525 twenty-third street, n.w. washington, dc 20037, u.s.a...

525 Twenty-third Street, N.W.Washington, DC 20037, U.S.A.

www.paho.org

Project4 6/8/06 12:01 PM

Operating Principles forthe Regional Revolving Fund forStrategic Public Health Supplies

A PAHO Mechanism for Procurement ofStrategic Public Health Supplies

Prepared by:The Unit of Essential Medicines, Vaccines and Health Technologies.

Pan American Health Organization/World Health Organization525 23rd St., N.W., Washington D.C., U.S.A. 20037

NDIN

A LUTS

O

R

OPS

AHO

NDIN

P

E

O V I M U

P

Pan American Health OrganizationUnit of Essential Medicines, Vaccines and Health Technologies525 23rd St NW Washington D.C., 20037, USA.

Web Page: www.paho.org/fondoestrategico

Editors:James Fitzgerald, Nora Girón

Thematic Coordination:Jorge Bermudez, James Fitzgerald, Amalia Del Riego, Pilar Ramon, Keith Carter,José Maria Parisi, Judi Shane, Patricia Ramos, Marcos Chaparro, René Solis,Nancy Fabara, Maria Teresa Villen, Heidi Jiménez, Nora Girón

Publisher:

The Pan American Health Organization welcomes requests for permission to reproduce or translate its pub-

lications, in part or in full. Applications and inquiries should be addressed to the Unit of Essential Medicines,

Vaccines and Health Technologies, Pan American Health Organization, Washington DC, USA, which will be

glad to provide the latest information on any changes made to the text, plans for new editions, and reprints

and translations already available.

© Pan American Health Organization 2006

Publications of the Pan American Health Organization enjoy copyright in accordance with the provisions of

Protocol 2 of the Universal Copyright Convention. All rights are reserved. The designations employed and

the presentation of the material in this publication do not imply the expression of any opinion whatsoever on

the part of the Secretariat of the Pan American Health Organization concerning the status of any country, ter-

ritory, city, area of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of

specific companies or of certain manufacturer's products does not imply that they are endorsed or recom-

mended by the Pan American Health Organization in preference to others of a similar nature that are not

mentioned. Errors and omissions accepted, the names of proprietary products are distinguished by initial

capital letters.

Operating Principles for the Regional Revolving Fund for Strategic Public Health Supplies

ii

Table of Contents

1. Background ........................................................................................................ 1

2. Objectives ........................................................................................................... 3

3. The Contribution of the Strategic Fund to PAHO Technical Cooperation 4

4. Member State and Global Fund Principle Recipient Participation ........... 6

5. Strategic Fund Products .................................................................................... 7

6. Fund Product Quality ....................................................................................... 8

7. Management of the Strategic Fund ................................................................ 11

8. The Strategic Fund Advisory Group .............................................................. 15

Annex I: Member States Participating in the Strategic Fund .......................... 16

Annex II: Strategic Fund Products ...................................................................... 17

A PAHO Mechanism for Procurement of Strategic Public Health Supplies

iii

1. Background

To achieve equitable delivery of health care services, access to affordable quality med-icines and medical supplies is required. Access to quality medicines and health suppliescan be facilitated if the selection process takes into consideration factors of quality, effi-cacy and cost, if transparent price information is available, if procurement mechanismspromote competition, and if planning systems ensure sustainable delivery.

To assist Member States in the acquisition of quality essential public health suppliesat affordable prices, the Director of the Pan American Health Organization (PAHO)established the Regional Revolving Fund for Strategic Public Health Supplies (theStrategic Fund) during the 42nd Directing Council of the Pan American HealthOrganization, Washington DC, 25th - 29th September 2000.

The Strategic Fund aims to build capacity in drug supply management and procure-ment programming and planning at the national level. One-third of PAHO MemberStates have signed agreements for participation in the Strategic Fund, and even if the useof the Fund as a procurement mechanism has been limited to a few countries to date, thepotential of the fund as a regional supply mechanism for priority public health com-modities is recognized within the context of PAHO support to Global Fund beneficiaries.

As a procurement mechanism, the Strategic Fund allows participating members toutilize a common fund for payment of authorized purchases of essential public healthcommodities. Members make reimbursement to the fund for the cost of each purchasewithin a specified period of time. The Fund is capitalized through the allocation of the3% procurement service charge to the Fund's capital account. As countries purchasethrough the Fund, the purchasing power of the Fund will increase resulting in lowerproduct prices for participating countries. As at the end of 2005, countries participatingin the fund have used the mechanism to purchase $35 million of essential public healthsupplies.

In September 2004, the 45th Directing Council of PAHO adopted a resolution to pro-mote access to medicines and public health supplies in the Region. As a key element ofthe strategy Member States endorsed the proposal to strengthen regional procurementmechanisms, including the PAHO Strategic Fund. The Directing Council noted that 'thedevelopment of the Fund will strengthen capacity in procurement, programming andplanning at the country level, lead to economies of scale through the consolidation ofrequirements, and promote continuity in supply through the development of the cyclicalprocurement system'.


