Guidance for contractors on the                                 development            and
implementation of SOPs for dispensing.

Background and Scope
From January 2005, the RPSGB will require all pharmacists to put in place and operate
written Standard Operating Procedures within individual pharmacies. These SOPs will
need to cover the entire dispensing process from the time that prescriptions are received
in the pharmacy until the dispensed items have been collected or transferred to the

A set of SOPs will be required even where there are no dispensary support staff employed
and the pharmacist is working single handedly.

Why is the requirement being introduced?

All healthcare professions are being required to put in place strategies for risk
management and harm minimisation. Contractors will be aware of the aspects of clinical
governance that are to be introduced into community pharmacy practice with the advent of
the new pharmacy contract. The Society’s requirement for SOPs is part of a process of
assuring clinical governance in the pharmacy setting. Pharmacists will continue to be
accountable for the dispensing process, but in developing and working to SOPs will be
able to examine/benchmark current practice and ensure that systems of practice operating
within pharmacies are safe. SOPs should allow for the continual improvement of standards
of service and provide evidence of commitment to protecting patients.

What is a standard operating procedure?
A standard operating procedure specifies in writing what should be done, when, where and
by whom. This can have a number of benefits:

 SOPs help to assure the quality and consistency of the service;
   SOPs help to ensure that good practice is achieved at all times;
   SOPs provide an opportunity to fully utilise the expertise of all members of the
    pharmacy team;
   SOPs enable pharmacists to delegate and may free up time for other activities;
   SOPs help to avoid confusion over who does what (role clarification);
   SOPs provide advice and guidance to locums and part-time staff;
   SOPs are useful tools for training new members of staff;
   SOPs provide a contribution to the audit process.

Professional accountability
The Society’s Code of Ethics states that pharmacists assuming responsibility for any
function (whether as a proprietor, employee or locum), are professionally accountable for
all decisions to supply a medicine and offer advice. As part of this accountability they must

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ensure that if any tasks are to be delegated, they are delegated to persons competent to
perform them. Pharmacists who delegate parts of the dispensing process to others will be
required to document within their SOPs the tasks that can be delegated and to which staff.
This process will provide an opportunity to clarify roles within the pharmacy. Staff will be
clearer as to when they should refer to the pharmacist, and be more aware of the limits of
their own competence. The qualifications and capabilities of individual members of staff
will regulate the extent to which individual tasks can be delegated. Those pharmacists who
employ competent support staff will be able to use SOPs to safely delegate the technical
aspects of the dispensing process, potentially freeing up time for the development of
clinical services such as medicines management.

The RPSGB has stated that from January 1, 2005, all pharmacy staff involved in
dispensing activities will need to be competent to a minimum standard (or undertaking
training in this respect). This is additional to the requirement for SOPs.

Content of the SOP
SOPs should define the process and specify which activities must be carried out
personally by a pharmacist, including the pharmaceutical assessment, which activities can
be delegated to identified competent support staff and how the checks for accuracy are to
be carried out. It is good practice for SOPs to incorporate an audit trail so that the
pharmacist can determine who is responsible for each aspect of the process.

SOPs should help to ensure that, other than in exceptional circumstances, recommended
procedures are followed at all times. Their introduction provides an opportunity for
pharmacists to define and assess their own practice, to communicate this to staff and help
to improve team working within the pharmacy.

There are a number of ways of laying out SOPs all of which may be equally valid. The
NPA Guide to Standard Operating Procedures presents the relevant documents under six
headings. To allow this PCT support document to be used in conjunction with the NPA
folder the same presentation and layout has been used. The relevant information is
presented under the following sections:

   Prescription reception
   Assessment of the prescription for validity, safety and clinical appropriateness
   Making interventions and problem solving
   Assembly and labelling of required medicine or product
   Accuracy checking procedure
   Transfer of the medicine or product to the patient

Each SOP is then described and presented under the various sections below:

Purpose: This defines what the procedure is trying to achieve?
Scope: This states the areas of work that are to be covered by the procedure?
The procedure or stages of the process: This can be a description of, or a step list of
how the task is to be carried out.
Responsibility: A statement of who is responsible for carrying out each stage of the
process under normal operating conditions and in different circumstances e.g. when staff
are sick or on holiday.

