J.7_Appendix_7.0_-_Medicine_Traceability_Model.pdf

Medicine Traceability Strategic Plan

FOOD, MEDICINE, HEALTHCARE ADMINISTRATION AND

CONTROL AUTHORITY

JANUARI 2018 ADDIS ABABA, ETHIOPIA

ACKNOWLEDGEMENTS

The Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA) would like to extend its sincere appreciation to USAID, UNFPA, and AIDSFree/JSI for the support of the development of the Pharmaceuticals Traceability Strategic Plan. We would also like to give special acknowledgement to the members of the National Traceability Steering Committee, National Traceability Technical Working Group & EFMHACA Technical Working Group , Ministry of Health, PFSA, USAID, AIDSFree/JSI, Bill & Melinda Gates Foundation, UNFPA, Ethiopia Medical Association, Ethiopian Pharmacy Association, UNICEF, St. Paul Millennium Medical College, Ethiopian Standard Agency, Myungsung Christian Medical Hospital, Ministry of Communication and Information Technology, Information Network Security Agency and USP/PQM for their unreserved effort to bring this document to reality.

FOREWORD

The Ethiopian Government with continued support and collaboration from the development partners achieved a lot towards improving the health status of its citizens.

The safety, quality and efficacy of health commodities is a challenging issue at global level. As a result, there is a tremendous surge in demand by healthcare providers to exchange information regarding medical products quality and traceability within their supply chain, and with the various sites and departments within their institutions. In response, many institutions and healthcare facilities are developing their own solutions without common basic principles and globally accepted standards that enables them to track and trace product delivery from the source to the patient and back through the supply chain.

This uncoordinated and fragmented approach makes the supply chain system inefficient and data collected inaccurate; this incurs cost and confusion in the healthcare business, threatening quality of care and patient safety.

Therefore, the need for the development of global standards which provide simplicity and consistency by promoting universal applicability and optimal functionality across the globe for all industry sectors is crucial.

Hence, EFMHACA would like to appreciate and thank all development partners and individuals who have been involved in the preparation of this valuable document. I also would like to thank the National Traceability Steering Committee, National Traceability Technical Working Group and EFMHACA Traceability Technical Working Group members for their valuable contribution and comments during the preparation of the document.

YEHULU DENEKEW ALAMNEH

Director General, Food, Medicines and Healthcare Administration and Control Authority of Ethiopia (EFMHACA)

EXECUTIVE SUMMARY

GLOSSARY OF TERMS

API Active Pharmaceutical Ingredient ANMAT National Administration of Drugs, Food and Medical Devices, Argentina DSCSA Drug Supply Chain Security Act EFMHACA Food, Medicine and Health Care Administration and Control Authority of Ethiopia EPCIS Electronic Product Code Information Services FMD Falsified Medicine Directive FMOH Federal Ministry of Health GDSN Global Data Synchronization Network GLN Global Location Number GS1 Global Standards 1 GTIN Global Trade Item Number GTSH Global Traceability Standard for Healthcare HSDP Health Sector Development Program HCMIS Health Commodity Management Information System HSTP Health Sector Transformation Plan iTS Pharmaceutical Track & Trace System JSI John Snow, Inc.

MO Member Organization MRIS Medical Registration Information System OTC Over the Counter PFSA Pharmaceuticals Fund and Supply Agency POP Prescription Durgs PSM Procurement and Supply Management SSCC Serial Shipping Container Code PTSP Pharmaceutical Traceability Strategic Plan TWG Technical Working Group UNFPA United Nations Population Fund UI Unique Identifier USAID United State Agency for International Development WHO World Health Organization

DEFINITION OF TERMS – to be updated

In this strategy, unless the context otherwise requires, Traceability means according to GS1’s Global Healthcare Standard, ‘the ability to track forward the movement through specified stage(s) of the extended supply chain and trace backward the history, application or location of that which is under consideration’

Label means any material which is printed or affixed to a packing material which provides the necessary information about a food or medicine, and includes an insert;

Medicine means any substance or mixture of substance:

• used in the diagnosis, treatment, mitigation or prevention of human disease, disorder, abnormal physical or mental state, or the symptoms thereof;

• used in restoring, correcting or beneficial modification of organic or mental functions in human;

• articles other than food, intended to affect the structure or any function of the body of human; and

• includes articles intended for use as a component of any articles specified in clause (a), (b) or (c).

