Can mind-altering prescription medicines be safe? Lessons from ketamine and esketamine.

INTRODUCTION: Recent decades have witnessed an extraordinary global crisis of drug misuse. Although opioid analgesics receive the most attention, numerous other drugs have increased rates of misuse. KETAMINE AND ESKETAMINE: Ketamine and esketamine offer a unique natural experiment to explore two medications that are similar pharmacologically but differ in their availability to users and in their regulation by government agencies. MISUSE AND ABUSE OF KETAMINE AND ESKETAMINE: Multisystem "mosaic" surveillance of many drugs using real-world data has emerged in recent years. Ketamine and esketamine have been monitored concurrently. Ketamine is much more widely available than esketamine and shows clear signs of increasing misuse and abuse. In contrast, esketamine is difficult to detect in postmarket surveillance even though availability is increasing. DISCUSSION: Ketamine and esketamine offer insights regarding the safety of prescription medications with the potential for misuse. Since the pharmacology of ketamine and esketamine are similar, the regulatory apparatus may be the primary difference that limits misuse. Ketamine has few restrictions and can be prescribed or administered by many healthcare providers, and is available as an illicit drug. In contrast, the product labeling for esketamine has rigorous restrictions on its use. Many important issues remain to be addressed. We need a more rigorous evaluation of the natural experiment of ketamine and esketamine. How does this experience relate to the introduction of new psychedelics? CONCLUSIONS: Ketamine misuse use and misuse are increasing while esketamine use in increasing, but misuse is not increasing. It is reasonable to reevaluate the regulatory controls on ketamine to reduce its misuse and abuse.

Dispensed prescription medications and short-term risk of pulmonary embolism in Norway and Sweden.

Scandinavian electronic health-care registers provide a unique setting to investigate potential unidentified side effects of drugs. We analysed the association between prescription drugs dispensed in Norway and Sweden and the short-term risk of developing pulmonary embolism. A total of 12,104 pulmonary embolism cases were identified from patient- and cause-of-death registries in Norway (2004-2014) and 36,088 in Sweden (2005-2014). A case-crossover design was used to compare individual drugs dispensed 1-30 days before the date of pulmonary embolism diagnosis with dispensation in a 61-90 day time-window, while controlling for the receipt of other drugs. A BOLASSO approach was used to select drugs that were associated with short-term risk of pulmonary embolism. Thirty-eight drugs were associated with pulmonary embolism in the combined analysis of the Norwegian and Swedish data. Drugs associated with increased risk of pulmonary embolism included certain proton-pump inhibitors, antibiotics, antithrombotics, vasodilators, furosemide, anti-varicose medications, corticosteroids, immunostimulants (pegfilgrastim), opioids, analgesics, anxiolytics, antidepressants, antiprotozoals, and drugs for cough and colds. Mineral supplements, hydrochlorothiazide and potassium-sparing agents, beta-blockers, angiotensin 2 receptor blockers, statins, and methotrexate were associated with lower risk. Most associations persisted, and several additional drugs were associated, with pulmonary embolism when using a longer time window of 90 days instead of 30 days. These results provide exploratory, pharmacopeia-wide evidence of medications that may increase or decrease the risk of pulmonary embolism. Some of these findings were expected based on the drugs' indications, while others are novel and require further study as potentially modifiable precipitants of pulmonary embolism.

EMR-Documented Contraception for Patients Prescribed Medications With Adverse Perinatal Outcomes.

This cross-sectional study examines the rates of method of contraception documentation in the electronic medical record (EMR) for patients receiving 1 of 3 drugs known to be associated with adverse perinatal outcomes.

Prescription Medication Use in Pregnancy in People with Disabilities: A Population-Based Cohort Study.

