Pharmaceutical Society of South Africa
PSSA ANNUAL REPORT 2015/2016
The Annual Report highlights only some of the PSSA’s activities. Many activities of the PSSA are routine and on-going. A comprehensive account of the year’s activities can be found in the documentation sent during the year to the National Executive Committee, the frequent e-newsletters issued by the National Office to all members and the South African Pharmaceutical Journal.
GENERAL
1. Changes in PPS contact details
For some years now, the PSSA Professional Indemnity Product has been offered in partnership with PPS. The primary contact person has been Charles Skinner, and many PSSA members have been assisted by him when they have been faced with a potentially devastating insurance claim.
Charles retired on 30 April 2016. The PSSA joined with PPS in thanking Charles for his valued service and input on the PSSA Professional Indemnity Scheme. He has always gone out of his way to support members who found themselves in the unfortunate situation where a negligence claim was filed against them. The PSSA wishes him a fruitful and satisfying retirement.
To ensure that the excellent service that Charles has provided continues following his retirement, PPS has taken steps to ensure that members will be given appropriate support. This will be achieved by allocation of various queries to appropriate entities. Members may contact the PSSA office for contact details.
2. Expanded services from PPS
PPS has announced further “free extensions” that will be added to the Professional Indemnity Product. The PSSA, in partnership with PPS, has arranged that certain extensions for the PSSA Professional Indemnity Product will be offered free of charge to PSSA members, and will become effective at renewal of the policy. The free extensions included from renewal are:
• Free Legal Assist Line • Health and Safety Hotline • Business Identity Theft Cover
3. Free CPA membership for PSSA members
The PSSA has been a member of the Commonwealth Pharmacists Association (CPA) for many years, and has been actively involved in its activities. A recent decision of the CPA was that it is important to expand its benefits to pharmacists. In the past, a pharmacist wishing to become an individual member of the CPA was required
to pay an annual membership fee.
The PSSA is delighted that free membership of the CPA is now offered to all registered pharmacists of CPA member organisations. PSSA members can register for free on the CPA website, and can enjoy the benefits offered to individual members by the CPA.
4. Specified Schedule 5 register
The PSSA is currently in the process of obtaining legal clarity on the current requirement of SAPC inspectors that community pharmacists should be in possession of, and should maintain, specified S5 registers. The legal opinion obtained will be forwarded to the relevant authority.
DISPENSING FEE
1. 9 September 2015 – Comment on the proposed dispensing fee for pharmacists published on 15 June 2015
The Pharmacy Stakeholders Forum (PSF) rejected the proposed fee and asked that that a fee adjustment in line with the inflation rate should be applied.
The PSF reminded the Pricing Committee that the dispensing fee should be adequate to cover all business costs, provide for a return on investment as well as the professional fee or salary for the pharmacist.
Despite the requirement that the dispensing fee should be reviewed annually since it came into operation in 2010, it was only adjusted in September 2013 and March 2015, and now in June 2015 a draft fee for comment has been published.
The PSF analysis of the proposed fee income compared to the March 2015 fee, utilising two independent data sets, one covering medicines dispensed over a three month period and the other covering a period of six months, reflected that the average fee income increase would be less than 2% whilst at the same time the inflation rate for South Africa for 2015, based on the consumer price index, was 4.36 % as at the end of July, with the July figure peaking at 4.7%.
For this reason, the PSF had no choice but to reject the proposed fee income and request that a fee adjustment in line with the inflation rate should be applied.
The zero base model on which the dispensing fee is calculated is very basic and outdated. We would therefore prefer that the review of the methodology for the systematic review of the dispensing fee for pharmacists, as published in Government Gazette No 39046 on 31 July 2015, be prioritised in order to develop a new and more equitable methodology be utilised for the determination of the dispensing fee for 2016.
2. 30 October 2015 – PSF comment on Methodology for the systematic review of the dispensing fee for pharmacists
Comment on the review of the methodology for the systematic review of the dispensing fee for pharmacists was published in Government Gazette No 39046 on 31 July 2015. The PSF requested that this should be prioritised in order to develop a new and more equitable methodology be utilised for the determination of the dispensing fee for 2016.