Counterfeiting means using in any way, the packing material, identification or trademark, trade name or any special mark thereon of an authentic product of a manufacturer and presenting such falsely labelled and packed food or medicine as if it is manufactured by the genuine manufacturer or altering content and properties of food or medicine that cause health hazards to human;

Barcode means a machine-readable code in the form of numbers and a pattern of parallel lines printed on and identifying a product for the purpose of monitoring by the manufacturer or executive organ;

Supply chain management (SCM) means the active streamlining of business' supply-side activities to maximize customer value and gain a competitive advantage in the marketplace. SCM represents an effort by suppliers to develop and implement supply chains that are as efficient and economical as possible. Supply chains cover everything from production, to product development, to the information systems needed to direct these undertakings.

Supply Chain means a network between a company and its suppliers to produce and distribute a specific product.

The supply chain represents the steps it takes to get the product or service to the customer.

Manufacturing means processing of raw materials into finished goods through the use of tools and processes.

Raw materials are materials or substances used in the primary production or manufacturing of goods. Raw materials are often referred to as commodities, which are bought and sold on commodities exchanges around the world. Raw materials are sold in what is called the factor market, because raw materials are factors of production along with labor and capital.

Manufacturer means any natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)

Importer means any natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed.

Distributor means any natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user

CONTENTS

ACKNOWLEDGEMENTS

FOREWORD

EXECUTIVE SUMMARY

GLOSSARY OF TERMS

DEFINITION OF TERMS – to be updated

1 Introduction

1.1 Mission, Vision and Values – Gamachis to update

2 Traceability

2.1 Advantages

2.2 Traceability models

2.3 Global standards that support traceability

2.3.1 Product and location identification

2.3.2 Master, transactional and event data transactions

3 Situational analysis for global standards implementation

3.1.1 Strengths

3.1.2 Weaknesses

3.1.3 Opportunities

3.1.4 Threats

4 Strategic objectives

5 Stakeholder roles and responsibilities

5.1 Defining roles of the key stakeholders

6 Implementation approach

6.1 Scope of traceability system

6.1.1 Traceability system requirements

6.1.2 Use of global standards

6.2 Phased implementation

6.2.1 Phase 1: Product identification and location and product master data

6.2.2 Phase 2: Batch traceability

6.2.3 Phase 3: Serialization and traceability of unique items

6.2.4 Phase 4: Use traceability data to improve patient safety and efficiency

7 Monitoring and evaluation

7.1 Responsible body

7.1.1 Traceability Office

7.1.2 EFMHACA Management Committee

7.1.3 National Steering Committee

7.1.4 Forum for the national alliance

7.2 Reporting

7.3 Information source

7.4 Indicators

7.5 Assumptions

REFERENCES – to be updated

ANNEX 1 ACTION PLAN

ANNEX 2 STRATEGIC PLAN

1 Introduction Even though Ethiopia has one of the fastest growing economies in the world, production capacity, technological developments, creation of employment opportunities and investments in the healthcare sector are behind on other sectors (HSTP, 2015), while at the same time due to population growth and longer life expectancy the Federal Ministry of Health is expecting an increase in demand of medication. This forms a threat to one of the biggest issues in the healthcare sector: the existence of falsified products in the legitimate pharmaceutical supply chain.

Falsified pharmaceuticals negatively impact patient safety, might lead to loss of lives, will have economic impact and will result in less trust in the healthcare system (USAID, 2016). Currently the government has limited resources to have adequate counterfeit control.

Next to the threats to patient safety, due to lack of visibility in product movement between trading partners and within organizations many inefficiencies in the Ethiopian pharmaceutical supply chain can be identified. Gaps in forecasting and distribution result in limited availability of key pharmaceuticals in hospital, long procurement lead time, problems in record-keeping, forecasted data quality, timely requisition and consumption reporting, no real-time stock status information at national level, wastage due to expiry and damage, theft and an inefficient recall system (HSPT, ?).

The past decades, the government of Ethiopia has invested a lot in health system strengthening to improve the quality and equity of the health services to the public. Maintaining accountability, responsiveness, informed decision, traceability and good governance in the pharmaceutical regulation and supply chain are key milestones that the authority is striving to ensure.

The Authority is actively implementing national policies and transformation agendas to ensure that pharmaceutical regulations are streamlined, effective, efficient and accessible to the community, including the Health Sector Development Program (HSDP) and National Growth and Transformation Plan II (2015/16-2019/20). Also, Information Revolution is a key transformation agenda set by Ethiopian Ministry of Health as one of the transformation agendas of the five-year Health Sector Transformation Plan (2015/16-2019/20). Information revolution will reform the methods and practice of collecting, analysing, presenting and disseminating information.

It is a radical shift from traditional way of data utilization to a systematic information management. It includes advancing the data collection, aggregation, reporting and analysis practice; promoting the culture of information use at place of generation; harnessing ICT; improving data visibility and access; and strengthening verification and feedback systems.

Moreover, the government has endorsed a National Strategy and Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia (2015-2025). This strategy aims to assist local pharmaceutical companies and to create a conducive environment for the growth of the pharmaceutical industry which is believed to attain national resilience in essential pharmaceuticals’ access to the public. This success is accompanied with success for the establishment of pharmaceutical industrial parks.

Although the efforts of the Ethiopian Ministry of Health have yielded significant progress and political commitment, good leadership, community mobilization and ownership and organized support from development partners has already resulted in improved health of the citizens of Ethiopia in the last two decades, many of the challenges in the pharmaceutical supply chain mentioned remain.

As a result, the Ministry and its specialized agencies, particularly the Ethiopian Food, Medicine and Healthcare Administration and Authority (EFMHACA) and the Pharmaceuticals Fund and Supply Agency (PFSA) have embarked on initiatives critical to build information systems fit to the purpose of ensuring patient safety, modernize regulatory functions and improve supply chain efficiency.

One of these initiatives is the implementation of global standards for product identification and data exchange to support the implementation of traceability in the pharmaceutical supply. The implementation of traceability in the pharmaceutical chain will help to improve patient safety by making sure patients aren’t exposed to falsified, expired, recalled other otherwise harmful pharmaceuticals and improve supply chain efficiency by enabling visibility of pharmaceutical product movement.

Global identification and serialization standards for the healthcare supply chain are implemented or in the process of being implemented in more than 40 countries worldwide and have received attention from global operating organizations such as the World Health Organization. The WHO (2015) states that, to build an interconnected world which is cost-effective in terms of health, the pharmaceutical industry should be motivated to implement traceability measures by means of adopting a single set of global standards.

Implementations worldwide have shown great benefits of implementation of standards, but also express the importance of governmental involvement. For Ethiopia, this is equally important. Many stakeholders in Ethiopia’s healthcare sector understand the importance of global standards. They however also recognize the duplication of efforts and lack of integration among the various actors in both public and private sectors, which affirmed the need for inter-sectoral collaboration. Without governmental involvement implementation will take many years, further endangering patient safety.

Building on the lessons learned in implementing the earlier regulatory plans, other countries’ experience on regulation and to be highly responsive to the current socioeconomic landscape of the country, the government of Ethiopia has developed this Pharmaceutical Traceability Strategic Plan (PTSP) as part of the Health Sector Transformation Plan (HSTP) for the implementation of global standards to support traceability in the pharmaceutical supply chain.

The Pharmaceutical Traceability Strategic Plan describes the strategic direction which will guide EFMHACA to improve patient safety and efficiency in the pharmaceutical supply chain by implementation of global standards for product identification and data exchange. This document describes the strategic objectives, including activities with time lines and responsibilities that must be undertaken the coming years in order to implement traceability.

1.1 Mission, Vision and Values – Gamachis to update

The PTSP has been drafted by the Ethiopian Food, Medicine, Health Care Administration and Control Authority with the input of many stakeholders in the pharmaceutical supply chain.

In accordance with Food, Medicine and Health Care Administration and Control Proclamation No. 661/2009, the Authority is provided with a mandate to regulate the 4Ps (Practice, Premises, Professionals and Products). Its mission is “To promote and protect the public health by ensuring safety and quality of products and health service through registration, licensing and inspection of health professionals, pharmaceuticals, food establishments and health institutions and provision of up-to-date regulatory information while promoting rational medicine use.”

Even though EFMHACA has taken the lead in developing the Pharmaceuticals Traceability Strategic Plan EFMHACA this document is a result of consultation with many stakeholders in the supply chain. The different stakeholders each have their own important role in the supply chain and contribute to health and wellbeing of Ethiopians through providing and regulating a comprehensive package of promotive, preventive, curative and rehabilitative health services of the highest possible quality in an equitable manner.

2 Traceability Traceability systems keep electronic records of transactions that result in a change of ownership or location of an item, from manufacturer until the dispenser, and in some cases even to the patient.

2.1 Advantages

A traceability system can be an enabler for visibility of product movement in a supply chain. The potential advantages of traceability implementation include ensuring patient safety by mitigating falsified and illegal medical products; ensures timely availability and authentication of pharmaceuticals and thereby decreasing the number of hospitalization days and even death; ensures that pharmaceuticals only circulate through the authorized health supply chain and avoids the distribution and usage of recalled or expired pharmaceuticals.

Implementation of traceability will improve efficiency by favouring an efficient, fast and safe recall procedure;

enables accurate inventory management, forecasting and planning; managing waste and expired products;

provides visibility into delayed shipments; provides brand protection; creates real-time visibility into product attributes; prevents insurance, reimbursement and tax fraud and enables the collection of meaningful product and usage data (USAID, 2017).

