Rx -to- OTC switch increased access and lowered cost of topical adapalene.

Topical adapalene gel is an effective and well tolerated acne treatment that transitioned from prescription to over-the-counter (OTC) availability in 2016. Historically, prescription to OTC transitions have lowered costs to patients and payers and increased access to medications. This study used sales and prescriber data to assess access to topical retinoid therapies and their costs in the pre- and post- Rx-to-OTC transition. We demonstrate that the prescription to OTC transition of adapalene gel increased access to this medication, while lowering costs to patients and payers, including Medicare patients. These results provide a necessary call to action for future OTC shifts with other high safety profile, well-tolerated medications in ultimate efforts and hopes of cost savings for patients, insurers, and Medicare within our healthcare industry.

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.

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.

Increases in retail sales of over-the-counter levonorgestrel emergency contraception in the United States, 2016-2022.

OBJECTIVES: To understand patterns in demand for emergency contraception (EC), we characterize the sales of over-the-counter (OTC) levonorgestrel (LNG) EC in the United States from traditional retail outlets. STUDY DESIGN: We describe sales of OTC LNG EC using retail sales data aggregated from traditional retail channels, including grocery stores, drug stores, mass merchandisers, club stores, dollar stores, and military outlets. RESULTS: Sales of OTC LNG EC doubled between 2016 and 2022 (approximately 7.2-14.8 million). CONCLUSIONS: Increasing sales of EC are consistent with increased use and use frequency of EC by those at risk of pregnancy in the United States. IMPLICATIONS: OTC LNG EC sales since 2016 exceed what national survey usage estimates would suggest, indicating that national surveys underreport EC use, those using EC purchase it somewhat frequently, and/or individuals stockpile EC for later use. The role of EC in individual contraceptive strategies, particularly as access to reproductive healthcare is restricted, warrants further study.

Spending on Dual Over-the-Counter and Prescription Drugs in the Medicare Part D Program.

This study compares Medicare and patient spending for dual over-the-counter and prescription drugs with their over-the-counter cash prices.

Patterns of prescription dispensation and over-the-counter medication sales in Sweden during the COVID-19 pandemic.

INTRODUCTION: On February 26th 2020, a high alert was issued in Sweden in response to the diagnosis of the first few coronavirus disease 2019 (COVID-19) cases in the country. Subsequently, a decreased supply of essential goods, including medical products, was anticipated. We aimed to explore the weekly patterns of prescription dispensing and over-the-counter (OTC) medication sales in Sweden in 2020 compared with previous years, to assess the influence of the government restrictions on medication sales, and to assess whether there is evidence of medication stockpiling in the population. METHODS: Aggregated data on the weekly volume of defined daily doses (DDDs) of prescription medication dispensed and OTC sales from 2015 to 2020 were examined. From 2015-2019 data, the predicted weekly volume of DDDs for 2020 was estimated and compared to the observed volume for each ATC anatomical main group and therapeutic subgroup. RESULTS: From mid-February to mid-March 2020, there were increases in the weekly volumes of dispensed medication, peaking in the second week of March with a 46% increase in the observed versus predicted number of DDDs dispensed (16,440 vs 11,260 DDDs per 1000 inhabitants). A similar pattern was found in all age groups, in both sexes, and across metropolitan and non-metropolitan regions. In the same week in March, there was a 96% increase in the volume of OTC sold (2,504 vs 1,277 DDDs per 1000 inhabitants), specifically in ATC therapeutic subgroups including vitamins, antipyretics, painkillers, and nasal, throat, cough and cold preparations. CONCLUSION: Beginning in mid-February 2020, there were significant changes in the volume of prescription medication dispensed and OTC drugs sold. The weekly volume of DDDs quickly decreased following recommendations from public authorities. Overall, our findings suggest stockpiling behavior over a surge in new users of medication.

Over-the-counter sale of antibiotics - Using Net-Map to identify and segment stakeholders as the first step towards the development of smart regulation.

INTRODUCTION: Antimicrobial resistance (AMR) is a complex public health problem requiring coordinated efforts by a multitude of public and private sector stakeholders. Over-the-counter (OTC) antibiotics sale is contributing to rising AMR. We applied NetMap, a research tool to identify, prioritize and assess relationships among stakeholders, also to identify the stakeholders that must be engaged for regulating antibiotic OTC sale for humans in India. METHODS: Through a one-day workshop, a team of expert facilitators engaged with a mixed group of stakeholders-regulators, drug manufacturers, retailers and consumers of antibiotics to identify and rank stakeholders based on their role, power/interest and influence. Stakeholders were listed and grouped as per the type of agency represented. Carrom discs were stacked against each stakeholder with the height of stack reflecting perceived power. RESULTS: A total of 25 stakeholders were identified from government, non-government, private/corporate, academic and research agencies and the general public. Based on the stacking exercise, a power/interest matrix was developed with six stakeholders having high power and high interest, five having high power but low interest, six having low power but high interest and eight having low power. A visual NetMap was developed to position the stakeholders as proximal, middle and distal based on their perceived influence. CONCLUSIONS: NetMap can be used with stakeholders with varying skill sets. It is a useful project initiation tool that was successfully used to prioritize stakeholders for reaching out, for targeted outreach and development of customized tools for developing innovative regulation for tackling OTC sale of antibiotics. It also pre-empted any conflict of interests.

Availability of over-the-counter antibiotics in Guatemalan corner stores.

Widespread availability of antibiotics without prescription potentially facilitates overuse and contributes to selection pressure for antimicrobial resistant bacteria. Prior to this study, anecdotal observations in Guatemala identified corner stores as primary antibiotic dispensaries, where people purchase antibiotics without prescriptions. We carried out a cross sectional study to document the number and types of antibiotics available in corner stores, in four study areas in Guatemala. A total of 443 corner stores were surveyed, of which 295 (67%) sold antibiotics. The most commonly available antibiotics were amoxicillin, found in 246/295 (83%) stores, and tetracycline, found in 195/295 (66%) stores. Over the counter sales result from laissez-faire enforcement of antibiotic dispensing regulations in Guatemala combined with patient demand. This study serves as a baseline to document changes in the availability of antibiotics in informal establishments in light of new pharmacy regulations for antibiotic dispensing, which were adopted after this study was completed.

Stocking pattern for anti-malarial medications among proprietary patent medicine vendors in Akinyele Local Government Area, Ibadan, Nigeria.

BACKGROUND: Policymakers have recognized that proprietary patent medicine vendors (PPMVs) can provide an opportunity for effective scaling up of artemisinin-based combination therapy (ACT) since they constitute a major source of malaria treatment in Nigeria. This study was designed to determine the stocking pattern for anti-malarial medications, knowledge of the recommended anti-malarial medicine among PPMVs in Akinyele Local Government Area (LGA) of Oyo State, Nigeria and their perception on ways to improve PPMV adherence to stocking ACT medicines. METHODS: A cross-sectional survey was conducted among 320 PPMVs using a mixed method of data collection. Survey respondents were consecutively selected as a complete listing of all the PPMVs was not available. A pretested interviewer-administered questionnaire was used to collect quantitative data and two focus group discussions (FGD) were conducted among PPMVs using a pretested FGD guide. RESULTS: Most PPMVs stocked artemether-lumefantrine (90.9%), dihydroartemisinin-piperaquine (5.3%) and artesunate-amodiaquine (2.8%). Drugs contrary to the policy, which included sulfadoxine-pyrimethamine, chloroquine, quinine, halofantrine, artesunate, and artemether were stocked by 93.8, 22.8, 0.6, 1.3, 6.6, and 7.8% of the PPMVs, respectively. Most PPMVs (96.3%) had good knowledge of artemether-lumefantrine as the first-line treatment for malaria and 2.8% had good knowledge of artesunate-amodiaquine as the alternate treatment for malaria. The major factors influencing stocking decision were government recommendations (41.3%) and consumer demand (40.30%). CONCLUSION: Stocking of artemisinin-based combinations was high among PPMVs, although they also stocked and dispensed other anti-malarial drugs and this has serious implications for drug resistance development. The PPMVs had considerable knowledge of the recommended treatment for uncomplicated malaria and stocking decisions were overwhelmingly driven by consumer demand. However, there is a need for more enlightenment on discontinuation of government-banned anti-malarial drugs.

Evaluating interventions to improve test, treat, and track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS) in some rural communities of Fanteakwa North district, Ghana: study protocol for a cluster randomized controlled trial.

BACKGROUND: The World Health Organization initiated test, treat, and track (T3) malaria strategy to support malaria-endemic countries in their efforts to achieve universal coverage with diagnostic testing, antimalarial treatment, and strengthening surveillance systems. Unfortunately, T3 is not adopted by over-the-counter medicine sellers (OTCMS) where many patients with malaria-like symptoms first seek treatment. Sub-Saharan African countries are considering introducing and scaling up RDTs in these outlets to reduce malaria burden. In this context, this study is aimed at improving implementation of the T3 among OTCMS using a number of intervention tools that could be scaled-up easily at the national level. METHODS/DESIGN: The interventions will be evaluated using a two-arm, cluster randomized trial across 8 rural communities (4 clusters per arm), in two adjacent districts (Fanteakwa North and Fanteakwa South districts) of Ghana. A total of 8 OTCMS in the intervention arm and 5 OTCMS in the control arm in the selected communities will participate in the study. In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately. Supervision, technical assistance, feedbacks, and collection of data will be provided on a regular basis at the participating medicine stores. The primary outcome is the proportion of children under 10 years with fever or suspected to have malaria visiting OTCMS and tested (using mRDT) before treatment. Secondary outcomes will include adherence to national malaria treatment guidelines and recommended mRDT retail price. Outcomes will be measured using mainly a household survey supplemented by mystery client survey and a surveillance register on malaria tests conducted by the OTCMS during patient consultations. Data collected will be double entered and verified using Microsoft Access 2010 (Microsoft Inc., Redmond, Washington) and analyzed using STATA version 11.0. DISCUSSION: The trial will provide evidence on the combined effectiveness of provider and community interventions in improving adherence to the T3 initiative among OTCMS in rural Ghana. ETHICAL CLEARANCE: NMIMR-IRB CPN 086/18-19 TRIAL REGISTRATION: ISRCTN registry ISRCTN77836926 . Registered on 4 November 2019.

Comparative efficacy, safety and cost of oral Chinese patent medicines for rheumatoid arthritis: a Bayesian network meta-analysis.

BACKGROUND: Rheumatoid arthritis (RA) is a common inflammatory disease with a substantial burden for society and economic worldwide. Chinese patent medicines (CPMs) have gained attention as alternative remedies due to they can exert the satisfactory therapeutic effects via holistic regulation. Currently, several oral Chinese patent medicines are routinely recommended for managing and treating RA. Therefore, a network meta-analysis (NMA), which tries to synthesize evidences for a decision making by evaluating the comparative effectiveness of multiple interventions against the same disease, was undertaken to identify the optimal intervention according to their efficacy in clinical treatment and symptom remission, safety profile and daily cost. METHODS: Randomized controlled trials (RCTs) regarding CPMs to treat RA were comprehensive retrieved from 3 foreign databases and 4 Chinese databases, and the retrieved results were last updated on January 10, 2019. The bias of the selected trials was assessed by two individuals independently through RoB2. A random-effects model was adopted during the meta-analytic procedures, and outcomes concerning efficacy and safety were evaluated as odds ratios (OR), mean differences (MD) and 95% credible intervals (CI) utilizing Stata 14.1 and WinBUGS 1.4.3 software. Furthermore, the cluster analysis and comprehensive investigation were preformed concerning the comparative efficacy, safety and cost of oral CPMs. RESULTS: One hundred sixteen RCTs involving 10,213 individuals met the inclusion criteria and were enrolled into current NMA. The results from existing evidence indicated that Biqi capsule and Yuxuebi capsule probably had a favorable balance in consideration of benefits, tolerability and daily cost. Furthermore, as the least expensive choice, glucosides of Tripterygium Wilfordii tablet was associated with displaying a trend of relieving joint tenderness, joint swelling, and morning stiffness for patients with RA. CONCLUSION: Biqi capsule, Yuxuebi capsule and glucosides of Tripterygium Wilfordii tablet were recommended for treating RA based on the favorable benefits in both clinical efficacy and symptoms, and they, meanwhile, might be associated with the more tolerable and acceptable therapeutic alternative in terms of safety profile and daily cost. Nevertheless, the additional results from high-quality, multi-center and head-to-head trials would be pivotal for supporting our findings.

