Over-the-Counter Analgesic-Related Exposure and Toxicity in Pediatrics.

BACKGROUND: Analgesics are one of the most commonly purchased and used OTC medication classes from pharmacies in the United States. Drug toxicity is a leading cause of injury death in the United States. Limited studies, if any, have examined the impact of specific OTC medication toxicities in the pediatric population. OBJECTIVE: To examine the toxicity arising from the use of over-the-counter (OTC) analgesic medications in pediatric patients in Ohio. METHODS: Data from National Poison Data System for Ohio was obtained for the past 5 years. This data was processed to focus on target populations; pediatrics defined as ages 0-17 years experiencing toxicities related to OTC analgesic medications. The data was categorized into three groups: 0-6 years old, 7-12 years old, and 13-17 years old and reported toxicity was studied based on medications used/given, reasoning for toxicity, and medical outcomes. RESULTS: Patients aged 0-6 years mainly experienced toxicities from acetaminophen (35%) and ibuprofen (52.7%), due to unintentional exposure (general misuse and therapeutic error; 74.2% and 25.4%, respectively), causing primarily minimal clinical effect (48.4%). Ages 7-12 experienced toxicities from acetaminophen (38.5%) and ibuprofen (44.9%) due to unintentional exposure therapeutic error (44.8%) and intentional suspected suicides (30.1%), causing mainly minimal clinical effects (35.5%) and no effect (23.4%). Pediatric ages 13-17 experienced toxicities due to ibuprofen (36.3%) and acetaminophen (38.9%), with primary reasoning of intentional suspected suicide (81.3%), causing medical outcomes of minor effect and no effect (38.2% and 31.2%, respectively). A chi-square test was performed to analyze correlation between case intention (unintentional or intentional) and age group. Proportion of intentional exposures differ by age [X2 (2, N = 18,766) = 14672, p < .0001]. CONCLUSION: Observations from this study underscore the importance of raising awareness about OTC analgesic toxicities which remain prominent in Ohio.

With Current Safety and Efficacy Data, Should Statins Be Made Available as Nonprescription Over-the-Counter Drugs?

PURPOSE OF REVIEW: Statins inhibit the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A reductase in the liver and reduce atherosclerotic cardiovascular disease (ASCVD) risk by enhancing low-density lipoprotein (LDL) clearance from the circulation. In this review, we discuss their efficacy, safety, and real-world utilization to make a case for reclassifying statins as nonprescription over-the-counter drugs to improve access and availability with the overarching goal of increasing statin utilization in patients most likely to benefit from this class of therapy. RECENT FINDINGS: Statin efficacy for reducing risk in primary and secondary ASCVD prevention populations as well as their safety and tolerability has been thoroughly investigated in large-scale clinical trials over the past 3 decades. Despite the overwhelming scientific evidence, statins are underutilized even among those at the highest ASCVD risk. We propose a nuanced approach to use statins as nonprescription drugs that leverages a multi-disciplinary clinical model. It integrates lessons learned from experiences outside the USA with a proposed Food and Drug Administration rule change that allows nonprescription drug products with an additional condition for nonprescription use.

Effect on Antimicrobial Resistance of a Policy Restricting Over-the-Counter Antimicrobial Sales in a Large Metropolitan Area, São Paulo, Brazil.

Although restricting over-the-counter (OTC) antimicrobial drug sales is recommended globally, no data track its effect on antimicrobial resistance (AMR) in bacteria. We evaluated the effect of a national policy restricting OTC antimicrobial sales, put in place in November 2010, on AMR in a metropolitan region of São Paulo, Brazil. We reviewed associations between antimicrobial sales from private pharmacies and AMR in 404,558 Escherichia coli and 5,797 Streptococcus pneumoniae isolates using a dynamic regression model based on a Bayesian approach. After policy implementation, a substantial drop in AMR in both bacterial species followed decreased amoxicillin and trimethoprim/sulfamethoxazole sales. Conversely, increased ciprofloxacin sales were associated with increased ciprofloxacin resistance, and extended spectrum ß-lactamases-positive E. coli isolates and azithromycin sales increases after 2013 were associated with increased erythromycin resistance in S. pneumoniae isolates. These findings suggest that restricting OTC antimicrobial sales may influence patterns of AMR, but multifaceted approaches are needed to avoid unintended consequences.

Use and Costs of Nonprescription Medications Among People With Spinal Cord Injury.

OBJECTIVES: The study objectives were to assess the prevalence of, and factors associated with the use and costs of nonprescription medications among people with spinal cord injury. DESIGN: Observational design; a cross-sectional online survey. SETTING: Community in Canada. PARTICIPANTS: Individuals with spinal cord injury (N=160). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Not applicable. RESULTS: A total of 160 individuals participated in this study. Of all study participants, 83% reported that they used at least 1 nonprescription medication over the last 12 months. On average, participants spent $52 per month on nonprescription medications. The average use and monthly expenditure did not differ significantly by age, sex, or injury parameters. Vitamins and minerals were most commonly used and constituted 62% of all nonprescription medications listed by the participants. Musculoskeletal issues were the most common health problems for which nonprescription medications were used. CONCLUSION: Nonprescription medications are a common part of therapeutic drug regimens for people with spinal cord injuries and are purchased as an out-of-pocket expense. These products may or may not have established benefits. Knowledge about the use of nonprescription medications may help prescribers to improve drug safety, medication affordability, and quality of pharmacotherapy for patients with spinal cord injury.

A cost utility analysis alongside a cluster-randomised trial evaluating a minor ailment service compared to usual care in community pharmacy.

BACKGROUND: Minor ailments are "self-limiting conditions which may be diagnosed and managed without a medical intervention". A cluster randomised controlled trial (cRCT) was designed to evaluate the clinical, humanistic and economic outcomes of a Minor Ailment Service (MAS) in community pharmacy (CP) compared with usual care (UC). METHODS: The cRCT was conducted for 6 months from December 2017. The pharmacist-patient intervention consisted of a standardised face-to-face consultation on a web-based program using co-developed protocols, pharmacists' training, practice change facilitators and patients' educational material. Patients requesting a non-prescription medication (direct product request) or presenting minor ailments received MAS or UC and were followed-up by telephone 10-days after the consultation. The primary economic outcomes were incremental cost-utility ratio (ICUR) of the service and health related quality of life (HRQoL). Total costs included health system, CPs and patient direct costs: health professionals' consultation time, medication costs, pharmacists' training costs, investment of the pharmacy and consultation costs within the 10 days following the initial consultation. The HRQoL was obtained using the EuroQoL 5D-5L at the time of the consultation and at 10-days follow up. A sensitivity analysis was carried out using bootstrapping. There were two sub-group analyses undertaken, for symptom presentation and direct product requests, to evaluate possible differences. RESULTS: A total of 808 patients (323 MAS and 485 UC) were recruited in 27 CPs with 42 pharmacists (20 MAS and 22 UC). 64.7% (n = 523) of patients responded to follow-up after their consultation in CP. MAS patients gained an additional 0.0003 QALYs (p = 0.053). When considering only MAS patients presenting with symptoms, the ICUR was 24,733€/QALY with a 47.4% probability of cost-effectiveness (willingness to pay of 25,000€/QALY). Although when considering patients presenting for a direct product request, MAS was the dominant strategy with a 93.69% probability of cost-effectiveness. CONCLUSIONS: Expanding community pharmacists' scope through MAS may benefit health systems. To be fully cost effective, MAS should not only include consultations arising from symptom presentation but also include an oversight of self-selected products by patients. MAS increase patient safety through the appropriate use of non-prescription medication and through the direct referral of patients to GP. TRIAL REGISTRATION: ISRCTN, ISRCTN17235323 . Registered 07/05/2021 - Retrospectively registered.

Over-the-counter medicines: Global perspective and Indian scenario.

