“Off-label” use occurs when a medication is prescribed for non-approved purposes. This case study explored physician experiences with prescribing gabapentin off-label. Semi-structured interviews with 10 specialists in the Greater Toronto Area provided data that were analyzed using qualitative content analysis. Specialists described prescribing gabapentin off-label as common practice and few expressed concerns about its safety. Knowledge from various interconnected sources influenced off-label prescribing decisions. These included: social knowledge, scientific knowledge, knowledge of the drug, knowledge of the patient, and experiential knowledge. Findings were similar to previous studies examining physician prescribing behaviour. Furthermore, lack of provincial-government reimbursement for off-label uses of gabapentin (knowledge of drug coverage) was a significant barrier to prescribing. Off-label prescribing differs from other types of prescribing since there is often a lack of scientific evidence for off-label uses. The complexities of the off-label prescribing process and the degree of importance between the various influences require further exploration.

“Off-label” use occurs when a medication is prescribed for non-approved purposes. This case study explored physician experiences with prescribing gabapentin off-label. Semi-structured interviews with 10 specialists in the Greater Toronto Area provided data that were analyzed using qualitative content analysis. Specialists described prescribing gabapentin off-label as common practice and few expressed concerns about its safety. Knowledge from various interconnected sources influenced off-label prescribing decisions. These included: social knowledge, scientific knowledge, knowledge of the drug, knowledge of the patient, and experiential knowledge. Findings were similar to previous studies examining physician prescribing behaviour. Furthermore, lack of provincial-government reimbursement for off-label uses of gabapentin (knowledge of drug coverage) was a significant barrier to prescribing. Off-label prescribing differs from other types of prescribing since there is often a lack of scientific evidence for off-label uses. The complexities of the off-label prescribing process and the degree of importance between the various influences require further exploration.

Zugl.: Mannheim, Univ., Diss., 2008

Class of 2016 Abstract / Objectives: The specific aims of this study were: 1) describe the frequency of off-label medication use in pediatric discharge medication regimens, 2) compare the frequency of FDA-approved and off-label medication use in pediatric discharge medication regimens, and 3) identify potential patient-specific risk factors, including use off-label use of medications, associated with 90-day readmission. Methods: This was a retrospective chart review of pediatric patients admitted to a tertiary academic medical center during a 6-month period. Inclusion criteria included age less than 18 years of age and admission between January 1, 2014 and June 30, 2014. Exclusion criteria included admission for oncology chemotherapy, admitted < 24 hours, admission to NICU only and patient expiration prior to discharge. Data collection included patient demographics, types and number of medications, and FDA approved and off-label indication of medications. Data analyses were completed on STATA 11.0 (College Station, TX) including student t-test/Mann Whitney U and Chi square/Fisher Exact test with a priori of α= 0.05. Results: A total of 706 admissions were included in the study. There were no significant differences in demographic characteristics between groups (readmitted within 90 days of discharge vs. not readmitted within 90 days of discharge) except sex (males vs. females, 56.3% vs. 44.2%, p=0.034). Length of hospital stay was significantly higher in subjects readmitted within 90 days of discharge compared to those who were not (8.55 ± 12.5 vs. 3.79 ± 4.43 days, p<0.001). Number of medications at discharge (7.31 ± 5.92 vs. 2.91 ± 2.93, p<0.001) and total number of non-FDA approved medications (3.16 ± 3.81 vs. 1.12 ± 1.44, p<0.001) were all significantly higher in subjects readmitted within 90 days of discharge compared to those who were not. The percentages of patients taking medications related to cardiovascular (6.1% vs. 2.4%, p=0.002), electrolytes and nutrition (12.2% vs. 8.5%, p=0.007), and gastrointestinal (19.2% vs. 14.3%, p=0.004) disorders were significantly higher in the subjects readmitted within 90 days of discharge compared to those who were not. Additonally, subjects readmitted within 90 days of discharge (versus those not readmitted within 90 days) demonstrated less use of medications related to neurology (17.7% vs. 25.8%, p<0.001) and respiratory (16.4% vs. 21.4%, p=0.008) disorders. A significantly higher percentage of subjects whose third party payor was Medicaid, were readmitted within 90-days of discharge (69.7% vs. 58.3, p=0.045). Conclusions: In comparing several characteristics of pediatric patients readmitted to a tertiary medical center within 90 days of discharge versus those who were not, it was noted that several factors may be associated with readmission, including: sex, length of initial hospital stay, third-party payor, and the number of medications as well as the types of medication a patient takes. Future research may be warranted to further investigate these potential patient-specific factors in helping identify children at increased risk for readmission and develop more effective approaches to patient education, discharge planning, and continuity of care to reduce preventable readmission.

Objectives: The study objectives were to (1) determine the types and frequency of off-label (OL) or unlicensed (UL) medications used in a pediatric emergency department (PED) and before admission, (2) describe OL/UL-associated adverse drug events (ADEs) resulting in admission to the PED and those occurring during patient care in PED, and (3) determine the outcomes of these ADEs. Methods: Medical records of patients 18 years or younger admitted to the PED over a 5-month period were reviewed. Off-label/UL use of medications was determined based on Food and Drug Administration-approved labeling. The Adverse Drug Reaction Probability Scale was used to determine ADE causality. Data were analyzed using descriptive statistics. Results: A total of 2191 patients with 6675 medication orders were evaluated. About 26.2% (n = 1712) of medication orders were considered as OL/ UL use; 70.5% (n = 1208) of these medications were ordered as part of treatment in the PED, and the remaining 29.5% (n = 504) were home medications before their PED evaluation. Inhaled bronchodilators (30.4%), antimicrobials (14.8%), and antihistamines/antiemetics (9.1%) were the most common OL/UL medication classes. The frequency of ADEs among licensed medication use was greater compared with OL/UL use by 2-fold. Reported overall rate of ADEs was 0.6% (n = 40). Of these 40 ADEs, 5 resulted from the use of an OL/UL medication, 3 from home medication use, and 2 from PED-prescribed medications. Conclusions: The frequency of reported ADEs associated with OL/UL medications was less than the frequency of ADEs from licensed medication use, with overall ADE frequency of less than 1%.

Introdução: O uso de formas farmacêuticas inadequadas à pediatria, também conhecido como uso off-label, pode levar a uma terapia medicamentosa insegura. No ambiente hospitalar, em especial nas Unidades de Terapia Intensiva Pediátrica, há alta prevalência de prescrições com medicamentos não apropriados para crianças, entre eles os antimicrobianos, devido à gravidade das infecções, o estado crítico dos pacientes internados, a maior realização de procedimentos invasivos e uma maior incidência de bactérias resistentes. Em geral, o uso de antimicrobianos em crianças, bem como dos demais grupos farmacológicos, tem sido baseado principalmente em extrapolações e adaptações do uso em adultos, informações obtidas de raros estudos observacionais e consensos de especialistas na área. Devido ao estado crítico dos pacientes, as complexas terapias envolvendo antimicrobianos nem sempre são feitas de forma adequada, podendo trazer prejuízos à saúde dos pacientes e contribuir, ainda, para a resistência bacteriana. Objetivo: Avaliar a incidência do uso de antimicrobianos em pacientes internados em Unidade de Terapia Intensiva Pediátrica. Método: Estudo do tipo transversal realizado na Unidade de Terapia Intensiva Pediátrica do município de Rio Branco, Acre, no período de agosto de 2014 a julho de 2015. A amostra foi composta por 246 crianças de zero a onze anos de idade, internadas com quaisquer patologias. Foram analisadas as prescrições das primeiras 24 horas. Pesquisou-se o uso off label de antimicrobianos e potenciais interações medicamentosas com esses medicamentos. Resultados: Duzentas e trinta e uma crianças (93,9 por cento ) receberam a prescrição de pelo menos um antimicrobiano. O antimicrobiano mais prescrito foi a ceftriaxona. Em média, cada paciente recebeu dois antimicrobianos. Em 66,8 por cento dos casos, houve uso off-label, sendo a dose prescrita superior ao recomendado em 41 por cento , dos casos. Em 56 por cento das prescrições havia pelo menos uma potencial interação medicamentosa envolvendo antimicrobianos. Ampicilina e gentamicina foram os antibióticos que mais se envolveram em interações. Conclusões: a alta frequência do uso off-label e interações medicamentosas potenciais envolvendo antimicrobianos foi confirmada neste estudo. Tratar crianças como adultos pequenos pode expor esses pacientes a eventos adversos a medicamentos que comprometem a segurança desse grupo específico de pacientes. Isso aponta para a necessidade de equipes multidisciplinares trabalharem em conjunto e serem estimuladas a realizar mais estudos que garantam a segurança do uso de medicamentos na pediatria. / Introduction: The use of inadequate dosage forms for pediatrics, also known as off-label use, may lead to unsafe drug therapy. In the hospital environment, especially in Pediatric Intensive Care Units, there is a high prevalence of prescriptions with drugs not suitable for children, among them antimicrobial agents, due to the severity of the infections, the critical state of the hospitalized patients, more accomplishment of invasive procedures and a higher incidence of resistant bacteria. In general, the use of antimicrobials in children, as well as other pharmacological groups, has been based mainly on extrapolations and adaptations of the use in adults. This information