The Misuse of Drugs (Amendment) (No. 2) (England, Wales and Scotland) Regulations 2015

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Misuse of Drugs Regulations 2001 (the “2001 Regulations”) by including within the definition of “health prescription” contained in regulation 2(1) of the 2001 Regulations a nurse independent prescriber, a pharmacist independent prescriber and a supplementary prescriber as persons who may issue such a prescription. They also insert a definition of an “organisation providing ambulance services” and a “prison.”

Regulations 6 and 7 of the 2001 Regulations are amended to give limited prescribing powers for certain controlled drugs to registered physiotherapists and registered chiropodists. Regulation 6 is also amended to allow the emergency supply (or offer to supply) of phenobarbital or phenobarbital sodium by a person lawfully conducting a retail business, subject to certain conditions.

Regulation 8 of the 2001 Regulations is amended by including within paragraph (2), in relation to the supply or offer to supply any drug specified in Schedule 2 or 5 to the 2001 Regulations, a person who is in charge, or is acting person in charge, of an organisation providing ambulance services, and by substituting a new paragraph (2)(e) which includes reference to the supply of such a drug in a prison and to a senior registered midwife or acting senior registered midwife. Regulation 8(b) is also amended to exempt ketamine from the restrictions on supplying or offering to supply controlled drugs, where this is done by specified healthcare professionals in accordance with the terms of a Patient Group Direction, except where the drug is administered for the purposes of treating addiction.

Regulation 9 of the 2001 Regulations is amended by including in paragraph (3), in relation to the supply or offer to supply any drug specified in Schedules 3 and 4 to the 2001 Regulations, a person who is in charge, or is acting person in charge, of an organisation providing ambulance services.

The definition of “midwife’s supply order” contained in regulation 11(3) of the 2001 Regulations is amended by including the name of the person to whom the relevant drug is administered or supplied within such an order, and the record‑keeping requirements contained in regulation 21(3) of the 2001 Regulations are amended to require record-keeping by a midwife when the relevant drugs are supplied to a person as well as when administered.

Regulation 14 of the 2001 Regulations is amended by specifying that the form of requisition to be obtained by a supplier of controlled drugs is to be in the form approved by the Secretary of State, the Welsh Ministers or the Scottish Ministers. A person who is in charge, or is acting person in charge, of an organisation providing ambulance services, an operating department practitioner and a person who holds a certificate of proficiency in ambulance paramedic skills are added to the list of recipients in regulation 14(4) of the 2001 Regulations. The requisition required under regulation 14(5)(b) is updated to refer to the Public Health etc. (Scotland) Act 2008 (asp 5) and the requisition required under regulation 14(6) applying when a controlled drug is supplied, in any hospital, care home, to an operating department practitioner, senior registered nurse or acting senior registered nurse, is widened to include a senior registered midwife or acting senior registered midwife and to include prisons. New paragraph (7)(d) is inserted into regulation 14 providing that nothing in that regulation shall have effect in relation to any drug which is required for use in a prison or care home, which as its whole or main purpose provides palliative care, subject to the provisions of paragraph (6).

Regulations 15 and 16 of the 2001 Regulations are amended by removing references to temazepam, so that it is no longer exempt from the requirements relating to the form of prescriptions. Also, in relation to regulation 15, paragraphs 1(1) and 1(aa) are amended to enable the electronic prescribing of Schedule 2 and 3 drugs. Paragraph 1(d) is amended to require prescriptions issued by a veterinary surgeon or veterinary practitioner to include the registration number of the person issuing it.

Regulation 19(3) of the 2001 Regulations, in respect of those persons to whom the record-keeping requirements set out in that regulation do not have effect, is amended to include a senior registered nurse or acting senior registered nurse, and a senior registered midwife or acting senior registered midwife. Regulation 21 is amended to include record keeping in respect of administration or supply.

Regulations 24 and 26 of the 2001 Regulations, in relation to the preservation of records relating to drugs in Schedules 3 and 5 and the furnishing of information with respect to controlled drugs respectively, are amended to refer to a person who is in charge, or is acting person in charge, of an organisation providing ambulance services.

Ketamine is moved from Part 1 of Schedule 4 to Schedule 2 to the 2001 Regulations. The heading of Schedule 3 is amended to remove the reference to temazepam being exempt from the requirements of regulation 15 of the 2001 Regulations. The schedule of the Regulations in which a controlled drug is placed affects the extent to which the drug can be lawfully imported, exported, produced, supplied or possessed. The controlled drugs placed in Schedule 1 to the Regulations are those subject to the tightest controls.

The requirement to use a mandatory form for the requisitioning of Schedules 2 and 3 controlled drugs shall not apply to requisitions issued before the coming into force of these Regulations.

The requirement to include a Royal College of Veterinary Surgeons registration number on a veterinary prescription for Schedules 2 and 3 controlled drugs shall not apply to veterinary prescriptions issued prior to 1st July 2015.

Full impact assessments of the effect that this instrument will have on the costs of business and the voluntary sector are available and published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.