SUMMARY:

Management Sciences for Health (MSH) has been awarded the RPM Plus follow-on: Strengthening

Pharmaceutical Systems (SPS), therefore all RPM Plus activities for FY 2008 will be undertaken by SPS.

SPS will strengthen the pharmaceutical component of the Prevention of Mother-to-Child Transmission

(PMTCT) services at the facility level and the role of pharmacy personnel in promoting and supporting

PMTCT services. Three activities have been identified: 1) strengthening health personnel capacity to

support the PMTCT program, assisting with the review of National PMTCT standard treatment guidelines

(STGs); 2) monitoring of PMTCT commodities; and 3) improving management of patients to support

National Department of Health (NDOH) prevention efforts. The major emphasis area is needs assessment,

and minor emphasis areas include human resources, linkages with other sectors, logistics and training.

Target populations include women, infants, family planning clients, people living with HIV (PLHIV), policy

makers, national program staff, and public doctors, nurses, pharmacists, and other healthcare workers.

BACKGROUND:

In South Africa, the implementation of PMTCT services is one of the key HIV and AIDS interventions, as

prevention remains the cornerstone of the country's response to HIV and AIDS. PMTCT services are

available through hospitals, midwife obstetric units, community health centers and primary healthcare

clinics. In 2003, RPM Plus received funds from the USAID Child Survival program to assist in strengthening

the "pharmaceutical component" of the PMTCT program. An in-depth analysis of existing policies and

practices was conducted and is being applied in collaboration with the National and all nine provincial

Departments of Health. SPS is also providing support to the NDOH Pharmaceutical Policy and Planning

Cluster (NDOH-PPP), and the Medicines Control Council (MCC) with the selection and review of the drug(s)

and regimen of choice for PMTCT.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Strengthening health personnel capacity to support the PMTCT program

SPS will conduct provincial workshops for pharmacists, pharmacist's assistants and nurses to address

issues identified during the assessment of PMTCT services and will include an update to health staff on

recommended ART regimen(s) for pregnant women and the associated clinical pharmacology (i.e., drug of

choice, adverse-drug-event while on ART). The focus of the provincial workshops will be on training primary

healthcare (PHC) level workers, as PHC sites constitute one of the primary sites for prevention, and also

diagnosis, staging, referral and routine follow-up of HIV-infected patients. Quantification of PMTCT related

medicines and commodities will also be addressed during the training. Additional provincial workshops will

be conducted during FY 2008. The expansion of the National ARV program to the PHC level is anticipated

to take place during this period. A full comprehensive training program will be implemented in provinces and

local government authorities.

ACTIVITY 2: Technical assistance

SPS will continue the ongoing support provided to the NDOH Essential Drugs List Committee in reviewing

PMTCT drug(s) of choice and standard treatment guidelines (STGs), to the MCC on regulatory issues, and

to the NDOH PMTCT Task Force in planning implementation of the strategy. This activity also includes the

review and development of training modules to include new PMTCT STGs in the training conducted by SPS

(e.g., HIV and AIDS management and Pharmaceutical and Therapeutic Committee training). The review of

the National PHC EDL is underway and includes the review of PMTCT STGs. In FY 2008 SPS will continue

to provide support in the implementation of the recommendations that arose from the PMTC assessment

and National workshop.

ACTIVITY 3: Monitoring of PMTCT commodities and patient management

SPS will implement systems (manual and computerized) to monitor the use of PMTCT commodities and the

management of patients at PHC level. This includes the monitoring of distribution and use of cotrimoxazole,

nevirapine and/or AZT.

These activities contribute to the PEPFAR 2-7-10 goals by improving the quality of the PMTCT services

provided at the facility level.

SUMMARY:

MSH has been awarded the RPM Plus follow-on: Strengthening Pharmaceutical Systems (SPS), therefore

all RPM Plus activities for FY 2008 will be undertaken by SPS. SPS will assist the National Department of

Health TB sub-directorate to strengthen drug supply management for TB and more specifically the

management of TB patient on ARVs by training health workers supporting the TB program on clinical

pharmacology related to TB/HIV coinfection, and improving infection control, adherence monitoring, adverse

drug-event reporting, medication errors and referral system(s) at selected government institutions

(hospitals, community health centers, primary health care clinics). SPS will also train pharmacists on

estimating requirements for ARV and TB medicines. The major area of emphasis include training and task

shifting, as pharmacists and pharmacist assistants will take on greater roles in TB/HIV care.

