Please consider the environment before printing

Quality assurance in humanitarian medical supply chains

June 2013

Dennis Bours, Dpbours@yahoo.com

Independent Assessment Report

Certification in Humanitarian Medical Logistics Practices, Fritz Institute

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Executive summary

The primary objective of humanitarian assistance is to save lives, alleviate suffering, and maintain

and restore human dignity. The focus of this publication is on humanitarian medical assistance, and

more specifically on quality assurance in humanitarian medical supply chains.

Humanitarian medical supply chains should be developed for flexibility reflected their ability to cope

with changing levels of responsiveness and the speed of scaling up or down. Medical humanitarian

assistance and related supply chain structure should take into account response phases and related

supply chain types an intervention might need to shift to and progress through over time.

Changing intervention phases, supply chain responsiveness required, levels of uncertainty in

operational context as well as beneficiary demand and inadequate structural funds for the

humanitarian supply chain function will impact and limit both the ability and speed of switching

supply chain types and related quality assurance measures for and management of the medical

supply chain.

Humanitarian organizations implementing medical programs in a variety of response phases often

follow the essential medicines lists of the WHO, the recipient country’s MoH essential medicine list if

more stringent, or internationally agreed upon and WHO-inspired catalogues of standardized medical

items. Operating in the emergency response phase, humanitarian organizations often make use of

the IFRC or interagency emergency health kits, which have been pre-qualified and cover the

minimum needs for a basic health-care system under emergency circumstances.

WHO/UN essential medicine lists, related pre-qualified suppliers and interagency emergency health

kits meet the medicine quality aspects as discussed in Chapter 2 and follow stringent quality

assurance rules as discussed in Chapter 3, which make them the preferred procurement choice.

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Quality assurance throughout the supply chain is complex due to large number of stakeholders

involved and the fact that big parts of the supply chain, both downstream as well as upstream, will

be external to the humanitarian organization implementing or taking part in a medical intervention.

Despite these complexities some recommendations towards quality assurance are given for the

supply chain management process in general and for each main supply chain component, i.e.

procurement and order management, transport, and warehousing and inventories, in Chapter 4.

The most obvious of recommendations concentrate on the need for clearly formulated roles and

responsibilities, policies and procedures, and clear information flows, suitable for the particular

programme, both in general technical terms as well as towards quality assurance.

Procurement should be limited to pre-qualified suppliers from “stringently regulated” countries

and/or medical Humanitarian Procurement Centres (HPCs), taking into account the reverse flow of

goods, and all items should have not only technical specifications, but also quality

indicators/specifications. Transport must take place in line with international and national

regulations and specific handling requirements of items transported. When focusing on warehousing;

rules, roles and regulations for the inspection, quality control and handling should be the same for all

warehousing environments, irrespective of the actor managing it and clear minimum standards

should be put in place.

Moving through the different response phases, quality assurance will need to be balanced against

needed responsiveness and anticipated uncertainty of demand / operational context, coming at a

certain financial cost. The responsive phases – emergency and transitional phases – will focus on a

coordinated response, emergency health kits, pre-positioned stocks and air transport, while in the

more efficient supply chain phases – developmental and risk reduction phases – will focus on open

tendering, development of blanket purchasing agreements, capacity development and more efficient

mixed transport modes.

Quality assurance in humanitarian medical supply chains demands a coordinated multi-stakeholder

approach, which could be improved by integrating current medical Humanitarian Procurement

Centres (HPCs) into the International Health Partnership (IHP+) to guarantee their adherence to all

medical good practice standards, a higher level of coordination between HPCs and provision of

services by all stakeholders under IHP+ that go beyond their internal medical supply chain and

current level of service, ie. supply of trainers, quality assessors, emergency pharmacists, etc. Another

solution might be to only accept humanitarian actors in humanitarian medical interventions who can

guarantee a minimum level of quality assurance in their work processes and outputs. This would also

make sense to curtail the uncontrollable flood of humanitarian initiatives after a disaster.

