Correspondence

Circular 019/2015: Misuse of Drugs (Amendment No. 2) (England, Wales and Scotland) Regulations 2015 (S.I. 2015/891)

Published 20 May 2015

Summary

This circular draws attention to the contents of the above Statutory Instrument (SI), S.I. 2015/891 which comes into force at 00:01 on 1 June 2015, save for the delayed provisions set out in paragraphs 21 & 22, 24 & 25 and 28 & 29.

The Misuse of Drugs (Amendment No. 2) (England, Wales and Scotland) Regulations 2015 amends the Misuse of Drugs Regulations 2001 (as amended) (the 2001 Regulations) (S.I. 2001/3998) as follows:

• includes new definitions of “prisons” and “organisation providing ambulance services”, and includes specific provisions relating to prisons in the 2001 Regulations
• amends the definition of a health prescription to include National Health Service (NHS) prescriptions issued by independent and supplementary prescribers
• regularises the emergency supply of phenorbarbital in the absence of a compliant prescription
• introduces limited independent prescribing authorities for registered physiotherapist independent prescribers and registered chiropodist independent prescribers
• provides authority for “organisation providing ambulance services”, similar to that currently applicable to hospitals and care homes, to possess and supply controlled drugs directly to their employees for use in the immediate treatment of sick or injured persons
• extends the authority to supply or offer to supply controlled drugs to senior registered nurses in charge of prison healthcare departments and midwife ward managers and includes them in provisions relating to requisitions and record-keeping
• changes midwife supply orders from a system through which stocks of controlled drugs can be obtained by making them patient specific
• makes the use of a specific form for the requisitioning of Schedule 2 and 3 controlled drugs in the community mandatory
• includes paramedics and operating department practitioners in the list of healthcare professionals requiring a requisition in order to obtain stocks of Schedule 2 and 3 controlled drugs
• exempts hospices and prisons from the requirement to present requisitions when obtaining stocks of controlled drugs
• removes the exemptions applicable to prescriptions for temazepam
• makes it a requirement for veterinary practitioners to include their Royal College of Veterinary Surgeon number on prescriptions for Schedule 2 and 3 controlled drugs
• introduces the use of electronic prescription forms under the NHS Electronic Prescribing Service (EPS) in relation to Schedule 2 and 3 controlled drugs
• moves ketamine from Part 1 of Schedule 4 to the 2001 Regulations to Schedule 2 and provides exemptions for continued use by specified healthcare professionals under Patient Group Directions.

The SI together with explanatory memoranda can be found at http://www.legislation.gov.uk. They are also published by The Stationery Office. Telephone orders/General enquiries 0870 600 5522 or online at http://www.tsoshop.co.uk.

Legislative background

Whilst the Home Office has legislative responsibilities for the Misuse of Drugs Act 1971 and its associated regulations, the policy area is shared with the Department of Health (DH) and this instrument has been drawn up in consultation with them. The amendments to the 2001 Regulations are being implemented to ensure the regulatory framework on controlled medicines, is effective, reflects current policy and complements changes in the health sector.

This SI is made under sections 7, 10 and 31 of the Misuse of Drugs Act 1971 (“the Act”). The Act received Royal Assent on 27 May 1971. Section 31(3) of the Act provides that the Secretary of State may not make regulations under the Act except after consultation with the Advisory Council on the Misuse of Drugs (ACMD). The amendments were drawn up in consultation with the ACMD and a wide range of stakeholders including key professional and regulatory bodies. The changes set out at paragraph 2 above have also been the subject of public consultation.

This SI implements the changes by amending Regulations 2, 6, 7, 8, 9, 11, 14, 15, 16, 19, 21, 24, 26, and Schedules 2, 3 and 4 of the 2001 Regulations. The instrument also inserts a new Regulation 6C.

