Pharmaceutical Sector Support from Site to National Levels

ACTIVITY HAS BEEN MODIFIED IN THE FOLLOWING WAYS:

This is a continuing activity from COP07 and COP08; the activity has been renamed, changing from

Rational Pharmaceutical Management Plus to Strengthening Pharmaceutical Systems (SPS).

The activity will no longer handle Site-Level Inventory Management, or other supply chain management-

related activities that were addressed by SPS (as the former RPM Plus) under COP06, COP07 and COP08.

While SPS has been very effective in supporting site-level pharmacy and inventory management, funding

decreases and the Ministry of Health (MOH) restructuring process have dictated a shift in allocation of

responsibilities for PEPFAR partners.

In this transition, under Cop09 facility level stock management will pass to the Supply Chain Management

System (SCMS), including prevention of drug and other commodity expiry by shifting stock among facilities.

The Pharmaceutical Supplies and Logistics Department (PSLD), formerly a major counterpart, seems likely

to disappear under the Ministry of Health's Business Process Reengineering (BPR) restructuring, and will

likely no longer be a major counterpart. In any case, collaboration with this entity or successor agencies will

not include supply chain or inventory control activities.

For example, SPS will not support facilities in submitting monthly orders using facility-based data.

In collaboration with the Drug Administration and Control Authority (DACA), Abt Associates and as part of

the public-private partnership (PPP) effort, SPS will provide technical assistance (TA) to Kenema (City

Council), Red Cross and selected private pharmacies in storing and dispensing ARV and related

commodities, with $500,000 of dedicated COP09 funding for that purpose under this activity.

Activities under COP07 and COP08 in improving quality assurance of ARV and related commodities will

shift to a new partner, the United States Pharmacopeia (USP), in a decision coordinated with

USAID/Washington technical staff.

As described above, activities in strengthening site-level pharmaceutical and laboratory information

management will shift to a pharmaceutical and laboratory management focus, with supply chain, logistics

and inventory control functions supported through SCMS. Links between the functions will be maintained

and strengthened through close collaboration between SCMS and SPS, who are co-located. SCMS will

assure that there are no treatment interruptions due to stock-outs of vital products, will minimize expiry of

expensive drugs, will support health facilities in preparing scheduled orders of HIV commodities, and will

support the Pharmaceutical Fund and Supply Agency (PFSA) in distributing these items from regional

stores to facilities. SCMS will build on SPS' experience to date, scaling up inventory management and

reporting at facility level, and will ensure that facility level data is compiled, analyzed and shared with

relevant agencies for quantification and redistribution, replacing SPS in this function. SCMS will continue

the SPS activity of implementing an electronic laboratory commodities information management tool.

Data clerks deployed in previous years are expected to be transitioned to MOH support under COP09.

ART site staff will no longer be trained in supply management by SPS - this activity will be handled by

SCMS.

Activities from COP08 centered on establishing Drug and Therapeutic Committees (DTC) and Drug

Information Centers (DIC), promoting rational drug use, inhibiting antimicrobial resistance will continue to be

supported by SPS, as will most capacity building at DACA with the exception of efforts to improve drug

quality, which will be handled by USP.

Collaboration with the MOH, DACA, SCMS, and the USAID/DELIVER in the implementation of the

Pharmaceutical Logistics Master Plan will be limited to pharmaceutical management areas that link with

logistics management, with SCMS assuming the former SPS roles in logistics management, primarily at site

level.

Wrap around with other PEPFAR activities

Presidential Malaria Initiative (PMI). For FY2009, PMI will be supporting MSH/SPS for implementing

activities to rationally manage anti-malarial drugs. Support to this activity includes the placement of a

resident advisor specifically to support malaria drug logistics management at the Oromia Regional Health

Bureau (RHB). Ongoing support at health facility level to ensure anti-malarial drug availability, per protocol

dispensing and reporting of stock-outs will be continued in hospitals, health centers as well as health posts

in Oromia, i.e. those health facilities where MSH/SPS is already implementing activities with PEPFAR

support.

