Prevalence Of Off-label Drug Use Research Articles

Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.

Off-label prescribing is widespread among pediatricians, and it is unlikely that this trend will soon be bound by a uniform legal framework. This is necessitated by the fact that there are four variables: the patient's health condition, the physician's experience and knowledge, the legislative measures (laws, directives, guidelines, and recommendations), and finally, the pharmaceutical industry. There is considerable concern worldwide about the use of off-label medicines in children. We may call it an enormous global problem that is much talked about and written about; however, we should not forget that the goal around which everyone should unite is the patient's life. For healthcare providers, the most important thing will always be the health and preservation of the patient's life, particularly when it comes to children with life-threatening conditions in neonatal and pediatric intensive care units (NICU and PICU). The study aimed to examine the prevalence of off-label drug use in pediatrics. Literature research was conducted, and we included studies from 2012 to 2022 that evaluated off-label drug prevalence in various pediatric patient populations.

Obat Off-label pada Pasien Pediatri Rawat Jalan: Penelitian Observasi Retrospektif di RSUD Dr. H. Abdul Moeloek Lampung

Several medications are prescribed for infants and children, but adequate information about these drugs are unavailable. Previous studies also revealed that the use of off-label drug is prevalent among pediatric outpatients. Therefore, this study aimed to determine the prevalence of off-label drug use in pediatric outpatients at Dr. H. Abdul Moeloek Lampung Hospital from January–June 2019. This observational descriptive was conducted using simple random and retrospective sampling methods. Drugs were identified using a brochure, British National Formulary for Children (BNF), and Specialist Health Science Formulary from the Indonesian Pediatrician Association (IDAI), followed by classification with the Anatomical Therapeutical Chemical (ATC). The results showed that there were 120 samples, of which 56% are males, while 42% are within the age range of 6–12 years. The most common diagnoses were SNRS, followed by epilepsy and anemia. A total of 393 drugs were used in this study and analgesic-antipyretic was the most prescribed. The prevalence of off-label drug usage in pediatric patients was 19.6%, where the off-label age was higher (16.29%) than indication (2,81%) and doses (0,5). Furthermore, most of these medications were for the cardiovascular, respiratory, digestive, and metabolic systems. There has been a 19,6% prevalence in the use of off-label drug among pediatric outpatients, where off-label age was the highest, and most of the medication are used for the treatment of the cardiovascular system.

Off-label drug use in an adult intensive care unit of a Brazilian hospital

The objective of this study was to determine the prevalence and describe the factors associated with off-label drug use in an adult intensive care unit (ICU) of a Brazilian hospital. An analytical, cross-sectional, prospective study was conducted in the adult ICU population from March 2018 to May 2018. Off-label use of medication was classified by indication, dosage, route of administration, type and volume of diluent, and duration of administration. Most patients were female (57.89%), non-elderly (56.14%), and had a mean age of 54.44 ± 17.15 years. The prevalence of off-label drug use was 70.31%, but was not associated with the clinical severity of the patients. A statistically significant association was observed between label use of drugs and prescribing potentially inappropriate medicines (PIM). The most common reasons for off-label drug use were therapeutic indication (19.58%) and volume of diluent (23.30%). Drug administration by enteral tubes accounted for the largest number of off-label uses due to route of administration (90.85%). There was a higher prevalence of off-label use of systemic antimicrobials (14.44%) and norepinephrine (9.28%). Our study provided a broad characterization of off-label drug use in an adult ICU and showed why it is important for health professionals to evaluate the specific risks and benefits of this practice.

Prevalence of Off-label Drug Use in Neonatal Intensive Care Unit of a Tertiary Care Teaching Hospital in India

Prevalence of Off-label Drug Use in Neonatal Intensive Care Unit of a Tertiary Care Teaching Hospital in India

Off-label use of drugs by age in Brazilian children: a population study.

