Advice on Standard Operating Procedures (SOPs)

A standard operating procedure is a written instruction describing how a routine task is to be carried out; when, where and by whom.

Why do I need SOPs?

SOPs play a fundamental role in continuous quality assurance and ensuring best practice at your pharmacy, in order to assist you in protecting the safety of your patients and members of the public. The implementation of SOPs, which are specific to your pharmacy, will help you to:

  • ensure quality and consistency of service to patients
  • ensure good practice is achieved at all times
  • utilise the expertise of the pharmacy team effectively
  • facilitate delegation of appropriate tasks to trained members of the pharmacy team
  • provide role clarification for all members of the pharmacy team
  • provide staff training
  • provide assurance of staff understanding of processes to be followed in the pharmacy
  • provide an opportunity for pharmacists to define and assess their practice
  • facilitate communication and team work

Who is responsible for SOPs?

As the person responsible for the management and administration of the pharmacy, it is the responsibility of the superintendent pharmacist to ensure SOPs are in place, and, to approve the SOPs.  It is good practice to include all staff, and in particular the supervising pharmacist, in the preparation of the SOPs. The SOP’s implementation date should be recorded, which is the date that the SOP shall become effective from.

As the person who is in ‘whole time’ charge of the pharmacy, the supervising pharmacist is responsible for the implementation of SOPs. It is important that they ensure that the processes outlined in the SOPs accurately reflect the practices at their pharmacy.

All members of the pharmacy team are responsible for following the implemented SOPs that are relevant to their roles and responsibilities.

Where do I start?

No single SOP template can be applied to all pharmacies, as individual pharmacies operate differently. Your SOPs need to reflect how your pharmacy operates. SOPs don’t have to be complicated, they should be written in a concise, step-by-step, easy-to-read format. SOPs should be specific to your pharmacy and accurately set out how a task is carried out at your pharmacy. In addition, the content of all SOPs must be accurate with respect to the legislation, current PSI Guidance and current good pharmacy practice.

Outline for Preparing SOPs

There is no right or wrong way to write an SOP but for each SOP, you should consider the following:

Objective What is the procedure trying to achieve?
Scope What should the procedure cover?
Process Description of how the task is to be carried out?
Responsibility Who is responsible for carrying out each stage of the process?
Training Have staff been trained on the SOPs?
Review Are SOPs specific, relevant and up to date?

At a minimum, you should have the following SOPs in place covering the day-to-day activities at the pharmacy:

  • Dispensing: This includes the entire process from the receipt of the prescription, through therapeutic review to the transfer of the medicine to the patient and patient counselling. Dispensing procedures should address the dispensing of different types of medicines, including high-risk medicines (Methotrexate etc.), high-tech medicines and controlled drugs
  • Sourcing of medicines
  • Storage of medicines
  • Expiry date checking
  • Sale and supply of non-prescription medicinal products
  • Sale and supply of non-prescription codeine containing medicines 
  • Management of controlled drugs (including storage and record keeping) 
  • Disposal of medicines and destruction of controlled drugs
  • Error and incident management (including near miss management)
  • Locum procedure 
  • Use of the patient consultation area
  • Policy on use of child resistant containers 
  • Management of emergency situations, e.g. loss of electricity/ power 
  • Keyholding policy (for the premises and CD Safe)
  • Housekeeping and cleanliness of the dispensary (including equipment),public pharmacy area and all other areas of the pharmacy
  • Protocol for temperature breach of pharmacy fridge
  • Confidentiality procedure
  • Pest control policy (as required)

However, please note, this list is not exhaustive.  Additional SOPs that cover additional services, such as point of care testing services, vaccination services, monitored dosage systems, veterinary services, methadone services, prescription home delivery etc., should also be developed if they are in line with the specific needs and activities of your pharmacy.

When you are preparing or reviewing your pharmacy’s SOPs, you need to make sure that they accurately record how the particular process is carried out at your pharmacy. One way to assure yourself of this is to observe other members of the pharmacy team completing a process outlined in the SOP. By doing this, you may identify deviations between the SOP and the process, for example, your process might have changed since the SOP was implemented, or maybe it does not reflect how things are actually carried out by the pharmacy team.

As part of your Pharmacy Assessment System, you are required to select one SOP relating to a process in your pharmacy, and by observing the process at your pharmacy you will check to see if it corresponds to the way the process is carried out. 

Staff members should receive training on the SOPs that are relevant to their roles and responsibilities to ensure they are working within the scope of their training and competence. All members of the pharmacy team are responsible for following the implemented SOPs that are relevant to their roles and responsibilities.

Signed and dated records of staff training should be maintained. Pharmacists should ensure that any changes to SOPs are brought to the attention of relevant staff members, and that they are retrained in the updated SOPs.

It is also important that SOPs are readily available to staff at the pharmacy including locum pharmacists, so that they can refer to relevant SOPs as needed.  This is particularly important if your SOPs are maintained online.

SOPs need to remain current to be useful.  It is the responsibility of the superintendent and supervising pharmacist to ensure they are updated and reviewed regularly, at a minimum annually or when any element of the process changes, for example if legislation or PSI Guidance has been updated or as a result of an error or incident.

SOPs should be clearly marked with a scheduled date for the next review.

When a review takes place, the review should be documented, i.e. dated and signed by the appropriate person, and the policy or procedure should be updated if necessary.

As part of your review, if an SOP is available for a service that is no longer provided then it should be withdrawn from the current set and archived.

Changes to SOPs should be recorded and approved by the superintendent and supervising pharmacist(s). If you maintain your SOPs in an electronic version, access should be limited to a read-only format, thereby protecting against unauthorised changes made to the document.

To make sure that only the most recent SOPs are being used in the pharmacy, all SOPs should be version controlled, e.g. version 1.0, version 2.0 etc.Old versions of SOPs should be archived, and kept separately from newer versions so there is no risk of out of date procedures being used by staff.

Last updated December 2016