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Proposals to Extend Emergency Supply Arrangements
The MHRA have published a consultation on the manufacture, distribution, sale and supply of medicines and devices during an influenza pandemic. At the same time, they are also consulting on expanding the provisions for the emergency supply of medicines (which will not be restricted to an influenza pandemic). Key proposals are outlined below:
Emergency Supply (not restricted to an influenza pandemic)
- Proposal to amend the POM Order to allow a pharmacist, following a request from a patient and at the professional discretion of that pharmacist, to make an emergency sale or supply of certain prescription only medicines for up to 30 days treatment.
- Proposal to allow emergency supplies at the request of a dentist.
Pandemic Flu
There are also proposed measures to ease access to essential medicines during a flu pandemic. These include:
- Supply of certain prescription only medicines without a prescription and that those medicines need not be supplied from registered pharmacy premises. Supply would be authorised by the “Flu-Line” in accordance with the clinical algorithm drawn from the DH protocol;
- Propose no change to the requirement that the sale and supply of Pharmacy medicines must be from a registered pharmacy by or under the supervision of a pharmacist;
- Propose no change to the requirements for the sale of GSL medicines including the requirement that the sale of GSL products must be from premises which can be closed to the public;
- Removal of the requirement for a pharmacist to have interviewed a person requesting an emergency supply of medicines during a pandemic (This proposal is in additon to the permanent proposed changes but will apply only for the period of the pandemic);
- Allow supply of expired and returned medicines - pharmacist’s discretion would be needed and guidance given to help them use that discretion;
- Changes to the Misuse of Drugs Regulations 2001 and corresponding regulations to allow healthcare professionals to exercise greater discretion and flexibility in relation to Controlled Drugs when responding to emergency situations. This includes a proposal to allow the emergency supply of controlled drugs (5 days for Schedule 2 and 3 and up to 30 days for Schedule 4 and 5 by pharmacists).
The consultation document can be downloaded from the MHRA website. PSNC will be responding in due course.
Posted 6 February 2009