[Actual Access and Usage of Antipyretic Analgesics before and after COVID-19 Vaccination: Pharmacist's Roles in Promoting Proper Use of Medicines during the Infodemic].

An overwhelming surge of information regarding preparedness for postvaccination side effects had caused widespread confusion approximately since April 2021, when the coronavirus disease 2019 (COVID-19) vaccination had started for the general population in Japan. Notably, this resulted in a remarkably increased shortage of OTC acetaminophen formulations. The aim of this study was to elucidate the actual responses of the public in such an environment, how individuals acquired and understood information related to the management of postvaccination side effects, and how they obtained and used antipyretic analgesics before and after COVID-19 vaccination. We conducted a web-based survey in January 2022, targeting 400 individuals aged ≥20 years, who had received two COVID-19 vaccine doses, and excluded qualified professionals such as physicians and pharmacists. The results revealed that 67% of the respondents had obtained antipyretic analgesics in anticipation of adverse effects after vaccination, whereas 38% had taken these medicines before and/or after the second vaccination. Possible misappropriation of medicines from others, preventive administration, and lack of dosage and administration confirmation are the problems identified in medication acquisition and usage. Additionally, avoidance of antipyretic analgesics based on information without scientific evidence was observed. This study revealed no small amount of inappropriate use of medicines in situations, such as the COVID-19 pandemic, where there is an "infodemic" of mixed-quality information. Pharmacists, as experts in medication, should play a crucial role in promoting appropriate medication usage by consistently staying updated with the latest scientific evidence and proactively supporting OTC drug selection and counseling medication.

A randomized controlled double-blinded split-face prospective clinical trial to assess the efficacy, safety, and tolerability of a novel 3-step routine compared to benzoyl peroxide for the treatment of mild to moderate acne vulgaris.

Adult acne vulgaris affects up to 43-51% of individuals. While there are numerous treatment options for acne including topical, oral, and energy-based approaches, benzoyl peroxide (BPO) is a popular over the counter (OTC) treatment. Although BPO monotherapy has a long history of efficacy and safety, it suffers from several disadvantages, most notably, skin irritation, particularly for treatment naïve patients. In this prospective, randomized, controlled, split-face study, we evaluated the comparative efficacy, safety, and tolerability of a novel 3-step azelaic acid, salicylic acid, and graduated retinol regimen versus a common OTC BPO-based regimen over 12 weeks. A total of 37 adult subjects with self-reported mild to moderate acne vulgaris were recruited. A total of 21 subjects underwent a 2-week washout period and completed the full study with 3 dropping out due to product irritation from the BPO routine, and 13 being lost to follow-up. Detailed tolerability surveys were conducted at Week 4. Additional surveys on tolerability and product preferences were collected monthly, at Week 4, Week 8, and Week 12. A blinded board-certified dermatologist objectively scored the presence and type of acne lesions (open or closed comedones, papules, pustules, nodules, and cysts) at baseline, Week 4, Week 8, and Week 12. Patients photographed themselves and uploaded the images using personal mobile phones. Detailed Week 4 survey results showed across 25 domains of user-assessed product performance, the novel routine outperformed the BPO routine in 19 (76%) which included domains in preference (e.g. "I would use this in the future) and performance ("my skin improved" and "helped my acne clear up faster"). Users of the novel routine reported less facial redness, itching, and burning, though differences did not reach statistical significance. In terms of efficacy, both products performed similarly, reducing total acne lesions by 36% (novel routine) and 40% (BPO routine) by Week 12. Overall, accounting for user preferences and tolerability the novel routine was more preferred than the BPO routine in 79% of domains (22/28). Differences in objective acne lesion reduction were not statistically significant (p = 0.97). In a randomized split-face study, a 3-step azelaic acid, salicylic acid, and graduated retinol regimen delivered similar acne lesion reduction, fewer user dropouts, greater user tolerability, and higher use preference compared to a 3-step BPO routine based in a cohort of participants with mild-to-moderate acne vulgaris.

Comparison of patients with benzodiazepine receptor agonist-related psychiatric disorders and over-the-counter drug-related psychiatric disorders before and after the COVID-19 pandemic: Changes in psychosocial characteristics and types of abused drugs.