BACKGROUND:

RPM Plus has been working very closely with the National Department of Health Pharmaceutical Policy and

Planning Directorate since 2004 to support the delivery of pharmaceutical services at all levels (national,

provincial, district, institutional). This included training TB provincial coordinators (and pharmacists) on Drug

Supply Management for TB in collaboration with the National TB sub-directorate. The coexistence of TB

and HIV infections has made the treatment of patients on ARVs more complex and health personnel need

to be trained to manage it. Moreover, a national plan has been developed to address what has been

described as the "TB Crisis," making TB and HIV management a priority. The smear negative rate at the

end of treatment in South Africa, 51%, remains well below the WHO target of 85%. These smear positive

patients remain infective and continue to spread TB; people infected with HIV are particularly vulnerable to

acquiring TB. It therefore follows that against the background of the high HIV prevalence rate in South

Africa it is important to reduce the infectious reservoirs within the community. Currently only 63% of patients

complete their course of treatment and the South African Medical Research Council estimates that 6.7% of

previously treated patients are resistant. The financial burden of multidrug-resistant TB (MDR-TB) is

considerable -- the usual course of treatment costs approximately $60 while that of MDR is approximately

$3,500. In addition the social impact is considerable as these patients are hospitalized in isolation facilities

for long periods of time. Recently extensively drug-resistant (XDR-TB) has been identified in South Africa

which requires highly specialized treatment facilities and medicines. In December 2005, RPM Plus

published the "Managing Pharmaceuticals and Commodities for Tuberculosis; A Guide for National

Tuberculosis Programs". This publication was shared with the National TB sub-directorate and they have

expressed interest in using these guidelines to support their own program. All these activities will be

conducted in close collaboration with the directorates dealing with TB, HIV and AIDS and Quality Assurance

at the National level. The Department of Correctional Services and local governments have requested

support from SPS to strengthen the role of pharmacy personnel in supporting the TB program.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Drug Supply Management for TB

RPM Plus has experience with ARV supply management in South Africa. As other projects are involved in

the actual patient care and medication administration, SPS will assure that the medications are where they

need to be and tracked appropriately. SPS will perform a similar function in the TB/HIV program area. In FY

2007 RPM Plus adapted the Drug Supply Management for TB training material they developed to include

topics related to the treatment of TB patients on ART. The training program covers clinical pharmacology

principles and other relevant issues such as: drug-to-drug interactions between Rifampicin and different

classes of ARVs; immune reconstitution inflammatory syndrome (IRIS); rationale for changing ART regimen

in the presence of TB; assessment of tolerance to TB drugs; increased toxicity; adherence to both ARV and

TB treatment; and counseling. One National and nine provincial workshops will be conducted for doctors,

pharmacists, and nurses involved in the management and implementation of the National TB program. The

integrated computerized drug supply management system developed by RPM Plus (RxSolution) will be

implemented at selected TB hospitals. The implementation of this system will assist these institutions in

providing data for the National TB indicators; this will also assist in validating the data captured on the

National Electronic TB Register (ETR) for these facilities and provide detailed information on patient

treatment. This activity will assist with the overall monitoring and evaluation of the TB program.

ACTIVITY 2: Adherence to Treatment and Rational Use of Medicines

SPS will directly assist selected institutions that are providing TB treatment to implement adherence

monitoring systems for TB patients on ARVs. This will include recognition, treatment and reporting of

adverse drug events (ADR) and medication errors reporting, and quality improvement strategy. The

institutions will be selected in consultation with provincial DOH, and will most likely be located in Eastern

Cape, KwaZulu-Natal, and Gauteng - priority provinces in the National TB Crisis Plan. SPS will also

strengthen the referral system for TB patients to access ARVs. SPS will provide assistance to the Eastern

