4 July 2019

EMA/632473/2018

Good practice guidance for communication to the public

on medicines’ availability issues
Recommendations for EU national competent authorities and EMA to ensure
adequate public information

1. Introduction

Medicine shortages or problems relating to the availability of medicines are a multifactorial problem
involving a wide range of stakeholders, from patients and animal owners to the pharmaceutical
industry. In addition to measures to improve reporting and management of availability problems,
measures aimed at improving communication of such issues to the public play an important role in
minimising their potential impact. There is also a need for more systematic involvement and
interaction with stakeholders, especially on issues with potential impact on patients. Timely and
comprehensive information is necessary to ensure planning, rationing of existing stocks and prevention
of stockpiling. Advice to healthcare professionals and patients on potential alternative medicinal
products is often needed. This approach to communicating shortages would also help to maintain and
improve trust in the regulatory system.

Most shortages and availability problems are managed at national level; some are managed at EU
level. Processes for communication to the public are already in place at EU and national level, however
communication practices vary amongst member states and there is a need to review and consolidate
existing practices into a single document providing clear and harmonised guidance to EU national
competent authorities and EMA, promoting good practices and improving EU coordination.

1.1. Purpose of the document

This document provides EU national competent authorities and EMA with key principles and examples
of good practices for communication to the public on shortages for human and veterinary medicines as
well as availability issues due to revocations or cessations of marketing authorisations. The document
is intended for guidance only. Implementation should be a matter for EMA and EU national competent
authorities taking into account available resources and the communication needs within their territory.

EMA/632473/2018 Page 1/15

It aims to promote good practice by:

• Enhancing current communication to the public and ensuring a multidisciplinary approach within
regulatory authorities;

• Aligning criteria for publication across the EU network;

• Increasing visibility and accessibility of information on the availability on medicines;

• Fostering interaction with stakeholders.

This document is based on the results of a survey of all EU member states carried out by the HMA-EMA
task force to collect information on how issues related to shortages and availability of medicines are
measured and communicated to the public.

The guidance addresses the following areas:

• Who should communicate

• Who is the target audience

• Which format or tools

• What information to be published

• When to publish

• How to involve stakeholders in the preparation and dissemination of information

• Internal collaboration

• Examples of communication to the public and interaction with stakeholders

Shortages referred to in this guidance are to be understood in the context of the harmonised definition
agreed by EMA-HMA in the “Guidance on detection and notification of shortages of medicinal products
for Marketing Authorisation Holders (MAHs) in the Union (EEA)”:

‘A shortage of a medicinal product for human or veterinary use occurs when supply does not meet
demand at a national level’.

The definition applies to all shortages that are already affecting or that are expected to affect one or
more EU member states in the future.

It applies to prescription and non-prescription medicines alike.

1.2. Key recommendations for good practice on publication of information

on availability issues

The below recommendations have been drawn up based on the results of the survey on existing
practices in member states and take into account the outcome of the workshop held at EMA in
November 2018 where stakeholders raised transparency and visibility of availability issues as crucial
elements for good shortage management. The recommendations also draw on EMA’s experience in
publishing information, which has been well established for medicine shortages affecting more than
one member state where an assessment and recommendations are made at EU-wide level. 1

1
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/medicine-shortages/shortages-catalogue

EMA/632473/2018 Page 2/15

Potential negative effects that could follow communication such as stockpiling need to be considered
when communicating and choosing the optimal timing and level of visibility are important to minimise
this risk.

It is recommended that information on shortages should be kept separate from information on

revocations and cessations of marketing authorisations. This will allow distinguishing between the
permanent disruption in the case of cessations and revocations of marketing authorisations and
temporary supply disruptions in the case of shortages. However it is recommended that this
information should be easily accessible and interlinked.

Key recommendations for shortages

Criteria for national • shortages of medicines within their territory (nationwide issues rather
competent authorities
than local issues). Ideally competent authorities should not apply
to make information
publicly available selection criteria for publication and should communicate on all
shortages occurring nationwide. In some instances, this communication
may complement information issued centrally by EMA.

Criteria for EMA to • shortages of medicines (that are centrally or nationally authorised)
make information
where the shortage affects more than one member state and EMA’s
publicly available
scientific committees have given recommendations to healthcare
professionals (a DHPC).