1

This document has been developed to present the basic framework of the StrategicFund to PAHO Member States. It has been elaborated based on the Model Agreementbetween Member States and the Pan American Health Organization for the participationof a Member State in the Regional Revolving Fund for Strategic Public Health Supplies,and Operating Procedures for the Regional Revolving Fund for Strategic Public HealthSupplies. It aims to:

• present Strategic Fund objectives • outline the scope of PAHO technical cooperation through the Fund• explain how PAHO Member States and Global Fund Principal Recipients in the

Region may participate• present the list of Strategic Public Health Supplies that can be purchased by par-

ticipants• detail the Strategic Fund product quality assurance system in procurement• present the management structure for the Strategic Fund as well as the mecha-

nism which will guide its future development.


2

2. Objectives

The Strategic Fund builds on the principle of 'Pan-Americanism' where countries inthe Americas address together common issues, and provide support to one another, inthis case, in procurement and supply management of quality essential public healthproducts. The Fund provides a means of ensuring the constant flow of pharmaceuticalsand supplies at reduced cost to priority public health programs through a procurementprocess that links demand forecasting, procurement and supply.

The Fund's objectives are:• to facilitate the acquisition of strategic public health supplies by PAHO Member

States at reduced cost by taking advantage of the potential savings offered byeconomies of scale;

• to further the continuous availability of public health supplies within PAHOMember States;

• to encourage Member States to improve planning capabilities and use of publichealth supplies;

• to promote the implementation of appropriate quality assurance procedures inordering supplies;

• to strengthen member states' public health programs and the application of perti-nent PAHO/WHO normative mandates.


3

3. The Contribution of the Strategic Fund to PAHO Technical Cooperation

PAHO technical programs have recognized the importance of promoting the contin-uous availability and affordability of key medical products to achieve reductions in dis-ease mortality and morbidity within PAHO Member States. This work is not new toPAHO but has been developed and integrated within the technical work program forsome time (Box 1).

The Strategic Fund aims to build on past achievements and ongoing efforts toimprove access to Strategic Public Health Products. It aims to provide added value toparticipating countries in three important ways, namely by;

• Focusing technical support to countries in procurement planning, distribution,and product forecasting.

• Ensuring the supply of quality product through the application of quality assur-ance norms in pharmaceutical procurement and quality control


4

Box 1. Examples of activities supported by PAHO Technical Programs promoting the con-tinuous availability and affordability of Strategic Public Health Supplies

• Provision of pharmaceuticals for national health programs in nutrition, child, adolescent and women'sreproductive health

• Procurement of HIV/AIDS medicines, including HIV/AIDS Antiretrovirals (ARV) on behalf of Member States• Brokering regional HIV/AIDS ARV price negotiations• Supporting countries in the acquisition of TB medicines either through the Global Drug Facility, or the Green

Light Committee.• Coordinating supply of antitrypanosomal drugs in the treatment of Chagas disease• Capacity building in pharmaceutical supply management for priority public health programs, for example the

RAVREDA project of the Roll Back Malaria Partnership, or the HIV/AIDS 3 by 5 Initiative.• Strengthening regional partnerships in procurement and supply management, for example through the

Caribbean Network of Pharmaceutical Procurement and Supply Management Agencies (CARIPROSUM)• Providing normative guidance in drug regulation and registration through the Pan American Network for

Drug Regulatory Harmonization (PANDHR)• Strengthening pharmaceutical quality control through the PANDHR External Quality Control Program• Promoting rational use of essential public health supplies through technical support in protocol develop-

ment and application• Supporting the development and implementation of procurement plans for grant applications to the Global

Fund against HIV/AIDS, TB and Malaria

• Facilitating communication and coordination between suppliers and participatingcountries to improve product availability and affordability

Participation in the Strategic Fund facilitates the delivery of technical cooperationthrough PAHO and collaborating partners to National Authorities and/or Global FundPrincipal Recipients, in order to strengthen national capacity in procurement and supplymanagement, as well as in the application of norms in procurement quality assurance(Box 2).

In addition, the Fund is used by countries as a reference for product pricing. It facili-tates the acquisition of stocks in cases of emergency, and improves coordination betweenPAHO Member States and global procurement initiatives such as the Global DrugFacility, The Green Light Committee, The Aids Medicines and Diagnostics Services(AMDS), and The Malaria Medicines Service (MMS). By using the Strategic Fund par-ticipating Member States are expected to achieve cost savings, and benefit from availableFund capital to purchase product in advance of payment. The Strategic Fund willstrengthen administrative and managerial capacity of program managers in pharmaceu-tical supply management. It stimulates the acquisition of essential public health suppliesat the national level as it heightens awareness in important areas of commodity planningand management.


