Detailed Mechanism Funding and Narrative

Years of mechanism: 2008 2009

Details for Mechanism ID: 588
Country/Region: South Africa
Year: 2009
Main Partner: Management Sciences for Health
Main Partner Program: NA
Organizational Type: NGO
Funding Agency: USAID
Total Funding: $5,503,922

Funding for Biomedical Prevention: Prevention of Mother to Child Transmission (MTCT): $339,817

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

In FY 2009 Management Sciences for Health (MSH), Strengthening Pharmaceutical Systems (SPS) will

focus on supporting the implementation of the new prevention of mother-to-child transmission (PMTCT)

dual therapy guidelines through strengthening the integration within pharmaceutical services in the

provinces and the metropolitan area. Specific activities include training of pharmacy and nursing personnel

at sites as well as support for implementing logistics systems for PMTCT commodities.

a. PMTCT Training

Training is provided to pharmacy and nursing personnel on implementation of PMTCT services in relation to

the new guidelines. An important focus of the training relates to the forecasting, procurement, storage, and

distribution of PMTCT medicines and related supplies, HIV tests and related laboratory reagents and

supplies for infection control and health worker safety. Participants are trained to identify critical issues in

systems and policies that may either facilitate or hinder services and PMTCT commodity security. They are

also trained to recognize areas that could be improved and provide alternative intervention options. The

training program also focuses on safety monitoring in patients offered PMTCT regimens.

b. Technical Assistance to Counterparts

Technical support is being provided to provincial counterparts to support program implementation and to

improve logistics management systems for PMTCT drugs and related supplies. A rapid assessment tool has

been developed to assist counterparts to assess the logistics capacity and readiness of sites to expand

PMTCT services and regimens in relation to new recommendations as well as to assess referral systems

for ART initiation in pregnancy.

c. Cross Links with Other SPS Activities

The availability and use of cotrimoxazole, nevirapine, AZT, test kits and other supplies will be monitored

using a routine information system (RxSolution), which is being deployed by SPS at selected sites. SPS has

also developed a morbidity-based quantification model for PMTCT commodities that has been introduced

during the National quarterly quantification workshops to assist the provinces in quantifying their

requirements. The implementation of this model will be part of the overall support provided under Health

Systems Strengthening.

SPS is also contributing to the review and promotion of the National Standard Treatment Guidelines for

PMTCT.

-------------------------

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 Narrative: 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.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14002

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14002 7854.08 U.S. Agency for Management 6682 588.08 Strengthening $349,200

International Sciences for Pharmaceutical

Development Health Systems

7854 7854.07 U.S. Agency for Management 4464 588.07 RPM Plus 1 $300,000

International Sciences for

Development Health

Emphasis Areas

Gender

* Increasing gender equity in HIV/AIDS programs

Workplace Programs

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $84,000

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.01:

Funding for Treatment: Adult Treatment (HTXS): $1,615,449

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

The signing of memorandums of understanding (MOUs) between Management Sciences for Health's (MSH)

Strengthening Pharmaceutical Services (SPS) with the provinces will enhance accountability by both sides

(SPS and counterparts) as the MOUs will list the obligations by both parties as well as the activities to be

undertaken.

SPS will keep providing support to this critical component of the National Strategic Plan (NSP), including the

strengthening/management of down referral systems.

-----------------------------------

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 DeliverySince 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: PharmacovigilanceThe 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 AdherenceSince 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 UseThe 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 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 ServicesThere is a need to scale-up access to ART. One strategy of the NDOH

Activity Narrative: 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 CounterpartsSince 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.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14005

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14005 3088.08 U.S. Agency for Management 6682 588.08 Strengthening $2,328,000

International Sciences for Pharmaceutical

Development Health Systems

7559 3088.07 U.S. Agency for Management 4464 588.07 RPM Plus 1 $2,000,000

International Sciences for

Development Health

3088 3088.06 U.S. Agency for Management 2703 588.06 RPM Plus 1 $1,050,000

International Sciences for

Development Health

Emphasis Areas

Health-related Wraparound Programs

* Child Survival Activities

* TB

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $499,158

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.09:

Funding for Treatment: Pediatric Treatment (PDTX): $1,121,395

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; 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, orphans and vulnerable children (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. With FY 2009 funding, 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: Standard Treatment Guidelines and Rational Drug Use

SPS will assist the NDOH in reviewing pediatric STGs and the primary health care Essential Drugs List

(EDL) on an ongoing basis as well as assist the provinces in promoting these STGs. SPS will also conduct

provincial workshops on rational drug use; strengthen provincial, district and institutional pharmaceutical

and therapeutic committees (PTCs); assist with the 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.

ACTIVITY 2: Adherence

The need to ensure optimum treatment outcomes and prevent resistance to ARVs is an important goal of

pediatric HIV management which relies strongly on the availability of adequate systems to monitor

adherence to treatment regimens. Identifying the complex issues around treatment adherence is important

for children, caregivers and providers. SPS has developed significant experience in this area following the

successful development and implementation of an adherence assessment tool for adults and will continue

working with key provincial and national counterparts and partners to develop optimum adherence

monitoring tools and identify interventions to support treatment adhrerence. These efforts will also

contribute to the overall strengthening of the health system as pediatric medication adherence monitoring

and support measures are generic tools that may be applied to settings providing treatment for other

chronic pediatric diseases.

ACTIVITY 3: Pediatric Pharmacovigilance.

Strengthening pharmacovigilance measures to ensure the safe and effective use of ARVs and other

medicines used in pediatric patients with HIV and AIDS is an important goal of the National HIV/AIDS

program. The training of health-care workers in the identification, diagnosis, management, prevention and

reporting of HIV medication-related adverse effects in pediatric patients is critical to improving healthcare

outcomes in this vulnerable population. SPS has developed training materials to meet this need and will

conduct training programs to build capacity by providing skills and knowledge to HIV and AIDS program

managers on the safe use of antiretroviral agents and related medicines in pediatric patients. In addition,

SPS will provide technical assistance to facility-based HIV and AIDS programs on the planning and

implementation of surveillance activities in this area of pharmacovigilance, with subsequent follow-up at the

provincial and national levels. SPS will support focused surveillance activities and operational research

relating to key pediatric drug safety issues through collaboration with university academic and research

departments and other key stakeholders and partners.

ACTIVITY 4: Training of Pharmacy and Nursing Personnel from ART and PMTCT sites

There is an urgent need to strengthen capacity among pharmacy and nursing personnel to manage

pediatric patients on ARVs. The SPS HIV/AIDS Pharmaceutical Management and PMTCT training courses,

intended for pharmacy and nursing personnel, address this need. Course materials focus on, amongst

others, prevention of mother-to-child transmission (PMTCT), follow-up care and testing of exposed infants,

management of TB/HIV, and food and nutrition guidance.

ACTIVITY 5: Monitoring of Pediatric ARVs and TB Drugs and Patient Management

SPS will implement systems (manual and computerized) to monitor the use of pediatric ARVs and related

medicines, management of patients as well as provide training to provincial pharmacy and nursing

personnel in quantifying requirements for pediatric ARVs and related medicines.

New/Continuing Activity: New Activity

Continuing Activity:

Emphasis Areas

Health-related Wraparound Programs

* Child Survival Activities

* TB

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $346,500

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.11:

Funding for Care: TB/HIV (HVTB): $485,452

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

Strengthening Pharmaceutical Systems (SPS) has made the following changes to the COP 2008 narrative:

BACKGROUND: The sentence in COP 2008, "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 should read as follows:

"The TB cure rate in South Africa, 51%, remains well below the WHO target of 85%. Smear positive patients

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

TB."

ACTIVITY 2: Adherence to Treatment and Rational Use of Medicines

SPS has developed an antiretroviral adherence assessment tool in close collaboration with the National

Department of Health's HIV/AIDS Directorate. This tool was fully tested and validated. It is currently being

deployed to sentinel sites in all provinces and included in the new national Standard Treatment Guidelines

(STGs). This one-page tool provides health personnel with a reliable and quick to administer method to

follow up patient adherence to treatment using four different complementary measures (Self-Reporting,

Visual Analog Scale, Pill Identification and Pill Count) and if required, to develop a patient specific

adherence improvement plan. In South Africa, DOTS is the method of choice for TB patients to ensure

adherence to treatment, however it has not been as successful as anticipated. SPS, in collaboration with

the national and provincial managers of the TB program will explore opportunities to adapt the SPS

Adherence Monitoring tool for TB patients as a complementary method to DOTS and/or as another way of

monitoring adherence were DOTS cannot be implemented. Any full-scale implementation will be preceded

by a pilot phase and evaluation.

ACTIVITY 3: Quantification

SPS will develop morbidity-based quantification models for multi-drug resistant (MDR-TB). Extensively drug

-resistant (XDR-TB) will also be considered once STGs are finalized.

ACTIVITY 4: TB/HIV Infection Control

"Settings" refers to health service delivery points.

SPS will include a specific TB Infection Control module into ICAT. The "National TB Infection Control

Guidelines", the "National Infection Prevention and Control Policy and Strategy", "A Policy on Quality in

Health Care for South Africa" and other reference documents developed by other partners such TB TASC

will be used to support this work.

The scaling up of isoniazid preventive therapy (IPT) will necessitate the review of protocols to ensure that all

health-care workers are trained appropriately.

SPS is currently collaborating with the National TB Programme (NTP) in the development and

implementation of surveillance systems for drug-related morbidity and mortality at MDR and XDR treatment

sites. SPS will support the NTP in developing a framework for focused surveillance of MDR and XDR-

related adverse drug reactions at sentinel sites in the various provinces. Support for this initiative will be

provided through training of personnel at identified sites in each province, support for implementation of

data management systems at MDR and XDR TB sites and support for the establishment of a framework for

data assessment at national level.

The SPS TB medicine management training program is aimed at optimizing the implementation of TB

services through strengthening integration with key programs including HIV and AIDS and pharmaceutical

services. The training program is aimed at pharmacy and nursing personnel and has an important focus on

forecasting, procurement, storage, and distribution of TB-related medicines and supplies. Participants are

trained to identify critical issues in systems and policies that may facilitate or hinder services and TB

commodity security, and to recognize areas for improvement, and provide intervention options. The training

program also focuses on safety monitoring in TB treated patients.

All training materials developed or updated by SPS will be field tested and submitted for accreditation to the

South African Pharmacy Council once finalized.

------------------------------

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:

Activity Narrative: 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

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 Narrative: 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".

New/Continuing Activity: Continuing Activity

Continuing Activity: 14003

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14003 7856.08 U.S. Agency for Management 6682 588.08 Strengthening $407,400

International Sciences for Pharmaceutical

Development Health Systems

7856 7856.07 U.S. Agency for Management 4464 588.07 RPM Plus 1 $300,000

International Sciences for

Development Health

Emphasis Areas

Health-related Wraparound Programs

* TB

Military Populations

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $150,000

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.12:

Funding for Treatment: ARV Drugs (HTXD): $970,905

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

SPS has been approached by other PEPFAR partners (i.e. Catholic Relief Services, REACTION, Right To

Care) to explore opportunities to use RxSolution for procurement, storage, and distribution of their

medicines and for dispensing and down referral activities. In some sites this also implies that an electronic

interface with their own patient management system may have to be developed, tested and implemented.

The Quantification models will also be updated (if required) to cater for any revisions of the national

standard treatment guidelines.

----------------------------------------

SUMMARY:

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

Systems (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

Activity Narrative: 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 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.

New/Continuing Activity: Continuing Activity

Continuing Activity: 14004

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

14004 3087.08 U.S. Agency for Management 6682 588.08 Strengthening $2,328,000

International Sciences for Pharmaceutical

Development Health Systems

7558 3087.07 U.S. Agency for Management 4464 588.07 RPM Plus 1 $1,000,000

International Sciences for

Development Health

3087 3087.06 U.S. Agency for Management 2703 588.06 RPM Plus 1 $1,950,000

International Sciences for

Development Health

Emphasis Areas

Health-related Wraparound Programs

* Child Survival Activities

* Family Planning

* TB

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $200,000

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.15:

Funding for Strategic Information (HVSI): $242,726

SUMMARY:

With FY 2009 PEPFAR funds, Management Sciences for Health's (MSH) Strengthening Pharmaceutical

Systems (SPS) project will continue to support the "HIV & AIDS and STI National Strategic Plan, 2007-

2011" (NSP). Under Strategic Information (SI), SPS will assist selected provincial pharmaceutical

directorates to: 1) conduct follow-up surveys (to the ones conducted in 2006-2007) in order to assess

compliance with legislation of health facilities providing pharmaceutical services, including the development

of standard operating procedures; 2) review and/or develop performance indicators to monitor the delivery

of pharmaceutical services at all levels and also develop provincial monitoring and evaluation plan; and 3)

implement medicines information centers to support the treatment program.

BACKGROUND:

At the SPS launch held in August 2008, Heads of Pharmaceutical Services for all provinces, Metros, the

Department of Correctional Services and the South African Military Health Services requested support in

the area of monitoring and evaluation of pharmaceutical services at a national and a provincial level,

assistance in reaching legislative compliance in all activities relating to the supply of medicine and the

monitoring thereof, the development of Standard Operating Procedures and the provision of medicine

information.

ACTIVITY 1: Compliance with legislation

SPS will continue to assist provincial and Metro authorities to ensure that pharmaceutical services provided

at provincial and Metro facilities comply with the legislation relating to the supply of medicine. Compliance

with legislation facilitates the accreditation of facilities to provide antiretrovirals. This activity includes

providing training of health care providers as well as training at a pre-service level regarding the legislative

requirements. Assistance will be provided to at least three of the provinces in conducting a full survey of

provincial facilities to assess the state of compliance. Data will be analyzed and reports prepared.

One of the key aspects of legislative compliance is the availability of standard operating procedures (SOPs).

Workshops will be conducted in the provinces and Metros on the principles of the development of SOPs.