AIM: To investigate changes in the clinical characteristics of patients who abused benzodiazepine receptor agonists (BZRA) or over-the-counter (OTC) drugs before and after COVID-19 based on the 2018 and 2022 data of the "Nationwide Psychiatric Hospital (NPH) Survey on Drug-related Psychiatric Disorders." METHOD: A total of 446 and 155 cases, and 435 and 273 cases, who mainly abused BZRAs or OTC drugs, respectively, were extracted from the database of the two NPH Surveys. Demographic variables, education, employment, criminal record, drug use during the previous year, psychiatric diagnosis, and types of abused drugs were compared between 2018 and 2022. RESULT: A comparison of BZRA abusers revealed a decreased number of users during the previous year and an increase in the comorbidity rate of other disorders (F3 and F4 in ICD-10) in 2022. Etizolam, flunitrazepam, triazolam, and zolpidem were used most in both years, with an increase in zolpidem and a decrease in triazolam in 2022. A comparison of OTC drug abusers revealed a higher proportion of women and young patients in 2022. An increase in the comorbidity rate of F3 and F9 and a significant increase in the use of dextromethorphan products were observed in 2022, although codeine products were in the majority in both years. CONCLUSION: By comparing NPH Surveys before and after the COVID-19 pandemic, both BZRA abusers and OTC drug abusers present complex pathologies, requiring tailor-made treatment. The younger OTC drug abusers were particularly evident among women, and the abuse of dextromethorphan-containing OTC drugs has increased alarmingly.

Over-the-counter products in tooth bleaching: A scoping review.

OBJECTIVE: To map and summarize the current scientific evidence concerning the active ingredients, effectiveness, and adverse effects of over-the-counter (OTC) bleaching products. DATA AND SOURCE: This study was conducted according to the PRISMA-ScR guidelines for scoping reviews and registered on the Open Science Framework platform. STUDY SELECTION: Database searches were conducted in PubMed/MEDLINE, Embase, and Scopus up to January 2024. All in vitro, in situ, and clinical studies evaluating the effectiveness and adverse effects of OTC bleaching products were included. A descriptive analysis of the included studies was performed. RESULTS: A total of 88 studies were included. Most of them were in vitro studies (n = 49), followed by randomized clinical trials (n = 28). The main OTC bleaching products identified were whitening or stain-removing toothpastes (n = 42), followed by whitening strips (n = 39). Most clinical studies indicate that whitening strips are effective in improving tooth color and providing whitening benefits. In contrast, the bleaching effectiveness of toothpastes, mouth rinses and whitening trays was mainly supported by in vitro studies. The main adverse effects associated with OTC bleaching agents were tooth sensitivity and gingival irritation. CONCLUSION: A wide variety of OTC bleaching products is available for consumer self-administered use. Clinical studies have mainly confirmed the bleaching effectiveness of whitening strips, while the validation for toothpastes, mouth rinses and whitening trays has mainly relied on in vitro studies. Nevertheless, the use of OTC bleaching products may result in adverse effects, including tooth sensitivity, gingival irritation, and enamel surface changes. CLINICAL SIGNIFICANCE: Some over-the-counter bleaching products may have whitening properties supported by clinical studies, particularly those containing hydrogen or carbamide peroxide. Nonetheless, clinicians must be aware of the potential risks associated with excessive self-administration of these products, which may result in adverse effects.

Safety evaluation of 8 drug degradants present in over-the-counter cough and cold medications.

Although the United States Food & Drug Administration (FDA) has provided guidance on the control of drug degradants for prescription drugs, there is less guidance on how to set degradant specifications for FDA OTC monograph drugs. Given that extensive impurity testing was not part of the safety paradigm in original OTC monographs, a weight of evidence (WOE) approach to qualify OTC degradants is proposed. This approach relies on in silico tools and read-across approaches alongside standard toxicity testing to determine safety. Using several drugs marketed under 21 CFR 341 as case studies, this research demonstrates the utility of a WOE approach across data-rich and data-poor degradants. Based on degradant levels ranging from 1 to 4% of the maximum daily doses of each case study drug and 10th percentile body weight data for each patient group, children were recognized as having the highest potential exposure relative to adults per body mass. Depending on data availability and relationship to the parent API, margins of safety (MOS) or exposure margins were calculated for each degradant. The findings supported safe use, and indicated that this contemporary WOE approach could be utilized to assess OTC degradants. This approach is valuable to establish specifications for degradants in OTCs.

