Provide integrated TB/HIV pharmaceutical care/services

In FY08 SPS will expand activities in this new initiative to improve quality of TB/HIV services. The activity

has 3 components of which the training component is follow-on to FY07 activity # 7136. This activity is

aimed at implementing pharmaceutical care strategies that will improve quality of life of patients on

treatment for HIV, and TB or any opportunistic infection (OI). Anecdotal reports suggest that some patients'

qualified for Cotrimoxazole prophylaxis therapy (CTX) and Isoniazid prophylaxis therapy (IPT) are not

offered treatment. In FY08 SPS will;

?Conduct a Public Health Evaluation (PHE) to identify the extent of the IPT, CTX guidelines non-compliance

and identify factors associated with it. SPS will develop Prescription Quality Indicators (PQI) to review

providers' compliance to ARV, IPT and CTX guidelines. This PHE will be implemented in collaboration with

TBCAP, DSP M&E, the HIVQUAL project and Therapeutics Committees (TC) from selected facilities to

build capacity and sustainability. SPS will work with the MoHSS to develop interventions to ensure that

prescriptions are monitored so that patients qualifying for CPT and IPT according to the Namibia guidelines

receive these medicines.

? Monitor side effects of TB medicines. Concerns has been raised about the side effects of TB medicines, in

FY08 SPS in collaboration with TBCAP will introduce and support patient-initiated adverse event reporting

and train community based organizations (CBOs)that support DOTS to monitor side effects and adverse

drug reactions to TB medicines in Erongo, Caprivi and Karas regions. These side effects and adverse drug

reactions will be tracked through the TIPC(Therapuetic Information and Pharmacovigilance Centre)

? Expand content of the HIV/AIDS pharmaceutical management training materials. SPS will expand the

content of the training material to include topics on rational use of TB medicines, good prescription

practices, prevention with positives, and palliative care medicines. To ensure sustainability NHTC will be

involved in the content review and in close collaboration with I-TECH.

Support scale-up and increased access to ART treatment.

This is a new activity to support initiatives for ART scale-up. The activity has two components. Success in

the Ministry of Health and Social Services (MoHSS) PUTT and ART programs since 2002 had resulted in

37,000 patients on ART in 35 facilities. However, the number of patients now overburdens care providers

compromising quality of care. In FY2008 this Strengthening Pharmaceutical Systems (SPS) project will

build on previous RPM Plus efforts to work closely with MoHSS in a new initiative to scale-up ART services

and to ensure that decentralization is adequately supported through:

? Provision of basic dispensing equipment to 10 health centers and clinics. SPS will strengthen storage,

inventory and dispensing practices to support the scale up of referral and outreach programs in 5 identified

regions.

? Develop a basic pharmaceutical management curriculum to support IMAI. Use the developed curriculum

to provide training to 30 pharmacy staff and nurses who work in the new ART facilities. SPS will also

collaborate with other partners to enhance supportive supervisory activities that will improve the quality of

ART services at the new facilities.

Overall, the objective is to shift basic pharmaceutical duties to other workers in these new facilities. SPS will

work closely with regional and district pharmacists on these activity to ensure sustainability.

Expand content of the HIV/AIDS pharmaceutical management training materials

SPS will expand the content of the training material to include topics on rational use of TB medicines, good

prescription practices, prevention with positives, and palliative care medicines. To ensure sustainability

NHTC will be involved in the content review and in close collaboration with I-TECH.

Support Therapeutics Committees (TC) to improve rational use and mitigate antimicrobial resistance (AMR)

This is an expansion of FY07 activity # 7136 into new initiatives in FY08 to improve quality, reduce

antimicrobial resistance and secure durability of current ART regimens. The activity has 3 components.

Since 2005 RPM Plus has been supporting Therapeutic Committees (TCs) to address issues related to

rational use of medicines in their facilities. In FY2008 SPS will:

? Host a national TC course for 25 Namibian doctors, pharmacists and nurses. The course will be tailored to

the Namibian experience and include sessions on containing AMR, pharmacovigilance and infection control

(IC)

? Support TC-led interventions aimed at implementing (IC) strategies, conducting drug utilization reviews

(DURs), and improving ADR reporting. SPS will implement the infection control assessment tool (ICAT) for

3 major hospitals. Improving IC will contribute to the containing of AMR and hence the continuing

effectiveness of used ARVs. SPS will work with the University Research Company (URC) and the MoHSS

Quality Assurance unit to strengthen national and facility level IC activities and improve awareness and

behavior for good IC practices. SPS trainings will emphasize secure availability of IC commodities at

facilities

? Conduct Drug utilization review (DUR). SPS will conduct DUR in 2 major hospitals in collaboration with

the Therapeutic Information and Pharmacovigilance Center (TIPC). The DUR will focus on ART, TB and OI

medicines use to develop interventions to minimize AMR. This PHE method involves a descriptive cross-

sectional design using prescription records. The evaluations proposed will be carried out in collaboration

with M&E subdivision of DSP and results will be disseminated during the annual program review meetings

by the DSP.