5

Box 2: Scope of Technical Support through the PAHO Strategic Fund

Procurement and Supply Management• Development and review of procurement plans• Capacity building in needs estimation, forecasting, purchasing, financing and pricing,

and factors relating to intellectual property rights• Procurement through the Fund mechanism• Supply chain assessment, support and monitoring• Linkages with other Global Procurement Mechanisms

Quality in Procurement• Supplier prequalification• Quality control of medicines• Capacity building for national QC laboratories• Technical support in procurement quality assurance

4. Member State and Global Fund Principle Recipient Participation

PAHO Member States may participate in the Fund by entering into an agreementdirectly with PAHO. The intention of this agreement is to commit participating MemberStates to abide by the requirements for procurement through the Fund, as well as to pro-vide and promote technical cooperation necessary to fulfill the objectives of the Fund. Inturn, the commitments of PAHO in administering the Fund are presented, including sup-port commitments of the organization in technical areas. A list of countries currently par-ticipating in the Strategic Fund is presented in Annex I.

Principle Recipients (PR) of projects financed by the Global Fund against HIV/AIDS,Tuberculosis and Malaria (GFATM) may also use the Strategic Fund for procurement ofStrategic Fund products. The GFATM was established to attract, manage and disburseadditional resources through a public private partnership to reduce infections, illnessand death, thereby mitigating the impact caused by HIV/AIDS, tuberculosis and malar-ia in countries of needs. Section III of the GFATM Framework document indicates that inmaking its funding decisions, the GFATM will support proposals that 'are consistentwith international law and agreement, respect intellectual property rights such as TRIPSand encourage efforts to make quality drugs and products available at the lowest possi-ble prices for those in need'.

It is noted that the objectives and purpose of the PAHO Strategic Fund fully convergewith those of the GFATM: accordingly the Strategic Fund is considered to be an ideal pro-curement mechanism for Principal Recipients of GFATM grants. In order for PRs to pur-chase products through the Strategic Fund, a Memorandum of Understanding (MOU)must be signed by PAHO and the PR.


6

5. Strategic Fund Products

The Strategic Fund was established to assist countries in ensuring continuous avail-ability of affordable Strategic Public Health Supplies. For the purpose of focusing thescope of the Strategic Fund on products deemed critical to public health programs, a'Strategic Public Health Supply' is considered to be a product that meets the followingcriteria:

• is listed, recognized and recommended by a WHO Expert Committee or WorkingGroup (e.g. Essential Medicines, WHOPES recommended compounds, HIVDiagnostics etc).

• is included in WHO recommended protocols or diagnostic algorhythms and isconsidered highly effective in disease treatment or prevention

• when continuously available, significantly contributes to improvements in mor-tality rates and patient quality of life, and/or minimizes possibilities of drugresistance in treatment

• is subject to particular challenges in areas of product sourcing, pricing, forecast-ing, and purchasing

• economies of scale are achievable as volumes purchased increase

PAHO technical units meet on an annual basis to review products used in disease pre-vention and treatment against the above criteria. This process results in the productionof the annual Strategic Fund product list presenting products that can be purchasedthrough the Strategic Fund for the following year. In accordance with internationalnorms, products are listed using the INN or generic name. The strength and product for-mulation are also listed, however presentation sizes are not listed as this varies accord-ing to country requirements. The Strategic Fund product list for the current year is pre-sented in Annex II.

The Strategic Fund Product list is not intended to be exhaustive. Consideration isgiven to requests from Member States and PRs participating in the Strategic Fund toinclude additional products. The request for inclusion of a product is considered by thePAHO technical unit working in the disease area, and a recommendation to include (ornot) is made. PAHO retains sole discretion to include or remove products from theStrategic Fund product list.


7

6. Fund Product Quality

One of the primary objectives of the Fund is to ensure the availability and use of qual-ity strategic public health products in participating countries. The quality of product sup-plied through the Fund is ensured through:

1. Prequalification of suppliers2. Quality Management in Procurement3. Quality Control of Products

In applying concepts of procurement with quality, Strategic Fund participating coun-tries receive the most cost-effective pharmaceutical products of quality, in correct quan-tities, procured on a timely basis, at the lowest possible total cost.

1. Prequalification of Suppliers

Given the multitude of pharmaceutical manufacturers and suppliers around theworld, PAHO applies a system of prequalification that permits the identification of a corelist of suppliers and/or products that meet PAHO quality criteria. Once prequalified,suppliers may be invited to participate in PAHO procurement bids.

The prequalification of PAHO suppliers applies to the procurement of 'medicines','pharmaceutical products' or 'multisource pharmaceutical products' as defined by theWorld Health Organization in the glossary, 'Marketing Authorization of PharmaceuticalProducts with Special Reference to Multisource (Generic) Products: A Manual for DrugRegulatory Authorities'.

The prequalification criteria applied by PAHO depend on available number ofsources of the pharmaceutical product:

• For multisource pharmaceutical products:– Suppliers that have been evaluated and prequalified by PAHO, providing evi-

dence that they conform to current requirements of Good ManufacturingPractices, and apply appropriate standards in quality assurance and control.

– The prequalification of such suppliers is ensured through the Unit of EssentialMedicines, Vaccines and Health Technologies at PAHO Regional Office.

