Trends of use of drugs with suggested shortages and their alternatives across 52 real world data sources and 18 countries in Europe and North America
Authors: Pineda-Moncusí Marta , Rekkas Alexandros , Pérez Álvaro Martínez , Leis Angela , Lopez Gomez Carlos , Fey Eric , Bruninx Erwin , Maljković Filip , Sánchez-Sáez Francisco , Rodeiro Jordi , Kiss Loretta Zsuzsa , Franz Michael , Mayer Miguel-Angel , Eleangovan Neva , Pau Pericàs Pulido , Natsiavas Pantelis , Şen Selçuk , Cooper Steven , Reisberg Sulev , Manlik Katrin , del Pino Beatriz , Uribe Albert Prats , Üresin Ali Yağız , Bastić Ana Danilović , Rodrigues Ana Maria , Afonso Ãngela , Palomar-Cros Anna , Verbiest Annelies , Delmestri Antonella , Erdoğan Barış , Dinkel-Keuthage Carina , Torre Carmen Olga , de Beukelaar Caroline , Eteve-Pitsaer Caroline , Gonçalves Cátia F. , de Palma Costantino , Gavina Cristina , Dedman Daniel , Price David Brendan , Balan Denisa Gabriela , Enders Dirk , Burn Edward , Henke Elisa , Scheurwegs Elyne , Callewaert Emma , Martínez Encarnación Pérez , Tan Eng Hooi , Prasser Fabian , Antonini Francois , Staelens Frank , Nyberg Fredrik , Agard Geoffray , Galli Gianluigi , Candore Gianmario , Mestdach Gianny , Shachaf Hadas , Rantala Harri , Li Huiqi , Reinecke Ines , López-Sánchez Irene , Poquet-Jornet Jaime E , de la Cruz Bertolo Javier , Evers Jelle , Firmino-Machado João , Wastesson Jonas , Bermúdez Juan Luis Cruz , Ramírez-Anguita Juan Manuel , Porkka Kimmo , Johnell Kristina , Boyer Laurent , Cool Lieselot , Moscetti Luca , Merkelbach Manon , Canelas-Pais Mariana , Dominici Massimo , Szilcz Máté , Puntoni Matteo , Mosseveld Mees , Tadrous Mina , Oltra-Sastre Miquel , Bové Mona , Rappoport Nadav , Barrio Noelia García , Ettala Otto , Baili Paolo , Mayo Paula Rubio , Prinsen Peter , Norris Raeleesha , Claire Ravinder , Yackob Reut Sherman , Lillini Roberto , Garcia-Torrens Salvador , Kukkurainen Sampo , Lazzarelli Silvia , Duarte-Salles Talita , Taveira-Gomes Tiago , Jansen Tim , Keilholz Ulrich , Man Wai Yi , Li Xintong , Bagyura Zsolt , Prieto-Alhambra Daniel , Rijnbeek Peter R. , Burkard Theresa 
Published: August 2024

Importance

Drug shortages leave affected patients in a vulnerable position.

Objective

To describe incidence and prevalence of use for medicines with suggested shortages in at least one European country, as announced by the European Medicines Agency, and to characterise the users of these drugs including the indication of use, duration of use, and dosage.

Design

We performed a descriptive cohort study from 2010 and up to 2024 in a network of databases which have mapped their data to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM).

Setting

Settings included primary care, secondary care, claims and various disease registries.

Participants

We included all patients with at least 365 days of history on the database.

Exposures

All medicines with a suggested shortage in at least one European country for more than 365 days (n=18). We also assessed their key alternatives (n=39).

Main outcomes and measures

We estimated annual incidence rates and period prevalence. A drop in incidence or prevalence of >33% after the shortage was announced was considered confirmation of a shortage.

Results

Among 52 databases from Europe and the United States, we observed shortages according to decreased incidence of use for 8 drugs and shortages according to prevalence of use for 9 drugs. The drugs varenicline and amoxicillin alone or plus clavulanate were in shortage in the most number of countries.

Conclusion and relevance

We compiled and analysed data of annual incidence and prevalence of use plus information on patient characteristics, indication, and dose for 57 medicines among 52 databases in Europe and the United States between 2010 and 2024. We detected shortages and observed a change in the users’ characteristics for several drugs.

We have described timely real-world scenarios of drug shortages and those unobserved in various health care settings and countries which helps to better understand how drug shortages play out in real life.