Implementation of adherence interventions in adults and children

This is a continuation of FY 2007 activity # 7136 that has not been updated.

Poor ART adherence is recognized as a major contributing factor to the development of AMR leading to

therapeutic failure. SPS will work with partners to identify correlates of adherence and develop strategies to

improve it. SPS will conduct PHE and other quality improvement initiatives to evaluate the impact of

adherence interventions. The time trend analysis/Interrupted time series methodology will be used for this

evaluation. The study will involve the evaluation of the effectiveness of an adherence intervention,

examples; use of standardized adherence counseling tool in improving patient understanding of treatment

goals, use of audiovisuals and patient information leaflets, use of reminders, reduction in dispensing waiting

time, etc. Repeated baseline measurements will be made before the implementation of interventions and

repeated measurements will also be made after intervention to establish impact. The time trend analysis will

be carried out across selected 5 sites simultaneously. This activity will be carried out in collaboration with

DSP. Results will be disseminated through the annual program review meeting and to the regional medical

teams to support evidence-based decision making. SPS will collaborate with ‘expert patients', PLWHA,

Community Counselors, CBOs, and DSP in carrying out this activity and in the implementation of

interventions to ensure sustainability.

Improve Private Public Partnerships and the quality of ART services in the private sector

This is a continuation of FY 2007 activity # 7136 that has not been updated.

As of December 2005, a total of 5,695 patients were receiving ARVs in the private sector. In FY 2008 SPS

will collaborate with partners to implement interventions to lower cost and access and quality of ART

services in the private sector. Adherence by private sector practitioners to National ART guidelines has

been reported to be poor, quickly exhausting treatment options and increasing risk of resistance when such

patients transfer to the public sector. In FY 2008 SPS and partners will continue work with private providers

(private clinics and pharmacies) to develop appropriate interventions to reduce costs of ART and improve

care for private sector patients. In FY 2007 RPM Plus was invited by PriceWaterCoopers working in

collaboration with German Development Cooperation (GDF) and the Ministry of Works, transport and

communication to partner in the activity; HIV/AIDS Impact Assessment for the Transport Sector in Namibia.

In FY08 SPS will continue work on this partnership by supporting the partnership with the review of

documents.

Activity Narrative:

Provide support through Potentia for selected positions

In FY 2008 SPS will continue to provide funding through Potentia for the employment of 15 Pharmacists

and 10 middle level pharmacy staff, critical positions identified by the MoHSS.

Two PHEs have been approved: (1) Compliance to guidelines & evaluation of medicines prescription; and

(2) evaluation of the impact of adherence interventions.

The title of the PHE is "Evaluation of the impact of adherence interventions." This PHE will be undertaken

with $50,000 FY2008 funds. The PHE will be initiated and completed in COP08.

SPS will conduct this activity and other quality improvement initiatives to evaluate the impact of adherence

interventions implemented in FY2007. The time-trend analysis/interrupted-time series methodology will be

used for this evaluation. The study will involve the evaluation of the effectiveness of adherence

interventions, such as: (1) use of standardized adherence counseling tool in improving patient

understanding of treatment goals, (2) use of audiovisuals and patient information leaflets, (3) use of

reminders, (4) reduction in dispensing waiting time, etc. Repeated baseline measurements will be made

before the implementation of the interventions and repeated measurements will also be made after

intervention to establish impact. The time-trend analysis will be undertaken among 5 selected sites

simultaneously. Selected facilities will be approached to identify principal investigators. This activity will be

carried out in close collaboration with the Response Monitoring and Evaluation subdivision of Directorate of

Special Programs (DSP), and results will be disseminated through a national workshop and during the

annual program review meeting. Results will also be disseminated to the regional medical teams to support

evidence-based decision-making at the regional level. SPS will collaborate with expert patients, PLWHA,

community counselors, community-based organizations, DSP and other relevant stakeholders to implement

best practices in adherence interventions. Examples of such interventions may include adherence tools,

mass media, audiovisual messages and patient information leaflets that have been locally adapted. This will

be an observational study that targets quality improvement. There are no ethical issues envisaged;

however, the local institution review board will be approached for relevant approvals.