Its motivation was that the current dispensing fee for pharmacists is based on a rudimentary Zero Base costing model, a conservative return on investment component and the expectation that 2300 items should be dispensed in order to determine a dispensing fee for an efficient pharmacy. Despite the fact that the dispensing fee is based on low operating costs recognising only 21 cost items, this fee is then published as the maximum dispensing fee income permitted. Publishing this fee as a maximum fee creates the impression that the fee is substantial, which results in a reimbursement level, as determined by medical schemes, at a considerably lower fee level, depending on medical scheme reimbursement policies. The result is that in many cases medicines are dispensed at a level that is inadequate for cost recovery. If a pharmacist charges any higher fee, it will be in contravention of the Medicines and Related Substances Act, 101 of 1965, which constitutes a criminal offence. This position emphasised the urgent need to review the methodology used in the determination of the dispensing fee for pharmacists and we will assist wherever possible.
A proposal on the methodology to be followed in the determination of a dispensing fee was prepared for the PSF by the company HealthMan, and accompanied the PSF submission.
3. 25 February 2016 – Letter to the Minister of Health requesting a meeting
On 5 February 2016, a new dispensing fee was published. The PSSA’s analysis of the maximum increase allowed by the new dispensing fee, that should cover the professional fee income and all business costs, reflects an increase of only 2.4 % year on year. This analysis was done comparing actual prescriptions dispensed over a one year period, January 2015 until December 2015, comparing the March 2015 fee with all these items “re-p riced” with the fee published on 5 February 2016.
The PSSA wrote to the Minister of Health, Dr Aaron Motsoaledi, requesting an urgent meeting to discuss the dispensing fee. A meeting with the Pricing Committee has now been scheduled for 18 May 2016.
NATIONAL HEALTH INSURANCE
PSSA comment on the White Paper
In December 2015, the White Paper on National Health Insurance was published in the Government Gazette for comment. At the time of writing this report, the PSSA is in the process of finalising the comment that will be submitted. Advocate Elsabe Klinck is assisting the PSSA in this process.
It is noted that the White Paper is substantially similar to the Green Paper, so the PSSA submission of 23 December 2011 is being used as a basis for the current submission. It will however be expanded with the emphasis on ensuring that the best pharmaceutical services are provided by the best trained healthcare professional, i.e. the pharmacist, and that other providers of these services should be the exception rather than the rule.
PRIVATE HEALTHCARE MARKET INQUIRY
PSSA submission to the HMI
The Healthcare Market Inquiry (HMI) launched by the Competition Commission has been in operation since early 2014, and has already accomplished many of its key objectives. In October 2014, the PSSA made a written submission to the HMI, which is currently in the process of gathering evidence on the possible impact of market structure and the conduct of market players on competition in the private healthcare sector. It is essential that extensive evidence, data and analyses are submitted, but the HMI is also engaged in interactions with stakeholders.
A number of public hearings into different aspects of private healthcare were scheduled for 2016. The initial set of hearings was conducted over a four week period, and was been roughly divided into four sets of stakeholders, namely consumers, service providers, funders and regulators.
In its brief to stakeholders, the HMI indicated that in addition to an indication of how private healthcare services are provided and funded, they would like to understand the impact of the regulatory framework on stakeholders.
In February 2016, the PSSA and ICPA were given the opportunity to address the panel, headed by former Chief Justice Sandile Ngcobo, on the challenges to pharmacists. The PSSA was represented by Joe Ravele, a community pharmacist who serves on the PSSA national executive committee, and Lorraine Osman.
The PSSA presentation was divided into four sections • Regulatory framework
• Healthcare funding
Because this set of hearings is general rather than technical, the presentation therefore focused on familiarising the Panel, the Evidence Leaders and the technical team with the community pharmacy environment.
The presentation was deliberately factual and professional, and it was made clear that the intention was to explain with examples, the complexities of the community pharmacy world, and not to go on a medical scheme or regulatory authority bashing expedition in an inappropriate forum.
Four documents are available on the PSSA website– the PSSA submission to the HMI, a summary of the points raised in the presentation, the PSSA presentation, and the notes to the slides.
