Understanding the Responsible Pharmacist requirements

Your quick reference guide

compiled by

Professor Joy Wingfield, special professor of pharmacy law and ethics, University of Nottingham

Welcome to this online resource that will build to help you understand what the new requirements mean for you in practice.

You can use this resource as an educational tool to help you understand the new regulations.

As such it can form part of your CPD record, and will help you address the following competencies

•           Pharmacists: G1, G2, G3, G5, G8

•           Pharmacy technicians: TG1, TG6, TG7, TG14, TG16

Part 1: Key facts

Part 2: What is new for front line pharmacists?

Part 3: What has not changed?

Part 4: What is new for owners and superintendents?

Part 5: Agreement to be a Responsible Pharmacist

Part 6: General FAQs and scenarios

Part 7: What should I know about absence of the Responsible Pharmacist?

Part 8: FAQs and scenarios on absence of the Responsible Pharmacist

Part 9: What should I know about Pharmacy Procedures (SOPs)?

Part 10: What should I know about records of the Responsible Pharmacist?

Part 11: Scenarios on Pharmacy Procedures and records of the Responsible Pharmacist

TAKE THE RESPONSIBLE PHARMACIST QUIZ >>

Part 1: Key facts

The Responsible Pharmacist legislation comes into force on  October 1, 2009

From October 1, 2009:

•           It is a legal requirement for every registered pharmacy to have a named Responsible Pharmacist

•           The law relating to ‘personal control’ is replaced by the Responsible Pharmacist law but, in addition, the new law adds further responsibilities

•           The sale or supply of P or POM medicines still needs the supervision of a pharmacist

•           The dispensing of NHS prescriptions for any medicine still needs the supervision of a pharmacist

The additional responsibilities of the Responsible Pharmacist concern

•           The establishment, maintenance and review of a range of Standard Operating Procedures

•           The making of entries in a formal record of the name and details of who is the Responsible Pharmacist in charge of the pharmacy at any particular time

•           Compliance with conditions concerning the absence of the Responsible Pharmacist

The Law

The law relating to the supervision of P and POM medicines is governed by the Medicines Act, and for the time being remains unchanged.

Until the law on the supervision of P and POM medicines is changed, the provisions for absence of the Responsible Pharmacist are unlikely to be useful unless arrangements can be made for a pharmacy to sell only GSL medicines.  

The RPSGB standards and regulatory guidance cover expectations for the practice of pharmacists and superintendents, and owners where they are pharmacists.

Misconduct is one of the many grounds that may be used to support an allegation that the fitness to practise of a pharmacist might be impaired. When deciding whether such an allegation is proved, the relevant fitness to practise committee will use the RPSGB standards and regulatory guidance as a basis for the standard of practice expected. However, a pharmacist can argue that, in his/her professional judgement, a different standard was appropriate at the time in question.

DH Guidance

The DH guidance is simply factual guidance. In essence it was produced because during consultation, pharmacists and others said they wanted it.

It provides some insights into the thinking of the Government and clarifications that were debated in Parliament during passage of the legislation. It includes exhaustive accounts of the legislation underpinning the Responsible Pharmacist requirements and gives guidance on a number of practical issues such as, for example, accountability and the assistance a superintendent might give to his/her Responsible Pharmacists in establishing Standard Operating Procedures. This might be useful in discussions with Superintendents, owners, middle managers and other staff about the Responsible Pharmacist requirements. The DH guidance also sets out a number of scenarios, some of which appear in this training material. However, the material carries a disclaimer saying that it not “an authoritative statement of the law”. 

Top