2.2 Traceability models

Several models for traceability in the pharmaceutical industry are currently implemented or in the process of being implemented, and serve as an example for Ethiopia’s roadmap. Depending on the specific challenges in their pharmaceutical supply chains the scope or phases of implementations worldwide could differ.

The WHO (2015) identifies a ‘point of dispensing check’, ‘full track and trace’ or a mixed traceability system. The advantage of a ‘point of a dispensing check’ in which products are being authenticated at the point of dispensing is that it’s an easier implementation than a ‘full track and trace’ implementation. A ‘full track and trace’ system however provides visibility of the whole product supply chain; makes it possible to in real time detect irregularities;

help improve the recall process; enhance inventory management and provides the possibility of conducting epidemiological studies and adopting focused health-related measures in any step of the supply chain. It however is more complex, a higher number of agents is involved, and could possibly slowdown logistic processes.

Turkey

ITS, the Turkish Pharmaceutical Track and Trace System defines the infrastructure constructed to track and trace all units belonging to each pharmaceutical product in Turkey. The regulation requires every pharmaceutical, reimbursable food supplement and reimbursable borderline product to be identified with a serialized GS1 DataMatrix. The serial numbers are being captured in a centralized database owned by the government. All pharmaceuticals on the market are traced by notifications in all of the phases in the supply chain, from production to consumption.

The requirements in Turkey have evolved over the years, requiring more data to be recorded at more points along the supply chain. In 2010 the first phase was the application of a serialized 2D barcode. Through the years more applications have been added, including tracking and tracing of individual items (ITS Management Guideline, 2012).

Argentina

In 2011 Argentina’s National Administration of Drugs, Foods, Medical Devices (ANMAT) developed the National Medicines Traceability System which requires all secondary packages with a certain Active Pharmaceutical Ingredient (API) to be uniquely identified with the Commercial Product Code, the GTIN and a serial number. The pharmaceuticals listed are recorded in real time in a centralized database managed by ANMAT. The system captures each movement of the drug. Some of the transactions that are required to be captured are issue, receipt and return. The traceability system can guarantee that the drug when reaching the patient has never abandoned the legal path of production and distribution.

Some of the objectives ANMAT wishes to achieve are detection of product duplication, improved efficiency, reduction of costs of health systems, minimize wrong supply, provide quality and safety for patients, facilitate effective product recalls and evaluate the consumption of each drug type (Successful Cases of Traceability in the Healthcare Sector in Argentina, 2014).

European Union

The European Commission published the Falsified Medicine Directive (FMD) to improve the protection of public health. The measure includes safety features on the outer packaging of medicinal products subject to prescription and strengthened record-keeping requirements for wholesale distributors. A unique identifier should be placed in a 2D barcode and contain the product code, batch number, expiry date and a serial number. The authentication of the medication should be guaranteed by an end-to-end verification system - “The authenticity of each pack is verified by (i) entering its identifier number into a repository system at the time of manufacture, and (ii) checking the unique identifier against its entry in the repository system at one or more points in the supply chain.” -supplemented by risk-based verification by wholesalers.

As a rule, the decommissioning of the UI takes place at the time the medicinal product is supplied to the public. As an exception, hospitals can decommission the UI at any time the medicinal product is in their physical possession.

When only part of a pack is supplied, the UI should be verified and decommissioned when the pack is opened for the first time (Medicines verification in Europe: What to expect in 2019, 2016).

The United States of America

The Drug Supply Chain Security Act (DSCSA) in the U.S.A. outlines critical steps to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed within the United States. A unique product identifier must be placed on certain prescription drug packages (in human and machine-readable format).

The system will facilitate the exchange of information by trading partners at the individual package level; improve efficiency of recalls; enable prompt response to suspect and illegitimate products when found and create transparency and accountability in the drug supply chain.

The US FDA has a phased approach for implementation of DSCSA. The first phase requires that supply chain participants share chain-of-ownership data. The second phase, requires that pharmaceutical products be marked with a National Drug Code, serial number, lot number and expiration date in both machine-readable and human-readable format. The third phase of DSCSA requires trading partners to share chain-of-ownership data to enable serialized item traceability back to the product origin, which usually is the manufacturer (Applying GS1 Standards for DSCSA and Traceability, 2016).

2.3 Global standards that support traceability

Even though scope and implementation phases could differ, the one thing these implementations have in common is that the foundation of the traceability implementation is built on global standards for product identification and data exchange. This means that trading partner in scope need to be able to document and produce the following:

• Products must be uniquely identified;

• Product and location master data must be shared;

• Transactional data needs to be captured (business transactions to capture information about the movement of the products);

• Event data needs to be captured (item specific data, product specific variable data – e.g. batch/lot/serial number, expiration date).