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Table of Contents

Executive summary ................................................................................................................................. 3

List of abbreviations ................................................................................................................................ 6

List of figures ........................................................................................................................................... 7

List of tables ............................................................................................................................................ 7

1. Introduction ......................................................................................................................................... 9

2. Aspects of medicine quality .............................................................................................................. 11

2.1 Common denominators of medicine quality .............................................................................. 11

2.2 Essential medicines ..................................................................................................................... 13

3. Critical elements of medical quality assurance ................................................................................. 15

3.1 Quality assessment vs. quality assurance ................................................................................... 16

3.2 Certification and quality assurance ............................................................................................. 16

4. Quality assurance throughout the supply chain ............................................................................... 18

5. Humanitarian response phases and quality assurance ..................................................................... 20

6. Concluding ......................................................................................................................................... 21

References ............................................................................................................................................. 23

Recommended reading ......................................................................................................................... 29

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List of abbreviations

3PL Third-party logistics

BAN British approved name

BOND British Overseas NGOs for Development

BP British Pharmacopoeia standards

DG ECHO European Commission’s Directorate General for Humanitarian Aid

EC European Commission

EDQM-PQS European Pharmacopoeia Reference Standards

EMEA European Medicines Agency

GDP Good distribution practices

GMP Good manufacturing practices

GSP Good storage practices

GTDP Good trade and distribution practices

HPC Humanitarian Procurement Centre

IATA International Air Transport Association

IFRC International Federation of Red Cross and Red Crescent Societies

IHP+ International Health Partnership

INN International non-proprietary name

ISO International Standards Organization

MDGs Millennium Development Goals

MoH Ministry of Health

MSF Médècins Sans Frontières

MSH Management Sciences for Health

PAHO Pan-American Health Organization

QA Quality assurance

RCRC Red Cross and Red Crescent movement

SCM Supply chain management

SHO Stichting Samenwerkende Hulporganisaties,

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Dutch: Cooperating Aid Organizations

UN United Nations

UNICEF United Nations Children’s Fund

UNOPS United Nations Office for Project Services

USAID United States Agency for International Development

USAN United States adopted name

USP United States Pharmacopeia Convention

WHO World Health Organization

List of figures

Figure 1: Humanitarian response phases and corresponding supply chain types ................................ 10

Figure 2: Elements of a quality assurance system ................................................................................ 15

Figure 3: Humanitarian response phases and medical procurement actions....................................... 20

List of tables

Table 1: Substances with potential bioavailability problems ................................................................ 12

Table 2: Substances with stability issues ............................................................................................... 12

Table 3: WHO criteria for the selection of essential medicines ............................................................ 13

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1. Introduction

The primary objective of humanitarian assistance is to save lives, alleviate suffering, and maintain

and restore human dignity, without regard for race, ethnicity, religion or political affiliation.

Humanitarian action should be undertaken for the benefit of vulnerable people, guided by principles

of humanity, impartiality, neutrality and independence. It should facilitate the return to normal lives,

seeking to lessen the destructive impact of disasters and complex emergencies.1 The focus of this

publication will be on humanitarian medical assistance, more specifically on quality assurance in

humanitarian medical supply chains.

Certain literature focusing on humanitarian medical standards is written specifically towards medical

assistance in (post-)disaster settings, e.g. the PAHO Guidelines on humanitarian medical supply chain

management (SCM), the EC guidelines for quality assurance (QA) in medical humanitarian aid and the

Sphere minimum standards in health action.2 Other guidelines focus on medical SCM in humanitarian

assistance, not specifying the humanitarian intervention phase, e.g. the USAID Deliver project

guidelines and MSH guideline on managing access to essential medicines and health technology.3

Irrespective of the approach, humanitarian medical supply chains should be developed for flexibility

reflected in being able to cope with changing levels of responsiveness and speed of scaling up or

scaling down. Medical humanitarian assistance and related supply chain structure should take into

account response phases and related supply chain types an intervention might need to shift to and

progresses through over time, visualized in Figure 1. Within each phase the humanitarian actor

strives to work in or close to the zone of strategic fit, hence finding the optimum situation to balance

beneficiary needs against supply chain capability and balance programmatic and supply chain

strategies to one another to guarantee (cost) efficiency.4

It should be understood that the supply chain function in humanitarian assistance is a support

function towards core (medical) activities and often receives its funding as a percentage of donor

funding or pledges for the implementation of core activities. The lack of structural support,

understanding of its value added and lack of acknowledgement of its importance has resulted in

limited longer term coordination and vision in humanitarian supply chain practices.5

