Framework for decision-making and enforcement action

In this section we describe the work we are doing to develop our approach to decision-making and enforcement action. We have included this section to provide information to inform responses to the consultation questions on the registration criteria and draft standards.

Decision making and enforcement

The GPhC’s focus will be on supporting people to meet the standards.

In addition to providing compliance indicators to sit alongside the standards and further compliance guidance for a limited number of situations, we propose to support compliance by visiting and inspecting registered pharmacies. We understand that every time an inspection is carried out at a registered pharmacy, it puts pressures on the time of the staff working in the pharmacy and draws time away from operation of services and direct patient care. However, we believe a robust inspection model is needed to protect patients, support compliance with the standards we are proposing to set and enable us to make a decision about any risks based on what we see during the inspection and evidence presented to us by the owner or superintendent.

How our current model of inspection works

We have a team of about 30 inspectors who currently visit registered pharmacies approximately every three years.

Our inspectors examine how the pharmacy operates and provide advice to pharmacy staff about what we believe needs to happen to ensure services are safe and effective.

They also look at specific services such as the management of controlled drugs to ensure legal requirements are being met and support our investigations team where there are concerns about a registrant’s fitness to practise.

In parallel with this consultation, we will also explore opportunities to use information from existing sources, such as primary care organisations or through existing NHS complaints mechanisms, as well as information from our own regulatory systems. This will assist the development of a genuinely risk-based approach to regulation focusing our attention on where the risks are higher and reducing burdens for those registered pharmacies which are safe and consistently complying with the required standards.

Developing our inspection model

We are proposing to move away from a ‘one size fits all’ inspection model, where all registered pharmacies are inspected at regular intervals of approximately every three years, to a model where we prioritise inspections for those registered pharmacies where we believe there is a higher risk to patients and the public, either because of the nature of the services they provide, or because we have concerns.

We intend to develop and publish risk indicators using evidence from a range of sources, including the inspections we conduct, when the new standards come into force.  The indicators are likely to develop further on the basis of feedback from pharmacy staff, employers and patients and the public and also, as more data is collected to inform our decisions about when and who to inspect. It is also likely to develop as we consider how new models of pharmacy service delivery emerge.

All registered pharmacies will be required to provide some core information as part of the application or renewals process. This information is likely to include information covering basic facts about the registered pharmacy such as the services it provides, for example whether it offers an internet service.

 

Risk based regulation

The proposed model for regulating pharmacy is intended to enable a more ‘risk-based’ approach to inspecting and enforcing our standards. As a concept risk-based regulation acknowledges that not all risk can be removed and to do so would be disproportionate. A risk-based approach to regulation targets resources at those areas where risk is deemed to be higher in relative terms, and resources and burden is reduced where there is evidence of lower risk.

Notice of an inspection

In most cases notice of an inspection will be issued to the registered pharmacy owner or superintendent in advance, consistent with current practice. However, we intend to carry out a small number of unannounced inspections, to enable us to compare whether there is any difference in the outcome between pre-notified inspections and unannounced inspections and assess whether our inspection model is robust. We also believe we may need to carry out a small number of unannounced inspections at short notice where concerns have been raised and where we believe there may be a serious risk to patient safety.

The nature of an inspection

We recognise that there will need to be significant changes to the current inspection model to take into account new standards once they are approved. We will develop the new model once the standards are approved.  As part of this, we will be considering what evidence we need to collect to confirm that the standards are being met, with particular regard to the outcomes for patients and the public and in a way that keeps burdens on the registered pharmacy to a minimum.

Some of the evidence might be gathered by reviewing information supplied at registration, renewal of registration (updated to reflect key changes), or in advance of an inspection.

The inspection team will review systems and processes, observe the delivery of services to patients, and speak with staff.  Wherever possible, inspectors will also speak with patients visiting the pharmacy during the inspection.  Decisions as to whether standards have been met will only be made following a physical inspection of the registered pharmacy and services provided.  We want the inspection model to be flexible. It is likely to vary depending on a number of factors including, but not limited to, the types of services provided by the registered pharmacy as well, any recent changes that have taken place to, for example, the range of services or the skills mix in the pharmacy.

