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RESPONSIBLE PHARMACIST

RESPONSIBLE PHARMACIST. Professional Empowerment and Responsible Pharmacist . BACKGROUND INFORMATION. A Review of Personal Control. Personal control = physical presence of the pharmacist in the pharmacy. Why introduce a change ? .

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RESPONSIBLE PHARMACIST

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  1. RESPONSIBLEPHARMACIST
  2. Professional Empowerment and Responsible Pharmacist

  3. BACKGROUND INFORMATION

  4. A Review of Personal Control Personal control = physical presence of the pharmacist in the pharmacy
  5. Why introduce a change ? It was felt that there was a need to introduce enabling legislation for pharmacists to pursue a greater clinical role Within the pharmacy In the same location adjacent to the pharmacy Elsewhere
  6. Phased Approach 1st step - responsible pharmacist regulations These set the quality framework 2nd step - supervision changes This will be enabling legislation Freeing up pharmacists time for enhanced roles
  7. Legal changes The Health Act 2006 Made changes to the personal control and supervision requirements Replaces ‘personal control’ with ‘responsible pharmacist’ Sets out statutory duty of responsible pharmacist Enables ministers to make regulations covering the ability of the responsible pharmacist to be absent from the pharmacy
  8. Superintendent Role Superintendent pharmacist role continues Pharmacies carried on by bodies corporate required to be under the management of a superintendent pharmacist Responsible pharmacist, where he is not the superintendent pharmacist, remains subject to the directions of the superintendent pharmacist

  9. RESPONSIBLE PHARMACIST REGULATIONS

  10. Key areas covered by law Provides detailed requirements for: Securing the safe and effective running of the pharmacy Display a notice Pharmacy procedures Pharmacy records Absence from the pharmacy
  11. Displaying the Notice As the RP you must display a notice with: Your name Your registration number That you are in charge of the pharmacy at that time The notice layout and design is discretionary
  12. The Pharmacy Record The Responsible Pharmacist must record: name and registration number date and time at which the responsible pharmacist: became the responsible pharmacist; ceased to be the responsible pharmacist; In relation to their absence from the pharmacy: The date of absence The time at which the absence commenced The time at which they returned
  13. The Pharmacy Record Can be electronic, in writing or both The pharmacy owner/SI must keep the record for 5 years Identify who has made alterations to either the paper or electronic record If same RP from Mon –Fri, could make record at end of week or every day, must be able to justify that it is a contemporaneous record
  14. Pharmacy Procedures RP must establish (if not already established) , maintain and review procedures Can be electronic, in writing or both Must be marked with date prepared and review date Amendment – temporary change Review – at least once every two years; re-evaluate the content
  15. Pharmacy Procedures Cover arrangements to secure that medicines are ordered, stored, prepared, sold, supplied, delivered & disposed of in safe & effective manner The giving of advice on medicines Identify pharmacy staff competent to undertake specific activities Record keeping (for bullet 1)
  16. Pharmacy Procedures Arrangements when RP absent Steps to be taken when RP changes Procedure when there is a complaint Procedure when there is an adverse incident Notification of changes to procedures to pharmacy staff
  17. Absence from the Pharmacy The Responsible Pharmacist may be absent from the pharmacy for a maximum of 2 hours In order to be absent RP must Remain contactable Be able to return with reasonable promptness If this is not possible another pharmacist must be available to provide advice GSL medicines can continue to be sold

  18. SUMMARY

  19. The Record Must contain: name, reg number, date & time you became RP. Date and time you stopped being the RP. If absent – date, time Must be kept for 5 years. The Notice Must be displayed at all times where members of the public can see it & contain RP name, reg number, state they are in charge of pharmacy. KEYPOINTS The Procedures Must be established, maintained and reviewed Must be marked with date, and date to be reviewed (every 2 years). Responsible Pharmacy Secure the safe and effective running of the pharmacy. Display a notice Complete the record Establish, maintain and review procedures.
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  22. HOSPITAL PHARMACY AND RESPONSIBLE PHARMACY

  23. Activities involving supply of individually dispensed medicines Supply of licensed or unlicensed medicines to patient of the same legal entity –registration with GPhC/PSNI not necessary Supply of licensed medicines to patient of a separate legal entity - registration with GPhC/PSNI is required Supply of licensed medicines to patient of a separate legal entity under a service level agreement or contract - registration with GPhC/PSNI is necessary Supply of unlicensed medicines to patient of a separate legal entity - registration with GPhC/PSNI not required (cannot be handed direct to patient)
  24. Wholesale of Medicines Pharmacy premises registered with the GPhC/PSNI are exempt from the need to hold a wholesale dealer licence (WDL), provided that: Transaction is supervised by a registered pharmacist Transaction constitutes no more than an inconsiderable part of the business carried on at that hospital (not defined in legislation) This is likely to change in the very near future following the consultation on the consolidation of the medicines act..
  25. Activities involving the wholesale of medicines Supply of licensed stock to separate legal entity – either WDL or registered pharmacy premises. Supply of assembled packs to another legal entity – need a manufacturers licence from MHRA. Supply of unlicensed stock to separate legal entity: If want to make the unlicensed medicine and wholesale them: need a manufacturers ‘specials’ licence (MS) If want to only wholesale the unlicensed medicines: need a WDL Supply of stock within the same legal entity: is called distribution – no need for licence or registered pharmacy premises.
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  27. CALL TO ACTION

  28. What can I do? Join the Professional Empowerment Priority Group go to: http://www.rpharms.com/priority-groups/professional-empowerment-group.asp and click on support the professional empowerment Ensure I feel happy with the way in which I work as an RP – talk to my employer / pharmacy owner / SI if I don’t Sign up to the establishment of a ‘Just Culture’ in pharmacy – more details about how to do this will be published over the next few weeks
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