1 IFRC 2002; SPHERE 2011.

2 PAHO 2001; Pomatto and Schuftan 2006; SPHERE 2011, pp. 287-354.

3 Owens and Warner 2003; USAID 2011; MSH 2012.

4 Cohen and Roussel 2005; Sunil and Meindl 2009; Chopra and Meindl 2013.

5 Buchanan-Smith and Randel 2002; Gustavsson 2003; Van Wassenhove 2006; Lee and Lee 2007.

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Figure 1: Humanitarian response phases and corresponding supply chain types

Changing intervention phases, supply chain responsiveness required, levels of uncertainty in

beneficiary demand as well as operational context and inadequate structural funds for the

humanitarian supply chain function will impact and limit both the ability and speed of switching

supply chain types and related quality assurance measures needed.

Chapter 2 focuses on aspects of medicine quality, related quality indicators and the concept of

essential medicines. Quality assurance (QA) and its critical elements are discussed in Chapter 3, with

a focus on quality assessment vs. assurance and the role of certification.

In Chapter 4 recommendations towards quality assurance are given for the supply chain

management process in general and for each main supply chain component, i.e. procurement and

order management, transport, and warehousing and inventories. Going back to the humanitarian

response phases, Chapter 5 looks at key medical procurement and supply chain management actions

exemplified in each response phase. This report concludes in Chapter 6 with some observations

towards the future of coordination and quality assurance in humanitarian medical supply chains.

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2. Aspects of medicine quality

An in-depth literature review6 showed that pharmaceutical quality can be qualified and tested in

many ways. The European Pharmacopoeia Reference Standards (EDQM-PQS), the British

Pharmacopoeia standards (BP) and the United States Pharmacopeia Convention (USP) are three

standards used frequently in developing settings, with each their specific strengths and limitations.7

2.1 Common denominators of medicine quality

Despite the absence of one uniform definition of pharmaceutical quality, and small differences in the

various existing standards, common denominators can be identified and these are presented below:

Identity: The correct active ingredient is present, certified by laboratory testing, and specified by the

international non-proprietary name of the active ingredient (INN) or the British approved name

(BAN) or United States adopted name (USAN)8.

Pharmacopoeial standard: A medicine is of good quality if its characteristics meet the standards

described in a widely accepted pharmacopoeia such as the European Pharmacopoeia Reference

Standards (EDQM-PQS), the British Pharmacopoeia standards (BP) or the United States

Pharmacopeia Convention (USP).

Purity: The medicine is not contaminated with potentially harmful substances.

Potency: The correct amount of active ingredient is present and certified by laboratory testing,

usually between 95 and 110 percent of the labelled amount.

Uniformity: Consistency of, shape, and size of the dosage form do not vary.

Bioavailability: Bioavailability refers to the speed and completeness with which an administered

medicine enters the blood stream, which must be consistent to provide a predictable therapeutic

result. Medicine bioavailability differences exist between manufacturers of the same product. A

number of oral medicines have known bioavailability issues (Table 1)9. Careful evaluation of generic

6 EC 1994; WHO 1997; PAHO 2001; EC 2003; WHO 2003A and 2003B; Toutain and Bousquet-Melou 2004; WHO 2005; Pomatto and Schuftan 2006;

WHO 2007; MSH 2007, pp.108-122; WHO 2009; EC 2010; MSF 2010; WHO 2010A, 2010B and 2010C; IFRC 2011A and 2011B; PATH 2011; UNICEF

2011; USAID 2011; WHO 2011A, 2011B, 2011C, 2011D and 2011E; Dasaklis, Pappis and Rachaniotis 2012; MSH 2012; WHO 2012; EC 2013;

Mosadeghrad 2013. 7 MSH 2012, pp. 351-370.

8 INN in line with the European Pharmacopoeia Reference Standards (EDQM-PQS), BAN in line with the British Pharmacopoeia standards (BP) or

USAN in line with the United States Pharmacopeia Convention (USP). 9 EMEA 2000; EMEA 2010; MSH 2012.

