Decisions taken at the October 2014 & February 2015 council meetings
The following is a summary of some of the issues discussed and decisions taken by Council during its meetings held on 15 and 16 October 2014 and 18 and 19 February 2015. Other important issues are dealt with as separate articles in this or future editions of Pharmaciae.
Drafting of qualifications for specialists in pharmacy
In October 2014, Council resolved that the Specialist in Pharmacy: MPharm (i.e. Public Health Pharmacy and Management, Clinical Pharmacy and Radiopharmacy) qualifications be approved for wider consultation by way of publication as a Board Notice in the Government Gazette for a period of two months.
Drafting of Good Pharmacy Education Standards (GPES)
In October 2014, Council resolved that:
- The Good Pharmacy Education Standards be approved for wider consultation by way of publication as a Board Notice in the Government Gazette for a period of two months subject to the removal of the code of conduct for students in the standards, as it did not relate to the provider, and that this code be included in the Rules relating to the code of conduct of registered persons.
- The Office of the Registrar consult with the Department of Higher Education and Training (DHET) when drafting the minimum standards for outsourcing services by accredited providers as the DHET will be drafting a policy on partnerships and collaborations.
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 pharmacist’s assistants and an appeal by an intern, Ms Jivan, for a reduction of her internship period. Council resolved that:
- Messrs M Kandimalla, M Valluru, PA Azeh, SKR Tangirala, SR Valluri, SI Mukardamwala, SI Patel, CS Moru and J Elugubanti, and Mses MC Koppuravuri, ASDCMF Pimentel, N Abdul Azeez, PA Liboke, and A Wafaa be registered as pharmacist interns after successfully completing the professional examinations and a minimum 12-month internship in an institutional or community pharmacy and the preregistration evaluation prior to registration as a pharmacist.
- Mr GM Mushayi and Ms LA Moore be registered as pharmacist interns after successfully completing the professional examinations and a minimum six-month internship in an institutional or community pharmacy and the preregistration evaluation prior to registration as a pharmacist.
- Ms T Mugodi be registered as a pharmacist intern subject to the submission of a certificate from the International English Language Testing System (IELTS) demonstrating English proficiency at an overall band score six, prior to writing the professional examinations. Ms Mugodi also be required to successfully complete the professional examinations and complete a minimum 12-month internship in an institutional or community pharmacy and the preregistration evaluation prior to registration as a pharmacist.
- Mr M Ndhlovu be allowed to register as a learner post basic pharmacist’s assistant and be required to complete a module on pharmacy law and ethics with an accredited provider. Mr M Ndhlovu also be required to successfully complete a minimum six-month in-service training at a registered training facility under the supervision of an approved tutor.
- Ms Jivan complete a six-month internship in an approved training facility under the supervision of an approved tutor. Ms Jivan also be required to successfully pass the preregistration examination.
- Mr NG Bepe be registered as a pharmacist intern after successfully completing the professional examinations and a minimum six-month internship in an institutional or community pharmacy and the preregistration examination, prior to registration as a pharmacist.
Second National Pharmacy Conference
In its 2014–2018 Strategic Plan, Council approved that a Second National Pharmacy Conference be held in September 2016. The Pharmaceutical Society of South Africa (PSSA) requested Council to consider a joint conference with pharmacy professional organisations.
In October 2014, Council resolved it would continue to host the 2016 conference on its own, and that 11–14 September 2016 be approved as the official conference date. This date will be communicated to Tshwane University of Technology as the convener of the Academy Conference for 2016 to ensure there are no clashes, and the Office of the Registrar will proceed with the appointment of a conference/event management company for the 2016 Second National Pharmacy Conference.
Preregistration evaluation: CPD and examination
In October 2011, Council resolved that the preregistration evaluation will consist of two components, the written preregistration examination and the online CPD submission.
In February 2012, Council further resolved that interns must successfully complete the CPD component of the preregistration evaluation. The criteria for successful completion are the submission of all required eight entries and competence in six of the eight entries. Interns are to submit a total of eight entries, one entry for each competence outcomes one to seven, plus one entry from competence outcomes eight to 10. One entry is to be submitted per month, with formative assessments taking place after four months, and summative assessments after eight months. Pharmacist interns may resubmit for summative assessment CPD entries that had been deemed not yet competent during formative assessment. The CPD entries are submitted online.