Background: Individuals with disabilities may require specific medications in pregnancy. The prevalence and patterns of medication use, overall and for medications with known teratogenic risks, are largely unknown. Methods: This population-based cohort study in Ontario, Canada, 2004-2021, comprised all recognized pregnancies among individuals eligible for public drug plan coverage. Included were those with a physical (n = 44,136), sensory (n = 13,633), intellectual or developmental (n = 2,446) disability, or multiple disabilities (n = 5,064), compared with those without a disability (n = 299,944). Prescription medication use in pregnancy, overall and by type, was described. Modified Poisson regression generated relative risks (aRR) for the use of medications with known teratogenic risks and use of ≥2 and ≥5 medications concurrently in pregnancy, comparing those with versus without a disability, adjusting for sociodemographic and clinical factors. Results: Medication use in pregnancy was more common in people with intellectual or developmental (82.1%), multiple (80.4%), physical (73.9%), and sensory (71.9%) disabilities, than in those with no known disability (67.4%). Compared with those without a disability (5.7%), teratogenic medication use in pregnancy was especially higher in people with multiple disabilities (14.2%; aRR 2.03, 95% confidence interval [CI]: 1.88-2.20). Furthermore, compared with people without a disability (3.2%), the use of ≥5 medications concurrently was more common in those with multiple disabilities (13.4%; aRR 2.21, 95% CI: 2.02-2.41) and an intellectual or developmental disability (9.3%; aRR 2.13, 95% CI: 1.86-2.45). Interpretation: Among people with disabilities, medication use in pregnancy is prevalent, especially for potentially teratogenic medications and polypharmacy, highlighting the need for preconception counseling/monitoring to reduce medication-related harm in pregnancy.

Adolescent Use, Diversion Sources, and Perceived Procurement Difficulty of Prescription Medications.

This study examines trends in medical use, nonmedical use, diversion sources, and perceived procurement difficulty of prescription medications for nonmedical use among US adolescents.

Patterns of paternal medication dispensation around the time of conception.

BACKGROUND: Past research on the safety of prenatal exposure to medications has focused on maternal use during gestation, with limited research into the potential effects of paternal use during the spermatogenic period preceding conception. Knowing the most common medications used by fathers around the time of conception can inform research priorities in this field. OBJECTIVES: To identify the most common medications dispensed to fathers in the preconception period. METHODS: Within the MarketScan research database of commercially insured individuals in the United States from 2011 to 2020, we identified pregnancies, estimated the date of conception, linked each pregnancy to the father using family enrolment information and required minimum enrolment period and prescription benefits. Then, we described the use of prescription medications by the father during the 90 days before conception based on pharmacy dispensation claims. RESULTS: Of 4,437,550 pregnancies, 51.6% were linked with a father. Among the 1,413,762 pregnancies connected with a father that also met the inclusion criteria, the most common classes of medications dispensed were psychotropics (8.66%), antibiotics (7.21%), and analgesics (6.82%). The most frequently dispensed medications were amoxicillin (3.75%), azithromycin (3.15%), fluticasone (2.70%) and acetaminophen/hydrocodone (2.70%). Some fathers filled prescriptions for medications associated with foetal embryopathy when used by the mother, including mycophenolate (0.04%), methotrexate (0.03%) and isotretinoin (0.02%). CONCLUSIONS: More than a third of fathers filled at least one prescription medication in the preconception period, and several of them are known to be embryotoxic, emphasizing the necessity for further investigation into the potential teratogenicity of paternal exposure.

Prescribed Drug Use and Aneurysmal Subarachnoid Hemorrhage Incidence: A Drug-Wide Association Study.