was obtained from rare observational studies and consensus of specialists in the area. Due to the critical condition of patients, the complex therapies involving antimicrobial agents are not always adequately done, which may cause harm to the patients\' health and also contribute to bacterial resistance. Objective: To evaluate the incidence of antimicrobial use in patients hospitalized in a Pediatric Intensive Care Unit. Method: A cross-sectional study conducted at the Pediatric Intensive Care Unit of the municipality of Rio Branco, Acre, from August 2014 to July 2015. The sample consisted of 246 children from zero to eleven years old and hospitalized with any pathologies. The prescriptions of the first 24 hours were analyzed. The use of off-label antimicrobials and potential drug interactions with these drugs was investigated. Results: Two hundred and thirty-one children (93.9 per cent ) received the prescription of at least one antimicrobial. The most commonly prescribed antimicrobial agent was ceftriaxone. On average, each patient received two antimicrobials. In 66.8 per cent of cases, there was an off-label use, with the prescribed dose being higher than recommended in 41 per cent of the cases. In 56 per cent of prescriptions there was at least one potential drug interaction involving antimicrobials. Ampicillin and gentamicin were the antibiotics most involved in interactions. Conclusions: the high frequency of off-label use and potential drug interactions involving antimicrobials was confirmed in this study. Treating children as young adults may expose these patients to adverse drug events that compromise the safety of this particular group of patients. That points to the need for multidisciplinary teams to work together and be encouraged to carry out more studies that ensure the safety of use of medication in pediatrics.

Objetivos: Determinar a frequência de prescrições de medicamentos off label e não licenciados para pediatria na Atenção Primária à Saúde do município de Viamão, no Rio Grande do Sul. Método: Estudo descritivo, analisando prescrições de 323 pacientes emitidas de Agosto a Dezembro de 2012 em duas unidades de atenção primária do Sistema Público de Saúde do município de Viamão, no Rio Grande do Sul. Resultados: Durante o período estudado obteve-se a prescrição de 731 medicamentos e houve frequência de 31,7% de medicamentos prescritos off label, especialmente anti-histamínicos e antiasmáticos (32,3% e 31,5%, respectivamente). O principal tipo de prescrição off-label foi dose (38,8%), seguida de idade (31,5%) e de frequência de administração (29,3%). Com relação à prescrição off label de dose, foi mais frequente a sobredose 93,3% do que a subdose 6,7%. Não foram encontradas prescrições de medicamentos não licenciados. Discussão e Conclusão: As dificuldades relacionadas às pesquisas com crianças propiciam a prescrição de medicamentos off label, prática que, apesar de não ser ilegal, gera insegurança em relação aos possíveis efeitos adversos em uma população com características peculiares como a pediátrica. O estudo mostrou que esta prática é comum na Atenção Primária a Saúde em uma cidade do Rio Grande do Sul, a exemplo de pesquisas em cidades europeias. Este é o primeiro estudo que analisa a frequência de prescrição de medicamentos off label no âmbito ambulatorial do Sistema Único de Saúde no país e espera-se que possa contribuir para a busca de alternativas que promovam o uso racional de medicamentos na pediatria. / Objectives: To determine the frequency of prescriptions for off label and unlicensed medicines for pediatrics at Viamão Primary Health Care in Rio Grande do Sul. Method: Descriptive study analyzing prescriptions of 323 patients, issued from August to December 2012, in two primary care units of Viamão Public Health System in Rio Grande do Sul. Results: During the study period 731 prescription drugs were observed. Off label frequency was 31.7%, especially antihistamines and anti-asthmatic prescriptions (32.3% and 31.5%, respectively). The main type of off-label prescribing was dose (38.8%), followed by age (31.5%) and frequency of administration (29.3%). Regarding the prescription off label of dose, was more frequent overdose (93.3%) than underdose (6.7%). No prescriptions for unlicensed medicines were found. Discussion and Conclusion: The difficulties related to research with children favor prescription drugs off label, a practice that is not illegal, but may produce adverse effects in a population with unique characteristics such as pediatric. The study showed that this practice is common in Primary Health Care in a city in Rio Grande do Sul, as it is in Europe, as reported by other researches. This is the first study that analyzes the frequency of off-label prescribing of drugs in outpatient under the National Health System in Brazil and it is expected to be able to contribute to the search for alternatives that promote rational drug use in pediatrics.