• For single or limited-source pharmaceuticals including HIV/AIDS Antiretrovirals(ARVs):


8

– A product listed in the most recent edition of the UN Pilot ProcurementQuality and Sourcing Project or

– A product authorized for use by the regulatory authority of a member of thePharmaceutical Inspection Convention or an entity participating in thePharmaceutical Inspection Cooperation Scheme or

– A product authorized by the regulatory authority of a member of theInternational Conference on Harmonization of Technical Requirements for theRegistration of Pharmaceuticals for Human Use

For non-pharmaceutical products, other source references to ensure procurement ofquality product are used. For example,

• For HIV Test Kits:– Manufacturers listed in 2003 WHO Bulk Procurement Scheme

2. Quality Management in Procurement

Principles of quality management are applied in the planning and procurement ofproducts through the Fund. The Fund Coordinator is responsible for the application ofOperating Procedures relating to coordination and communication betweentechnical/administrative units and countries. The Prequalification of suppliers is execut-ed according to procedures elaborated and overseen by the Unit of Essential Medicines,Vaccines and Health Technologies at PAHO. Pharmaceutical procurement is executedaccording to PAHO Rules and Regulations, and in consultation with the Unit of EssentialMedicines, Vaccines and Health Technologies at PAHO. Supplier performance in termsof product quality is monitored by the Procurement Services and Unit of EssentialMedicines.

Quality management in procurement of pharmaceuticals is overseen by the Unit ofEssential Medicines, Vaccines and Health Technologies at PAHO.

3. Quality Control

Pharmaceutical products and insecticides supplied through the Strategic Fund aresubject to certain requirements in quality control. Manufacturers and suppliers of multi-source pharmaceutical products are required to provide a Certificate of Analysis perbatch of product supplied to a country. In addition, the Certificate of Analysis must com-ply with international norms as specified in the International Pharmacopoeia (IP), TheUnited States Pharmacopoeia, The European Pharmacopoeia (EP), The BritishPharmacopoeia (BP), or with other specifications as required by PAHO.


9

Member States participating in the Strategic Fund are expected to implement qualitycontrol tests according to specifications and national requirements. Tests should be com-pleted within a reasonable period, and not later than 60 days after the date of receipt atthe principal storage location within the country.

PAHO reserves the right to use a laboratory of its choice to execute quality controltesting of Strategic Fund products, prior to or following shipment, or to obtain and retainsamples of a batch of product and/or the active pharmaceutical ingredient. In such cases,the cost of quality control testing is to be borne by the supplier. Quality control testing ofinsecticides is executed independently by a PAHO/WHO Collaborating Center selectedby the Organization, after receipt of the product at the principal storage site. The QualityControl evaluation of pesticides must comply with the Pesticide Evaluation Scheme'WHO Specifications for Pesticides Used in Public Health' (WHO/CTD/WHOPES 97.1).

If a product does not meet PAHO quality criteria, it will be returned to the supplier.In such cases the supplier will be responsible for costs associated with the product return.


10


11

7. Management of the Strategic Fund

The achievement of Strategic Fund objectives requires the commitment and collabo-ration of participating Member States and the Pan American Health Organization, atboth the regional and national level.

Technical and Administrative Management at the Regional Level

The administrative management of the Strategic Fund is ensured by theAdministrative Services of PAHO under the direction of the Office of the Director ofAdministration located at PAHO Headquarters, Washington DC. Each service is respon-sible for specific functions guaranteeing the operation of the Fund. The ProcurementServices Unit (AM/PRO) manages the procurement process and facilitates the shipmentof products to consignees. AM/PRO also reviews and authorizes the payment of suppli-er invoices. The Finance Service (AM/FMR) manages deposits and Member StatesAccounts, makes payments to suppliers, maintains the Fund accounts, and providesfinancial statements to Member States.

Issues relating to participation agreements and other legal issues are handled byLegal Affairs under the Office of the Deputy Director (DD/LEG). Legal Affairs draftscountry agreements, approves bid documents, assists in the drafting of contractualagreements and provides other legal services.

Technical services in support of Fund activities and specifically in procurement plan-ning and quality assurance of products are directed by the Technical Areas. Three PAHOtechnical areas provide technical input and support to Member States: the Area ofDisease Prevention and Control (DPC), with specific input in the areas of medicines andsupplies used in the management and control of diseases such as Tuberculosis, Malariaand Leishmaniasis; the Area of Family and Community Health (FCH) with focus onmedicines and diagnostics management in HIV/AIDS, child and adolescent, and mater-nal health; and the Area of Technology and Health Service Delivery (THS) with focus onissues of supply management, quality, and rational use of essential medicines and healthtechnologies.

The Project Support Unit (PPS/PS) within PAHO supports the development of theFund, its orientation and operation in accordance with the mandates of the PAHOGoverning Bodies.


