Alison Hunter

Introduction

Standard operating procedures (SOPs) are written procedures or protocols to describe the way that tasks and activities within the pharmacy must be carried out. The NHS, and organizations contracted to them, must continually improve the quality of their services and ensure they are safeguarding the public by providing high standards of care. This is known as clinical governance (see Ch. 9). Every pharmacy must have an identifiable clinical governance lead, who is responsible for applying clinical governance principles to the delivery of all services. This will include the use of SOPs; recording, reporting and learning from incidents; participation in clinical audit and continuing professional development (CPD, see Ch. 6); and assessing patient satisfaction through surveys. Therefore, within clinical governance, SOPs are a legal requirement of the community pharmacy contract and of hospitals in England, Scotland, Wales and Northern Ireland, to ensure a high quality of service and patient safety.

Background to SOPs

In January 2005, it became a requirement for pharmacists to establish and operate within SOPs. These SOPs were to be used in both hospital and community to cover the dispensing processes, including all the tasks that take place from the time that prescriptions are received in the pharmacy until the items are transferred to the patient.

In England, Wales and Northern Ireland, these requirements currently sit within essential services under clinical governance for core pharmacy activities. SOPs should, also, be produced to cover all advanced and enhanced services. In Scotland, SOPs are required within each element of the four core services and any local services. In hospitals, SOPs are the responsibility of the local trust.

It was recognized that there is a great deal of variance between each pharmacy, therefore no specific set of SOPs could be developed to cover all pharmacies. Each pharmacy can have individual SOPs, although larger companies may have a single SOP for each activity that covers all of their premises.

Regulations

The standards for owners and superintendent pharmacists of retail pharmacy businesses, published by the GPhC, specifies that SOPs should be in place for all aspects of the safe and effective provision of pharmacy services and that they must be maintained and regularly reviewed. Procedures must respect and protect confidential information about patients and employees in accordance with current legislation, relevant codes of practice and professional guidelines. The Pharmaceutical Society of Northern Ireland requires SOPs for dispensing services that the pharmacist provides or is responsible for.

Responsible pharmacists in the UK must ensure that pharmacy procedures are established (where not already established) and SOPs are in place, to ensure the safe and effective running of the pharmacy. These procedures need to be maintained and regularly reviewed.

Reducing risk to patient safety

Set up as part of the process of assuring clinical governance, SOPs should be designed to reduce risk and the chance of harm to patients. They should allow for continuing improvement to the standards of service offered to the public. Pharmacists should be able to ensure that their teams are working consistently to the safest method possible. SOPs should enable pharmacists to delegate and therefore, fully use the expertise of all pharmacy team members. The qualifications and capabilities of individual members of staff will determine the extent to which individual tasks can be delegated. This may in turn create efficiencies to free up time for other tasks and for talking to patients about their care. SOPs will also help to advise locums and new members of the pharmacy team where guidance is needed, which will reduce the chance of mistakes happening.