by that misuse, to both the individual and society. Schedule 1 CDs are subject to the greatest restrictions and Schedule 5 the least. Drugs within:

Schedule 1 have little or no therapeutic value and have a high potential for misuse; they are the most strictly controlled and can only be lawfully dealt with under a Home Office licence or a DHSSPS licence if in Northern Ireland. They are not used in veterinary medicines.

Schedule 2 have therapeutic value but are highly addictive. Their use is strictly controlled, including special prescription, storage, destruction and record keeping requirements.

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the human sector for dispensing methadone but may be used by veterinary surgeons.

Supply of a Controlled Drug 18. A veterinary surgeon may supply a CD that he/she has prescribed. Alternatively

another veterinary surgeon, or a pharmacist, may also supply a CD against a written prescription from a veterinarian.

19. A veterinary surgeon or pharmacist supplying a CD specified in Schedule 2 or 3 must

ascertain that the address specified in the prescription is the address of the person issuing it and is an address within the UK. The person supplying the CD must also be satisfied that the signature in the prescription is genuine, for example, by contacting the prescribing veterinary surgeon.

20. A veterinary surgeon or pharmacist supplying a CD specified in Schedule 2 or 3,

must, at the time of the supply, mark on the prescription the date on which the drug is supplied and retain the prescription on the premises from which the drug was supplied for at least 5 years.

21. Veterinary nurses are not permitted to possess or supply Schedule 2 CDs under the

misuse of drugs legislation unless under the supervision of a veterinary surgeon. Errors on a prescription 22. No person may alter a written prescription unless authorised to do so by the person

who signed it. A pharmacist supplying a CD may accept a prescription if it contains minor typographical errors or spelling mistakes provided that:

he/she is satisfied on reasonable grounds that he/she is supplying the drug in accordance with the intention of the person issuing the prescription;

he/she amends the prescription in ink or otherwise indelibly to correct the minor typographical errors or spelling mistakes or so that the prescription complies with the requirements to contain the total quantity of the preparation or the number of dosage units in either words or figures but not both (i.e. they may add the words or the figures to the prescription if they have been omitted); and

he/she marks the prescription so that the amendment he/she has made is attributable to him/her.

Wholesale supply 23. A wholesaler must be in possession of the original signed (hand-written in ink)

requisition form for a CD specified in Schedule 2 or 3 before supply is made. This is necessary so that the supplier can satisfy themselves, as required under the misuse of drugs legislation, of the genuineness of the signature and the profession/occupation of the person requisitioning the CD.

24. A faxed or emailed requisition is permissible but only as an instruction to the

wholesaler to prepare the CD for delivery and on the condition that the original will be provided to the wholesaler prior to physical delivery at the practice. Where faxed or emailed requisition orders are used, a signed requisition form must be handed over to the delivery driver prior to the CDs being delivered.

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VMGN No 20

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Record Keeping Requirements 30. Any person who purchases or supplies any product containing a CD specified in

Schedule 2 must maintain a Controlled Drugs Register (CDR). This is in addition to the existing record keeping requirements detailed in VMGN 14 Record Keeping Requirements for Veterinary Medicinal Products, which is published on the VMD’s website: http://www.vmd.defra.gov.uk/public/vmr_vmgn.aspx

The Register must:

• be either: a computerised system, or a bound book - which does not include any form of loose leaf register or card index;

• be separated into each class of drug;

• have a separate page for each strength and form of that drug at the head of each page;

• have the entries in chronological order and made on the day of the transaction or, if not reasonably practical, the next day;

• have the entries made in ink or in a computerised form in which every entry is capable of being audited;

• not have cancellations, obliterations or alterations. Corrections must be made by a signed and dated entry in the margin or at the bottom of the page;

• be kept at the premises to which it relates and be available for inspection at any time. A separate register must be kept for each set of premises;

• not be used for any other purpose;

• be kept for a minimum of two years after the date of the last entry. 31. The misuse of drugs legislation allows for the physical task of completing the CDR to

be delegated by the prescribing veterinary surgeon. However the responsibility for the supply remains the responsibility of the prescribing veterinary surgeon.

32. The MDR 2001 and the MDR(NI) 2002 do not specify the format in which the Register

must be kept, however they do specify that the following headings must appear for all CDs purchased and supplied. Additional, but relevant, information may also be included in the Register such as running balances and the veterinary surgeon’s name and RCVS number, which are a matter of good practice to keep.

33. For each CD purchased the following details must be recorded in the Register:

• Date supply received • Name and address from whom received (e.g. wholesaler, pharmacy) • Quantity received

34. For each CD supplied (including by way of administration) the following details must

be recorded in the Register:

• Date supplied • Name/address of person or firm supplied

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VMGN No 20

15

Controlled Drug Liaison Officer (CDLO) or a Single Point of Contact (SPOC) for CDs 58. Most Police forces throughout the UK have a dedicated CDLO or SPOC who is

available to liaise with any veterinary practice within their area. A CDLO or SPOC is able to offer advice on safe storage; auditing; destruction; suspicious activity; internal thefts; forged or stolen prescriptions; as well as ‘current crime trends’ and ‘demands on the streets’; etc. A CDLO is also authorised under the MDR (if a Constable), or authorised by the Primary Care Trust (PCT) Accountable Officer (if employed by the Police service as a civilian) to witness the disposal of CDs.

59. A list of CDLOs and SPOCs is available on the VMD website http://www.vmd.defra.gov.uk/mswd/controlled-drug.aspx Import and Export 60. The import and export of CD raw materials and finished preparations within

Schedules 2, 3 and 4 Part I of The MDR 2001 are subject to an import/export licensing regime which is operated by the Home Office Drugs Licensing and Compliance Unit.

61. Those Schedule 4 Part II drugs in a medicinal form for personal use (i.e. already

dispensed for a named animal or animals) will not need a personal import or export licence to enter or leave the United Kingdom, as are all of the preparations within Schedule 5. However, recent changes in the regulations enabling importation and exportation for personal use now require Schedule 4 Part II drugs to be carried on the patient (or pet owner), or in their luggage, through UK ports. Importation or exportation using postal or courier services is not permitted.

Restriction on the export of Controlled Drugs to specific destination countries 62. Exporters should be aware that on 20 December 2011 the European Union adopted a new EU-wide control on the export of certain drugs. 63. As a result of these EU imposed controls, exporters need to seek appropriate

permission to export to any destination outside the EU ‘short and intermediate acting barbiturate anaesthetic agents including, but not limited to’ the following Controlled Drugs:

Amobarbital (CAS RN 57-43-2) Amobarbital sodium salt (CAS RN 64-43-7) Pentobarbital (CAS RN 76-74-4) Pentobarbital sodium salt (CAS 57-33-0) Secobarbital (CAS RN 76-73-3) Secobarbital sodium salt (CAS RN 309-43-3)

64. The control also applies to products containing one or more of the above. These controls are intended to apply to finished products - in other words, those that are packaged for human or veterinary use. It is not intended that they should apply to raw materials or to intermediate products (i.e. products that require further processing to make them suitable for human or veterinary use.

VMGN No 20

16

65. For further information, exporters are required to consultation against the UK Strategic Export Control Lists when exporting these drugs to specific countries. 66. For further guidance and information on licensing requirements use the link: https://www.gov.uk/controlled-drugs-licences-fees-and-returns 67. For guidance on taking a veterinary medicinal product containing a CD prescribed to

and accompanied by the nominated animal into or out of the UK use the link: https://www.gov.uk/controlled-drugs-licences-fees-and-returns#import-and-export-licences

68. For guidance on importing or exporting a stock of CDs into or out of the UK, use the link: https://www.gov.uk/controlled-drugs-licences-fees-and-returns#import-and-export-licences

Further Information 69. For more information on the requirements for veterinary medicines containing CDs

please contact the VMD’s Legislation team on 01932 338312 or alternatively contact VMD reception on 01932 336911 and ask for information on “controlled drugs”.

VMGN No 20

17

List of Abbreviations

CD CDLO CDR DHSSPS MA MDR MDR (NI) RCVS SPOC VMD

Controlled Drug Controlled Drugs Liaison Officer Controlled Drugs Register Department of Health, Social Services and Public Safety Marketing Authorisation Misuse of Drugs Regulations 2001 Misuse of Drugs Regulations 2002 Royal College of Veterinary Surgeons Single Point of Contact for Controlled Drugs Veterinary Medicines Directorate

VMGN Veterinary Medicines Guidance Note VMP Veterinary Medicinal Product VMR Veterinary Medicines Regulations

VETERINARY MEDICINES GUIDANCE NOTE Veterinary Medicines Directorate

Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS Telephone (+44) (01932) 336911 Fax: (+44) (01932) 336618

Search for VMD on www.gov.uk