Project description:BackgroundThe aim of this work is to find the factors related to over-the-counter drug (OTC) consumption in Europe considering the differences in OTC market regulation.MethodsA sample obtained from the European Health Interview Survey (EHIS) of 2019 is used to estimate a logistic regression. This sample includes 286,413 people from 26 countries. The outcome variable is derived from the question about the use of non-prescribed drugs. The independent variables include a set of predisposing, enabling, and need factors. Finally, countries with similar OTC retail market regulations are considered to control for heterogeneity in this regard.ResultsThe main findings show that OTC market deregulation is not strictly related to the share of OTC consumption. Despite some heterogeneity based on the type of OTC retail market regulation, there is a set of common drivers for its use by people across countries, such as age, gender, education, suffering from chronic disease or pain and being on a waiting list for medical treatment. When considering individual country and cluster of countries controls, there are some relevant results such as the role played by accessibility to pharmacies and OTC retailers; the positive correlation between OTC drugs and prescribed drug consumption, and the positive correlation between unmet health care needs due to financial household constraints and OTC drugs use.ConclusionsThere is no clear relationship between OTC drug use and OTC retail market regulation. There are several predisposing, enabling, and need factors that promote the use of OTC drugs. The relevant policies relate to the inequal access to OTC drugs across countries that may result from different market regulations and different consumption drivers.
Project description:South Africa has two types of animal farming systems, being the commercial industry and subsistence farming in more rural areas, with commercial farmers having more access to veterinary services. To cater for the absence of sufficient veterinary service, the country allows farmers to access certain over the counter medications (stock remedies), as a way to assist them to farm sustainably and profitably. However, with any drug use, their true benefits are only realized following correct use. The aim of this study was to describe and assess the adequacy of the current use of veterinary drugs by rural-based farmers. A scheduled structured questionnaire with close-ended questions and direct observation was employed. The most important finding was the absence of proper training in the area, with 82.9% not receiving any training related to livestock production or use/handling of stock remedies, highlighting the urgent need for proper training. Of interest, a large proportion of the farmers (57.5%) left the care of their animals to herders. Concerns were also noted in the application of withholding periods, transport of medication, disposal of medication, calculation of drug doses, correct route of administration and carcass disposal with no difference in response between farmers receiving training and those who didn't. These finding not only indicates the importance of farmer training, but shows that for such training to be effective, information should not only cover farming activities but must include primary animal health care and an understanding of information contained in package leaflets. It would also be important to ensure that herdsmen are also included in such training initiatives as they are the primary careers of the animals.
Project description:ObjectiveNearly 1.5 billion people of an Asian country are living their lives without a country-specific over-the-counter (OTC) drug list. A study was planned to assess the understanding and practice of OTC medication consumption in the pregnant population.MethodsA questionnaire-based cross-sectional study evaluating different perspectives on OTC drug consumption was planned in around 500 pregnant women attending tertiary care outpatient antenatal clinics. The association of knowledge, attitude and practice versus indications, knowledge regarding harmful effects possible, reasons for choosing OTC medication, the practice of consulting nonmedical persons and drug interactions with the disease or prescription medications was determined. Regression analysis was performed in statistical software R.ResultsSeven percent (36/516) of pregnant women were found to consume oral antimicrobials without prescription. Local chemist consultation was the most common channel (72.48%) to procure the OTC medicines. Participants with good knowledge score showed an odds ratio (OR) of 1.87 (95% C.I.; 1.28-2.73), 1.6 (95% C.I.; 0.99-2.63), 1.66 (95% C.I.; 1.14-2.42) and 2.66 (95% C.I.; 1.49-4.89) for self-medication encouragement tendency possible, restricting sale of OTC medications, the habit of reading drug leaflets and understanding the potentially harmful effects, with OTC drugs, respectively. Right-attitude participants showed an OR of 1.89 (95% C.I.; 1.29-2.80) and 1.8 (95% C.I.; 1.19-2.76) for identifying knowledge of acetaminophen overdose and liver damage link as well as the disease symptom masking possibility with OTC, respectively. Participants with insufficient knowledge and attitude scores showed an association with more OTC antacid-antiemetics and analgesic use, respectively.ConclusionAntenatal pregnant women need to be guided on avoiding OTC antimicrobial usage. Both obstetricians and regulators have to play an active role in educating pregnant women and contributing to developing country-specific OTC drug lists with the guidelines.Supplementary informationThe online version contains supplementary material available at 10.1007/s13224-021-01481-2.