BACKGROUND AND OBJECTIVES: Current benefits of invasive intracranial aneurysm treatment to prevent aneurysmal subarachnoid hemorrhage (aSAH) rarely outweigh treatment risks. Most intracranial aneurysms thus remain untreated. Commonly prescribed drugs reducing aSAH incidence may provide leads for drug repurposing. We performed a drug-wide association study (DWAS) to systematically investigate the association between commonly prescribed drugs and aSAH incidence. METHODS: We defined all aSAH cases between 2000 and 2020 using International Classification of Diseases codes from the Secure Anonymised Information Linkage databank. Each case was matched with 9 controls based on age, sex, and year of database entry. We investigated commonly prescribed drugs (>2% in study population) and defined 3 exposure windows relative to the most recent prescription before index date (i.e., occurrence of aSAH): current (within 3 months), recent (3-12 months), and past (>12 months). A logistic regression model was fitted to compare drug use across these exposure windows vs never use, controlling for age, sex, known aSAH risk factors, and health care utilization. The family-wise error rate was kept at p < 0.05 through Bonferroni correction. RESULTS: We investigated exposure to 205 commonly prescribed drugs between 4,879 aSAH cases (mean age 61.4, 61.2% women) and 43,911 matched controls. We found similar trends for lisinopril and amlodipine, with a decreased aSAH risk for current use (lisinopril odds ratio [OR] 0.63, 95% CI 0.44-0.90, amlodipine OR 0.82, 95% CI 0.65-1.04) and an increased aSAH risk for recent use (lisinopril OR 1.30, 95% CI 0.61-2.78, amlodipine OR 1.61, 95% CI 1.04-2.48). A decreased aSAH risk in current use was also found for simvastatin (OR 0.78, 95% CI 0.64-0.96), metformin (OR 0.58, 95% CI 0.43-0.78), and tamsulosin (OR 0.55, 95% CI 0.32-0.93). By contrast, an increased aSAH risk was found for current use of warfarin (OR 1.35, 95% CI 1.02-1.79), venlafaxine (OR 1.67, 95% CI 1.01-2.75), prochlorperazine (OR 2.15, 95% CI 1.45-3.18), and co-codamol (OR 1.31, 95% CI 1.10-1.56). DISCUSSION: We identified several drugs associated with aSAH, of which 5 drugs (lisinopril and possibly amlodipine, simvastatin, metformin, and tamsulosin) showed a decreased aSAH risk. Future research should build on these signals to further assess the effectiveness of these drugs in reducing aSAH incidence. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that some commonly prescribed drugs are associated with subsequent development of aSAH.

Eyelash serums: A comprehensive review.

BACKGROUND: Eyelash serums, both prescription and over-the-counter, are gaining popularity for enhancing the appearance of eyelashes through various biologically active molecules. Categorized into prostaglandin analogs and non-prostaglandin analogs, these serums claim increased strength, length, luster, and thickness. Current United States law also requires no efficacy or safety assessments by the Food and Drug Administration before approving products for consumer use, potentially posing health risks for patients seeking over-the-counter eyelash enhancements. AIMS: Our aims include exploring proposed benefits and adverse effects associated with eyelash serums, while providing evidence-based clinical recommendations on their use. We aim to contribute valuable insights to the understanding of eyelash serums and their respective safety considerations. METHODS: The authors conducted a comprehensive electronic search across databases including PubMed, Embase, Cochrane Central, and Google Scholar to evaluate eyelash serum ingredients. Articles were evaluated by two independent researchers for relevance, and the ingredients discussed were analyzed and given clinical recommendations for eyelash serums based off the Oxford Centre for Evidence-Based Medicine. RESULTS: Results highlight bimatoprost's efficacy, supported by numerous studies evaluating safety and adverse effects. Other prostaglandin ingredients show potential benefits, but further studies are encouraged to enhance the understanding of respective safety profiles. While non-prostaglandins ingredients show promising data, more studies are needed due to a lack of formal evidence in eyelash serum use. CONCLUSION: As the cosmeceutical market for eyelash serums is growing, dermatologists need to be knowledgeable about evidence-based information regarding prescription and over-the-counter eyelash serum products before making recommendations to patients.

Black Cohosh Interactions with Prescription Medications Associated with Serotonin Toxicity and Rhabdomyolysis: A Case Report.

BACKGROUND: Serotonin toxicity is a well-described phenomenon that is commonly attributed to a variety of drug-drug combinations. Some unregulated herbal supplements have been implicated in the onset of serotonin toxicity, however, there is currently minimal literature available on the potential for black cohosh to contribute to rhabdomyolysis and serotonin toxicity, in spite of its known serotonergic properties. CASE REPORT: A middle-aged woman presented to the emergency department with serotonin toxicity and rhabdomyolysis shortly after taking black cohosh supplements in the setting of long-term dual antidepressant use. The serotonin toxicity and rhabdomyolysis resolved with IV fluids, benzodiazepines, and discontinuation of the offending drugs. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Patients are sometimes not aware of how over-the-counter supplements might interact with their prescription medications. Female patients taking black cohosh to manage hot flashes and menopausal symptoms could be at risk for developing rhabdomyolysis and serotonin toxicity if they are also taking other serotonergic agents.

