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These Regulations amend the Misuse of Drugs (Safe Custody) Regulations 1973 (S.I. 1973/798) (“the 1973 Regulations”) and the Misuse of Drugs Regulations 2001 (S.I. 2001/3998) (“the 2001 Regulations”), and make consequential amendments to the Misuse of Drugs (Amendment No. 2) Regulations 2006 (S.I. 2006/1450) and the Misuse of Drugs (Amendment No. 3) Regulations 2006 (S.I. 2006/2178).
Regulation 3(1) to (3) amends the 1973 Regulations to update the references to various premises covered by these Regulations. Regulation 4(2)(b) and (3) update references in the 2001 Regulations to ‘nursing home’ to ‘care home’. Regulation 4(4) updates references in the 2001 Regulations to ‘sister’ to ‘senior registered nurse’. Regulation 4(1)(c) to (h) and 4(16) update definitions of various healthcare practitioners.
Regulation 4(5) to (7) amend regulations 8, 9 and 10 of the 2001 Regulations to allow operating department practitioners to possess and supply or offer to supply any controlled drug specified in Schedules 2, 3 or 5 or any drug specified in Schedule 4 which is contained in a medicinal product, for the purposes of administration to a patient in a ward, theatre or other department, in accordance with the directions of a doctor, dentist, supplementary prescriber acting under a clinical management plan or (to the extent she is authorised to prescribe) a nurse independent prescriber. Regulation 4(5)(c) and 4(6)(b) extend the authority of a senior registered nurse or acting senior registered nurse to supply the same categories of drugs.
Regulation 4(8) amends regulation 14 of the 2001 Regulations so that a person (other than a wholesale dealer or a person responsible for dispensing and supply of medicines at a hospital or care home) who supplies a controlled drug for human use on a requisition must add to that requisition his name and address and send it to the relevant National Health Service agency.
Regulation 4(9) and (15) amend regulation 19 of and omit Schedule 6 to the 2001 Regulations so that the prescribed form of the controlled drugs register is replaced with prescribed headings to be used in that register. Regulation 4(10) amends regulation 20 to impose a requirement that a separate page in the register be used for each strength and form of the drug and that the class of drug, its strength and form be specified at the head of each such page.
Regulation 4(11) amends regulation 23 of the 2001 Regulations so that requisitions no longer need to be preserved for a period of 2 years and that original prescriptions mentioned in regulation 23(4) are to be sent to the relevant National Health Service agency.
Regulation 4(12) amends regulation 27 of the 2001 Regulations to allow accountable officers to authorise people to witness the destruction of controlled drugs.
Regulation 4(13) and (14) reclassify Midazolam from Part I of Schedule 4 to Schedule 3 to the 2001 Regulations. Regulation 4(6)(e) amends regulation 9 of the 2001 Regulations to enable Midazolam to continue to be supplied under a patient group direction and regulation 3(4) amends Schedule 1 to the 1973 Regulations so that Midazolam continues to be an exempted drug under those Regulations.
Regulations 5 and 6 repeal prospective amendments to the 2001 Regulations concerning the format of the controlled drug register which are redundant in consequence of these Regulations.
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