Interest in over-the-counter progestin-only pills among transgender, nonbinary, and gender-expansive individuals in the United States.

BACKGROUND: In July 2023, the US Food and Drug Administration approved the first nonprescription oral contraceptive, a progestin-only pill, in the United States. Transgender, nonbinary, and gender-expansive people assigned female or intersex at birth face substantial contraceptive access barriers and may benefit from over-the-counter oral contraceptive access. However, no previous research has explored their perspectives on this topic. OBJECTIVE: This study aimed to measure interest in over-the-counter progestin-only pill use among transgender, nonbinary, and gender-expansive individuals assigned female or intersex at birth. STUDY DESIGN: We conducted an online, cross-sectional survey from May to September 2019 (before the US Food and Drug Administration approval of a progestin-only pill) among a convenience sample of transgender, nonbinary, and gender-expansive people assigned female or intersex at birth who were aged 18 to 49 years from across the United States. Using descriptive statistics and logistic regression analyses, we estimated interest in over-the-counter progestin-only pill use (our outcome) overall and by sociodemographic and reproductive health characteristics (our exposures). We evaluated separate logistic regression models for each exposure. In each model, we included the minimally sufficient adjustment set to control for confounding pathways between the exposure and outcome. For the model for age, we ran a univariable logistic regression model; for all other exposures, we ran multivariable logistic regression models. RESULTS: Among 1415 participants in our sample (median age, 26 years), 45.0% (636/1415; 95% confidence interval, 42.3-47.6) were interested in over-the-counter progestin-only pill use. In separate logistic regression models for each exposure, there were higher odds of interest among participants who were aged 18 to 24 years (odds ratio, 1.67; 95% confidence interval, 1.33-2.10; vs those aged 25-34 years), those who were uninsured (adjusted odds ratio, 1.91; 95% confidence interval, 1.24-2.93; vs insured), those who currently used oral contraceptives (adjusted odds ratio, 1.69; 95% confidence interval, 1.17-2.44; vs non-users), had ≤high school degree (adjusted odds ratio, 3.02; 95% confidence interval, 1.94-4.71; vs college degree), had ever used progestin-only pills (adjusted odds ratio, 2.32; 95% confidence interval, 1.70-3.17; vs never users), and who wanted to avoid estrogen generally (adjusted odds ratio, 1.32; 95% confidence interval, 1.04-1.67; vs those who did not want to avoid estrogen generally) or specifically because they viewed it as a feminizing hormone (adjusted odds ratio, 1.72; 95% confidence interval, 1.36-2.19; vs those who did not want to avoid estrogen because they viewed it as a feminizing hormone). There were lower odds of interest among participants with a graduate or professional degree (adjusted odds ratio, 0.70; 95% confidence interval, 0.51-0.96; vs college degree), those who were sterilized (adjusted odds ratio, 0.31; 95% confidence interval, 0.12-0.79; vs not sterilized), and those who had ever used testosterone for gender affirmation (adjusted odds ratio, 0.72; 95% confidence interval, 0.57-0.90; vs never users). CONCLUSION: Transgender, nonbinary, and gender-expansive individuals were interested in over-the-counter progestin-only pill use, and its availability has the potential to improve contraceptive access for this population.

Over-the-counter access to hormonal contraception: a global perspective.

PURPOSE OF REVIEW: Oral contraceptive pills are among the most popular contraceptives worldwide, including among adolescents, and are available over the counter in over 100 countries. However, when a prescription is required, oral contraceptives may be difficult to obtain, particularly for adolescents. Recent approvals of over-the-counter progestin-only pills in the United Kingdom and United States have brought widespread attention to this topic. RECENT FINDINGS: Progestin-only pills, including the norgestrel pill recently approved for over-the-counter use in the United States, are highly effective and may be used safely without a prescription or medical monitoring, including by adolescents. These pills are associated with relatively high user satisfaction. Although over-the-counter availability may improve contraceptive access overall, issues related to insurance coverage and out-of-pocket cost may continue to pose practical barriers to access for many individuals. SUMMARY: Over-the-counter oral contraceptives are an appropriate and important contraceptive option for many adolescents. Over-the-counter availability has the potential to increase access to safe and effective contraception in the United States, United Kingdom, and other countries where a prescription is currently required. Future research on use patterns among adolescents is needed, as are advocacy efforts and policies to ensure access and affordability.

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.

The validity of over-the-counter skin, hair, and nail recommendations for adult patients with cancer: A systematic review.