Cape and Mpumalanga provincial Departments of Health to develop and pilot a standardized adherence

package for TB patients. The ARV adherence assessment tool recently developed by RPM Plus will be

adapted by SPS for use in TB patients by both the patient as well as the treatment supporter. Training will

be provided to staff in the application of the adherence package for MDR and XDR-TB patients. Finally

technical support will be provided to the MDR-TB facilities in order to improve referral mechanisms, comply

with regulatory requirement pertaining to XDR treatments, reporting and quality improvement of medication

errors and the reporting and management of adverse drug events. In 2006 RPM Plus medication error

surveillance systems identified an ongoing trend of prescribing errors in hospitalized TB patients. In order to

further define the required rational prescribing interventions, Drug Utilization Reviews (DUR) will be

conducted at selected sites. The findings will then be used in the planning and execution of a TB rational

prescribing intervention at the hospital level. This is significant because an increasing number of patients

who are HIV-infected require initiation of TB treatment at the hospital level. The piloting of the DUR tool has

revealed deficiencies in the pharmacy discharge procedures and patients are sent home with treatment

without the necessary referral to DOTS. SPS will develop guidelines to improve referral to DOTS supporter.

In the Eastern Cape SPS will use the Medicines Information center at Rhodes university to provide patient

and prescribing information for MDR and XDR-TB medications. Furthermore this service will provide

support to pharmacists and prescribers in assessing drug interactions. SPS will be training pharmacy

personnel (and other health workers) on the management of both TB and HIV/AIDS (see ARV Services) to

Activity Narrative: support the national effort in integrating TB and HIV programs within the national health services.

ACTIVITY 3: Quantification

The management of TB in HIV-infected patients is critical since TB is the number one opportunistic infection

and the leading cause of death for HIV-infected clients - making the availability of TB medicines critical.

SPS will train provincial and district pharmacists in the use of morbidity-based quantification models for the

quantification of TB medicines using TB National Standard Treatment Guidelines (STGs). Pharmacists will

be trained. This activity will also assist in monitoring prescription trends against National TB STGs.

ACTIVITY 4: TB/HIV Infection Control

TB infection control, given the high burden of HIV co-morbidity, has been identified as a critical area

needing support. RPM Plus has developed an Infection Control Assessment Tool (ICAT) which will be used

to assess infection control practices in these settings. SPS will train health workers on implementing TB

infection control measures and procedures at facilities where TB/HIV services are provided. As a follow-up

an Infection Control improvement plan will be developed to address gaps identified using the ICAT.

Opportunities to work with other PEPFAR partners will be explored. This is done in collaboration with the

National Department for Quality Assurance.

All these activities contribute to the PEPFAR 2-7-10 goals by improving the treatment of patients with TB

and HIV infection and supporting the national effort in dealing with the "TB crisis".

SUMMARY:

With FY 2008 PEPFAR funds, Management Sciences for Health's (MSH) Strengthening Pharmaceutical

Services (SPS) project will continue and expand activities already underway in South Africa to support the

effective management of antiretroviral (ARV) medicines. SPS will continue to influence drug provision

positively by improving estimation of needs for ARV, opportunistic infection (OI), and sexually transmitted

infection (STI) drugs; implementing systems to support drug supply management activities and to monitor

drug availability at the institution and district levels; and developing a highly skilled pool of pharmacy

personnel to manage them. The objective is also to strengthen the use of Drug Supply Management

Information for government facilities at all levels. The emphasis areas are human capacity development,

and wraparound programs. Target populations include National AIDS Control Programme staff, other

national and provincial Department of Health (DOH) staff, nurses, pharmacists and pharmacist assistants.

Opportunities for collaboration with the Partnership for Supply Chain Management will be explored.

BACKGROUND:

Since FY 2004, RPM Plus has been working in close collaboration with the National Department of Health

(NDOH) Pharmaceutical Policy and Planning unit, and provincial and local government pharmaceutical

services to support the delivery of pharmaceutical services at all levels (national, provincial, district, and

institutional). The following activities are a continuation of the activities initiated since FY 2004. Systems and

models for drug supply management have been developed and tested. In FY 2008, SPS will continue the

implementation of these systems on a larger scale and will monitor the impact on the delivery of

antiretroviral treatment (ART) at accredited sites (including down referral and primary healthcare sites).