12

Coordination of Fund Management

Coordination of activities between Member States and the technical /administrativeunits of PAHO is essential to ensure the continued growth and future development of theFund. The activities of the Strategic Fund are coordinated by the Strategic FundCoordinator, Unit of Essential Medicines, Vaccines and Health Technologies, PAHO.

The Fund Coordinator facilitates the procurement planning process between thecountry and regional level and coordinates Strategic Fund interventions by administra-tive and technical units within PAHO. The Coordinator also plays an important role insupporting PAHO Country Offices and participating Member States in issues relating tothe Strategic Fund, and is responsible for communication with regard to the StrategicFund.

Management at the PAHO Country Office Level

Member States and PRs participating in the Fund coordinate activities with therespective PAHO Country Office. The Ministry of Health (MOH) of a Member State or aPR participating in the Fund is required to nominate a professional responsible for liais-ing with technical and administrative units within the MOH on issues relating to pro-curement through the Fund. He/she also acts as the counterpart for the designated focalpoint at the PAHO Country Office in all matters relating to the Fund.

Procurement of supplies through PAHO at the request of a Member State is coordi-nated with the Ministry of Health through the PAHO Country Representation. When aMember State or PR wishes to purchase, the Ministry of Health or PR works directly withthe PAHO Country Office in product selection and forecasting (Box 3), and will executethe procurement order through the PAHO Country Office according to the ProcurementRegulations for the Strategic Fund.

Financial Management

The Financial Management of the Strategic Fund is governed by PAHO FinancialRules and Regulations. Member States and PRs participating in the Strategic Funddeposit funds with PAHO in order to purchase products through the Fund. On receipt ofa payment from a Member State or PR, PAHO assigns the funds to the Member Stateaccount from which supplier invoices are paid. Any balances are retained in this accountfor future procurement by the Member State, or refunded as required.

When the Member State makes payments to PAHO, it is required to pay a servicecharge of 3% of the cost of the goods purchased (excluding freight and insurance). The

3% service charge is used to increase the capital of the Strategic Fund to facilitate the pos-sibility of future procurement without prepayment by participating Member States. Asprocurement proceeds through the Fund, the Fund Capital increases. In addition to cap-italization through procurement, PAHO may mobilize funds for capitalization of Fund.


13

Box 3: PAHO Lead Time Estimates for Procurement of Strategic Fund Products

Consignee Transit:By Air: 2 weeks

By Ocean: 6 weeks

By Air: 2 weeksBy Ocean: 4 weeks Consignee Transit:

By Air: 1 weekBy Ocean: 4 weeks

PAHO/Purchase

Manufacturer

Manufacturer7 weeks

From Stock / 1 week

Shipment2 weeks

Product Release QA1 week

Supplier

From Stock1 week

Shipment2 weeks

Source Shipment by Air Shipment by Oceanof Product (weeks) (weeks)

Manufacturer from Stock 5 9 - 13

Manufacturer requiring Production 12 16 - 20

Supplier from Stock 4 7 - 11

Supplier requiring contract manufacture 15 18 - 22

Reporting

Within the framework of the technical program of work, PAHO Technical Units andparticipating Member States are developing a reporting system that can evaluate the per-formance of the Fund against Fund objectives. The methodology is to include the fol-lowing minimum elements:

• the development of a tool to collect data at the country level monitoring drugquality and supply management parameters for product supplied through theStrategic Fund

• the development of process and performance indicators using the data collected,defining objectives of the indicators and providing interpretation of the outcomeor tendency

• the review of indicators on a regular basis, and the preparation of an analyticalreport with recommendations for submission to participating countries

At the financial level, participating countries will receive in the first quarter of eachyear a financial report issued by PAHO presenting country procurement activity, receiptsand disbursements, as well as allocations made to the country capitalization account.

In accordance with the rules and regulations of PAHO, the Strategic Fund is subjectto an external audit carried out every two years (biennium). The results of the audit arepublished in PAHO Financial Reports and are made available to all PAHO MemberStates

14


8. The Strategic Fund Advisory Group

The strategic development of the Fund will be guided by the Strategic Fund AdvisoryGroup, a technical group established with the participation of Fund countries to monitorthe performance of the Fund against objectives and to provide guidance and recommen-dations for the future development of the Fund.

The Advisory Group is composed of 7 members:• 3 members from different countries participating in the Fund• 1 Member from the Area of Family and Community Health, PAHO• 1 Member from the Area of Technology and Health Services Delivery, PAHO• 1 Member from the Area of Disease Prevention and Control, PAHO• 1 Member from the Office of the Director of Program Management, PAHO• 1 Member from the Office of the Director of Administration, PAHO

The Unit of Essential Medicines, Vaccines and Health Technologies acts as Secretaryto the Committee.

Fund countries are invited to participate in the Advisory Group in alphabetical order.Participation at the Advisory Group level is staggered so that every year, one countrycompletes participation and is replaced by a new country. PAHO staff participating in theAdvisory Group will be selected by the Office of the Assistant Director and the Office ofthe Director of Program Management respectively. Countries and PAHO Offices willselect Advisory Group members on the basis of knowledge, understanding and experi-ence in issues relating to the procurement, supply management and use of essential pub-lic health supplies in priority public health programs.