Policy context

In 2010 the Home Office invited views from key stakeholders, including DH and healthcare regulatory bodies, on changes necessary to ensure the 2001 Regulations remained fit for purpose and kept up with changes in health policy and structures. These views were developed into specific proposals (listed at paragraph 2 above, with the exception of changes relating to independent prescribing authorities for physiotherapists and chiropodists, rescheduling of ketamine and the removal of temazepam exemptions) which were subjected to a public consultation in late 2011. With the exception of a Shipman Inquiry related proposal on the use of a specific form for the requisitioning of Schedule 2 and 3 controlled drugs in the community, the vast majority of respondents supported the proposals to amend specific provisions under the 2001 Regulations as it was felt that these changes were necessary to ensure the regulatory framework continued to be fit for purpose. The original proposal not to introduce a specific form for the requisitioning of Schedule 2 and 3 controlled drugs had to be reconsidered due to the significant concerns raised by respondents who opposed the proposal. A policy decision was subsequently made with the agreement of DH and the regulatory bodies as well as the pharmaceutical wholesale sector to introduce a mandatory form as recommended by the Shipman Inquiry.

The proposal to introduce independent prescribing authorities for physiotherapists and chiropodists and the electronic prescribing of Schedule 2 and 3 controlled drugs were consulted on separately by DH following approval by the Commission on Human Medicines and DH Ministers. These proposals are aimed at increasing flexibility and responsiveness in health and social services, improving safety and health outcomes by improved access to medicines and more timely treatment, improving patient convenience and experience, lowering the risk of patient safety, maximising efficiency savings to prescribers and dispensers, enhancing the audit trail of medicines prescribed electronically under the Electronic Prescription Service (EPS), as well as providing enhanced security over and above what is delivered by ‘wet signatures’ for the most potent drugs. As owners of controlled drug legislation, the Home Office supported and worked with DH in developing the proposals on independent prescribing for physiotherapists and chiropodists and electronic prescribing of Schedule 2 and 3 drugs.

The rescheduling of ketamine followed a review by the ACMD in 2013, prompted by commissioning from the Home Secretary and borne out of increasing public concern around the harms caused by ketamine misuse. The ACMD review identified that the harms from ketamine misuse had developed from when it last reviewed the evidence on misuse and harms and recommended that ketamine should be reclassified as a Class B and a Schedule 2 drug. The Government accepted the ACMD advice and Ketamine was reclassified in June 2014. Proposals to reschedule ketamine in line with the ACMD recommendation to ensure it remained available for use in healthcare, but subject to a framework that reduces the risk of diversion and misuse, were then subjected to a public consultation. These proposals were supported by the majority of respondents.

The prescribing of temazepam has been subject to an exemption under the 2001 Regulations since it was rescheduled to Schedule 3 in 2003. In light of the ACMD recommendation to subject tramadol to control under the 1971 Act as a Class C and Schedule 3 drug, it became necessary to consider removal of the current exemption to ensure all Schedule 3 drugs were treated in the same way under the 2001 Regulations. Additionally, subsequent regulatory changes which enabled prescriptions for Schedule 2 and 3 drugs to be computer generated, and the low number of temazepam prescriptions, compared to when it was rescheduled to Schedule 3 had led to a significant reduction in the burden on healthcare professionals identified at the time of rescheduling. In light of this the argument to maintain the exemptions was significantly weakened. Proposals to remove the exemption were therefore subject to a public consultation alongside proposals for the scheduling of tramadol. The view that the exemption was no longer warranted was confirmed by the consultation responses with the vast majority supporting the removal of the exemptions to bring temazepam in line with all Schedule 3 drugs.

Specific Amendments

Amendments to the definition of “health prescriptions”

“Health prescriptions” defined under the 2001 Regulations as “prescriptions issued by a doctor or a dentist under the National Health Service….” is being amended to include the prescribing activity of other healthcare professionals such as nurses and pharmacists who are currently able to prescribe controlled drugs under the NHS as independent or supplementary prescribers. All prescriptions issued under the NHS by appropriate healthcare professionals now qualify as “health prescriptions” under the 2001 Regulations.

“Organisation providing ambulance services” – definition and authority to possess and supply controlled drugs to healthcare employees

A new definition of an “organisation providing ambulance services” which covers:

(a) an NHS trust or NHS foundation trust established under the National Health Service Act 2006 which has a function of providing ambulance services

(b) an NHS trust established under the National Health Service (Wales) Act 2006 which has a function of providing ambulance services

(c) the Scottish Ambulance Board

is inserted in regulation 2 to identify specific organisations being authorised through further regulatory changes to possess and supply controlled drugs to healthcare professionals in their employment for the immediate treatment of sick and injured patients.