Format and tools • EU national competent authorities and EMA should use a
systematic listing (usually in the form of a catalogue, one for human
medicines and one for veterinary medicines) to communicate on
shortages.

• For shortages with a high impact on patients or animals, consideration

should be given to using high-profile communication tools (i.e. press
release) in addition to systematic listing in the catalogue.

• Regardless of the tools used, all shortages issues should be easily

accessible on a webpage of the regulatory authority.

• The content of the catalogue should be easily searchable. Non-machine

readable data formats (such as PDFs) are not recommended and
should be avoided as far as possible. Providing colour-coded or symbol-
differentiated information for shortages could help to distinguish
between different shortage situations (indicating impact and status of
supply situation).

• The use of electronic Product Information (ePI), once this is

implemented across the EU, will offer opportunities to better
communicate information on shortages in a timely and targeted
manner.

Information to be Details of medicine • Trade name

published in the
• Active ingredient (INN)
catalogue
• Pharmaceutical form and strength

• MAH

EMA/632473/2018 Page 3/15

 Key recommendations for shortages

• For veterinary medicines the species

Details on shortage • Date of the beginning of the shortage

(may be anticipated date) or availability
issue

• Expected end date of the shortage, if

applicable

• Reason for shortage and actions taken

to mitigate shortage

If applicable, advice for • Potential alternative medicinal products,

healthcare professionals if applicable, which may include
patients, veterinarians or imported medicines
animal keepers
• Recommendations for change in clinical
practice/ change in use of medicine/ use
of a suitable alternative

Updates to current status of • Updates should be issued to reflect

shortage resolution or any change in
recommendations, if applicable

Timing of publication • Publication should occur once the shortage has been confirmed by the
marketing authorisation holder for the affected medicine and, if
applicable, recommendations have been agreed. The exact timing may
be determined at national level taking into account national
requirements. However, early communication to the public is
encouraged and important to allow for adequate planning and to
ensure continuity of care.

• Updates should be issued to reflect any relevant change in the situation

including recommendations. For supply situations that have been
resolved, this should be reflected as soon as the notification from the
marketing authorisation holder has been received that the shortage is
resolved. Once a shortage is declared as resolved, there may be a
delay before supplies are fully re-established and it is recommended
that a disclaimer is included to explain this in shortages
communications.

• A record of supply problems that have been resolved should be kept for
a set period of time, i.e. at least 6 months.

Audience • Primarily healthcare professionals and patients, or veterinarians and

animal owners.

• Other regulators and industry (including wholesale distributors).

To address this wide audience, the language used in any communication

should be public friendly, concise and should use lay terms.

EMA/632473/2018 Page 4/15

 Key recommendations for shortages

Collaboration with • EU national competent authorities and EMA should consider involving
stakeholders relevant stakeholder groups (in particular patients’, consumer and
healthcare professional organisations) on availability issues, especially
in those with higher potential impact on patient care. Wholesale
distributors may also be involved for questions on sourcing of
medicines. Involvement should aim at obtaining advice and feed-back
on potential suitable alternatives and recommendations, if applicable,
as well as feedback on whether key messages are well communicated
and how to ensure adequate dissemination.

• EU national competent authorities and EMA should consider sharing the

final communication with marketing authorisation holders for
information.

• EU national competent authorities and EMA should explore ways to

multiply their communication through relevant organisations’ channels
(patients, healthcare professionals, consumer organisations, animal
owners, veterinarians), learned societies, professional/medical journals,
media (press, TV), newsletters, and potentially electronic prescribing
systems (enabling the electronic generation, transmission, and filling of
a medical prescription). To increase visibility and knowledge about
shortage catalogues, communication campaigns may be considered at
national level.

Internal collaboration • For the assessment and communication of shortages, advice and
within the network consultation may be sought where needed from the Single Point of
Contact (SPOC) network. 2

• Ideally, communication staff within EU national competent authorities

or EMA should be involved in the drafting of relevant communication.

Key recommendations for other availability issues

Criteria for national • revocations or suspensions of marketing authorisations within their
competent authorities
territory.
to make information
publicly available
• relevant cessations of marketing authorisations in their territory.
For medicines, where the cessation of marketing authorisation is due to
commercial reasons and other generic options remain on the market,
the inclusion into the catalogue is optional.