These activities have received the full support of the NDOH Pharmaceutical Policy and Planning unit and

the Provincial Pharmaceutical Services. The Department of Correctional Services has requested SPS

support in strengthening the delivery of pharmacy services.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Drug Supply Management Information System

RPM Plus developed an integrated, computerized drug supply management information system

(RxSolution) to assist hospital, community health center and district level pharmacy personnel to manage

drug supply activities from hospital bulk stores to the patients through satellite pharmacies (outpatient and

inpatient), wards and down referral clinics. This supports the management of purchase orders, inventory,

issues to clients (satellite pharmacies, wards, and primary healthcare (PHC) clinics), and budgets. It also

supports the management of patient records, prescriptions and quantities dispensed directly to the patient

or through down referral sites. Data links with electronic patient registers have been implemented. The

RxSolution system is currently used in five provinces (Eastern Cape, Mpumalanga, Gauteng, North West

and Free State) at government and local government sites. In the Eastern Cape alone, the existing sites

have contributed to the treatment of 15,000 patients. RxSolution is used at hospitals to support the down-

referral of patients to a primary healthcare institution, typically patients on chronic medication or stabilized

ARV patients. The main objectives are to reduce the burden on the hospital and decrease the cost for the

patient. Some of the ARV sites using RxSolution have shown great improvement in the management of

their supplies for ART and non-ART medicines. As a result, more ART-accredited sites (hospitals, wellness

centers) have requested to use this system. As SPS scales up, different approaches will be used to ensure

adequate support and maintenance. In the Free State, the government has hired a pharmacist/IT manager

to support RxSolution. SPS will develop an interface between RxSolution and the new provincial warehouse

management system. This application is expected to be deployed to additional sites and other provinces.

During FY 2007 SPS is expected to develop an interface between RxSolution and Therapy Edge, used by

Right to Care, and pilot it at Right to Care (and other) ART sites. This activity is done in collaboration with

the Supply Chain Management System (SCMS) Project. Additional joint sites will be identified during FY

2008. RxSolution is currently used in over 100 sites throughout South Africa, Swaziland and Lesotho with

RPM Plus/SPS support.

The SPS system goes beyond ARV management. All medicines used at the facilities can be tracked,

including drugs for TB and opportunistic infections, as well as any other type of commodity (medical

supplies, lab reagents, etc.). The dispensing module of the system allows providers to monitor any lab test

(and results) performed for any type of patient. It also allows tracking loss-to-follow-up, defaulters, etc.

Lastly, the system is also able to monitor adherence to treatment. Treatment can be classified as first line

and/or second line, and can be referenced by the International Statistical Classification of Diseases and

Related Health Problems, 10th Revision (ICD-10) as well. All this information should assist in monitoring the

overall program and identifying any trends (including prescribed regimen vs. standard regimen). Overall the

system can thus provide a mix of logistic (availability, consumption, expenditures) and clinical (treatment,

treatment outcomes, use, and disease and prescribing patterns) data.

ACTIVITY 2: Support National/Provincial Quantification

SPS is constantly improving and developing new models to estimate and monitor drug needs using

morbidity and consumption data. These models are specifically tailored to the South African National

Standard Treatment Guidelines (STGs) for HIV and AIDS, STIs, OIs, other priority diseases and post-

exposure prophylaxis (PEP). RPM Plus has trained provincial staff responsible for the submission of

provincial estimates, provincial pharmaceutical warehouse managers and pharmacists responsible for the

procurement of ARVs and medicines used for the treatment of OIs and STIs at the institutional level

(hospital, community health center and district). In FY 2008, training in quantifying ARV-related drug

requirements will continue through national and provincial workshops. These workshops provide an

opportunity to establish a national network to discuss and report consumption trends and issues, to maintain

a dialogue with representatives from the pharmaceutical industry and to prepare reports for the National

Comprehensive Care, Management and Treatment of HIV and AIDS forum. Training in quantification needs

to be an ongoing function, especially in the public sector in South Africa where community service

pharmacists are often in charge of the ARV pharmacy for their year of service, then leave the public sector

for the private sector without plans for succession. The quantification models will be shared with the SCMS

and joint training workshops will be conducted for PEPFAR partners.

