Trends of drug use with suggested shortages and their alternatives across 41 real world data sources and 18 countries in Europe and North America (2024)

Competing Interest Statement

AMR declares consulting and/or speaking from Abbvie, Amgen; Research grant from Novartis, Pfizer, Amgen. APU has received consultancy fees from Synapse Partners unrelated to the work. CDK is a full-time employee of Bayer AG. CGdeclares consulting and/or speaking from AstraZeneca, Bayer, BIAL, Boehringer-Ingelheim, Daiichi Sankyo, Lilly, MSD, Novartis and Novo Nordisk. CT holds shares and is an employee at Roche Pharmaceuticals. DBP has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Viatris, Teva Pharmaceuticals; consultancy agreements with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Viatris, Teva Pharmaceuticals; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Chiesi, Viatris, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Inside Practice, GlaxoSmithKline, Medscape, Viatris, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme, Teva Pharmaceuticals; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Novartis, Medscape, Teva Pharmaceuticals.; owns 74 of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61 of Observational and Pragmatic Research Institute Pte Ltd (Singapore); is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. EB owns Pfizer Shares. EHT received consultancy fees from Janssen Pharmaceutica NV, outside the submitted work. FN owns some AstraZeneca shares. GC is a full-time employee of Bayer AG. KM is a full time employee of Bayer AG. MT has received consulting fees from Health Canada and CDA. PR works for a research group that receives/received unconditional research grants from Chiese, GSK, UCB, Amgen, Johnson and Johnson, European Medicines Agency, none of which relate the content of this manuscript. TB declares consultant for IBSA. DPA's research group has received grant/s from Amgen, Chiesi-Taylor, Lilly, Janssen, Novartis, and UCB Biopharma. His research group has received consultancy fees from Astra Zeneca and UCB Biopharma. Amgen, Astellas, Janssen, Synapse Management Partners and UCB Biopharma have funded or supported training programmes organised by DPA's department.

Clinical Protocols

https://catalogues.ema.europa.eu/node/3843/administrative-details

Funding Statement

Funding This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 806968. The JU receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Use of Clinical Practice Research Datalink (CPRD) data for this study was approved via the Research Data Governance (RDG) Process of the UK Medicines and Healthcare Products Regulatory Agency (protocol 23_003389). Ethical approval for Fundacion para la Investigacion del Hospital Universitario La Fe de la Comunidad Valenciana (HULAFE) was obtained from the Comite de etica de la investigacion con medicamentos (number 2024-561-1). Ethical approval for IMIM-Hospital del Mar Barcelona (IMASIS) was obtained by the Parc de Salut Mar Research Ethics Committee CEIm-Parc de Salut Mar (number 2023/11266). Ethical approval number for Hospital District of Helsinki and Uusimaa (HUS) in this study was HUS/325/2023. Ethical approval number for Istanbul University (ITF) was 2302692. Ethical approval number for Netherlands Comprehensive Cancer Organisation (NCR) was K23.338. Ethical approval number for University Medicine Dresden (UM DRESDEN) was SR-EK-181052024. Ethical approval number for Optimum Patient Care Limited (OPCRD) was ADEPT0624. Ethical approval number for Clinical-hospital center Zvezdara (CHCZ) was FWA00024180. Ethical approval number for Fundacio Institut d'Investigacio Sanitaria Illes Balears (PRISIB) was CI-866-24. Ethical approval number for EGAS MONIZ HEALTH ALLIANCE (EMHA ULSRA and EMHA ULSGE) was 4/2023 Ref 19-CE-ICVS/CAC-EMHA. Ethical approval number for FISABIO-HSRU (VID-CONSIGN) was 2023/382. Ethical approval number for University Hospital Antwerp (UZA) was 5957-EDGE 3372-BUN. Ethical approval number for AZ Groeninge (AZGR) was AZGD2024008. Ethical approval number for Viecuri was 2022_088. Ethical approval number for Charite - Universitatsmedizin (CHA CAN) was EA1/04124. Ethical approval number for THIN databases was 2024-06-R. Ethical approval for The Integrated Primary Care Information Project (IPCI) was obtained by the Integrated Primary Care Information review board (registration number 9/2023).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes