Explanatory note

These Regulations amend the Misuse of Drugs Regulations (Northern Ireland) 2002 (S.R. 2002 No.1) (“the 2002 Regulations”).

Section 5 of the Misuse of Drugs Act 1971 (c. 38) places a general restriction on possessing controlled drugs, subject to exceptions in regulations. In the case of drugs supplied by pharmacists, drugs specified in Schedules 2 to Part 1 of Schedule 4 to the 2002 Regulations presuppose the existence of directions of a person lawfully entitled to prescribe the drug.

In a pandemic situation, the Department may make an announcement permitting pharmacists without prescribing rights to issue the necessary directions themselves in relation to health service supplies, in two circumstances. Both of these relate to easements from the normal restrictions on supplies of prescription only medicines in the Human Medicines Regulations 2012 (S.I. 2012/1916) - both relate to continuity of treatment.

The first easement relates to a pharmacist’s ability, in a pandemic situation, to supply at registered pharmacy premises prescription only drugs previously supplied to a patient on prescription. The second easement relates to supplies under a serious shortage protocol, where currently, to help manage a serious shortage (not necessarily in a pandemic situation), a pharmacist at a registered pharmacy may, under a serious shortage protocol issued by the Secretary of State for Health and Social Care and the Minister for Health (NI) acting jointly or alone, supply an alternative quantity, strength, pharmaceutical form or medicine that is both available and suitable as prescribed in the protocol. Regulation 4 inserts a new regulation 10A into the 2002 Regulations to enable these easements to apply, in a pandemic situation, to drugs specified in Schedule 2 to Part 1 of Schedule 4, in the case of health service supplies. The announcement may only permit this utilisation for up to three months, but that period may be extended for further periods of up to three months.

The 2002 Regulations contain restrictions on the form of prescriptions of Schedules 2 and 3 drugs, which include, in the case of drugs intended to be supplied by instalments, requiring the prescriber to specify the intervals between the supply of the instalments. Regulation 5 amends regulation 15 of the 2002 Regulations to enable, in a pandemic situation, the Department to make an announcement that would permit pharmacists to change the intervals for Schedule 2 and 3 drugs with the agreement of the prescriber or their appointed representative, where these are supplied under health service arrangements. The announcement may only permit this utilisation for up to three months, but that period may be extended for further periods of up to three months.

There is also a consequential amendment to the interpretation provision of the 2002 Regulations (regulation 3).