OTHER SUBMISSIONS AND OFFICIAL
COMMUNICATION
1. 4 May 2015 – Recommendation to amend General Regulation 28 of the Medicines and Related Substances Actm 101 of 1965
General Regulation 28 of the Medicines and Related Substances Act, 101 of 1965, states that the particulars listed in the regulation are the minimum that must appear on a prescription. Clearly, the prescriber is at liberty to add additional information should s/he believe that it is appropriate. The PSSA recommended to the Director General: Health that consideration should be given to inclusion of an additional piece of mandatory information. The addition of the patient’s identity number to the mandatory particulars would assist pharmacists and prescribers to ensure that specific medication supplied to patients can be easily and suitably monitored.
2. 14 May 2015 – Norms and Standards Regulations in terms of Section 90(1)(b) and (c) of the National Health Act, 2003 (Act No. 61 of 2003), applicable to certain categories of health establishments
Introduction of these norms and standards should go a long way to ensuring that the quality of all health services is continually improving.
Although these regulations deal with policy issues that must be implemented in practice, there are a number of operational issues that must be addressed by health establishments.
It is clear that to enable pharmaceutical services to fulfil their role in health care, Health Establishments must ensure that the pharmacy has appropriate and sufficient resources in order to do so. At present, the inadequacies are particularly evident in Human Resources and computerisation. In particular, computer systems to manage stockholding, ordering and dispensing are no longer a luxury and should be a minimum requirement in any pharmacy facility.
Computerisation is also critical if the requirements of Regulation 62 are to be met. This regulation deals with health records management. Manual systems for patient recordkeeping are notoriously unreliable and largely inaccessible, especially once
they have been archived.
The only way the health establishment (public sector) could possibly comply, would be to computerise patient recordkeeping.
3. 14 May 2015 – Procedural regulations pertaining to the functioning of the Office of Health Standards Compliance and its Board made in terms of section 90(1)(a) of the National Health Act, 2003 (Act no. 61 of 2003)
In general, these regulations were supported but it was pointed out that both the Pharmacy Council and Medicines Control Council have extensively trained and experienced inspectors. It would be useful to make use of their expertise by appointing these inspectors in terms of this Act.
4. 28 May 2015 – Draft Good Pharmacy Practice Standards
Many members expressed their belief that if the draft standards were accepted, they would be unlikely to stand up to scrutiny should they be challenged in court. The recent Supreme Court of Appeal judgement in the case of Medirite v South African Pharmacy Council (197/2014) [2015] ZASCA 27 (20 March 2015) was quoted to support their opinion.
The proposed amendments were to Rule 1.4 (Minimum standards for community or institutional pharmacies providing mobile pharmaceutical services), Rule 1.5 (Minimum standards for community or institutional pharmacies operating internet sites), and Rule 2.7.5 (Minimum standards relating to the collection and the delivery of medicines to patients from a community or institutional pharmacy). An additional rule, Rule 1.10 (Minimum standards for a community pharmacy or institutional pharmacy operating a remote automated dispensing unit (RADU)) was also proposed.
5. 18 September 2015 – 2015-2016 COIDA Medical Tariffs Consultations
The Executive Director of the PSSA met with officials of the Compensation Fund to discuss the complexities of remuneration of pharmacists for their professional services. In view of the fact that the dispensing fee for pharmacists is regulated by the Medicines and Related Substances Act, 65 of 1965, and is not left to free market forces, the PSSA believes that it is appropriate to remunerate pharmacists by paying the legislated dispensing fee.
6. 18 September 2015 – Proposal to amend the inscription of codeine and dihydrocodeine in the Schedules
7. 13 October 2015 – Amendments to the PMB Regulations as proposed in Government Gazette No. 38990, 14 July 2015
The PSSA believes that significant discussion with stakeholders is required prior to finalisation of any amendments to the PMB regulations. All possible unintended consequences would come to light during such discussions, and other shortfalls, such as the lack of the mandatory 2-year review of the PMBs, and its contribution to the current uncertain PMB environment, would be better understood.
8. 4 November 2015 – Legal opinion on publication of fees
The PSSA obtained legal opinion from Pierre Marais on the current publication of fees by the SA Pharmacy Council as a board notice rather than as regulations. This continues to be disputed by the SAPC. The PSSA is currently continuing investigation into this matter.
9. 18 December 2015 – Proposed guidelines for the issuing of licences for pharmacy premises
The revisions that were made following the previous publication for comment in 2014 are appreciated, and the PSSA continues to support the intention to have clear guidelines that will be fair, practical and consistently applied. The guidelines are clearly intended as an administrative aid in ensuring appropriate and effective implementation of regulation 7(2) of the Regulations relating to Ownership and Licensing of Pharmacies, GNR 533 of 25 April 2003.