FY2009 PMI activities to ensure the quality of anti-malarial drugs in both the private and public sectors

throughout Ethiopia will be jointly implemented by USP with funding from both Presidential Initiatives.

COP08 Narrative

Dispensing, Rational Use and Site-level Inventory Management of Antiretroviral (ARV) Drugs and Related

Products

This activity focuses on facility-level stock management of essential HIV commodities, such as ARV and

opportunistic infection (OI) drugs, lab supplies; prevention of drug expiry by shifting stock among facilities,

and raising the current low standard of dispensing to acceptable levels. The activity is related to good

Activity Narrative: clinical and pharmacy practice and is a component of the rational use of drugs (rational prescribing, rational

dispensing and rational use by the patient). MSH/RPM PLUS will continue to collaborate with the Drug

Administration and Control Authority (DACA), the Provisional Supplies and Logistics Department (PSLD) of

the Ministry of Health (MOH), the Partnership for Supply Chain Management (PSCMS), as well as new

entities such as the U.S. President's Malaria Initiative(PMI) and the MSH Care and Support Program, and

other relevant organizations, to implement rational HIV commodity dispensing and use for ARV, OI drugs,

malaria and tuberculosis (TB) products, PMTCT supplies, laboratory reagents and test kits at ART facilities

It will support facilities in submitting monthly orders using facility-based data; in collaboration with DACA,

Abt Associates and as part of the public-private partnership (PPP) effort, it will provide technical assistance

(TA) to Kenema (City Council), Red Cross and selected private pharmacies in storing and dispensing ARV

and related commodities.

Improving Quality Assurance of ARV and Related Commodities

Quality assurance of ARV and other drugs plays a vital role in guaranteeing favorable treatment outcomes

and decreasing toxicity. This is a continuing activity from COP06 and COP07. MSH/RPM PLUS will

continue to provide TA to DACA by seconding Quality Control/Quality Assurance (QC/QA) pharmacists,

supporting regional activities to ensure the quality, safety and efficacy of HIV/AIDS, TB, malaria and OI

drugs. DACA's capacity to monitor and control the movement of counterfeit pharmaceuticals will be

strengthened. DACA's drug QC laboratory will be supported in the proper storage of reagents and

chemicals, record keeping, and provision of reference books and standards, computers and accessories,

TA in the development of new standard operating procedures (SOPs) and in managing an electronic data

base and reporting system for their QC Laboratory. In collaboration with PSMCS, MSH/RPM PLUS will

support DACA and PHARMID's efforts in post-marketing surveillance of drugs, establishing six QC mini-

labs at selected sites.

Strengthening Site-Level Pharmaceutical and Laboratory Information Management

This activity will assure that there are no treatment interruptions due to stock outs of vital products, will

minimize expiry of expensive drugs. RPM PLUS has implemented pharmacy-based patient medication

records for more than 70,000 ART patients nationwide; some are computerized. Facilities have been

provided with over 50 computers and printers and 62 pharmacy data clerks have been deployed to hospitals

and health centers to ensure quality data entry and reporting. These activities will be maintained and further

expanded during FY08. RPM PLUS will support health facilities in preparing scheduled orders of HIV

commodities, and will support PSCMS in distributing these items from PHARMID regional stores to facilities.

MSH/RPM PLUS will build on the experience to date, scaling up inventory management, patient pharmacy

records and reporting at facility level and ensuring that ART Standard Operating Procedures (SOP) and

pharmacy-related formats and registers are available at all ART/PMTCT sites. Routine commodity audit

systems will be introduced at all ART sites. Target facilities will be provided with computers and printers.

Access to telephones and internet will continue to be supported to facilitate reporting and track defaulters. In

order to ensure ownership and utilization of data, data managers will be recruited and deployed at RHB.