Patients often approach a pharmacist instead of visiting a doctor for minor ailments such as cough, cold, allergies, pain, fever, acidity, diarrhea, and skin-related conditions. Purchase of specific medicines over the counter is legally recognized in most countries. 'Over-the-Counter (OTC) Medicines' means drugs which are legally allowed to be sold by pharmacists without need for a prescription. The term does not have a legal definition in India. Technically, drugs are OTC unless they are specifically stated as prescription only drugs. OTC drugs allow faster and cheaper access to healthcare; however, their misuse and adverse health effects cause concerns. This article describes concept of OTC medicines and practices in India against the background of globally prevalent regulations and practices. A recognized category of OTC medicines by law, patient awareness programs, and support of pharmacists and pharmaceutical companies are required to optimize the use of OTC medicines in India.

Cost-Effectiveness of Reclassifying Triptans in Australia: Application of an Economic Evaluation Approach to Regulatory Decisions.

BACKGROUND: Migraine is a common, chronic, disabling headache disorder. Triptans, used as an acute treatment for migraine, are available via prescription in Australia. An Australian Therapeutic Goods Administration (TGA) committee rejected reclassifying sumatriptan and zolmitriptan from prescription medicine to pharmacist-only between 2005 and 2009, largely on the basis of concerns about patient risk. Nevertheless, pharmacist-only triptans may reduce migraine duration and free up healthcare resources. OBJECTIVES: To estimate the cost-effectiveness of reclassifying triptans from prescription-only to pharmacist-only in Australia. METHODS: The study design included decision-analytic modeling combining data from various sources. Behavior before and after reclassification was estimated using medical practitioner and patient surveys and also administrative data. Health outcomes included migraine frequency and duration as well as adverse events (AEs) discussed by the TGA committee. Efficacy and AEs were estimated using randomized controlled trials and observational studies. RESULTS: Reclassifying triptans will reduce migraine duration but increase AEs. This will result in 337 quality-adjusted life-years gained at an increased cost of A$5.9 million over 10 years for all Australian adults older than 15 years (19.6 million). The incremental cost-effectiveness ratio was estimated to be A$17 412/quality-adjusted life-year gained. CONCLUSIONS: The incremental cost-effectiveness ratio is likely to be considered cost-effective by Australian decision makers. Serotonin syndrome, a key concern of the TGA committee, had little impact on the results. Further research is needed regarding pharmacist-only triptan use by migraineurs currently using over-the-counter medicines and by nonmigraineurs, the efficacy of triptans, and the risk of cardiovascular and cerebrovascular AEs and chronic headaches with triptans.

Analysing the landscape for prescription to non-prescription reclassification (switch) in Germany: an interview study of committee members and stakeholders.

BACKGROUND: Non-prescription medicines are increasingly used in Germany, aided by prescription-to-non-prescription reclassification (or switch). This study aimed to examine the barriers and enablers to reclassification of medicines in Germany and provide recommendations for change. METHODS: Face-to-face conversational interviews with purposively selected key informants in Germany were conducted in 2017 by a researcher informed in the area. Interviews were transcribed, coded in NVIVO and systematically analysed using a framework approach. RESULTS: Twenty-four interviews were conducted with 32 participants including members of the committee considering reclassifications, and representatives from government, industry, health insurance, academia, and pharmacy, medical, and patients' organisations. A range of enablers and barriers emerged that influence reclassification including effects on the committee and process, or the desire of pharmaceutical companies to pursue reclassifications. Enabling market factors included the large population and a culture of self-medication. Enabling health system factors include the pharmacy-only category. Some pharmacy factors appeared enabling (e.g. a positive experience after reclassifying emergency contraception) while others appeared to hinder reclassification (e.g. insufficient pharmacy practice research). Some medical factors were enabling (e.g. reported waiting times) and others limited reclassification (e.g. opposition to some reclassifications). Some committee and government openness to reclassification and self-medication reportedly enabled reclassification, while conservatism was considered a barrier, particularly for classifications with special conditions for supply such as initial doctor diagnosis or other complexities. Some improvements to the committee constitution and considerations were recommended. Some participants found the reclassification process after the committee recommendation opaque, with opportunity for delays and political interference. Industry factors included both enablers such as capability in reclassification, and barriers, such as a perceived low market potential of some reclassifications, and doubt that some candidates would be approved. A need for more data emerged strongly, both pre-reclassification in applications, and post-reclassification. Many participants saw merit with reclassification in non-traditional areas such as hypertension, diabetes and oral contraception. CONCLUSIONS: Many factors influence reclassification in Germany. Recommended improvements included aspects of the process and committee consideration, and more data collection. Sufficient market exclusivity linked to data collection could aid the generation of evidence to aid committee considerations and encourage more applications of high quality.

[Pharmacology of non-opioid analgesics]. / Pharmakologie der Nichtopioidanalgetika.

Due to high prescription rates as well as the frequent use as over the counter drugs, it is of interest to consider non-opioid analgesics when evaluating the quality and appropriateness of a given overall medication. This article sums up the basic pharmacology and main adverse effects of these analgesics. Non-opioids can be further classified according to their additional mechanisms of action besides analgesia. High-dose acetylsalicylic acid, traditional nonsteroidal anti-inflammatory drugs, and coxibs exhibit antipyretic and anti-inflammatory properties. Acetaminophen and metamizole (dipyrone) are analgesics and antipyretic agents, while metamizole exhibits also spasmolytic effects. Capsaicin and intrathecal ziconotide are pure analgesics.

Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children.

BACKGROUND: The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System. METHODS: The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each data source was evaluated by the proportion of detected cases determined to be eligible (met case criteria) and the proportion determined to be evaluable (able to determine causal relationship between adverse event and exposure). RESULTS: A total of 7184 unique cases were identified from 27,597 detected reports. Of these, 6447 (89.7%) were evaluable. The data source with the highest volume of detected cases was news/media; however, only 0.3% of those cases were eligible for panel review and only 0.2% (24 out of 13,450 cases) were evaluable. The data source with the highest proportion of eligible and evaluable cases was NPDS with 7691 detected cases, 6113 (79.5%) eligible cases, and 5587 (72.6%) evaluable cases. CONCLUSIONS: The data sources utilized to evaluate the safety profile of pediatric CCMs yielded variable detection and evaluation rates, but overall provided a comprehensive look at exposures that otherwise cannot be studied in clinical trials. While this study suggests that each source made a valuable contribution and that evaluable cases are generalizable, improvements are needed in case completeness and accuracy to enhance the quality of postmarket safety evaluations.

Pain and development of identity in adolescents who frequently use over-the-counter analgesics: A qualitative study.

AIMS AND OBJECTIVES: This study aims to describe conditions that may influence the development of identity in adolescents frequently using over-the-counter analgesics. BACKGROUND: Frequent self-medication with analgesics among adolescents is associated with several physical pain points, low self-esteem and low ambitions for the future. Continuous use of over-the-counter analgesics can keep adolescents from learning healthier coping strategies. DESIGN: Qualitative individual interviews with adolescents and their mothers were conducted and transcribed. Furthermore, they were analysed as dyads. SETTING AND PARTICIPANTS: Students aged 14-16 years in 9th and 10th grades in 10 Norwegian junior high schools self-reporting at least weekly use of analgesics were asked to participate. Those who wanted to take part took a consent letter to their parents, also inviting the parent to participate. RESULTS: Six girls, two boys and their mothers were included. The teenagers were highly dependent on their mothers. They had often been bullied, lacked good relationships with peers, avoided conflicts and strived to be accepted. Their mothers felt solely responsible for their upbringing and showed great concern for all the pain experienced by their child. A close relationship between mother and child influenced how the adolescent managed their pain, including their use of over-the-counter analgesics. Three main themes were identified in the stories of mother and child: "Vulnerable adolescents," "Mother knows best" and "Pain is a shared project." CONCLUSIONS: Pain among adolescents may be amplified by a difficult family situation and insecure relationships with peers. Strategies within the family may sustain pain as a shared project keeping the adolescent and main caregiver close together, and this might be hampering identity development. To help adolescents with pain and high consumption of over-the-counter analgesics, the adolescents' relationship with parents must be considered in designing an intervention. Guidance on pain assessment, pain management, including appropriate use of over-the-counter analgesics, should be included.