IMPORTANCE: Patients undergoing cancer treatment experience a multitude of skin, hair, and nail adverse events, prompting them to use non-evidence-based and often restrictive over-the-counter (OTC) recommendations to alleviate their symptoms. Comprehensively assessing evidence-based OTC modalities is crucial to enable cancer patients to comfortably resume their lives post-treatment and integrate clinically sound practices into their self-care routines. OBJECTIVE: Perform a systematic review and assessment of evidence-based OTC skin, hair, and nail care recommendations for adult patients undergoing cancer treatment. EVIDENCE REVIEW: PubMed, Cochrane, Embase, and Medline databases were searched in March 2023 to identify English articles addressing OTC skin, hair, and nail care recommendations for adult patients before, during, and after cancer chemotherapy or radiation therapy (RT). Quality was assessed with Oxford Centre for Evidence Based Medicine criteria. FINDINGS: 2192 unique articles were screened, of which 77 met inclusion criteria consisting of 54 randomized controlled trials (RCT), 8 non-randomized controlled cohorts, 1 non-randomized controlled clinical trial, 3 controlled prospective cohorts, 4 prospective cohorts, 2 controlled clinical trials, 1 prospective comparative study, 2 case reports, and 2 case series discussing 9322 patients. An additional article outside of our database search was included for a total of 78 articles. OTC skin care treatments with the best quality of evidence included moisturizing creams. Our review revealed a paucity of evidence-based hair and nail care practices. CONCLUSIONS AND RELEVANCE: This systematic review serves to highlight the efficacy of diverse OTC skin, hair, and nail care recommendations for adult cancer patients while encouraging further clinical trials to establish evidence-based management guidelines.

Associations between over-the-counter analgesics usage and symptoms of anxiety and depression in adolescents: a network analysis.

BACKGROUND: The use of over-the-counter analgesics (OTCA) is common among adolescents and has been linked with increased symptoms of anxiety and depression. However, little is known about which specific symptoms are most strongly connected to OTCA usage. The current study assessed which anxiety and depression symptoms were most closely associated with OTCA usage in a large sample of adolescents and examined whether this differed across genders. METHOD: The present study was based on data from 626,581 participants from the Ungdata survey in Norway. Associations between OTCA and anxiety and depression symptoms were examined using network analysis. Non-regularized partial-correlation networks were constructed to estimate the conditional dependent relations between the use of OTCA and symptoms while controlling for pain. Gender-specific networks were created for comparison. RESULTS: OTCA usage was associated with most symptoms, even after controlling for pain, with the strongest associations with "sleep problems", "stiff or tense", "everything is a struggle" and "suddenly scared". There were some gender differences, showing that "sleep problems" and "hopeless" were more strongly related to OTCA usage in females, whereas "stiff or tense" was more strongly related to OTCA usage in males. CONCLUSION: Overall, the somatic symptoms of anxiety and depression displayed the strongest associations with OTCA usage. When examining the gender-specific networks, both showed similar trends, although males exhibited slightly stronger associations between OTCA usage and somatic symptoms.

A Review of Wastewater-Based Epidemiology Studies for the Assessment of Over-the-Counter Medicines Used as Recreational Drugs: The Example of Dextromethorphan.

The 'recreational use' of selected over-the-counter (OTC) medicines is an unofficial activity. The traditional surveys assessing the use of drugs are affected by the bias of underreporting and are thus unreliable. The development of analytical techniques helps to monitor the substances at trace levels, such as in wastewater, and might be applied to estimate the consumption of an analyte of interest and ensure additional, evidence-based information complementary to population surveys. We reviewed studies focused on evaluating the estimated consumption of drugs as a reliable and unbiased source of evidence-based information (called wastewater-based epidemiology, WBE) to monitor the scale of this phenomenon. We found there is a need to test not only narcotics in the environment but also medicines that may be abused or recreationally used. The reviewed studies show methods that might provide reliable information about consumption of drugs, narcotics, and OTC medications for proposing targeted, preventive actions. Moreover, as all the selected studies were based on mass spectrometry, there is a potential to include the dextromethorphan and/or related compounds as part of the screening for narcotics and OTC drugs that can be socially harmful, overused, or misused. This article reviews the analytical methods for detecting dextromethorphan and/or its transformation products in environmental water samples.

Effects of nonprescription therapies on vestibular migraine: a questionnaire-based observational study.

