Naloxone Availability and Cost After Transition to an Over-the-Counter Product.

Importance: The US Food and Drug Administration approved Narcan, a nasal spray formulation of naloxone, for sale as an over-the-counter (OTC) medication in March 2023. The purpose of OTC approval was to improve naloxone accessibility to reduce opioid overdoses; however, research has not yet evaluated whether naloxone's availability and cost changed since this policy was implemented. Objective: To evaluate whether the accessibility and cost of naloxone at North Carolina community pharmacies changed after OTC naloxone became available and whether cost and availability varied by pharmacy type and urbanicity. Design, Setting, and Participants: This longitudinal telephone-based secret shopper survey study included a stratified sample of 202 North Carolina community pharmacies, including health department, independent, and chain pharmacies. There were 2 separate data collection efforts from March to April 2023 (before OTC naloxone could be sold at pharmacies) and November 2023 to January 2024 (after OTC naloxone was sold at pharmacies). Exposure: OTC naloxone first became available for sale at community pharmacies in September 2023. Main Outcomes and Measures: The main outcomes were same-day availability of naloxone without a clinician-issued prescription and the quoted out-of-pocket cost for cash-paying patients. Results: Data were collected from 192 pharmacies. Same-day naloxone availability increased from 42.2% (81 of 192) before OTC naloxone availability to 57.8% (111 of 192) after (P < .001). The mean (SD) quoted out-of-pocket cost decreased from $90.93 ($42.6) pre-OTC availability to $62.67 ($41.0) post-OTC availability (P < .001). Independent pharmacies had higher mean (SD) costs than chain pharmacies in both the pre-OTC phase ($109.47 [$37.90] vs $86.40 [$35.70]; P < .001) and post-OTC phase ($77.59 [$38.90] vs $57.74 [$35.90]; P = .004). Out-of-pocket costs did not differ by urbanicity in the pre-OTC phase; however, mean (SD) costs were higher at suburban ($88.67 [$66.80]) and rural ($65.43 [$35.00]) pharmacies compared with urban pharmacies ($53.58 [$29.00]) in the post-OTC phase (P = .003). Conclusions and Relevance: The Food and Drug Administration's approval of OTC naloxone nasal spray contributed to an increase in pharmacy-based availability of naloxone and a reduction of its cost for cash-paying patients. Cost was higher at independent pharmacies compared with chain pharmacies and lower in urban pharmacies compared with suburban and rural pharmacies.

A qualitative exploration of the over-the-counter availability of oral contraceptive pills in Australia.

INTRODUCTION: The prevention of unintended pregnancy is a public health issue affecting women worldwide. In Australia, women are required to get a prescription to obtain the oral contraceptive pill (OCP), which may limit access and be a barrier to its initiation and continuing use. Changing the availability of the OCP from prescription-only to over-the-counter (OTC) is one solution, however, to ensure success policymakers need to understand women's preferences. Telehealth services also might serve as an alternative to obtain prescriptions and increase accessibility to OCPs. This study aims to explore the preferences for OTC OCPs among Australian women, and whether the expansion of telehealth impacted women's preferences. METHODS: A mixed methods approach was used to explore women's preferences regarding access to the OCP. Focus group discussions (FGDs) were conducted to organically identify the preferences followed by an empirical ranking exercise. Three FGDs in two phases were conducted, pre and post-expansion of telehealth in Australia due to the COVID-19 pandemic. Convenience sampling was employed. The technique of constant comparison was used for thematic analysis where transcripts were analysed iteratively, and codes were allowed to emerge during the process to give the best chance for the attributes to develop from the data. RESULTS: Thematic analysis revealed that women perceived OTC availability of OCPs as a mechanism to increase the accessibility of contraception by reducing cost, travel time, waiting time, and increasing opening hours. They also believed that it would increase adherence to OCPs. However, some potential safety concerns and logistical issues were raised, including pharmacist training, access to patient's medical history, the ability to discuss other health issues or undertake opportunistic health screening, adherence to checklists, and privacy in the pharmacy environment. Following the expansion of telehealth, accessibility issues such as opening hours, travel time, and location of the facility were considered less important. CONCLUSIONS: The participants expressed their support for reclassifying OCPs to OTC, particularly for repeat prescriptions, as it would save valuable resources and time. However, some safety and logistical issues were raised. Women indicated they would balance these concerns with the benefits when deciding to use OTC OCPs. This could be explored using a discrete choice experiment. The expansion of telehealth was perceived to reduce barriers to accessing OCPs. The findings are likely to be informative for policymakers deciding whether to reclassify OCPs to OTC, and the concerns of women that need addressing to ensure the success of any policy change.

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.

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.

Over-the-Counter Oral Contraception as an Opportunity to Reduce Contraceptive Access Inequity.

This Viewpoint argues that making a progestin-only contraceptive pill available for sale as an over-the-counter product will help reduce logistic barriers to safe and effective birth control.

Assessment of without prescription antibiotic dispensing at community pharmacies in Hazara Division, Pakistan: A simulated client's study.

Antibiotics dispensing without a prescription is an irrational practice and can increase the risk of antibiotic resistance, which is a significant public health concern around the globe. This study was aimed to determine the extent to which antibiotics are supplied without prescription in the community pharmacies (CPs) at Hazara Division from November 2020 to February 2021. The simulated client method (SCM) was used, and the data were gathered, recorded, and analyzed through different statistical methods with descriptive and inferential techniques. The antibiotic dispensing was observed in CPs (90.5%), the most dispensed antibiotics were azithromycin (29.4%) and ciprofloxacin (46.5%) respectively. Furthermore, visited medical stores/ drug outlets, 9.5% of the visited stores denied dispensing of antibiotics because they preferred a referral to visit physicians (23. 9%) and (12.8%) did not had the antibiotics at the time of visits. Antibiotics were more obtainable in retail medical stores (AOR = 8.6, 95 percent Cl: 3.0-24.7; p = 0.001) than in pharmacies. In rural areas antibiotics dispensing was more (p = 0.004) as compared to urban areas. Staff members also had asked about patient's (17.7%) symptoms and drug allergies (12.3% and 3.9%), and (1.5%) they consoled them about their medications. The findings of this study indicate that nonprescription antibiotic sales are very common, despite national rules prohibiting this activity. When the simulated Client requested for any medication to relieve his or her discomfort, many antibiotics were given out without a prescription. Pharmacies/medical stores in Hazara Division selling antibiotics without a prescription are worrying and need immediate action by regulators.

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.

Naturaleza de las dispensaciones durante el servicio de guardia de fin de semana de las farmacias en la ciudad de Teruel / Nature of dispensations during the weekend guardservice of pharmacies in the city of Teruel

INTRODUCCIÓN: el trabajo que los farmacéuticos y otros profesionales sanitarios realizan durante el servicio de guardia tiene una importancia esencial, ya que asegura la accesibilidad al medicamento, ofreciendo consejo sanitario, seguimiento farmacoterapéutico y apoyo profesional a los pacientes fuera del horario habitual. OBJETIVO: conocer la naturaleza de las dispensaciones en el servicio de guardia de las farmacias de la ciudad de Teruel durante el fin de semana. METODOLOGÍA: estudio observacional descriptivo transversal realizado en tres farmacias comunitarias de la ciudad de Teruel. El primer período analizado comprende desde abril hasta junio de 2019 y el segundo en marzo de 2020, durante los cuatro fines de semana que las farmacias estudiadas estaban de guardia. RESULTADOS: de las 4.245 dispensaciones de los fines de semana analizadas en 2019, 1.059 (26,4 %) fueron medicamentos con prescripción realizada por servicios médicos de urgencia; 965 (21,8 %) de fármacos con prescripción crónica; 655 (15,2 %) no tenían prescripción médica de ningún tipo, pero se consideraron necesarios; 1.067 (25,8 %) no tenían prescripción médica y no se consideraron necesarios, y 499 (10,8 %) fueron dispensaciones no ortodoxas. CONCLUSIONES: el patrón de las dispensaciones durante las guardias de las farmacias es constante, independientemente de que el fin de semana sea ordinario, situación especial (Semana Santa) o situación de alarma ("COVID"). El servicio de urgencias farmacéutico no está siendo bien utilizado por la población, ya que el porcentaje de actuaciones farmacéuticas que tiene su origen en una urgencia médica es muy bajo

INTRODUCTION: The work that pharmacists and other healthcare professionals during the on-call service shades an importance that ensures accessibility to the drug, health advice, pharmacotherapeutic monitoring and profesional support to patients; out of regular hours. OBJECTIVES: Know the nature of the population in the guardservice of the pharmacies in the city of Teruel during the weekends. METHODOLOGY: Cross-sectional observational study conducted in three community pharmacies in the city of Teruel. The first period analyzed ranges from April to June 2019 and the second in March 2020, during the four weekends that the pharmacies studies were on call. RESULTS: Of the 4245 weekend dispensations analyzed in 2019: 1059 (26.4%)were prescription drugs performed by emergency medical services, 965 (21.8%) of chronically prescribed drugs, 655 (15.2%) did not have a prescription of any kind but were considered necessary, 1067 (25.8%) had no prescription and were not considered necessary and 499 (10,80%) were non-orthodox dispensations. CONCLUSIONS: The pattern of dispensing during pharmacy guards is constant, independently of whether the weekend is ordinary, special situation (Easter) or an Alarm Situation ("COVID"). The pharmaceutical emergency service is not being used well by the population, the percentage of pharmaceutical actions that originate from a medical emergency is very low

How patients in Denmark acquire their medicines: overview, data sources and implications for pharmacoepidemiology.