In October 2014, Council resolved that the entrance requirements for the preregistration examination, in addition to registration for a minimum period of six months by the examination date, also include the submission of four CPD entries and at least one progress report, i.e. the 12th week progress report. The entrance requirements for the preregistration examination for a pharmacist intern registered for a minimum period of nine months by the examination date, also include the submission of eight CPD entries and the 12th, 24th and 36th week progress reports.
Recognition of previous postgraduate qualifications for specialisation and access to the Specialist Register
The Office of the Registrar is receiving enquiries from individuals, who have already acquired postgraduate qualifications, enquiring if their qualifications will be recognised when registering as a specialist. This matter was also raised during the narrow consultation meeting with stakeholders in July 2014. In October 2014, Council resolved that candidates who have achieved a relevant master’s degree and who wish to register within one of the specialities, request an accredited provider of the professional master’s degree(s) registered for specialisation purposes for assessment or recognition of prior learning, the provider issue a certificate of competence when the candidate has met the relevant professional master’s degree qualification requirements, and that Council recognise and register, for the period of practical training, those candidates deemed competent by the accredited providers of the specialist qualifications.
Monitoring visit to Health Science Academy (PTY) Ltd
Council conducted a monitoring visit to Health Science Academy (Pty) Ltd (HSA) in July 2014. In October 2014, Council resolved that the report on the monitoring visit to Health Science Academy (Pty) Ltd be accepted and approved. Further, that HSA be required to provide an updated long term business plan incorporating the 2014 plan and detailing the deployment of its leadership (organogram) to ensure the effective delivery of the programme. These documents should be submitted to the Office of the Registrar no later than thirty days from Council’s approval of the report and receipt by the HSA. Council’s resolutions included HSA provide evidence to indicate that all the quality management system activities are recorded and communicated to all the staff within thirty days of receipt of the final report, and, although assessments are revised during June and November, as there is no written policy, such policy should be submitted to the Office within thirty days of receipt of the final report.
Minimum standards for pharmacy premises, facilities and equipment
The Office of the Registrar published Board Notice 272 on 20 December 2013 for comment for a period of three months. The board notice incorporated various Good Pharmacy Practice (GPP) amendments and new standards. Comments were invited until 20 February 2014. Some stakeholders were invited to give oral presentations to clarify some salient aspects of their comments. Most comments, particularly from public sector institutions, stated it would be practically impossible to list all the names, especially those of the pharmacy support personnel. However, it was noted that Council is not prescriptive on the size of the board to be used for the names. In October 2014, Council resolved that the registered designation of the pharmacist be used (e.g. specialist, responsible pharmacist), and a statement, indicating the badge can be either a single or multiple badges, be included to provide clarity on the standard. The minimum standard was approved and published for implementation.
Authority, duties and responsibilities of a responsible pharmacist
The Office of the Registrar published Board Notice 272 on 20 December 2013 for comment for a period of three months. The board notice incorporated various GPP amendments and new standards. Comments were received and acted upon as above. The proposed amendment to the minimum standard is informed by the fact that Council observed that a number of pharmacists were abusing the provision of rule 2.1.1 of Annexure A of the Good Pharmacy Practice, namely the Circumstances and conditions under which a responsible pharmacist may be absent from his/her pharmacy. Such amendments were to take the form of a preamble seeking to explain the intention of Council and amendment to sub rule 184.108.40.206. In October 2014, Council resolved that the suggested preamble be removed from the minimum standard since the intention of the standard is clear enough and cannot be misinterpreted, the amendment to sub rule 220.127.116.11 be accepted, and the amended minimum standards be approved and published for implementation.
Minimum standards for the procurement, storage and distribution of thermolabile pharmaceutical products
The Office of the Registrar published Board Notice 272 on 20 December 2013 for comment for a period of three months. The board notice incorporated various GPP amendments and new standards. Comments were received and acted upon as above. In October 2014, Council resolved that sentence 3.1 (b) that read “No domestic refrigerators shall be deemed suitable for the storage of thermolabile pharmaceutical products” be removed from the minimum standard, the amended standard be approved and published for implementation, and Council allow a period of 48 months for the implementation.