Efficacy and safety of seven Chinese patent medicines combined with conventional triple/quadruple therapy for Helicobacter pylori-positive peptic ulcers: a systematic review and network meta-analysis.

OBJECTIVES: To compare the efficacy and safety of seven Chinese patent medicines (CPMs) combined with conventional triple/quadruple therapy (T/Q) for Helicobacter pylori-positive peptic ulcers. DESIGN: A systematic review and network meta-analysis. DATA SOURCES: China National Knowledge Infrastructure, VIP database, Wanfang database, ScienceDirect, EBSCO, EMBASE, Web of Science, Cochrane Library and PubMed were searched through 1 June 2022. ELIGIBILITY CRITERIA: Randomised controlled trials (RCTs) testing CPMs combined with T/Q for H. pylori-positive peptic ulcers were included. The CPMs included Anweiyang capsule, Jianweiyuyang tablets/capsule/granule, Jinghuaweikang capsule, Kangfuxin liquid, Puyuanhewei capsule, Weifuchun tablets/capsule and Weisu granule. At least one of the following outcome indicators was recorded: complete ulcer healing rate (CUHR), effective rate (ER), H. pylori eradication rate (HPER), rate of peptic ulcer recurrence (RPUR) and incidence of adverse reactions (IAR). DATA EXTRACTION AND SYNTHESIS: Two researchers independently conducted the study selection and extracted data for included studies. The risk of bias was assessed using the Cochrane risk of bias tool. A pairwise meta-analysis was performed using RevMan V.5.3. Network meta-analysis was performed using STATA/MP V.15.0. Confidence in the evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluation. RESULTS: A total of 36 RCTs involving 3620 patients were included. Compared with T/Q alone, Weisu+T/Q, Weifuchun+T/Q and Puyuanhewei+T/Q had the highest CUHR, ER and HPER, respectively. Weisu+T/Q and Jianweiyuyang+T/Q had the lowest RPUR and IAR, respectively. The cluster analysis results showed Jianweiyuyang+T/Q might be the best choice concerning efficacy and safety simultaneously, followed by Kangfuxin+T/Q. CONCLUSION: Among the combination therapies with the CPMs, Jianweiyuyang+T/Q might be the most favourable option for H. pylori-positive peptic ulcers, followed by Kangfuxin+T/Q. Considering the limited quantity and quality of the included RCTs, the results should be interpreted with caution. PROSPERO REGISTRATION NUMBER: CRD42022327687.

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.

Efficacy and safety of Chinese patent medicine in the adjuvant treatment of prostate cancer: A Bayesian network meta-analysis.

BACKGROUND: Prostate cancer is the most common cancer in men. In China, traditional Chinese medicine is used to treat prostate cancer. However, there is a lack of evidence for differences in the effectiveness and safety of different Chinese patent medicines. Therefore, we conducted this Network Meta-analysis to investigate the efficacy and safety of different Chinese patent medicines in the treatment of prostate cancer. METHODS: We systematically search PubMed, Web of Science, Embase, Cochrane library, CNKI database, VIP database, wanfang database, and SinoMed Randomized controlled trials of Chinese patent medicines for the treatment of prostate cancer sores included in the database were retrieved until June 1, 2023. The included studies were assessed for risk of bias using Cochrane randomized controlled trial Bias risk Assessment tool. The main outcome indicators were Efficacy, Prostate Specific Antigen, and adverse reaction. Since different courses of treatment were used in the included studies, we used Bayesian mesh meta-regression to investigate the effects of treatment courses on efficacy and safety. RESULTS: Twenty-seven articles were included, involving 1885 patients. Including 9 kinds of Chinese patent medicine. The results of Network Meta-analysis show that: ① efficacy: compared with androgen antagonists, Bruceolic oil emulsion (relative risk = 1.70, 95% credibility interval [CI] (1.30, 2.29)), Compound Kushen injection (relative risk = 1.39, 95%CI (1.19, 1.70)) had significant advantages. There was no significant difference among all Chinese patent medicines (P > .05). The top 3 Chinese patent medicines were Bruceolic oil emulsion, Zhibodihuang pill, Compound Kushen injection. ② Prostate specific antigen: compared with androgen antagonists, Bruceolic oil emulsion (mean difference [MD] = -10.4, 95%CI [-17.6, -3.21]), Compound Kushen injection (MD = -4.46, 95%CI [-8.80, -1.70]), Shenfu injection (MD = -14.7, 95%CI [-23.4, -6.01]) had significant advantages. The top 3 Chinese patent medicines were Shenfu injection, Bruceolic oil emulsion, Compound Kushen injection. adverse reaction: compared with androgen antagonists, there was no significant difference among all PCM (P > .05). CONCLUSION: Compared with androgen antagonists, Chinese patent medicine has significant difference in effectiveness. The effect of Chinese patent medicine is little affected by the course of treatment and dose. From comprehensive analysis, Bruceolic oil emulsion combined with androgen antagonist is the best intervention measures.

Assessment of color changes and adverse effects of over-the-counter bleaching protocols: a systematic review and network meta-analysis.

OBJECTIVES: To assess color change efficacy and the adverse effects of varied over-the-counter (OTC) bleaching protocols. METHODOLOGY: The study included randomized clinical trials evaluating color changes from OTC bleaching agents. Nine databases were searched, including the partial capture of the grey literature. The RoB2 tool analyzed the individual risk of bias in the studies. Frequentist network meta-analyses compared treatments through common comparators (∆Eab* and ∆SGU color changes, and tooth sensitivity), integrating direct and indirect estimates and using the mean and risk differences as effect measures with respective 95% confidence intervals. The GRADE approach assessed the certainty of the evidence. RESULTS: Overall, 37 remaining studies constituted the qualitative analysis, and ten composed the meta-analyses. The total sample included 1,932 individuals. ∆Eab* was significantly higher in groups 6% hydrogen peroxide (HP) strips (≥ 14 h). ∆SGU was significantly higher in groups at-home 10% carbamide peroxide (CP) (≥ 14 h), followed by 6% HP strips (≥ 14 h) and 3% HP strips (≥ 14 h). At-home 10% CP (7-13 h) and placebo showed lower risks of tooth sensitivity without significant differences between these treatments. CONCLUSION: Considering the low level of evidence, OTC products presented satisfactory short-term effects on tooth bleaching compared to the placebo, with little to no impact on dentin hypersensitivity and gingival irritation. CLINICAL RELEVANCE: OTC products are proving to be practical alternatives for tooth whitening. However, patients should be advised about the possible risks of carrying out such procedures without professional supervision.

Clinical characteristics of over-the-counter (OTC) drug abusers in psychiatric practice in Japan: Comparison of single and multiple OTC product abusers.

OBJECTIVE: To examine the clinical characteristics of over-the-counter (OTC) drug abusers in psychiatric practice in Japan. METHOD: We examined the attributes, ICD-10 subcategory, and comorbid mental disorders of patients who mainly abuse OTC products and compared the clinical characteristics of single product and multiple products abusers, using the database of the "2022 Nationwide Mental Hospital Survey of Drug-related Disorders." RESULTS: Among the 2468 subjects included in this survey, 273 (11.1%) used OTC products as main drugs. Of these, 209 (78.3%) and 58 (21.7%) were classified into the single product group and the multiple products group, respectively. Six were excluded for unknown ingredients. By comparing these groups, we found that many of the multiple products group consisted of young women who were recently treated for drug problems. Many subjects in the group also had a short treatment period. No differences were observed between the groups regarding the ICD-10 F1 subcategory, but many subjects in the multiple products group fulfilled the criteria of F6 "disorders of adult personality and behavior." CONCLUSION: OTC products are easily accessible drugs of abuse for young women in Japan. The results of this study indicate the necessity to reconsider the educational approach for preventing drug abuse, which has focused on illicit drugs. The study also indicates that some OTC products, which contain ingredients banned overseas due to their harmful effects, are still sold in Japan and that abusers for those products exist. Measures by the government are considered urgently needed.

Development and validation of a brief screening tool for over-the-counter codeine dependence.