2.3.1 Product and location identification

Products in scope and locations must be globally uniquely identified. Unique product identification is about assigning data attributes to a product, which could include unique identification number for the product or package and other data attributes, like expiry data, lot/batch number and serial number. Unique product identification provides an additional identification feature to more accurately identify a package, and enables authentication of the package.

Data capture refers to the methods of automatically entering the data attributes directly into computerized systems without human involvement. Identification keys unlock access to information held in computer files, information about companies, locations, packages, products and price.

Note: unique product identification alone does not ensure the contents are genuine. It must be used with additional processes, security features and measures.

2.3.2 Master, transactional and event data transactions

When products and locations are uniquely identified, information about these products and locations should be shared across the supply chain: Three types of data that need to be shared are identified: master data, transactional data and event data.

Master data refers to data that is associated with the product and mostly remains unchanged, e.g. the product description. Global data synchronization enables healthcare trading partners to share trusted product master data, locally and globally, in an automatic and efficient way. This enables reduction in errors and increased efficiency.

Inconsistent, inaccurate and outdated product information makes it, for example, nearly impossible for hospitals to conduct effective supply chain procurement. This can have a ripple effect across all other processes and systems in a hospital which require accurate and correct product information, ultimately affecting patient safety.

Transactional data refers to data that is shared between two trading partners in the sale/purchase process (Electronic Data Interchange), e.g. purchase order, delivery note, invoice, payment. Global data synchronization provides for electronic business messaging that allow rapid, efficient and accurate automatic electronic transmission of agreed business data between trading partners.

Event data refers to activities that a product goes through as it moves through the supply chain. An event has four dimensions:

• What physical objects were involved (e.g. serialised product identifier in a data carrier)?

• When the event took place (e.g. timestamp)?

• Where the event took place (e.g. location identifier)?

• Why: what business process step was being carried out (e.g. receiving, shipping)?

3 Situational analysis for global standards implementation To understand Ethiopia’s readiness for implementation of traceability discussed in chapter two an analysis has been done to understand the different strengths, weaknesses, opportunities and threats to consider while deciding on the strategic framework. The assessment has been conducted via workshops, face-to-face discussions, site visits and a questionnaire with different stakeholders.

3.1.1 Strengths

Strengths are identified from an internal governmental perspective, identifying the current strengths that will help standards implementation, and that we will need to cherish.

Strong governmental commitment

The Federal Ministry of Health has strong commitment to lead the implementation of traceability in the pharmaceutical supply chain. EFMHACA is the governmental body currently overseeing regulating the pharmaceutical supply chain, with support from the Ethiopian Ministry of Health.

Availability of regulatory tools

EFMHACA has the right tools to implement a regulatory framework to make implementation happen. Also, different supply chain tools to support product registration are currently being developed by EFMHACA and PFSA, including the Medicine Registration Information System.

3.1.2 Weaknesses

Weaknesses are identified from an internal governmental perspective.

Absence of structure to implement global standards

Currently, the regulatory framework to support implementation of global standards is not in place: There is no dedicated team working on standard implementation at the regulatory body, thus human resource needs to be improved; EFMHACA processes aren’t adjusted to global standards implementation and there is no regulation for global standard implementation in place yet.

Limited knowledge & awareness

In general, the implementation of global standards for product identification and data exchange is a new concept, not only in the pharmaceutical supply chain, but also in other sectors. Unfortunately, most stakeholders in the supply chain, including the governmental bodies, do not have any experience with using global standards for product identification and data exchange in their processes and are not aware of the importance of these standards.

Even though, many international manufacturers do have experience with implementation of global standards for product identification, unfortunately a lot of issues regarding good quality barcodes and data quality remain.

Limited coordination and communication among stakeholders

Implementation of traceability will require stakeholders in the supply chain to actively communicate. Currently communication between stakeholders is not sufficient for the implementation of global standards.

3.1.3 Opportunities

There are different opportunities that can be identified in Ethiopia’s current pharmaceutical supply chain and worldwide that provide a good environment for implementation of global standards.

Availability of global experience

The use of global standards in the pharmaceutical industry is implemented or in the process of being implemented in more than 40 countries worldwide. Many of the learnings from these implementations will be taken into account while moving forward in Ethiopia, including, making patient safety our primary objective, involvement of stakeholders, make actors in the supply chain aware of the challenges that need to be addressed, consider reasonable timeframes for implementation, don’t underestimate the complexity and resources that will be needed for implementation, provide constant training and support and make sure to keep global and technological developments into account.

Presence of global standards and expertise

With growing implementation worldwide, and a globalizing world, more stakeholders present in the Ethiopian pharmaceutical supply chain (especially international manufacturers) will use global standards for product identification and data exchange.