Criteria for EMA to • revocation or suspension of centrally and nationally authorised

make information
medicines.
publicly available

2
Single Point of Contacts (SPOC) are contact points at each human and veterinary medicines regulatory agency in the
EU/EEA responsible for sharing information with other SPOCs and coordinating subsequent actions in relation to shortages
and availability of authorised medicines. They have been nominated by the Task Force on Medicines Availability with the
aim to facilitate better prevention, identification, management and communication of shortages and availability issues.

EMA/632473/2018 Page 5/15

 Key recommendations for other availability issues

• cessations of marketing authorisations for centrally authorised

medicines.

Format and tools • EU national competent authorities and EMA should use a
systematic listing (usually in the form of a catalogue, one for human
medicines and one for veterinary medicines) to communicate on other
availability issues.

• For other availability issues with a high impact on patients or animals,

consideration should be given to using high-profile communication tools
(i.e. press release) in addition to systematic listing in the catalogue.

Information to be Details of medicine • Trade name

published in the
• Active ingredient (INN)
catalogue
• Pharmaceutical form and strength

• MAH

• For veterinary medicines the species

Details on availability issue • Date of the beginning of the cessation

or revocation

• Reason for availability issue

If applicable, advice for • Potential suitable alternatives, if

healthcare professionals applicable
patients, veterinarians or
• Recommendations for change in
animal keepers
clinical practice/ change in use of
medicine/ use of suitable alternatives

Timing of publication • For suspensions and revocations of marketing authorisations:

− Publication as soon as the suspension or revocation has been

recommended, and recommendations (if applicable) have been
agreed.

− Updates to reflect any change in recommendations, if applicable.

• For relevant cessations of marketing authorisations: publication at

time of cessation.

• It is good practice to keep a public record for at least 6 months.

Audience See recommendations for shortages

Collaboration with See recommendations for shortages

stakeholders

Internal collaboration See recommendations for shortages

within the network

EMA/632473/2018 Page 6/15

2. Annex I. Full analysis

In May 2018, EMA and HMA carried out a survey to map public communication on shortages and
availability of human medicines 3 by EU regulators. The purpose was to assess, qualitatively and
quantitatively, how EU regulators communicate to the public on shortages and supply issues.

The results of the survey build on existing knowledge on communication practices gained from
previous work which led to the development of EMA’s public catalogue on shortages.

The survey comprised a questionnaire with 7 questions on the public communication practices in
individual EU member States.

The questionnaire focused on public communication activities to the general public, mainly in relation
to shortages.

The survey was sent to the Single Point of Contact (SPOC) nominated for human and veterinary
medicines at the relevant regulatory authority for each Member state.

For human medicines, the survey was sent to 33 SPOCs (28 EU Member states, including 2 SPOCs for
Germany to cover the two regulatory agencies (BfArM and PEI), including EMA and 3 for EEA). Of
these, 30 responded. The response rate was 90%.

For veterinary medicines, the survey was sent to 30 SPOCs and 27 responded. The response rate was
90%.

The survey found the following results:

• For human medicines a majority (87%) of EU regulatory authorities (national competent

authorities and EMA) already publish information on shortages on their website.

• Amongst the authorities that publish information, a majority (69%) do not have set criteria for
publication and publish on any shortage that is reported. Only selected member states have criteria
for publication based on the duration of the shortage and the criticality of the medicine.

• Most authorities also communicate on other issues such as revocation or suspension of medicines
(50%) or withdrawals of medicines due to commercial reasons (70%). However this information is
not necessarily reflected in the listing of shortages and various other communication tools may be
used (such as press releases for individual availability issues).

• Globally, a similar picture for human medicines can be seen as in the EU. In the USA, the
Association of Health System Pharmacists and the Food and Drug Administration publish a web
listing of medicine shortages.4,5 Both listings include information on current and resolved shortages
as well as other information for patients and consumers. The websites contain concise information
on products affected by the shortage, the reason for the shortage, suitable alternatives and the
expected resolution date. The information on the FDA website covers ‘medically necessary’
medicines as well as those considered non-medically necessary for which the FDA has received
multiple requests for information. However it does not include information on shortages of brief
duration.

