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ANNUALREPORT2016/2017

PSSASection 22 of the PSSA Constitution requires that an AGM of the General Council of the PSSA must be held. This section also specifies the business of the AGM. This includes the report of the President, on behalf of the Executive Committee, covering the activities of the Society and its branches during the past year, as well as the report of the Honorary Treasurer on the audited Annual Financial Statements.

Many of the PSSA activities are ongoing and a comprehensive account can be found in the documentation sent during the year to the PSSA National Executive committee, the frequent newsletters to all members as well as the South African Pharmaceutical Journal, the PSSA website and facebook pages.

Please note:In some instances mentioned below, published legislation is recorded, although at the time of implementation the only activity required by the PSSA was to inform its members so that the legislation could be implemented in practice.

NATIONALACTIVITIES

1. NATIONAL HEALTH ACT, 61 OF 2003

1.1 Universal Access to Health care ( National Health Insurance)

In December 2015, the White Paper on National Health Insurance was published in the Government Gazette for comment. On 24 May 2016, the PSSA submitted its comment to the Director General of Health.

The PSSA was disappointed that the recommendations in its 2011 submission on the NHI Green Paper were not incorporated into any of the elements of the NHI White Paper.

PSSA submission May 2016

In its May 2016 submission, the PSSA reiterated its commitment to universal coverage in healthcare for all. It also confirmed its views that:

• The pharmacist should stand central in the rendering of pharmaceutical services, as is envisaged by pharmacy and medicines legislation;
• Pharmacists are able to render a comprehensive service related not only to medicines, but to primary healthcare and health promotion;
• There are serious concerns as to the CCMDD and PUPs;
• Pharmacists who are contracted into the NHI should be compensated fairly;
• Discussions as to the pricing model for medicines should commence urgently;
• Pharmacists should be actively involved in all the NHI Work Streams;
• Details as to the NHI funding and financing are urgently required.

PSSA meeting with the Director General

On 8 May 2017, representatives of the PSSA and the ICPA met with the Director General (DG) of Health. She explained the background to the discussions about achieving universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.

The DG posed the following questions:

• The Centralised Chronic Medicine Dispensing and Distribution (CCMDD) system is working. How can pharmacists help the DoH to continue working and, for example, to bring the system into townships and rural areas where there are no pharmacies?
• What model of contracting should be used?
• What will it take to get a pharmacy everywhere so that medicines can be obtained without going to tender?
• How is NHI going to create employment for the new generation of pharmacists?

Dr Anban Pillay has worked with the workstream dealing with the purchaser-provider split. It has become clear that the CCMDD is needed in townships and rural settings.

The NDoH is currently working with a process to register healthcare professionals and patients for NHI services. Compliance with the norms and standards for Primary Healthcare services, as contained in the National Health Normative Standards Framework, will be essential for enrolment, which will only be on-line. An important target for 2017 is to register all patients.

The DG explained that the NHI will eliminate all out-of-pocket payments when people need to access healthcare services. This includes abolition of the Uniform Patient Fee Schedule (UPFS) used in the public sector. It has been suggested that medical schemes should collapse the number of options that are offered, and should start by implementing the Essential Medicines List and Standard Treatment Guidelines on some of their options.

According to the DG, the main mechanism of contracting healthcare professionals will be a risk-adjusted capitation system, with an element of performance based payment. In effect, it will be a combination system.

A comprehensive package of healthcare services must be developed. All clinics, including those within pharmacies, must follow the ideal clinic model. Pharmacies that wish to be involved must determine their proximity to a clinic. They must provide health promotion and those services that have been identified as being within their scope of practice, e.g. screening tests.

The DG suggested that the PSSA should meet with SAMA to discuss the “scope creep” that occurs when doctors dispense and pharmacists prescribe. She also appealed to the profession to bring back professionalism.

The next step is to be a follow up meeting with Dr Pillay and the NHI co-ordinator at the Department of Health. The DG said that she needs much firmer proposals than the comment received – the proposals must include implementation plans and no comments or policies.

After the meeting, it was agreed that PSSA and ICPA should work together to present a consolidated model.

Issues raised by Dr Motsoaledi

Although the draft White Paper proposed mandatory membership of NHI and a reduced role for medical schemes to providing only "complementary services", recent media interviews with Dr Motsoaledi have indicated a potentially softer approach, with medical scheme existence continuing into exist in the transition to NHI. The focus during this stage will be to reduce both the number of medical schemes and the number of options, so that all members received the same benefits regardless of their socioeconomic status.

Medical scheme subsidies and tax credits are also likely to be revoked in line with the Treasury's announcement in the February budget of the government's plan to establish an NHI Fund later in the year. The fund might be partially financed by a reduction in the tax subsidy given to medical scheme members.

Publication of NHI White Paper

On 30 June 2017, the National Health Insurance Policy: Towards Universal Health Coverage was published in the Government Gazette, in terms of the National Health Act, 2003. It has yet to be scrutinised by the PSSA.

1.2Draft Norms and standards regulations applicable to various categories of health establishments

Draft regulations were published for comment in GN 10 on 4 January 2017. The PSSA was pleased to note that the SAPC’s GPP standards anticipated the norms and standards for facilities and services. The SAPC has enforced compliance by performing regular pharmacy inspections based on these rules for many years. Non-compliance with the rules has led to disciplinary action taken against the pharmacist responsible for the facility. Pharmacy therefore has the advantage and experience to support the Department and the Office of Health Standards Compliance in the introduction of these regulations.

As the country moves towards implementation of NHI, it has become evident that intra- and inter-professional collaboration is necessary. An example in the pharmacy environment is the use of Central Chronic Medicine Dispensing and Distribution Programme (CCMDD), where a facility may dispense and distribute medicines on behalf of primary health clinics in a local authority or district health system. It is important that the generators of the prescriptions can trust the standards used in the dispensing and distribution of the prescriptions. Another area where collaboration would be invaluable is that of clinical care, where prescribers and pharmacists may have different information about patients.

These norms and standards will go a long way to identifying areas where inter-professional teamwork will improve healthcare outcomes. It has long been a source of concern to the PSSA that there appears to be little or no follow up to ensure GPP compliance by professionals authorised to compound and dispense medicines in terms of section 22C of the Medicines and Related Substances Act, 101 of 1965. This is because the SAPC has no mandate to inspect premises from which these healthcare professionals practise. These regulations will no doubt be applied and monitored to ensure the suitability of such premises.

The National Health Act, 61 of 2003, defines “health establishment” as:

“the whole or part of a public or private institution, facility, building or place, whether for profit or not, that is operated or designed to provide inpatient or outpatient treatment, diagnostic or therapeutic interventions, nursing, rehabilitative, palliative, convalescent, preventative or other health services”

This definition makes it clear that all health establishments, in both public and private sectors, will be required to comply with the requirements of the National Health Act and its regulations.

The National Act therefore applies equally to individual healthcare practitioners engaged in their own private sector practices to public sector quaternary hospitals. There are a number of the norms and standards which are impractical to apply to individual private practices, and it is hoped that this will be addressed in the final regulations.

1. MEDICINES AND RELATED SUBSTANCES ACT, 101 OF 1965

2.1Dispensing fee 2017

On 27 January 2017, the current dispensing fee for pharmacists was published and came into operation on the day of publication. The fee analysis reflected an increase from the 2016 fee as well as an increase on the draft fee that was published in August 2016.

On 19 May 2017, a draft fee was published for comment. Analysis of the fee, compared with the fee published in January 2017, reflects an increase, for all pharmacy groups, from R49.37 to R50.97 (VAT exclusive).

Comparing the different categories of pharmacies the following is noted. For independent pharmacies the average income for all bands increases from R44.17 to R45.79. Corporate pharmacies increase from R49.04 to R50.93 and courier pharmacies increase from R67.17 to R71.64.

The challenge presented by our analysis is that it takes a sample of products at a fixed point in time, re-prices that same sample at that same point in time, and then compares the two results. This kind of analysis does not accommodate the shift, either up or down, of the SEP or the annual SEP increase. It should be noted that an increase of say 5% on a product of R50.00 has a significant effect on the increase of the dispensing fee for the first and even the second dispensing fee bands. These are the dispensing fee bands having a high percentage component in the fee calculation.

When the original fee published in November 2010 is re-calculated to include annual inflation, the current fee target is shown to be slightly below the Pricing Committee (PC) target for all pharmacies but significantly below the fee target for independent pharmacies. It is also below the PSF fee target.

Focal areas for discussion with the PC

• The use of the PC data set appears to give a different (higher) fee when compared to the dataset to which the PSF has access. This results in a different fee from that calculated by the PSSA, with the PC fee appearing much more optimistic.

• The fee target of the PC seems to be lower than the PSF fee target, which has been adjusted to accommodate inflation over the period since 2010.
• The zero base costing methodology used has not been revisited since 2010 although there have been significant changes in some of the cost lines such as salaries.
• The average fee calculation puts the independent pharmacies at risk as reflected above.
• The analysis is a “theoretical” income as most medical schemes do not remunerate at the published fee level.
• It is critical to move away from the “maximum fee” model to a ”fixed fee model”.
• The possibility of the SAPC taking over the regulation of the pharmacist’s dispensing fee should be explored.
• It is an acceptable practice by medical schemes to calculate medical inflation as inflation plus 2% or even 3 %. This is not done for pharmacy fees.

The fee published for comment seems to be the fee intended for 2018, but the PSF believes it is essential to meet with the PC as soon as possible, as a new PC has been appointed and the PSF must ensure members have a full understanding of the fee model used and the challenges that this model presents.

2.2Pricing committee

In November 2016, the PSF wrote to the Minister of Health, requesting urgent appointment of the Pricing Committee, which was at that stage overdue. It is believed that the Committee has since been appointed, but no notification has yet been seen in the Gazette.