Understanding importance of implementation by actors in the supply chain

Even though local manufacturers, wholesalers and importers, just like healthcare providers or PFSA and FMHACA in Addis Ababa and around the country have little to no experience with the implementation of standards they all seem to understand the importance of implementation for patient safety and improvement of supply chain efficiencies. As one manufacturer mentioned: “In the end, it’s also our family that at some point might require reliable medication.”

But also, the benefits for improved efficiency are very much understood. Many stakeholders mention that with the help of the standards they think they can improve inventory management, data quality and, for example reduce waste. Another important opportunity mentioned by many stakeholders is getting data visibility not just for their own organization, but for the entire supply chain. Implementation of global standards will for example help all the parties get information about national consumption.

One of the improvements healthcare providers also hope implementation will bring is improved and greater visibility in suppliers’ stock levels. Now, healthcare providers can’t rely on availability of products and must implement strategies to address unavailability of products, which means buying products from the private sector.

Investments in pharmaceutical manufacturing sector

The government has endorsed a National Strategy and Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia (2015-2025). This strategy aims to assist local pharmaceutical companies and to create a conducive environment for the growth of the pharmaceutical industry which is believed to attain national resilience in essential medicine access to the public. This success is accompanied with success for the establishment of pharmaceutical industrial parks.

For the future, with the current focus of the Ethiopian government on product export, the implementation of global standards makes it possible for Ethiopian manufacturers to enter the global market. International requirements regarding product identification and data exchange will be easily met.

Government commitment to replace Proclamation 661/2009

The government is committed to replace the current Proclamation with a Proclamation that will make it possible to create the regulatory framework to make standard implementation mandatory.

Focus on Information Revolution

Information Revolution is a key transformation agenda set by Ethiopian Ministry of Health as one of the transformation agendas of the five-year Health Sector Transformation Plan (2015/16-2019/20). Information revolution will reform the methods and practice of collecting, analysing, presenting and disseminating information.

It is a radical shift from traditional way of data utilization to a systematic information management. It includes advancing the data collection, aggregation, reporting and analysis practice; promoting the culture of information use at place of generation; harnessing ICT; improving data visibility and access; and strengthening verification and feedback systems.

Support from stakeholders

The health sector currently works with many stakeholders on the implementation of global standards, including the Ministry of Health, Ethiopian Standard Agency, Manufacturing organization, healthcare providers and other.

3.1.4 Threats

Threats are identified as external challenges that must be considered while moving forward. These are more difficult to influence than internal challenges, and therefore even more important.

Limited readiness of stakeholders to implement global standards

There is no use of global standards in the pharmaceutical supply chain. No local manufacturer uses barcodes to uniquely identify their products, no wholesaler or importer receiving products from abroad use the barcodes that are already on products and there is no standardized way of master or event data exchange.

Limited resources: technology, human capacity and finances

A great challenge named by many stakeholders is having enough resources, in money, time and people at all the different levels of the supply chain, starting at the regulatory bodies.

Manufacturers will have to make sure that a project team will be developed, which includes many departments of their organization, for example, ICT, regulatory, logistics, artwork and labelling. Once global standards have been implemented and it can be transitioned to ‘business as usual’ less capacity is needed.

Even though deviation from global standards will come at greater costs an initial investment must be made by supply chain actors. Some of these investments include: GS1 subscription for product identification and data exchange, printers, scanners and software. The costs will depend on the scope of the regulation, status of current implementation for that stakeholder and revenue.

Also, one of the challenges identified by different organizations, but especially by the manufacturers, is the lack of a strong supporting industry with quality services and products like printing, labelling, packaging, inventory management software and verification industry. For good quality barcodes good printers, good quality ink and paper are necessary. Quality data and data exchange will rely on appropriate software applications. Especially a good quality packaging industry is mentioned as one of the biggest challenges.

Absence of GS1 office in Ethiopia

One of the requirements for proper support for all the parties in the supply chain, including the government is the existence of a GS1 Member Organization (MO). Unfortunately, there is no office in Ethiopia yet. In Africa, there are a couple of MO’s, with closest GS1 Egypt and GS1 Tanzania. Even though support from these MO’s and GS1 Global Office can be expected, it is important to have support from GS1 staff knowledgeable about Ethiopia’s specific context and challenges.

Limited technological capabilities

Some stakeholders mentioned concerns about the technological capabilities of Ethiopia’s healthcare sector for the implementation of global standards. Concerns about connectivity, especially in the areas outside Addis Ababa, reliability of internet, data security, confidentiality and the availability of back-up systems have been raised.