The means by which patients acquire their medications differ between countries, and a knowledge of this is essential when conducting and interpreting pharmacoepidemiological studies. The aim of this paper is to provide an overview of how patients obtain medicines in Denmark, to relate these to nationwide registries available for research and to discuss the implications for research. Health services are predominantly tax-funded in Denmark, with dentistry and some medicine bought at community pharmacies being exceptions, involving partial reimbursement of charges. The paper gives an overview of prescription medicines acquired from community pharmacies (including magistral preparations), over-the-counter medicines, vaccinations and in-hospital medicine including so-called "free medicine" (in Danish: "vederlagsfri medicin"). "Free medicine" is medicines for a defined list of diseases and indications that is provided free of charge to patients in outpatient clinics. The paper also describes the content of the various Danish data sources about medicine use, summarizes their strengths and limitations, and exemplifies the ways of evaluating their completeness. An example is provided of the regional variation in the means by which medicines are acquired.

Factors impeding the supply of over-the-counter medications according to evidence-based practice: A mixed-methods study.

OBJECTIVE: Despite the positive attitudes pharmacists have toward evidence-based practices (EBPs), its application in community pharmacies in Saudi Arabia is lacking. Therefore, this study aimed to explore and assess EBPs by community pharmacists in Saudi Arabia when they dispense over-the-counter (OTC) medications for three minor ailments: diarrhea, cough, and the common cold. RESEARCH DESIGN AND METHODS: We used a mixed-methods approach consisting of two study parts. The first was a quantitative investigation that used mystery shoppers. Four researchers, posing as mystery shoppers, visited 214 randomly selected pharmacies in the Riyadh region of Saudi Arabia. They used 14 questions from a standardized checklist to examine EBPs by community pharmacists. The qualitative part of the study entailed three focus-group discussions with 13 pharmacists from different community practice settings and explored factors that affected the application of EBPs when supplying OTC medications from the pharmacists' point of view. RESULTS: The analysis indicated that 40% of pharmacists dispensed OTC medications according to EBPs. Logistic regression analysis showed that one question, "Describe your symptoms", predicted the correct supply of OTC medications (p = 0.021). The qualitative section of the study identified nine factors that affected EBP. Some of these factors facilitated EBP, such as established patient-pharmacist relationships, some acted as barriers such as conflicts between available evidence, while other factors could either facilitate or hinder EBPs, such as the health literacy of the patient. CONCLUSION: Given that dispensing OTC medication is a core function of pharmacists, this study uncovered low adherence to EBPs by community pharmacists in Saudi Arabia when dispensing OTC medication for three minor ailments: diarrhea, cough, and the common cold. Furthermore, this study identified a number of explanatory factors for this low adherence. Targeting these factors could help change the behavior of pharmacists and decrease undesirable outcomes.

Knowledge, Attitude, and Practice of Unused and Expired Medication Disposal among Patients Visiting Ayder Comprehensive Specialized Hospital.

BACKGROUND: Accumulation of unused and expired medicines at home is a source of environmental hazards and public health problems due to lack of awareness on appropriate medicine disposal methods. Therefore, the study was conducted to assess the knowledge, attitude, and practice of unused and expired medicine disposal among patients visiting Ayder Comprehensive Specialized Hospital. METHODS: A descriptive cross-sectional study was conducted among 384 patients who visited Ayder Comprehensive Specialized Hospital outpatient pharmacy from April to June 2019. Convenience sampling was used to recruit the participants, and data was collected by a face-to-face interview using a structured questionnaire. The data were entered and analyzed by using SPSS version 21.0. Descriptive statistics on sample characteristics was computed, and results were presented in the form percentage using table and statements. RESULTS: Out of the 384 respondents included in the study, 205 (53.4%) of them were males. More than half (199 (51.8%)) of the respondents did not correctly knew about medicine waste, and 233 (60.7%) of them did not have any prior information regarding medicine waste disposal instruction. But 351 (91.4%) of the participants correctly responded that inappropriate unused and expired medicine disposal can cause environmental harm. Above half (218 (56.8%)) of the respondents "agreed" about the potential risks related to having unused/expired medicines at home, and 206 (53.6%) of them "strongly agreed" that children are more vulnerable. One hundred fifty-nine respondents had unused/expired medicines in their homes. The most commonly used disposal practice for unused medicines were throwing them in a household trash as reported by 297 (77.3%) followed by flushing unused medications in toilet/sink 152 (39.6%). Throwing them away in household garbage and flushing them in toilet/sink were also the most commonly preferred disposal practice for expired medicines. CONCLUSION: The majority of the study participants dispose unused and expired medicine in household garbage and toilet/sink. This is against the recommendations of both national and international policies and guidelines on safe and appropriate pharmaceutical waste disposal.

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.