10. 13 January 2016 – Proposed application fee: Application for a licence for pharmacy premises The draft fee was published by the Director-General: Health in terms of regulation 8(1)(b) of the Regulations Relating to the Ownership and Licensing of Pharmacies.
The PSSA is very sensitive to fees and firmly believes that the licence application fee must not be viewed in isolation. It must be considered within the context of the cost of registering a pharmacy. Current fees are:
• Pharmacy premises application for licensing R1000.00 • Recording of a pharmacy R9845.71 • Recording of a pharmacy owner R1866.77 • Registration of a Responsible Pharmacist R1829.43
These are merely some of the costs which must be considered, together with those associated with the Good Pharmacy Practice requirements of the Pharmacy Council.
It must also be noted that these costs are also incurred when relocation, which may be beyond the control of the pharmacist, is treated in the same way as a new application.
The draft fee proposed would be R 1857.98, which would be an unacceptable increase of 85.8%, which the PSSA could not accept.
11. 30 March 2016 – Comment on the National Public Health Institute of South Africa Bill
The PSSA supports the Bill in general but suggested that the composition of the Board should be amended so as to include five members with special knowledge rather than four. The additional member should be a pharmacist with special knowledge of medicine supply management.
While there is certainly much corrective action taking place currently, logistics and the supply of medicines frequently appear to be problematic. Medicines form the basis of most interventions made by healthcare professionals. In order to achieve the object of providing a high level of coordination across functions, therefore, the PSSA suggested that it is appropriate that a medicine supply management specialist should join the Board.
12. 28 April 2016 – Letter to SMASA supporting SMASA’s comment on the proposed rescheduling of diclofenac
The PSSA congratulated SMASA on the comprehensive comment submitted to the Medicines Control Council, particularly the methodical analysis of the data presented by the MCC as well as the additional information supplied. The PSSA supports the submission and SMASA’s recommendations.
MEMBER COMMUNICATION AND
PUBLICATIONS
E-newsletters to members – The e-newsletters continue to be
the most significant way in which the PSSA keeps its members informed of current events and important information.
Journals – Medpharm Publications continues to publish the
South African Pharmaceutical Journal and the South African Pharmacist’s Assistant on behalf of the PSSA. Current discussions are on the implementation of an Executive Committee decision to publish the SAPJ six times a year instead of the current ten times a year. This decision was made largely because of the financial implications of publishing the SAPJ. It is believed that, thanks to the e-newsletters and the facebook page, members will not be disadvantaged by this, as important information is sent out on an immediate ad hoc basis.
Facebook – In addition to the PSSA’s facebook page, SAAHIP
has a page, as do a number of PSSA and SAAHIP branches. This continues to be well supported, with more than 1000 members.
Media relations – from the beginning of 2016, the PSSA has been
working together with Refresh Connect, a communications firm. A number of media releases have been successfully sent out, covering various events on the health calendar. Coverage in the media, including various radio interviews of Lorraine Osman, Gary Black and Jackie Maimin, as well as publication on a number of media websites, has been satisfying.
PSSA Pharmacy Law Compendium – This continues to be
PSSA National Executive Committee
2016/2017
The PSSA is pleased to announce its new National Executive Committee.
President Sarel Malan
Deputy President Stéphan Möller Honorary Treasurer Michéle Coleman
Past President Johann Kruger
Vice President (APSSA) Sandra van Dyk Vice President (SAACP) Christine Venter Vice President (SAAHIP) Joggie Hattingh Vice President (SAAPI) Yolanda Peens
Border and Eastern Districts Sim Pambuka
Cape Midlands Peter Giltrow
Cape Western Province Donald Black, Nadine Butler, Gawie Malan, Aadila Patel
Free State Blenn Eagar
KwaZulu-Natal Coastal Evan Lapin, Patrick O’Donoghue KwaZulu-Natal Inland Juané van der Merwe
Limpopo Eric Seepe
Mpumalanga Francois van der Walt
Northern Cape Shawn Zeelie
North West and YPG Mariet Eksteen
Pretoria Morné Adamson, Joe Ravele
Southern Gauteng Val Beaumont, Charlie Cawood, Walter Mbatha, Lynette Terblanche
