Workplace Regulations - Standard Operating Procedures

• What is a standard operating procedure?

  A standard operating procedure (SOP) specifies in writing whatshould be done, when, where and by whom
• What are the benefits to having an SOP? (8)

  *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 *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 be in charge of writing SOPs?

  • The development of SOPs should be overseen by the responsiblepharmacist.
  • Alternatively, the superintendent pharmacist will be accountable forensuring that SOPs are developed and implemented.
  • It is good practice to involve all staff involved in the dispensingprocess in the preparation of SOPs or tailoring of SOP templates.
  • This will help to engage staff and ensure that the proceduresspecified are followed
• What are must covers in legislation of SOPs?

  • 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
• What are the arrangements of 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
• What are the staff competence for tasks (sop related)?

  • Pharmacists who delegate parts of the dispensing process toothers are required to document (within an SOP) the tasksthat can be delegated and to which staff.
  • This process provides an opportunity to clarify roles within thepharmacy.
  • Staff will be clearer as to when they should refer to thepharmacist and be more aware of the limits of their owncompetence.
• What are some pharmacy procedures in practice we must have in place?

  • 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*pest control policy *confidentiality procedure AND MANY MORE
• What should SOPs be?

  SOPs should:* Be pharmacy specific* Be dependent on the competence of the staff working in thatpharmacy;* Under normal circumstances, be applicable at all times, i.e. notdependent on the presence of the pharmacist under whoseauthority the procedure was prepared
• What should be considered when preparing the SOPs?

  • Objectives
  • Scope
  • Process
  • Responsibility
  • Training
  • Review
• How often should the SOP be reviewed and + what should be identified?

  • Royal Pharmaceutical Society recommend once every two years or if anincident occurs.
  • The pharmacy procedures should identify:
  • the Responsible Pharmacist who reviewed the procedure,
  • the procedures in place
  • which procedures were previously in place
• What is a temporary adjustment + what to do?

  • 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