Workplace Regulations – Standard Operating Procedures Flashcards
the Responsible Pharmacist
establish, maintain and keeping under review pharmacy procedures
for safe working
Legislation - Medicines Act 1968 (as amended by the Health Act 2006)
Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008
* Regulation 4
Simple definition
A standard operating procedure (SOP) specifies in writing what
should be done, when, where and by whom.
Benefits of workplace regulations
- 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.
he 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)
- 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 and
* 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.
Pharmacy Procedures (in practice)
At a minimum, you should have the following in place covering the day-to-day activities at the
pharmacy:
Dispensing
* Receipt of the prescription
* Therapeutic review
* Transfer of the medicine
* Patient counselling.
* Dispensing high-risk medicines (Methotrexate etc.),
* Dispensing 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)
All pharmacies operate differently, and will need to reflect this. However, 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, i.e. not dependent on the presence of the pharmacist under whose authority the procedure was prepared.
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
how often must the pharmacy procedures be reviewed?
Royal Pharmaceutical Society recommend once every two years or if an
incident occurs
pharmacy procedures should identify:
- Responsible Pharmacist who reviewed the procedure,
- the procedures in place
- which procedures were previously in place
Temporary Adjustments
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
