Italian Medicines Agency Agenzia Italiana del Farmaco

Medicine shortages

Medicine shortages and unavailability

The shortage and unavailability phenomena and monitoring activities

The temporary lack of supply on the national market of medicines essential for the treatment of certain diseases is monitored by AIFA on the basis of an ad hoc procedure.

‘shortage’ refers to the situation where a medicinal product is not available throughout the country, as the marketing authorisation holder (MAH) cannot temporarily ensure an appropriate and continuous supply.

A shortage on the market can be determined by several factors, including, for example, the unavailability of the active substance, manufacturing problems, regulatory framework, unforeseen increase in the demand for a particular medicinal product, or health emergencies in the countries of production.

The actual shortage of a medicinal product must be distinguished from its momentary unavailability caused by distortions of distribution dynamics.

European legislation does not contain a harmonised definition of the terms ‘shortage’ and ‘unavailability’ of medicines. The two phenomena refer in fact to two situations of different nature:

  • shortages related to manufacturer-related issues are generally due to production difficulties, but may also be related to the decision to suspend the marketing of ‘older’ or low-cost medicines with limited profitability.
  • the unavailability generated by market distortions can be attributed to the phenomenon of parallel trade, which exploits the price differences of medicines on the different markets.

For alerts concerning shortages of medicinal products transmitted by MAHs, AIFA shall:

  • ascertain the effectiveness and extent of the shortage;
  • assess the specific criticalities by verifying:
    • the type of shortage (periodic, recurrent, chronic or new reporting);
    • the availability of similar products on the Italian or foreign market or the uniqueness of the medicine;
  • contact the MAH of the medicinal product, of analogues and the other parties involved (producers, intermediaries, distributors, importers, health facilities and authorities, etc.)

Based on the performed assessment, AIFA shall take the necessary measures:

  • issuance of import authorisation for the medicinal product subjected to shortage;
  • issuance of import clearence (nulla osta) for individual health structures requesting it;
  • other specific measures (e.g. determinations, rationalisation of use for certain categories of patients, etc.)

List of medicine shortages

AIFA periodically updates and publishes on the institutional portal a list of the medicinal products temporarily subjected to shortages, containing the following information:

  • trade name of the medicinal product, active substance, pharmaceutical form, packaging and name of the MAH;
  • date of commencement and presumed conclusion of the shortage;
  • whether or not there is a therapeutic alternative;
  • reasons which led to the shortage;
  • suggestions and/or measures taken by AIFA.

This list is compiled from information provided by MAHs and on the basis of the alerts received and verified by AIFA’s competent Office.

In addition, the list of medicinal products temporarily subjected to shortages for which AIFA issued an import authorisation to health structures for analogous products authorised abroad or has issued an import determination to the MAH, is published as an extract from the above list.

Finally, AIFA publishes since 2018 a list of determinations by which MAH of medicines under shortage have been authorised to import analogous medicines from abroad.

Authorisations granted to MAH to import medicines temporarily subjected to shortage

Shortages

Reports from pharmacies and patients

In the event that a medicine, which is not included in the list of shortages published by AIFA, is not available on the territory, pharmacists (and patients through them) may report, pursuant to art. 105, c. 3bis of Legislative Decree 219/06, to the contact point of the Region or Autonomous Province, directly or through trade associations, for the purpose of an evaluation and intervention, and for possible forwarding to the Ministry of Health and to AIFA when concerning issues of national interest.

Contact points for Regions and Autonomous provinces:

Regione Piemonte: settore.farmaceutico@regione.piemonte.it

Regione Valle d'Aosta: farmacia@ausl.vda.it

Regione Lombardia: ida_fortino@regione.lombardia.it

Provincia Autonoma di Bolzano: governosanitario@provincia.bz.it

Provincia Autonoma di Trento: annalisa.campomori@apss.tn.it

Regione Veneto: olivia.basadonna@regione.veneto.it

Regione Friuli Venezia Giulia: info@federfarmafvg.itfarmaceuticasalute@regione.fvg.it

Regione Liguria: farmaceutica.alisa@regione.liguria.it, direzione.sanitaria@regione.liguria.it

Regione Emilia Romagna ERSalute@Regione.Emilia-Romagna.it, Urp@Regione.Emilia-Romagna.it

Regione Toscana: claudio.marinai@regione.toscana.it

Regione Umbria: mrossi@regione.umbria.it

Regione Marche: assistenza.farmaceutica@regione.marche.it, regione.marche.assistenzafarmaceutica@emarche.it