BACKGROUND: Low-dose codeine is sold without a prescription in countries like the UK, Ireland, and South Africa. Due to misuse concerns, exploring pharmacy screening tools to identify those at risk and needing additional support is vital. OBJECTIVES: The study aims to develop and validate a brief screening tool that assesses the risk of codeine dependence with language appropriate for routine use in community pharmacies. METHOD: Scale development and validation occurred over two studies. In Study 1, scale item generation was based on structured analyses of psychosocial and pharmacy variables from frequent over-the-counter codeine consumers (N = 795). CFA was used to assess the cohesiveness of the resultant four-item Codeine Dependence Scale (CDS). ROC analyses were used to assess the performance of the CDS against risk cases identified by the Severity of Dependence Scale; identifying an optimal cut-off value of ≥2 as representing individuals at risk of codeine dependence. In Study 2, this CDS threshold was assessed against positive DSM-5 Opioid Use Disorder (OUD) cases related to codeine use assessed using the AUDADIS-IV. RESULTS: With a cut-off score of ≥2, the CDS has sensitivity and specificity of 76% and 48%, respectively, against a DSM-5 codeine-related OUD diagnosis using the AUDADIS-IV. For identification of any codeine-related OUD (as measured by the AUDADIS-IV) 15 months after baseline, the CDS achieved an overall correct classification rate of 52%; 72% for positive cases. CONCLUSIONS: The CDS exhibits reasonable cross-sectional and longitudinal sensitivity but low specificity, partly due to its brevity. However, the inclusive nature of the CDS is not a negative for application as a screening tool in a pharmacy setting as individual CDS items represent critical conversation points with a pharmacist, regardless of the screening outcome. The non-confronting nature of CDS items make the scale a viable option for pharmacy-based SBI in countries where codeine remains OTC.

Factors influencing pharmacists' roles in preventing prescription and over-the-counter opioid misuse: a systematic review and narrative synthesis.

BACKGROUND: The prescribing rate of opioids is increasing and is a main contributor to opioid misuse. Community pharmacists can help reduce opioid misuse rates by carrying out prescription and over-the-counter (OTC) opioid misuse prevention services. Understanding the barriers and facilitators to community pharmacists' involvement has the potential to improve these services. OBJECTIVE: To review the literature on the barriers and facilitators of community pharmacists' involvement in prescription and OTC opioid misuse prevention. METHODS: A systematic review of primary research was carried out in MEDLINE, Embase, Scopus, Web of Science, CINAHL, and APA PsycINFO from January 2022 to March 2022. Narrative synthesis underpinned by the COM-B model was used to analyse findings from the included articles. Studies were included if they used qualitative or mixed methods; published in English and focussed on OTC or prescription opioids. RESULTS: Ten studies were included in the review. Barriers and facilitators were grouped into individual, environmental, and system-level factors. Based on the COM-B model, these factors were classified as capabilities (knowledge and skill), opportunities (e.g. relationship with prescribers, time), and motivation (pharmacists' attitude). CONCLUSION: Improving pharmacists' capabilities and opportunities might improve pharmacists' motivation to offer opioid misuse services. This could improve pharmacists' behaviour, that is, their role in preventing prescription and OTC opioid misuse. The findings of this review were based on information obtained from primary evidence from qualitative studies; However. further empirical work is needed to identify how pharmacists can be supported.

Individual Article: Evaluation of Efficacy and Tolerability of Two Over-the-Counter Eczema Itch Relief Products.

BACKGROUND: Study to compare efficacy, tolerability, and patient perception between an over-the-counter itch relief gel (IRG) and itch relief moisturizing cream (IRMC) after a single application.  Methods: Single-center, randomized, blinded, split-body study comparing IRG vs IRMC in adults with eczema-prone skin and mild-to-moderate itch. Assessments included itch relief duration upon application, itch severity (0=none to 9=severe at baseline [BL], 8, 12, and 24 hours), tolerability (0=none to 3=severe), and self-assessment questionnaire about product attributes and preference.  Results: Thirty-three females and males with a mean age of 49.7 completed the study. Average time to itch relief was 28.5 seconds for IRG vs 41.8 for IRMC (P<0.05), with first onset at 5 seconds. In the IRG group, itch severity was reduced from 4.4 at BL to 1.4 at 8 hours; in comparison, itch was reduced from 4.4 at BL to 2.6 at 8 hours in the IRMC group (P<0.05). Both products significantly relieved itch vs baseline at all time points. IRG had better tolerability, with burning/stinging going from 1.5 at BL to 0.8 at 24 hours vs 1.5 at BL to 1.2 at 24 hours for IRMC (P<0.05). There was a trend in favor of IRG vs IRMC on the patient satisfaction self-assessment questionnaire. CONCLUSIONS: IRG provided rapid itch relief and significantly outperformed IRMC. Both products significantly improved itch severity for up to 24 hours after application, with IRG outperforming IRMC at 8 hours. Additionally, IRG moderated stinging/burning sensations better than IRMC. Further, IRG was preferred by participants over IRMC.J Drugs Dermatol. 2023;22:10(Suppl 2):s10-15.  .