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medicines may be necessary, but if purchasing is done through established and reliable suppliers, the

bioavailability of most brand-name and generic medicines used in primary health care is sufficient.

Table 1: Substances with potential bioavailability problems

Stability: The activity of the medicine is ensured for the period of time stated on the product label,

that is, until the expiration date. Improper storage and distribution can lead to physical deterioration

and chemical decomposition, reduced potency, and occasionally, formation of toxic by-products of

degradation. Some medicines have found to be more sensitive to tropical conditions and excessive

temperatures (over 40 ⁰C). An overview of medicines with stability problems is presented in Table 2.

Table 2: Substances with stability issues

Shelf life: The medicine has a shelf life of 2 years, that is, up to expiration date, or for products with a

shelf life of less than two years at time of manufacture, at least 75% of the life must be remaining.

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2.2 Essential medicines

Up to 70 percent of all pharmaceuticals are duplicative or non-essential.10 The World Health

Organization (WHO) defines essential medicines as “those that satisfy the priority health care needs

of the population. They are selected with due regard to public health relevance, evidence on efficacy

and safety, and comparative cost-effectiveness”.11

While most reasons to develop an essential medicine list focus on fairness of access to medicine,

consensus on first choice treatment and reduction of health care cost, it also helps to concentrate

medical procurement and SCM efforts on a limited number of items in terms of quality control and

medicine management, ie. stock management, distribution and monitoring of medical supply

pipelines (Table 3).

Moreover, the WHO essential medicines criteria also focus on medicine quality in terms of potency,

uniformity, stability and also bioavailability; common denominators of medicine quality to be taken

into account with respect to quality assurance in medical humanitarian supply chains.

Table 3: WHO criteria for the selection of essential medicines11

10

MSH 2012, pp. 289. 11

WHO 2008; 2010B, 2011D, 2011E and 2012.

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Humanitarian organizations implementing medical programs in a variety of response phases often

follow the essential medicines list of the WHO, the recipient country’s MoH essential medicine list if

more stringent, or internationally agreed catalogues of standardized medical items based upon the

WHO essential medicine list. Operating in the emergency response phase, humanitarian

organizations often make use of the IFRC or interagency emergency health kits, which have been pre-

qualified and cover the minimum needs for basic health-care systems under emergency

circumstances.12

WHO / UN / multilateral organizations’ essential medicine lists, related pre-qualified suppliers and

interagency emergency health kits meet the medicine quality aspects as discussed and follow

stringent quality assurance rules discussed in Chapter 3, making them the preferred procurement

choice.

12

MSF 2010, IFRC 2011A and 2011B, UNICEF 2011, WHO 2011B, 2011D and 2011E.

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3. Critical elements of medical quality assurance

Quality assurance (QA) is a wide-ranging concept covering matters that individually or collectively

influence the quality of a product. With regard to pharmaceuticals, quality assurance can be divided

into four major areas: quality control, production, distribution, and inspections.

Figure 2: Elements of a quality assurance system13

While some humanitarian actors might have the capacity to implement all the elements of a quality

assurance system, most humanitarian actors will depend on UN/multilateral bodies and their

suppliers to be actively involved in specific quality assurance activities part of the QA system, ie.

inspection of product samples, monitoring of manufacturing sites, product testing, certification, etc.

13

Adapted from MSH 2012, pp. 350.

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3.1 Quality assessment vs. quality assurance

Quality assessment is part of the (often mostly internal) quality management process and often

refers to the (continuous) monitoring/measurement of quality within a humanitarian medical

intervention, based on set policies, processes and protocols to assure a medical intervention is

optimally delivered and it includes indicators that measure whether success is being achieved.

Quality assurance is a wider process of guaranteeing quality, based on product (medicines, medical

materials and equipment) and process quality indicators being measured and quality standards being

reached through the quality management process. Common denominators of medicine quality have

already been put forward; process quality standards focus on, among others, good manufacturing

practices (GMP) – also captured in EC guidelines and standards, good distribution practices (GDP),

good storage practices (GSP) and good trade and distribution practices (GTDP).14

Product and process quality management standards focus on the fundamentals of quality

management systems that need to be in place to assure quality, as do the GMP and ISO standards.