Regione Lazio: mgiuliani@regione.lazio.it

Regione Abruzzo:

Regione Molise: urp.cardarelli@asrem.org, antonella.lavalle@regione.molise.it

Regione Campania: adriano.cristinziano@ospedalideicolli.it

Regione Puglia: f.colasuonno@regione.puglia.it

Regione Basilicata: mariarosaria.puzo@regione.basilicata.it

Regione Calabria: farmaceutica.salute@pec.regione.calabria.it, crfv.calabria@pec.regione.calabria.it

Regione Sicilia: farmaco.vigilanza@regione.sicilia.it

Regione Sardegna: san.urp@regione.sardegna.it
 

AIFA: farmacicarenti@aifa.gov.it  

In addition, it should be noted that in the event that a product not included in the list of medicine shortages is not available in the distribution network, pharmacists may activate, through emergency contacts made available by the MAH, the procedure for direct supply, as provided for in art. 105-comma 4 of the Legislative Decree of 24 April 2006, n. 219, according to which the MAH "is obliged to supply within forty-eight hours, at the request of pharmacies, including hospital ones, or points of sale (as foreseen in Article 5 of Decree-Law No 223 of 4 July 2006, converted, with modifications, by Law No 248 of 4 August 2006), a medicinal product that is not available in the regional distribution network”.

Unavailabilities

The issue of “unavailability”, unlike “shortages”, is generated by market distortions often linked to dynamics at distribution chain level, such as parallel trade.

The need for systematic and incisive interventions on the numerous reports concerning unavailability of certain medicines in our country led, in 2015, to the establishment of a technical working group, involving other public and private bodies/associations, with the support of the Carabinieri NAS (Italian specialized police force dealing with health-related matters) and to the launch of a pilot project aimed at identifying shared ways to enforce supervisory activities on the concrete application of existing rules through a series of checks on the territory.

One of the first results of the technical working group was a Paper on the Distribution of Medicines (available in the Related Links Box) signed in 2016, which reaffirms the fundamental regulatory principles governing the medicines sector – which must firstly be considered as “public service” – with particular regard to distribution-related aspects, both wholesale distribution and retailling, whose ultimate aim is to protect public and individual health, ensuring availability and accessibility to medicines.

Activities of the group and results achieved have also been described in a scientific publication signed by all participants, available online and downloadable from the Related Documents Box.

Missing hospital supplies

There have been increasingly frequent cases of medicines whose supplies are temporarily not guaranteed in the quantities and times intervals indicated in the supply contracts of healthcare structures/ regional purchasing centres. This situation generates uncertainty about whether or not healthcare structures can rely on existing contracts, thus forcing them to activate additional contracts or determining the succession of clearance requests, in order to make up for the failed supply.

This case is particularly relevant for hospital medicines that cannot be substituted.

Under these circumstances, it appears appropriate to ensure a mapping in the AIFA alert system of these “shortages”, with modalities to be defined in agreement with Regions/ Central Purchasing Bodies, in addition to those concerning medicines for which the MAH has notified manufacturing- related and distribution-related issues.

Establishing mandatory corporate responsibility as regards disservices resulting from failed supplies is also considered important: for example, making import requests by MAHs mandatory in case of shortage and/or late delivery and/or insufficient quantities in relation to orders, as well as ensuring examination of import documentation for quality check of the imported products

Given the challenges of implementing direct centralised interventions, the discussion initiated within the Technical working group on unavailability led to a first intervention – through MAHs trade associations – based on the frequency of reporting for a given company, and at a later stage, to the launch of a SIFO-AIFA project, DrugHost (access from the Related Links section), consisting of a web platform for systematic sharing of reports on “hospital supply failures” and which will be used to create company “profiles”, to the benefit of Regions, which can include severe safeguard clauses for companies labelled as less reliable according to DrugHost data. The DrugHost project was launched in 2019 as a pilot in the Region of Puglia, with a view to extending it at the national level.

An operational proposal addressing this topic was discussed by AIFA’s Board of Directors in 2020, and AIFA will support its implementation in cooperation with Regions and Autonomous Provinces concerned: the document describing the proposal, drafted by competent offices in collaboration wih dr. Giovanna Scroccaro (President of AIFA’s Prices and Reimbursement Committee), is available in the Related Documents Box.

Cooperation among Regions and Autonomous Provinces, AIFA and pharmaceutical companies against shortages of COVID-19 medicines

Ufficio di riferimento

Reference offices

Product Quality and Pharmaceutical Crime Counteracting

Domenico Di Giorgio (ad interim)

d.digiorgio@aifa.gov.it
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