Responsible Pharmacist

1. Responsible Pharmacist Helen Jackson

2. A Review of Supervision is needed • Supervision linked to personnel control • Personal control = physical presence of the pharmacist in the pharmacy

3. Why introduce a change now? • There is 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

4. 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

5. Legal changes • The Health Act 2006 • Makes 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

6. Responsible pharmacist regulations • The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 • Provides the detailed requirements of the Responsible Pharmacist • Coming into force 1st Oct 2009 • Statutory Instruments • 2008 No. 2789 Medicines The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 • Made 24th October 2008 • Laid before Parliament 29th October 2008 • Coming into force 1st October 2009

7. Key areas covered by Law • Provides detailed requirements for: • Secure the safe and effective running of the pharmacy • Display a notice • Pharmacy procedures • Pharmacy records • Absence from the pharmacy

8. Displaying the Notice From 1st Oct 2009 – do not need to display registration certificate conspicuously 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

9. 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

10. 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 • Contemporaneous record

11. Pharmacy Procedures • RP must establish , 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

12. 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)

13. 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

14. 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

15. Possible scenarios “You are the RP and have agreed to attend the local surgery meeting and still act in the RP capacity for the premises” Thinking about the notice, do you? • Remove the RP notice • Remove the RP notice but add in you are absent • Do nothing

16. Quick Quiz • What is the maximum number of responsible pharmacists there can be at any one time for a registered pharmacy? • Do you have to record the date on which you joined the RPSGB register in the pharmacy record? • You have just become the responsible pharmacist, and the previous responsible pharmacist was absent for 2 hours. How long can you be absent for? • Can the delivery driver pick up bagged checked prescriptions in your absence?

17. The Record Must contain , name, reg number, date and time you became RP Date and time you stopped being the RP If absent – date, time Must be kept for 5 years Must be filled in daily K E Y P O I N T S 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 Responsible Pharmacist Secure the safe and effective running of the pharmacy Display a notice Complete the record Establish, maintain and review procedures The Procedures Must be established, maintained and reviewed Must be marked with date, and date to be reviewed (every 2 years)

18. Support to introduce RP regulations www.responsiblepharmacist.org • RPSGB – toolkit • Developed through feedback by practising pharmacists • Includes • Legal requirements • Good practice pre flight check • Info for locums • Info for support staff • RP certificate • FAQ • Legal and Ethical Advisory Service: leadvice@rpsgb.org

19. The New ProfessionalBody For Pharmacy Update on Progress for TransCom 13th May 2009

20. GPhC and a new Professional Leadership Body • 2007 White Paper: Trust, Assurance and Safety – The Regulation of Health Professionals in the 21st Century • Demerger of the regulatory and professional roles of the Society • In 2010 the General Pharmaceutical Council (GPhC) will be established as the new regulator • A new professional leadership body (PLB) will be created alongside this • RPSGB is working with the profession to build this new body

21. GPhC • The Pharmacy Order 2009 will establish the General Pharmaceutical Council (GPhC) which will be the new regulator for Great Britain’s pharmacists, pharmacy technicians and pharmacy premises in 2010. • The draft Pharmacy Order now has to be finalised before it is laid in Scottish and Westminster Parliaments. The next stages will include the Constitution Order, which will give the detail of the composition of the Council, and the completion of the work which has begun to develop the rules and standards of the GPhC under the Order. • Much of the important detail that will affect pharmacists in their daily work remains to be drafted in the rules and standards.

22. GPhC Will have the following principal functions: • provide for statutory regulation of pharmacists and pharmacy technicians • establish and maintain a register of pharmacists, pharmacy technicians and pharmacy premises • establish and promote standards of proficiency for the safe and effective practice of pharmacy in registered pharmacies • establish and maintain requirements by reference to which registrants must demonstrate that their fitness to practise is not impaired • promote the safe and effective practice of pharmacy by registrants • establish and promote standards in respect of education, training, continuing professional development, acquisition of experience necessary to achieve entry onto the register, or to receive an annotation in the register and to maintain competence.

23. Clarke: New Professional Body • Attitudes towards RPSGB strongly influenced by regulatory role • Must be perceived as new, not just a “re-badged RPSGB” • Mass membership - inclusive, but leading edge too. Pharmacists at the core • Must earn respect of members, Government, regulator and the public • Must generate income from core activity

24. What you told Clarke • You want a professional body • You can have a meaningful relationship with at all stages of your career • Help you network; share good practice; develop as a professional • To fight to raise the status and reputation of pharmacy; and speak for a united profession

25. Member Services • A range of ‘core’ member services • Leadership, representation and advocacy • Professional development and education • Professional support • Professional networking • Professional publications

26. Member Services • Additional services • Members can access on a personalised basis • ‘return to practice’ support • Personalised review of your CPD records • Management support • All services delivered in a variety of ways • Web technology, print, meetings, phone and email

27. What you will see locally • Local Practice Forums developed, working in collaboration to ensure education ‘joined up’ • Pharmacists able to organise themselves locally • Continue as they are currently • Use new Local Practice Forums

28. What you will see nationally • Significant voice for pharmacy in the media and with the public • Able to speak authoritatively on any aspect of members’ practice • Able to speak on all issues affecting the safe and effective use of medicines

29. How will it be structured? • National Boards to form the backbone of the new Professional Body • Members directly elected with seats allocated by sector of pharmacy • Assembly made up of nominated members, to maintain overall strategic direction

30. Who will be able to join? • Members: • Member • International Member • Student Member • Pre-Reg Member • Pharmaceutical Scientist Member • Fellows / Honorary Members: • To continue as is • Post-nominals

31. Thank You