Facility level data will be compiled, analyzed and shared with relevant agencies for quantification and

redistribution. Monitoring of ARV drug management and use will be supported. In consultation with PSCMS

and other partners, MSH/RPM PLUS will continue to work on implementing an electronic laboratory

commodities information management tool.

Strengthening Pharmacy Human Resource Capacity

This activity is part of an overall human resource (HR) capacity building effort with local and U.S.

universities, the Clinton HIV/AIDS Initiative (CHAI) and JHPIEGO). HR-related constraints are perhaps the

greatest challenge for the health system at present. Through pre-service and in-service training (PST/IST)

in conjunction with the Ethiopian Pharmaceutical Association, training will be provided to pharmacy

personnel and students. To date RPM PLUS has trained more than 1400 pharmacy and allied professionals

in HIV product management and rational drug use. Refresher trainings need to be conducted to update staff

and address high staff turnover. ART site staff will be trained in supply management, pharmaceutical care

and RDU as well as basic computer skills. Training will be followed by supportive supervision and

mentoring. External short-term training in relevant areas will be facilitated for selected participants. In

collaboration with DACA, RPM PLUS will promote public awareness and education by training media

personnel to promote RDU, including containment of antimicrobial resistance (AMR), adherence,

awareness about counterfeits, etc., and providing up-to-date specialty books and reference materials to

health facilities. A critical task assigned to MSH/RPM PLUS by the MOH during the plan year is the

assessment of pharmaceutical HR needs and development requirements of the pharmaceutical sector as

outlined in the Pharmaceutical Sector Master Plan.

Provision of Technical Assistance and Coordination

RDU is a key element to maximize treatment options for chronic diseases such as HIV/AIDS. Monitoring

and minimizing adverse drug reactions (ADR) is instrumental in increasing adherence to treatment, which

supports the success of treatment. Clients will get improved pharmaceutical care, and the development of

viral or AMR will be minimized. TA will be provided in the following areas: 1) RDU, (2) establishing Drug and

Therapeutic Committees (DTC) and Drug Information Centers (DIC), in collaboration with DACA, PSLD,

RHB, CHAI's Hospital Improvement Initiative and others (3) AMR containment, (4) ADR monitoring and, 5)

adherence monitoring and promotion through workshops, studies and development of facility level action

plans. Activities envisaged include collaboration with programs such as the new Care and Support Program

at health centers, at community and household levels with health extension workers; through HIV/TB drug

management, with PMI in management and rational use of malaria products; and by linkages to with

stakeholders to conduct drug-related operational research. Working closely with DACA and PSLD, RPM

Plus will support improved governance in the pharmaceutical sector by providing TA in pharmaceutical

policy, regulation and quality services in support of the national pharmaceutical and logistics master plans,

and will collaborate with the MOH, DACA, PSCMS, and the Implementation Support Team (IST) of the

Logistics Master Plan in the transformation of PSLD to the "New PSLD" and Pharmid to the new Agency.

New/Continuing Activity: Continuing Activity

Continuing Activity: 16678

Continued Associated Activity Information

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

System ID System ID

16678 10534.08 U.S. Agency for Management 7500 3798.08 RPM Plus $4,130,000

International Sciences for

Development Health

Emphasis Areas

Health-related Wraparound Programs

* Malaria (PMI)

* TB

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $929,357

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Program Budget Code: 16 - HLAB Laboratory Infrastructure

Total Planned Funding for Program Budget Code: $27,907,714

Total Planned Funding for Program Budget Code: $0

Program Area Narrative:

Laboratory organizational and physical infrastructure, procurement systems, supply availability, equipment, and trained staff are

critical for PEPFAR Ethiopia's program implementation. It is necessary to strengthen the laboratory infrastructure at all levels to

improve service quality and achieve targets. PEPFAR Ethiopia, in collaboration with the Ethiopian Ministry of Health (MOH), is

strengthening facilities at regional, hospital and health center levels to support HIV/AIDS prevention, care, and treatment

programs. The laboratory still faces several challenges, including upgrade or refurbishment of physical laboratory infrastructure,

expansion of laboratory quality assurance programs, sustaining sample referral testing, capacity building, reliable equipment

maintenance policy and expansion of laboratory information system. Accordingly, PEPFAR Ethiopia supported the comprehensive

renovation of the Ethiopian Health and Nutrition Research Institute (EHNRI) reference laboratory and five hospital and regional

laboratories. These laboratories have been furnished with standard laboratory furniture and equipment. Six regional laboratories

have been completely renovated, furnished and equipped in FY08, and are performing DNA Polymerase Chain Reaction (PCR)

testing for Early Infant Diagnosis (EID), in addition to other standard tests.

PEPFAR Ethiopia supported the development of standardized curricula for in-service training on chemistry, hematology, CD4,

laboratory management, facility level laboratory management and, health center level laboratory technician training, opportunistic

infections (OI) diagnosis including tuberculosis (TB) microscopy, HIV rapid testing, EID and quality systems. In addition,

development of guidelines, operational plans, log sheets, standard operating procedures (SOPs), test request and record forms

have been supported. PEPFAR has trained more than 1,400 laboratory technologists, supervisors, and directors on laboratory

diagnosis of HIV, TB, sexually transmitted infections (STI), laboratory management and quality systems, as well as laboratory

monitoring (chemistry, hematology and CD4 count) of ART. A decentralized approach was used for training, in which most training

was conducted at regional and site levels.

Laboratory quality assurance for both methods and data are high priority for PEPFAR Ethiopia and EHNRI. PEPFAR has

established external quality assurance (EQA) for CD4, chemistry, hematology and HIV rapid testing at 52 ART sites. Additionally,

PEPFAR is preparing to decentralize EQA further down the tiered laboratory network. For ease of management, quality of

laboratory data, and to improve efficiency, PEPFAR Ethiopia supported pilot implementation of a Laboratory Information System

(LIS) at selected hospitals, national referral and regional laboratories. As part of the LIS implementation, more than 25 working

stations were networked with broadband internet service at EHNRI HIV reference laboratory.

PEPFAR purchased and distributed essential laboratory equipment to regional and hospital laboratories, including automated

clinical chemistry, hematology analyzers, FACSCount machines, biosafety cabinets, incubators, centrifuges, PCR machines and

accessories for EID at 6 regional labs. PEPFAR Ethiopia supported the maintenance of all the equipment through EHNRI and

provided technical and logistic support for transportation and installation of laboratory equipment purchased by the MOH with

funds from the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) for 63 ART hospitals. Effective referral testing has

been provided to more than 240 health centers for CD4 and ART.

PEPFAR Ethiopia also supports laboratory-based targeted evaluation of laboratory diagnosis and disease monitoring. Procedures

for HIV pro-viral DNA PCR detection from dried blood spots (DBS) has been validated and implemented nationwide at ART sites.

PEPFAR is preparing to establish testing centers at six other sub-regional reference or hospital laboratories and to scale up

diagnostic services through DBS sample referral linkages. PEPFAR has supported training in the use of and implementation of a

WHO recommended commercially-based kit for HIV-1 drug resistance monitoring. Furthermore, PEPFAR is implementing an "in

house HIV-1 drug resistance genotyping assay" at the EHNRI HIV Reference Laboratory. PEPFAR has also successfully piloted a

standardized HIV rapid test results logbook at sites in Addis Ababa, with next phase being expansion to sites. In the area of

logistics supply chain management, PEPFAR has seconded an advisor to EHNRI to support quantification for laboratory reagents

and supply procurement, and has also placed five Regional Laboratory Logistics Associates (RLLAs) in key regions to support

supply distribution.

