Drug Utilization Research / Trends and comparisons

4C-05 - Impact of Cardiovascular Drug Shortages on Chronic Disease Patient Care in France between 2014 and 2019

Monday, August 25, 2025

5:15 PM - 5:30 PM ET

Presenting Author(s)

HM

Hugo Marthinet

Biostatistician
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1, Lyon, France, France

Co-Author(s)

AM

Aurélie Moskal, PhD

Data Analyst
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1, Lyon, France, France
AL

Aubane L'Hospital

Data Analyst
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1, Lyon, France, France
AT

Annaëlle Testud

Biostatistician
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1, Lyon, France, France
SB

Serge Bakchine, MD, PhD

Université de Reims Champagne Ardennes, CHU de Reims, Reims, France
MC

Marc Chanelière, MD, PhD

Collège universitaire de Médecine Générale, Université Lyon 1, Villeurbanne, France
AJ

Annie-Pierre Jonville-Bera, MD, PhD

Centre Régional de Pharmacovigilance, CHRU de Tours, Hôpital Bretonneau, Tours, France
SM

Sabine Mainbourg, MD, PhD

Laboratoire de Biométrie et Biologie Evolutive UMR 5558, CNRS, Université de Lyon, Université Lyon 1, France
TN

Teddy Novais, PharmD, PhD

Hospices Civils de Lyon, Service pharmaceutique, Lyon, France, France
CP

Cécile Payet, PhD

Biostatistician
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1, Lyon, France, France
MV

Marie Viprey, PharmD, PhD

Epidemiologist
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1, Lyon, France, France

Background: In France, drug shortages are increasingly frequent, especially impacting cardiovascular medications for chronic diseases. However, few studies have explored the impact of these shortages on patient care.

Objectives: This study aimed to measure the effects of cardiovascular drug shortages on medication management and overall clinical outcomes (medical encounters, hospitalization, death) in patients with chronic treatment.

Methods: A population-based, before/after study was conducted using the French National Health Data System (SNDS). The study focused on four major drug shortages between 2014 and 2019: altizide/spironolactone, atenolol/nifedipine, valsartan and valsartan/hydrochlorothiazide. For each treatment, the exposed group included patients on chronic treatment at the shortage date; the unexposed group included patients on the same treatment one year before the shortage.
Patients' socio-demographic and clinical characteristics, medication management (treatment discontinuation and substitution), and clinical outcomes (hospitalization days, emergency department visits) were studied over 12 months. Fine and Gray competing risk survival models for treatment discontinuation, treatment substitution, first hospitalization and first emergency department visit, each time with death as a competing risk, were adjusted depending on shortage exposure for each drug of interest.

Results: We included a total of 1,294,097 exposed patients and 1,285,463 non-exposed patients over the four selected medications. Exposed patients showed increased risks of treatment discontinuation (HR between 4.69 [4.65-4.74] and 9.30 [9.05-9.56] depending on the medication) and risks of treatment substitution (HR between 7.02 [6.78-7.27] and 12.55 [12.43-12.66]) compared to non-exposed patients. Emergency department visit (HR ranging from 1.02 [1.01-1.03] to 1.05 [1.03-1.07] depending on the medication) and hospitalization (HR ranging from 0.99 [0.98-0.99] to 1.02 [1.01-1.03]) risks were slightly increased among exposed patients, although the size effect remains small.

Conclusions: While our study demonstrates the major impact of cardiovascular treatment shortages on overall medication management, they seem to have a limited impact on key clinical outcomes.