Drugs That May Cause or Exacerbate Heart Failure: A Scientific Statement From the American Heart Association.

Heart failure is a common, costly, and debilitating syndrome that is associated with a highly complex drug regimen, a large number of comorbidities, and a large and often disparate number of healthcare providers. All of these factors conspire to increase the risk of heart failure exacerbation by direct myocardial toxicity, drug-drug interactions, or both. This scientific statement is designed to serve as a comprehensive and accessible source of drugs that may cause or exacerbate heart failure to assist healthcare providers in improving the quality of care for these patients.

Deregulation of sale of over-the-counter drugs outside of pharmacies in the Republic of Korea: interrupted-time-series analysis of outpatient visits before and after the policy.

BACKGROUND: We evaluated the effectiveness of a policy allowing for the sale of over-the-counter drugs outside of pharmacies by examining its effect on number of monthly outpatient visits for acute upper respiratory infections, dyspepsia, and migraine. METHOD: We used medical claims data extracted from the Korean National Health Insurance Cohort Database from 2009 to 2013. The Korean National Health Insurance Cohort Database comprises a nationally representative sample of claims - about 2% of the entire population - obtained from the medical record data held by the Korean National Health Insurance Corporation (which has data on the entire nation). The analysis included26,284,706 person-months of 1,042,728 individuals. An interrupted-time series analysis was performed. Outcome measures were monthly outpatient visits for acute upper respiratory infections, dyspepsia, and migraine. To investigate the effect of the policy, we compared the number of monthly visits before and after the policy's implementation in 2012. RESULT: For acute upper respiratory infections, monthly outpatient visits showed a decreasing trend before the policy (ß = -0.0003);after it, a prompt change and increasing trend in monthly outpatient visits were observed, but these were non-significant. For dyspepsia, the trend was increasing before implementation (ß = -0.0101), but this reversed after implementation(ß = -0.007). For migraine, an increasing trend was observed before the policy (ß = 0.0057). After it, we observed a significant prompt change (ß = -0.0314) but no significant trend. CONCLUSION: Deregulation of selling over-the-counter medication outside of pharmacies reduced monthly outpatient visits for dyspepsia and migraine symptoms, but not acute upper respiratory infections.

Validation of low-dose aspirin prescription data in The Health Improvement Network: how much misclassification due to over-the-counter use?

PURPOSE: We aimed to quantify the extent of over-the-counter (OTC) low-dose aspirin use among patients in The Health Improvement Network (THIN) in the UK. METHODS: In September 2013, a random sample of low-dose aspirin users (75 past users and 75 never users) was identified based on prescriptions recorded in THIN. Primary care practitioners (PCPs) were sent questionnaires to provide information on patients' use of OTC low-dose aspirin. RESULTS: One hundred and forty valid questionnaires were received (93.30% [95%CI: 88.16-96.34] response rate). Current use of low-dose aspirin was reported by PCPs in 4.23% (95%CI: 1.45-11.70) (n = 3) of past users (OTC use in one patient) and in 2.9% (95%CI: 0.78-9.70) (n = 2) of never users (OTC use in one patient). In addition, PCPs reported past use of low-dose aspirin in 88.70% (95%CI: 79.31-94.18) (n = 63) of past users (all prescribed; none as OTC) and in 2.82% (95%CI: 0.78-9.70) (n = 2) of never users (as OTC). Among past users, PCPs reported the indication for low-dose aspirin as primary cardiovascular disease (CVD) prevention in 63.16% (95%CI: 50.18-74.48) of patients and secondary CVD prevention in 31.58% (95%CI: 21.00-44.48) of patients. Corresponding percentages based on THIN were 78.95% (95%CI: 66.71-87.53) and 21.1% (95%CI: 12.47-33.29), respectively. CONCLUSION: Our findings show the small impact of potential misclassification of low-dose aspirin use in THIN due to unrecorded OTC use. The small proportion of false negatives confirms the utility of THIN for utilization and outcome studies of low-dose aspirin.

Over-the-Counter Drugs to Avoid in Older Adults with Kidney Impairment.

Older adults (age 65 years or older) are at especially high risk of having adverse events from over-the-counter (OTC) drugs, and older adults who have kidney disease are at an even higher risk. These older adults with kidney impairment may need to completely avoid, or at the least reduce, their exposure to certain OTC products, such as nonsteroidal inhibitors. When older adults with kidney impairment are counseled about the safety of OTC drugs, they need to be made aware that some drugs may also require dose adjustments. Several categories of drugs that commonly require dosage changes include antihistamines, histamine-2 receptor antagonists, oral decongestants, codeine, and a few gastrointestinal drugs. Another concern is for the possibility of there being a drug-drug interaction between an OTC medication and a prescription drug. Careful consideration needs to be paid to the choice of drugs given to older adults. Patient education is essential to reduce the occurrence of adverse events.

Treatment of Heartburn: A Survey of Ontario and Québec Community Pharmacists.

The shift of proton pump inhibitors (PPIs) from prescription to nonprescription (nonRx) status in Canada has altered pharmacist treatment options for heartburn. This report examines pharmacist approaches to therapy based on case severity; pharmacist confidence and consult duration were also explored. A 2022 online survey gathered data from Ontario and Québec pharmacists regarding their therapeutic approaches for two hypothetical heartburn cases. A total of 715 pharmacists participated, with most having 1-10 years of experience. In Ontario, common choices for the milder case included a solo histamine-2 receptor antagonist (H2RA) (21.2%), combination H2RA + antacid (29.4%), and nonRx PPI (22.3%). For the more severe case, common choices for Québec were switches to nonRx H2RA (22.1%), combination H2RA + antacid (13.4%), a nonRx PPI (24.9%), or prescription PPI (22.5%). Pharmacists often recommended switching medications or referring patients with recurring symptoms after seven days. The approaches varied significantly between cases and provinces. The Ontario pharmacists favoured a combination H2RA + antacid for the milder case, while the Québec pharmacists preferred a solo H2RA. For the more severe case, both groups often chose nonRx H2RA followed by nonRx PPI. Despite the differences, the pharmacists demonstrated confidence in managing these situations. These findings highlight potential debates regarding optimal therapeutic approaches and the impact of drug scheduling on patient care.

Role of community pharmacy and pharmacists in self-care in Brazil.

Global healthcare systems, including the National Health System in Brazil - one of the largest public models in the world -, continue to evolve, as well as populations' health needs, currently shaped on individuals feeling a greater desire to manage their own health. Self-care practices are part of several public policies and clinical guidelines in Brazil including the National Policy on Complementary and Integrative Practices, the National AIDS Control Program, the National Policy for Women's Health, and the Guidelines for Care of People with Chronic Diseases. There are over 100,700 community pharmacies, in the country (89.2% privately owned) employing 234,300 pharmacists, representing an important delivery point for self-care, as they are the first point of access to care for most patients. Self-medication is a common practice in Brazil (prevalence rates of self-medication ranging from 16.1% to 35.0%), especially with non-prescription/over-the-counter medicinal products (65.0%). In fact, these products represent over 25% of volume marketed of medicines, summing revenues of USD 1.9 billion per year. Studies demonstrated a positive budget impact as important savings for the National Health System due to reductions of unnecessary medical appointments and loss of working days. In addition to minor ailments management, other self-care services provided by community pharmacies that are frequently sought by Brazilian citizens (20-25% of cases) are smoking cessation and weight management (costs per service ranging from around USD 5.00-12.00). However, pharmacy services are not yet as fully integrated in Brazil to the same extent as in other countries. Barriers such as standardization of processes (from services' design, implementation, and evaluation in practice), pharmacist remuneration for the provision of services and the amount to be charged for the service are still a matter of controversy. For more rapid and sustainable advances in these practices, communication among various stakeholders, professional practice and healthcare regulations, standardization of services and financing of self-care (both publicly and privately) are urgently needed. This paper provides an overview of some self-care services provided by community pharmacies in Brazil and call attention to the ongoing challenges to move the National Health system forward.