The organisations listed above are now treated in a similar manner to hospitals under the 2001 Regulations. These organisations are authorised, under Regulations 8, 9 and 10 of the 2001 Regulations and through the person in charge, or acting person in charge, of that organisation, to order, stock, supply or offer to supply the drugs listed in Schedules 2 to 5 to paramedics and other healthcare professionals employed by the organisation. As with hospitals, the authority to supply is limited to supplies directly to employees for the purposes of immediate treatment of sick or injured persons, but does not extend to the supply of wholesale stocks to other legal entities, organisations or satellite sites. The authority granted to the person in charge is transferred where there is a pharmacist employed by the organisation, responsible for the dispensing and supply of medicines, to that pharmacist as currently applies to hospitals. The authority granted also requires a requisition for controlled drugs, where furnished by the person in charge or acting person in charge of these organisations, to be signed by a doctor or dentist engaged in or employed by the organisation. The record keeping requirements placed on hospitals under the 2001 Regulations apply equally to organisations providing ambulance services.

The authority granted will ensure that the management and use of controlled drugs in this sector is more robust, provides a good audit trail and reduces the risk of diversion currently associated with ongoing practices introduced in the absence of this authority. The authority granted to organisations providing ambulance services under these changes does not extend to private ambulance services who continue to require a Home Office licence for controlled drugs possessed and supplied to healthcare professionals employed by the service.

Midwife Supply Orders – made patient specific

The midwives supply order (MSO) is being made patient specific, rather than as a means of obtaining stocks of controlled drugs. All MSOs signed by an “appropriate medical officer” (i.e. a doctor or head of midwives), in addition to existing requirements, now need to be issued in the name of an expecting mother or patient. The changes being introduced place MSOs on a similar footing to prescriptions i.e. when dispensed, the controlled drugs become the patient’s property and therefore their responsibility rather than the responsibility of the midwife; thereby removing the risks associated with midwives carrying controlled drug stocks in the community. All other arrangements for obtaining an MSO remain the same. Midwives continue to have authority to possess any unused controlled drugs and to supply them to a person who may lawfully have those drugs in their possession, such as a pharmacist, for destruction.

As a result of the above change, midwives are now able to either supply or administer controlled drugs to expecting mothers or patients. The record keeping requirements in respect of MSOs under regulation 21 are also amended with the effect that the name of an expecting mother or patient for whom controlled drugs are obtained and administered or supplied also needs to be recorded as part of records kept by midwives.

Paramedics and Operating Department Practitioners – Regulation 14 requirements

Paramedics and Operating Department Practitioners (ODPs), currently authorised to possess, administer and offer to supply or supply controlled drugs when acting in that capacity, are being added to the list of healthcare professionals required to present a compliant requisition under regulation 14 when obtaining stocks of the controlled drugs listed in Schedules 2 and 3 of the 2001 Regulations. This change corrects a current anomaly, brings paramedics and ODPs in line with other healthcare professionals such as nurse and pharmacist independent prescribers, and places what has been best practice over the past years on a legislative footing. This will enable the capturing and monitoring of individual requisition activity by paramedics, within the community, and ODPs within the hospital setting when required.

Senior Registered Nurses in charge of prison healthcare centres and Midwife Ward Managers – authorities to possess and supply in ward and health centre settings

A new definition of a prison which includes HM prisons, young offenders’ institutions and remand centres has been inserted in Regulation 2 of the 2001 Regulations in light of changes being introduced in the regulations which impact on specific healthcare professionals and activity within the sector.

Regulations 8(2)(e) and 9(3)(c) of the 2001 Regulations currently provide authority to senior registered nurses in charge of a ward, when acting in that capacity, to supply or offer to supply controlled drugs to patients in the case of a drug supplied to them by a person responsible for dispensing and supply of medicines in a hospital. Under regulation 10, senior registered nurses in charge of wards have authority to possess the relevant controlled drugs. This instrument extends the authorities under regulations 8, 9 and 10 to possess, supply or offer to supply controlled drugs to senior registered nurses in charge of prison health centres or departments in order to provide better governance for the management of controlled drugs in this sector. The extension of this authority does not negate the need for licensing for the activities of private companies and other organisations operating in the secured environment sector who continue to require a Home Office licence for the possession and supply of controlled drug stocks to their employees.

