Off‐label prescribing during pregnancy in the UK: an analysis of 18 000 prescriptions in Liverpool Women's Hospital

Herring, Christopher; McManus, Aine; Weeks, Andrew

doi:10.1211/ijpp.18.04.0007

Cited by 30 publications

(3 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…An increased understanding of which medications are safe to take during pregnancy is also highly prioritised by respondents, and this responds to a clear challenge in evidence-based perinatal prescribing. Because so few drugs are developed and tested for use during pregnancy (Chappell and David 2016) many drugs have to be used 'off-label' to treat pregnant women (Herring et al 2010), and in many cases the implications may be unknown, or medications are known to be unsafe may be prescribed (Hardy et al 2006). Another risk is that women do not receive treatment for conditions (such as UTIs) due to uncertainty or concerns around the safety of medications (Twigg et al 2016).…”

Section: Preventing and Managing Mental Health Problemsmentioning

confidence: 99%

Pregnancy research review: Policy report

2020

View full text Add to dashboard Cite

Section: Preventing and Managing Mental Health Problemsmentioning

confidence: 99%

Pregnancy research review: Policy report

2020

View full text Add to dashboard Cite

“…Approved treatment options for rare diseases 1 or vulnerable populations, including children, 2–5 pregnant women 6 and elderly patients, 7,8 are often limited. In such cases, health care providers may have to resort to prescribing or administering medicines or medical procedures outside the terms of their marketing authorization, an approach known as ‘off‐label use’ 9–14 .…”

Section: Introductionmentioning

confidence: 99%

Impact of off‐label use regulations on patient care in dermatology – a prospective study of cost‐coverage applications filed by tertiary dermatology clinics throughout Germany

Werner

Pennitz

Eisert

et al. 2022

Acad Dermatol Venereol

View full text Add to dashboard Cite

Background In dermatology, a medical speciality with a relatively high number of rare diseases, physicians often have to resort to off-label treatment options. To avoid claims, physicians in Germany can file a cost-coverage request (offlabel application, OL-A).Objectives Our aim was to investigate the extent to which the current regulations affect patient care.Material and methods Prospective cohort study among tertiary dermatology clinics throughout Germany, consecutively including OL-As (05/2019-09/2020) and assessing the follow-up correspondence. We modelled regressions to assess factors associated with cost-coverage decisions and the time needed by health insurers to process the OL-As.Results Thirteen clinics provided data on 121 OL-As, two of which applied for on-label treatments. Of the remaining 119 OL-As, 70 (58.8%) were immediately approved and 44 (37.0%) rejected. Including cases with one or more appeals, 87 of 119 OL-As (73.1%) were finally approved and 26 (21.9%) rejected. There was an association of the final approval rate with (1) the class of medication/treatment, with approval rates being significantly lower for JAK inhibitors than for biologics (OR 0.16, 95%-CI: 0.03-0.82); (2) German state, with approval rates being lower in eastern than in western states (OR 0.30, 95%-CI 0.12-0.76); and (3) cost of the intervention (no linear trend). However, none of these predictors was significant in our multiple logistic regression models. The median health insurer's processing time (first response) was 29 days . Our analyses showed no evidence of an association with the predictors we assessed. In cases approved, the median time from the decision to file an OL-A to the actual initiation of the treatment was 65.5 days .Conclusions Our study points to substantial delays and inequalities in the provision of timely health care for dermatological patients with rare diseases, often involving treatments for which there is no adequate approved therapy.

show abstract

“…Orphan patients and patients with cancer mostly rely on OLDU treatments. Although OLDU ratios vary among different countries, the worldwide rates declared are between 18% and 36% in adults (3,4,5,6).…”

Section: Introductionmentioning

confidence: 99%

A Multifaceted Evaluation of National Off-label Neurology Applications

Yurtoğulları¹,

Rahmanlar²,

Alkan³

et al. 2020

tnd

View full text Add to dashboard Cite

Re cei ved/Ge lifl Ta ri hi: 16.10.2019 Ac cep ted/Ka bul Ta ri hi: 23.01.2020Objective: Off-label drug use (OLDU) of neurologic diseases is approved by a regulatory authority, the Turkish Medicines and Medical Devices Agency (TMMDA) in Turkey. It was aimed to investigate the most common neurologic drugs relevant to off-label prescribing and the most prescribed diagnosis, demographic and medical characteristics of patients with OLDU applications in Turkey. Materials and Methods: Four years "TMMDA"s electronic OLDU application records, 9,758 applications in total, were evaluated retrospectively. Information regarding patients' demographic characteristics, diagnoses, ordered drugs, and institutions were evaluated. Results:The most OLDU applications were mostly made in 2015, the majority of which were associated with neurodegenerative diseases. The mean age of the patients was 41.6 years and 65% were female. Some 62.1% of off-label drug application patients' age range was found as 18-64 years. The most common applications were from the Marmara region with 36% and neurology clinics of university hospitals with 81%. Multiple sclerosis (MS) was the most common diagnosis and the most frequently used group of drugs was disease-modifying drugs used in the treatment of MS. Conclusion:Based on the four-year survey of OLDU applications for adult neurologic patients showed that unlicensed drug prescriptions were high. There are very few studies on the result of OLDU applications in neurology worldwide. We believe that this study will be a guide to neurologists with off-label application processes and the results in our country and will make a significant contribution to the literature.

show abstract

Off‐label prescribing during pregnancy in the UK: an analysis of 18 000 prescriptions in Liverpool Women's Hospital

Cited by 30 publications

References 3 publications

Pregnancy research review: Policy report

Pregnancy research review: Policy report

Impact of off‐label use regulations on patient care in dermatology – a prospective study of cost‐coverage applications filed by tertiary dermatology clinics throughout Germany

A Multifaceted Evaluation of National Off-label Neurology Applications

Contact Info

Product

Resources

About