Assistance will then be provided to provinces in the development, review and/or revision of sets of generic

sets of SOPs for pharmaceutical services and the adaptation thereof for use at facility level. Once SOPs are

finalized support will be provided in the implementation thereof. A key focus of this activity will be capacity

building and the transfer of skills to personnel of the province or Metro to ensure sustainability.

ACTIVITY 2: Monitoring and evaluation of pharmaceutical services

Workshops will be conducted in all nine provinces to provide training on the basic principles of monitoring

and evaluation and the application of these principles to pharmaceutical services. Technical assistance will

then be provided in the development of provincial indicators to be used in the monitoring of service

provision. Aspects that will be addressed will include all aspects of medicine supply management, the

availability of medicine including medicine used in the prevention and treatment of HIV and AIDS, TB and

associated morbidities, compliance with legislation, quality of care provided to patients, pharmacovigilance

and the rational use of medicine. Assistance will be put in place to ensure routine collection of the data

needed for the monitoring pharmaceutical services as well as the preparation of reports. Assistance will also

be provided in the evaluation of specific projects as needed. A key focus of this activity will be capacity

building and the transfer of skills to personnel of the province or Metro to ensure sustainability.

ACTIVITY 3: Medicine information

Work will continue in setting up systems for the supply of medicine information in selected provinces,

whenever feasible this activity will be conducted jointly with a provincial academic institution.

New/Continuing Activity: New Activity

Continuing Activity:

Emphasis Areas

Health-related Wraparound Programs

* Child Survival Activities

* Family Planning

* TB

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $62,500

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.17:

Funding for Health Systems Strengthening (OHSS): $728,178

SUMMARY:

With FY 2009 PEPFAR funds, Management Sciences for Health's (MSH) Strengthening Pharmaceutical

Systems (SPS) project will continue to support the "HIV & AIDS and STI Strategic Plan for South Africa,

2007-2011". Under Health Systems Strengthening (HSS), SPS will continue to support the national,

provincial pharmaceutical directorates and other statutory bodies by: 1) assisting with the review and update

of national standard treatment guidelines, policies and procedures related to medicines legislation;

regulations and pricing; and pharmacy practice, 2) promoting best practices for infection control practices,

and 3) strengthening medicines supply management information systems.

BACKGROUND:

After the launch of SPS in August 2008, most of the provinces and metros requested additional support in

new areas to support governance (e.g. management and leadership, strategic planning, and project and

financial management). Therefore SPS will continue to provide assistance to all provinces in monitoring

progress towards compliance with the Pharmacy Act and Medicines Control Act legislative requirements

that relate to the delivery of pharmaceutical services as well as the applicable standards for the

accreditation of health institutions (hospitals and community health centers) to provide ART.

ACTIVITIES AND EXPECTED RESULTS:

SPS will carry out the following three separate activities in this program area.

ACTIVITY 1: Policies and Procedures

SPS will provide assistance with the development of policies and procedures at all levels. It will also support

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

to patients with HIV/AIDS, tuberculosis (TB) and other diseases, capacity building in the areas of

governance, pharmaceutical care and monitoring and evaluation of pharmaceutical service delivery.

SPS will continue to provide technical assistance to non-governmental organizations such as the SA

Pharmacy Council (SAPC) and the South African Qualifications Authority (SAQA) in a wide range of

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

etc.

SPS will also continue to support the development and review of the standard treatment guidelines, pricing

regulations to promote equitable and affordable access to medicines, and maintain its involvement with the

Medicines Control Council (MCC).

ACTIVITY 2: Infection Control

The Infection Control Assessment Tool (ICAT) has been approved as the National Standard for assessing

infection control. SPS will continue to provide technical assistance to national and provincial Departments of

Health (N/PDOHs) to improve infection control programs in hospitals.

Planned activities include but are not limited to the following:

- Conduct training of trainers (TOT) workshop in the Western Cape province

- Finalize and officially launch the tool

- Print and disseminate hand hygiene posters

- Continue the on-going collaboration with the Soul City producers on the hand hygiene public awareness

campaign

- Work with the NDOH and Medical School of the University of KwaZulu-Natal on the infection control

manual

-Train pharmacy personnel on infection prevention and control practices

ACTIVITY 3: Medicines Supply Management Information Systems

SPS will continue to deploy its computerized medicines supply management (RxSolution) and quantification

models at the facility level. SPS focus will to train manager on using information to support decision making.

New/Continuing Activity: New Activity

Continuing Activity:

Emphasis Areas

Health-related Wraparound Programs

* Child Survival Activities

* TB

Workplace Programs

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $187,500

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.18:

Cross Cutting Budget Categories and Known Amounts Total: $1,529,658
Human Resources for Health $84,000
Human Resources for Health $499,158
Human Resources for Health $346,500
Human Resources for Health $150,000
Human Resources for Health $200,000
Human Resources for Health $62,500
Human Resources for Health $187,500