Efficacy and safety of Chinese patent medicine compound preparation combined with routine treatment in vitiligo: A Bayesian network meta-analysis.

BACKGROUND AND PURPOSE: Treating vitiligo in clinical practice is challenging. Furthermore, oral drugs used in Western medicine have considerable side effects and are unsuitable for long-term treatment. In contrast, Chinese patent medicines (CPMs) are more suitable for long-term oral vitiligo treatment, but medical evidence of their efficacy and safety is lacking. Therefore, in this study, the efficacy and safety of CPMs were evaluated and ranked using a Bayesian network meta-analysis. METHODS: Seven Chinese and English databases were searched for all relevant articles published up to February 2023. The Bayesian network meta-analysis method was used to analyze the extracted data to evaluate efficacy and safety. RESULTS: Six common CPMs for treating vitiligo were selected in our study, and 48 targeted articles and 4446 patients were included. This study showed that Qubai Babuqi tablets (QT) were the most effective for short-term treatment of vitiligo, and that vitiligo capsules or pills (VCP) were the most effective for long-term treatment, together with compound Quchong Banjiuju pills (QP). In terms of surface area under the cumulative ranking curve (SUCRA) values, the order of efficacy of each treatment was as follows: QT (92.18%) > Taohong Qingxue pills (TP) (63.81%) > VCP (55.53%) > QP (50.72%) > Bailing tablets or capsules (BTC) (49.01%) > Baishi pills (BP) (35.69%)>routine therapy (RT) (3.1%) in terms of total effective rate and QT (92.05%) > VCP (71.50%) > QP (66.60%) > TP (42.95%) > BTC (39.66%) > BP (36.60%)>RT (0.6%) in terms of improvement rate. In addition, the safety of the 6 CPMs did not significantly differ in terms of adverse effects. The SUCRA values indicated that QT performed slightly worse than other drugs. DISCUSSION: In treating vitiligo, QT is most effective but only suitable for short-term administration owing to its poor safety. VCP and QP could be used as first-choice long-term medications. TP may positively affect repigmentation in patients with limited lesion areas.

The use, perceptions and knowledge of safety of over-the-counter medications during pregnancy in a Canadian population.

BACKGROUND: The prevalence of prenatal over-the-counter medication use in Canadian women is unknown. METHODS: A cross-sectional study of prenatal over-the-counter medication use and safety knowledge was conducted among pregnant and post-partum women attending an academic hospital obstetrics clinic. RESULTS: Seventy-two women participated; 90.3% were Caucasian, 69.4% had a college/university degree, and 61.1% lived in an urban area. Of the 72 women, 87.5% used over-the-counter medications prenatally, first (55.6%), second (65.3%), and third (47.2%) trimesters, with prenatal acetaminophen use most common (72.2%). Women who used over-the-counter medications 1-0onths before conception were more likely to use over-the-counter medications during pregnancy, and 18% of women initiated over-the-counter medications in pregnancy. Women self-reported a medium level of over-the-counter medication safety knowledge (73.6%) and responded that not all over-the-counter medications are safe during pregnancy (95.8%). CONCLUSION: Despite limited safety profiles of some over-the-counter medications, pre-conception and prenatal over-the-counter medication use was high. Further research on the risk of over-the-counter medications and combinations in pregnancy is needed to help women to make safe choices during pregnancy.

Elevating Safe Use of Over-The-Counter Medications in Older Adults: A Narrative Review of Pharmacy Involved Interventions and Recommendations for Improvement.