One of PEPFAR Ethiopia's goals in FY09 is to access majority of HIV infected pregnant women whom without any intervention

may have a high risk of transmitting HIV to their child in utero, intrapartum and during breast feeding. These efforts aimed at

reaching pregnant women by the prevention unit will be strongly coordinated with PEPFAR Ethiopia laboratory. Several reasons

make it compelling for joint coordination with laboratory. First, this new pool of pregnant women once accessed should be offered

HIV testing and counseling. Secondly, the laboratory would determine eligibility of the pregnant women for antiretroviral

prophylaxis as well as monitoring them while on ARV. Sample referral system and results reporting will ensure specimens are

appropriately transported to maintain their integrity and tested and results returned within specified turn around times for

appropriate interventions for PMTCT.

Furthermore, an estimated 2.3 million children worldwide are living with the HIV. Almost half of these children will die before

turning 2 years of age, if left untreated. By age 5 years, 75% of these children will die if they fail to receive treatment. PEPFAR

Ethiopia's goal is to rapidly scale up pediatric care and treatment services. This program will liaise and coordinate with the PMTCT

and laboratory programs. That way, infants can be accessed and quickly diagnosed. Laboratory capacity for DNA PCR testing for

EID will be increased by adding six new DNA PCR testing sites to already existing ones to match the increase in access and

identification of infected infants. Coordination of Dried Blood Spot (DBS) sample referral with facilities lacking this technology will

be implemented and monitored.

PEPFAR Ethiopia aims at improving the low case detection rate for TB. Laboratory capacity will be strengthened for intensified TB

case finding. Training on TB smear microscopy and quality assurance will continue. PEPFAR Ethiopia will implement capacity for

liquid culture at regional laboratories for TB detection.

In FY09, PEPFAR Ethiopia will continue to implement the quality assurance (QA) program with emphasis on sustainability and

integrated laboratory service delivery. PEPFAR will strengthen tiered, quality-assured laboratory networks and implement

nationally developed policies and strategic planning across the network. Integrated laboratory services and referral linkages will

be implemented across the tiered laboratory network. This network will provide an efficient mechanism for providing integrated

services to expand ART programs. PEPFAR Ethiopia will also continue to support all laboratory trainings, external quality

assessment (EQA) and site supervision at 138 ART health networks (including 138 hospitals and 281 health centers). PEPFAR

will train more than 1,800 laboratory professionals on HIV rapid testing, diagnosis of TB/OI, STI, laboratory monitoring of ART and

laboratory quality, information, logistic system and management systems. The national "training of trainer (TOT)" based trainings

will be conducted by EHNRI in collaboration with CDC, the American Society of Clinical Pathologists (ASCP), and the Association

of Public Health Laboratories (APHL). Regional laboratories, US-based universities and Management Science for Health (MSH)

will be involved in regional and site level trainings. The Clinical Laboratory Standard Institute (CLSI), the American Society for

Microbiology (ASM), ASCP, and APHL will assist in developing, customizing, and standardizing different training modules.

Additionally, PEPFAR will coordinate with the President's Malaria Initiative to leverage funds for quality laboratory diagnosis

especially as an integrated laboratory service approach is sought.

In FY09, PEPFAR will support EHNRI in the implementation of the "Maputo Declaration on strengthening laboratory systems".

PEPFAR will assist EHNRI to establish a national equipment maintenance policy. This will involve training of engineers at different

levels, making available spare parts and a proper equipment inventory. PEPFAR will support establishing a "bundling" mechanism

that ties purchase of selected reagents to equipment maintenance with vendors of equipment as well as by consolidating

maintenance contracts with equipment manufacturers or their local representatives especially as laboratory services with

numerous equipments are expanding.

PEPFAR Ethiopia will also support implementation of the National Master Plans for Laboratory Services and Logistics

Management. The Supply Chain Management System (SCMS) will provide logistics support for the transportation and distribution

of all laboratory commodities to all 138 ART hospital networks. PEPFAR will support reagent management needs, while inventory

and forecasting of supplies will be supported through technical assistance, with these efforts coordinated with other governmental

and donor stakeholders. For example, coordination with or leveraging GFATM monies for purchase of some test kits will occur,

particularly with HIV rapid test kits. PEPFAR will continue to develop the capacity of personnel at the national, regional and local

levels to implement an efficient supply chain management system for laboratory commodities. SCMS will work to develop the

capacity of the Pharmaceutical Funds and Supply Agency (PFSA, the national medical stores) to strengthen its central and

regional hub capacity to handle the special logistics needs for laboratory supplies, including cold chain requirements. SCMS will

deploy three additional RLLAs, and will supply CD4, chemistry and hematology commodities per the National HIV Commodity

Quantification Exercise, in coordination with EHNRI and Clinton HIV/AIDS Initiative staff jointly undertaking quantification.

With the support of CDC, EHNRI will provide national leadership in strategic planning, laboratory policies, guidelines, integrated

services and testing, and ensure implementation of laboratory standards. With EHNRI support, regional reference laboratories will

coordinate activities, including regional training, reference testing, EQA services, viral load and EID. APHL, ASCP, ASM and CLSI

will provide technical assistance at several levels for quality improvement, EQA data analysis and interpretation and evaluation of

programs, networking, referral linkages, developing and standardizing of training modules, SOPs, development of laboratory

policies and guidelines, guidance towards accreditation, and certification of clinical laboratory services. CDC, with partners, will

support EHNRI to establish a national accreditation committee, using the WHO laboratory accreditation guidelines/checklist to

support accreditation of national, regional, district and health center laboratories. The WHO accreditation system provides a cost

effective approach for different levels of laboratories.

PEPFAR Ethiopia partners will support standard clinical laboratory services for HIV/AIDS at the site level. U.S. universities will

work closely with laboratories at the regional level to provide technical assistance (site level training, laboratory management, and

follow up of implementation of standardized laboratory services) within their respective regions and health networks (hospitals and

health centers). University partners will also be involved in providing technical assistance for referral linkages between hospital

and health centers, including specimen management and transport, sample tracking, and recording and reporting systems. They

will work in close collaboration with, and under the leadership of EHNRI and regional labs in implementation of the Maputo

recommendations. They will work to integrate OI and STI diagnosis with the existing HIV/AIDS laboratory support. At the health

center level, MSH will support laboratories in training, sample referral testing, implementing quality assurance based on national

plans, minor renovation and furnishings, coordination of referral testing in collaboration with university partners, establishing

simple diagnostic techniques for OIs at facilities, and providing comprehensive laboratory site-level support at health centers in

major regions and Addis Ababa.

By the end of FY09, diagnosis of HIV/TB/OI/STI and laboratory monitoring services (hematology, biochemical, and CD4 profiles)

will be provided to more than 450,000 pre-ART patients on care and 210,000 patients on ART, as per the "National Guidelines for

Use of ARV Drugs". PEPFAR will support DNA-PCR based early virologic tests to approximately 48,800 infants. The revised

national HIV rapid testing algorithm and QA/QC program will be operational at all VCT sites. All major regional specialized referral

hospitals and regional laboratories will be networked and the laboratory information system will be operational for effective

implementation of QA, monitoring and evaluation of services. With PEPFAR Ethiopia partners, CDC Ethiopia will coordinate and

follow up integrated laboratory services including HIV/AIDS care, treatment, and prevention activities.

PEPFAR Ethiopia recognizes that sustainability of USG supported programs requires more than close collaboration with the GOE.

It also requires the support of non-governmental, indigenous organizations. As part of local capacity development and

sustainability, PEPFAR Ethiopia partners are required to work directly with such local organizations. ASCP and APHL will work

closely with local organizations including the National Reference and regional laboratories. APHL will support the Ethiopian Public

Health Laboratory Association and regional reference laboratories. ASCP will work with the Ethiopian Medical Laboratory

Association (EMLA) and laboratory schools. PSCMS will also work closely with the national supply chain management system

and ensure that local capacity is developed to implement the supply chain services. These efforts will ensure the development of

excellent laboratory capacity, including leadership, within the country.

Table 3.3.16: