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Pharmacy compliance with RP regulations is mandatory, not optional

The PDA has responded to discussions about compliance with the Responsible Pharmacist (RP) regulations, which underpin patient safety and support high-quality pharmacy services.

Fri 8th April 2022 The PDA

In recent days there has been considerable talk on social media of pharmacies allegedly being operated outside the Responsible Pharmacist (RP) regulations. This includes unauthorised activity occurring when no RP is signed in.

There have been comments made that some pharmacists and pharmacy team members may fear repercussions from challenging or whistle-blowing about such behaviour. To assist members with the interpretation of the RP regulations, the PDA has made available a legal briefing note about the RP regulations produced by a specialist pharmacy regulation law firm.

PDA members are advised to check their understanding of what activities can legitimately take place when no RP is signed in at the pharmacy or the absence provisions are used. Non-compliance with the regulations by pharmacy teams should be reported to the pharmacy superintendent.

The PDA appreciates that the 2021 Safer Pharmacies Survey showed that only 10.6% of respondents always felt able to raise concerns (only 6.1% of those working for CCA members), however, the PDA has significant experience in supporting members who wish to make protected disclosures (whistle-blowing). If members feel they are having undue pressure placed upon them by managers to compromise professional standards when acting as the RP, or they have reason to believe that the RP regulations are not being followed at other times, then they can contact the PDA Service Centre for advice and support.

Download the briefing note here:

thumbnail of Responsible Pharmacist Obligations briefing note_296514055_1

Sufficient rest

Alongside compliance with the RP regulations, the PDA also advises members to ensure they take adequate rest breaks. Sadly, only 11.5% of Safer Pharmacies Survey respondents (10.5% of those working at CCA members) said they always had adequate rest while at work. Pharmacists have strict professional regulatory obligations which require them to “practise only when fit to do so”. This standard encompasses rest breaks, and the pharmacist must be mindful of the impact of their working hours and workload on their ability to practice.

Adequate rest breaks must be taken to maintain safe practice. If an incident were to occur related to fatigue caused by lack of a break for example, then pharmacists may be asked to explain to the regulator why they did not take a rest break. Professional obligations may require more frequent rest breaks above those specified in the Working Time Regulations, which are the bare minimum set out in health and safety legislation.

Alternatively, some pharmacists may feel an implicit obligation to patients, colleagues, or the business they work in, that if they don’t forgo rest breaks that the work will not all be achieved. This is not a sustainable approach and could lead to a mistake being made through tiredness as well as damage to the pharmacist’s own wellbeing. PDA members can contact the PDA Service Centre for advice on rest breaks in a pharmacy.

Read more about taking breaks in the PDA rest breaks guidance here. While written for pharmacists at the largest employer, the principles are consistent wherever individuals practice.

Learn more


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The Pharmacists' Defence Association is a company limited by guarantee. Registered in England; Company No 4746656.

The Pharmacists' Defence Association is an appointed representative in respect of insurance mediation activities only of
The Pharmacy Insurance Agency Limited which is registered in England and Wales under company number 2591975
and is authorised and regulated by the Financial Conduct Authority (Register No 307063)

The PDA Union is recognised by the Certification Officer as an independent trade union.

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