The principle functions of the Strategic Fund Advisory Group are: • To evaluate and monitor Fund performance against objectives on an annual basis• To provide options in the strategic development of the Fund• To promote participation of countries in the Fund• To liaise with technical programs and administrative services within PAHO

and/or within countries and to issue recommendations in areas relating to selec-tion, planning, procurement, distribution and use of products listed in the Fund.

The Strategic Fund Advisory Group meets on an annual basis, or as required andissues recommendations by consensus. The Advisory Group does not have decisionmaking authority: its recommendations and meeting reports are submitted to theDirector of PAHO for consideration and action when appropriate.


15

Annex I: Member States Participating in the Strategic Fund

Barbados HondurasBelize JamaicaBolivia NicaraguaBrasil PanamaEl Salvador ParaguayGuatemala PeruHaiti Trinidad & Tobago


16


17

Annex II: Strategic Fund Products

Drug name (INN)

Acyclovir

Amoxicillin

Azitromicin

Cefixime

Ceftriaxone

Ciprofloxacin

Clotrimazole

Doxycicline

Erythromycin

Espectinomicine

Fluconazole 50mg

Metronidazole

Miconazole

Penicillin

Penicillin G benzathine

Penicillin procaine

Podofiline

Tinidazole

Strength

200mg, 800mg

250mg, 500mg

250mg, 500mg

400mg

125mg, 250mg

250mg, 500mg

100mg, 500mg

100mg

250mg,500mg

125 mg/5 ml

400mg/ml

50mg,100mg,150mg200mg

250mg, 500mg

0.75%

200mg

300.000 UI

600.000 UI

1.2 MUI

1.2 MUI

10-25%

0.5%

250mg, 500mg

Formulation

Tablets

Capsules

Tablets or Capsules

Capsules

Powder for suspension (vial)

Tablets

Vaginal tablets

Capsules

Tablets

Suspension


Capsules

Tablets

Gel

Vaginal Tablet





Solution or gel

Solution

Tablets

HIV/AIDS Opportunistic Infections


18

Annex II: Strategic Fund Products (Continued)

Drug name (INN)

Abacavir (ABC)

Didanosine (DDI)

Lamivudine (3TC)

Stavudine (d4T)

Zidovudine (ZDV)

ZDV + 3TC*

ZDV + 3TC + ABC*

d4T + 3TC + NVP*

Tenofovir (TDF)

Efavirenz (EFV)

Nevirapine (NVP)

Indinavir (IDV)

Lopinavir/ritonavir (LPV/r)

Ritonavir (r )

Nelfinavir (NFV)

Saquinavir (SQV)

Strength

300mg

20mg/ml

100mg, 150mg, 200mg,

10mg/ml

125mg,200mg,250mg

400mg

100mg, 150mg

10mg/ml

15mg, 20mg, 30mg ,40mg

1mg/ml

100mg,250mg

10mg/ml

300mg

300mg + 150mg

300mg + 150mg + 300mg

30mg + 150mg + 200mg

40mg + 150mg + 200mg

300mg

50mg, 100mg, 200mg

30mg/ml

200mg

10mg/ml

100 mg, 200 mg, 333mg,

400mg

133.3mg + 33.3mg,

80mg/ml + 20mg/ml

100mg

80mg/ml

250mg

500mg/g

200mg

Formulation

Tablets

Oral Solution

Tablets

Oral Solution

Capsules

Tablets

Solution

Capsules

Oral Solution

Capsules

Syrup

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Capsules

Syrup

Tablets

Oral Solution

Capsules

Capsules

Oral Solution

Capsules

Oral Solution

Tablets

Oral powder

Soft Capsule

Antiretrovirals

* PAHO/WHO encourages the use of fixed-dose combinations (FDC) when formulations of assured quality and proven bioequivalence are available and offer operationaladvantage. The FDCs included in the PAHO Strategic Fund are those that have been evaluated for prequalification by WHO. The list of WHO prequalified manufacturersand products is continuously updated and is available at : http://www.who.int/medicines


19


HIV Simple Rapid Assays

Bioline HIV 1/2 3.0

Bionor HIV-1 & 2

Capillus HIV-1/HIV-2

Determine HIV- 1/2

Diagnostic Kit for HIV (1 +2)

