Decisions taken at the Feb & May 2016 Council meetings
The following summary contains the issues discussed and decisions taken by Council during its meetings held on 14 and 15 October 2015, and 17 and 18 February 2016. Some issues are dealt with as separate items in this edition of Pharmaciae or directly with affected parties, and the remaining will be addressed in future editions.
Applicants with a qualification obtained outside South Africa
The Office of the Registrar received applications from candidates who wished to be registered as pharmacists or pharmacy support personnel.
In July 2011, Council resolved that applicants who supplied proof of completion of internship with the regulatory authority of their country of qualification be required to register as interns and complete six months of internship.
In July 2015, Council also resolved that candidates approved to complete a minimum of six months internship be required to submit documentary evidence, from the regulatory body of their country of qualification, they have complied with the continuing professional development (CPD) requirements. Council resolved further that candidates who failed to submit proof they had complied with CPD requirements be required to comply with the CPD requirements for interns registered with Council, to ensure fair and equitable requirements are applicable to all interns.
Council previously approved Guidelines for persons who hold qualifications in pharmacy obtained outside South Africa, as well as criteria to be used in the evaluation of these applications.
In October 2015, Council resolved that the sentence ‘a certified copy from the International Language Testing System’ in the guidelines for persons who hold qualifications in pharmacy obtained outside the Republic be replaced by ‘an original certificate from the International English Language Testing System’, and all certificates received be authenticated with the British Council.
Council resolved the following during the October 2015 and February 2016 meetings.
- Mses E Chingwaru and MS Mabaudi be registered as pharmacist interns after successfully completing the professional examinations and a required minimum of six months internship in an institutional or community pharmacy, and the preregistration examination, CPD requirements and one (1) progress report, prior to registration as pharmacists.
- Messrs MNS Patel, MBA Tailor, CE Theketsa, NS Naik, C Bojedla, V Muppalla, A Sumanth, NCK Panja, LI Khoete, FMS Patel, MJ Mosola, and Mses KBM Monanabela and A Mahoro be registered as pharmacist interns after successfully completing the professional examinations and a required minimum of 12 months internship in an institutional or community pharmacy, and the preregistration evaluation, prior to registration as pharmacists.
- Council resolved further that it would consider reducing the internship of candidates in (b) above to six months on condition they submit proof of practical training/internship from the pharmacy regulatory body in their country of qualification.
- Ms VA Amlabu be registered as a pharmacist intern after successfully completing the professional examinations and a required minimum of six months internship in an institutional or community pharmacy. Ms Amlabu also be required to successfully complete the preregistration examination, CPD requirements, or provide documentary evidence of compliance with the CPD requirements in her country of qualification and one (1) progress report, prior to registration as a pharmacist.
- Mses FGV Lavreau and JA Gawehn, and Messrs R Paturi and S Lorato be registered as pharmacist interns after successfully completing the professional examinations and a required minimum of 12 months internship in an institutional or community pharmacy, and the preregistration evaluation, prior to registration as pharmacists.
- Ms M Sithole be allowed to register as a pharmacist’s assistant learner post-basic and be required to complete a module on pharmacy law and ethics with an accredited provider. Mr Sithole also be required to successfully complete a minimum of six months in-service training at a registered training facility under the supervision of an approved tutor and submit a four (4) month progress report.
Amendment to the Guidelines for persons with qualifications obtained outside South Africa
The Office of the Registrar received an anonymous email in July 2015, alleging that one of the applicants who had submitted an application for evaluation of credentials may have submitted a fake copy of an International English Language Testing System (IELTS) certificate.
Pursuant to the allegation, the Office requested the applicant submit an original IELTS certificate. As of the date of this publication the applicant had not submitted the original certificate.
The Office received another email in July 2015, concerning the submission of fake copies of IELTS certificates by some applicants from a particular country. The current guideline requires an applicant to submit a certified copy of the IELTS certificate.