BACKGROUND: Vestibular migraine (VM) is a common cause of recurrent vertigo. Migraine headache preventative therapies are currently prescribed to control vertigo symptoms in VM. Clinical trials of nutraceuticals for migraine headache prevention have shown positive outcomes, but, to date, there have been no studies to assess their effectiveness in the management of VM. AIMS: To report the effects of nonprescription therapy management on VM symptoms. METHODS: We undertook a prospective, questionnaire-based assessment of patients diagnosed with VM between November 2019 and August 2021 at two Sydney tertiary referral clinics. Patients were advised on optimising sleep, hydration, exercise and nutrition and instructed to use an over-the-counter combination product containing riboflavin 200 mg, magnesium 150 mg, coenzyme Q10 75 mg and feverfew 200 mcg. Symptom severity and frequency were assessed using the Dizziness Handicap Inventory (DHI), the Vertigo Symptom Score short-form (VSS-sf) and two visual analogue scales for severity (VAS-s) and frequency (VAS-f) before and 3 months after commencing treatment. RESULT: In 82 participants (78% female; mean age, 44 ± 14 years) we recorded a decrease in DHI (mean, 16.8 [95% confidence interval (CI), 12.8-20.9], VSS-sf (9.3, 7.1-11.5), VAS-s (3.0, 2.2-3.8) and VAS-f (2.8, 2.1-3.4), equating to an improvement of 44.1%, 44.9%, 44.1% and 38.9% for each measure respectively. On the DHI and VSS-sf, 41 (50%) and 44 (53.7%) patients showed improvement in their symptoms; 39 (47.6%) and 36 (43.9%) patients noted no change and two patients reported worsening. The supplement was well-tolerated. CONCLUSIONS: The results provide preliminary evidence that VM symptom frequency and severity can be reduced by using nonprescription therapies.

Is health literacy of adolescent athletes' parents whose children belonged to sports clubs related to their children's intention to receive medications, vaccines, supplements, and energy drinks? A cross-sectional study.

BACKGROUND: Adolescent athletes' values ​regarding health behaviors, including their attitudes toward doping, are largely derived from those of their parents. Therefore, clarifying the factors that affect parents' intentions regarding their children's medicine intake and nutrition can help elucidate the process of forming values ​​of healthy behaviors in young athletes. METHODS: Between March 8 and March 9, 2021, an online questionnaire survey was conducted via an Internet research company; data from 2,000 residents in Japan were collected. Participants were male and female residents aged 30-59 years with children in elementary or high school and belonging to sports clubs. The survey items included respondent's and child's basic information, respondent's health literacy, and level of sports in which the respondent and child were (or are) engaged. Respondents were also asked if they would like their children to receive prescription drugs, over-the-counter drugs, herbal medicines, vaccines, supplements, or energy drinks. Logistic regression analysis was performed to analyze the relationship between respondents' basic information and health literacy and their intention to receive prescription and over-the-counter drugs, herbal medicines, vaccines, supplements, and energy drinks. RESULTS: Higher parental health literacy was associated with higher children's willingness to receive prescription drugs (odds ratio [OR] = 1.025, 95% confidence interval [CI]: 1.016-1.035), over-the-counter drugs (OR = 1.012, 95% CI: 1.003-1.021), prescription herbal medicines (OR = 1.021, 95% CI: 1.021-1.030), over-the-counter herbal medicines (OR = 1.012, 95% CI: 1.003-1.021), and vaccines (OR = 1.025, 95% CI: 1.016-1.035). Conversely, the children's intention to receive energy drinks (OR = 0.990, 95% CI: 0.980-1.000) decreased significantly. As the child's athletic level increased, parents' willingness for their children to receive oral prescription medicines decreased (OR = 0.886, 95% CI: 0.791-0.992) and that to receive supplements (OR = 1.492, 95% CI: 1.330-1.673) and energy drinks significantly increased (OR = 1.480, 95% CI: 1.307-1.676). CONCLUSION: Health literacy of adolescent athletes' parents is associated with their children's willingness to receive medicines. Healthcare providers should counsel parents of adolescent athletes to allow their children to receive necessary drug treatments and prevent doping violations caused by supplement intake.

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.

An Over-the-Counter Healing Ointment: Benefits in Dry Skin and Wound Healing.

