The Pharmaceutical Journal
Vol 279 No 7478 p558
17 November 2007

This article
Reprint   Photocopy

PDF 30K, Acrobat Reader

Responsible pharmacist: what should be in the procedures and record?

The responsible pharmacist consultation dedicates two chapters to what the pharmacy procedures and record should cover. Dawn Connelly (on the staff of The Journal) reports

Related websites
Responsible pharmacist resources

Since introduction of the responsible pharmacist paves the way for periods of absence from the pharmacy, it is essential that effective procedures are in place to ensure pharmacy staff continue to work under the direction and authority of the responsible pharmacist when he or she is away from the registered premises.

The responsible pharmacist will therefore be required to establish (if necessary), maintain and review pharmacy procedures designed to secure the safe and effective running of the pharmacy, as set out in amendments to the Medicines Act 1968.

Two chapters in the responsible pharmacist consultation (PJ, 3 November 2007, p494) are dedicated to the Government’s proposals on what should be included in these procedures and what record should be kept.

Pharmacy procedures

When establishing procedures, the Government expects responsible pharmacists to build on experience and good practice provided by existing standard operating procedures and to take account of guidance available from the professional regulatory bodies and, if appropriate, the superintendent pharmacist.

The consultation states that their needs to be a balance between consistency and flexibility within the procedures. The Government believes that consistency will support an incoming responsible pharmacist in assessing whether the procedures are comprehensive while flexibility will allow him or her to review or amend the procedures if, in their professional judgement, they consider this necessary.

The Government suggests the procedures should, as a minimum, cover arrangements for:

• The safe, secure and effective ordering, storage, preparation, dispensing, sale or supply, delivery and disposal of medicines

• The supply of Controlled Drugs

• Activities that can be carried out by specified pharmacy staff and the level of training, qualification and competence required to undertake these

• Record keeping

• Providing advice to patients on medicines by the pharmacist and by pharmacy staff and when they should seek advice from the responsible pharmacist

• When the responsible pharmacist is absent

• Recording amendments to the procedures

• Responding to complaints and adverse incidents relating to the sale and supply of medicines

• The transfer of responsibility for the pharmacy between responsible pharmacists

The consultation asks for views on whether the procedures should include arrangements for the sale of general sale list medicines. Its own view is that they should, given that people may choose to buy these medicines from a pharmacy in order to benefit from the professional advice that is available there.

The Government proposes that the regulations allow procedures to be written on paper or electronically, as long as they are available to those who may need to see them.

The consultation also seeks views on whether an incoming responsible pharmacist should have to sign to indicate that he or she is satisfied with the procedures at the time that responsibility is assumed.

The Government’s view is that when the responsible pharmacist (including a locum taking on responsibility for the pharmacy) takes charge, he or she should check the pharmacy procedures and assess the need for any changes.

“The responsible pharmacist will use his or her knowledge of the pharmacy business and the skills and experience of staff working in the pharmacy to satisfy him or herself that the procedures in place support safe working in the pharmacy and that staff are working to these procedures.”

If changes are thought necessary, for example, when a key member of staff is absent, these can be discussed and agreed with the superintendent pharmacist or pharmacy owner, says the consultation.

If the responsible pharmacist reviews procedures he or she must ensure that pharmacy staff understand new or amended procedures and how they relate to their individual responsibilities, the consultation says.

“Any practice resulting in numerous, frequent, changes to procedures could result in unsafe working in a pharmacy where pharmacy staff have had insufficient time and training to gain an understanding of changes,” it adds.

The consultation highlights that the superintendent pharmacist role is distinct from, but complementary to, that of the responsible pharmacist. The superintendent will have a duty to ensure that each pharmacy has procedures in place and that there are mechanisms for their review (see Panel below).

Pharmacy record

Pharmacists will no longer have to display their registration certificates in the pharmacy once amendments to the Medicines Act 1968 come into force. It is thought that since more than one certificate is often displayed, it is difficult for members of the public to determine who is in charge.

Instead the responsible pharmacist will have to display a notice conspicuously in the pharmacy giving a registration number and stating that he or she is the pharmacist in charge on that date and at that time.

In addition, a record will be kept whereby each responsible pharmacist signs in and out. The Government believes that this record should be simple and include the name and registration number of the responsible pharmacist, and the date and time that he or she assumed responsibility, was absent and ceased to have responsibility.

However, informal consultations have shown that some people would like the record to include details of the responsible pharmacist’s registration date, the reason for their absence and information on other staff working in the pharmacy. The Government does not support these suggestions but asks for views on this issue.

The pharmacy record replaces the requirement for pharmacy owners to make an annual return to the Registrar with details of the pharmacist in personal control of the pharmacy. Instead, the owner must make sure the responsible pharmacists keep the pharmacy record properly and must preserve it for a period to be set out in the regulations.

Failure to do this is an offence and owners will be subject to a fine on conviction, the consultation states. The Government suggests that the record should be kept for five years from the date of last entry.

The next article will look at the circumstances in which a responsible pharmacist can be responsible for more than one pharmacy, the role of guidance to support the changes and the time needed to prepare for them.