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The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008
These Regulations were laid before Parliament on 29 October 2008 and come into force on 1 October 2009.
The lengthy period before the Regulations come into force is to allow pharmacy contractors to introduce the necessary changes. The Regulations set out the duties of responsible pharmacists who are required to secure the safe and effective running of a pharmacy business, so far as it concerns the retail sale or supply of medicines at the premises. These provisions will, from 1 October 2009 replace the current provisions relating to personal control of a pharmacist, which has been interpreted as requiring the pharmacist to be present on the pharmacy premises at all times that the pharmacy is operating.
Under these new arrangements, a responsible pharmacist will be able to be absent from the pharmacy (but see note below) for up to two hours a day. During absence, the responsible pharmacist must remain contactable, and be able to return to the pharmacy with reasonable promptness. If these conditions cannot be met, the responsible pharmacist must make arrangements before leaving the pharmacy, to ensure that another pharmacist is available and contactable to give advice.
An important change to the current arrangements is that general sale list medicines may continue to be sold, even during the absence of the responsible pharmacist.
The second limb of the revision to the medicines legislation involves clarification of the supervision requirements. Government will be consulting later on the requirements that currently exist, which require a pharmacist to supervise the sale or supply of pharmacy medicines and prescription only medicines. The responsible pharmacist regulations do not make any changes to supervision requirements, so in the absence of the responsible pharmacist, no sales or supplies of POM or P medicines can take place unless there is another pharmacist available on the premises to supervise.
Every pharmacy will be required to have pharmacy procedures, which cover matters such as the ordering, storage, preparation, sale, supply (i.e. dispensing), delivery and disposal of medicines.
The procedures will also need to set out the circumstances in which a member of pharmacy staff who is not a pharmacist may give advice about medicinal products; the identification of members of pharmacy staff who are, in the view of the responsible pharmacist, competent to perform certain tasks relating to the pharmacy business; the keeping of records about the pharmacy procedures; the arrangements which are to apply during the absence of the responsible pharmacist from the premises; the steps to be taken when there is a change of responsible pharmacist at the premises; the procedure which is to be followed if a complaint is made about the pharmacy business; the procedure which is to be followed if an incident occurs which may indicate that the pharmacy business is not running in a safe and effective manner; and the manner in which changes to the pharmacy procedures are to be notified to pharmacy staff.The Responsible Pharmacist will need to establish these procedures if they are not already in place, and will take day to day decisions on whether the procedures are appropriate, to secure the safe and effective operation of the pharmacy, with respect to the sale and supply of medicines.
The Responsible Pharmacist is required to keep records and the owner of the pharmacy must ensure that the records are preserved. These may be in writing, in electronic form or both. The particulars which must be included are: the responsible pharmacist’s name and registration number; the date and time at which the responsible pharmacist became the responsible pharmacist; the date and time at which the responsible pharmacist ceased to be the responsible pharmacist; and additional records relating to absence of the Responsible pharmacist.
The Department of Health is to publish guidance on the Regulations, and the Royal Pharmaceutical Society of Great Britain is to review the Code of Ethics and Standards and guidance, to supplement the legislative framework, with the intention of publishing the Standards in summer 2009.
At this stage, pharmacy contractors need to be aware that there are to be significant changes, and pharmacy procedures will be required to be refreshed during 2009, once the RPSGB and the Department of Health have published their documents.
The Regulations are available here
Posted 19 November 2008