Updating National Essential Medicine Lists

A Step-by-Step Advocacy Guide

ACKNOWLEDGMENTS
This guide has been developed with financial support from the UN Commission on Life-Saving
Commodities for Women and Children (UNCOLSC), and in consultation with the UNCOLSC’s
Maternal Health Technical Reference Team. Support for copy-editing and design was provided
by USAID’s Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program.
Management Sciences for Health (MSH) would like to thank the individuals and organizations
for their valuable contributions. In particular, we are grateful for technical review and input from
Deborah Armbruster (USAID), Kabir Ahmed (UNFPA), Ashley Latimer (PATH), Laura Frye and
Jill Durocher (Gynuity Health Projects), and Nancy Goh (Clinton Health Access Initiative). We
hope this guide provides information that can be used by country stakeholders to take action to
improve the availability, affordability, quality, and use of essential medicines.

ACRONYMS AND ABBREVIATIONS

EML Essential Medicines List

MOH Ministry of Health

RMNCH Reproductive, Maternal, Newborn, and Child Health

UNCOLSC UN Commission on Life-Saving Commodities for Women And Children

USAID United States Agency for International Development

WHO World Health Organization

Shafia Rashid | August 2016

© Management Sciences for Health, 2016.

Updating National Essential Medicine Lists: A Step-by-Step Advocacy Guide 2

BACKGROUND
In 2012, the UN Commission on Life-Saving Commodities for Women and Children (UNCOLSC)
identified 13 overlooked reproductive, maternal, newborn, and child health (RMNCH)
commodities1 for safeguarding the health and well-being of the world’s women, newborns, and
children. According to the Commission, if these 13 commodities were more widely available and
properly used, they could save the lives of more than 6 million women and children per year
(UNCOLSC, 2012). The UNCOLSC identified key areas of action to ensure their widespread
availability and use in low- and middle-income countries. One priority area is ensuring these
commodities are included in national essential medicines lists (EMLs), as one step towards
ensuring their availability in the public health sector.

In some countries, national EMLs are not regularly updated and do not include key RMNCH
commodities—even when there is a solid evidence base for their effectiveness and safety. An
analysis in 2012 (Hill et al, 2012) showed that essential medicines for women and children are
not universally listed in national EMLs. For example, magnesium sulfate—a medicine proven
effective in preventing pre-eclampsia and treating eclampsia—appeared on the essential
medicines lists of only 50% of countries surveyed.

The World Health Organization (WHO) defines essential medicines as those that meet the
priority health needs of a given population. These medicines are identified as essential because
they meet specific criteria, including:

 Relevance to public health/prevalence of disease

 Evidence of efficacy and safety
 Costs and cost-effectiveness

According to WHO, essential medicines must be available “at all times in adequate amounts, in
the appropriate dosage forms, with assured quality, and at a price the individual and the
community can afford.” (WHO, 2015) The WHO developed its Model List of Essential Medicines
to guide national governments in selecting those medicines and technologies that best address
public health needs. Every two years, WHO convenes an expert committee to update the model
list to review new evidence and developments in relation to medicines that will best address
public health needs The WHO Model List forms the basis of national medicine policy in many
countries, and governments often refer to WHO recommendations when making decisions on
which medicines to prioritize in their national lists (IMS Institute for Healthcare Informatics,
2015).

A country’s national EML is a selective list of medicines and technologies approved by the
government for use in the public health sector (IMS, 2015). National EMLs are often used by
governments to guide purchase of priority health commodities. Some countries have also
adopted EMLs at a sub-national or state/province level as part of decentralizing health services.
Together with standard treatment guidelines, EMLs often serve as the basis for education and
training for health providers and for educating the public about the use of medicines and
technologies (PATH, 2006). A country’s EML reflects a government’s commitment to ensuring

1The 13 commodities include emergency contraceptive pills, female condoms, and contraceptive implants; oxytocin,
misoprostol, and magnesium sulfate; antenatal corticosteroids, chlorhexidine, injectable antibiotics, and resuscitation
equipment; amoxicillin, oral rehydration salts, and zinc.

Updating National Essential Medicine Lists: A Step-by-Step Advocacy Guide 3

that quality health commodities are available and accessible to the population, and can serve an
important tool for advocacy.