BACKGROUND: The use of ointments can be beneficial for dry, chapped, or cracked skin and also for supporting wound healing. We describe the results of 2 studies with an over-the-counter healing ointment (HO) to evaluate the effects on skin hydration and in the setting of wound healing after dermatologic procedures.  Methods: Study 1 was a single-center, in-use study using HO on qualified areas at least once daily for 4 weeks in subjects with dry, cracked body skin and self-perceived sensitive skin. Study 2 was a multi-center study of wound healing in subjects using HO on a daily basis after having dermatologic surgical procedures.  Results: In Study 1, there was a significant reduction in skin dryness after 1 and 4 weeks of HO use (P<0.05). Image analysis of the skin revealed a significant increase in skin smoothness after the first application of HO in 100% of subjects (P<0.05). Tolerability and safety were excellent, and HO was well-perceived by subjects throughout the study. In Study 2, HO improved clinical assessments at all time points compared with baseline with a decrease in erythema, edema, scabbing/crusting, and an improvement in overall wound appearance (P<0.05). There was no worsening or significant increase in measures for tolerability parameters at any study visits. Additionally, HO achieved a favorable perception by study subjects.  Conclusions: HO has a well-established safety profile and has been shown to improve both skin hydration and the overall wound healing process after dermatologic surgical procedures. J Drugs Dermatol. 2024;23(5):360-365. doi:10.36849/JDD.8224.

Nonprescription Treatment Options.

The pathogenesis of atopic dermatitis (AD) is complex and multifactorial. However, recent advancements in the genetics and pathophysiology of AD suggest that epidermal barrier dysfunction is paramount in the development and progression of the condition (Boguniewicz M, Leung DYM, Immunol Rev 242(1):233-246, 2011). In addition to standard therapy for AD, there are a plethora of nonprescription treatment modalities which may be employed. Over-the-counter treatments for atopic dermatitis can come in the form of topical corticosteroids, moisturizers/emollients, and oral antihistamines. Though these treatments are beneficial, prescription treatments may be quicker acting and more efficacious in patients with moderate to severe disease or during flares. OTC agents are best used for maintenance between flares and to prevent progression of mild disease. Alternative and complementary treatments lack strong efficacy evidence. However, wet wraps, bleach baths, and other treatments appear to be promising when used in conjunction with conventional treatments. With the financial burden of atopic dermatitis ranging from 364 million to 3.8 billion dollars each year in the United States, we suspect this topic will gain further research attention.

Moving Naloxone Over the Counter Is Necessary but Not Sufficient.

Naloxone is an opioid antagonist that is available in numerous formulations and can be easily administered to avert death from opioid overdose. Amid a historic overdose crisis in the United States, naloxone has a crucial role in stemming the loss of life. However, it remains largely inaccessible to the public. Recently, the U.S. Food and Drug Administration announced the approval of the first over-the-counter formulation of naloxone. Although this historic change provides an important opportunity to increase distribution of naloxone, we must take careful steps during this transition so that it does not paradoxically threaten overall access to this life-saving medication. Specifically, we must ensure that a larger supply of naloxone will meet the newly increased demand at a sustainable price for consumers who are most in need. We must also continue to prioritize comprehensive methods of distribution, such as overdose education and naloxone distribution programs, that serve as important tools to reach the most vulnerable populations. In addition, simultaneous investment in harm-reduction strategies, such as supervised consumption spaces, is critical to ensure that naloxone is available in settings where its life-saving potential can be most fully realized.

A comprehensive quality evaluation strategy of Shensong Yangxin capsules based on qualitative, fingerprint and quantitative analyses.

Shensong Yangxin capsule (SSYXC), an effective Chinese patent medicine, has been recorded in the Chinese Pharmacopeia, mainly for the treatment of coronary heart disease and ventricular premature beat. To further complete the quality evaluation of SSYXC, a comprehensive analysis strategy was established. Firstly, the components of SSYXC were qualitatively analysed using ultra-high- performance liquid chromatography-Fourier transform ion cyclotron resonance mass spectrometry. A total of 134 compounds were identified or tentatively characterized. Additionally, the fingerprint of SSYXC was established by HPLC, and the similarity of 10 batches of SSYXC was elucidated by similarity analysis. The result indicated that the consistency of chemical composition is good. Finally, to enhance the quality control of SSYXC, according to the results of the fingerprint analysis, the contents of the seven active components was determined, comprising morroniside, loganin, paeoniflorin, salvianolic acid B, palmatine hydrochloride, berberine hydrochloride and tanshinone IIA. In conclusion, the established method, comprising identification of components, fingerprint analysis and quantification of multicomponents, can be sensitively and comprehensively applied to the quality evaluation of SSYXC, which can provide chemical ingredients bases for quality control and the pharmacodynamic mechanism of SSYXC, which could serve as a benchmark for controlling the quality of other Chinese patent medicines.