How Do Risk Evaluation and Mitigation Strategies Impact Clinical Practice? A National Survey of Physicians.

The US Food and Drug Administration can require risk evaluation and mitigation strategy (REMS) programs for prescription drugs to ensure the benefits of use outweigh the risks. We conducted a national survey of physicians' experiences prescribing eight REMS-covered drugs: (1) ambrisentan; (2) bosentan; (3) clozapine; (4) isotretinoin; (5-7) the multiple myeloma (MM) drugs lenalidomide, pomalidomide, thalidomide; and (8) sodium oxybate. Between May 2022 and January 2023, we surveyed 5,331 physician prescribers of these drugs, and 1,295 (24%) returned surveys (range: 149 for bosentan to 226 for MM drugs). Although 765 (68%) respondents thought the certification process provided useful drug information, 757 (67%) wanted materials to include benefit data and 944 (84%) non-REMS-related risk data. A majority (704, 63%) thought the safe use requirements facilitated discussion with patients, but a similar number (637, 57%) attributed delayed medication access to these requirements. In multivariable modeling, MM drug and isotretinoin respondents were less likely than sodium oxybate respondents to agree that the certification process provided useful drug information (MM drug: odds ratio (OR) = 0.37, 95% confidence interval (CI) = 0.25-0.55; isotretinoin: OR = 0.39, 95% CI = 0.25-0.61), and isotretinoin, clozapine, and bosetan respondents were more likely than sodium oxybate respondents to agree that the safe use requirements often delayed medication access (isotretinoin: OR = 5.83, 95% CI = 3.70-9.19; clozapine: OR = 1.65, 95% CI = 1.08-2.54; bosentan: OR = 1.78, 95% CI = 1.12-2.85). Most physicians believe REMS programs convey useful drug safety information and facilitate discussion with patients but also seek information on benefits and non-REMS-related risks and better integration of REMS processes into clinical workflows.

Healthcare providers' use of a concise summary to prescribe for lactating patients.

BACKGROUND: Most breastfeeding individuals take at least one prescription drug, yet limited data from lactation studies are available to inform the safety of these drugs during breastfeeding. As a result, healthcare providers (HCPs) rely on available information about safety of drugs used during pregnancy or on personal experiences to inform prescribing/counseling decisions for breastfeeding individuals. To improve risk communication regarding drugs used during lactation, the U.S. Food and Drug Administration published the Pregnancy and Lactation Labeling Rule (PLLR) in 2015, which added a narrative summary of available risk information to the lactation section of Prescribing Information (PI). Prior studies on labeling in PLLR format revealed that although HCPs found these details valuable, they regarded the narrative as too long to support decision-making during patient encounters. OBJECTIVE: This qualitative study's objective was to assess the utility of adding a concise summary to the Lactation subsection of PI to complement the narrative and succinctly communicate to busy HCPs a drug's risks when used during lactation. The concise summary consisted of a bolded headline, bulleted descriptions of available study findings and potential adverse reactions, and recommendations for risk mitigation. METHODS: Twenty-five online focus groups were conducted with five segments of HCPs to obtain their feedback on the concise summary and discuss their prescribing/counseling decisions for four fictitious prescription drugs including one vaccine. RESULTS: HCPs utilized the concise summary to make initial prescribing/counseling decisions. Many also used the labeling narrative for a comprehensive benefit-risk assessment. CONCLUSION: The findings indicate a need to continue to improve communication about safety of drugs used during lactation, and that the concise summary may help facilitate this communication. The study also highlights the need to educate HCPs about PI limitations when clinical data are lacking and the need to encourage clinical studies to be conducted to support actionable recommendations about use of prescription drugs during lactation.

The association between wealth and sleep medication use in a nationally-representative sample of older Medicare beneficiaries.

BACKGROUND: Sleep disorders are common among older adults, leading to high prevalence of over-the-counter and prescription sleep medication use. Socioeconomically disadvantaged individuals have higher prevalence of sleep disorders. Frequent use of sleep medications can increase the risk of falls. Little is known about the association between wealth and sleep medication use in older adults. METHODS: We conducted a cross-sectional analysis using a nationwide sample of 7603 Medicare beneficiaries (65+ years) from Round 1 (2011) of the National Health and Aging Trends Study. We measured self-reported wealth as the sum of assets (retirement savings, stocks/bonds, checking/savings accounts, business assets, and home value) minus liabilities (mortgage, credit card, and medical debt). Self-reported sleep medication use in the past month was categorized as frequent (5-7 nights/week), sometimes (1-4 nights/week), or never (0 night/week). We estimated differences in the prevalence of sleep medication use by quintiles of wealth using crude and adjusted binomial regression models. Individuals missing sleep medication information were excluded. RESULTS: Median wealth was $152 582 (IQR: $24 023-412 992). Sixteen percent reported frequent sleep medication use, 15% reported some use, and 70% reported no use. Frequent sleep medication use was more common in lower wealth quintiles (lowest: 20%, highest: 12%). Alternatively, some use was more common in higher wealth quintiles (lowest: 11%, highest: 18%). Results were similar after adjustment for demographic factors, anxiety, depression, and sleep disorders. CONCLUSIONS: In this study, less wealthy older adults had higher prevalence of frequent sleep medication use. This may lead to dependency or increased fall risk in this vulnerable population.

Lack of information on gender differences in the package inserts of prescription drugs in Japan.

The package inserts of prescription drugs provide essential information for the proper administration of pharmacotherapy. The incidence of adverse reactions for several drugs is known to be higher in women than in men. However, no studies have examined whether information on gender differences is included in Japanese package inserts. Therefore, this study investigated information on gender differences in the package inserts of Japanese prescription drugs, using the drug information database JAMES provided by the Medical Information System Development Center and the Japan Pharmaceutical Information Center. Non-proprietary names of prescription drugs were yielded 1,679 in Japan. Of the 1,679 ingredients in package inserts of prescription drugs, 76 (4.5%) included information on gender differences. The number of inserts that contained information on gender differences in the "DOSAGE AND ADMINISTRATION," "ADVERSE REACTIONS," and "PHARMACOKINETICS" sections was 3, 16, and 62, respectively. Furthermore, in the "ADVERSE REACTIONS" section, 15 of the 16 inserts mentioned a higher frequency of adverse reactions in women compared with men. Importantly, most of the inserts with information on gender differences in the "PHARMACOKINETICS" section mentioned a higher area under the curve for women than for men. Most of the package inserts of prescription drugs with information on gender differences provide useful information aimed at preventing risks in women. However, there is an extreme lack of information on gender differences in the package inserts of prescription drugs in Japan, and we consider enhancing information on gender difference as an urgent issue.

Perfil do consumo dos benzodiazepínicos nos anos de 2019 e 2020 no brasil e regiões / Profile of the benzodiazepines in the years 2019 e 2020 in Brazil and regions / Perfil de consume y hospitalizaciones de los benzodiacepinas en los años 2019 y 2020 enBrasil y regiones

Os benzodiazepínicos estão entre os medicamentos mais prescritos, principalmente em países ocidentais, onde estimativas mostram um consumo anual de 1% a 3% da população.Objetivo:Estudar o perfil do consumo dos benzodiazepínicosnos anos de 2019-2020. Metodologia:Foram estudadas a taxa de desocupação segundo o Instituto Brasileiro de Geografia e Estatística, consumo dos benzodiazepínicosa partir do Sistema Nacional de Gerenciamento de Produtos Controlados da Agencia de Vigilância Sanitáriae quantidade de internações por envenenamento com exposição (acidental ou proposital), auto-intoxicação e efeitos adversos aos anticonvulsivantes, sedativos, hipnóticos, antiparkinsonianos e psicotrópicos segundo o Departamento de Informática do Sistema Único de Saúde no Brasil. Resultados:A região Norte e Nordeste apresentou um aumento na taxa de desocupação. O rendimento nominal mensal domiciliar per capitada população residente nas regiões Norte e Nordeste se manteveabaixo de 01 salário-mínimo nos anos de 2019 e 2020. De 2019 para 2020, o princípio ativo mais utilizado dos benzodiazepínicos industrializados foi o Clonazepam com incremento de 9,81% no Brasil e 22,52% na região Nordeste. Todas as formas farmacêuticas manipuladas apresentaram umaredução no consumo de 2019 para 2020, com exceção da forma em mililitros que apresentou um incremento para o bromazepam (42,1%), clonazepam (8,76%) e diazepam (5,27%). De 2020 em relação a 2019, ocorreu um incrementode 119,05% e 25% nas regiões Nordeste e Centro-Oeste, respectivamente, nasinternações por envenenamento [intoxicação] por exposição, a anticonvulsivantes (antiepilépticos), sedativos, hipnóticos, antiparkinsonianos e psicotrópicos não classificados em outra parte, intenção não determinada. Conclusões:Ocorreu um aumento no consumo de benzodiazepínicosindustrial no ano de 2020 sendo o envenenamento [intoxicação] umadas principais causasde internação. Há necessidade de um controle do consumo e vigilância aos psicotrópicos visto que estes fármacos estão dentre aqueles com risco de internações devido àexposição acidental ou não, autointoxicaçãoou efeitos adversos (AU).

