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	The Pharmaceutical Journal Vol 269 No 7205 p12 6 July 2002	This article Reprint Photocopy
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News feature

Standard operating procedures for dispensing: the countdown begins

The Royal Pharmaceutical Society’s Council has a policy that standard operating procedures for the dispensing process should be up and running in all community and hospital pharmacies from 1 January 2005. Guidance on developing and implementing SOPs for dispensing is being sent to all practising pharmacists this month in the form of a new section in the latest edition of ‘Medicines, ethics and practice: a guide for pharmacists’ (see p36). Andrew Haynes looks at the reasons for the SOP requirement and what pharmacists need to do during the 30-month countdown to its introduction

Background

In 1999, as a step towards ensuring clinical governance in dispensing, the Society's Council agreed that every pharmacy should put in place written standard operating procedures covering dispensing activities by 1 January 2005.

Because implementation required the involvement of other pharmacy bodies, the Society chose to work through the pharmacy sector committee of the Science, Technology and Mathematics National Training Organisation, on which the major employers of pharmacists and support staff are represented. Having decided that pharmacies differed too much to allow a universal SOP, the sector committee elected to develop a set of guiding principles centred around the key elements of the dispensing process along with mechanisms for supporting pharmacists in developing their own SOPs.

The resulting draft guidance was issued for consultation by the Society's Practice Committee in May 2001 (PJ, 5 May, p616). The committee amended the document in the light of the comments received, but referred the section on accuracy checking to the Council. At its October 2001 meeting, the Council agreed that an accuracy check should wherever possible be undertaken by a second person but that self-checking would be permitted in exceptional circumstances.

Over the next two-and-a-half years, pharmacists are being asked to find the time to prepare written procedures for the way in which dispensing is handled in their pharmacies. No doubt some will be tempted to complain about what they see as yet another bureaucratic and onerous imposition from the Society. But before doing so, they should note the following. First, written SOPs have clear benefits for the individual pharmacist and for the profession. Secondly, the Society's policy is endorsed by every major organisation involved in community and hospital pharmacy.

Before continuing, it might be appropriate to give a definition of an SOP for the sake of those not familiar with them: "A standard operating procedure is a written specification of what should be done, when, where and by whom." In other words, an SOP is essentially just a documented version of the dispensing procedures that the pharmacist already has in place.

So, if SOPs are little more than written descriptions of existing processes, why do pharmacies need them at all? Some benefits of SOPs are clearly set out in the guidance:

They help assure the quality of the service
They help ensure the achievement of good practice at all times
By enabling pharmacists to delegate they may free time for other activities
They help avoid confusion over who does what
They provide advice and guidance to locums and part-time staff
They are useful tools for training new members of staff
They contribute to the audit process

Because of the value of SOPs in quality assurance and achieving good practice, it is possible that local primary care organisations will require community pharmacies to have them in place before they can tender for local "high level" contracts. They could also become a requirement of a new national contract for National Health Service pharmaceutical services.

How to handle the introduction of SOPs was the topic of a meeting called by the Society on 1 July — exactly 30 months ahead of the implementation date. Invitations had gone to a range of stakeholders, including the Pharmaceutical Services Negotiating Committee, the National Pharmaceutical Association, the Centre for Pharmacy Postgraduate Education, pharmacy multiples and, within the Society, the Community Pharmacists Group, the Hospital Pharmacists Group, the Scottish and Welsh Executives and the inspectorate.

A major item on the agenda was how to support pharmacists in developing their SOPs. One form of support that was not considered was the provision of a "one size fits all" standard. Although individual SOPs will have much in common, each will need to be tailored to fit the characteristics of the individual pharmacy, including the mix of staff competencies and, in some cases, the physical layout of the premises.

Although a universal SOP is a non-starter, pharmacists can be helped by the production of templates or sample SOPs. The NPA has already announced that it is to produce templates for each of the six main stages of the dispensing process: prescription receipt; pharmaceutical assessment; interventions and problem solving; assembly and labelling; accuracy checking procedures; and transfer to the patient.

Pharmacy multiples are planning to produce frameworks that their pharmacists can customise to produce SOPs to suit their specific circumstances. Limits of variation will be set down by the company's head office so that it can retain overall control.

One proposal that met with the meeting's general approval was that the development of an SOP should cover one stage of the dispensing process at a time. Lessons learned from getting the first stage right will help when one moves on to the next stage.

Pharmacists who already have well-developed dispensing procedures could begin by documenting what they already do and then reviewing it. Others will need to build their SOPs from scratch.

A consensus of the meeting was that pharmacists should get together locally for mutual peer support. There was general agreement that local pharmaceutical committees should take the lead, working closely with the Society's inspectors and others. It was suggested that LPCs may be able to bid for money from the local clinical governance allocation to support work on SOPs.

The meeting also considered the role of the Society's§ inspectorate. All agreed that over the next 30 months the inspectors should encourage pharmacists to develop SOPs but should not get involved in writing them and should give advice and opinions only if asked. From 1 January 2005, their role would be to check that an SOP exists and that the staff know how to use it, but they would not be expected to approve it. However, if a body such as a primary care organisation required accreditation that an SOP was in place, the inspector was the best person to provide that accreditation.

Looking at the position of locum pharmacists, the meeting agreed that if locums were not comfortable with the way SOPs delegated tasks to support staff they should be entitled temporarily to reduce that delegation and perform those tasks themselves. However, it would not be acceptable to increase the level of delegation or to replace the pharmacy's SOP with their own.

A training package giving guidance on writing and implementing SOPs has been available for some time from the Welsh Centre for Postgraduate Pharmaceutical Education (PJ, 5 May 2001, p615). It is now also available in England through the CPPE. (The position in Scotland was unclear as The Journal went to press.)