Project description:In the last two decades, many European countries allowed the sale of over-the-counter (OTC) drugs outside pharmacies. This was expected to lower retail prices through increased competition. Evidence of such price reductions is scarce. We assess the impact of supermarket and outlet entry in the OTC drug market on OTC prices charged by incumbent pharmacies using a difference-in-differences strategy. We use price data on five popular OTC drugs for all retailers located in Lisbon for three distinct points in time (2006, 2010, and 2015). Our results suggest that competitive pressure in the market is mainly exerted by supermarkets, which charge, on average, 20% lower prices than pharmacies. The entry of a supermarket among the main competitors of an incumbent pharmacy is associated with an average 4% to 6% decrease in prices relative to the control group. These price reductions are long-lasting but fairly localized. We find no evidence of price reductions following OTC outlet entry. Additional results from a reduced-form entry model and a propensity score matching difference-in-differences approach support the view that these effects are causal.
Project description:IntroductionAntimicrobial resistance (AMR) is a global issue that needs addressing. While antibiotic stewardship has improved often by restricting antibiotic use, some antibiotics that are still sold legally over the counter (OTC), notably in sore throat medications. Recent findings suggest OTC antibiotics could trigger cross-resistance to antibiotics used in clinical treatments, whether systemic or topical. Here we investigated the impact of three antibiotics contained in OTC sore throat medicines on emerging AMR in vitro.MethodsBacterial pathogens were exposed to a bactericidal concentration of an aminoglycoside in the presence or absence of a during-use concentration of bacitracin, gramicidin or tyrothricin in a time-kill assay. Damage to the bacterial membrane was also investigated by measuring potassium leakage and membrane potential alteration post-OTC antibiotic exposure.ResultsGramicidin (15 µg/mL) significantly decreased the bactericidal activity of amikacin, tobramycin or gentamicin in Acinetobacter baumannii. It also decreased gentamicin bactericidal activity in Enterobacter cloacae, Escherichia coli and Klebsiella pneumoniae, while tyrothricin decreased the aminoglycoside efficacy in E. cloacae and E. coli. Gramicidin significantly decreased bacterial membrane potential and caused significant potassium leakage.ConclusionGramicidin and to some extent tyrothricin impacted aminoglycoside efficacy by affecting membrane potential, which is essential for aminoglycosides uptake. Thus, some OTC antibiotics can interfere with aminoglycoside activity, which could in turn affect treatment efficacy. Although the likelihood of OTC antibiotics and aminoglycosides being used at the same time might not be common, this research highlights one potential reason for OTC antibiotics' usage to result in treatment failure and their contribution to AMR development.
