Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing

Fleischman, William; Auth, Doris; Shah, Nilay D.; Agrawal, Shantanu; Ross, Joseph S.

doi:10.1001/jamanetworkopen.2019.1340

Cited by 13 publications

(11 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Our study confirms previous findings that IRF prescribing is low in European countries [ 24 , 25 ]. After all, IRF should be reserved as a last resort for breakthrough pain in cancer.…”

Section: Discussionsupporting

confidence: 92%

Immediate release fentanyl in general practices: Mostly off-label prescribing

Weesie

Dijk

Bouvy

et al. 2023

European Journal of General Practice

View full text Add to dashboard Cite

Background The immediacy of the onset of opioids may be associated with the risk of dependency and accidental overdose. Nasal and oromucosal fentanyl dosage forms are so called immediate release fentanyl (IRF). These IRFs have been approved to treat breakthrough pain in patients with cancer who are on chronic opioid treatment only. There are signals of increased off-label prescribing of IRFs in general practices. Objectives This study aims to provide insight into the frequency of IRF prescription in Dutch general practices and the extent to which IRF is prescribed off-label. Methods Routinely collected electronic health records of general practices (GPs) participating in Nivel Primary Care Database were used. Adult patients with IRF prescriptions in 2019 were selected from whom dispensing data on 2018 and 2019 was available. Diagnoses were recorded by GPs using International Classification of Primary Care. Descriptive analyses were performed. Results This study included 342 GPs with a patient population of 1,297,942 patients, 1,368 patients received at least one IRF prescription in 2019, which is equal to 1.1 patients per 1,000 registered patients. Most patients (74.9%) with an IRF prescription received an off-label prescription. A slight majority had a cancer diagnosis but nearly 65.2% did not have a maintenance therapy and 14% were opioid-naive before receiving their first IRF prescription. Conclusion IRFs are not prescribed frequently in Dutch general practices. However, when prescribed, a relatively large portion of patients received an off-label prescription.

show abstract

“…Our study confirms previous findings that IRF prescribing is low in European countries [ 24 , 25 ]. After all, IRF should be reserved as a last resort for breakthrough pain in cancer.…”

Section: Discussionsupporting

confidence: 92%

Immediate release fentanyl in general practices: Mostly off-label prescribing

Weesie

Dijk

Bouvy

et al. 2023

European Journal of General Practice

View full text Add to dashboard Cite

show abstract

“…A United States FDA Risk Evaluation and Mitigation Strategy (REMS) program was also implemented to assess transmucosal immediate-release fentanyls (TIRFs) and found that substantial rates of TIRFs were prescribed inappropriately 145,146 . With the findings of deficiencies in the structure and administration of TIRFs, the development of other REMSs is needed to ensure the safe and appropriate use of approved drugs, especially dangerous opioid drugs 147 .…”

Section: Interventions For the Management And Prevention Of Fentanyl mentioning

confidence: 99%

The rising crisis of illicit fentanyl use, overdose, and potential therapeutic strategies

et al. 2019

View full text Add to dashboard Cite

Fentanyl is a powerful opioid anesthetic and analgesic, the use of which has caused an increasing public health threat in the United States and elsewhere. Fentanyl was initially approved and used for the treatment of moderate to severe pain, especially cancer pain. However, recent years have seen a growing concern that fentanyl and its analogs are widely synthesized in laboratories and adulterated with illicit supplies of heroin, cocaine, methamphetamine, and counterfeit pills, contributing to the exponential growth in the number of drug-related overdose deaths. This review summarizes the recent epidemic and evolution of illicit fentanyl use, its pharmacological mechanisms and side effects, and the potential clinical management and prevention of fentanyl-related overdoses. Because social, economic, and health problems that are related to the use of fentanyl and its analogs are growing, there is an urgent need to implement large-scale safe and effective harm reduction strategies to prevent fentanyl-related overdoses.

show abstract

“…8 However, few analyses of REMS programs with ETASU provide insight into patient experiences and perceptions. [9][10][11] A study by the manufacturer of the teratogenic multiple myeloma drugs lenalidomide and thalidomide found a high rate of self-reported adherence with birth control requirements (96%) and comprehension of teratogenic risk (98%). 12 Another investigation reported that while 89% of patient educational materials from 23 REMS programs met the criteria for being understandable, only 49% were deemed actionable, resulting in the reader knowing how to act on the messages being communicated.…”

Section: Introductionmentioning

confidence: 99%

Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use

et al. 2022

View full text Add to dashboard Cite

IMPORTANCEThe US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to impose safety requirements on drugs with important risks, such as prescriber certification or routine laboratory testing, to ensure that the benefits of use outweighed the risks. However, little is known about patient and caregiver experiences with these Risk Evaluation and Mitigation Strategy (REMS) programs with Elements to Assure Safe Use (ETASU). OBJECTIVE To understand patient and caregiver experiences with and perceptions of REMS programs with ETASU. DESIGN, SETTING, AND PARTICIPANTS This qualitative study included semistructured qualitative phone interviews conducted between 2016 and 2017, with initial analysis performed in 2017 and reanalysis performed in 2021. Adult patients prescribed natalizumab or sodium oxybate, adult patients or caregivers of adult patients prescribed vigabatrin, and adult female patients of reproductive age prescribed riociguat were included. MAIN OUTCOMES AND MEASURESAssessment of knowledge, decision-making, medication access, and perceptions of medical privacy. RESULTS Among 63 participants, 46 (73%) were female. Twenty-five participants (40%) had taken natalizumab, 10 (16%) riociguat, 15 (24%) sodium oxybate, and 10 (16%) vigabatrin. One participant had taken both natalizumab and vigabatrin; 4 (6%) were caregivers of patients using vigabatrin. Most participants expressed knowledge of REMS program requirements, but many lacked the insight that these requirements were part of an FDA-mandated special safety program and expressed difficulty understanding program education materials. REMS requirements made some participants more likely to initiate treatment. However, many reported burdens accessing medication, including the need to travel to certified prescribers or pharmacies. Manufacturer access to personal health information was also controversial, although some participants expressed an altruistic desire to assist others. CONCLUSIONS AND RELEVANCEThis qualitative study found that REMS programs with ETASU reassured patients and their caregivers about drug safety and helped support medication initiation.However, steps are needed to improve the quality of REMS educational materials, promote efficient medication access, and protect patient privacy.

show abstract

Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing

Cited by 13 publications

References 16 publications

Immediate release fentanyl in general practices: Mostly off-label prescribing

Immediate release fentanyl in general practices: Mostly off-label prescribing

The rising crisis of illicit fentanyl use, overdose, and potential therapeutic strategies

Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use

Contact Info

Product

Resources

About