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

Shakeel, Sadia; Nesar, Shagufta; Rehman, Hina; Jamil, Khizra; Mallick, Imran Ahsan; Mustafa, Muhammad Shahid; Anwar, Mudassir; Jamshed, Shazia Qasim

doi:10.3390/pharmacy9040203

Cited by 4 publications

(3 citation statements)

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“…It was worrying that around 40% of the respondents informed their patients when prescribing an OLMU whereas more than 75% did not request informed, written / verbal consent from patient or attendant before OLMU. Shakeel et al reported that the majority of the responders did not notify the patient while prescribing an off-label ( 27 ). Varying approaches for informed consent have been proposed in Australia based on different degrees of evidence in off-label medication ( 28 ).…”

Section: Discussionmentioning

confidence: 99%

Assessment of Knowledge, Attitude, and Practice of Obstetricians and Gynecologists Toward Off-Label Medicine Use in Female Reproductive Health Issues

Shakeel

Iffat

Qamar

et al. 2022

Front. Public Health

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BackgroundOff-label medication usage (OLMU) is prevalent in the treatment of various diseases, including female reproductive health issues (FRHIs). However, there is a paucity of literature on the perspective of health professionals on this subject. The purpose of the current study was to assess gynecologists/obstetricians' knowledge, attitude and practice toward OLMU in the treatment of FRHIs.MethodsThe current cross-sectional study was conducted in September and October 2021, at five tertiary care hospitals (two public and three private sector), different clinics and maternity homes in a metropolitan city of Karachi, Pakistan. The target population was gynecologists, obstetricians and physicians/residents working in the ob/gyn department in various hospitals and clinical settings of Karachi.ResultsThe overall response rate was 77.1%. The mean age of the study respondents was 36.1 ± 7.7 years; n = 85 (55.9%) respondents were working in primary patient care. The majorly reported OLMU by the respondents were clomiphene citrate in unexplained infertility (n = 66; 43.4%), metformin to improve cycle regularity in females with polycystic ovary syndrome (PCOS) (n = 59; 38.8%) and letrozole to induce ovulation (n = 31; 20.4%). The majorly stated categories of OLMU were at a different dose (n = 95; 62.5%) and at different indications than approved to treat (n = 89; 58.5%). It was reported by the majority of the respondents (n = 95; 62.5%) that they do not follow any guidelines or regulations for OLMU in their work setting; however, the response was statistically varied with the working organization (CI 2.14–2.93; p = 0.037) and practice area (CI 2.85–4.32; p = 0.0001) of respondents.ConclusionsThe present study revealed that the respondents were well-familiar with the practice of OLMU in the treatment of FRHIs. They expressed their concerns about decreasing such practices by being involved in collective decision-making procedures, and they were inclined to accept initiatives aimed at ensuring drug safety in patients.

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Section: Discussionmentioning

confidence: 99%

Assessment of Knowledge, Attitude, and Practice of Obstetricians and Gynecologists Toward Off-Label Medicine Use in Female Reproductive Health Issues

Shakeel

Iffat

Qamar

et al. 2022

Front. Public Health

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Section: Introductionmentioning

confidence: 99%

“…Many medications are used more often off-label than for their original indications, approved especially in pediatrics, 27,28 oncology, 29 and psychiatry. 30,31 Avastin is a medication to treat cancer, but it is also used off-label -successfully-for macular degeneration. 32,33 Regulating the freedom of therapy requires a type of approach in which anything that is not explicitly prohibited and is for the benefit of the patient is permitted.…”