The purpose of this PHE is to:

1) Implement and review the implementation of adherence interventions in selected treatment facilities;

2) Evaluate the effectiveness of key interventions;

3) Recommend successful, cost-effective interventions and best practices for scale-up.

The $50,000 budget for this PHE will provide for the costs of salary for a short-term data entry clerk,

stationeries and supplies, travel, etc. Budget for FY 2008 includes: Per diems, salaries for data entry clerks,

literature review, meetings, stationeries and supplies, travel, reports and others.

The title of the PHE is "Compliance to guidelines and evaluation of medicines prescription." This PHE will be

carried out twice in the year and each activity will last 1 month. The proposed budget is $10,000 FY2008

funds.

SPS will develop a Prescription Quality Indicator (PQI) specifically for the study of providers' compliance to

ARV, Isozianid Preventive Therapy (IPT) and cotrimoxazole guidelines. PQI will be developed using

recommendations from the relevant guidelines, for example: the sections of the TB/HIV guidelines on

prescription of Isoniazid for latent TB in qualifying patients, and the prescription of Cotrimoxazole for

prophylaxis of Pneumocysis Carinii Pneumonia (PCP). There are anecdotal reports that some patients'

qualified for Cotrimoxazole prophylaxis therapy (CPT) and IPT are not offered treatment. Local providers

and clinicians will be involved through the Delphi method for the adoption of the PQI. The PQI will be

administered in 5 treatment facilities (different from the ones used in the other MSH PHE on ART

adherence). The use of the PQI to measure practice is a form of clinical audit. The TC from each selected

hospital will be requested to identify a key member to serve as the local co-investigator/principal investigator

(PI). This evaluation will be conducted through review of medical records, provider observation and

interviews. This will be an observational study that targets quality improvement. There are no ethical issues

envisaged; however, the local institution review board will be approached for relevant approvals.

The purpose of this PHE is to:

1) Assess prescription quality for patients who qualify for IPT and CTX and make recommendations for

possible interventions

2) Identify key factors that influence low coverage of IPT and CTX to PLWHA

3) Make recommendations to improve the coverage of IPT and CTX to all qualifying patients and also to

improve compliance to guidelines in general

This PHE will be carried out in close collaboration with the TC of the 5 selected hospitals. For more than 3

years and as a continuation of FY2007 activities, RPM+/SPS has been providing support and training to TC

members on how to identify medicines use problems in their facilities. It is envisaged that limited funds, in

this case $10,000 ($2,000 projected to be spent per selected treatment facility), will be required to conduct

this PHE. This PHE will provide TCs and the local PIs with the opportunity to develop local capacity to

conduct of clinical audits. Findings from the study will be presented to the TCs and Directorate of Special

Programs and disseminated during the annual program review meeting.

The $10,000 budget for this PHE will provide for the costs of the PI's per diem, salary for a short-term data

entry clerk, stationeries and supplies, and travel. Budget for FY2008 includes: Per diems, stationeries and

supplies, travel, reports and others.

The strategic information activities described below will facilitate procurement and distribution of ART

commodities nation wide. This activity is related to USG technical advisors supported through CTS Global

(7233) and strategic information personnel supported through Potentia (7338). The strategic information

gained from the information systems and evaluations described below will strengthen ART services nation

wide.

Support the implementation of the ART Commodity Tracking System at treatment facilities

This activity is a continuation of FY2007 activity that has not been updated. In FY2007 SPS continued the

roll out of the ART Dispensing Tool (ADT) to more treatment facilities. FY2008 funds will be used to;

* Continue ADT rollout to about 10 new treatment facilities with the highest volume of patients

* Train 20 pharmacy and nursing staffs that directly use the ADT in those new facilities Support the use of

data generated by the ADT for periodic review of use of ARVs and OI medicines

* Support development of a national level database at the MoHSS

* Support a technical position of an Information Systems Administrator to ensure that centrally the ADT and

other electronic tools provided to Pharmaceutical services division are adequately supported and

maintained. This position is part of the HTXS support through Potentia.

SPS ACTS data will be provided to SCMS to ensure that monthly and quarterly reports are summarized and

disseminated to MoHSS and other stakeholders and are used for making appropriate and timely

quantification of medicines to the facilities to prevent under or overstocking. SPS will encourage the use of

the ADT tool for periodic review of use of ARVs and OI medicines and to obtain data on number of patients

by category receiving treatment at facilities, for promoting rational use and planning of ART services.