Minimum standards relating to automated dispensing units for the purpose of dispensing medicines and medical devices
The Office of the Registrar published Board Notice 272 on 20 December 2013 for comment as above and comments were received and acted upon. In October 2014, Council resolved that the amended minimum standard be approved and published for implementation.
Selling of Council registers in light of the Protection of Private Information Act
Council is currently selling the registers of persons registered with Council in terms of Sections 14(d), 25 and 27(2) of the Pharmacy Act, 53 of 1974. Section 14(d) states that, with regard to the registration of persons and the recording of pharmacy premises, the Council shall keep, amend, correct and maintain such registers in the format as Council deems necessary, and to cause copies of such registers to be printed at the discretion of Council.
Section 25 states that the Registrar shall cause copies of the registers or supplementary lists showing all alterations, additions, revisions and deletions since the last publication of the complete registers, to be printed and published; and Section 27(2) provides that the Registrar may issue a certified extract of the register to any person upon payment of the prescribed fees. Any person(s) wishing to purchase the register/s may do so by completing the Order Form for Pharmacy and Pharmacist Lists. The use of the registers purchased from Council vary, and include for research purposes, reference lists for manufacturing and wholesale pharmacies, important information pertaining to product/batch withdrawals and direct marketing.
The Consumer Protection Act, 68 of 2008 allows for direct marketing to consumers, provided there is an opt-out option to the direct marketing. Therefore, it is permissible for Council’s registers to be purchased for purposes of direct marketing provided that the recipients of such direct marketing have the ability to inform the marketer that they wish to opt-out of receiving such marketing material. In November 2013 the Protection of Private Information Act, 4 of 2013 (POPI) was assented to by the State President, however only certain sections are currently in operation. When POPI becomes fully operational, one of the things that will change is that when a person provides personal information they must be given the choice to opt in to the sharing of such information before such information is collected. Organisations who have existing data bases of personal information must give existing data subjects the opportunity to make a choice as to whether they opt in to their information being shared.
In light of the impending provisions of POPI it is necessary for Council to ensure that all persons registered with Council, based on the personal information kept by Council, be given the choice as to whether they wish to have their personal information distributed, thus exercising the opt-in option. In October 2014, Council resolved that an opt-in option be included on the register system for all persons registered with Council for purposes of selling or distributing registers, persons who exercise the opt-in option shall have all their personal information included in the register when such register is distributed or sold, Council shall amend the Order Form for Pharmacy and Pharmacist Lists to include the reason for the purchase of the register; and all Council registers distributed or sold shall contain the following clauses: Council registers have been sold in accordance with the POPI Act and that such persons may have chosen to have their personal information excluded from the register for purposes of the distribution or sale of such register; and any person who makes use of the registers for purposes of direct marketing shall ensure that the recipients of such marketing have an opt-out option in terms of the Consumer Protection Act.
Accreditation/monitoring visit: University of Limpopo (Turfloop Campus)
A Council delegation visited the University of Limpopo (Turfloop Campus) between 1 and 5 September 2014 in terms of the Pharmacy Act, 53 of 1974. The University of Limpopo (Turfloop Campus) is currently offering the Bachelor of Pharmacy (BPharm) programme. In 2011, the university did not enrol new first year students. In September 2011, Council resolved that the University of Limpopo (Turfloop Campus) should submit two reports per year and that monitoring visits be conducted yearly to monitor progress on the shortcomings cited in the previous visits. In February 2015, Council resolved that the report on the accreditation/monitoring visit to the University of Limpopo (Turfloop Campus) be accepted and approved, the Office of the Registrar prepare a letter to the university stipulating a deadline for a report on the measures taken (together with verifiable evidence) to correct the identified shortcomings, the quality improvement plan be discussed at the next monitoring visit and the next monitoring visit be conducted before June 2015.
Scope of practice for pharmacy technician students
Council received an enquiry on whether a pharmacy technician student is permitted to work during their training to gain work experience and experiential learning. According to Chapter IV of the practice regulations, pharmacy students may perform the scope of practice of a pharmacist’s assistant (basic) under the direct personal supervision of a pharmacist in a pharmacy. Pharmacy students who have successfully completed their second year of study may perform the scope of practice of a pharmacist’s assistant (post basic) under the direct personal supervision of a pharmacist in a pharmacy. In February 2015, Council resolved that a pharmacy technician student who has elected to proceed with the pharmacy technician qualification, be permitted to practise the scope of practice of a pharmacy technical assistant to gain work experience.
Accreditation/monitoring visit: University of Limpopo (Medunsa Campus): Pharmacy Training and Development Project
In August 2014, Council conducted a monitoring visit to the University of Limpopo: PTDP. In February 2015, Council resolved that the report on the monitoring visit to the university be approved and a letter be written to the university requesting information on how they will address the issues mentioned in the report by 30 June 2015.
Accreditation/monitoring visit: University of the Western Cape
On 18 September 2012, Council received the new University of the Western Cape (UWC) BPharm curriculum for accreditation. The revised curriculum was evaluated in 2013 and approved, subject to the UWC submitting outstanding/further information before the accreditation visit to the school, and Council checking all the evidence during the accreditation visit. Council conducted an accreditation/monitoring visit to the UWC in August 2014. During the visit the panel evaluated the phasing in of the new BPharm programme and the phasing out of the old programme. In February 2015, Council resolved that the accreditation/monitoring report on the UWC be approved and a letter be written to the university requesting information on how they will address the issues mentioned in the report.
Monitoring visit: Abaluleki Professional Consulting: University of Fort Hare Consortium
Council conducted a monitoring visit to Abaluleki Professional Consulting–University of Fort Hare Consortium (APS-UFC) on 23 and 24 October 2014. The institution is currently accredited for the National Certificate: Pharmacy Assistance (Institutional). This was the second visit since the accreditation visit conducted on 12 September 2011. Council resolved in February 2015 that the monitoring visit report on APS-UFC be approved, continued accreditation be subject to the response to deficiencies raised by Council, the response be forwarded to Council within 21 days of receipt of Council’s communication, and a follow-up visit be scheduled for the first quarter in 2015.
Accreditation/monitoring visit: Nelson Mandela Metropolitan University (NMMU) for the PT Programme
In March 2012, Council received the new curricula for the Higher Certificate: Pharmacy Support (PTA) and Advanced Certificate: Pharmacy Support (PT) for accreditation. The curriculum for PTA was approved in 2012 and the PT curriculum was approved in 2013. The first students for the PTA programme were enrolled in 2013 and for the PT programme in 2014. Council conducted an accreditation visit to NMMU for the PTA programme in October 2013. The report and the executive summary of the accreditation/monitoring visit to NMMU were approved by the Executive Committee in April 2014. In October 2014, Council conducted an accreditation visit to NMMU for the PT programme and a follow up on the implementation of Council recommendations made in 2013. In February 2015, Council resolved that the response from NMMU regarding the accreditation visit for the PTA programme conducted in October 2013 be approved, the report on the accreditation visit to NMMU for the PT programme be approved, and the executive summary of the report on the accreditation visit to NMMU for the PT programme also be approved.
Rules relating to services for which a pharmacist may levy a fee and guidelines for levying such a fee or fees
The Board Notice “Rules relating to services for which a pharmacist may levy a fee and guidelines for levying such a fee or fees” (Board Notice No. 193 of 2010) was published for implementation in 2011. The fees were revised by the actuarial company, Fifth Quadrant, in line with the Consumer Price Index for 2012. The revision of the fees is in line with Council’s decisions in 2010, and the rules have been revised annually in line with the CPIX. The Rules relating to services for which a pharmacist may levy a fee have been updated in line with the CPIX 2015 of 6.5% as per budget assumptions of 2014/2015. In February 2015, Council resolved that the revised fee(s) be approved and published.
Accreditation visit to Tshwane University of Technology
The Office of the Registrar received an application to accredit Tshwane University of Technology (TUT) as a provider of the BPharm qualification in May 2012. The Office received copies of their curriculum in July 2012, which Council evaluated in 2013. Council accredited the TUT BPharm curriculum subject to receipt of the requested outstanding information before the accreditation visit, all the evidence being checked during the accreditation visit, and accreditation of TUT as a provider. Council conducted an accreditation visit to TUT in July 2013. In October 2013, Council approved the report on the TUT accreditation visit and its response to identified shortcomings. In February 2015, Council resolved that the TUT response on the issues raised in the Registrar’s October 2013 letter be accepted, the institution be accredited to commence with the training of pharmacists on the BPharm programme with the first student intake from January 2015; provided that TUT supplies the Office of the Registrar with the pharmaceutical department’s vision and mission that is aligned to the university by no later than 1 May 2015, provides signed MoUs to facilitate experiential learning for second year and higher students by no later 1 October 2015. Council further resolved that postgraduates students may be involved in facilitation, but assessments must be conducted by personnel with at least a masters qualification, and the implementation of the programme based on the business plan (2015-2020), including the handling of the pipeline students, be monitored on a yearly basis.
Pharmacist’s assistant learners (basic or post basic) who fail to complete their qualification within 30 months
The Office of the Registrar is experiencing challenges regarding learners who do not complete the qualification within the stipulated time frame of 30 months. This results in blockages of training positions at facilities and reduced throughput in the training of persons in such categories. Council has developed the guidelines for providers of education and training who wish to offer the National Certificate: Pharmacist’s Assistance and the Further Education and Training Certificate: Pharmacist’s Assistance learning programmes. According to these guidelines, the completion time for a learning programme should be less than 30 months. Learners who do not complete the programme within the stipulated time, must be removed from the registers and not be allowed to enrol for the same qualification for a period of two years. These guidelines are enforceable and apply to all pharmacist’s assistants registered for the revised qualification, that is, learners registered with Council from 21 August 2010.
In May 2014, Council resolved that all learners registered under the revised qualification who have exceeded the allotted 30 months, including learners that should be completing the qualification by 1 July 2014, be given an extension of 12 months, to 30 June 2015, to complete their qualification before any deregistration as learners is considered. In February 2015, Council resolved that learners who have exceeded the 30 months or who are about to exceed the 30 months be granted an additional seven-month extension, the extension of which be granted on a case-by-case basis subject to learners submitting the current or latest statement of results from their provider, and a motivation letter from their tutors supporting the request for the extension.
Integration of pharmacy students training in India into the South African system on their return
The Office of Registrar received an enquiry about the students sent to India for the BPharm degree on how they will be integrated into the South African system on their return. In February 2015, Council resolved that students who were sent to India to study a BPharm degree be treated as any other foreign qualified student, i.e. be subjected to the normal process of recognition of foreign qualifications by Council, and that the Office of the Registrar write a letter to the MEC of Health in KwaZulu-Natal regarding Council’s decision and outlining the process. In addition, the Office is to ensure that all the MECs of Health in South Africa receive the information.
Pharmacy Training and Development Project (University of Limpopo Medunsa Campus): Re: second language for post basic pharmacist’s assistants (PBPA)
In July 2014, Council resolved that the recommendation by FET providers for Council to recognise the second language on the Grade 12 certificate for learner post-basic pharmacist’s assistants be rejected and that each provider should use a recognition of prior learning (RPL) process, if appropriate, to credit learners for the second language. In February 2015, Council resolved that the Council resolution of July 2014, that each provider use an RPL process to credit PBPA learners for the second language, be rescinded, and that learners enrolling for the post-basic pharmacist’s assistant programme must have passed the second additional language at NQF level 4 with a minimum of 50% in order to be exempted from the second additional language requirement. Those candidates who achieved a mark below 50% would be required to complete the second additional language component.
Accreditation/monitoring visit: Pharmagenius
Council conducted a monitoring visit to Pharmagenius Academy in August 2014. The institution is currently accredited for the National Certificate: Pharmacist’s Assistance (Community) and Further Education and Training Certificate: Pharmacist’s Assistance (Community). Council resolved in February 2015 that the report on the monitoring visit to Pharmagenius Academy be approved.