3.2 Certification and quality assurance

Certification refers to the assurance of certain quality standards being in place. First-party

certification refers to internal quality assessment and continuous monitoring, whereas second-party

and third-party certification refers to qualification or certification by either an association to which

the organization belongs or in the latter case certification by an independent, accredited body.

Suppliers and manufacturers can be qualified to work in line with (often voluntary) good practice

process quality standards like the GMP, GDP, GSP or GTDP standards of the WHO and/or less

voluntary EC equivalents, which are often part of a pre-qualification process of suppliers and

manufacturers. At the same time they can be certified to follow specific quality management

standards like ISO 9000:2005 and ISO 9001:2008, quality management standards specifically focusing

on medical materials like the ISO 11608:2012 or ISO 10555:2013 series, standards for medical devices

like ISO 13485: 2003 or the older equivalent EN 46001 / EN 46002, and standards focusing on

packaging materials for medicinal products, like ISO 15378:2011.15

14

EC 1994 and 2003; WHO 2003A, 2003B and 2005; Pomatta and Schuftan 2006; WHO 2007; EC 2010; WHO 2010A, 2010C and 2010D; EC 2013.

15 ISO 2005, 2007, 2008, 2011, 2012 and 2013.

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Procuring from suppliers/manufacturers registered and certified in countries that are considered to

have “stringently regulated” national drug regulatory authorities16 guarantees the adherence to good

practices and certified quality management standards, thus assuring the quality of medical items

procured.

16

The following countries are considered to be highly regulated by their national drugs regulatory authorities: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Malaysia, Netherlands, Norway, Portugal, Romania, Singapore, Slovak Republic, Spain, Sweden, Switzerland, UK, ICH European Union Members, Japan and USA.

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4. Quality assurance throughout the supply chain

Quality assurance throughout the supply chain is complex due to the fact that big parts of the supply

chain, both downstream as well as upstream, will be external to the humanitarian organization

implementing or taking part in a medical intervention. This complexity is further increased by the

vast number of stakeholders17 involved in the external supply chain elements and related quality

assurance.

Despite these complexities, some recommendations towards quality assurance can be given for the

supply chain management process in general and for each main supply chain component:

- Different medical interventions and types of items used in them require that clear policies and

procedures for procuring, moving, storing, using and disposing of items need to be in place.

These need to be suitable for the particular programme, follow appropriate minimum standards

and must be understood and followed by all actors involved in the supply chain process;

- Roles and responsibilities of all supply chain actors should be very clear and defined both in

general technical terms as well as towards quality assurance throughout the supply chain;

- Quality assurance throughout the supply chain demands a clear information flow, containing all

information necessary to handle and process medical orders and additional information on

specific handling requirements, controlled substances, dangerous goods requirements, etc. by

means of certificates, declarations, licenses and specific packaging, marking and labelling.

Procurement and order management:

- Procurement, as the action of obtaining or acquiring supplies, can take place from suppliers,

distributors, UN agencies, RCRC, donors or the government. Order management can be external

from the humanitarian organization as implementing partner. Roles and responsibilities of all

actors involved towards these processes as well as quality assurance should be clearly defined;

- Procurement should be limited to pre-qualified suppliers (pre-qualified by e.g. WHO, UN, RCRC,

MSF or a INGO collaborative like BOND or SHO) from “stringently regulated” countries and/or

medical Humanitarian Procurement Centres (HPCs)18, following good practice process quality

standards19 and with certified quality management standards;

17

First, second and third-tier ssuppliers, distributors, 3PL providers, governments, UN agencies, RCRC, standardization and/or quality control institutes, other humanitarian organizations, donors, etc.

18 HPCs are not-for-profit organisations specialised in the technical and commercial management of supplies and services necessary for the

implementation of humanitarian actions. They can provide technical assistance in procurement or supply pre-established stocks, purchasing or logistics capacity. http://ec.europa.eu/echo/partners/humanitarian_aid/procurement_en.htm [Accessed 28 June 2013].

19 WHO 1999 and 2007; MSF 2010; IFRC 2011A and 2011B; UNICEF 2011; WHO 2011D and 2011E; MSH 2012; WHO 2012.

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- The reverse goods flow – in case of quality problems, damage and/or expiration – should

already be taken into account during the procurement phase;

- All items should have not only technical specifications, but also quality indicators/specifications.

