Tag Archive | SAHPRA

New health regulations in place soon: DoH

Must precede world health HIV/AIDS conference….

precious matsosoDr  Precious Matsoso, Director General, Department of Health (DoH), has told Parliament that it is essential to have the South African Health Products Regulatory Authority (SAHPRA) in place before South Africa hosts the World AIDS Conference.

On the health agenda also in South Africa, she added, is a World Hospitals Conference and Regulatory Agencies Conference, in which case the existence of a working SAHPRA was almost obligatory.  Dr Matsoso was in Parliament to brief MPs on the DoH fourth quarter results.

Dr Matsoso has recently been elected as an Executive Board Member of the World Health Organisation (WHO) and, in addressing the portfolio committee on health, all MPs congratulated her They expressed value of her appointment to South Africa in the context of promoting health on the sub-continent.

Minister absent

Dr Aaron Motsoaledi, the Minister of Health, was away an overseas visit for what is undoubtedlyamotsoaledi DoH’s most important presentation of the year, the last quarter, and both departmental officials presenting and responses from parliamentarians were relatively upbeat on improvements in DoH performance results.

In reporting on the final quarter as far as performance and finance was concerned, Dr Matsoso advised that in the year under review, aggregate pre-audited spending so far was at 98.4% of the total budget of R30.8bn, i.e. R30.3 bn. The R489m not spent in the year was for a number of reasons but mainly because of staffing vacancies provided for but not filled.

In general, she said there had been “an overall improvement in spending and compliance, and tightened monitoring and evaluation both at national and provincial level.”

New drive for medical staff

hospital newAttracting qualified staff to serve in government health was still a major problem but she stated that DoH intended to publish magazines and undertake promotions that were to be part of a new image intended to represent the changes that were taking place in public health.

Major items covered in the DoH presentation included the overall integration of health services on a national basis; progress with the ten National Health Insurance (NHI) pilot programmes; the situation with regards to HIV/AIDS; improved access to community-based primary health care facilities; and progress with legislation, particularly the Medicines and Related Substances Amendment Bill.

Getting to grips with HIV virus

HIV and AIDS, TB and maternal child and women’s health was a separate programme  and DoH hadhiv aids logo recorded over 9.5 million HIV tests in the year under review. The year ended with a total of 3,103, 902 clients now registered on anti-retroviral treatment (ARVs).

In discussion with concerned MPs, it emerged the number of HIV positive cases was increasing.  The department acknowledged that was always going to be the case until changes occurred in people’s habits, the largest problem sector in the fight against HIV/AIDS. The highest incidence of HIV was amongst women between the ages of 15 and 24.

Clearly, the country was on top of AIDS as a disease with the use of ARVs but the unknown and major worry was incidence of unaware persons not knowing or not caring on how to avoid becoming victims of the HIV virus.   This was due to a variety of reasons, Dr Matsoso said, and she told members that “DoH had started a project aimed at showing young women how to take charge of their lives; how to negotiate with older men; and how to take decisions.”

TB prevalent but under control

On TB, the most worrying issue was the much publicised multi-drug resistant virus. Over 120 professional nurses in service had been trained to initiate MDR TB treatment. Matters were now under control.  In general terms on TB treatments, fifty  hospitals had been assessed on TB criteria and diagnosis.

In passing, Dr Matsoso added that 90% of correctional services centres were now conducting routine TB screening.  TB was still mainly associated, she said, with impairment of the immune system as a result of being HIV positive or for nutritional reasons, both issues being usually coupled together when dealing with those below the breadline.

Community stress factors

high blood hungerIn the area of primary care, various DoH heads of departments reported  and it became apparent that 169,418 people had been counselled and screened for high blood pressure, a major problem in high stress and impoverished  communities.

A start had been made on mental disorders by commencing a registry system and a mobile SMS application was being piloted in the three districts to improve reporting times for ARV treatments to chase up on irregular calls for treatment.

One system, also at pilot level, was called “MotherCall” and dealt with mother care and maternity issues on an SMS basis, especially where calls to clinics by patients were needed on a regular basis but this was found to be somewhat restrained by cell phone coverage in the deeper rural areas.

Almost malaria free

Only one malaria endemic district had reported any malaria cases, which had been dealt with withinmalaria 24 hours of diagnosis. In all areas, 837 645 high risk individuals had been vaccinated against influenza. A draft model for rehabilitation and disability services had been developed and was ready for discussion with stakeholders and presentation to the National Health Council.

There had been 985 cataract surgery operations for the poor without medical aid cover but this area was a growing problem and the cost of spectacles added to eyesight impairment issues, affecting mainly the poor as far as education was concerned.

Mum on NHI

Dr Matsoso seemed somewhat reluctant to talk on the monitoring and evaluation that had taken place in ten NHI pilot districts, probably because DOH had not finalised its White Paper on the subject and conducted its talks with National Treasury. She conceded, however, that recruitment of various categories of health practitioners needed for the NHI pilots had been below expectations.