Over-the-counter (OTC) medications are products that have been made easily accessible to allow patients to treat common ailments without a prescription and the cost of a doctor's visit. These medications are generally considered safe; however, there is still a potential for these medications to lead to adverse health outcomes. Older adults (ages 50+) are especially susceptible to these adverse health outcomes, due to age-related physiological changes, a higher prevalence of comorbidities, and prescription medication use. Many OTC medications are sold in pharmacies, which provides pharmacists and technicians with the opportunity to help guide safe selection and use for these medications. Therefore, community pharmacies are the ideal setting for OTC medication safety interventions. This narrative review summarizes the findings of pharmacy-involved interventions that promote safe OTC medication use for older adults.

Over-the-Counter Pain Medication Use During Pregnancy.

PURPOSE: To examine over-the-counter pain medication use in pregnancy. STUDY DESIGN AND METHODS: Secondary analysis of a weighted surveillance survey using the 2019 Iowa Pregnancy Risk Assessment Monitoring System (PRAMS) data. A sample of 759 pregnant women of childbearing age from Iowa was weighted to represent 31,728 Iowa mothers. The weighted sample represents 80% non-Hispanic White mothers, with smaller percentages of Hispanic (10%) mothers and non-Hispanic Black (7%) mothers, consistent with the population of Iowa. Approximately two-thirds of women had commercial insurance (66%), some college or greater education (62%), and were from urban areas (59%). ANALYSIS: Descriptive statistics were calculated. Variables include over-the-counter pain reliever usage among all respondents and by race/ethnicity and education level. RESULTS: Seventy-six percent of women reported taking over-the-counter pain relievers during pregnancy. Of these, 71% reported taking acetaminophen, 11% reported taking ibuprofen, 8% aspirin, and 3% naproxen. Nearly 80% of non-Hispanic White mothers reported taking an over-the-counter pain reliever during pregnancy compared to just 64% of mothers reported as Hispanic. Iowa mothers with a college education or greater were more likely to report over-the-counter pain reliever use during pregnancy (84%) than their counterparts with a high school education or less (64%). CLINICAL IMPLICATIONS: Some medications may cause harm to the fetus if taken at specific time during pregnancy. Reinforcement of current pain medication education, including risks to fetus throughout pregnancy may be needed.

Ventricular Arrhythmias Associated With Over-the-Counter and Recreational Opioids.

BACKGROUND: Epidemic increases in opioid deaths prompted policies limiting access to prescription opioids in North America. Consequently, the over-the-counter opioids loperamide (Imodium A-D) and mitragynine, the herbal ingredient in kratom, are increasingly used to avert withdrawal or induce euphoria. Arrhythmia events related to these nonscheduled drugs have not been systematically studied. OBJECTIVES: In this study, we sought to explore opioid-associated arrhythmia reporting in North America. METHODS: The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), and Canada Vigilance Adverse Reaction (CVAR) databases were searched (2015-2021). Reports involving nonprescription drugs (loperamide, mitragynine) and diphenoxylate/atropine (Lomotil) were identified. Methadone, a prescription opioid (full agonist), served as a positive control owing to its established arrhythmia risk. Buprenorphine (partial agonist) and naltrexone (pure antagonist), served as negative controls. Reports were classified according to Medical Dictionary for Regulatory Activities terminology. Significant disproportionate reporting required a proportional reporting ratio (PRR) of ≥2, ≥3 cases, and chi-square ≥4. Primary analysis used FAERS data, whereas CAERS and CVAR data were confirmatory. RESULTS: Methadone was disproportionately associated with ventricular arrhythmia reports (PRR: 6.6; 95% CI: 6.2-7.0; n = 1,163; chi-square = 5,456), including 852 (73%) fatalities. Loperamide was also significantly associated with arrhythmia (PRR: 3.2; 95% CI: 3.0-3.4; n = 1,008; chi-square = 1,537), including 371 (37%) deaths. Mitragynine demonstrated the highest signal (PRR: 8.9; 95% CI: 6.7-11.7; n = 46; chi-square = 315), with 42 (91%) deaths. Buprenorphine, diphenoxylate, and naltrexone were not associated with arrhythmia. Signals were similar in CVAR and CAERS. CONCLUSIONS: The nonprescription drugs loperamide and mitragynine are associated with disproportionate reports of life-threatening ventricular arrhythmia in North America.