First Response HIV

Genedia HIV 1 / 2 Rapid 3.0

Genie II HIV-1/ HIV-2

HIV 1&2 Doublecheck

HIV Tridot

Immunocomb II Bispot

Instantchek HIV 1 + 2 Rapid Test

Serodia HIV -1/2

Uni-Gold HIV-1/HIV-2

HIV Elisa Assays

Anti-HIV 1 + 2, Antibiotics Elisa

Diagnostics Kit

Enzygnost Anti-HIV 1 / 2 Plus

Genedia HIV Ag-Ab

Genscreen Plus HIV Ag-Ab

HIV EIA

Murex HIV Ag-Ab

UBI HIV- 1 / 2 EIA

Vironostika HIV Uniform II Plus

HIV Type

HIV 1 + 2

HIV 1 + 2

HIV 1 + 2

HIV 1 + 2

HIV 1 + 2

HIV 1 + 2

HIV 1 + 2

HIV 1 + 2

HIV 1 + 2

HIV 1, HIV 2

HIV 1, HIV 2

HIV 1 + 2

HIV 1 + 2

HIV 1 + 2

HIV Type

HIV 1 + 2

HIV 1 + 2

O

HIV 1 + 2

O

HIV 1 + 2

O

HIV 1 + 2

HIV 1 + 2

O

HIV Ag

HIV 1 + 2

HIV 1 + 2,

O

Assay Type / Antigen Type

Lateral flow / Recombinant Proteins

Synthetic peptides

Agglutination / Recombinant proteins

Lateral flow / Recombinant Proteins/ Synthetic peptides

Lateral Flow





Flow through / Recombinant Proteins

Dipstick / Synthetic proteins

Lateral Flow

Agglutination / Recombinant proteins



Recombinant Proteins, Synthetic Peptides

Recombinant Proteins

HIV Ag recombinant proteins, synthetic peptides

HIV Ag recombinant proteins, synthetic peptides

Synthetic peptides


Synthetic peptides


HIV/AIDS Diagnostics

Notes: 1/ Assays denoted as HIV 1 HIV 2 are able to distinguish between HIV-1 and HIV-2.


20


HIV Viral Load Testing

Amplicor Monitor Test

No. of Tests per Kit

Various

HIV Type

HIV 1


RNA

HIV/AIDS Diagnostics (Continued)

Drug Name (INN)

Nifurtimox

Benznidazol

Strength

30mg, 120mg

250mg

Formulation

Tablet

Tablet

Anti Chagas

Drug Name (INN)

Diethylcarbamazine (DEC)

Albendazol

Mebendazol

Ivermectin

Praziquantil

Strength

50mg, 100mg

400mg

50mg, 100mg

3mg, 6mg

600mg

Formulation

Tablets

Tablets

Tablets

Tablets

Tablets

Anti Helminthes

Drug Name (INN)

Rifampicin

Isoniazid

Pyrazinamide

Ethambutol

Ethambutol + Isoniazid

Rifampicin + Isoniazid + Pyrazinamide

Rifampicin + Isoniazid + Pyrazinamide

Rifampicin + Isoniazid + Pyrazinamide + Ethambutol

Rifampicin + Isoniazid

Streptomycin

Strength

150mg, 300mg, 100mg/5ml

100mg, 300mg

100mg/2ml

500mg

400mg

400mg + 150mg

120mg + 60mg + 300mg

150mg + 75mg + 400mg

150mg + 75mg + 400mg + 275mg

150mg + 100mg

300mg + 150mg

1g

Formulation

Tablets

Syrup

Tablets

Ampoules

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Tablets

Vial

Anti Tuberculosis


21


Drug Name (INN)

Ribavirin

Amantadine

Rimantadine

Oseltamavir

Strength

200mg, 500mg

1g

100mg

50mg/ml

100mg

50mg/ml

75mg

Formulation

Tablets

Ampoule

Tablets

Syrup

Tablets

Syrup

Tablets

Anti-Virals (Other Emerging and Re-emerging Diseases)

Drug Name (INN)

Amodiaquine

Artemether

Artemether-Lumefantrine

Artesunate

Artesunate + Amodiaquine

Artesunate + Mefloquine

Chloroquine

Doxycycline

Mefloquine

Primaquine

Proguanil

Quinine

Sulfadoxine + Pyrimethamine

Strength

153mg (base),

200mg (base)

40mg

80mg/1ml

20mg-120mg

50mg, 200mg

50mg + 150mg,

50mg + 250mg

50mg + 250mg,

200mg + 250mg

100mg, 150mg

50mg/ml

40mg/5ml

100mg

250mg

7.5mg, 15mg

100mg

200mg, 300mg

300mg/ml

500mg + 25mg

Formulation

Tablets

Tablets, Capsules

Ampoules

Tablets

Tablets

Tablets

Tablets

Tablets

Syrup

Ampoule

Tablets, Capsules

Tablets

Tablets

Tablets

Tablets

Ampoule

Tablets

Anti-Malarial Medicines


22


Product

Long lasting Insecticide

Nets (LLINs)

Kato-Katz kits

ICT Rapid Test

OptiMAL-IT Rapid Test

Strength or Description

Polyester, 100 or 75 den

N/A

Detects P. falciparum malaria. Differentiates

P. falciparum from other species and plasmodium

Differentiates between P. falciparum and non

P. falciparum strains

Other Information

Ref: RBM Publication on

Sources and Prices

Diagnosis of intestinal

helminthes and intestinal

schistosomiasis

Also referred to as ICT

malaria Pf test card

Detects presence of pLDH

Anti-Malarial Supplies

Description and Concentration

Mosquito Growth Inhibitor

Bacterial Larvicide, Bacilus Thuringiensis Var. Israelensis

(H-14), Vectobac. G, Granular Formulation (Corncob 5/8 Mesh), Minimum

200ITU/MG, for control of Mosquito Larvae including Aedes Aegypti.