Transport:

- Again a range of actors will be involved in the transport element, possibly cross-border and

making use of a range of transport methods, and roles, responsibilities and specific quality and

handling requirements in line with GDP / GTDP standards20 should be clear to all actors involved;

- Transport must take place in line with international and national regulations, e.g. International

Air Transport Association (IATA) regulations and regulations for controlled substances21;

- Roles, responsibilities and quality assurance regarding the handling of goods during stevedoring

and cross-docking activities should be clearly defined.

Warehousing and inventory:

- Warehousing and inventories can take place at various stages in the supply chain, within or

outside the scope of the humanitarian organization implementing or taking part in a medical

intervention. Rules and regulations for the inspection, quality control and handling should be

the same for all warehousing environments, irrespective of the actor managing it, in line with

GSP standards22 and clear minimum standards should be put in place;

- Clear quality management procedures should be put in place with specific damage reporting and

quality problem reporting formats.

20

EC 1994; PAHO 2001; WHO 2003A; WHO 2005; Pomatto and Schuftan 2006; WHO 2007 and 2010A; USAID 2011; MSH 2012; EC 2013.

21 UN 1971, 1988 and 2001; INCB 2008;IATA 2013.

22 PAHO 2001; WHO 2003B; Pomatto and Schuftan 2006; WHO 1020C; USAID 2011; MSH 2012.

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5. Humanitarian response phases and quality assurance

Going back to Figure 1 in the introduction, on the humanitarian response phases, corresponding

medical procurement and supply chain management actions per phase are visualized in Figure 3 and

further explained below.

Figure 3: Humanitarian response phases and medical procurement actions

Developmental programmes: With a certain demand and low responsiveness need, the focus is on

essential medicines; open tendering for both medical procurement and order transport – from

suppliers in stringently regulated countries or medical HPCs. International transport will be mainly by

sea, if applicable.

Disaster risk reduction / preparedness: The focus is on capacity development, supporting the

government in adjusting the essential medicines list and streamlining its medical logistics and

preparedness, focus on open tenders and development of blanket purchasing agreements, pre-

positioning of emergency medical stocks and transport will be mainly by sea, if applicable.

Emergency response: Focus on the use of emergency health kits, possibly as implementing partner in

a coordinated response, most items come from pre-positioned stocks and the focus is on high

responsiveness and as such air transport is the main mode of transport.

Transitional programmes: Move from the ordering / use of emergency health kits to essential

medicines from suppliers in stringently regulated countries and/or medical HPCs, calling from partly

pre-positioned goods under blanket purchasing agreements. Transport will be a combination of air

and sea transport, as far as applicable.

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6. Concluding

Quality assurance in humanitarian medical supply chains demands a coordinated multi-stakeholder

approach, currently already reflected in the inclusive way in which good practice standards are

developed, adapted and implemented by the WHO, UN, RCRC, EC, INGO stakeholders, governmental

and commercial partners.

Although ownership, alignment, harmonization, results-oriented management and mutual

accountability are the five pillars of the Paris Declaration of Aid Effectiveness23, which inspired the

International Health Partnership (IHP+) focusing on the health-related Millennium Development

Goals (MDGs), this has not yet resulted in a concerted humanitarian supply chain wide approach to

quality assurance and related management of humanitarian medical supply chains.

One solution might be the integration of current medical Humanitarian Procurement Centres

(HPCs)24 in the IHP+ to guarantee their adherence to all medical good practice standards, a higher

level of coordination between HPCs and provision of services by all stakeholders under IHP+ that go

beyond their internal medical supply chain and current level of service, ie. supply of trainers, quality

assessors, emergency pharmacists, etc. Another solution might be to only accept humanitarian

actors in humanitarian medical interventions – or in any type of humanitarian intervention as such –

who can prove a minimum level of quality assurance in their work processes and outputs. This would

also make sense to curtail the uncontrollable flood of humanitarian initiatives after a disaster.

23

OECD 2008.

24 http://ec.europa.eu/echo/files/partners/humanitarian_aid/HPC-register_en.pdf [Accessed 30 June 2013].

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