Off‐Label Prescribing by Psychiatrists: What is the Practitioner's Liability?

Bartoli, Christophe; Berland-Benhaïm, Caroline; Sastre, Caroline; Baillif-Couniou, Valérie; Kintz, Pascal; Léonetti, Georges; Pélissier-Alicot, Anne-Laure

doi:10.1111/1556-4029.12814

Cited by 4 publications

(3 citation statements)

References 31 publications

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“…12,13,[16][17][18][19][20] In addition to these concerns, the provision of PrEP to youth may present unique challenges related to the ability of minor adolescents to access PrEP without parental consent. 21 Clinicians may also be wary of the possible legal consequences of prescribing PrEP off-label to adolescents, 22,23 which could negatively impact clinician willingness to recommend or prescribe this method to youth. To optimize PrEP uptake by adolescents, it is critical to understand clinicians' attitudes about prescribing PrEP.…”

mentioning

confidence: 99%

Adolescent Human Immunodeficiency Virus Care Providers’ Attitudes Toward the Use of Oral Pre-Exposure Prophylaxis in Youth

Mullins

Zimet

Lally

et al. 2016

AIDS Patient Care and STDs

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mentioning

confidence: 99%

Adolescent Human Immunodeficiency Virus Care Providers’ Attitudes Toward the Use of Oral Pre-Exposure Prophylaxis in Youth

Mullins

Zimet

Lally

et al. 2016

AIDS Patient Care and STDs

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“…As a recommendation, patients should be properly educated about every off‐label drug use, supporting evidence, the risk of toxicities and financial impact on treatment costs . Obtaining informed consent was highly recommended by participants to safeguard patient autonomy leading to better healthcare decision with off‐label use and to prevent any future legal liabilities . The oncology practitioners generally agreed upon on moderate enhancement in the overall quality of life than specific survival gains with off‐label drug use.…”

Section: Discussionmentioning

confidence: 99%

Perception of oncology practitioners towards off-label use of anticancer medicines in Singapore

Saiyed

Ong

Chew

2017

J Pharm Health Serv Res

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Objectives Prescribing drugs outside regulatory recommendation is known as off‐label use. Studies have reported widespread off‐label drug use in oncology practice. But the clinical, economic and humanistic outcomes for such practice are often uncertain. Hence, it is important to gather oncology practitioners’ perspective for the creation of clinical practice framework and policies. The aim of the study was to evaluate perception of oncology practitioners on off‐label use in cancer therapy. Methods This study employed a cross‐sectional design implemented in the form of the self‐administered questionnaire at National Cancer Centre Singapore where more than 50% cancer patients of the country are treated. Key findings Eighty‐one practitioners involving nurses (38%), medical oncologist (37%) and pharmacists (25%) were surveyed. The majority of practitioners (57%) agreed off‐label use as indispensable practice in cancer therapy. Main reasons cited include advanced cancers where standard lines of treatment are exhausted (58%), lack of alternative approved drug (43%) and rare tumours (47%). Compared with other practitioners, medical oncologists viewed Phase 2 (73% versus 31%, P = 0.001) and conference abstracts (56% versus 23%, P = 0.003) as reasonable evidence for off‐label use. Major concerns included lack of efficacy (58%), patient understanding (47%), uncertain safety (43%) and out‐of‐pocket cost (41%) associated with off‐label use. Most viewed need for obtaining informed consent (86%) and institutional guidance (75%) as important elements in practice framework. Conclusion The study provides insights about off‐label drug use practice and establishes the need for robust clinical guidance and educational strategies for oncology practitioners.

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“…A semi-structured guide was developed based on a comprehensive review of the literature and the practices of OLDP reported previously [14,[21][22][23][24][25]. The guide was intended to explore the respondent's knowledge about OLDP, their concerns about its safety and efficacy, the probability of ADRs and their current practices of OLDP.…”

Section: Development Of Interview Guidementioning

confidence: 99%

Patterns and Predictors of Off-Label Drug Prescribing in Psychiatric Practice: A Qualitative Study

Shakeel

Nesar²,

Rehman

et al. 2021

Pharmacy

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Off-label drug prescribing (OLDP) must be based on strong scientific evidence to make sure that patients get the optimum therapeutic outcomes. Adherence to the prerequisites is determined by the physicians’ attitude and knowledge. In this context, the present study was conducted with the goal of investigating psychiatrists’ perceptions of the use of OLDP in their clinical practice. A total of 14 psychiatrists were interviewed using a semi-structured interview guide. Thematic content analysis was performed. Data saturation was achieved at the 12th interview. Six major themes and fifteen subthemes emerged from qualitative interviews. Among the major themes were knowledge and concepts about the off-label drugs, attitude and current practice of prescribing off-label drugs, and rationale of prescribing and suggestions for reducing the use of off-label drugs. Almost all of the respondents interviewed provided detailed comments concerning the OLDP concept, depicted an optimistic approach and deemed that OLDP is quite common in psychiatry. Off-label usage of benzodiazepines such as clonazepam, diazepam and lorazepam in mania, depression, and obsessive–compulsive disorder were commonly reported. It was observed that the majority of the respondents did not inform the patients before prescribing off-label drugs. The present findings revealed that respondents had awareness; however, they depicted diverse attitudes towards prescribing off-label drugs. Further education and sensitization in regions with impoverished knowledge would certainly assist in preventing the risks associated with the use of OLDP.

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Off‐Label Prescribing by Psychiatrists: What is the Practitioner's Liability?

Cited by 4 publications

References 31 publications

Adolescent Human Immunodeficiency Virus Care Providers’ Attitudes Toward the Use of Oral Pre-Exposure Prophylaxis in Youth

Adolescent Human Immunodeficiency Virus Care Providers’ Attitudes Toward the Use of Oral Pre-Exposure Prophylaxis in Youth

Perception of oncology practitioners towards off-label use of anticancer medicines in Singapore

Patterns and Predictors of Off-Label Drug Prescribing in Psychiatric Practice: A Qualitative Study

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