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DEC 23/2013

Preparing for the new model of pharmacy inspections

Pharmacy staff are currently seeing a number of changes affecting the sector. The government and Department of Health are reassessing the role that community pharmacies play in UK healthcare provision, while various changes to the regulation and oversight of the sector are coming into effect.

One of the most important of these changes - and one that will affect staff most directly - is the new model of pharmacy inspections and ratings that is currently being rolled out by the General Pharmaceutical Council (GPhC).

The organisation is taking over responsibility for being the principal regulator in charge of pharmacy inspections, with the aim of improving the inspection regime, lessening the bureaucratic burden on pharmacy businesses, enhancing quality and professional development, and ultimately ensuring high standards of patient safety.

The new model
The GPhC states that the purpose of the new regulatory standards - which were introduced on November 4th 2013 - is "to create and maintain the right environment, both organisational and physical, for the safe and effective practice of pharmacy".

Premises must be able to prove their adherence to five key principles: that governance arrangements safeguard the health and wellbeing of patients; that staff are sufficiently empowered and competent to fulfil this goal; that the environment and condition of the pharmacy premises are suitable; that service delivery methods - including the management of medicines and medical devices - are appropriate; and that the equipment and facilities used in the provision of services are safe and effective.

In most cases, inspectors will send a letter to pharmacies notifying them that they will be inspected in the next four to six weeks - though in some cases the visits will be unannounced, as the GPhC is still testing the potential benefits of this method of inspection.

Inspections will generally take up to two hours, during which time staff will need to demonstrate how they meet the standards for registered pharmacies across all five principles. The GPhC representatives will now speak to the pharmacy team as a whole, rather than just the owner, superintendent or responsible pharmacist.

Assessments will be conducted on how processes and policies work in practice and interactions with patients will be observed, in a departure from the previous focus on paperwork and controlled drugs.

Following the inspection, the evidence will be reviewed and a summary judgement produced. This will include an overall rating for the pharmacy of poor, satisfactory, good or excellent for each of the five core principles, as well as for the pharmacy as a whole.

Pharmacies that fall below standards in one or more areas will receive an action plan detailing what remedial actions need to be taken and the timescale in which these changes will happen. Depending on the nature of the issues highlighted, follow-up inspections may be necessary.

The introduction of the regime has been welcomed by many in the industry. Leading chain Rowlands Pharmacy, for example, described the scheme as being transparent and clear enough to make a significant positive impact on the sector.

Meanwhile, the National Pharmacy Association is delivering a series of practical sessions throughout the coming months to ensure all pharmacy staff are ready for the new inspection system; these events will also give workers an opportunity to raise any concerns about the revised arrangements, which will then be brought to the attention of GPhC officials.

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