Benzodiazepines are among the most prescribed drugs, especially in Western countrieswhere estimates show an annual consumption of 1% to 3% of the population.Objective: To study the profile of benzodiazepinesconsumptionfrom the National Controlled Products Management System of the Sanitary Surveillance Agencyin the years 2019 and 2020.Methodology:The unemployment rate,according to theBrazilian Institute of Geography and Statistics,benzodiazepines consumptionfrom the National Controlled Products Management System of the Sanitary Surveillance Agency, and the number of hospitalizations due to poisoning with exposure (accidental or intentional), self-intoxication, and adverse effects to anticonvulsants, sedatives, hypnotics, antiparkinsonian drugs and psychotropic drugs according to the Department of Informatics of the Unified Health System in Brazil were studied.Results:The North and Northeast regions showed an increase in the unemployment rate. The nominal monthly household income per capita of the population residing in the North and Northeast regions remained below 01 minimum wage in the years 2019 and 2020. From 2019 to 2020, the most used active substanceof industrialized benzodiazepines was Clonazepam with an increase of 9.81% in Brazil and 22.52% in the Northeast region. All compounded pharmaceutical forms showed a reduction in consumption from 2019 to 2020, with the exception of the form in milliliters which showed an increase for bromazepam (42.1%), clonazepam (8.76%) and diazepam (5.27%). In 2020 compared to 2019, there was an increase of 119.05% and 25% in the Northeast and Midwest regions, respectively, in hospitalizations for poisoning[intoxication] due to exposure toanticonvulsants (antiepileptics), sedatives, hypnotics, antiparkinsonian drugs,and psychotropic drugs not elsewhere classified with intent undetermined.Conclusions:There was an increase in the consumption of industrial benzodiazepines in 2020, with poisoning [intoxication] being one of the main causes of hospitalization. There is a need to control the consumption andincrease the surveillance of psychotropic drugs becausethese drugs are among those that involverisk of hospitalization due to accidental or non-accidental exposure, self-intoxication or adverse effects (AU).

ntroducción: Las benzodiacepinas se encuentran entre los fármacos más recetados, especialmente en los países occidentales, donde se estima que de 1% al 3% de la poblaciónde estos países los consumen. Objetivo: Estudiar el perfil del consumo de benzodiacepinas en los años 2019-2020.Metodología: Se midieron la tasa de desempleo según elInstituto Brasileño de Geografía y Estadística, el consumo de benzodiacepinasdel Sistema Nacional de Gestión de Productos Controlados de la Agencia de Vigilancia Sanitariay el número de hospitalizaciones por intoxicación con exposición (accidental o intencional), además se estudiaron autointoxicaciones y efectos adversos a los anticonvulsivos, sedantes, hipnóticos, drogas contra el mal de Parkinsony psicotrópicossegún elDepartamento de Informática del Sistema Único de Salud de Brasil.Resultados: Las regiones Norte y Nordeste presentaron aumento de la tasa de desempleo. El ingreso nominal mensual de los hogares per cápita de la población residente en las regiones Norte y Nordeste se mantuvo por debajo de 01 salario mínimo en los años 2019-2020. De 2019 a 2020, el principio activo más utilizado de las benzodiacepinas industrializadas fue el clonazepam con un aumento de 9,81% en Brasil y de22,52% en la región Nordeste. Todas las formas farmacéuticas compuestas mostraron una reducción en su consumo de 2019-2020, a excepción de la forma en mililitros que mostró un aumento para bromazepam (42,1%), clonazepam (8,76%) y diazepam (5,27%). En 2020 respecto a 2019, hubo un aumento del 119,05% y 25% en las regiones Noreste y Medio Oeste, respectivamente, en las hospitalizaciones por intoxicación por exposición aanticonvulsivos (antiepilépticos), sedantes, hipnóticos, drogas contra el mal de Parkinsony psicofármacos no clasificados en otra parte conintención indeterminada.Conclusiones: Hubo un aumento en el consumo de benzodiacepinas industriales en 2020, siendo las intoxicaciones una de las principales causas de hospitalización. Existe la necesidad de controlar el consumo y vigilancia de los psicofármacos, ya que estos fármacos se encuentran entre los de riesgo de hospitalización por exposición accidental o no accidental, autointoxicación o efectos adversos (AU).

Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations.

The availability of clinical pharmacology and safety data regarding the use of prescription medications in pregnant and lactating individuals has been historically limited, despite significant efforts to improve the quantity and quality of the information in labeling. The Food and Drug Administration's (FDA) Pregnancy and Lactation Labeling Rule took effect on June 30, 2015, and updated information in labeling to more clearly describe available data to assist health care providers in counseling pregnant and lactating individuals. Additionally, the FDA published a revised draft guidance, "Clinical Lactation Studies: Considerations for Study Design," to provide pharmaceutical companies and investigators with information about how and when to conduct lactation studies. Clinical pharmacology information derived from lactation studies is important in determining the presence of medications in breast milk and counseling lactating individuals regarding the potential of medication exposure in the breast milk and its attendant risks to the breastfed infant. Examples of Pregnancy and Lactation Labeling Rule labeling changes that resulted from dedicated clinical lactation studies for certain neuropsychiatric medications are described in this publication. These medications are discussed because neuropsychiatric conditions commonly affect women of reproductive potential, including lactating individuals. As the FDA guidance and these studies illustrate, bioanalytical method validation, study design, and data analysis considerations are essential for obtaining quality lactation data. Well-designed clinical lactation studies play an important role in informing product labeling that ultimately is useful to health care providers in making prescribing decisions with lactating individuals.

Prevalence and correlates of high-dose opioid use among survivors of head and neck cancer.

BACKGROUND: We characterized prescription opioid medication use up to 2 years following the head and neck cancer (HNC) diagnosis and examined associations with moderate or high daily opioid prescription dose. METHODS: Using administrative data from Veterans Health Administration, we conducted a retrospective cohort analysis of 5522 Veterans treated for cancers of the upper aerodigestive tract between 2012 and 2019. Data included cancer diagnosis and treatments, pain severity, prescription opioid characteristics, demographics, and other clinical factors. RESULTS: Two years post-HNC, 7.8% (n = 428) were receiving moderate or high-dose opioid therapy. Patients with at least moderate pain (18%, n = 996) had 2.48 times higher odds (95% CI = 1.94-3.09, p < 0.001) to be prescribed a moderate opioid dose or higher at 2 years post diagnosis. CONCLUSIONS: Survivors of HNC with at least moderate pain were at elevated risk of continued use of moderate and high dose opioids.

Patterns of Prescription Medication Use during the First Trimester of Pregnancy in the United States, 1997-2018.

The objective of this analysis was to describe patterns of prescription medication use during pregnancy, including secular trends, with consideration of indication, and distributions of use within demographic subgroups. We conducted a descriptive secondary analysis using data from 9,755 women whose infants served as controls in two large United States case-control studies from 1997-2011 and 2014-2018. After excluding vitamin, herbal, mineral, vaccine, i.v. fluid, and topical products and over-the-counter medications, the proportion of women that reported taking at least one prescription medication in the first trimester increased over the study years, from 37% to 50% of women. The corresponding proportions increased with increasing maternal age and years of education, were highest for non-Hispanic White women (47%) and lowest for Hispanic women (24%). The most common indication for first trimester use of a medication was infection (12-15%). Increases were observed across the years for medications used for indications related to nausea/vomiting, depression/anxiety, infertility, thyroid disease, diabetes, and epilepsy. The largest relative increase in use among women was observed for medications to treat nausea/vomiting, which increased from 3.8% in the earliest years of the study (1997-2001) to 14.8% in 2014-2018, driven in large part by ondansetron use. Prescription medication use in the first trimester of pregnancy is common and increasing. Many medical conditions require treatments among pregnant women, often involving pharmacotherapy, which necessitates consideration of the risk and safety profiles for both mother and fetus.

Trends in Emergency Department Visits for Unsupervised Pediatric Medication Exposures.

INTRODUCTION: Emergency department visits and hospitalizations for unsupervised medication exposures among young children increased in the early 2000s. Prevention efforts were initiated in response. METHODS: Nationally representative data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project collected from 2009 to 2020 were analyzed in 2022 to assess overall and medication-specific trends in emergency department visits for unsupervised exposures among children aged ≤5 years. RESULTS: From 2009 to 2020, there were an estimated 677,968 (95% CI=550,089, 805,846) emergency department visits for unsupervised medication exposures among children aged ≤5 years in the U.S. Most visits involved children aged 1-2 years (2009-2012 [70.3%], 2017-2020 [67.4%]), and nearly one half involved prescription solid medications (2009-2012 [49.4%], 2017-2020 [48.1%]). The largest declines in estimated numbers of annual visits from 2009-2012 to 2017-2020 were for exposures involving prescription solid benzodiazepines (-2,636 visits, -72.0%) and opioids (-2,596 visits, -53.6%) and over-the-counter liquid cough and cold medications (-1,954 visits, -71.6%) and acetaminophen (-1,418 visits, -53.4%). The estimated number of annual visits increased for exposures involving over-the-counter solid herbal/alternative remedies (+1,028 visits, +65.6%), with the largest increase for melatonin exposures (+1,440 visits, +421.1%). Overall, the estimated number of visits for unsupervised medication exposures decreased from 66,416 in 2009 to 36,564 in 2020 (annual percentage change= -6.0%). Emergent hospitalizations for unsupervised exposures also declined (annual percentage change= -4.5%). CONCLUSIONS: Declines in estimated emergency department visits and hospitalizations for unsupervised medication exposures from 2009 to 2020 coincided with renewed prevention efforts. Targeted approaches may be needed to achieve continued declines in unsupervised medication exposures among young children.

Adherence to prescription medication during pregnancy: Do pregnant women use pharmacological treatment as prescribed?

AIMS: Pregnant women are hypothesized to have low adherence to prescribed medication, because of concerns about harmful effects on the unborn child. However, very little is known about the actual adherence to prescribed medication during pregnancy. We determined to what extent women follow treatment recommendations regarding prescribed medication use in mid-pregnancy. METHODS: Dutch women participating in the PRIDE Study completed a 6-week diary on medication use. Additionally, pharmacy records were obtained. For each medication dispensed, we determined 3 measures of adherence: (i) whether use was reported in the diary (actual use); (ii) difference between dispensing date and date of first reported use (initiation time); and (iii) proportion of days with at least the correct number of doses taken (implementation adherence). RESULTS: During the 6-week study period, 235 of 816 women (29%) were dispensed medication. Actual use was highest for medications used for chronic conditions (88%; 95% confidence interval [95% CI] 81-93), followed by medication for pregnancy-related conditions (79%; 95% CI 71-86) and medication for occasional and short-time use (69%; 95% CI 60-77). We observed a ≥1-day delay in treatment initiation for 42% of medications dispensed for the first time in the study period. Mean implementation adherence was 74.2% (95% CI 69.3-79.2) for medications that were actually used. CONCLUSION: Although actual use of medications dispensed was high, many pregnant women did not adhere to treatment recommendations. This nonadherence may impact maternal and child health and lead to overestimation of medication use in studies in perinatal pharmacoepidemiology relying on administrative databases.