Availability of technology is important to consider, not only for manufacturers. Also, even though the growth of the use of smart phones and mhealth applications in Africa is enormous, still a large group of people can’t afford a smart phone or don’t have access to a data network. This is the main challenge for one of the end goals, verification of a product by the patient.

Dependency of stakeholders on other parties

The implementation of global standards requires cooperation of the entire supply chain. If a manufacturer doesn’t barcode the product correct, doesn’t provide good quality data, all the parties down the supply chain will be influenced. The manufacturer is the source of the data.

Currently, the Ministry of Health, EFMHACA and PFSA depend for a great deal on technical and financial support from development organizations: USAID, UNFPA and JSI. Even though this support provides a lot of opportunities for the government to achieve the goals set in their Health Sector Transformation Plan (2015), with global developments and new US government continues support might be at risk.

4 Strategic objectives Achievement of the goal; improve patient safety and supply chain efficiency in the pharmaceutical supply chain by implementation of traceability supported by global standards; requires several measures and creation of an environment in which implementation is possible, taking the strengths, weaknesses, opportunities and threats of the healthcare sector for implementation of global standards in Ethiopia into account.

The strategy sets out the details of the different objectives and activities to be undertaken in the coming years and sets out two phases.

(1) Creation of an environment in which implementation is possible.

The current healthcare sector is not ready for implementation of global standards. The first four objectives will provide a regulatory framework, build and sustain the technical infrastructure to support traceability, strengthen stakeholder’s capacity for standard implementation and build and improve communication and collaboration.

(2) Implementation of global standards for traceability to improve patient safety and efficiency in the pharmaceutical supply chain.

While working on building an environment in which standards implementation can be achieved, EFMHACA will need to work on the implementation of the standards and inform stakeholders accordingly. The strategic objectives will focus on the actual creation of visibility in the pharmaceutical supply chain and the use of traceability data to improve patient safety and efficiency.

A detailed description of the different activities to achieve the objectives, including time lines and responsibilities can be found in Annex 1 Action Plan.

Currently, the pharmaceutical regulatory framework (including regulatory documentation) and systems are not equipped to support implementation of global standards. Different activities will be undertaken to strengthen the regulatory system to be able to publish regulatory documentation and successfully implement traceability of medicine.

Activities

1.1 Develop required strategic plan for implementation of traceability system for pharmaceuticals.

The Pharmaceutical Traceability Strategic Plan describes the strategic direction which will guide EFMHACA to improve patient safety and efficiency in the pharmaceutical supply chain by implementation of global standards for product identification and data exchange. This document describes the traceability approach, relevant standards, a short summary of the assessment done to assess stakeholders’ readiness for standard implementation and the strategic objectives, including activities with time lines and responsibilities that will have to be undertaken over the coming years.

1.2 Establish Traceability Office at EFMHACA.

A well-resourced, effectively functioning national medicine regulatory authority is a prerequisite for implementation of traceability, therefore there is the need to establish a Traceability Office responsible for all the different activities around implementation of global standards. Because knowledge about global standards is currently limited within the different governmental bodies, human capacity and resources will have to be built.

1.3 Establish national alliance to support implementation of traceability.

Next to establishing the Traceability Office, stakeholders need continuous involvement via different means, including a National Traceability Steering Committee and Technical Working Groups. The National Steering

1. Strengthen regulatory system to enable implementation of traceability of medicine

Committee consists of important stakeholders, such as Ministries, development partners, and other stakeholders.

Technical Working Groups will be established to support implementation by addressing specific challenges.

1.4 Conduct assessment on internal and external regulatory processes.

An assessment must be done to know the impact of standard implementation on regulatory processes and documentation. Based on the assessment actions will be undertaken to make processes fit for implementation.

1.5 Prepare and enforce regulatory documentation.

New regulatory documents, such as Regulations, Directives and Guidelines will have to be prepared and existing documentation will have to be revised for implementation of product identification and data exchange to support traceability.

The technical infrastructure to support a national traceability system to capture product movement and detect irregularities in the supply chain must be developed. A combination of hardware and software technologies, business processes and over or covert item identifiers enables auditable recordkeeping of the physical movement of the item. The outcome of this strategic objective is to have the technical infrastructure in place to support the objectives of the implementation.

Activities

2.1 Conduct traceability technical infrastructure gap analysis.

The technical infrastructure document will describe the current technical infrastructure, technical requirements and the different activities to undertake, including timelines and responsibilities to achieve the required technical infrastructure to implement traceability of pharmaceuticals taking the challenges in the supply chain (e.g. network reliability) and objectives for improvement of patient safety and efficiency into account.

The infrastructure will be based on global GS1 standards for product identification and data exchange, track and trace feature and the ability to impact and meet the goal of mitigating falsified pharmaceuticals, providing supply chain security, visibility and ease of product recall. Also, new technological and standard developments will be considered.

2.2 Develop and sustain technical infrastructure.

After description of the desired technical infrastructure, actions will have to be undertaken to build and pilot the technical infrastructure. Also, a system will have to be set into place to monitor performance of the system, monitor incidents, provide an escalation process and support to stakeholders with technical requirements or questions.

Currently no stakeholder in the Ethiopian pharmaceutical supply chain uses global standards for product identification or data exchange. The outcome of this strategic objective is building stakeholder’s capacity and ease implement global standards.

3.1 Conduct gap analysis for stakeholder readiness.

2. Build and sustain technical infrastructure to support implementation of traceability

3. Build stakeholder’s capacity to ease implementation of traceability

A gap analysis will have to be conducted in terms of technology and human resources to understand stakeholders’ capabilities concerning the standard implementation. This analysis will describe the needs of the industry and suggests how to best improve the capabilities of stakeholders to comply with the regulatory requirements.

EFMHACA will have to define the minimum requirements for manufacturers, supporting industries (such as packaging, printing, labelling soft- and hardware), healthcare providers and other organizations involved in implementation of global standards.

3.2 Undertake support activities for capacity building.

Based on the gap analysis, EFMHACA will have to undertake activities to support local manufacturing industry, supporting industries and other stakeholders like the Ethiopian Standards Agency and Universities with implementation of the standards.

Implementation of global standards is a very new concept in Ethiopia’s healthcare sector. Currently there is lack of awareness, knowledge and human resources at all stakeholders. Therefore, knowledge, communication and collaboration must be strengthened throughout the entire supply chain. The outcome of this strategic objective is improvement of knowledge for all stakeholders, a strengthened communication and collaboration with and between stakeholders in the supply chain to ease implementation.

Activities

4.1 Develop communication and collaboration plan.

A communication plan must be drafted describing, among other, the knowledge that needs to be shared (per stakeholder) the message that needs to be communicated, and how.

4.2 Create communication and collaboration material.

Support material for awareness creation, knowledge building, communication and training will have to be developed, including documentation, website, presentations and other.

4.3 Provide continuous communication and collaboration.

Awareness creation, training and support is a continuous activity which must be undertaken by EFMHACA to make sure stakeholders are up-to-date on developments throughout the implementation phases and after. This can be done through:

• Public workshops and meetings

• Professional conference participation

• Calls and webinars

• Website

• Checklists, guidance and implementation documentation

Next to support, EFMHACA will collaborate with stakeholders via Strategic and Technical Working Groups

The activities undertaken while implementing strategic objective five will enforce use of the standards to implement traceability of medicine. The outcome of this strategic objective is the implementation of global

4. Strengthen knowledge, communication and collaboration to ease implementation of traceability

5. Improve patient safety and efficiency in the pharmaceutical supply chain by use of traceability data standards to create traceability in the pharmaceutical supply chain. Even though this implementation occurs in phases, each activity already provides benefits.

Activities

Activity 5.1: Enforce presence of unique identification of distributed pharmaceuticals in Ethiopia.

The first step is to make sure all distributed items in Ethiopia are uniquely identified and that this unique identification number is captured in a data symbol that can be electronically captured through scanning.

Activity 5.2: Enforce stakeholders to share standardized product and location master data.

The next step is to have standardized product and location master data available.

Activity 5.3: Enforce implementation of batch traceability.

The next step is to make sure all stakeholders in the supply chain register product movement in the traceability system. Implementation of traceability will be done in phases, starting with traceability of items based on batches.

Activity 5.4: Enforce implementation of traceability based on serialized pharmaceuticals.

Learning from batch traceability will give input to implementation of traceability for identified unique distributed items in the country. A pilot phase before batch traceability and traceability based on unique items will be implemented prior to actual implementation.

Implementation of traceability will provide data. This data will have to be efficiently managed, analyzed and most importantly used to improve patient safety and efficiency in the supply chain.

Implementation of this strategic objective will make it possible to detect falsified or illegal pharmaceuticals in the supply chain. The responsible body will have the processes in place to act upon detection of these irregularities.

The data captured in the supply chain will also provide input for improvement of efficiency: recalls can be executed more effective and it will support efficient inventory management

Activities

Activity 6.1: Identify what kind of information to monitor and data to capture to achieve the objectives.

An analysis will have to be made to decide what kind of supply chain information will have to be captured and monitored to enable detection, notification and response to improve patient safety and efficiency.

Activity 6.2: Implement systems and processes to capture data.

The data that will be captured will have to be translated in understandable dashboards and reports and will serve as input for management teams of different organizations.

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