Section: Introductionmentioning

confidence: 99%

Against Authority: The Bioethics of Ivermectin Use for COVID-19 Infection

Astărăstoae

Rogozea

2023

American Journal of Therapeutics

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Background:The COVID-19 pandemic has brought new ethical challenges to both health care professionals and the general public. Among the ethical problems amplified during this period were the making of medical decisions to quickly introduce some drugs into therapeutic practice with unproven or insufficiently proven effects (such as ivermectin), the validity of drug testing, and the allocation of limited resources.Fields of Uncertainty:The COVID-19 pandemic brought to the attention of the entire scientific world a new problem, which exceeded the guidelines and rules known until then. Out of the desire to quickly solve this medical problem, a series of measures were taken, however not sufficiently validated in scientific terms; the recommendations regarding the use of drugs known for their properties to treat a greater number of conditions, such as ivermectin, was tried.Data Sources:A narrative review of the specialized literature was carried out using keywords such as COVID-19, ivermectin, ethics, and off-label medication from Scopus and Google Scholar but also of official documents developed at the international level (World Health Organization).Ethics and Therapeutic Advances:The off-label use of ivermectin alone or in combination with other medications during COVID pandemic raised problems related to the demonstration of its effectiveness, but also to ethics, starting from the expectations that both the medical staff and the population had of it. Ivermectin therapy was also evaluated by analyzing the behavior of ivermectin based on ethical principles (nonmaleficence, beneficence, and respect for one's autonomy) or on justice. Even in times of pandemic, exceptionalism must not triumph, and finding an effective treatment must be done through studies that respect ethical standard.Conclusions:The failures or rather lack of success in decision making during the pandemic showed that alongside scientific knowledge and the development of health policies, it is necessary to constantly evaluate the measures and decisions from an ethical point of view, and the prevention of slippages and abuses is not only necessary but even mandatory.

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Factors associated with long-term benzodiazepine and Z-drug use across the lifespan and 5-year temporal trajectories among incident users: a Swedish nationwide register-based study

Isomura

Wang

Chang

et al. 2023

Eur J Clin Pharmacol

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Purpose Despite being discouraged by guidelines, long-term use of benzodiazepines and related Z-drugs (BZDR) remains frequent in the real-world. An improved understanding of factors associated with the transition from new to long-term BZDR use and of temporal BZDR use trajectories is needed. We aimed to assess the proportion of long-term BZDR use (> 6 months) in incident BZDR-recipients across the lifespan; identify 5-year BZDR use trajectories; and explore individual characteristics (demographic, socioeconomic and clinical) and prescribing-related factors (pharmacological properties of the initial BZDR, prescriber’s healthcare level, and concurrent dispensing of other medications) associated with long-term BZDR use and distinct trajectories. Methods Our nationwide register-based cohort included all BZDR-recipients in Sweden with first dispensation in 2007–2013. Trajectories of BZDR use days per year were built using group-based trajectory modelling. Cox regression and multinomial logistic regression were fitted to assess the predictors of long-term BZDR use and trajectories’ membership. Results In 930,465 incident BZDR-recipients, long-term use increased with age (20.7%, 41.0%, and 57.4% in 0–17, 18–64, and ≥ 65-year-olds, respectively). Four BZDR use trajectories emerged, labelled ‘discontinued’, ‘decreasing’, ‘slow decreasing’ and ‘maintained’. The proportion of the ‘discontinued’ trajectory members was the largest in all ages, but reduced from 75.0% in the youths to 39.3% in the elderly, whereas the ‘maintained’ increased with age from 4.6% to 36.7%. Prescribing-related factors, in particular multiple BZDRs at initiation and concurrent dispensing of other medications, were associated with increased risks of long-term (vs short-term) BZDR use and developing other trajectories (vs ‘discontinued’) in all age groups. Conclusions The findings highlight the importance of raising awareness and providing support to prescribers to make evidence-based decisions on initiating and monitoring BZDR treatment across the lifespan.

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

Cited by 4 publications

References 40 publications

Assessment of Knowledge, Attitude, and Practice of Obstetricians and Gynecologists Toward Off-Label Medicine Use in Female Reproductive Health Issues

Assessment of Knowledge, Attitude, and Practice of Obstetricians and Gynecologists Toward Off-Label Medicine Use in Female Reproductive Health Issues

Against Authority: The Bioethics of Ivermectin Use for COVID-19 Infection

Factors associated with long-term benzodiazepine and Z-drug use across the lifespan and 5-year temporal trajectories among incident users: a Swedish nationwide register-based study

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