Support data quality, program monitoring system and Pharmacy Management Information System

SPS will support the regional pharmacists to recognize data quality issues in their regions and how they

affect program management. SPS will provide series of support to improve data quality including; improve

timeliness, completeness, accuracy and quality of data collected and reported, conduct data quality audit

activities in selected facilities, and provide training on data quality to all regional pharmacists from the 13

regions. Also 30 pharmacy staffs will be trained on the PMIS. SPS will provide support data synthesis and

triangulation of HIV treatment data and link this information with other care indicators e.g. palliative care,

IPT, CPT, CB DOTS. Since 2004, RPM Plus has been supporting the development of a Pharmacy

Management Information System (PMIS), which was launched in June 2007. In FY2008, SPS will provide

technical assistance for the PMIS in the following areas;

* Use PMIS data to monitor quality of pharmaceutical care and services including ART services at treatment

facilities

* Identify weaknesses and design interventions to improve quality of treatment and care

* Incorporate key PMIS indicators into the national essential indicator framework for the health sector.

SPS will also continue to provide technical assistance to the Monitoring and Evaluation committee by

submitting reports on specific pharmaceutical indicators, as requested.

All the proposed studies are observational descriptive and analytical in methodology and are part of quality

improvement evaluation. They will assist in determining program effectiveness, outcomes and impact and

provide the evidence base for taking best practices to scale.

Support data quality, program monitoring system and Pharmacy Management Information System

SPS will support the regional pharmacists to identify strengths and weaknesses in data quality in routine

program monitoring systems collection and management systems, including specific risks to data quality

and provide TA in mechanisms to improve data quality. Efforts to improve timeliness, completeness,

accuracy and quality of data collected and reported and data quality audit activities in selected facilities will

be supported. Interventions like data quality training will be carried out to ensure improvement in data

quality reported. SPS will provide TA in data synthesis and triangulation of HIV treatment data, by age, sex,

etc and link this information with other care indicators e.g. palliative care, IPT, CPT, CB DOTS and support

managers in making appropriate managerial decisions. Since 2004, RPM Plus has been supporting the

development of a Pharmacy Management Information System (PMIS), which was launched in June 2007. In

2008, SPS will provide technical assistance for the PMIS to be used to monitor the quality of pharmaceutical

care and services including ART services at treatment facilities. Using the information gathered from the

PMIS, SPS will provide technical assistance in identifying weaknesses and designing pharmaceutical

interventions to improve quality of treatment and care services at all levels of the healthcare system. SPS

will provide technical assistance for the incorporation of key PMIS indicators into the national essential

indicator framework for the health sector. SPS will also continue to provide technical assistance to the

Monitoring and Evaluation committee by submitting reports on specific aspects of treatment and care, as

requested. SPS will encourage the use of the ADT tool for periodic review of use of ARVs and OI medicines

and to obtain data on number of patients by category receiving treatment at facilities for promoting rational

use and planning of ART services.

This activity is to strengthen the regulatory framework to ensure safety and efficacy of ARVs, TB and OI

medicines. This is an expansion of FY07 activity # 7135 into new initiatives. This activity has many

components, some of which are continuation of COP07 activities that has not been updated. The activity is

aimed at strengthening the Medicines Control Council (MCC) to ensure quality, safety and effectiveness of

ARV and related medicines that are imported, distributed and used within Namibia. In FY2008, SPS will

achieve this by applying an integrated approach to medicines regulation through a number of activities.

-Support registration and dossier review. This will include the provision of ongoing support to the registration

database; Pharmadex, the renovation and binning of dossiers and conduct of a dossier review retreat. SPS

will also support the registration unit to ensure timely review and approval of pediatric formulations to

guarantee un-interrupted availability and support better medicines for children initiatives

-Introduction of second-line TB medicines. In collaboration with DSP/TBCAP, SPS will provide support for

the registration of new 2nd line TB medicines, and support regulation and control of already existing ones

including the introduction of kanamycin to replace amikacin.

-Strengthening TIPC and adverse events data collection, analysis and use for regulatory and policy

decisions. Ongoing support to TIPC include continuing the subscriptions for softwares, database, journals,

infrastructure and support for the development of IEC materials; provide training on ADR reporting for 120

health care workers and support for highly skilled short term consultancies.

-Improve inspection activities of the Pharmaceutical Control and Inspection (PC&I). SPS will support PC&I

to develop inspection SOPs and provide training to 30 persons on medicines inspection. SPS will improve in

-country monitoring of ARV medicines through the implementation of the Minilab technology at selected

ports of entry in Namibia and provide other infrastructural support to improve inspection activities. PC&I has

limited capacity to communicate to the large body of pharmacists in the country and applicants for

medicines registration. SPS will continue work with PC&I on the development of a website and domain for

MCC and provide reference materials and equipment to enhance the capacity of MCC towards greater

attention to in-country quality assurance and post marketing surveillance activities.