The authorities under regulations 8(2)(e), 9(3)(c) and 10 of the 2001 Regulations are also being extended to registered midwife ward managers when acting in that capacity in a hospital setting. Midwife ward managers are now able to possess, supply or offer to supply controlled drugs obtained within the hospital environment for the treatment of patients within a ward. The authorities being granted will correct an existing anomaly and ensure registered midwife ward managers have the same authority and responsibility in relation to controlled drugs supplied to them for patients in a maternity ward as applies to senior registered nurses in charge of a hospital ward.

Inclusion of Royal College of Veterinary Surgeon number on Schedule 2 and 3 Prescriptions

The key Shipman Inquiry recommendation for private prescriptions for Schedule 2 and 3 controlled drugs in the community to include the prescriber’s unique identification number was implemented for human healthcare by Regulation 15(1)(ab) of the 2001 Regulations which came into force on 1 January 2007. Veterinary prescriptions are private prescriptions. However, veterinary practitioners have until now not been required to include a unique identification code when prescribing Schedule 2 and 3 controlled drugs.

This instrument makes it a requirement for all veterinary prescriptions for Schedule 2 and 3 controlled drugs issued from 1 July 2015 to include the unique Royal College of Veterinary Surgeons registration number. This change brings the veterinary sector in line with the private human healthcare sector, improving the ability to collate data on individual prescribing activity for the veterinary sector for monitoring when required.

Hospices and Prisons – exemption from Regulation 14 requisition requirement

This instrument exempts care homes which, as their whole or main purpose, provide palliative care (i.e. hospices) and prisons from the requisition requirements under regulation 14 of the 2001 Regulations. These organisations are now able to obtain stocks of Schedule 2 and 3 controlled drugs using other means such as duplicate books or through contracts set up for the supply of these drugs without the need to present a compliant requisition each time they request the supply of controlled drug stocks. These changes are being made to ensure requisition data provided to the NHS Business Services Agency and subsequent analysis are more robust and reflect the original policy intent of capturing requisition activity by individual practitioners in the community.

Introduction of mandatory requisition forms for Schedule 2 and 3 drugs

Under current provisions a wholesale supplier of the controlled drugs listed in Schedules 2 and 3 is required to obtain specific information (a requisition) from a requisitioner before supplying the drugs. From 30 November 2015, this instrument introduces a further requirement – a mandatory form – issued by the Secretary of State in England, and Scottish and Welsh Ministers for Scotland and Wales, which must be used for the purposes of requisitioning Schedule 2 and 3 controlled drugs in the community. The mandatory form incorporates the information currently required under regulation 14(2). The requirement to use the mandatory form applies to the professionals listed at regulation 14(4), which now includes paramedics and the person in charge or acting person in charge of an organisation providing ambulance services (as defined), and only when stocks of the relevant controlled drugs are to be obtained in the community, including from wholesalers but outside settings such as hospitals. Registered nurses, operating department practitioners and other healthcare professionals working within a hospital setting will continue to comply with the current requirement under regulation 14(6) to provide a signed requisition specifying the quantity of a drug to be supplied, but are not required to use the mandatory form for drugs obtained specifically for use within wards etc, or to provide the full information specified at regulation 14(2).

The introduction of a mandatory requisition form is the final remaining Shipman Inquiry recommendation aimed at ensuring the purchase of all stocks of Schedule 2 and 3 controlled drugs by healthcare professionals within the community is capable of being monitored.

Physiotherapists and Chiropodists – independent prescribing authorities

This instrument introduces limited independent prescribing authorities for physiotherapists and chiropodists by inserting a new regulation 6C which authorises registered and qualified physiotherapist independent prescribers to independently prescribe temazepam (oral), lorazepam (oral), diazepam (oral), dihydrocodeine (oral), morphine (oral and injectable), fentanyl (transdermal) and oxycodone (oral). The instrument also authorises registered and qualified chiropodist independent prescribers to independently prescribe temazepam (oral), lorazepam (oral), diazepam (oral), and dihydrocodeine (oral). Both professions are authorised to administer the specific drugs they are authorised to prescribe, but are not authorised to possess, stock or supply these drugs. Both professions are also authorised to prescribe independently on the conditions that they prescribe the relevant drugs within their competence, by the specified routes and only for the treatment of organic disease in patients, but not for the purposes of treating addiction.

Emergency supply of medicines containing phenobarbital or phenobarbital sodium

This instrument amends regulation 6 the 2001 Regulations to introduce emergency provisions complementing existing provisions under the Human Medicines Regulations 2012 (HMR 2012). The HMR 2012 provisions enable the emergency supply of medicines containing phenobarbital or phenobarbital sodium, in the absence of a prescription, for the emergency treatment of epilepsy. This free standing provision is considered to be at odds with the spirit of the 2001 regulations as it relates to the supply of a potent Schedule 3 drug in the absence of a prescription. The change being made regularises the emergency supply of medicines containing phenobarbital or phenobarbital sodium for the emergency treatment of epilepsy in accordance with Regulations 224 and 225 of the HMR 2012 under the 2001 Regulations.

Rescheduling of ketamine and Patient Group Directions

This instrument reschedules ketamine from Part I of Schedule 4 to Schedule 2 to the 2001 regulations from 30 November 2015 with the effect that all the requirements applicable to Schedule 2 drugs, including record keeping, witnessing of destruction and prescribing etc, will apply to the use of ketamine in research, industry and veterinary and healthcare sectors from this date.

There is no impact on the use of ketamine under Patient Group Directions (PGD) as a result of this change. Registered nurses and the healthcare professionals specified in Schedule 8 to the 2001 Regulations, when acting in that capacity, continue to be authorised to use ketamine in accordance with the terms of a PGD under amendments to Regulation 8(b) of the 2001 Regulations.

Introduction of electronic prescribing of Schedules 2 and 3 controlled drugs

This instrument introduces the electronic prescribing of Schedule 2 and 3 controlled drugs under the National Health Service Electronic Prescribing Service (EPS) structure with its incorporated layers of security, including the use of an Advanced Electronic Signature. The authority being granted applies to England, Wales and Scotland and restricts the electronic prescribing of these drugs to EPS only. Private prescribing of Schedule 2 and 3 drugs are also enabled under these provisions but are also restricted to when such prescribing takes place under EPS. The provisions introducing electronic prescribing of Schedule 2 and 3 drugs are enabling and not mandatory. Prescribing of these drugs under EPS will run alongside paper prescribing to provide flexibility and ensure prescribers are able to prescribe in settings where access to an electronic system is limited, such as in the community.

The DH as lead department for this policy will progress the necessary structural changes required to implement this policy, including in respect of private prescribing of these drugs under EPS in England.

Removal of temazepam prescribing exemptions

The instrument removes the current exemptions applicable to prescriptions for temazepam with the effect that all the requirements applicable to Schedule 3 drugs, when prescribed in healthcare and veterinary sectors, now also apply to temazepam. With the extension of EPS to Schedule 2 and 3 drugs (paragraphs 30 and 31 above) any impact from the removal of this exemption is minimised.

Application to England, Wales and Scotland

The changes to the Misuse of Drugs Regulations 2001 described in this circular apply to England, Wales and Scotland. Northern Ireland will amend its own Misuse of Drugs Regulations separately. The contact there is;

Seamus Camplisson
Health Protection Branch
Department of Health, Social Services and Public Health
22 Castle Buildings,
Stormont
Belfast BT4 3SQ

Seamus.Camplisson@dhsspsni.gov.uk

Enquiries

Any enquiries about the contents of this circular should be directed to;

Des Niimoi
Drugs and Alcohol Unit
Home Office
5th Floor Fry Building NE
2 Marsham Street
London
SW1P 4DF

Yours faithfully,

Des Niimoi
Drugs and Alcohol Unit
Home Office