IMPACT ON ANTIHYPERTENSIVE PRESCRIBING AFTER THE DEAR HEALTHCARE PROFESSIONAL LETTER ON INCREASED RISK OF SKIN CANCER RELATED TO HYDROCHLOROTHIAZIDE

Author(s)

Schulz M1, Kieble M1, Enners S1, Laufs U2, Böhm M3, Kintscher U4, Mahfoud F3
1DAPI - German Institute for Drug Use Evaluation, Berlin, Germany, 2University Hospital of Leipzig, Leipzig, Germany, 3Saarland University Medical Center, Homburg, Germany, 4Charité - Universitätsmedizin, Berlin, Germany

OBJECTIVES: Hydrochlorothiazide (HCTZ) is a frequently used diuretic. On 17/10/18, marketing authorization holders in agreement with the EMA issued a Dear Healthcare Professional Letter (DHCPL), informing on a dose-dependent association of HCTZ use and risk of non-melanoma skin cancer. We explored the potential impact on the prescribing of all antihypertensives (AHTs) and all low-ceiling diuretics in detail.

METHODS: We analyzed the DAPI database, which contains anonymous claims data of drugs dispensed at community pharmacies (CPs) at the expense of the Statutory Health Insurance (SHI) Funds. Nearly 88% of Germany's population is insured by the SHI system. This database covers all claims data from a representative sample of >80% of all CPs and were extrapolated to 100% of the SHI insured population. We analyzed the ATC codes C02, 03, 07–09. For HCTZ and other low-ceiling diuretics, we included all mono and fixed-dosed combination preparations available on the market. We calculated the average monthly dispensings in the periods 1–9/18 vs 1–6/19.

RESULTS: Overall prescribing of AHTs, on average 36.5 million packages/quarter, remained nearly unchanged throughout 1/18–6/19. HCTZ dispensings decreased from on average 1.78 million packs/month in 1–9/18 to 1.45 million/month in 1Q19 and 1.41 million/month in 2Q19. All low-ceiling diuretics’ dispensings decreased from 1.90 million packs/month before the DHCPL to 1.62 million/month in 2Q19, a minus of 0.28 million packs/month. Xipamide, indapamide, and chortalidone dispensings increased after 10/18, eg for chlortalidone to 50,700 packs in 11/18.

CONCLUSIONS: Monthly HCTZ dispensings in 1Q19 decreased by 326,000 packs compared to 1–9/18. Assuming one patient is receiving one pack/quarter, appr. 978,000 fewer patients received HCTZ. A minor increase in dispensings of alternative low-ceiling diuretics did not compensate for this decline, resulting in an overall minus of 0.28 million packs/month. These findings highlight the potential risks associated with safety warnings of chronic cardiovascular medications used by large populations.

Conference/Value in Health Info

2020-05, ISPOR 2020, Orlando, FL, USA

Value in Health, Volume 23, Issue 5, S1 (May 2020)

Code

PCV64

Topic

Epidemiology & Public Health, Health Service Delivery & Process of Care

Topic Subcategory

Prescribing Behavior, Public Health, Safety & Pharmacoepidemiology

Disease

Cardiovascular Disorders, Drugs

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