Introdução: O uso de formas farmacêuticas inadequadas à pediatria, também conhecido como uso off-label, pode levar a uma terapia medicamentosa insegura. No ambiente hospitalar, em especial nas Unidades de Terapia Intensiva Pediátrica, há alta prevalência de prescrições com medicamentos não apropriados para crianças, entre eles os antimicrobianos, devido à gravidade das infecções, o estado crítico dos pacientes internados, a maior realização de procedimentos invasivos e uma maior incidência de bactérias resistentes. Em geral, o uso de antimicrobianos em crianças, bem como dos demais grupos farmacológicos, tem sido baseado principalmente em extrapolações e adaptações do uso em adultos, informações obtidas de raros estudos observacionais e consensos de especialistas na área. Devido ao estado crítico dos pacientes, as complexas terapias envolvendo antimicrobianos nem sempre são feitas de forma adequada, podendo trazer prejuízos à saúde dos pacientes e contribuir, ainda, para a resistência bacteriana. Objetivo: Avaliar a incidência do uso de antimicrobianos em pacientes internados em Unidade de Terapia Intensiva Pediátrica. Método: Estudo do tipo transversal realizado na Unidade de Terapia Intensiva Pediátrica do município de Rio Branco, Acre, no período de agosto de 2014 a julho de 2015. A amostra foi composta por 246 crianças de zero a onze anos de idade, internadas com quaisquer patologias. Foram analisadas as prescrições das primeiras 24 horas. Pesquisou-se o uso off label de antimicrobianos e potenciais interações medicamentosas com esses medicamentos. Resultados: Duzentas e trinta e uma crianças (93,9 por cento ) receberam a prescrição de pelo menos um antimicrobiano. O antimicrobiano mais prescrito foi a ceftriaxona. Em média, cada paciente recebeu dois antimicrobianos. Em 66,8 por cento dos casos, houve uso off-label, sendo a dose prescrita superior ao recomendado em 41 por cento , dos casos. Em 56 por cento das prescrições havia pelo menos uma potencial interação medicamentosa envolvendo antimicrobianos. Ampicilina e gentamicina foram os antibióticos que mais se envolveram em interações. Conclusões: a alta frequência do uso off-label e interações medicamentosas potenciais envolvendo antimicrobianos foi confirmada neste estudo. Tratar crianças como adultos pequenos pode expor esses pacientes a eventos adversos a medicamentos que comprometem a segurança desse grupo específico de pacientes. Isso aponta para a necessidade de equipes multidisciplinares trabalharem em conjunto e serem estimuladas a realizar mais estudos que garantam a segurança do uso de medicamentos na pediatria. / Introduction: The use of inadequate dosage forms for pediatrics, also known as off-label use, may lead to unsafe drug therapy. In the hospital environment, especially in Pediatric Intensive Care Units, there is a high prevalence of prescriptions with drugs not suitable for children, among them antimicrobial agents, due to the severity of the infections, the critical state of the hospitalized patients, more accomplishment of invasive procedures and a higher incidence of resistant bacteria. In general, the use of antimicrobials in children, as well as other pharmacological groups, has been based mainly on extrapolations and adaptations of the use in adults. This information was obtained from rare observational studies and consensus of specialists in the area. Due to the critical condition of patients, the complex therapies involving antimicrobial agents are not always adequately done, which may cause harm to the patients\' health and also contribute to bacterial resistance. Objective: To evaluate the incidence of antimicrobial use in patients hospitalized in a Pediatric Intensive Care Unit. Method: A cross-sectional study conducted at the Pediatric Intensive Care Unit of the municipality of Rio Branco, Acre, from August 2014 to July 2015. The sample consisted of 246 children from zero to eleven years old and hospitalized with any pathologies. The prescriptions of the first 24 hours were analyzed. The use of off-label antimicrobials and potential drug interactions with these drugs was investigated. Results: Two hundred and thirty-one children (93.9 per cent ) received the prescription of at least one antimicrobial. The most commonly prescribed antimicrobial agent was ceftriaxone. On average, each patient received two antimicrobials. In 66.8 per cent of cases, there was an off-label use, with the prescribed dose being higher than recommended in 41 per cent of the cases. In 56 per cent of prescriptions there was at least one potential drug interaction involving antimicrobials. Ampicillin and gentamicin were the antibiotics most involved in interactions. Conclusions: the high frequency of off-label use and potential drug interactions involving antimicrobials was confirmed in this study. Treating children as young adults may expose these patients to adverse drug events that compromise the safety of this particular group of patients. That points to the need for multidisciplinary teams to work together and be encouraged to carry out more studies that ensure the safety of use of medication in pediatrics.

Objetivos: Determinar a frequência de prescrições de medicamentos off label e não licenciados para pediatria na Atenção Primária à Saúde do município de Viamão, no Rio Grande do Sul. Método: Estudo descritivo, analisando prescrições de 323 pacientes emitidas de Agosto a Dezembro de 2012 em duas unidades de atenção primária do Sistema Público de Saúde do município de Viamão, no Rio Grande do Sul. Resultados: Durante o período estudado obteve-se a prescrição de 731 medicamentos e houve frequência de 31,7% de medicamentos prescritos off label, especialmente anti-histamínicos e antiasmáticos (32,3% e 31,5%, respectivamente). O principal tipo de prescrição off-label foi dose (38,8%), seguida de idade (31,5%) e de frequência de administração (29,3%). Com relação à prescrição off label de dose, foi mais frequente a sobredose 93,3% do que a subdose 6,7%. Não foram encontradas prescrições de medicamentos não licenciados. Discussão e Conclusão: As dificuldades relacionadas às pesquisas com crianças propiciam a prescrição de medicamentos off label, prática que, apesar de não ser ilegal, gera insegurança em relação aos possíveis efeitos adversos em uma população com características peculiares como a pediátrica. O estudo mostrou que esta prática é comum na Atenção Primária a Saúde em uma cidade do Rio Grande do Sul, a exemplo de pesquisas em cidades europeias. Este é o primeiro estudo que analisa a frequência de prescrição de medicamentos off label no âmbito ambulatorial do Sistema Único de Saúde no país e espera-se que possa contribuir para a busca de alternativas que promovam o uso racional de medicamentos na pediatria. / Objectives: To determine the frequency of prescriptions for off label and unlicensed medicines for pediatrics at Viamão Primary Health Care in Rio Grande do Sul. Method: Descriptive study analyzing prescriptions of 323 patients, issued from August to December 2012, in two primary care units of Viamão Public Health System in Rio Grande do Sul. Results: During the study period 731 prescription drugs were observed. Off label frequency was 31.7%, especially antihistamines and anti-asthmatic prescriptions (32.3% and 31.5%, respectively). The main type of off-label prescribing was dose (38.8%), followed by age (31.5%) and frequency of administration (29.3%). Regarding the prescription off label of dose, was more frequent overdose (93.3%) than underdose (6.7%). No prescriptions for unlicensed medicines were found. Discussion and Conclusion: The difficulties related to research with children favor prescription drugs off label, a practice that is not illegal, but may produce adverse effects in a population with unique characteristics such as pediatric. The study showed that this practice is common in Primary Health Care in a city in Rio Grande do Sul, as it is in Europe, as reported by other researches. This is the first study that analyzes the frequency of off-label prescribing of drugs in outpatient under the National Health System in Brazil and it is expected to be able to contribute to the search for alternatives that promote rational drug use in pediatrics.