In October 2011, Council resolved that the Office of the Registrar request that foreign qualified pharmacists who obtained their qualifications in any language other than English submit their IELTS certificates demonstrating their English proficiency at overall band score six before their application to sit the examination be considered. The IELTS band six indicates they can use and understand fairly complex language, particularly in familiarly situations.
In May 2012, Council resolved that all applications must include a certificate from the International English Language Testing System (IELTS) demonstrating English proficiency at overall band score six.
In October 2015, Council resolved that all new applications for evaluation of foreign qualifications must include original IELTS certificates and that these must be checked for authenticity with the British Council, and that the Office of the Registrar authenticates with the British Council all IELTS received from 2012.
Primary Care Drug Therapy update workshop
In July 2015, the Office of the Registrar informed pharmacists that the PCDT medicine list had been approved by the Medicines Control Council (MCC) and outlined the process of issuing PCDT permits in terms of section 22(A) 15 of the Medicines and Related Substances Act.
The North-West University (NWU) enquired if they could hold PCDT update workshops in 2015/16, considering the list of medicines for PCDT pharmacists had been updated. This was to accommodate pharmacists who completed the PCDT course prior to 2011.
In June 2012, the Education Committee approved that both Nelson Mandela Metropolitan University (NMMU) and NWU could offer PCDT update workshops for a period of one year. The NWU is accredited/approved by Council as the provider of Pharmacotherapy I, Pharmacotherapy II and Applied Pharmacotherapy and, upon successful completion of this supplementary training, the candidates become eligible for registration with Council.
In October 2015, Council resolved that the NWU and NMMU continue offering the workshops as previously approved by Council, but that other providers wishing to offer the PCDT update workshops be required to follow the normal process of accreditation by Council.
Control of access to pharmacy premises
In June 2015, Council inspectors raised a concern over the definition of unfettered access to pharmacy premises. In some of the pharmacies, the inspectors observed that the pharmacist and a store manager, who was not registered with Council, held keys to the pharmacy – the so-called double lock system which requires that both the pharmacist and the person in possession of another key need to be present to open the premises.
According to the Rules relating to good pharmacy practice, a pharmacist must have unfettered 24-hour access to the pharmacy. The rules state further that, for control of access to pharmacy premises, the responsible pharmacist must ensure that any key, or device which allows access to a pharmacy, is kept only on their person or that of another pharmacist.
Given the legislative provisions, it appears that the pharmacist in such instances does not have unfettered access to the pharmacy premises and persons who are not registered with Council have uncontrolled access to medicines and scheduled substances.
Council indicated they did not foresee a problem with a double-lock system as the pharmacist has to be present when the pharmacy is opened.
The term “unfettered” is outdated and does not take into consideration the changes in the market and the fact that there are now pharmacies within malls, etc. There was a proposal to consider removing the sentence ‘the requirement for unfettered access to the pharmacy’ and replacing it with ‘A pharmacist must have access to medicines when present in the pharmacy but they must, however, ensure that there is no unauthorised access to medicines in their absence’.
The responsible pharmacist must demonstrate to the inspector they are able to open the pharmacy at any time of the day. A pharmacy must be opened by a pharmacist and may only trade when the pharmacist is present. The responsible pharmacist must provide a written standard operating procedure (SOP) that clearly shows they are able to access the pharmacy at any time of the day, and which covers access to the pharmacy in emergency or extraordinary situations.
In the case of a primary healthcare clinic (PHC), the post-basic pharmacist’s assistant must ensure that any key, or device which allows access to a dispensary or medicine room, is kept only on their person, another pharmacist’s assistant (post-basic), a licensed dispenser or a pharmacist, at all times. Council was informed that the operational manager/nurse may hold the pharmacy keys, but a pharmacist’s assistant (post-basic) or pharmacy technician must be present when the dispensary opens.
In October 2015, Council resolved that the inspection questionnaire be amended to include a question on SOP on persons authorised to hold the key to the pharmacy in emergency circumstances in line with Good Pharmacy Practice (GPP) rule 1.2.4(c), which states “a procedure must be in place to ensure access to pharmacy premises in an emergency situation in compliance with the Occupational Health and Safety Act, 85 of 1993.