Implied Claims in Drug Advertising: A Review of Recent Literature and Regulatory Actions.

Federal agencies and self-regulatory bodies help to ensure prescription and nonprescription drug promotion contains accurate information; however, false or misleading claims may cause people to have inaccurate perceptions of a drug and inhibit their ability to make informed decisions. We conducted a systematic review assessing evidence from 2012-2021 on how consumers and healthcare providers (HCPs) interpret claims made indirectly or through inference (implied or implicit claims) as well as synthesizing prescription and nonprescription drug advertising claims that have been the subject of regulatory actions from 2017-2021. Our search identified 16 studies from the peer-reviewed literature and 26 letters or case reports issued by the Food and Drug Administration (FDA) or National Advertising Division (NAD). Results from peer-reviewed studies suggest that implied claims can result in inferences that may not be warranted by the material facts about the drug. Perceptions of a drug's efficacy and, to a lesser extent, risk, are influenced by implied and explicitly false claims in prescription drug promotion. Claims related to implied superiority and overstatement of efficacy were the most prevalent claims flagged for review and examined in the literature. These types of claims were also the subject of many of the compliance actions by the FDA and case reports from the NAD. More research is needed to understand how people interpret varying types of implied claims and the impact of such claims on key outcomes. From a policy standpoint, understanding how people interpret implied claims can inform how the FDA approaches these claims in the marketplace.

Development of a Potential-Modulated Electrochemiluminescence Measurement System for Selective and Sensitive Determination of the Controlled Drug Codeine.

Codeine is a common analgesic drug that is a pro-drug of morphine. It also has a high risk of abuse as a recreational drug because of its extensive distribution as an OTC drug. Therefore, sensitive and selective screening methods for codeine are crucial in forensic analytical chemistry. To date, a commercial analytical kit has not been developed for dedicated codeine determination, and there is a need for an analytical method to quantify codeine in the field. In the present work, potential modulation was combined with electrochemiluminescence (ECL) for sensitive determination of codeine. The potential modulated technique involved applying a signal to electrodes by superimposing an AC potential on the DC potential. When tris(2,2'-bipyridine)ruthenium(II) ([Ru(bpy)3]2+) was used as an ECL emitter, ECL activity was confirmed for codeine. A detailed investigation of the electrochemical reaction mechanism suggested a characteristic ECL reaction mechanism involving electrochemical oxidation of the opioid framework. Besides the usual ECL reaction derived from the amine framework, selective detection of codeine was possible under the measurement conditions, with clear luminescence observed in an acidic solution. The sensitivity of codeine detection by potential modulated-ECL was one order of magnitude higher than that obtained with the conventional potential sweep method. The proposed method was applied to codeine determination in actual prescription medications and OTC drug samples. Codeine was selectively determined from other compounds in medications and showed good linearity with a low detection limit (150 ng mL-1).

Preventing the Abuse and Misuse of Over-the-Counter Medicines: A Survey of Community Pharmacists in Finland.

BACKGROUND: Over-the-counter (OTC) medicines intended for short-term use for self-care may be abused or misused. AIM: To explore the experiences and perceptions of community pharmacists (dispensers, pharmacists, and pharmacy owners) of the use, abuse, and misuse of OTC medicines by pharmacy customers, and to identify their perceptions of the most appropriate methods to prevent inappropriate use of OTC medicines. METHOD: A cross-sectional national online survey to community pharmacists in Finland. A previously validated structured questionnaire was modified. Three national pharmaceutical associations were contacted to help in recruitment of their members (n = 5594, calculated target sample size n = 360). Descriptive statistical analyses were conducted. RESULTS: In total, 442 responses were received. Most respondents strongly agreed (Md all = 5) that OTC medicines could be abused or misused; pharmacy owners were more likely to strongly agree than pharmacists (p = 0.012). Pharmacy owners were more likely to think that laxatives were liable for abuse than dispensers (p = 0.008), and that travel sickness medicines were liable for misuse than dispensers (p < 0.001) and pharmacists (p = 0.013). Patient counseling was the most commonly employed method to prevent the problem. Respondents perceived that providing training to staff about OTC medicines that can be abused (Md all = 5) was the most appropriate strategy to prevent OTC medicine abuse; pharmacy owners were more likely to strongly agree or agree of this (p = 0.005) than dispensers. Conclusion: Community pharmacists are aware of the liability of OTC medicines for the potential abuse and misuse. They employ various methods as advising and counseling the customer to support the rational use of OTC medicines.