L’utilisation des antipsychotiques (AP) pour une indication non approuvée autrement dite off-label, peut être associée avec des effets indésirables graves chez les ainés. Étant donné le peu d’études portant sur le sujet, cette étude vise à déterminer la prévalence et les facteurs associés à l’utilisation off-label des AP chez les ainés âgés ≥ 65 ans vivant dans la communauté au Québec. Des analyses secondaires des données provenant de 2 enquêtes «l’Étude sur la Santé des Aînés» (ESA) et ESA-Services, étaient effectuées sur un échantillon total de 4018 ainés. L’utilisation off-label d’AP était définie par l’absence d’une indication approuvée selon la liste d’approbation publiée par Santé Canada en juin 2016, durant la même année. Les diagnostics ont été repérés dans les registres administratifs des services médicaux et pharmaceutiques de la « Régie de l’Assurance médicale du Québec» (RAMQ) en utilisant les codes internationaux de maladies (CIM-9) validés par d’autres études, et les codes CIM-10 appropriés selon la formule de changement CIM-9/10 fournie par la RAMQ. Le cadre conceptuel d’Andersen & Newman conçu pour expliquer le comportement de l'utilisation des services de santé selon trois catégories de facteurs (prédisposant, facilitants et de besoin) a été utilisé pour étudier, avec des régressions multinomiales, l’utilisation off-label des AP comparée à la non-utilisation et à l’utilisation approuvée dite labeled. La prévalence d’utilisation d’AP dans cet échantillon d’ainés était estimée à 2.5%. Parmi les utilisateurs d’AP, 78% étaient considérés comme off-label. L’utilisation off-label des antipsychotiques comparée à la non-utilisation était associée à l’âge (RC : 0.46; 95%CI: 0.27-0.78) , le niveau de scolarité (RC: 2.68; 95%IC: 1.64- 4.40), le nombre de visites ambulatoires incluant les visites chez le médecin traitant (≥ 6) (RC: 2.39; 95%IC: 1.34- 4.25), l’utilisation d’antidépresseurs ou de benzodiazépines (RC: 5.81; 95%IC: 3.31- 10.21), et la présence d’un syndrome cérébral organique et de la maladie d’Alzheimer (RC: 5.73; 95%IC: 1.74- 18.89). L’utilisation off-label des AP comparée à l’utilisation labeled était associée avec l’insomnie (RC: 0.13; 95%IC: 0.02- 0.91) et la dépression majeure (RC: 0.02; 95%IC: <0.01-0.11). Cette étude a montré une prévalence élevée de l’utilisation off-label des AP chez les ainés vivant dans la communauté au Québec. En résumé, l’utilisation off-label des AP était associée à la présence de visites ambulatoires répétées, l’utilisation d’autres médicaments psychotropes et la présence d’un syndrome cérébral organique, reflétant potentiellement un profil des cas cliniques plus complexes. / Abstract: The risk of using antipsychotics (AP) for off-label indications may outweigh the benefits in older adults. Due to the scarcity of studies describing off-label use of AP in older adults, this study aimed to determine the prevalence of the off-label use of AP in Quebec, and to determine, using Andersen & Newman’s model of healthcare seeking behaviour, the predisposing, enabling and need factors associated with the off-label use of AP. We used data from a socio-demographically (age, sex, and postal code representing population density) weighted sample (n = 4018) of older adults living in the community and who participated in the «Enquête sur la Santé des Aînés» (ESA) and ESA-Services health studies. AP use was identified from the RAMQ pharmaceutical registry. The presence of off-label use of AP (yes/no) was identified from validated ICD-9/10 diagnoses codes found in the RAMQ and MED-ÉCHO medical services and hospitalisations databases. The off-label use of AP was defined by the absence, during the same one-year period, of an approved indication for a delivered AP, according to Health Canada’s approval database as of June 2016. Multinomial logistic regression was used to study the off-label use of AP as compared to both labeled use and non-use as a function of predisposing, enabling and need factors. In this study, the prevalence of AP use reached 2.5%, of which 78% was off-label. Compared to non-use, off-label AP use was associated with age (OR: 0.46; 95%CI: 0.27-0.78); education level (OR: 2.68; 95% CI: 1.64- 4.40), a higher number of outpatient visits including physicians visits (OR: 2.39; 95%CI: 1.34- 4.25), antidepressant or benzodiazepine use (OR: 5.81; 95%CI: 3.31- 10.21), and the presence of an organic brain syndrome & Alzheimer’s disease (OR: 5.73; 95%CI: 1.74- 18.89). Compared to labeled use, off-label use was less likely in those with major depression (OR: 0.02; 95%CI: <0.01-0.11) and insomnia (OR: 0.13; 95%CI: 0.02- 0.91). In summary, off-label use is highly prevalent among community living older adults using AP. Off-label use was associated with the presence of an organic brain syndrome & Alzheimer’s disease, other psychotropic drug use and with increased outpatient visits, suggesting the off-label use of AP in more complex and severe clinical cases. Future longitudinal studies should focus on health related changes among incident off-label users of AP.