-Implement active ADR reporting to support policy decisions. In FY2007 SPS developed a

pharmacovigilance model to introduce patient-initiated adverse event reporting. SPS in collaboration with

DSP/TBCAP will continue this activity to train CBOs that support DOTS in monitoring side effects and

adverse drug reactions to TB medicines in 3 regions. Data collected will be useful in defining and

quantifying the incidence and prevalence of adverse drug events related to TB medicines. Results from

these analyses will inform guidelines changes and regulatory decisions.

This integrated approach to strengthening medicines regulation will improve local capacity and lead to

sustained awareness, improved stewardship in safeguarding public health and guaranteed public trust in

the safety of program medicines.

Support the policy framework to improve access to treatment for PLWHA

Expanding access to ARVs in remote areas and improving access to palliative care has been compromised

by restrictions in prescription and dispensing policies. The National Policy on HIV/AIDS recognizes the

need for a continuum of care for persons living with HIV/AIDS (PLWHA). This policy also encompasses the

provision of more comprehensive HIV/AIDS treatment and care services that include palliative and home

based care. In FY2008, SPS will work with MoHSS, to review the national policy to ensure that specific

cadres of nurses trained in palliative care are allowed to prescribe and dispense morphine and other

indicated palliative care medicines to PLWHA. Review of the policy will also ensure uninterrupted availability

of morphine in health centers thus improving access of morphine and other palliative care medicines to

patients. SPS will also work with other partners including home based care organizations and volunteers to

ensure that the increased availability of morphine in the facilities is adequately utilized when indicated by

home based care providers in the communities. This is a new activity that will support the scaling-up of care

services. In collaboration with ITECH, SPS will develop modules on rational use of palliative care medicines

and train 120 CBOs of palliative care medicines including narcotic medications.

In FY2006 and FY2007 RPM Plus conducted a consultancy that reviewed the National Medicines Policy

(NMP). In FY2008 SPS will work with MoHSS to conduct a workshop for the update of the NMP.

To support the development of the national formulary initiated in FY2007, SPS will provide support for the

finalization and launch of Namibia first national Formulary. In addition SPS will support the revision, printing,

and distribution of the Namibia Essential Medicines List (NEMList) which was last updated in 2002.

Procurement based on the revised NEMlist will improve the availability of essential medicines and supplies

to facilities and ensure quality service delivery. In accordance with the World Health Assembly (WHA)

resolution, SPS will advocate for and support the establishment of a multidisciplinary team at the national

level to address issues of rational use including compliance to treatment guidelines.

Strengthen sustainable human resource capacity for the delivery of pharmaceutical services

Unavailability of sufficient, adequately trained and skilled manpower continues to be a challenge in the

provision of quality pharmaceutical care services required to support the expansion and scale-up of ART

services in Namibia. This activity is a continuation of FY2007 activities and focuses on human capacity

development. The aim is to improve local capacity at all levels for sustainable pharmaceutical management

expertise. This will be achieved in a number of ways;

-SPS will collaborate with the NHTC, Namibia Polytechnic, UNAM, Interim Health Professions Council

(IHPC), Pharmaceutical Society of Namibia (PSN), MoHSS and other stakeholders to develop a strategy for

increased enrollment and training of pharmacist's assistants and other middle level pharmacy officers. SPS

support will strengthen IHPC and PSN continuing professional development (CPD) programs to ensure that

pharmacy officers are adequately trained on provision of pharmaceutical care. SPS will collaborate with

UNAM, NHTC and stakeholders to ensure sustainable leadership and management training programs and

promote the incorporation of continuous quality improvement skills (like MTP-Monitoring Training and

Planning) into pre-service training for health providers.

-SPS will support the UNAM pharmacotherapy program for nurses to incorporate HIV/AIDS pharmaceutical

management module

-In FY2008, SPS will work with the MoHSS to review the pharmaceutical staff establishment at the central

level to meet the current scope of pharmaceutical services.

-SPS will work with the MoHSS to develop policies and support Regional Pharmacists to improve support

supervision to lower level facilities. Regional Pharmacists will be supported to ensure availability of

treatment data for compilation of information, analysis and dissemination. This will encourage data use in

decision making at the regional level. This improvement in supervision will lead to improvement in service

Activity Narrative: delivery and ultimately improved health outcomes.