Factors influencing non-prescription sales of antibiotics among patent and proprietary medicine vendors in Kano, Nigeria: a cross-sectional study.

Patent and proprietary medicine vendors (PPMVs) increase access to antibiotics through non-prescription sales in their drug retail outlets. This fosters irrational antibiotic use among people, thus contributing to the growing burden of resistance. Although training programmes on antibiotic use and resistance exist, they have disproportionately targeted health workers in hospital settings. It's unclear if there is a relationship between such trainings and non-prescription sales of antibiotics among PPMVs which are more embedded in communities. Therefore, a cross-sectional study was conducted to elicit the determinants of non-prescription antibiotic sales among PPMVs in Kano metropolis, Nigeria. Through brainstorming, causal loop diagrams (CLDs) were used to illustrate the dynamics of factors that are responsible for non-prescription antibiotic sales. Multilevel logistic regression model was used to determine the relationship between training on antibiotic use and resistance and non-prescription antibiotic sales, after controlling for potential confounders. We found that two-third (66.70%) of the PPMVs reported that they have sold non-prescribed antibiotics. A total of three CLDs were constructed to illustrate the complex dynamics of the factors that are related to non-prescription antibiotic sales. After controlling for all factors, PPMVs who reported that they had never received any training on antibiotic use and resistance were twice as more likely to sell antibiotic without prescription compared with those who reported that they have ever received such training (OR = 2.07, 95% CI: 1.27-3.37). This finding suggests that there is an association between training on antibiotic use and resistance and non-prescription sales of antibiotics. However, the complex dynamics of the factors should not be ignored as it can have implications for the development of intervention programmes. Multifaceted and multicomponent intervention packages (incorporating trainings on antibiotic use and resistance) that account for the inherent complexity within the system are likely to be more effective for this setting.

Modeling the Impacts of Price of an Over-the-Counter Progestin-Only Pill on Use and Unintended Pregnancy among U.S. Women.

OBJECTIVE: To model the impacts of out-of-pocket cost of an over-the-counter (OTC) progestin-only pill on use and associated unintended pregnancy among U.S. women. STUDY DESIGN: Using data from a 2015 nationally representative survey of 2,539 U.S. women aged 15 to 44 assessing interest in using an OTC progestin-only pill, we used discrete survival analysis and a Markov model to analyze women's likelihood of using of an OTC pill at different price points and by sociodemographic characteristics. We modeled the impact of product price on the potential total number of U.S. users and on unintended pregnancies in 1 year among adult women at risk of unintended pregnancy. RESULTS: In a model assuming no out-of-pocket costs, more than 12.5 million adults and 1.75 million teens reported likely use of an OTC progestin-only pill if available. Among adults, this resulted in an estimated 8% decrease in unintended pregnancy in 1 year. Adult and teen women on average were willing to pay $15 and $10, respectively, resulting in 7.1 million adult and 1.3 million teen users and an estimated 5% decrease in unintended pregnancy among adults. CONCLUSIONS: At low and no out-of-pocket cost, a large population of women in the United States might likely use an OTC progestin-only pill. A low retail price and insurance coverage are necessary to provide equitable access to this method for low-income populations across the United States, fill current gaps in contraceptive access, and potentially decrease unintended pregnancy.

OTC drug advertising in Japan: the role of need for cognition and celebrity endorser credibility.

This research explores how the level of consumers' need for cognition (NFC) is associated with celebrity endorser credibility and examines its effects on advertising-related attitudes. A 3 (endorser types: actor/actress, athlete, TV personality/talent) × 2 (endorser's gender) factorial experiment with 435 Japanese consumers was conducted. Concerning Japanese OTC drug advertising, lower NFC individuals perceived celebrity endorsers as more credible in comparison to higher NFC individuals. The main effects of NFC and endorser type on endorser credibility existed; however, no interaction between the two variables was found. The endorser type had an influence on attitudes toward ads and the advertised brand.