A departmental spokesperson confirmed that a dispensing and distributing system for centralised chronic medicine had been implemented for three-quarters of the facilities in all ten NHI districts. A system was also being tested whereby monies paid by patients was retained by the unit involved in a self sustaining exercise and not remitted to National Treasury.

He said that in the past three years of the particular pilot, R1.3bn had been collected by 13 hospitals, R450.6m being collected and held for the year under review.

Infrastructure build

primary care clinicIn general, 700 primary health care facilities were under construction or being opened in the ten NHI districts and some 3,500 computers on LAN equipment had been distributed and installed amongst the pilot areas enabling systems to work in individual clinics and hospitals with networking within their particular environment.

Further on primary care and in order to reduce the maternal mortality rate, a 53.9% rate of ante-natal first visits before 20 weeks of pregnancy had been achieved, against a target of 65%. The actual maternal mortality rate had been 132.5 per 100 000 live births. This was very much a question of education programmes.

Nursing practices and qualifications

On nursing generally, a further departmental spokesperson on the issue confirmed that four regional nursing training centres, or pilot “colleges”, had been established and were functional in Mpumalanga, Limpopo, Gauteng and North West. However, no public nursing colleges had yet been accredited in terms of the new system announced since  the whole question of accreditation was still being debated with both stakeholders and nursing bodies. Most of this debate involves whether nurses in training should get or not het  “field training” after each level of training.

A Chief Nursing Officer had now taken on her duties in a new DoH post who had the critical job of dealing with the major investment and finance required to “train the trainers” bearing in mind all colleges must fall into the Higher Education specifications now required. The entire matter was going forward, however, she said.

NHI still in principle is alive and well

precious matsosoOn legislation, Dr Matsoso reported that the draft white paper on the forthcoming NHI Bill was ready to go to Cabinet; the Medicines and Related Substances Amendment Bill had been tabled and was going through the parliamentary process with public hearings completed; and amendments to the Traditional Health Practitioners Act had been proposed.

A regulatory impact assessment was being conducted on the draft Control of Marketing Alcohol Beverages Bill.

MPs raised the question of schools feeding which they stated was not ideal from a nutritional aspect.  Dr Matsoso agreed and said it was important to change the school feeding programme, as children should not be served just soup and bread. There was a need to look at whether the nutrition provided at ECDs, crèches and pre-schools was appropriate generally. She said she was aware of the problem and it was to be addressed.

The larger picture of health in SA

schools feedingAlso, at schools generally, she said, over 200,000 learners had been screened with resultant indications that as many as 54,000 schoolchildren with some sort of health problem or impairment existed that could affect basic education. These students could suffer in their approach to matriculation and subsequent job attainment. Nutritional problems and troubled backgrounds were at the forefront.

Drug “stockouts” still there

Dr Anban Pillay of DoH addressed the issue of “stock outs” and drug shortages and said that, on the whole, DoH facilities were unfortunately geared nationally just to treat patients, rather than explaining to them how the treatment programme worked. This was being addressed.

Dr Pillay said stock outs could be supplier problem, as well. There had been a time when suppliers were unable to supply as many as 168 items and there were was a contractual agreement in place usually requesting suppliers to advise immediately when they anticipated problems. In this case, the 168 items that suppliers were unable to supply were not available either in the private or public sectors.

Online with the world

medicines, pillsHe said that DoH had approached the WHO for a list of pre-qualified suppliers outside South Africa that could be considered and some stocks like Benzylpenicillin and Atropine had had to be flown in from other places. Dr Matsoso commented that in some cases the U.S., Canada, Australia, Europe and the U.K. could indicate that there was a general stock out problem worldwide.

In most cases, however, Dr Pillay said that stock outs were as a result of a local facility forgetting to order and would run out between orders but barcode systems and central stock controls had been upgraded and the whole question of stock outs was improving, he said.

A system on stock control using cell phone technology was expected to take over the manual system completely but currently, 600 clinics were linked to the SMS system and more would be linked. A call-free line for patients had been established for any patient to advise if they could not get drugs from a particular clinic. Over 20 000 items were stored in an emergency “buffer stock” in Centurion, Pretoria.

Other stock outs could occur when pharmaceutical manufacturing companies closed for factory maintenance at the same time resulting in shortages and DoH representatives said that this could be solved by common negation on maintenance certificate timings.

Ebola never an SA issue 

ebola SAFinally, Dr Matsoso  commented on the outbreak on the continent of Ebola.

DOH, she said, had provided humanitarian financial assistance for the recruitment of Cuban doctors to provide health services in Sierra Leone and had established a knowledge and information sharing platform on various areas of collaboration with Botswana, Uganda, Namibia and Ghana.

In local terms, DoH Primary Health Care Services had seen over-expenditure due to the appointment of 25 local environmental health practitioners in response to the Ebola outbreak as a precautionary measure.