An EML review committee, most often appointed by the ministry of health (MOH), is responsible
for identifying which commodities to add to (or remove from) the national EML. The committee
members include representatives from procurement and supply chain, public health, and
medicine (PATH, 2006). WHO recommends that the EML, along with standard treatment
guidelines and the national formulary, be regularly updated (at least every other year) and that
there be regular monitoring to assess availability and use of essential commodities (PATH,
2006).

PURPOSE OF THIS GUIDE

This guide provides national stakeholders and advocates with information and guidance to
update the national EML to include a new commodity, a new indication, or a new formulation
based on the available evidence and based on country need and disease burden. While the
actors, timeline, and process may vary from country to country, this guide presents the broad
steps involved in revising an EML for any health commodity. Additional resources and a
glossary are included to provide supplemental information and to clarify key terms.

Updating National Essential Medicine Lists: A Step-by-Step Advocacy Guide 4

STEPS FOR UPDATING EML

1
Obtain a copy of the most recent EML.
Country EMLs can be accessed through the WHO website:
http://www.who.int/selection_medicines/country_lists/en/. Confirm that this is the
latest version. You may need to contact the Ministry of Health to obtain the most
recent version of the EML.

Confirm whether the commodities of interest are included, and determine if a

specific medical indication is identified. Often commodities are listed in the EML
without a specified indication. In these cases, it may be helpful that any update of
the EML include the evidence-based indication(s) that is most relevant based on
a country’s disease burden.

2
Coordinate and work with partners in-country.
Identify the key partners who could contribute to the EML review by providing
support, additional knowledge and resources, and credibility and influence

Specify the partner who will take the lead in gathering information, and meeting
with key officials and EML review committee members.

3
Determine the process for updating the EML.
Identify and meet with key officials and decision makers who are part of the EML
review committee, and who make decisions regarding the update.

Ascertain the timing and timeframe for the next EML update. EMLs should be
updated regularly and the timing is often determined by the EML committee.

Determine requirements and process for the addition of new commodities (or a
change in formulation or indication) to the national EML.

Updating National Essential Medicine Lists: A Step-by-Step Advocacy Guide 5

 4
Gather research and evidence needed for submission/request to the
EML review committee.
This may include:

Identify the commodity’s International Nonproprietary Name (INN) (also known as

the generic name). The INN identifies the active pharmaceutical ingredient that is
globally recognized and is public property as well as other names available in the
market. A listing of INNs is available:
http://www.who.int/medicines/services/inn/en/

Identify the clinical condition for which the commodity is intended to diagnose,
treat, or improve upon. Some medicines can have more than one indication,
which means that the medicine can be used to address more than one disease
or illness.

Specify the burden of disease, either at the global level or in the national context,
related to the clinical condition.

Provide the dosage, route of administration, and formulation based on current

evidence and global recommendations. If applicable, use the World Health
Organization (WHO) Model Essential Medicines List to develop these
recommendations.

Provide clinical and programmatic evidence (from research studies, clinical trials
or other sources) which support the use of the commodity for the given
indication.

Evidence is required in support of a commodity’s:

 Relative efficacy
 Relative safety
 Acceptability among the target population
 Relative cost (compared to a medicine already listed for the same
indication)

Evidence can include global, regional or local data from:

 Literature reviews
 Published systematic reviews
 Single articles concerning randomized controlled trials
 Case reports
 Observational studies
 Global recommendations
 Policies and guidelines, for example the 19th WHO Model List of
Essential Medicines (April 2015)

Updating National Essential Medicine Lists: A Step-by-Step Advocacy Guide 6

 5
Compile a dossier of the available evidence, based on the requirements
of the EML review committee, and submit to the committee, based on
the deadline set.

6
In coordination with the EML committee and MOH stakeholders, develop
a dissemination plan to share the outcomes and decisions of the EML
committee.
Once the EML is updated, share it widely with key stakeholders, including
ministry of health officials, procurement officers, national health professional
associations, and health care providers, among others, in printed and electronic
formats. Dissemination plans can include an official launch event, media
coverage, and sub-national meetings to share the outcomes with provincial- and
district-level health teams. Ensure that the EML is published on a public web site.