• For veterinary medicines, the picture is similar with fewer EU regulatory authorities publishing
information with only 52% publishing information on shortages on their website.

3
This guidance applies only to human medicines at present, however a similar approach will be taken to address veterinary
medicines.
4
http://www.ashp.org/menu/DrugShortages/CurrentShortages.aspx
5
https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages

EMA/632473/2018 Page 7/15

Based on the analysis of the survey results the following key areas for communication on availability
have been identified:

Key recommendations

Public communication should be considered for

• any shortage of a medicine that affects the whole country (nationwide issues rather than local
issues).

• revocations or suspensions of medicines.

• cessations of marketing authorisations. For cessation of marketing authorisations due to

commercial reasons, information may be less relevant for stakeholders as these medicines can
usually be substituted.

2.1. Which format and tools?

The survey found the following results for the formats and tools used by regulatory authorities:

• For human medicines, 88% of authorities who already publish information on availability issues,
usually do this in the form of a systematic listing, i.e. a catalogue format. The majority of
authorities (69%) do not have set criteria for publication and publish all reported shortages. Only
selected member states have criteria for publication related to the duration of the shortage and the
criticality of the medicine.

• In addition to the shortage catalogue EU regulatory authorities (national competent authorities and
EMA) use a variety of communication tools to inform on availability issues: Press releases (57%),
newsletters (30%) and social media (23%).

• For veterinary medicines, the proportion of authorities that use a catalogue listing is 64%. Most of
those (64%) do not use any selection criteria when publishing information. Communication tools
used by veterinary regulatory authorities are press releases professional organisations and
professional journals.

A catalogue listing is ideal for providing information on shortages as it allows quick one-stop
referencing and is ideal for stakeholders looking for specific information. Presentation of information
can be in summarised in bullet-point format and colour coded to highlight new and more relevant
shortages.

It is envisaged that in the future a single portal will give access to all information on availability issues
from EU regulatory authorities. While the single portal is being built, as an interim solution, both the
HMA webpage (https://www.hma.eu/598.html) and the EMA Webpage
(https://www.ema.europa.eu/en/human-regulatory/post-authorisation/medicine-shortages/shortages-
catalogue) provide a listing of links to national shortage catalogues.

EMA/632473/2018 Page 8/15

Key recommendations

EU national competent authorities should use a systematic listing in a catalogue to communicate

on the following issues:

• shortages of medicines affecting the country. In some instances this communication complements
information issued centrally by EMA. Ideally regulatory authorities should not apply selection
criteria for publication and should communicate on any nationwide shortage (as per the agreed
EMA-HMA definition).

• revocations or suspensions of medicines within their territory.

• cessations of marketing authorisations in their territory. For cessation of marketing authorisations

due to commercial reasons, this should be decided at national level depending on the relevance to
stakeholders (especially for generics where there may be many other generic alternatives).

EMA should use a systematic listing in a catalogue to communicate on the following issues:

• shortages of medicines (centrally or nationally authorised) where the shortage affects more than
one member state and EMA’s scientific committee has given recommendations (a DHPC).

• revocations or suspensions of centrally and nationally authorised medicines.

• cessations of marketing authorisations for centrally authorised medicines.

• For availability issues with a high impact on patients or animals, EU national competent authorities
and EMA should consider using additional communication tools (press releases, newsletter or social
media) and reflect the information on the homepage. High-patient impact is usually associated
with safety-related issues or unavailability of a critical medicine.

• Regardless of the tools used, all availability issues should be accessible on a single webpage.

2.2. What information to publish

When the decision to publish a shortage in a catalogue has been made, the information to publish
should be brief, concise but sufficient for healthcare professionals and patients or veterinarians and
animal owners to identify the medicine involved and take the required actions. The information is
based on information published by those member states who already publish (see annex I) and is
summarised in the table below:

Table 1: Recommendations for publishing information on medicine’s availability issues

Information to publish in the catalogue

Details of medicine • Trade name

• Active ingredient (INN)

• Pharmaceutical form and strength

• MAH

• For veterinary medicines the species should be specified

Details on availability • Date of the beginning of the shortage (may be anticipated

issue/shortage date) or availability issue

EMA/632473/2018 Page 9/15

 Information to publish in the catalogue

• For shortages, expected end date of the shortage

• Reason for availability issue or shortage

Advice for healthcare • Potential alternative medicinal products, if applicable

professionals/ patients, if
• Recommendations for change in clinical practice/ change in
applicable
use of medicine, if applicable

Updates to current status of • Updates to reflect resolution or any change in

availability issue/shortage recommendations, if applicable

2.3. When to publish

Communication to the public needs to be timely and up-to-date to ensure effective planning. The
survey found that:

• EU national competent authorities and EMA always update their published information on shortages,
as new information becomes available and when the shortage is resolved.

• In addition, some member states (35%) review their information at set time intervals (ranging
from daily to monthly).

• Once a shortage is resolved, most authorities remove the information (62%) and only 38% keep
this information on their website.

• For veterinary medicines, 71% of EU regulatory authorities also update their information as new
information becomes available. 27% review the information at set time intervals. Once a shortage
is resolved 57% of authorities remove the information from the website.

Key recommendations

• For shortages: publication should occur once the shortage has been confirmed by the MAH and
recommendations have been agreed (if applicable). The exact timing may be determined at
national level taking into account national requirements. Updates should be issued to reflect any
potential change in the recommendations. For supply situations that have been resolved this needs
to be reflected as soon as notification is received that the shortage is resolved. This could be by
updating the catalogue listing to mark the medicine as available again. It is good practice to keep a
record of supply problems that have been resolved for a set period of time, i.e. at least 6 months.

• For suspensions and revocations of marketing authorisations: publication should be as soon as

a recommendation for suspension or revocation has been given. Updates should be issued to
reflect any potential change in the recommendations.

• For relevant cessations of marketing authorisations: publication should be at time of cessation.

2.4. Who is the target audience

• For human medicines most EU national competent authorities and EMA mainly target healthcare
professionals (100%) and patients (92%) in communication. Industry and other regulators are also
targeted in 60% of the cases.

EMA/632473/2018 Page 10/15

• For veterinary medicines 93% target veterinarians and 64% are targeting animal owners.
Wholesalers are also targeted in 57% of the cases, industry and regulators less frequently (in 36%
and 43% of the cases).

• Healthcare professionals and patients, veterinarians and animal owners are the key audience who
require timely accurate and up-to-date information from public health authorities on availability
issues. This is particularly important as information from other sources on availability issues is
sparse and early knowledge is important to allow for early planning and adjustment of clinical
practice. Other regulators and industry (including wholesale distributors) are less often targeted
but would also benefit from early information.

Key recommendations

• Public communication by EU national competent authorities and EMA should primarily target
patients and healthcare professionals for human medicines and veterinarians and animal owners
for veterinary medicines.

• Other regulators and industry (including wholesale distributors) should also be targeted.

• To address this wide audience the language of any communication should be public friendly,
concise and using lay terms.

2.5. Other communication tools used and how to involve stakeholders in

the preparation and dissemination of information

It is important to involve stakeholders in the preparation of public communication documents to

address their concerns and information needs.

The survey found that:

• For human medicines 54% of authorities who communicate on availability issues overall also
engage with their target audience in their communication. For veterinary medicines it is only 26%
who engage with their target audience. In both cases, it is not clear whether this is seeking active
advice or rather for dissemination only.

• EU national competent authorities and EMA use a variety of communication tools to disseminate
information on availability issues: Communication through relevant organisations’ channels
(patients, consumers, healthcare professionals or learned societies) (63% for human medicines
and 48 % for veterinary medicines), press releases (57% and 48% for veterinary medicines),
professional/medical journals (57% for human medicines and 48% for veterinary medicines),
media (press, TV) (33% for human medicines and 30% for veterinary medicines), newsletters
(30% for human medicines and 20% for veterinary medicines), social media (23% for human
medicines and 26% for veterinary medicines).

Some EU authorities feed information about shortages into the national electronic patient health
systems (EMR) and electronic prescribing systems (7% for human medicines and 11% for
veterinary medicines). Thus, healthcare professionals and veterinarians will get instant alerts
about shortages when prescribing or dispensing the medicine in question.

