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PGEU GPUE
Pharmaceutical Group of European Union
Groupement Pharmaceutique de l’Union Européenne

Statement
Medicine Shortages in European
Community Pharmacies

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INTRODUCTION
Today, shortages of medicines are a worldwide problem. Shortages are occurring across the supply chain
and evidence suggests that the problem is getting worse. Persistent shortages of medicines are already
recognised as a public health problem1 which directly affects patient care.
The number of reports of medicine shortages in the EU is increasing2,3. All classes of medicines are
affected, from complex chemotherapy agents and anaesthetics to diabetes, hypertension, and asthma
medication. However, there is still very little reliable EU wide data available and therefore there is no
clear understanding of the scope and extent of the problem. Furthermore there is little understanding of
how medicine shortages affect community pharmacists and ultimately the patients they serve.
At the beginning of 2012, PGEU conducted a survey among its members, national community pharmacy
associations, in order to better understand the extent of medicine shortages in the EU. According to the
survey results, although some countries are more affected than others, medicine shortages have been
reported by all respondents to the survey and the problem is increasing. According to the survey, a broad
range of medicines is affected, including even basic medication such as aspirin4. The survey suggests that
the prevalence of medicine shortages has increased in the past year- just in the UK over 1 million
branded medicine supply failures occur each year5.
In response to the problem national authorities in a number of EU Member States have started
monitoring the situation and have set up websites for the public where information about current
shortages is available6,7. For example, KNMP, the national pharmacist association in the Netherlands has
established a website8 which informs pharmacists about the problem, the expected date of resuming
normal deliveries, alternatives on the market and the impact on the patient if alternatives are not
available.
CAUSES
What is causing the shortages? No single response exists. There are a number of reasons why some
medicines are sometimes unavailable. The medicines supply chain is highly complex and its efficiency
relies on the performance of each individual supply chain actor including raw material suppliers,
manufacturers, wholesalers, community pharmacies and intermediaries. If there is a disruption at any
point of the supply chain, shortages can occur.
Such disruptions can be caused by:
 The increasingly globalised nature of pharmaceutical manufacturing, with production concentrated
in fewer sites distributed around the world. This tendency can have a severe impact on production
1

http://www.npr.org/blogs/health/2011/11/14/142311786/drug-shortages-affect-more-than-half-a-million-cancer-patients
http://www.guardian.co.uk/world/2012/jun/08/greek-drug-shortage-worsens
3
http://www.dailymail.co.uk/news/article-2163593/NHS-drug-shortage-scandal-Patients-life-threatening-conditions-struggle-medicine.html
4
http://www.bloomberg.com/news/2012-01-10/greek-crisis-has-pharmacists-pleading-for-aspirin-as-drug-supply-dries-up.html
5
http://www.appg.org.uk/APPG%20Pharmacy%20-%20Report%20of%20Inquiry%20Into%20NHS%20Medicines%20Shortages.pdf
6
http://www.fagg-afmps.be/fr/items-HOME/indisponibilites_de_medicaments/
7
http://www.agenziafarmaco.gov.it/sites/default/files/elenco_dei_medicinali_carenti_22_marzo_2012.pdf
8
http://farmanco.knmp.nl
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capacity when for example, quality issues arise, or where there is difficulty in sourcing raw
materials.
Shifts in demand, resulting from longer term factors such as demographic change, but also short
term factors such as tendering of medicines leading to difficulties in proving sufficient quantities of
medicines for some markets.
Extreme cost-pressure on the supply chain, resulting in concentration of manufacturing capacity,
reduced stock-keeping.
In some cases, pricing strategies and regulatory changes may impact on supply.
The imposition of fixed quotas of medicines by the pharmaceutical industry, often inaccurately
judging the true level of patient needs as well as removal of traditional role of the full line
wholesalers as a result of DTP schemes in some markets.
The abolition of public service obligation /minimum national stock keeping requirements in some
countries.
The lack of priority given to smaller markets.
The effects of the European internal market (e.g. exports) and different medicine prices.

