Insfrastructure and systems
While administratively and financially independent, the TAC Treatment Project has a very close relationship with, and receives indispensable support from the Treatment Action Campaign. It has an office in the TACs national office and the TAC is providing logistical support in the form of telephones, faxes, internet access, etc. The TAC TPs national coordinator (i.e., its director) is a seconded TAC employee.
In the period under review, and infrastructure was established for the implementation and scaling up of the project. While significant shortcomings remain (and improvement of infrastructure will be an important task over the next months) a system is now in place that is capable of delivering the core services of the project.
Clinical guidelines and facilities
Detailed clinical guidelines were developed and are being implemented by the TAC TP. The guidelines were designed to comply with the World Health Organisation guidelines for ART in resource-limited settings and the Southern African HIV Clinicians Society. The guidelines include details on selection criteria, drug regimens, informed consent and treatment support procedures, data management, visit and laboratory monitoring schedules, adverse event management and reporting procedures and evaluation procedures. The guidelines have been adapted to be compatible with the public sector ART programme (e.g. the same drug regimens are used) and are designed to be easily implemented by doctors at public facilities.
As patients were selected, clinicians (as far as possible at public facilities) were recruited to treat them. In cases where suitable doctors could not be found in the public sector, private practitioners were recruited. Good working relationships were formed with many doctors in public sector facilities. However, it remains an onerous process recruiting and inducting clinicians into the programme. Doctors are also often inexperienced, but are always willing to consult more experienced doctors. The TAC TP will continue streamlining this process and it is hoped that the experience clinicians gain in the public sector programme will reduce the overhead in this regard.
Drug procurement and distribution
It was originally hoped that unregistered generic antiretrovirals could be procured from the Generic Antiretroviral Procurement Project. The TAC TP and other members applied under the auspices of GARPP for authorisation under section 21 of the Medicines Act to use unregistered generic drugs. However these applications were not granted and GARPP is still not fully operational. The TAC TP was therefore compelled to continue employing other routes for drug procurement. The use of predominantly unregistered generic medicines is also continuing to impose a severe administrative burden on the project by requiring applications for special authorisation to the Medicines Control Council for each patient individually.
The TAC Treatment Project has employed a registered pharmacist who oversees procurement and distribution of medicines. A partnership was established with Litekem pharmacy in Cape Town for the use of their storage and dispensing facilities. The TAC TP also applied for a licence to act as a pharmaceutical distributor. This is required in order to supply to other projects, but also to import medication. We have been informed that our application was approved by the SA Pharmacy Council, but that the licence must still be signed by the Director General of Health and that this will not occur before the end of January.
The following encouraging developments leads us to expect that drug procurement will become less of a problem in 2004:
· Aspen and Cipla stavudine products being placed on the market;
· Ciplas zidovudine/lamivudine and lamivudine products being placed on the market;
· significant reductions in preferential prices of GSK antiretrovirals (TAC TP is now eligible for these after its NPO registration came through) in response to the referral of case brought before the Competition Commission by TAC;
· Additional voluntary licenses to be granted by GSK and Boehringer Ingelheim as part of a settlement resulting from the Competition Commission case;
· Boehringer Ingelheim granting the TAC TP and GARPP voluntary licences for Nevirapine and Nevirapine-containing products;
· Imminent registration of 3-drug Fixed Dose Combinations;
However, there may be significant further delays before affordable generic antiretroviral drugs are available on the South African market. Especially nevirapine and nevirapine-containing FDCs are currently not available at affordable prices. As an interrim strategy the TAC TP has taken the following steps:
· requested permission from the MCC to import a large quantity of unregistered Cipla Triomune (d4T/3TC/NVP);
· pending above-mentioned approval and distributor licence, a large order will be placed for Triomune and Nevimune with Cipla in India and imported directly (some of this stock might be supplied to other projects;
· the TAC TP is currently negotiating a supply contract with GSK under their access programme (if Cipla cannot match their prices for lamivudine and zidovudine/lamivudine, it will be procured from GSK);
However, drug procurement and distribution has easily kept up with demand and has not so far caused a bottle-neck preventing an increase in the number of patients on treatment. The matter needs to be resolved before significant scale-up can be achieved, however.
Human resources (staff and training)
At national level a coordinator seconded by TAC (full time), an administrator (full time) and a pharmacist (part time) make up the staff complement. At the time of the first Board meeting, three provincial TAC TP coordinators had been recruited (essentially volunteers receiving small stipends) for the Western Cape, Gauteng and KwaZulu-Natal. The intention was to start implementation in those three provinces immediately and in Eastern Cape, Mpumalanga and Gauteng as soon as possible thereafter. It was decided that during 2003 the focus would remain on those three provinces and possibly Eastern Cape the others to be brought on board in early 2004. In November a coordinator for the Eastern Cape was recruited. No staff have been recruited in Mpumalanga or Limpopo as yet. In addition, trained counsellors have been recruited as volunteers in all provinces and volunteers from local branches have been trained as treatment monitors.
Owing largely to the fact that volunteers are used, the TAC TP has experienced capacity problems in some provinces. A strategy has been developed to address this, including the following elements:
· a comprehensive staff evaluation process in January 2004;
· permanent employment of provincial coordinators at reasonable salaries (the evaluation process will indicate whether new, more skilled staff will be recruited or current coordinators employed);
· a training and development programme aimed at empowering new staff or addressing weaknesses identified in the evaluation process;
· a new model comprising district-level volunteers reporting to the provincial coordinators and individuals at ranch-level with responsibility for TP work;
· more formalised standard operating procedures
· TAC TP wellness and selection process deeply integrated with branch development and district health system development programmes of TAC;
· Continued integration of TAC TP wellness programme with TACs Treatment Literacy work.
It is imperative that provincial infrastructure be strengthened if scale-up is to be successful. This means investing in staff to ensure capacity exists to sustain growth.