Frequently asked questions

General questions:

What is the General Pharmaceutical Council?

What are these new standards for?

  • The consultation also sets out the GPhC’s proposals for how it will make sure that pharmacies are delivering the outcomes required by the new standards, and the action it will take if the standards are not being met.

When will the new standards and inspection model come into force? 

  • Our current aim is to introduce the new standards and inspection model from early 2013 subject to approval of the standards by our Council this summer
  • We will make sure that owners and superintendents have the time to prepare for the introduction of our standards before we begin inspecting against them and using our enforcement powers
  • However where we identify immediate patient or public safety risks, we will use existing powers to address those risks.
  • You can see the next steps here


How did you consult with pharmacy professionals and their representative bodies in coming up with these recommendations?

  • Before developing these proposals, we asked a range of stakeholders about the issues they face in pharmacy, how they felt about Council’s desire to move to outcome-focussed standards and what they saw as low and high risk indicators in pharmacy.
  • We held roundtable events with pharmacy professionals and engagement meetings with patients and the public across Great Britain
  • We also heard from the key professional and representative bodies, trade associations, insurers and trade unions across Great Britain.
  • This early engagement with all of the key interest groups has been very helpful in developing these draft standards and informing our approach to regulation.

Won’t these new standards and the new inspection and enforcement regime put an additional burden on pharmacy owners and superintendents?

  • Our aim is to ensure there is minimal or no additional burden on the vast majority of registered pharmacies who are already meeting the outcomes we describe in the proposed standards
  • We believe that the standards we have proposed simply reinforce what every good pharmacy should be doing already in order to achieve good outcomes for their patients and the public
  • Where there is any additional work to ensure familiarisation with the standards, or where changes need to be made in registered pharmacies, we believe these will be justifiable to protect patients
  • However, during the consultation period we will be listening to feedback from all stakeholders to fully understand what extra work pharmacies believe they may need to do under the new system. This will help us develop a regulatory Impact Assessment.

 

The draft standards:

What does the GPhC mean by outcomes-focused standards?

  • We have described the outcomes we expect to see in registered pharmacies to ensure safe and effective practice
  • By setting outcomes, we are enabling professionals to exercise their judgement in how best to meet those outcomes for their pharmacy
  • We are concerned with protecting patient safety and it is the outcome that is important.
  • The process to meet the outcomes may vary, depending on the environment you work in, the patients you serve and local needs.

Is focusing on outcomes in your standards the best way to protect patients? 

  • Yes, it enables the pharmacy professional to use their knowledge, skills and judgement to decide how best to meet the outcomes we have outlined
  • It is not our role to tell pharmacy owners and superintendents exactly how they should run their pharmacy and develop patient focused pharmacy services; they are in the best position to do this
  • If our outcomes are met, patients and the public will receive safe, effective pharmacy services.

How are the new standards different to the interim standards that have been in place?

  • In the new standards, we have focused on the outcomes that pharmacies need to meet, rather than providing lots of detailed rules for pharmacy professionals to follow
  • The interim standards followed a rules-based approach and were more prescriptive in detail than the new standards. For example, the interim standards set out a number of requirements in relation to Standard Operating Procedures.

 

Registration:

How will conditional registration work?

  • We have legal powers to impose or change conditions on premises applying to be a registered pharmacy, or renewing or restoring their registration
  • We have identified a number of situations where we think we should be able to impose conditions on pharmacies:
  • Initial application to register pharmacy premises: we may impose a condition that the new pharmacy must be open and trading by a certain date, and if it was not ready to open on this date, then conditional registration could be extended
  • Temporary premises: we will impose a condition that any temporary pharmacies (e.g. at a major sporting event) can only be registered for the period of and immediately around that event
  • Closed pharmacies: we will impose a condition that any ‘closed’ pharmacies (e.g. internet pharmacies), that are not open for patients and the public to visit, cannot begin opening for patients and the public without our notification and assessment
  • We are developing the model that we will use to ensure that pharmacies comply with these conditions, and the feedback we receive through the consultation will be very helpful in making sure the final model works well.

 

Securing compliance and the approach to enforcement:

Who is responsible for making sure these standards are met?

  • Responsibility for meeting the standards lies with the pharmacy owner. If the registered pharmacy is owned by a ‘body corporate’ (for example a company) the superintendent pharmacist also carries responsibility along with the company.
  • However everyone working in a registered pharmacy, including the Responsible Pharmacist, other pharmacists and pharmacy technicians, will need to be familiar with these new standards and will have an obligation to raise concerns if the standards are not being met – this is a requirement of the standards of conduct, ethics and performance for pharmacists and pharmacy technicians

 

Will unregistered pharmacies (e.g. hospital pharmacies) also be expected to meet these standards? 

  • Our standards apply to all registered pharmacies
  • We know that patients and the public can get their medicines from other providers, for example a hospital or a doctor’s surgery
  • We do not regulate the supply of medicines in these environments, but we will continue to work with the organisations that do regulate these environments, so that regardless of where patients and the public receive their medicines they receive consistent advice and support from their health professional.

How will you identify ‘high risk’ pharmacies that need more regular inspection?  What criteria will you use and why?

  • We are in the process of developing risk criteria and will listen carefully to the views we hear through the consultation as to what those criteria should be
  • The criteria will centre around the risks to patient or public safety, the likelihood of the risk happening, and the impact that this would have on individual or groups of patients, or the wider public
  • The risks will be evidence based and we will not make significant changes until we have an evidence base to support changes
  • We will explore opportunities to use information from existing sources, for example information from our own regulatory systems.

What core information will registered pharmacies have to supply and when will this start?

  • We are working now to develop the baseline information that will help to inform us about the likely levels of risk that individual pharmacies may carry
  • The information that pharmacies are likely to need to provide will include basic facts about the services provided, for example whether it offers an internet service
  • We will be discussing with stakeholders the sorts of information pharmacies could be asked to share with us in the course of this consultation.

Didn’t find what you were looking for? Email consultations@pharmacyregulation.org 

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