procedure guideline for the management … · procedure guideline for the management of the...

Procedure guideline for the management of the

Regional antiretroviral drugs buffer stock

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West Africa Health Organization

Iamey/AbWEST AFRICAN HEATH ORGANIZATION

PROCEDURE GUIDELINE FOR THE MANAGEMENT OF

THE REGIONAL ANTIRETROVIRAL DRUGS BUFFER

STOCK

Addressee: West African Heath Organization (WAHO), Central Medical Stores in

ECOWAS countries, National Drug Regulating Authorities, National

AIDS Control Programs

Release Date :

NAME AND TITLE

SIGN

DATE

Prepared by Dr B.G. Josias YAMEOGO, WAHO Consultant

Pharm. Samuel BOATENG, WAHO Consultant APRIL 2013

Reviewed by

Dr Carlos BRITO, PO HIV and AIDS/WAHO

APRIL 2013

Approved by

Dr Placido CARDOSO, Director General of

WAHO



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TRACKING OF CHANGES

Date of creation: March 2013

Date of last update Concerned pages and

paragraphs

Editor’s signature Approver’s

Signature



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FOREWORD

This procedure guidelines is part of a process initiated by the West African Health

Organization (WAHO), in partnership with the JURTA PSM Group (Comprising UNAIDS,

WHO, UNICEF, OCEAC and ECOWAS/WAHO) in organizing mechanisms for

antiretroviral drugs (ARVs) buffer stock to mitigate any risk of stock out and ensure the

continued availability and access to ARV drugs by people living with HIV/AIDS and are

receiving treatment in ECOWAS countries.

After the development of a technical document that describes the mechanism for

troubleshooting, the size of the buffer stock and the eligibility criteria for the Collaborating

Central Medical Store, The West African Health Organization commissioned a team to carry

out a review to help decide where best to locate a Regional Antiretroviral Drug buffer Stock

and to propose procedure guidelines for the management of the stock.

This procedure manual is the result of numerous discussions between experts, resource

persons of WAHO and key persons of central medical stores visited. It is intended as an

operational and suitable tool to be used by all involved in the management of the regional

buffer stock.

WAHO would like to express its sincere thanks to all those who have contributed directly or

indirectly to the development of this document.

The adoption of this procedure guideline by the Central Public procurement Agencies thus

appears as a common commitment which will provide a basis of control, acceptable for all.

Any difficulty encountered in the implementation should be notified to the WAHO

department in charge of this process which will make arrangements for changes / revisions.

DIRECTOR GENERAL WAHO



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West African Health Organization

TABLE OF CONTENT

TRACKING OF CHANGES ..................................................................................................... 2

FOREWORD ............................................................................................................................. 3

TABLE OF CONTENT ............................................................................................................. 4

I. INTRODUCTION .................................................................................................................. 5

II SCOPE AND REFERENCES ............................................................................................ 6

III. ABBREVIATIONS AND DEFINITIONS OF TERMS ...................................................... 7

IV. CREATING STANDARD OPERATING PROCEDURES (SOPs) ............................. 10

V. REVISION AND UPDATE .......................................................................................... 11

VI. STANDARD OPERATING PROCEDURES (SOPs) ....................................................... 12

1. Standard Operating Procedure for Coordination and Information Management System ..... 13

2. Standard Operating Procedure for Reporting, Forecasting and Quantification .................... 18

3. Standard Operating Procedure for Procurement process management- placement of drug

orders ........................................................................................................................................ 20

4. Standard Operating Procedure for receiving and storage of drugs of the regional buffer

stock ......................................................................................................................................... 23

5. Standard Operating Procedure for inventory management of the regional buffer stock ...... 28

6. Standard Operating Procedure for record keeping for WAHO-funded antiretroviral drugs at

ARV bulk store......................................................................................................................... 31

7. Standard Operating Procedure for quality assurance ........................................................... 33

8. Standard Operating Procedure for early warning and requesting ARV drugs from regional

ARV buffer stock ..................................................................................................................... 37

9. Standard Operating Procedure for administrative management ....................................... 40

10. Standard Operating Procedure on Financial Procedure ................................................ 42

APPENDIX .............................................................................................................................. 46



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I. INTRODUCTION

This procedure guidelines aim to organize the functioning and the management of the

regional antiretroviral drugs buffer stock.

It allows the use of a single framework to establish the relations among all stakeholders

involved in the process of implementing the buffer stock and the definition of WAHO actions

towards central medical stores in ECOWAS countries in case of urgent requests for ARV

stock.. It takes into account the following broad objectives:

- Efficiency gains in the execution of tasks,

- Ensuring continuity in the functioning of the process,

- Management tool,

- Key control instrument.

This procedures guide will be the reference tool for WAHO, the Collaborating central medical

store and the other central medical stores within ECOWAS, in the implementation,

management, application and mobilization in case of emergency and monitoring of the buffer

stock.

It aims to:

- Optimize the inventory management of the regional antiretroviral drugs buffer stock,

- Ensure good coordination between WAHO and the different actors involved in the

process, including the Central medical stores and Procurement Agencies in ECOWAS

countries,

- Ensure an information system that can provide reliable data on the status of stocks of

ARV drugs necessary for urgent decision making,

- Promote cooperation, coordination and exchange of information between Member

Central medical stores/ Procurement Agencies on one hand and the central medical

stores/ Procurement Agencies and WAHO on the other hand.

It describes the functioning and management of the buffer stock through the definition of the

various procedures relating thereto. It also includes sections on definitions and scope. It is

presented in loose-leaf form to facilitate handling and especially the necessary updates.

The different procedures have been done to reflect the practices in the host central medical

stores in order to allow for safe integration of the buffer stock into the National stock.



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II SCOPE AND REFERENCES

2.1 Scope of Guide

The procedures for the management of the regional antiretroviral drugs buffer stock of the

West African Health Organization (WAHO) applies to all activities and services provided

through the establishment, coordination, inventory management and the trigger of

troubleshooting in case of alert.

It covers all activities described in this guide as well as institutions or national or regional

establishments and their staff involved in its implementation.

2.2 References

This Procedures Manual is established with reference to:

- Good storage and preservation practices of pharmaceutical products,

- Good distribution practices of pharmaceutical products,

- Legislation and laws in force in the countries of the ECOWAS,

- Procedures for the West African Health Organization (WAHO),

- WHO Model Quality Assurance System (MQAS) for Procurement Agencies



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III. ABBREVIATIONS AND DEFINITIONS OF TERMS ARVs Antiretroviral

CTD Common Technical Document

ECOWAS Economic Community of West African States

GMP Good Manufacturing Practices

ISO International Standard Organization

MQAS Model Quality Assurance System

MQS Management Quality System

NDRA National Drug Regulatory Authority

PO Purchase order

QA Quality Assurance

QC Quality Control

SOP Standard Operating Procedures

WAHO West African Health Organization

- Procurement: The process of purchasing or otherwise acquiring any pharmaceutical

product, vaccine, or other health products for human use. For the purpose of this

document, procurement means the pre-selection of products and manufacturers through a

procedure of qualification, including prequalification and continuous monitoring

thereafter, purchase of the prequalified products from prequalified manufacturers (linked

to the specific product) through defined purchasing mechanisms, storage and distribution.

- Quality Assurance: Quality assurance is a wide-ranging concept covering all matters

that individually or collectively influence the quality of a product. It is the totality of the

arrangements made with the object of ensuring that pharmaceutical products are of the

quality required for their intended use.

- Marketing Authorization: A legal document issued by the competent drug regulatory

authority for the purpose of marketing or free distribution of a product after evaluation

for safety, efficacy and quality. It must set out, inter alia, the name of the product, the

pharmaceutical dosage form, the quantitative formula (including excipients) per unit dose

(using INNs or national generic names where they exist), the shelf-life and storage

conditions, and packaging characteristics. It specifies the information on which

authorization is based (e.g. “The product(s) must conform to all the details provided in

your application and as modified in subsequent correspondence.”). It also contains the

product information approved for health professionals and the public, the sales category,

the name and address of the holder of the authorization, and the period of validity of the

authorization.

- Procurement Agency: Any organization purchasing or otherwise acquiring any

pharmaceutical product, vaccine or other health products for human use. A procurement

agency is defined as any organization purchasing pharmaceutical products, vaccines, or

other health sector goods or otherwise involved in their prequalification, purchasing,

storage and distribution.



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- Procurement agency collaborator/ central medical store Collaborator: Procurement

agency/central medical store identified by WAHO to host the regional antiretroviral drugs

buffer stock.

- WHO certification scheme: A certificate of pharmaceutical product of the type defined

in the WHO certification scheme on the quality of pharmaceutical products moving in

international commerce

- Quality Control: Quality control is concerned with sampling, specifications and testing,

and with the procurement agency’s documentation and acceptance/rejection procedures

which ensure that the necessary and relevant tests are actually carried out and that

starting materials, intermediates and finished products are not accepted for use, sale or

supply until their quality has been judged to be satisfactory.