EFFECT ON COMMUNITY PHARMACY PRACTICE
Patients are the ones ultimately affected by medicine shortages. The unavailability of a medicine causes
unnecessary inconvenience and distress to the patient, but worse, may affect patient outcomes. If a
prescribed medicine is not available, the patient may be given an alternative, which in some cases is not
adequate and may be more expensive. Where there are no alternatives available, and the patient does
not receive his/her treatment, the outcome may be fatal. Ultimately, patients may lose confidence in
the health system. Some governments have allowed emergency importation of medicines from other
countries where there are no alternatives to medicines in short supply on the national market. However
this could ultimately create a shortage in the exporting country.
Shortages are of great concern to community pharmacists, and in some countries already affect our daily
practice. It is reported that in the UK, pharmacy staff spend an average of three hours each week
sourcing medicines which they are not able to order from their usual wholesaler9. This equates to 156
hours per UK pharmacy per year. Community pharmacists often turn to the national or regional
community pharmacy network to source medicines. Patients, who have been tradionally accustomed to
a highly reliable medicines supply in Europe, often have diffculty in understanding why a medicine is
unavailable, and can become distressed.
Time solving problems caused by shortages is time that could better spend advising and caring for
patients. Furthermore, often pharmacists do not have legal rights to assist the patients in need, even if
they have the right skills. Therapeutic substitution by the pharmacist10 or alteration of prescriptions is
illegal in the majority of Member States.
An additional source of frustration among community pharmacists is the lack of communication about
the shortage, its severity, and how long will it take to be resolved. This information, if it is provided in a
timely and efficient manner, would allow pharmacists to serve their patients better and plan their
practice and stock accordingly. Italian medicines supply chain partners including community pharmacists
9

http://www.npa.co.uk/Documents/Docstore/Press-Releases/Pharmacy%20Voice%20Cutting%20Red%20Tape.pdf
Dispensing of a different chemical entity within the same medicine class.

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have started an initiative which encourages communication of such information once the shortage is
experienced by all stakeholders. The reasons for the shortage, the extent of the problem and the time
when it will be resolved is among the information which is communicated to community pharmacists,
allowing timely information to be provided to patients.
CONCLUSIONS AND RECOMMENDATIONS
The findings of our survey confirm that most community pharmacists in Europe are experiencing some
medicine shortages during their practice. Addressing shortage problems is a frustrating and time
consuming diversion from patient care. Worse, medicines shortages can hinder therapy and may
ultimately be fatal.
We propose a set of recommendations to address this problem at European and national level:
1) In developing business policies and national laws and strategies all stakeholders and
governments must put patient needs first. These strategies should first and foremost aim to
ensure timely and adequate supply of medicines to patients.
2) The full impact on the supply and availability of medicines of policies aimed at reducing
medicines prices needs to be taken into account by policy makers.
3) The scope of pharmacy practice should be extended when medicines are in short supply, so
pharmacists can use their skills to better manage patient care. Where a medicine is not
available, an alternative medicine could be supplied following local guidelines and in
consultation with a treating physician.
4) Supply chain partners should be encouraged to communicate disruptions in medicines supply
to community pharmacists once they occur, as well as the cause and duration of the
disruption(as now happens in Italy). In addition, wholesalers should be encouraged to exchange
information about minimum stock levels of medicines, so medicine shortages can be anticipated.
5) Government policies should promote the adequate supply of medicines. Although no
government can order manufacturers to manufacture certain medicines, they can request the
maintenance of a minimum national stock of certain medicines by wholesalers and
manufacturers so to ensure adequate supply, and place public service obligations on wholesalers
where these are not currently in place. Article 81 of the EU Directive on Medicines for Human
Use 11 was intended to ensure adequate supply of any given product to the market. However,
there is extensive evidence of situations where pharmacies can’t obtain the medicines that they
need for their patients. Consideration should be given to strengthening the provisions of Article
81.
Finally, we invite our medicines supply chain partners, governments and EU Institutions to work closely
together to better plan the supply of medicines in Europe and inform each other about possible
shortages well in advance, so as to ensure that European patient needs are met and patients can
receive their medicines in time.

11

DIRECTIVE 2001/83/EC http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF

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