Develop a brochure or pamphlet, in printed and electronic format, to summarize

relevant information that can be shared with a wide audience

7
Follow-up through ongoing monitoring and evaluation to ensure that
EML updates are fully implemented and leads to the availability and use
of the commodity(ies).
Specifically, ensure that:

National procurement authorities take steps to ensure that the commodity is

procured in the right dosage and formulation based on the indication(s) specified in
the EML

National resource allocations support the right amount of quantities needed for
the indication(s) and regimen specified

Standard treatment guidelines and pre- and in-service training curricula reflect
the updated national EML (if needed)

Health care workers are trained on proper use.

Updating National Essential Medicine Lists: A Step-by-Step Advocacy Guide 7

CONCLUSION
National EMLs often specify which commodities the public health sector will procure for use in
the health system. EMLs are used by governments to purchase and distribute priority health
commodities, and they can also help in identifying quality assured and cost-effective products.
However, country-level EMLs are not always regularly updated with newer or less well-known
technologies, even though these products have been included on the WHO Model EML.
Concerted effort by many partners is needed to ensure that national EMLs are revised
periodically to reflect emerging health priorities, and to reflect updates in the evidence.

Beyond the national EML itself, advocacy is required to ensure that countries are indeed
providing a reliable, high-quality supply of key health commodities. Work on EMLs is a starting
point that needs to be linked with other efforts, including sound supply chains, training, and on-
going monitoring and evaluation.

GLOSSARY
Dosage The amount of a medicine that should be taken during a specific
period of time.

Formulation The specific state (solid, semisolid or liquid) in which a medicine

is supplied to a patient.

International Identifies the active pharmaceutical ingredient, also known as a

Nonproprietary Name generic name.

National Formulary Manual containing pharmacological information about selected

medicines and commodities. In some countries the national EML
and formulary are identical.

Quality-assured A range of factors (including development, quality control,

production, distribution, and inspections) that determine the
quality of a product.

Standard Treatment A set of written standards systematically developed and designed

Guidelines to assist health providers and patients in making decisions about
appropriate care for specific clinical conditions.

Systematic review A review of the evidence to identify, select, and critically appraise
primary research.

Updating National Essential Medicine Lists: A Step-by-Step Advocacy Guide 8

ADDITIONAL RESOURCES: FOR MORE INFORMATION
Searchable Database of national EMLs for 13 Essential Medicines for Reproductive Health:
New or Underutilized Family Planning and Guiding Principles for Their Inclusion on
Maternal Health Commodities National Medicines Lists. PATH, the World
Health Organization, and the United Nations
WHO List of Country Essential Medicine Lists Population Fund. Seattle: 2006.
World Health Organization Global Essential How to develop a National Essential
Medicine List (updated: April 2015) Medicines List (WHO, 2011).
Case studies of successful changes to EML: Systems for Improved Access to
Pharmaceuticals and Services (SIAPS)
 Burkina Faso: Advocacy success
Program. 2013 Supporting the Development
story: Burkina Faso broadens access
and Implementation of Essential Medicines
to misoprostol, an essential maternal
Lists. flyer.
health medicine
 Pakistan: Building the Momentum: Understanding the Role and Use of Essential
Misoprostol for Postpartum Medicines Lists . Report by the IMS Institute
Hemorrhage in Pakistan for Healthcare Informatics. April 2015.
 Malawi: Increasing access to key
reproductive health and newborn WHO Essential Medicines and Health
commodities in Malawi Products Information Portal.

REFERENCES
Hill S, Yang A, Bero L. 2012. Priority Medicines for Maternal and Child Health: A Global Survey
of National Essential Medicines Lists. PLoS ONE 7(5): e38055.
doi:10.1371/journal.pone.0038055

IMS Institute for Healthcare Informatics. Understanding the Role and Use of Essential
Medicines Lists. Parsippany, NJ; IMS: 2015.

PATH, World Health Organization, United Nations Population Fund. Essential Medicines for
Reproductive Health: Guiding Principles for Their Inclusion on National Medicines Lists. Seattle:
PATH; 2006.

United Nations Commission on Life-Saving Commodities for Women and Children.

Commissioners’ Report. New York, NY: the Commission; 2012.

WHO. Definition of essential medicines. 19th edition. WHO; 2015.

http://www.who.int/medicines/services/essmedicines_def/en/.

Updating National Essential Medicine Lists: A Step-by-Step Advocacy Guide 9