- The logistic cycle: set of elements that can make available to users the products that they

need to perform activities.

- Document: Any written/recoverable information, which gives guidance (e.g. instructions

including policy statements, manuals, reference values and their origins, procedures,

specifications, tables, posters, notes, memorandum, plans, software, drawings, regulations

and standards).

- Procurement and stocks management (PSM): All management activities necessary to

provide the end user quality products in sufficient quantities, purchased at the lowest

price possible and in accordance with national and international law, and this in a safely

and timely manner.

- Indicator: Criterion used to measure changes, directly or indirectly, and to assess the

extent to which the targets or objectives of a program or project are being attained.

Indicators should meet the criteria of clarity, usefulness, measurability, reliability,

validity and acceptance by key stakeholders.

- Product information: information on pharmaceutical products submitted by

manufacturers or suppliers in any of the formats specified in the procurement agency’s

guidelines (including product dossiers, product questionnaires or other formats) to obtain

prequalification for the products.

- Quality Management: Series of activities of the general function of management which

determine quality policy, the objectives, responsibilities and implementation of these

through measures such as planning, control, assurance and improvement of quality within

the framework of the system.

- Quality: Series of characteristics of an element, which make it capable of satisfying

explicit and implicit requirements.

- Quantification: This is the quantitative assessment of needs according to available

resources.



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- Analytical report (certificate): Document, which contains the results of the analyses and

any other information relating to the test.

- Process: set of interrelated or interacting activities, which transform inputs into output

elements.

- Operating procedure: specified way to perform an activity or process.

- WHO prequalification Program: program established by WHO, allowing it to pre-

qualify the quality medicines whose purchase by United Nations specialized agencies is

considered acceptable and the laboratory of quality control of drugs.

- Selection: Consists of qualitative evaluation for an efficient selection of drugs according

to the target groups and the national and international standard devices (Standard

Therapeutic and Guidelines, Essential Medicines List).

- Storage: action to warehouse, that is to say to place in a identified location objects or

substances which it is desired to have available quickly if necessary



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IV. CREATING STANDARD OPERATING

PROCEDURES (SOPs)

This paragraph describes the procedure for creating standard operating procedures (SOPs) to

apply to Regional buffer stock for ECOWAS countries for the duration of the program.

The document is lay laid out in an orderly fashion with the contents in clearly defined sections

to facilitate revision of any section without having to rewrite the entire document. Each SOP starts with the title of the SOP, which are descriptive, unambiguous, in a direct

style to declare what is done in relation to what.

The SOPs are easily identified by a unique serial number for each SOP. The system of numbering adheres to the following format:

ARV-SS SOP##/Issue#.Revision#

“ARV-SS” denotes an SOP related to antiretroviral drugs security stock

SOP## refers to a unique, two-digit SOP number (i.e. SOP number 01, 02, etc)

Issue# refers to the issue number for each SOP (i.e. issue number 1, 2, etc.)

Revision# refers to the revision number per SOP issue (i.e. 0 for the first issue, 1

for the first revision, etc). For example, for the first SOP at the antiretroviral drugs security stock, issued for the first

time with no revisions, thus it has been numbered ARV-SS01/1.0. The number of pages, the preparer’s name and title, signature and date of finalization as well as the approver’s name, title, signature and date of authorization are indicated. The date of issue of the SOP is the date it is approved for use. An objective is stated for each SOP. This objective provides a description of the overall

goal of the SOP. A list of all persons who are responsible for understanding and complying with the actions

listed in the SOP is provided. Any forms, tools, etc. that are necessary to complete the actions listed in the SOP are

referenced in a separate resources section. Where SOPs bear procedural instructions, they are written as numbered steps which are

clear, precise, unambiguous and use language that the user can understand. Where the SOP refers to other documents, a copy is provided of the document as an attachment to the SOP. Attachments are numbered in ascending order (i.e. Appendix 1, 2, etc).



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V. REVISION AND UPDATE

5.2 Revision of the Guide

The procedure guidelines for the management of the WAHO antiretroviral drugs buffer stock

will be made available to as many actors involved in the process of implementation of

activities related to the ARV drug regional buffer stock.

5.2 Update of the Guide

The procedures established in this manual must be followed consistently and rigorously.

However, in order to improve on the system, updates could be considered as and when

necessary to make it a real management tool. The responsibility for updating this guide lies

with the Director General of WAHO or person designated by him.

The guide is updated when:

- The mechanism used to ensure the operation and / or management of security stock has

been modified,

- There are changes in how to proceed.

Any proposed changes to the procedures established in this manual should be brought to the

attention of the Director General of WAHO, by written notice, who will evaluate the

timeliness and relevance.

If the proposed amendment is considered appropriate and relevant, the Director General of

WAHO will instruct the WAHO Program officer of the HIV / AIDS (responsible for the

process) to prepare a draft amendment to be submitted to the heads of the institutions

involved in the implementation of the procedure in question. The proposed amendment will

be accompanied by a Note Verbale containing the following information:

- The existing procedure to be changed, and

- The reasons for the change.

The recommendations made by the officials specified above are collated by the WAHO

Program officer of the HIV / AIDS, and then submitted to the Director General of WAHO for

approval.

An official report of change will be finally prepared by the responsible officer and must

include all details, including the accompanying measures.

After adoption of the final text, the responsible officer must ensure the distribution of relevant

sections to all stakeholders.



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VI. STANDARD OPERATING PROCEDURES (SOPs)

This section contains formalized procedures whose implementation meets the following

objectives:

- Define a formal framework for management and conduct of operations, consistent

with the vision of WAHO; which is to improve the availability of ARV drugs in

ECOWAS countries by meeting the urgent demands, capacity building and

coordination of regional emergency system;

- Increase the accountability of Central medical stores and other actors involved in the

performance of specific tasks by a clear definition of roles, responsibilities and

expected results;

- Increase the accountability of the collaborating central medical store and WAHO in

the effective implementation of the system and the management of the buffer stock;

- Optimize reporting and information sharing;

- Facilitate decision-making.

- Implement a mechanism for effective monitoring and control.

The different procedures established in this manual are:

- SOP for the for Coordination and Information Management System;

- SOP for reporting, forecasting and quantification;

- SOP for procurement process management;

- SOP for receiving and storage of drugs;

- SOP for inventory management;

- SOP for record keeping for WAHO-funded Antiretroviral drugs;

- SOP for quality assurance;

- SOP for early warning and requesting ARV drugs from regional ARV buffer stock;

- SOP for Administrative Management.

- SOP for Financial Management



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1. Standard Operating Procedure for Coordination and

Information Management System

Number of Pages: 5 Serial number: ARV-SS 01/1.0

Prepared by: Title:

Sign:

Date:

Reviewed by: Title:

Sign:

Date:

OBJECTIVE:

To allow for an efficient implementation and an optimal operation of the regional

antiretroviral drugs buffer stock.

Ensure proper coordination between the Central Medical Stores in ECOWAS countries and

the different actors involved in the process.

RESPONSIBILITY:

- Director General of WAHO

- Managers of the Central Medical Stores in ECOWAS countries

- Managers of the national AIDS control Programs in ECOWAS countries

RESOURCES:

- Diagram of the coordination system

- Web software for information sharing

PROCEDURE:

1. Establishment of a system for coordination and management

1.1. A coordination and management system will be established to provide a formal

framework for implementation of related activities and optimize the flow of goods and

information for the regional buffer stock.

1.2. This system aims to promote exchanges between different actors in order to improve

the overall management of the buffer stock upstream and downstream. It has among its

objectives to optimize information visibility, coordination and facilitate follow-up

requests in case of emergency.

1.3. Regional or national structures, members of the coordination and management system

are:

West African Health Organization (WAHO);



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Central Medical Stores in ECOWAS countries;

National AIDS Control Program in ECOWAS countries.

1.4. In terms of organization and human resources:

Regional coordination is ensured by WAHO and managed by the Director General of

WAHO. The WAHO program officer of HIV / AIDS will be responsible for the

implementation and functioning of the process.

The management of stock is ensured by the Central Medical Stores in the country that

houses the buffer stock through the manager and the person in charge of the management

of the ARV drug stock in collaboration with the Procurement agent and the responsible

officers in charge of PSM and the National AIDS Control Program.

In each of the other countries within the community, the responsible officer in charge of

PSM in the National AIDS Control Program will be appointed as the focal point.

1.5. The system set in place will allow an urgent response to countries with acute ARV

stock out supply situation. Functional links created for this purpose should allow the

execution of various activities in the agreed terms, while avoiding the use of many

intermediaries.

1.6. WAHO will be responsible for all purchases of the buffer stock and ensure the

following:

- The procurement of all products purchased under this process will be in accordance

with the procurement procedures at WAHO;

- The granting of exemption for clearance of goods. where necessary;

- The contracting of the collaborating Central Medical Store and suppliers;

- Logistical support to the collaborating Central Medical Store

- The delivery of the stock at the collaborating Central Medical Store ;

- The logistics coordination of ARV buffer stocks in ECOWAS countries;

- The management of an early warning system;

- The monitoring, evaluation and control of the management of the buffer stock;

1.7. The collaborating Central Medical Store will undertake the following activities:

- The receipt of goods in accordance with procedures specified in the relevant section of

the SOP;

- The selection of quality control laboratory for testing and management of test results,

- The logistics management of the buffer stock in the country;

- The quality assurance of the product in accordance with the procedures specified in

the relevant section of the SOP;

- The preparation of stock in case of emergency and delivery to the recipient central

medical store in accordance with the procedures specified in the relevant section of

the SOP.

He will contract a shipping company to handle the stocks shipping procedures to the

recipient central medical store.



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1.8. The country focal points will ensure the following:

- The reporting of data on ARV stock management.

- The requests for ARVs in emergencies through the National AIDs Control

Programme;

- The management of the importation and customs clearance process in their country.

1.9. The National Drug Regulatory Authorities (NDRA) of the host country will undertake

the following activities

- The responsibility for quality assurance of medicines and compliance with regulatory

requirements for import and export of medicines within the ECOWAS countries

- The conduct GMP and good storage practices inspections at the supplier’s sites and

collaborating Central Medical store.

1.10. WAHO will ensure the upgrading of the warehouses of the collaborating Central

Medical Store to the required standard before stocking.

1.11. The diagram in Figure 1 (Appendix 1) summarizes the steps in the management and

coordination process.

2. Operation of the information Management system.

2.1. The coordination mechanism defined in the context of ARV stock security constitutes

a framework between the Central medical stores and national AIDS control Programs,

WAHO, JURTA PSM and other donors involved in the management of HIV / AIDS. It

describes how national AIDS control Programs, Central medical stores in ECOWAS

countries and WAHO work together in this process. It is intended to:

- Lend credibility to the vision of WAHO;

- Create a true synergy between the different actors;

- Speak with one voice;

- Optimize inventory management and resources

2.2. After the signing of the contract between WAHO and collaborating central medical

store, procurement will be initiated by WAHO for all products of the buffer stock and

supply plan will be developed.

2.3. The receipt, storage, quality assurance and logistics management of drugs will be

conducted by the collaborating central medical store.

2.4. WAHO will work in collaboration with National AIDS Control Programs and Central

medical stores of ECOWAS countries to improve communication and information sharing

between all stakeholders, both horizontally and vertically.

The web based information system will increase visibility of information through a

Procurement Planning and Monitoring Report (PPMR) and ARV Interchange web based

system. The PPMR is a monthly report that describes national stock status of ARVs. It

includes commodity security updates and stock status data. By providing visibility into

information about national ARV supply chains, it supports planning, coordination, and



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strategic allocation of resources. The ARV Interchange is a website that helps coordinate

ARV orders and shipments by gathering and storing data from the central procurement

offices of major ARV donors and governments, and provides access to timely information

that can be used for pipeline monitoring, commodity management, and planning. These

two tools help improve visibility of information among global and national partners. As

actors become more willing to share their information and increase data visibility, it builds

trust among partners; with greater trust comes even more comfort in sharing information.

Subsequently, donors and governments are able to make better informed decisions about

timing and quantities of shipments, responses to emergency orders, and allocation of resources

There will be a system of sharing information through a web based computerized platform

developed by WAHO. The Information system would allow the focal points of National

AIDS Control Programs, to transmit the digital data on stocks for first line treatment in

countries, thereby facilitating the management of the regional buffer stock.

The implementation of the web-based software is designed to improve the availability of

ARVs at the country level, provide real time information on the status of stocks of ARVs

and promote transparency and accountability. Data on stocks of first line treatment ARVs

will be entered monthly in the web-based software. This will create a registry on the

availability of stocks of ARVs and allow easy access to information.

This software will allow access:

- To more accurate estimates of stock and status of availability of first line treatment

ARVs at the country level.

- To a monitoring system which is more sensitive to detect risk of stock out through an

early warning system.

- To an integrated information system that can serve as an example for other programs.

Each country can join freely and access the monthly reports on first line ARVs. The

country focal points will be trained in the use of this software and each will receive a

specific Web access code specific to the software to provide details of their stock of

ARVs.

Items to be entered include:

- Country;

- date of submission of data;

- The stock level indicators for each of the first line ARVs (in months stock) minimum

stock, maximum stock, buffer stock, average monthly consumption, countries’

threshold alert level of ARV stock defined according to the number of patients ;

- The status of each first-line ARV stock: quantity, number of months available stock,

stock status (above or below the alert threshold or the minimum stock) expiration

date ;

- Expected delivery Date and supply of pipeline stock;

- Recommended actions.

The country focal points would update the status of their first line ARV drugs not later

than the fifth of each month.



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WAHO Program Officer for medicines and vaccines is designated to centrally manage the

information system. He receives monthly reports through this web-based software and

conducts analysis and interpretation to aid in decision-making. Risks of stock outs

identified are subject to the decision of the Director general of WAHO. This reduces the

processing time and improves visibility of the country needs. It is possible for different

donors, to access country-specific data if they so wish.

2.5. Annual coordination meetings of stakeholders will be organized under the auspices of

WAHO. These meetings will allow exchange of views on specific issues related to the

management of the buffer stock. The collaborating Central medical store will present

during these meetings, its activities, the status of the buffer stock, the difficulties

associated with the management of this stock and proposed solutions. These annual

meetings will also afford the opportunity to improve coordination and management of the

Buffer stock and validate the relevant annual work program of the Regional Coordination

Unit and the management unit of the Buffer stock host country.

2.6. WAHO will ensure that an agreement is signed between the customs authorities of

different countries in order to facilitate the quick transfer of ARVs from the collaborating

central medical store to the other central medical stores of ECOWAS countries.



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2. Standard Operating Procedure for Reporting, Forecasting and

Quantification


Prepared by: Name: Title:

Sign:

Date:

Reviewed by: Name: Title:

Sign:

Date:

OBJECTIVE:

To describe the procedures for reporting, forecasting and quantifying antiretroviral

(ARV) drug requirements for the Regional buffer stock. RESPONSIBILITY:

Central Medical Stores in ECOWAS countries

WAHO RESOURCES:

Forecasting Spreadsheet Inventory tracking form at the collaborator Central Medical stores

PROCEDURE:

1. Data reporting and validation

1.1. The Central Medical Stores in ECOWAS countries will submit to WAHO Program

Officer for HV/AIDs, morbidity data by 31st December of each year and

consumption data every month. The morbidity data shall comprise the total

number of Adult clients on first line Antiretroviral Therapy (ART), yearly target

for first line ART, number or % of Adult clients on the various options of first line

Antiretroviral Therapy. The consumption data shall comprise logistics information

for each of the Antiretroviral medicines used by first line ART clients. The details

of data to be provided are shown in Appendix 2 and 8.

1.2. The WAHO Program Officer for HV/AIDs collates the NACP-specific consumption

and stock balance data for each country in addition to receipt and distribution

activity at the collaborator Central Medical Store Warehouse into one report

a) The report should include drugs from all sources (i.e. WAHO procured,

donations, government-provided, etc.)

b) The National AIDs Control program manager should be notified of any high or

low levels of stock that could lead to expiries or stock-outs, respectively.

1.3. WAHO to review each monthly report for the following:

a) Sufficient stock in the pipeline at the national level

b) Accuracy in reporting last receipts to enhance accountability. This should match

the distribution plan

c) Discrepancies between the previous month’s closing balance and the opening

balance of the current month



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d) Sufficient stock in the pipeline at the warehouse level (three-month supply)

e) Slow moving stocks and advice on how to manage to avoid expiries

f) Extremely high levels of stock that could lead to potential expiries

2. Forecasting and Quantification of products

2.1. WAHO collects/generates information on products selected, proportion of

distribution in use for each drug, number of patients on each drug

2.2. ARV drug forecasts will be based on estimates of the number of patients to be

enrolled on treatment and the number of patients to be maintained on treatment in

the given budget period or year.

2.3. Upon discussion with the collaborating Central Medical Store, WAHO determines the

appropriate quantities to be ordered per each procurement cycle, taking into

consideration manufacturer lead times and country storage capacity. Consideration

shall also be given to the possible pipeline stocks of drugs from one cycle to the

next.

2.4. WAHO shall integrate the stock movement information with patient and treatment

information to forecast and quantify drug requirements for a defined period of

time not less than 12 months on a rolling basis. A supply plan is then prepared for

the requirements and shared among the participating countries. This activity is

done annually at the Annual coordination meetings of stakeholders to make it all

inclusive so that all country teams are also represented.

2.5. This drug quantification report is sent to the Director-General of WAHO for review

and approval.

2.6. Quantification information will be shared as follows: a) National Stakeholders involved in HIV/AIDs prevention and treatment b) National AIDs/STI Control Programmes for coordination and Harmonization of

HIV/AIDS c) The WAHO management team in each country for planning purposes d) Procurement agents/suppliers and manufacturers



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3. Standard Operating Procedure for Procurement process management-

placement of drug orders



Sign:

Date:

Approved by: Name: Title:

Sign:

Date: OBJECTIVE:

To describe the procedure for placement of drug orders from manufacturers to collaborating

Central Medical Store. RESPONSIBILITY:

Director general of WAHO WAHO procurement office/ Procurement agent

WAHO Finance Department WAHO Program Officer for HIV/AIDs

RESOURCES:

List of first treatment ARVs included in the buffer stock;

Specifications

Call for expressions of interest;

Information on products ;

Information on manufacturing site;

Evaluation reports;

Reports of inspection of manufacturing sites;

Contract between the supplier and WAHO;

Purchase Order (PO) Logistics Management Information System (LMIS) Procurement Planning and Monitoring Report (PPMR) and ARV Interchange web based system

PROCEDURE:

1. Development of the specifications of list for products

1.1. The list of products for the buffer stock will be mainly those recommended at

the international level and at the different countries of ECOWAS in the first-line

treatment of HIV / AIDS.

1.2. WAHO, in collaboration with the collaborating Central Medical Store will

develop the terms of reference taking into account the specific technical and

administrative requirements (product specifications, requirements for the site

manufacturing etc) as well as WAHO requirements for the procurement of Health

Products.



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1.3. The specifications will be detailed, clear and unambiguous and should specify

at least the following:

o the name of the active ingredient (s);

o reference pharmacopoeia;

o the strength

o the dosage form;

o the route of administration;

o the size of the package;

o the packing material;

o Labelling requirement.

2. Call for expressions of interest

2.1. The Director General of WAHO will issue a call for expressions of interest to

enable suppliers to submit proposals in respect of goods specified in the call.

2.2. This call for expressions of interest will normally be published on the website

of WAHO and possibly through other media outlets, such as the international press.

2.3. Calls for expressions of interest will be open to manufacturers of finished

pharmaceutical products in ECOWAS region.

2.4. Expressions of interest must be sent to WAHO within the time specified in the

call for expressions of interest. A receipt number and / or a registration number will be

assigned to each expression of interest received.

2.5. The applicant must send the following documents to WAHO as part of the

expression of interest:

- A letter that expresses interest and confirm that the information provided in the

application is complete and in proper form;

- The product dossier in the format specified in the Standard Tender documents relating

to the presentation of the product data and information;

- Product samples to allow visual examination, chemical and pharmacological analysis;

- A site dossier for each manufacturing site listed in the product folder, in the format

required specified in the WHO guidance on the submission of a dossier of

establishment.

3. Pre-qualification of suppliers

3.1. WAHO should undertake a comprehensive evaluation of the quality of ARV

products, based on information provided by the manufacturers of those products and

following the inspection of corresponding manufacturing facilities.

3.2. Upon the filing of appropriate folders, WAHO in collaboration with the NDRA

of the buffer stock host-country, will carry out the following activities:

- Assessment of product dossiers, which should include data and information on the

products as specified in the Standard Tender documents.

- Inspection of manufacturing sites of finished products which must comply with GMP



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3.3. The information on the products presented in the dossier submitted during pre-

selection will be sent to a team in charge of product evaluation. The team will evaluate

all aspects of the dossier, request additional information if necessary, and will issue its

recommendations on the proposed product. This team will include: a representative of

WAHO to lead the team, the person in charge of registration of health products in the

NDRA of the buffer stock host-country and the person in charge of the selection of

suppliers of collaborating central medical store.

3.4. The information on the manufacturing site will be sent to a team in charge of

inspection which will conduct a site inspection, request for corrective and preventive

measures where appropriate, and decide on compliance with GMP by the

manufacturing sites. The inspection team include: a qualified inspector representing

the WAHO to lead the team and an inspector appointed by the NDRA of the buffer

stock host-country. An inspector from the NDRA of the country where the

manufacturing site is located must be chosen as an observer.

3.5. The site inspection will not be applicable if the manufacturer is WHO pre-

qualified and provides all the necessary documentation on compliance with GMP.

3.6. The two teams will work collectively on the outcome of their work and submit

recommendations on the pre-qualification to WAHO for the establishment of the list

of selected products and suppliers.

3.7. If the evaluation shows that a product and its corresponding manufacturing site

meet the standards recommended by the WHO, this product will be added to the list of

pharmaceuticals that are considered acceptable and in principle, can be procured by

WAHO.

3.8. Pre-qualified suppliers would be invited to register the corresponding products

at the NDRA of the buffer stock host-country. Registration arrangements for these

products will be a contract between WAHO and NDRA of the buffer stock host-

country.

4. Procurement of the products

4.1. Procurement shall be conducted in accordance with ECOWAS Tender Code

and Procedures, with pre-qualified suppliers.



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4. Standard Operating Procedure for receiving and storage of drugs of the

regional buffer stock

Number of Pages: 5 Serial number: ARV-SS 04/1.0 Prepared by: Name:

Title:

Sign:

Date:

Approved by: Name:

Title:

Sign:

Date:

OBJECTIVE:

To assist both the flow and reliability of supplies from source to user as economically and

reliably as possible, and without significant wastage, loss of quality, or theft.

ARVs purchased, will be received and stored so that their quality and integrity are

maintained, that batch traceability is in place and that stock rotation is possible. RESPONSIBILITY:

WAHO Program Officer for HIV/AIDs Collaborating Central Medical Store Manufacturer Manufacturer’s shipping agent

RESOURCES:

Airway Bill

Packing List

Goods Received Report/Stores Receipt Voucher

Goods Received Discrepancy Report

Shipment Discrepancy Report

Delivery Note

Product Index;

Certificate of quality control;

Certificate of pre-shipment control;

ARVs Management Software of collaborator central medical store. PROCEDURE:

1. Receipt of products

1.1. Four weeks prior to the delivery of the products, the supplier will send to the

collaborating central medical store, and the WAHO program officer of HIV / AIDS, a

notice of delivery of goods and copies of the air waybill, packing list and other

documents required by the regulatory body such as certificates of quality control of

each batch of product.

1.2. If the shipping documents are not ready four weeks prior to shipment, the

supplier shall inform the parties mentioned above of the intended date for delivery of

products. The different regulatory and quality assurance documents will be provided



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as soon as possible with specific shipping dates for final confirmation. These shipping

documents and confirmation must be received by the collaborator central medical

store collaborator at least two weeks in advance to ensure that all local regulations and

customs process will be completed on time.

1.3. The supplier shall transport the ARVs in good conditions to the port of entry of

the buffer stock host-country. Twenty-four hours in advance, the supplier shall notify

the collaborator central medical store of the imminent arrival of products in order for

arrangements to be made for the receipt of goods.

1.4. On arrival of goods in the buffer-stock host-country, the shipping agent of the

supplier and shipping agent of the collaborator central medical store will perform the

customs formalities following regulations of the country.

1.5. The stock is then transferred to the premises of the collaborating central

medical store in accordance with the required transport conditions.

1.6. The manager of the collaborating central medical store is notified by the

shipping agent of the arrival of the products in the premises of the collaborating

central medical store.

1.7. The person in charge of the management of ARVs in the collaborating central

medical store goes to the receiving store and shall, with the receiving team of the

central medical store, receive the products in the following steps :

Verification of the presence of accompanying documents:

- Waybill

- Packaging list

- Certificate of quality control of each batch of products delivered

- Certificate of pre-shipment control

In addition to the above, the team will check for discrepancies between the order, the

delivery bill and the supplier labels: verify that quantity and technical specifications

fully conforms to that spelt out in the contract. In addition, the compliance with

product labelling will be assessed as well as the minimum shelf life of at least 2/3 of

their useful life of the product. The integrity of packages, seals of cargo and

uniformity of containers will be checked. If more than one batch of products are

delivered, it will be subdivided in accordance with the batch numbers of the supplier,

and then inspection of each container carefully conducted to ensure it was not

contaminated, tampered with or damaged and any container suspected to be sub-

standard or incomplete, will be isolated.

1.8. Notification in writing for any problem identified shall be made in the presence

of the freight forwarder of the supplier. Products close to their expiry date will not be

accepted.

1.9. Any damage of the container and any other problem related to quality of the

product will be subject to an investigation and the WAHO program officer of HIV /



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AIDS will be notified of this fact. Medicines under quality assurance investigation

will be the responsibility of the supplier and should not be distributed for use.

1.10. If delivery is compliant, products are validated provisionally subject to the

independent quality control laboratory. The form of quarantine reception is completed

and the provisional acceptance report written. A copy of the report is addressed to the

WAHO Program Officer accompanied by copies of all supporting documents and a

copy of the quarantine reception certificate. The problems identified are reported in

the report of receipt.

1.11. In order to collect samples for testing, a random sampling is performed

according to the procedures in force at the collaborating central medical store for an

independent laboratory control.

1.12. After sampling, the products are placed in quarantine under the conditions of

storage of ARVs. The isolation of batches is maintained during quarantine and

throughout the storage period. Products remain in quarantine until authorization

(results of independent quality control found to comply with the product

specifications), which allows release for use. In this case, complete a stores receipt

voucher. Take ARVs on ledger charge and complete operation in the ARVs

management software of the central medical store by including all required

information on the products and the supplier.

1.13. At each stage of quality control, a report is sent to the Director General of

WAHO with relevant documents: Copies of certificates of analysis, copies of stores

receipt voucher, copies of certificates of analysis.

1.14. In the case of rejection, a letter of notification of rejection is sent to the

Director General of WAHO with copies of test results.

1.15. Strict precautions must be taken to prevent rejected drugs being used. Rejected

drugs must be clearly demarcated and stored in a locked room accessible only to

authorized personnel, waiting to be destroyed or returned to suppliers.

1.16. The Director General of WAHO has a period of one month from the receipt of

the letter of notification to decide what action to take for the products concerned. At

the end of this period, the products are destroyed according to the procedures of the

collaborating central medical store and a copy of the minutes of destruction is sent to

the Director General of WAHO.

1.17. On complete verification of the received goods, the distributor records the

quantity of each product received, batch number and expiry date on a goods received

note or stores receipt voucher which is subsequently signed.

1.18. Once drugs are certified as received, property of the goods passes to WAHO.

However, safe custody risk passes to the warehousing and distribution agent.

1.19. The collaborating Central Medical Stores sends a copy of the signed goods

received report/stores receipt voucher to the WAHO Program Officer for HIV/AIDs.



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As this document is required for supplier payment, it should be forwarded to the

WAHO Program Officer for HIV/AIDs as soon as possible after receipt of goods.

1.20. On receipt of this report and a supplier invoice, the WAHO Program Officer

for HIV/AIDs in conjunction with the program and finance departments will process

payment to the supplier for the delivered products, less any amount due to

discrepancies in the delivery, if applicable.

1.21. If the order is completed by the delivery, the purchase order (PO) is closed on

final payment. If any portion of the order remains outstanding, the PO will remain

open until full delivery is made and payments made.

2. Shipment discrepancy reportage

2.1. Errors in shipment must be recorded on the Shipment Discrepancy

Report. Errors in shipping may include the following:

- Damaged products, including:

o Broken tablets

o Drugs that arrive past their expiration date

o Items that have no labels

o Refrigerated items that arrive at room temperature or are warm

o Inappropriate storage procedure during transportation of refrigerated items - Requirements from the tender that have not been met - Items listed on the invoice/delivery note that are missing from the Shipment

- Items received that were not ordered or were not listed on the

invoice/delivery note

2.2. The Shipment Discrepancy Report should be writing by the receiving officer

and should be witnessed by another staff member.

2.3. Shipment Discrepancy Report will include:

- Date of shipment

- Name of receiving officer

- Name of witnessing pharmacy staff member

- Invoice Number

- Number of boxes received

- Number of other containers received: describe the type received, e.g., drum

- For each item that is damaged, missing, or incorrect, fill out:

o Serial No.: where the product is recorded (if you are reporting items

missing from the shipment, this will be left blank)

o Item Description : Generic drug name, Strength/concentration, Dosage form

o Code No.: number which is specific to each drug, strength/concentration,

and dosage form

o Unit: unit of issue (i.e., number of tablets per package)

o Quantity Broken, Quantity Missing, Quantity in Error: items

Broken/missing/issued in error



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o Comments: describing nature of error (i.e., broken bottles, expiration date for

drugs delivered expired, missing drugs, or drugs received that were not

ordered or not listed on invoice, etc.)

Signatures and names of receiving officer and witnessing pharmacy staff member.

2.4. The original copy of the Shipment Discrepancy Report is sent to the WAHO

Programme manager for HIV/AIDS for action and one copy is kept on file with the

Counter Receipt Voucher.

3. Storage of ARV drugs

3.1. The buffer stock shall be stored upon receipt into an air-conditioned zone (18-

25°C) in accordance with the SOP for the storage of ARVs at the collaborating central

medical store (storage mode, location, arrangement).

3.2. Compliant products are recorded in the corresponding management tools of the

collaborating central medical store (ledger, stock cards,) with batch numbers and

expiry dates.

3.3. There is no physical separation between the ARVs of the regional buffer stock

and those from other donors.

3.4. The cartons are packed so that the arrows point upwards and that identification

labels, expiry dates and manufacturing dates are clearly visible.

3.5. Store pharmaceutical products in order to facilitate the principle of "first

expired, first out" (FEFO) and inventory management.

3.6. Monitoring of storage conditions (temperature control, ...) shall be performed

according to the operating procedures of the central medical store and all monitoring

records are retained for at least one year after the end of the shelf life of stored product

or as long as required by national legislation.

3.7. The cases of defective air conditioning system and corrective actions carried

out should be a report that will be archived. This report and monthly reports on storage

conditions must be made available to consult by WAHO whenever needed.

3.8. Separate damaged or expired products, removing them from the stock in the

month N-1 of their expiration and destroy in accordance with central medical stores

SOP.



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5. Standard Operating Procedure for inventory management of the regional

buffer stock

Number of pages: 3 Serial number: ARV-SS 05/1.0


Sign:

Date:


Sign:

Date:

OBJECTIVE:

Help ensure optimal management and adequate monitoring of stocks in order to:

- Ensure the continued availability of products necessary for an optimal management of

HIV / AIDS;

- Know the status of the stock of ARVs available for troubleshooting;

- Ensure traceability of inventory movements;

- Effectively manage the triggering mechanisms of alert in case of stock out.

RESPONSIBILITY:

- Central medical store collaborator,

- WAHO.

RESOURCES:

- inventory management Sheet

- ARVs management software

- Bulk Store Bin Card

- Inventory reports

- Stock Count Discrepancy Report

- inventory correction Sheets

PROCEDURE:

1. To ensure proper rotation of stock and inventory management, ARVs management

computer system of the collaborator central medical store will be used.

2. This system must follow the strict control of batch numbers and expiry date which are

essential elements of pharmaceutical management. The expiry dates of antiretroviral drugs

(ARVs) must be tracked strictly.

3. For the proper management of the stocks, inventory records are maintained and updated at

each movement (input, or output).

4. The actual level of stock is periodically compared to the level recorded on the stock card.

All the obvious differences between these two figures give rise to an investigation to

prevent confusion and / or incorrect deliveries.



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5. A Stock Count Discrepancy Report is completed when a physical count in the ARV

bulk store is different from the count recorded on the Bulk Store Bin Card. It can also be

used to record broken or damaged tablets/bottles that cannot be dispensed.

Countercheck any discrepancy in the ARV store on the Bulk Store Bin Card with the

corresponding Stores Ledger and Stock Control Card.

Give a full explanation for any discrepancy reported (e.g. discovery of drugs or drug

packaging that are damaged or expired and must be destroyed, or the accidental loss of

drug via spillage, etc.).

Give the original copy of the Stock Discrepancy Report to the WAHO Programme

manager for HIV/AIDS and keep one copy on file with the Bulk Store Bin Cards in the

ARV bulk store.

6. Physical inventory of stock will be monthly and reports submitted to WAHO via the

integrated information sharing software.

7. A report shall be drawn up after each inventory and a copy sent to the WAHO Program

Officer of HIV / AIDS. WAHO reserves the right for announced or unannounced

inventory assessment to verify compliance of reports that are transmitted by the central

medical store collaborator.

8. All these inventories should allow:

- A physical count of all stock (valid, expired and damaged) ;

- Identification and treatment of damaged and expired products;

- Determination of any differences between the recorded stock and physical inventory

with a precise identification of the causes of these differences;

- An action on the causes of these differences.

9. Stock movements must be suspended during the physical inventory, stock cards updated

and prepared orders not yet delivered shelved.

10. The results of the inventory are reported on the stock cards.

11. Corrections are made to the stock after the physical inventory.

12. As shown in Figure 2 (Appendix 3) related to the basic principle of the physical inventory

management, the central medical store collaborator must adjust the values of these key

inventory control indicators, taking into account the level of the regional buffer stock.

13. Management tools related to incoming and outgoing flows (stock cards, inventory sheet

and purchase/delivery order) must be filled as the implementation of activities.

14. Antiretroviral drugs (ARVs) are removed from the stock in the month N-1 of their

expiration and destroyed in accordance with central medical stores SOP.

15. The officer in charge of the ARV bulk store separates damaged or expired ARVs and



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makes the necessary adjustments to the Stores Ledger and Stock Control Card and Bulk

Store Bin Cards and filled Stock Count Discrepancy. All stock set aside is kept for

destruction, including patient returns, separate from other stock in the ARV bulk.

A letter of notification is sent to WAHO with the list of products damaged or expired and

the point of remaining stock of buffer-stock.



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6. Standard Operating Procedure for record keeping for WAHO-funded

antiretroviral drugs at ARV bulk store

Number of pages:2 Serial number: ARV-SS 06/1.0


Sign:

Date:


Sign:

Date:

OBJECTIVE: To describe procedures for maintaining records for all activities that concern WAHO-funded

ARV stock in the ARV bulk store.

RESPONSIBILITY: Documentation and recording of all ARV drug receipts and issues from the ARV bulk

store is the responsibility of the officer in charge of the ARV bulk store or his/her

designated proxy. RESOURCES:

- Stores and Ledger Stock Control Card

- Bulk Store Bin Card

- Counter Receipt Voucher PROCEDURES: 1. When ARV drugs arrive in the central medical store collaborator and the delivery

complaint with the order, the quarantine reception form is completed by the quarantine

receiving officer and the provisional acceptance report written by the pharmacist in

charge of ARV management.

2. Errors in shipment (damaged products, missing items, items received that are not

ordered or listed in invoice, requirement from tender that have not been met) are

recorded on the Shipment discrepancy Report.

3. When the results of quality control are found to comply with the product specifications and

ARV drugs transfer at the ARV bulk store, the receiving officer completes the Counter

Receipt Voucher as described in procedure for receiving the regional antiretroviral

Drugs Bulk Store. The goods received report is also establish and sign.

4. The information from the Counter Receipt Voucher is used to complete the Stores

Ledger and Stock Control Card.

5. The information from the Stores Ledger and Stock Control Card is used to complete the

Bulk Store Bin Card.

Cards must be used until all entries are completed on both sides of the card. Balances

from the completed card must be transferred to a new card.



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6. The designated pharmacy staff should check the physical count of each ARV preparation

in stock any time there is a receipt or issue at the ARV bulk store to ensure that the

physical stock balance corresponds with that shown on the Bulk Store Bin Card. If a

difference is found, a Stock Count Discrepancy Report is completed as described in

inventory management procedure.

7. When damaged or expired ARVs were removed from the stock the officer in charge of

ARV bulk store shall complete the slip of withdrawal of stock and make the necessary

adjustments by to Stores Ledger and Stock Control Card. The Stock Count Discrepancy

Report is also completed.

8. The Stores Ledger and Stock Control Cards are kept in a serialized booklet and are

stored in the ARV bulk store under the custody of the designated officer. The Stores

Ledger and Stock Control Cards are kept with the Counter Receipt Voucher forms.

9. The Bulk Store Bin Cards are kept with the goods in the ARV bulk store. Each Bulk

Store Bin Card is kept on top of the stock of the corresponding item.

10. Old cards must be retained for at least 5 years from date of last entry or as long as

required by national legislation.

11. Temperature records are performed twice daily on Temperature control Log. The case

of temperature not within acceptable range, any problems with air-conditioning system

and corrective actions are recorded and reported to WAHO.

12. All litigations shall be subject to a written report by the officer in charge of the

management of ARV and signed by the responsible officer of the central medical

collaborator.

13. ARV management computer system of the central medical store is completed at the

same time as keeping paper supports.



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7. Standard Operating Procedure for quality assurance



Sign:

Date:


Sign:

Date:

OBJECTIVE:

Ensure the quality of regional buffer stock throughout the supply chain.

RESPONSIBILITY:

- Central medical store collaborator,

- WAHO.

RESOURCES:

- Standard treatment guidelines

- Essential Medicines List

- Marketing authorization

- Certificate of analysis

- Return or withdrawal of stock list

PROCEDURE:

1. Quality assurance Policy:

1.1. The ARVs drugs of the buffer stock must meet the following requirements, in

accordance with the procedures described in the quality policy of the different

ECOWAS countries:

- The products must be included in the standard treatment guidelines and the national

essential medicine list of the buffer stock host-country.

- The products must be pre-qualified by the WHO pre-qualification program or be

recommended for use by the Committee of Experts set up by WAHO. The list of

suppliers and products recommended by the committee of experts is set for a validity

of twelve months until the product / manufacturer is pre-qualified by WHO.

- The products must be registered in the country that houses the regional buffer stock.

1.2. Each batch of finished product is tested at a laboratory before shipment in

order to check its compliance with the specifications of the finished product.

Certificates of analysis for each batch of products must accompany each shipment of

products.

1.3. Central medical store collaborator ensures that buffer stock ARVs are received

and stored properly, in accordance with the laws and regulations applicable. They are



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received and stored so that their quality and integrity are maintained, that batch

traceability is permanent and that stock rotation is possible.

1.4. The quality of ARVs purchased should be monitored. In collaboration with the

NDRA, the Central medical store collaborator must ensure that random samples are

taken at different stages of the supply chain (from the initial receipt of the products in

the country to delivery to end users / patients) in order to control the quality of the

products by an independent laboratory. These samples must be sent to a laboratory

under contract with the Central medical store collaborator to be tested for quality

control.

1.5. The sampling for quality control must be performed by qualified and trained

personnel in charge of this activity at the central medical store or NDRA or quality

control laboratory.

1.6. The Central medical store shall submit to WAHO, all the results of quality

control test performed on the batches of buffer stock.

2. Selection criteria for quality control laboratories

2.1. Reliability, reputation and competence of the laboratory in the pharmaceutical

field;

2.2. Experience with the Central medical store collaborator in the control of ARV

drugs;

2.3. Test results provided within one month from the date of receipt of specimens.

3. Modalities of validating the results of quality control

3.1. Compare the results of the independent laboratory with the results of the

quality control certificate provide by supplier;

3.2. Compare the results of the independent laboratory with pharmacopoeia

standards;

3.3. Take into account in the interpretation of results, the comments in the quality

control form of the laboratory;

3.4. If the results of the laboratory test certificate are consistent with those of the

supplier and pharmacopoeia standards, then accept (validate) the results.

3.5. Otherwise ask for an independent expert opinion at the supplier's expense or

reject the results.



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4. Product release from quarantine

4.1. Only ARV drugs subjected to quality control by an independent laboratory for

which the results were validated by the central medical store collaborator may be

released from quarantine.

4.2. The person in charge of the management of ARVs informs WAHO of the

release of product from quarantine.

5. Discharge of non-conforming products

5.1. If as a result of any quality control test or an independent expert opinion on the

non-conformity of the product is confirmed, it should be process to the withdrawal of

the stock by issuing a return slip.

5.2. The person in charge of the management of ARVs informs WAHO of the non-

compliance in quality control and removal of stock.

6. Litigations

6.1. Litigations with suppliers.

In case of litigations with supplier the collaborating central medical store must:

- Note the non-compliance with respect to predetermined specifications;

- Check that the application of quality assurance standards has been respected;

- Notify the Quality Assurance elements of the dispute;

- Inform WAHO of the Quality Assurance elements of the dispute;

- Decide what to do depending on the nature of the dispute and SOP of the central

medical store (withdrawal of the batch, product release, quality control), in

consultation with the regional coordination unit;

- WAHO will discuss with the supplier concerned, ways of settlement of the dispute.

6.2. Litigation with customers.

In case of litigations with customer the collaborating central medical store must:

- Note the litigation presented by the client;

- Register quality assurance elements of the dispute according to the operating

procedures of the Central medical store;

- Accept the litigation when there are:

o presentation of a product sample intact or partially used;

o Identification of the product as a product of the regional buffer stock. For

this purpose refer to the reception sheets and delivery orders ;

- Decide what to do depending on the nature of the dispute and SOP of the central

medical store (recall, withdrawal, warning, claim against the supplier) in

consultation with WAHO;

- Discuss means of settlement with the customer;

- Propose elements of settlement of the dispute, in consultation with WAHO.



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7. Damage, breakage and lapsing:

7.1. Identify affected products and remove them from the stock;

7.2. Establish a slip of return or withdrawal of stock and make corrections in the

stock cards and management software;

7.3. Send a letter of notification to WAHO with the list of products and point of

remaining stock.



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8. Standard Operating Procedure for early warning and requesting ARV

drugs from regional ARV buffer stock



Sign:

Date:


Sign:

Date:

OBJECTIVE:

Allow quick and efficient troubleshooting of countries that are on alert of stock shortage of

ARV drugs.

RESPONSIBILITY:

- Central medical store of ECOWAS countries which is at risk of stock out;

- National AIDS control program of country which is on alert;

- WAHO;

- Central medical store collaborator.

RESOURCES:

- Declaration Form for risk of stockout

- Declaration Form for drugs exportation

- Delivery order

- Packaging list

- Air Waybill

PROCEDURE:

1. In case of a necessity to declare a risk of shortage to WAHO, the responsible officer of

Central medical store shall immediately refer to the head of the National AIDS

Control Program.

2. The head of the national AIDS Control Program or his authorised representative will

complete and sign declaration form attached as Appendix 4. The declaration is co-

signed par the head of AIDS Commission and send to the WAHO by fax or e-mail,

with a copy to the Minister of Health of requesting country. The information provided

in this form will be taken into account by WAHO in the stock transfer instruction

given to the central medical store collaborator.

3. For efficiency and speed of action, the declaration may be made by telephone,

informing the WAHO Program Officer of HIV / AIDS, of a need for troubleshooting

with first line treatment ARV drugs. The call will be confirmed within hours by a

written application.



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4. The country requests are received by WAHO Program Officer of HIV / AIDS who

summarises and prepares the letters of stock transfer instruction for the signature of

the Director General of WAHO. The transfer instruction is sent to the Head of the

central medical store collaborator. It shall specify: the recipient country, the drugs

involved (name and dosage) and quantities to be transferred. The transfer instruction

letter is also transmitted by fax or e-mail.

5. The stock transfer instruction can also be given by telephone, informing the officer

responsible for the management of ARVs in the central medical store collaborator of

an urgent need of ARV drugs transfer to a given country. The call will be confirmed

within hours in writing by a transfer instruction letter.

6. Immediately after receipt of the transfer order (phone call and/or letter) indicating the

need for transfer of products, the officer in charge of management of ARVs shall

notify the chief storekeeper of the central medical store who shall pack the necessary

quantities of products and fill the transfer voucher.

7. The transit company under contract with collaborating central medical store is also

notified by the officer in charge of management of ARVs. It will dispatch without

delay, its agents to the central medical store collaborator to perform the following:

valuation, packaging and shipment of stock, as well as transport to the port of

shipment (airport).

8. The packed goods must be under the control of chief storekeeper of the central

medical store collaborator who shall ensure that the right storage conditions are

maintained during transportation

9. The officer in charge of management of ARVs will fill the export form (Appendix 5)

and the delivery order (Appendix 6) which are subject to the signature of the officer

responsible of central medical store. The packing list is also prepared. Copies of all

these documents are sent to the focal point of the recipient country and to the WAHO

program officer of HIV / AIDS who are also notified of the date of arrival of products.

The quality control certificates of the corresponding batches of drugs (certificates of

suppliers or certificates of analysis carried out by the central medical store in

independent laboratory) and the air waybill shall also be included.

10. The focal point of the beneficiary country shall arrange with the NDRA for permission

for release the products by Customs Service.

11. Unloading of products to the warehouses of beneficiary central medical store shall be

in the presence of an agent of the transit company and the officer in charge of

management of ARVs of the beneficiary central medical store.

12. The usual checks are performed at the reception. If delivery is compliant, products are

approved, the receipt slip is completed and the report of receipt written. A letter of

acknowledgment of receipt shall be sent to the Director General of WAHO

accompanied by a copy of the report of receipt and a copy of the receipt slip. Any

problems identified shall be noted in the report of receipt.



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13. A report on the use of the products obtained shall be addressed to the Director General

of WAHO by the head of the national AIDS control program, once the emergency is

lifted.

14. Central purchasing collaborator cannot consume the regional buffer stock except in the

event of force majeure duly justified and after authorization by the Director General of

WAHO. It should follow the procedure until the transfer instruction of the Director

General of WAHO.

15. Based on the analysis of country data from web software, risk of stock-outs can be

identified in a country by WAHO. In this case, the WAHO program officer of HIV /

AIDS shall notify the head of National AIDS Control Program in that country, to

initiate an investigation within 48 hours. The results of the investigation, including

how to react in future shall be brought to the attention of the Director General of

WAHO.

16. The troubleshooting flow chart is provided in Figure 3 (Appendix 7). It allows taking

appropriate action as soon as possible to ensure public health. The processing time of

an application must be less than or equal to 3 days (from the reception of the country’s

alert to the delivery of products to the recipient).



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9. Standard Operating Procedure for administrative management



Sign:

Date:


Sign:

Date:

OBJECTIVE:

Provide a formal framework for the implementation of administrative operations.

RESPONSIBILITY:


- Manager of collaborating Central medical store - WAHO finance department

RESOURCES:

- Contracts signed within this process

- Delivery Note Summary Sheet

- Order Lead Time Spreadsheet

- Purchase Order (PO)

- Signed Delivery Note(s)

- Supplier/ Distributor Invoice

PROCEDURE:

1. This process is placed under the authority of the Director General of WAHO.

2. The WAHO program officer of HIV / AIDS is responsible for setting up and operation

of process.

3. The WAHO program officer for medicines and vaccines shall be responsible for the

management and analysis of the stocks reporting data.

4. No recruitment is planned as part of the implementation of this process, neither at

regional or national level nor at the institutional level.

5. Central medical store collaborator is fully empowered in the management of the drug

of the buffer stock. It features flexibility for handling these products.

6. Contracts and agreements made in this process are managed by WAHO except

contracts with independent quality control laboratory and with Transit Company for



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shipments of products in case of emergency, which are managed by central medical

store collaborator.

7. After signing, all contracts are recorded in the structures that are responsible.

8. Consultant service contracts will be in accordance with the procedures of WAHO.

9. All purchases of products are the responsibility of WAHO. Payments of suppliers will

be in accordance with the requirements of WAHO.

10. The WAHO program officer of HIV / AIDS has the responsibility to follow the orders

made in this process until the delivery by suppliers to the central medical store

collaborator. For tracking delivery times, it shall prepare the written reminders signed

by the Director General of WAHO.

11. Monitoring of contracts signed with WAHO in this process is also done by the WAHO

Program Officer of HIV / AIDS.

12. Monitoring of contracts awarded by central medical store collaborator is the

responsibility of the Responsible Officer of said structure.

13. In case of absence of a key person of the coordination or alert mechanism, his Interim

within the structure will perform related activities on his behalf.

14. All official correspondence from WAHO, related to this process must be signed by the

Director General of WAHO or his designated representative. All incoming mail must

be sent to the Director General of WAHO copied to the WAHO Program Officer of

HIV / AIDS. All correspondence must be registered. Fax correspondence is registered

with the transmission report issued by the fax machine.



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10. Standard Operating Procedure on Financial Procedure



Sign:

Date:


Sign:

Date:

OBJECTIVE:

Provide a formal framework for the implementation of financial operations.

RESPONSIBILITY:


- Manager of collaborating Central medical store - WAHO finance department

RESOURCES:

- Contracts signed within this process

- Financial Management Procedures of WAHO

- Delivery Note Summary Sheet

- Order Lead Time Spreadsheet

- Purchase Order (PO)

- Signed Delivery Note(s)

- Supplier/ Distributor Invoice

PROCEDURE:

1. Processing invoices:

1.1. Manufacturer submits invoices to the Director-General of WAHO.

1.2. The collaborating Central Medical Store will also submit invoices together

with signed delivery notes and packing lists to WAHO.

1.3. WAHO will review all supplier invoices and country warehousing and

distribution agents’ invoices. In the event of a discrepancy, the invoice issuer will

be contacted immediately and asked to provide relevant supporting information

and/or documents as applicable.

1.4. For all invoices from manufacturers, the WAHO will verify that: - T h e items listed for payment on the invoice conform to the approved PO(s). If

prices vary from the signed PO, WAHO concurrence documentation must also be attached. a copy of the corresponding PO must be included with the invoice for payment



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- T h e item in question has not already been paid for. - E a c h invoice is accompanied by a goods received note or stores receipt

voucher signed and/or stamped by the authorized personnel at the collaborating Central Medical Store.

1.5. All suppliers’ invoice must be approved by the WAHO Programme Officer before payment.

1.6. The collaborating Central Medical Store shall submit monthly invoices and

transaction records detailing quantities of drugs delivered to each country in the

month to the WAHO Programme Officer for HIV/AIDS for review and

verification that:

- The invoice accurately depicts the amount of stock distributed, if applicable, by

the agent. the agent must include either the original or a copy of a delivery note, signed by an authorized country representative, that verifies delivery of the drug product in question. If the delivery note has been misplaced, a different form of correspondence from the country can be accepted (e.g. endorsed packing list).

- The invoice accurately depicts the value of stock received, if applicable, by the agent. The agent will include a packing slip and invoice from the supplier which denotes the value of the goods distributed. This packing slip or invoice would have been received along with the shipment of drug product.

- The distribution fee charged on the total value of stock distributed matches the fee listed in the current distributor contract. If the fee does not match, supporting documentation must be provided.

1.7. Upon verification that the warehousing and distribution agent invoices are in

order, the WAHO Programme Officer for HIV/AIDS will send a written

recommendation for payment to the in-country finance department. This

recommendation will certify that the agent has provided services in line with the

existing contract and that the invoice amount is correct, indicating the invoice

number, date and services rendered. The WAHO Programme officer for

HIV/AIDS will sign and date the request for payment and forward it to the finance

department together with the invoice and all supporting documents mentioned

above.

1.8. Upon receipt of the warehousing/distribution agent invoice, the in-country

finance department must verify that: a. E a c h invoice is accompanied by the appropriate delivery notes, which are signed by staff at the receiving country b. T h e drug quantities and value claimed on the invoice for both receipt and distribution are supported by a supplier invoice (or similar documentation) and delivery note c. T h e warehousing and distribution fees charged are based on the Cost, Insurance and Freight (CIF) price.

The finance department will then process payments as per country program

procedures.

1.9. Upon verification that the supplier invoice(s) are correct, the following should

be completed and attached to the supplier invoices before forwarding for



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payment: a. R e q u e s t for payment b. B u d g e t Summary Sheet. This form can be found with the WAHO program manager/coordinator.

Settlement of other incidental expenditures such as Laboratory services shall

follow the same procedures as above.

1.10. Upon completion of the appropriate forms, all invoices for payment must be

reviewed by the WAHO coordination unit and Financial Controller or his/her

designate. The WAHO program assistant must ensure that the appropriate

approvals are obtained

1.11. Upon receipt of appropriate approvals, the WAHO program assistant will make

two copies of all of the invoices and supporting documentation. One copy each

will be provided to the WAHO coordination unit and Financial Controller and the

other copy will be kept in the supply chain file. The WAHO program assistant

will then forward the invoices and supporting documentation to the WAHO

accountant for payment.

2. Financial management

2.1. For any payment to be made on a contract, the officer in charge of HIV / AIDS

program of WAHO must ensure that supporting documents are attached to the

payment order.

2.2. Handling costs and annual management fees will be paid by WAHO to the

central medical store collaborator to help ensure the management of the buffer

stock. These costs will also be used to manage contracts awarded by central

medical store collaborator, including the quality control aspects (at receipt and

during storage) and aspects of shipping in case of emergency. Annual reports on

expenditures shall be sent to the WAHO by the accounting officer of the central

medical store collaborator.

2.3. Stock transferred to a country will be valued and reimbursed to WAHO by the

beneficiary country.

3. Refund of cost of ARVs by Beneficiary Country:

3.1. Upon receipt of the monthly transactional records for drugs supplied to

beneficiary countries by the collaborating Central Medical Store, the WAHO

Programme Officer for HIV/AIDS will prepare invoices for the Beneficiary

Country. This invoice will be accompanied by a formal request for payment signed

by the Director-General of WAHO.

3.2. WAHO will also submit invoices together with signed delivery notes and

packing lists to the Beneficiary Country Central Medical Store.

3.3. The Beneficiary Country Central Medical Store will review all WAHO invoices

and country warehousing and distribution agents’ invoices. In the event of a



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discrepancy, WAHO will be contacted immediately and asked to provide relevant

supporting information and/or documents as applicable.

3.4. For all invoices from WAHO, the Beneficiary Country Central Medical Store

will verify that: - T h e items listed for payment on the invoice conform with the approved PO(s).

If prices vary from the signed PO, WAHO concurrence documentation must also be attached. a copy of the corresponding PO must be included with the invoice for payment

- T h e item in question has not already been paid for. - E a c h invoice is accompanied by a goods received note or stores receipt

voucher signed and/or stamped by the authorized personnel at the collaborating Central Medical Store.

3.5. The Beneficiary Country Central Medical Store will then process payment to a designated WAHO Account and a receipt issued to cover payment:



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APPENDIX APPENDIX 1 :

Figure 1: coordination system and mechanism for the management of the regional buffer stock of

ARV drugs.



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APPENDIX 2

Total number of Adult clients on first line ART as at 31st

December

Yearly target for Adult clients on first line ART

1st Line Adult Regimen Strength % of clients Number on clients

Zidovudine + Lamivudine +

Nevirapine (AZT+3TC+NVP) 300mg + 150mg+200mg

Zidovudine + Lamivudine +

Efavirenz (AZT+3TC+EFV) 300mg + 150mg + 600mg

Tenofovir Disoproxil Fumarate +

Lamivudine + Nevirapine

(TDF+3TC+NVP)

300 mg + 300 mg + 200

mg


Lamivudine + Efavirenz

(TDF+3TC+EFV)

300 mg + 300 mg + 600

mg


Emtricitabine + Efavirenz

(TDF+FTC+EFV)

300 mg + 300 mg + 600

mg


Emtricitabine + Nevirapine

(TDF+FTC+NVP)

300 mg + 300 mg + 200

mg



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APPENDIX 3:

Figure 2: Physical stocks management indicators of the central medical store collaborator



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APPENDIX 4:

STOCKOUT OR RISK OF STOCKOUT DECLARATIN FORM

For antiretroviral drugs used in first-line treatment

In the urgency, information on the context of the stock-out can be sent later.

Date: Country: Name and contact details of the responsible for the dossier (phone, fax et e-mail):

Data on the stock of ARV drugs involved:

Designation Form/Dosage Alert threshold for the country

Available and usable Stock (month stock)

Expected date for stock-out

Expected date for replenishment

AZT+3TC+ NVP

Cp/(300+150+200) mg

AZT+3TC+EFV

Cp/(300+150+600) mg

TDF + 3TC

Cp/(300+300) mg

EFV

Cp/600 mg

Context of the stock-out: - - -

ARVs drugs requested in emergency

Designation Form/Dosage Desired quantity in month stock

Desired quantity in unit number

AZT+3TC+ NVP

Cp/(300+150+200) mg

AZT+3TC+EFV

Cp/(300+150+600) mg

TDF + 3TC

Cp/(300+300) mg

EFV

Cp/600 mg

Stamp and Signature

Declaration to send by fax (n° 00226.00.00.00.00)

ou par e-mail : @wahooas.org

mailto:[email protected]



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APPENDIX 5:

EXPORT DECLARATION FORM EXPORT STATEMENT

DESTINATION intended for

…………………….

I the undersigned…………………… , Responsible Officer, of the Pharmaceutical company…………….......... , housing the regional buffer stock of antiretroviral drugs, certify the following : Name of the medicinal product, dosage strength, pharmaceutical form, packaging : Formula : Status of the medicinal product in the exporting country :

registered

other (to be specified) : Manufacturing pharmaceutical site :

holder of the attached certificate

Prequalified by WHO

other (to be specified) : I state the drug is exported to meet an emergency, expressed by the health authorities of the recipient country in the framework of regional security stock antiretroviral drugs WAHO

The Responsible Officer At………………………………………. date: …………………………………..



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APPENDIX 6:

DELIVERY ORDER N° ……….

Central medical store of departure: Central medical store recipient:

Reference of transfer instruction:

Designation Form/

Dosage Packaging Batch

N° Expiration date

Quantity request

Quantity delivered

Observa-tions

The Responsible officer The Responsible officer

Central medical store of departure Central medical store recipient



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APPENDIX 7:

Figure 3: Alert and troubleshooting flow chart



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APPENDIX 8 Minimum stock (in months of stock)

Maximum stock (in months of stock)

No. International Non-

Proprietary Name Strength Effective

Stock on hand (in months of stock)

EffectiveStock on hand (number of tablets)

Expiration date

Average monthly consumption (number of tablets)

Stock in the pipeline (number of tablets)

Expected delivery date

Funding source of pipeline stock

1

Zidovudine + Lamivudine + Nevirapine

300 mg + 150 mg+200 mg

2

[Zidovudine + Lamivudine] + Nevirapine

[300 mg + 150 mg]+200 mg

3 Zidovudine + Lamivudine

300 mg + 150 mg

4 Nevirapine 200 mg

5

[Zidovudine + Lamivudine] + Efavirenz

300 mg + 150 mg + 600 mg

6 Efavirenz 600mg

7

[Tenofovir Disoproxil Fumarate+ Lamivudine] + Nevirapine

300 mg + 300 mg + 200 mg

8 Tenofovir Disoproxil Fumarate 300 mg

9 Lamivudine 300 mg

10 Lamivudine 150 mg



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No. International Non-Proprietary Name

Strength Effective Stock on hand (in months of stock)

EffectiveStock on hand (number of tablets)

Expiration date

Average monthly consumption (number of tablets)

Stock in the pipeline (number of tablets)

Expected delivery date

Funding source of pipeline stock

11

Tenofovir Disoproxil Fumarate+ Lamivudine

300 mg + 300 mg

12

Tenofovir Disoproxil Fumarate + Lamivudine + Efavirenz

300 mg + 300 mg + 200 mg

13

Tenofovir Disoproxil Fumarate + Emtricitabine

300 mg + 300 mg

14 Zidovudine 300 mg

15 Zidovudine 10 0 mg

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