Week 27 - workplace regulation Flashcards
SOP
A standard operating procedure (SOP) specifies in writing what
should be done, when, where and by whom
Benefits
-Help to assure the quality and consistency of the service
-Help to ensure that good practice is achieved at all times
-Provide an opportunity to fully utilise the expertise of all members of the pharmacy team
-Enable pharmacists to delegate and may free up time for other activities
-Help to avoid confusion over who does what (role clarification)
-Provide advice and guidance to locums and part-time staff
-Are useful tools for training new members of staff
-Provide a contribution to the audit process
Who should write them
-The development of SOPs should be overseen by the responsible pharmacist -> alternatively the superintendent pharmacist will be accountable for ensuring that SOPs are developed and implemented
-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
Responsible pharmacist
The responsible pharmacist must maintain and keep under review procedures designed to secure the sale and effective running of the business
->If they are already established
Pharmacy procedures (in legislation)
Must cover:
-Arrangements for medicinal products
-Advice given by non-pharmacists
-Staff competence for tasks
-Record keeping
-Responsible Pharmacist absence arrangements
-Responsible Pharmacist handover
-Complaint’s procedures
-Incident management
-Changes to the procedures
Arrangements for medicinal products
The arrangements to secure that medicinal products are:
-Ordered
-Stored
-Prepared
-Sold by retail
-Supplied in circumstances corresponding to retail sale
-Delivered outside the pharmacy
-Disposed of in a safe and effective manner
Staff competence for tasks
Pharmacists who delegate parts of the dispensing process to
others are required to document (within an SOP) the tasks that can be delegated and to which staff
-This process provides 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
Content
All pharmacies operate differently -> and will need to reflect this
There are some general principles that will apply
SOPs should:
-Be pharmacy specific
-Be dependent on the competence of the staff working in that pharmacy
->Under normal circumstances, be applicable at all times - not dependent on if Responsible Pharamacist is present
-There is no single template that can be applied to all pharmacies
Pharmacy staff
-You need to be satisfied the pharmacy staff are aware of and
understand the pharmacy procedures which are in place
->Includes any amendments or changes to the pharmacy
procedures during reviews
-One way of ensuring this is keeping a log where once members of staff read and have understood the pharmacy procedures the log is
completed to show this
->Additional points to consider could include team training on
procedures
Preparing SOPs
There is no right or wrong way to write an SOP but for each
SOP, you could consider the following:
-Objectives
-Scope
-Process
-Responsibility
-Training
-Review
Objectives
What is the procedure trying to achieve?
Scope
What areas of work are to be covered by the procedure?
Stages of the process
Description of how the task is to be carried out
Responsibility
Who is responsible for carrying out each stage of the process?
-Under normal operating conditions and under different circumstances
Review
->The pharmacy procedures must be reviewed regularly
-Royal Pharmaceutical Society recommend once every two years or if an incident occurs
The pharmacy procedures should identify:
-The Responsible Pharmacist who reviewed the procedure
-The procedures in place
-Which procedures were previously in place
Temporary adjustments
E.g. Staff off sick
-Use professional judgement!!
Maintain an audit trail to identify:
-Which procedures are in place
-Which procedures were previously in place
-The Responsible Pharmacist who amended the procedure
-The date on which the amendment was made