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Review procedure: This will ensure that the procedure continues to be useful, relevant
and up to date. Reviews should be undertaken at least once every two years.
Known risks: Whilst the SOP should be designed to minimise risks by highlighting any
potential pitfalls this is an extra measure to ensure risk reduction.
Details of when prepared and by whom:
Signed declarations from all staff that they have read and understood the SOP:

Who should write them

In normal circumstances, the development of SOPs should be overseen by the pharmacist
who is in day-to-day charge of the pharmacy. That pharmacist will be accountable for the
SOP. There will, however, be situations in which this is not practical, for example where
there is no pharmacist manager and the pharmacy is being supervised by locums. In this
situation the superintendent pharmacist will be accountable for ensuring that SOPs are
developed and implemented. The name of the pharmacist under whose authority the SOP
was prepared should be clearly specified.

How to proceed

This support document has been produced to help contractors develop and implement
their own individual Standard Operating Procedures to cover the dispensing process. It is
important to note that this is not a stand-alone document. SOPS are pharmacy specific
and so this document, without appropriate editing does not and cannot constitute a set of
SOPs. For this document to have any relevance in an individual pharmacy it must be
edited to accurately document the individual steps of the dispensing process in that

A suggested procedure to follow to convert the attached document into a set of SOPs is as

   1. Pass a paper copy of this document to each member of your staff in turn who is
      involved in any way in the dispensing process in your pharmacy. Request that they
      read the foundation SOP templates and add notes where appropriate to highlight
      any steps, stages or processes that need to be added to produce a representative
      documentation of the dispensing process in your pharmacy.It is good practice to
      involve all staff involved in the dispensing process in the preparation of SOPs or
      tailoring of SOP templates. This will help to engage staff and ensure that the
      procedures specified are followed.

   2. Consider the contributions from each member of staff and after carrying out a risk
      assessment of each statement edit the electronic version of the template to produce
      a working SOP for your pharmacy. It is suggested that each procedure/process be
      edited and given a letter. This letter can then be placed against the members of
      staff listed in “Responsibility” who are involved in each particular process.

   3. After producing the SOP it should be distributed to all staff for consultation and
      discussion. There may need to be some further editing as a result of this process.
      Any changes or omissions of contributions from staff made during the initial
      preparation at stage 1 need to be highlighted.

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   4. After producing the working SOP each member of staff (including part-time staff and
      locums) needs to read and then sign that they have read and understood the
      contents and implications of the SOP.

   5. NPA members should refer to the NPA “Guidance on SOP” folder and store
      prepared and completed SOPs here for reference. All staff should be made aware
      of where the SOP documents are stored.

   6. There are a number of other stages and processes that form part of the overall
      dispensing process. An SOP needs to be written for each of these. Each contractor
      should consider the list below (which is not exhaustive) and using the blank SOP
      template prepare additional SOPs relevant to their individual pharmacy.
          Collection and delivery
          Domiciliary oxygen services
          MDS dispensing
          CD instalment dispensing
          Measuring for surgical hosiery and trusses

   7. It needs to be understood that the SOP is an evolving document which needs to be
      kept up-to-date and must be subjected to constant revision. Pharmacists should
      ensure that any changes to SOPs are brought to the attention of all relevant staff.

It is hoped that this guidance on the development and implementation of SOPs for
dispensing will help pharmacy contractors in Coventry to develop comprehensive,
accurate and representative SOPs for their individual pharmacies. It is further hoped that
this in turn will contribute to maintaining the high levels of quality and good practice of the
pharmaceutical service that they provide.

Any comments on the guidance and documents enclosed should be addressed to
Laurence Tressler, Deputy Head of Medicines Management at Coventry PCT.

Further References:

The attention of contractors is drawn to the following references from which this document
has heavily borrowed and due credit acknowledged:

Developing and implementing standard operating procedures for dispensing, RPSGB.
The NPA Guide to Standard Operating Procedures, NPA.
Clinical Governance in Community Pharmacy, Standard Operating Procedures, Swale

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