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.

Pharmacy staff-reported adaptations to naloxone provision and over-the-counter (OTC) syringe sales during the COVID-19 pandemic: Experiences across multiple states and 2 pharmacy chains.

BACKGROUND: Access to harm reduction materials was greatly disrupted during coronavirus disease 2019 (COVID-19). Community pharmacies often continued provision of harm reduction materials as part of their usual operations during the pandemic, but little is known about what, if any, adaptations were made and the perceived impact of these actions from the perspective of pharmacy staff. OBJECTIVES: We explored how pharmacy staff across 4 states in 2 major pharmacy chains adapted to the COVID-19 pandemic for ongoing naloxone and over-the-counter (OTC) syringe access and how staff perceived the pandemic affected drug use in the community they served and their pharmacy's volume of syringe sales and naloxone provision. METHODS: We analyzed 134 pharmacy staff responses to a 12-month follow-up assessment for an educational intervention conducted in 2 pharmacy chains in Oregon, Washington, Massachusetts, and New Hampshire. Respondents answered closed- and open-ended questions collected online from July 2020 to February 2022. Questions measured prevalence of adaptations and perceived uptake of naloxone and OTC syringe services. Descriptive statistics summarized adaptations and perceived impact and chi-square tests explored differences by state and pharmacy chain. Open-ended responses were reviewed and analyzed to identify summary points and themes. RESULTS: With few differences by state or pharmacy chain detected, pharmacy staff reported more naloxone mailing, requests by phone, streamlined counseling, and drive-thru provision adaptations to OTC syringe sales and naloxone provision during the pandemic. Most staff perceived adaptations as increasing or maintaining naloxone provision and OTC syringe sales. Respondents described specific aspects of the pharmacy that contributed to successful adaptations, including tailoring to specific product demand, inventory levels, drive-thru access, and a perception of extraordinary public health need at a time of and in places affected by the opioid crisis. CONCLUSIONS: Pharmacy OTC syringe and naloxone access continued during the COVID-19 pandemic through streamlining workflows and innovating no-contact harm reduction services, reinforcing pharmacy's public health role.

Patients' willingness to pay for naloxone: A national cross-sectional survey of prescription opioid users with chronic pain in the United States.

BACKGROUND: Millions of U.S. people have been heavily affected by opioids. In March 2023, the Food and Drug Administration approved naloxone as an over-the-counter medication. This has allowed more access to patients at high risk of opioid overdose. However, the patient's willingness to pay for naloxone at the pharmacy counter has not been assessed. OBJECTIVES: This study aimed to characterize factors associated with the willingness to pay for naloxone among the patient group. METHODS: A cross-sectional Qualtrics online panel survey instrument was developed. This survey was distributed to patients in the United States, aged ≥ 18 years, with any chronic pain and taking opioids. The survey included demographics, and clinical characteristics (pain assessment, opioid use, and knowledge of naloxone). In addition, willingness to pay was assessed using a 7-point Likert scale ranging from strongly disagree to strongly agree. An ordinal logistic regression model was used to examine demographic and clinical characteristics. RESULTS: A total of 549 subjects completed the survey (women [53.01%], white or Caucasian (83.61%), age mean [SD] 44 [13]). Women were associated with less willingness to pay (adjusted odds ratio [aOR] 0.685 [95% CI 0.478-0.983], P = 0.0403). Compared with the high household income group (≥ $150,000), low household income ≤ $25,000 (aOR 0.326 [95% CI 0.160-0.662], P = 0.0020) or income between $25,000 and 74,999 (aOR 0.369 [95% CI 0.207-0.657], P = 0.0007) was associated with less likelihood of willing to pay. Patients with a previous diagnosis of obstructive sleep apnea were associated with a higher likelihood of willingness to pay (aOR 1.685 [95% CI 1.138-2.496], P = 0.0092). Each unit increase in pain was also associated with a higher likelihood of willingness to pay (aOR 1.247 [95% CI 1.139-1.365], P < 0.0001). CONCLUSIONS: Demographics and clinical factors were associated with willingness to pay for naloxone. This study's findings are useful in the development of interventions to address pharmacy-based naloxone distribution programs.