Standards for registered pharmacies
You are here
Standards for registered pharmacies
The GPhC has developed new standards for registered pharmacies. This is an important milestone for us and a once in a generation change in pharmacy regulation as we move from a rules-based approach to one focusing on the achievement of results for patients.
Duncan Rudkin, GPhC Chief Executive and Registrar, presented the new standards for registered pharmacies at the Pharmacy Show in Birmingham.
The new standards have now replaced the interim standards for pharmacy owners and superintendent pharmacists of retail pharmacy businesses. For more details, view the standards for registered pharmacies [PDF]. View the Welsh version here [PDF].
Our governing council approved the new standards on 13 September 2012.
The standards are designed to strengthen the regulation of pharmacies. They recognise that the decisions that pharmacy owners and superintendents make have a powerful influence on safety, quality and the standard of services that patients and the public receive.
The standards focus on achievement of results for patients and move away from a prescriptive or rules-based approach.
They replace the interim standards for pharmacy owners and superintendent pharmacists of retail pharmacy businesses from 28 September 2012.
We will not have a full range of powers to enforce these standards before October 2013 at the earliest. This gives pharmacy owners, superintendents, pharmacists and pharmacy technicians plenty of time to familiarise themselves with the new standards and to make sure they are meeting them.
We will also be introducing a new approach to inspection, to support compliance with and enforcement of the new standards, and will provide more information about how we are developing the new inspection model over the next few months.
The standards need to be put into Rules and those Rules consulted upon and then approved and laid before Parliament. We do not expect this to happen before October 2013, at the earliest.
Over the next 12 months, we are keen to work with patients and the public, pharmacy professionals, pharmacy owners and superintendents, and professional, industry and trade bodies to plan and manage the transition to the new standards. Partnership working is going to be critical to the success of the transition to the new standards. And there will be a special edition of our registrant bulletin, Regula+e, going out to every registrant in mid October.
Supply of P Medicines
The new standards place a clear responsibility on owners of pharmacies (and superintendents if the owner is a company) to ensure that pharmacy services are managed and delivered safely and effectively. And this includes making sure that medicines are safeguarded from unauthorised access and supplied safely. The legal requirement for a pharmacist to supervise the supply of Pharmacy medicines remains in full effect, of course.
The GPhC’s blanket prohibition on the self selection of P medicines remains in place until at least October 2013, when the new standards are expected to be fully enforceable, and other additional safeguards are in place.
The GPhC is committed to setting standards which focus on the achievement of results for patients, and to avoid setting prescriptive and inflexible rules. When regulations and requirements from the regulator are overly prescriptive, this limits the opportunities for innovation or for pharmacists and pharmacy technicians to use their professional judgement; it also allows regulators, professionals and owners to hide behind rules rather than focus on what matters to patients.
The GPhC Council considered if there was a specific need to diverge from its overall approach to standards setting, and decided that there was not.
The majority of owners and superintendents may well, once implemented in full from autumn 2013, decide that no P category medicines should be available for self-selection. For those owners and superintendents who wish to consider different models, they would need to meet a number of requirements set by the GPhC as the pharmacy regulator.
First and foremost, Council have confirmed that a pharmacy owner and/or superintendent would have to notify us in advance of their intention to enable self selection, so we can track what is happening on the ground.
Secondly, they will have to be able to demonstrate that they are meeting the new standards and complying with specific guidance we are developing.
We want to work closely with pharmacy professionals and their representative bodies, as well as patients and the public, in developing this guidance. We wish to avoid pre-judging the detailed content, but it will inevitably consider areas such as additional governance requirements including local risk assessments. These sorts of considerations would address concerns from some about company decisions not taking into account local issues and concerns.
Thirdly, we have set out that there can be no change in this regard until at least October 2013, so that we have the full range of powers needed to make sure that pharmacies meet the required standards. These include the power, following the roll-out of a new inspection model, to issue improvement notices and to place conditions on registered pharmacies.
The powers we can use if the standards are not met specifically relate to those responsible for meeting the standards – pharmacy owners and superintendents - rather than individual pharmacists who may be employed by them, contracted to work as a locum, or acting as the Responsible Pharmacist.
Extemporaneous preparation of methadone
As part of the development of new standards, and taking into account recent judgments from the European Court of Justice, the Council has further clarified that it does not believe that the supply of unlicensed extemporaneously prepared methadone, as an alternative to an available licensed version, is compatible with the law in this area. An ‘exemption’ was previously granted by the RPSGB, which was adopted on an interim basis by the GPhC. Read more here