Other articles in this category or as background
Health dept winning on HIV/AIDS therapy and TB – ParlyReportSA
State acknowledges responsibility to increase health staff
Competition Commission promises health care inquiry – ParlyReportSA
SA health welfare starts in small way – ParlyReportSA

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Medicines Bill : focus on foodstuffs

DOH responds on new Medicines Bill……

patientDr Anban Pillay, DDG of the department of health (DoH), has made it quite clear in answering public comments on the proposed amendments to  the Medicines and Related Substances Act  that their concerns regarding foodstuffs are not just confined to the labelling of food and providing a list of the contents of any food products but also the actual food content itself contained in the product and any harmful effect it might have on the consumer.

In this regard, Dr Pillay has said there was to be much closer contact between DoH and the department of Agriculture, Forestry and Fisheries (DAFF), the lack of co-ordination becoming apparent during the recent scandal when horse meat and donkey meat had been discovered in the contents of named foodstuffs brands without any public awareness to this effect.

This and many other comments were made on submissions recently put before the parliamentary portfolio committee on health during the debate on the Medicines and Related Substances Amendment Bill.

No separation from cosmetics

Dr Pillay also made it quite clear that comments in submissions suggesting that food stuffs and cosmetics be isolated into separate legislation parallel with medicines and related substances was a non-starter.  DoH, he said, had already recruited 25 new permanent staff members that would be working for the South African Heath Products Authority (SAHPRA) who were in the process of considering a food agency, food being very much within the ambit of the one Act.

A good number of the changes in the Bill before Parliament arose in the area of vitro diagnostics (IVD), or tests with equipment which assisted medical diagnosis by sampling body tissue and fluids.    In this regard, the wording of international medical regulatory bodies had been used whereby such equipment had to meet certain performance requirements. This was in contrast to medicines and related substances issues which dealt primarily with matters of efficacy.

Big retailers excluded

On the question of the issue of licences to trade issued by the new Medical Control Council (MCC), it had been conceded that retailers dealing exclusively with bulk products classified as unscheduled medicines did not have to comply with all SA Pharmacy Association requirements or obtain a licence from the MCC.

Comments in submissions had been made and by the opposition that the regulating body would find it difficult to exercise its authority with regard to product advertising in all forms of electronic media, particularly if it extended to social media.  Dr Pillay said that this was acknowledged but he asked for his detractors to note that advertising and marketing world was an ever-evolving subject and attempts had to be made to deal with false claims and failure to meet requirements in all forms of advertising media whatever the problems of doing so.

Debate on medical devices

Regarding criticism on the descriptions and definitions in the amending Bill with regard in the approval of medical devices and the ambits of inclusion and exclusion, Dr Pillay said DoH had fallen back on an updated version agreed upon by the International Medical Device Regulatory Forum, which was more appropriate, he said.

Considerable debate took place upon the issue of controls on pricing, raised in a number of written submissions. DoH had agreed that the amendments would clearly state that the agreed pricing committee would be the final body to make recommendations on such matters to the minister of health. Meanwhile, the MCC would confine its activities to quality, safety and efficacy, not pricing.

Furthermore, Dr Pillay confirmed it was the pricing committee alone who were to “pronounce on marketing, bonusing and pricing matters”, bonusing usually being related the incentives to doctors to recommend certain medicines in relation to price.

Traditional medicines

As expected, the EFF and the ANC raised the question of traditional medicines and asked why there was no reference to such in the “description of medicines and products”.  On this, Ms Malebona Matsoso, DG of DoH, replied that department was fully aware of the need to incorporate traditional medicines.

She said that DoH was now distributing a booklet on the process they intended to use to regulate for traditional medicines and how DoH planned to carry out any regulations. The booklet was not available at the time but would be sent to parliamentarians, she said.

The DG, DoH, said that eventually SAHPRA would regulate all products that were processed in laboratories as well as the plants that were used during the process of making medicines. She explained that one of the main drivers for the establishment of SAHPRA was that MCC appointed members were contributors from different industries and not only public servants.

The establishment of SAHPRA therefore would be on a permanent DoH staff member basis and would deal with this as well as foodstuffs and cosmetics in terms of “products” under the Bill. Ms Matsoso confirmed again that traditional medicines and products had not been excluded under the Bill since the Bill included all products. How the regulations were to be extended to include traditional medicines was now being established, she said, and university research particularly from the University of the Western Cape and UN World findings would be used.

Animal world

Despite some objections in written submissions, DoH was insistent that veterinarians had to ensure that they were issued with licences wherever medicines were either compounded or dispensed. Also, Dr Pillay pointed out that the new Bill would not regulate for electronic-medical and radiation devices, the worry of one submission, and hence the question of the Hazardous Substances Act did not arise, he said.

In an earlier meeting with the DoH, also led by Dr Anban Pillay, the portfolio committee debated the section of the Medicines and Related Substances Amendment Bill that covered the formation and running of SAHPRA. What SAHPRA would do and the manner it would operate in the industry, he said, would be dealt with by the regulatory process to be devised.

Other articles in this category or as background
http://parlyreportsa.co.za/health/medical-food-intellectual-property-tackled/
http://parlyreportsa.co.za/health/sa-allow-avoidance-medical-patents/
http://parlyreportsa.co.za/health/medicines-and-related-substances-bill-now-tabled/

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