Activity Narrative: ACTIVITY 3: Data for Decision Making

With FY 2008 PEPFAR funding, SPS will continue the training of pharmacy personnel in using their data for

decision making to ensure that the increasing demand for medicines required for the care and treatment of

HIV and AIDS and other related programs is met, and to monitor national drug supply management

indicators. This also provides an opportunity to strengthen the working relationship between pharmacists

and other program managers. Individuals from the Provincial Pharmaceutical Services and from the

National Pharmaceutical Policy and Planning unit will be trained. SPS will assist provinces with the national

reporting system. All the activities above will indirectly support all HIV-infected clients who will be receiving

care and treatment at government ARV accredited sites through the improvement of the delivery of

pharmaceutical services.

These activities support PEPFAR 2-7-10 goals as well as the vision outlined in South Africa's Five-Year

Strategy by facilitating the national ARV rollout.

SUMMARY:

Management Sciences for Health's (MSH) Strengthening Pharmaceutical Services (SPS) project will

support the South African Government's (SAG) Operational Plan for Comprehensive HIV and AIDS Care,

Management and Treatment (CCMT). SPS improves the reliable provision of ARV services and other

related services; support monitors progress towards compliance with pharmaceutical legislation and ARV

accreditation requirements for provincial health facilities; trains pharmacists and pharmacist assistants in

basic principles of HIV and AIDS management; trains health personnel in conducting medicine use

evaluations, using adherence to antiretroviral treatment (ART) measurement tools; supports the review of

national standard treatment guidelines (STGs) for HIV and AIDS, TB, STI and other diseases; strengthens

the provincial implementation of pharmaceutical therapeutic committees and medicine information centers;

and strengthens pharmacovigilance reporting. The emphasis areas are human capacity development and

wraparound programs. Target populations include National AIDS Control Program staff, policy makers,

public and private health care workers (especially pharmacists), people living with HIV (PLHIV) and their

families, OVC and the general population of children, youth and adults. SPS will work in all nine provinces

to support national, provincial and local government pharmaceutical services as well as the Department of

Correctional Services. Opportunities for collaboration with the Supply Chain Management System (SCMS)

Project will be explored.

BACKGROUND:

Since FY 2004, RPM Plus has been working in close collaboration with the National Department of Health

Pharmaceutical Policy and Planning (NDOH-PPP) Unit, and provincial and local government

pharmaceutical services to support the delivery of pharmaceutical services at all levels. The following

activities are a continuation of the activities initiated since FY 2004. Systems and models have been

developed and tested. In FY 2008, SPS will continue the implementation of these on a larger scale and

monitor the impact on the delivery of ART at accredited sites. These activities have received the full support

of the NDOH-PPP unit and the provincial pharmaceutical services.

ACTIVITIES AND EXPECTED RESULTS:

ACTIVITY 1: Pharmaceutical Services Delivery

Since 2004 RPM Plus has provided assistance to all provinces in monitoring progress towards compliance

with the SAG legislative requirements that relate to the delivery of pharmaceutical services as well as the

applicable standards for the accreditation of health institutions (hospitals, community health centers) to

provide ART. This activity addresses issues related to infrastructure, human resources, equipment and

systems. Thus far activities have included the development of a monitoring tool and the conducting of

reviews in the provinces and Metros. A national workshop was held in 2007 which was attended by

representatives of all provinces, the national office, local governments and correctional services. In FY 2008

the work will continue with the focus being on strengthening pharmaceutical services within the legislative

framework. Activities will include assistance with the development of policies and procedures at all levels,

development and implementation of models of service delivery to support the provision of quality service to

patients with HIV and AIDS, TB and other diseases, capacity building in the areas of governance,

pharmaceutical care and monitoring and evaluation of pharmaceutical service delivery.

ACTIVITY 2: Pharmacovigilance

The CCMT recognizes the importance of strengthening pharmacovigilance measures to ensure the safe

and effective use of ARVs and other medicines used in HIV and AIDS patients. The identification, diagnosis,

management and reporting of HIV medication-related adverse effects are critical. RPM Plus has worked

with the national and provincial health departments and other key stakeholders to develop training materials

to meet this need. SPS will conduct training programs to build capacity by providing skills and knowledge to

HIV and AIDS program managers and the Medicine Regulatory Authority (MRA) on the principles of public

health pharmacovigilance and the safety of antiretroviral agents. In addition, SPS will assist and advise

facility-based HIV and AIDS programs on the planning and implementation of pharmacovigilance

surveillance activities, with subsequent follow-up at the provincial and national levels; support scientific

research relating to key drug safety issues identified in the region; assist in the communication of

information obtained from pharmacovigilance systems and research managed by the national and local HIV

and AIDS programs; and establish networks linking pharmacovigilance programs in the region with each

other in order to encourage information exchange and skills transfer.