To estimate the prevalence of off-label drug use by age in children 12 years old and younger in Brazil. Population-based cross-sectional study (National Survey on Access, Use and Promotion of Rational Use of Medicines - PNAUM), including 7,528 children aged 12 years or younger. Face-to-face interviews were used to collect the data in the domiciles. The age-related off-label classification was carried out using the electronic medication compendium of National Agency of Sanitary Surveillance (ANVISA). Sociodemographic characteristics, presence of chronic disease, use of health services and characteristics of the informant were collected. Data were expressed by relative frequencies and 95% confidence intervals. Pearson's chi-square test was used to evaluate the statistical significance of the differences between the groups, with a significance level of 5%. Main outcome measure was the prevalence of off-label use. The prevalence of off-label use by age was 18.7% (95%CI 16.4 - 21.3). Children younger than 2 years old presented the highest prevalence of off-label use. The most frequently used off-label drugs by age were amoxicillin, nimesulide and the combination of phenylephrine and brompheniramine. The off-label use of drugs by age is common in the Brazilian pediatric population, especially among children under two years old.

Drug use beyond the licence in palliative care: A systematic review and narrative synthesis

Drug use beyond the licence (off-label use, off-label drug use) is a common practice in palliative care and respective recommendations can often be identified in the literature. It is both risky and offers opportunities at the same time and, therefore, requires special attention in clinical practice. To determine the prevalence of off-label drug use in palliative care and to identify, evaluate and critically appraise studies describing the clinical practice, healthcare professionals' awareness, knowledge and attitudes towards off-label-use and management strategies. Systematic literature review following the guidance of the Centre for Reviews and Dissemination. Medline, Embase, Web of Science and Current Contents Connect were searched in July 2018 as well as hand searches. The reference lists of pertinent studies were screened for further relevant publications, and citation tracking was performed. Eight studies met the inclusion criteria. Due to the variety in study designs and settings, no meta-analysis or meaningful statistical analysis was possible and a narrative synthesis of the data was performed. Frequency of off-label drug use ranged from 14.5% to 35%. Up to 97% of palliative care units did not have any policy or guidance on handling off-label drug use. About 20% of prescribers never obtain consent in the context of off-label use. Off-label use is common in palliative care with up to one-third of prescriptions affected. Challenges are often related to obtaining informed consent. Little is known about the decision-making process. More information and guidance for the prescribers are needed to enable safe handling of drugs outside their licence in palliative care.

Off-label drug use in human immunodeficiency virus disease.

We wished to determine the extent to which drugs used to treat HIV disease and its clinical manifestations are prescribed for conditions other than those listed on the U.S. Food and Drug Administration's approved drug label, how such "off-label" use varies by patient characteristics and type of HIV-related medical condition, and the extent to which physicians alter the way they treat HIV-related conditions because of reimbursement problems associated with off-label drug use. We surveyed 1,530 primary care providers for people with HIV disease between February and May 1993. A three-part survey instrument was used to obtain data on the drugs prescribed for the last three patients with HIV disease treated by the provider, the preferred choice of therapy for 32 specific HIV-related conditions, and the extent to which providers faced reimbursement problems regarding the use of drugs for off-label indications. Three drug compendia were used as cited sources of off-label drug uses. In all, 387 (32%) evaluable surveys were returned, yielding data on 1,148 patients. The majority (81%) of patients received at least one drug off-label, and almost half (40%) of all reported drug therapy was off-label. Most off-label drug use was for treatment and prevention of HIV-related opportunistic infections, which frequently represented the community standard of practice (e.g., trimethoprim/sulfamethoxazole for prevention of Pneumocystis carinii pneumonia), or the de facto standard of practice when no licensed therapies were available (e.g., drugs for treatment of Mycobacterium avium complex, MAC). More than 75% of off-label usage was cited in at least one of the three authoritative medical compendia. The use of drugs for off-label indications in HIV care is common and frequently represents community standards of care. Reliance on drug compendia for support of off-label drug use accounts for the majority of such uses, although many legitimate off-label uses may not be included because of compendia publication lag. The prevalence of off-label drug use in routine clinical practice and the development of newer and more costly drugs for treatment of HIV and its medical complications argues for the articulation of an explicit national reimbursement policy for off-label uses of prescription drugs so that medically appropriate therapies will be available to those with insurance in a rational, consistent way.