EMA/632473/2018 Page 11/15

Key recommendations

• EU national competent authorities and EMA should consider involving relevant stakeholder groups
(patients, consumers and healthcare professional organisations) on availability issues especially in
those with higher potential impact on patient care.

• Wholesale distributors may also be involved for questions on sourcing of medicines. Involvement
should aim at obtaining advice and feed-back on potential suitable alternatives and
recommendations when applicable as well as for ensuring that the key messages are well
communicated and ensuring adequate dissemination.

• EU national competent authorities and EMA should consider sharing the final public communication
for information with marketing authorisation holders for information.

• EU national competent authorities and EMA should explore ways to multiply their communication
through relevant organisations’ channels (patients, consumers, animal owners, veterinarians,
healthcare professionals or learned societies), professional/medical journals, media (press, TV),
newsletters, and potentially electronic prescribing systems. Other means to explore to interlink
shortage information could be electronic product information.

2.6. Internal collaboration

The survey found that most communication materials are prepared by the departments involved in the
assessment of the availability issue (i.e. inspection) but often also involve communication colleagues
(57% for human medicines, 30% for veterinary medicines).

As an outcome of this review it is recommended to systematically consider involvement of

communication staff in the drafting of relevant communication to ensure that it fulfils the needs of the
target audience.

In addition during the assessment and communication of a shortage member states should seek advice
and consultation where needed using the the Single Point of Contact (SPOC) network.

2.7. Examples of public communication and interaction with stakeholders

Based on the survey feedback, the following initiatives were identified in selected EU member states as
examples of public communication and collaboration which could potentially be implemented in other
member states:

• A monthly newsletter highlighting new and relevant availability issues

• Involving stakeholders i.e. in disseminating information on shortages

• Alerts (pop-ups) on shortages in electronic patient records and electronic prescription systems to
alert doctors and pharmacists at the point of prescribing or dispensing the medicine in question.

• Collaboration with the most commonly used sources of medicinal product information among
healthcare professionals (i.e. electronic pharmaceutical compendiums). In some countries
compendiums publish real-time alerts on important safety issues, shortage situations etc.,
providing instant information for the patient or physician.

EMA/632473/2018 Page 12/15

2.8. Review

It is proposed that public communication practices in EU member states on availability issues will be
reviewed regularly and this guidance will be updated accordingly and as needed.

EMA/632473/2018 Page 13/15

 3. Annex II. Information currently provided in shortage catalogues

Table 1: Information provided in shortage catalogues for human medicines by individual EU authorities

Estimated Alternatives Alternatives

Active Start
Trade Pharmaceutical Cause of end date available, available,
EU authority ingredient Strength MAH date of Other
name form shortage of without with
(INN) shortage
shortage details details

Austria X X X X X X X X X

Belgium X X X X X X X X

Bulgaria X X X X X X X

Croatia X X X X X X X X X

Czech Republic X X X X X

Denmark X X X X X X X

Estonia X X X X X X

Finland X X X X X X X

Germany (PEI) X X X X X X X X X

Germany (BfArM) X X X X X X X X X X X

Greece X X X X X X X X

Hungary X X X X X X X X X

Iceland X X X X X X

Italy X X X X X X X X X X

Latvia X X X X X X X

Lithuania X X X X X X X X X X

Netherlands X

Norway X X X X X X X X X X

Romania X X X X X X X X

Slovak Republic X X X X X X X

Slovenia X X X X X

Spain X X X X X X X X

Sweden X X X X X X X X X

EMA X X X X X X X X

EMA/632473/2018 Page 14/15

 Table 2: Information provided in shortage catalogues for veterinary medicines by individual EU
authorities

Estimated Alternatives Alternatives

Active Start
Trade Pharmaceutical Cause of end date available, available,
EU authority ingredient Strength Species MAH date of Other
name form shortage of without with
(INN) shortage
shortage details details

Austria X X X X X X X

Belgium X X X X X X X X X

Denmark X X X X X X X

Estonia X X X X X X

Finland X X X X X X

Germany
X X X X
(PEI)

Greece X X X X X X X

Liechtenstein X X X

Norway X X X X X X X X X X

Slovenia X X X X X

Spain X X

Sweden X X X X X X X

UK X X X X X X

EMA/632473/2018 Page 15/15