ACTIVITY 3: ART Adherence

Since August 2005, RPM Plus has been working in collaboration with the national and Eastern Cape HIV

and AIDS units and other key stakeholders to improve treatment outcomes and prevent resistance to ARVs

through the development of ART adherence measurement tools and determining best practices. Following

the successful development and piloting of an adherence assessment tool the National Department of

Health requested RPM to roll out the tool in May 2007. Clinical staff (doctors, nurses and pharmacists) will

be trained by SPS in providing: patient education on HIV, AIDS and ART; provider education on HIV, AIDS

and ART; psychological and social screening of patients to assess readiness for treatment; and support

services to facilitate resolution of barriers to adherence. These efforts will also contribute to the overall

strengthening of the health system as medication adherence monitoring and support measures are generic

tools that may be applied to settings providing treatment for other chronic diseases. In the long-term the

goal is to develop a network of expertise and facilities, and establish South Africa as a Regional

Pharmaceutical Technical Collaboration Centre (RPTCC) for ARV adherence-related matters.

ACTIVITY 4: STGs and Rational Drug Use

The revised edition of the South Africa adult and pediatric STGs for the hospital level has just been

published. These STGs include new chapters on HIV and AIDS care and treatment. SPS will assist the

NDOH in reviewing these STGs and the primary health care EDL on an ongoing basis, and the provinces in

promoting these new STGs. SPS will also conduct provincial workshops on rational drug use; strengthen

provincial, district and institutional pharmaceutical and therapeutic committees (PTCs); assist with the

Activity Narrative: development of provincial formularies; train staff in basic principles of pharmacy economics and the use of

evidence-based principles for drug selection; and implement provincial medicines information centers.

Through these activities SPS will also assist the NDOH in reviewing their infection control policies and

guidelines.

ACTIVITY 5: Down Referral and Integration of Services

There is a need to scale-up access to ART. One strategy of the NDOH is to down refer stabilized patients

on ART to their nearest primary health care (PHC) facility. The other long-term approach is to initiate the

treatment at PHC level. SPS will support these two critical initiatives by assisting in the development,

implementation and strengthening of down referral systems as well as the integration of the provision of

ART with the supply of medicine for other conditions treated at PHC level. RPM Plus has included a down

referral module in their integrated drug supply management system (RxSolution).

ACTIVITY 6: Training of Pharmacy Personnel from ART sites (and others)

There is an urgent need to build capacity among pharmacy personnel to manage patients on ARVs. The

anticipated deployment of the National AIDS treatment program at PHC level, make this activity a priority.

RPM Plus has developed a 5-day HIV and AIDS training program specifically for Pharmacists and

Pharmacist's Assistants. This training program is being accredited by the South African Pharmacy Council.

In FY 2006 over 1200 health personnel have been trained. SPS will expand this program to PHC Level

Pharmacy personnel and to other counterparts such as Correctional Services.

ACTIVITY 7: Technical Assistance to Local Counterparts

Since its inception in 2003, RPM Plus has been requested on a regular basis by government (e.g.

Medicines Control Council) and non-government organizations (e.g. the South African Pharmacy Council,

the South African Qualifications Authority) to provide ad hoc technical assistance for a wide range of

services such as the development of staffing norms for pharmaceutical services, accreditation of facilities,

development of standards of pharmacy practice, the review/revision of the scope of practice and

competency standards for persons involved in the provision of pharmaceutical services, implementation of

legislation to reduce the price of medicine and improve medicine availability to communities, (including

ARVs and medicine used in the treatment of co-morbidities) and the development and implementation of

public-private partnership service level agreements. In FY 2008 SPS will continue to provide technical

assistance in these areas as well as other emerging issues such as pharmacy care and monitoring and

evaluation.

All these activities will build South African capacity and support the improvement of health services. This will

contribute to the achievement the overall PEPFAR goals of reaching 10 million people with care and 2

million with treatment.