2.3Specified Schedule 5 Registers

The PSSA has been concerned about an apparent change of policy by the SAPC which is being enforced by its inspectors. In 2008, Council recorded a decision to remove the requirement that inspections should report on Specified Schedule 5 register maintenance, because it was acknowledged that there was a contradiction between Section 22A of the Act and Regulation 30 of the General Regulations. This decision appeared to have been overturned, as the PSSA was aware of pharmacies that were downgraded following inspections that recorded a failure to maintain such a register.

The Registrar of the SAPC was contacted and a copy of a legal opinion obtained was sent to him. The opinion states that “retail pharmacists and pharmacies are not by law required to keep specified schedule 5 or schedule 6 medicines registers” and they “cannot be legally or lawfully forced or required to do so without an amendment to the Medicines Act, and in particular subsection 22A(6) of the Medicines Act.”

The SAPC has since removed the requirement from the inspection questionnaires. In addition, the PSSA has it on good authority that, when the final General Medicines Regulations are published, they will reflect that this is not a requirement for healthcare professionals who supply specified Schedule 5 substances to the public on prescription.

2.4Medicines and Related Substances Amendment Acts

The President of South Africa determined 1 June 2017 as the date on which the Medicines and Related Substances Amendment Act (Act 72 of 2008) comes into effect (Proclamation Notice 20 of 2017; Government Gazette No. 40869, 26 May 2017).

This automatically triggers the implementation of the Medicines and Related Substances Amendment Act (Act 14 of 2015), as section 27 of that Act states: "This Act is called the Medicines and Related Substances Amendment Act, 2015, and comes into operation immediately after the commencement of the Medicines and Related Substances Amendment Act, 2008 (Act No. 72 of 2008)."

The PSSA understands that the amended General Regulations have been finalised and publication is imminent.

The Minister of Health has called for nominations for the board of the South African Health Products Regulatory Authority, which will replace the Medicines Control Council.

2.5Draft amendment to general regulations

On 25 July 2016, draft General Medicine Regulations were published in order to accommodate complementary medicines and health supplements in the regulations

2.6Draft general regulations

On 27 January 2017, more draft General Medicine Regulations were published. These however did not propose ad hoc amendments but will replace the current regulations in their entirety. These regulations are intended to give effect to the two Medicines and Related Substances Amendment Acts discussed in 5.2 above.

2.7 Regulations relating to Medical Devices and in vitro Diagnostic Medical

Devices (IVDs)

These regulations were published on 9 December 2016. Concern has been expressed about the restrictions to marketing sale of devices.

1. PHARMACY ACT, 53 OF 1965, AND SA PHARMACY COUNCIL MATTERS

3.1Community service for pharmacists (CSP)

It is a statutory requirement for pharmacist interns to perform a year of community service in the employ of the state. The onus therefore remains on the state to ensure timeously that there are sufficient suitable posts in the public sector to accommodate all pharmacist interns.

Unfortunately, untested changes in the placement process, particularly the use of inadequately tested software, together with the attrition of staff at the NDoH and the insufficient provincial posts available, led to widespread confusion, with about 10% of interns unplaced by the end of 2016. This was resolved by permitting private sector facilities, in particular Pick up Points for the CCMDD, to employ CSPs. It is important that immediate attention should be given to resolving the technical problems encountered with the new software as well as the funding and identification of suitable posts.

In April 2017, representatives of the Workforce Cluster at the NDoH met with the various professional societies/associations to discuss the proposed guidelines which the NDoH had written and which had been approved by the National Health Council. It was decided that the system would not be opened for applications until there are enough posts as the Department does not want a repeat of the fiasco that occurred in 2016.

The “five province rule” was changed so that only three choices can be made. Each choice has the same weighting. The guidelines also include a weighting system to be used to decide on personal considerations.

The system was opened in June for pharmacy interns to register. At the time of writing this report the system had not been opened for applications.

3.2Increases in fees payable to council

The PSSA continues to be concerned by the way in which increases in fees are communicated to pharmacists. Legal opinion was obtained in which it is stated that there is a “prohibition against sub-delegation by the Minister, of his / her delegated legislative authority in sub-section 49(1)(d) of the Pharmacy Act, to prescribe annual fees, to the SAPC, which means that only the Minister may prescribe the annual fees by way of regulations in terms of the statutory process outlined in subsection 49(5) of the Pharmacy Act.”

In February 2017, the PSSA brought the matter to the attention of the Minister in a letter, asking for clarity on the matter.

To date, the matter remains unresolved.

3.3PCDT

After some years, the National Department of Health resumed issuing permits to pharmacists trained and registered as Primary Care Drug Therapists. The South African Medical Association was concerned about the consequences for the patient. The PSSA issued a media release, reassuring the public and SAMA that there is no danger of a dramatic change in the scope of practice of pharmacists, nor will patients be put at risk by inadequately trained pharmacists. The background to the introduction of PCDT was explained, as well as the training and the conditions of the permit. The PSSA firmly believes that PCDT pharmacists can increase the access to primary health care services in their communities.