Criteria for decision-making

Decisions on the extent to which standards have been met will be based on an assessment of risk to patient safety.  We will develop and publish decision-making criteria, using evidence from inspections of registered pharmacies conducted prior to the standards coming into force.

The criteria will take into account:-

  • the nature of the risk
  • the impact of the risk on patient and public safety if not effectively mitigated, and
  • the likelihood of the risk occurring.

Clearly, the greater the impact and likelihood of the risk occurring, the higher priority must be given to mitigating the risks, through improvement action.

Our decision framework is likely to propose that an inspection will result in one of three outcomes (these are working titles only at this stage):

  • full compliance: there is evidence that all of the standards are being met
  • substantial compliance: there is evidence that most of the standards are being met. The risks to patient or public safety are not high (less likely to occur and/or relatively low impact), or
  • major non-compliance:  there is evidence either that many of the standards are not being met or of a major breach of one or more of the standards.  The risks to patient and public safety are high (likely to occur and/or with significant impact).

We believe that it is in the best interests of patients and the public for decisions about compliance to be published and intend to do so once new standards for registered pharmacies are in place. As part of this process of publication we expect to issue the inspection report to the owner in advance, detailing the outcome and the evidence found to support that outcome. Where appropriate, the report will also identify post-inspection requirements.

The report would be published on the online extract of the register relating to the registered pharmacy.

Enforcement

The main focus of an inspection will be to support achievement of compliance.

However, where the inspection team identifies major non-compliance with the standards or a failure to remedy weaknesses as previously agreed, we would use the powers (Article 13, Pharmacy Order 2010) we have to issue an improvement notice, requiring the owner(s) to take specified measures to address those areas of non-compliance, and the timescale within which improvements must be made (If the Registrar considers it necessary, he may also impose immediate conditions on the premises, under t s74(D)(2) of the Medicines Act 1968).

If on further inspection, at the expiration of the period set out in the improvement notice, the inspector remains of the view that the standards have not been met, the GPhC then has powers (Article 14, Pharmacy Order 2010) to:

  • remove the  entry from the register, or
  • suspend the entry until such time as the owner has complied with the improvement notice and impose such other requirements or conditions as the registrar considers it necessary to impose.

The GPhC can also consider prosecution for failure to comply with the terms of an improvement notice if we think that this would be necessary to protect the public.

Disqualification of a body corporate

In addition to specific powers of enforcement as set out above, we also have the ability, following proper process (S80 Medicines Act 1968 as amended), to disqualify a corporate body and direct removal of the registered pharmacy in limited circumstances, one of which is failure to make sure that our standards are met. The relevant legislation also sets out detail in relation to the grounds for disqualification(S81Medicines Act 1968 as amended).

Inspections and fitness to practise

We know that we need to be clear and open about how we will manage our work including the regulation of the ‘system’ or services provided by registered pharmacies and our regulation of individuals, ‘professional regulation’ where our interest is in the fitness to practise of the individual pharmacist or pharmacy technician.

We use our fitness to practise procedures to manage concerns raised about pharmacist or pharmacy technician registrants. They serve an important purpose but they are not the enforcement mechanism for making sure that our standards for registered pharmacies are met.

Inevitably, in the course of our work to ensure appropriate standards are maintained for registered pharmacies, it is possible that fitness to practise concerns may emerge in respect of individual registrants which may need to be considered through our fitness to practise procedures. These concerns may relate to an individual pharmacy professional working within the pharmacy, or may relate to the pharmacy owner, where they are a pharmacist or a superintendent pharmacist. For example, fulfilling the superintendent’s responsibilities is an important part of their professional practice; therefore major non-compliance with these standards may raise a question about their fitness to practise, although consideration of this would form part of a separate decision-making process.

It is our view that high quality provision of healthcare is most likely when all parts of the ‘health system’ are working well together: professionals, colleagues in teams, employers and national bodies and regulators. Conversely serious problems happen when these individuals or groups do not work well together or when there is no effective link between available information. This information could include data from our inspection model or information available from other sources such as primary care organisations or concerns raised by either professionals, patients or others such as regulators. We believe our proposed model can help to mitigate these risks, helping to maintain high quality care from registered pharmacies through modern pharmacy regulation.

 

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