Organochlorides

DDT Technical (Specification WHO/SIT/1.R7)

DDT Water Dispersible Powder (Specification WHO/SIF/1.R7)

Organophosphates

Temephos 1%, Sand Granules, Specification WHO/SIF/40.R1

and WHO/SIF/40.R1, 500g Plastic Bags.

Malathion, ULV, 96% Minimum Technical, Specification

WHO/SIT/10.R7, 200L PVC Drums, Minium Active Ingredient

960g/Kg + or - 20g/Kg, maximum 0.5% isomalation, maximum 0.1% malaoxon.

Fenitrothion, Wettable Powder, 40%, Specification

WHO/SIT/29.R4 and WHO/SIT/17.R4, 250g Plastic Bags,

Minimum Active Ingredient, 400G/Kg.

Unit

Kg

Kg

Kg

Kg

Lt

Kg

Insecticides


23



Organophosphates (Continued)

Temephos Technical (Specification WHO/SIT/19.R3)

Temephos Emulsifiable Granules (Specification WHO/SIT/31.R3)

Malathion Water Dispersible Powder (Specification WHO/SIF/10.R6)

Malathion Emulsifiable Concentrate (Specification WHO/SIF/14.R6)

Malathion Dustable Powder (Specification WHO/SIF/22.R5)

Fenitrothion Technical (Specification WHO/SIT/15.R3)

Fenitrothion Emulsifiable Concentrate (Specification WHO/SIF/28.R4)

Fenitrothion Aqueous Suspension Concentrate

Fenitrothion Sand Granules

Primiphos Methyl Technical (Specification WHO/SIT/30)

Primiphos Methyl Water Dispersible Powder (Specification WHO/SIF/52)

Primiphos Methyl Emulsifiable Concentrate (Specification WHO/SIF/53)

Carbamates

Bendiocarb Wettable Powder, 80%, 500G Containers, Specification WHO/SIF/41.R2

and WHO/SIT/23.R2

Bendiocarb Technical (Specification WHO/SIT/23.R1)

Bendiocarb Ultra Low Volume Liquid (Specification WHO/SIF/58)

Propoxur Technical (Specification WHO/SIF/18.R3)

Propoxur Water Dispersible Powder (Specification WHO/SIF/30.R3)

Propoxur Ultra Low Volume Liquid

Synthetic Pyrethroids

Cypermethrin 20%, Emulsifiable Conc., 3G active ingredient per hectare.

Cypermethrin WP 40%, (approximately 78G Charge), 125mg/m2 final dosage

of active ingredient

Alphacypermethrin Technical (Specification WHO/IS/98.1.1)

Alphacypermethrin Wettable Powder (Specification WHO/IS/98.1.2)

Alphacypermethrin Aqueous Suspension Concentrate (Specification WHO/IS/98.1.3)

Cyfluthrin Technical (Specification WHO/IS/98.2.1)

Deltamethrin Technical (Specification WHO/SIT/24.R1)

Unit

Kg

Kg

Kg

Kg

Kg

Kg

Kg

Lt

Kg

Kg

Kg

Kg

Kg

Kg

Lt

Kg

Kg

Lt

Lt

Ch

Kg

Kg

Kg

Kg

Kg

Insecticides (Continued)


24



Synthetic Pyrethroids (Continued)

Deltamethrin Water Dispersible Powder (Specification WHO/SIF/42.R1)

Deltamethrin Water Dispersible Powder for overseas shipment(Specification WHO/SIF/43.R1)

Deltamethrin Ultra Low Volume Liquid (Specification WHO/SIF/46)

Deltamethrin Aqueous Suspension Concentrate (Specification WHO/IS/98.3.1)

Etofenprox Technical (Specification WHO/IS/97.24.1)

Etofenprox Water Dispersible Powder (Specification WHO/IS/97.24.2)

Etofenprox Emulsifiable Concentrate

Etofenprox Emulsion, Oil in Water

Lambda-Cyhalothrin Technical (Specification WHO/IS/1.3021-1.rev1)

Lambda-Cyhalothrin Water Dispersibel Powder (Specification WHO/IS/2.3021-1.rev1)

Permethrin Technical (Specification WHO/SIT/28)

Permethrin Aqueous Suspension Concentrate

Permethrin Emulsifiable Concentrate (Specification WHO/SIF/50

Unit

Kg

Kg

Lt

Lt

Kg

Kg

Lt

Lt

Kg

Kg

Kg

Lt

Kg

Insecticides (Continued)

525 Twenty-third Street, N.W.Washington, DC 20037, U.S.A.

www.paho.org

Project4 6/8/06 12:01 PM Page 1

525 twenty-third street, n.w. washington, dc 20037, u.s.a...

Documents