Project description:BackgroundLoperamide at supratherapeutic doses can cause cardiac toxicity, presenting as cardiogenic shock, prolonged QT, malignant arrhythmias, or in severe cases sudden cardiac death. Surreptitious loperamide use is difficult to diagnose. We present an interesting case of loperamide use presenting with polymorphic ventricular tachycardia, cardiogenic shock.Case summaryA 25-year-old female presented with multiple syncopal episodes for 12 months with an electrocardiogram showing a Brugada-like pattern for which she underwent implantable cardioverter-defibrillator placement. One day following the procedure, she developed cardiogenic shock and was transferred to our tertiary care centre. Extensive workup was unrevealing. She responded well to supportive management, recovering from shock and was transferred to the floor. Unfortunately, she again developed cardiogenic shock, ultimately leading to cardiac arrest. Given the unclear cause for her cardiovascular symptoms, futher medication history was obtained. It was revealed that she was taking 100-150 tablets of loperamide per day. The decision was made to treat with intralipid emulsion therapy empirically given the strong suspicion for loperamide toxicity. The patient recovered well with supportive care. Loperamide levels returned elevated at 190 ng/mL. Repeated studies showed improvement of the conduction block, resolution of arrhythmias, and recovery of right and left ventricular function.DiscussionAcute loperamide toxicity can present as biventricular failure, with difficult-to-control arrhythmias. It requires a high index of suspicion. Treatment for loperamide toxicity is mainly supportive, lipid emulsion therapy can be considered in severe or refractory cases.
Project description:ObjectiveTo develop a drug facts label prototype for a combination mifepristone and misoprostol product and to conduct a label-comprehension study to assess understanding of key label concepts.MethodsWe followed U.S. Food and Drug Administration guidance, engaged a multidisciplinary group of experts, and conducted cognitive interviews to develop a drug facts label prototype for medication abortion. To assess label comprehension, we developed 11 primary and 13 secondary communication objectives related to indications for use, eligibility, dosing regimen, contraindications, warning signs, side effects, and recognizing the risk of treatment failure, with corresponding target performance thresholds (80-90% accuracy). We conducted individual structured video interviews with people with a uterus aged 12-49 years, recruited through social media. Participants reviewed the drug facts label and responded to questions to assess their understanding of each communication objective. After transcribing and coding interviews, we estimated the proportion of correct responses and exact binomial 95% CIs by age and literacy group.ResultsWe interviewed 851 people (of 1,507 people scheduled); responses from 844 were eligible for analysis, and 35.7% (n=301) of participants were aged 12-17 years. The overall sample met performance criteria for 10 of the 11 primary communication objectives (93-99% correct) related to indications for use, eligibility for use, the dosing regimen, and contraindications; young people met nine and people with limited literacy met eight of the 11 performance criteria. Only 79% (95% CI 0.76-0.82) of the overall sample understood to contact a health care professional if little or no bleeding occurred soon after taking misoprostol, not meeting the prespecified threshold of 85.0%.ConclusionOverall, high levels of comprehension suggest that people can understand most key drug facts label concepts for a medication abortion product without clinical supervision and recommend minor modifications.
Project description:BACKGROUND:In Japan, non-pharmacists who are accredited as registered salespersons can sell over-the-counter (OTC) drugs, and they play a very important role in supporting proper OTC drug use by consumers. The purpose of this study was to evaluate information provided to and information collected from consumers, and cooperation with pharmacists during OTC drug sales by registered salespersons, and to clarify their related concerns and behaviors. METHODS:A cross-sectional questionnaire-based survey of 385 registered salespersons working at 56 drugstores throughout Japan was conducted. Based on the questionnaire survey, the frequency of information provision/collection in various categories was determined for the registered salespersons. The relation between concerns of registered salespersons relating to OTC drug sales and the frequency of information provision/collection was examined. The frequency of consultation of registered salespersons with a pharmacist was calculated for registered salespersons with/without in-store pharmacists. The χ-square test or Fisher's exact test was performed to assess the significance of differences. RESULTS:Two hundred and seven registered salespersons (53.7%) responded completely. A greater number of OTC drug purchasers per day was associated with a greater frequency of information provision about "side effects" and information collection about "favorite items" (alcohol, tobacco, health foods, etc.) (p < 0.05). One hundred and thirty-nine (67.2%) participants had concerns about "interactions between OTC drugs and prescription drugs", and these concerns were related to the frequency of information provision/collection (p < 0.05). Regarding the frequency of consultation with a pharmacist, 35 of 46 participants (76.1%) working with pharmacists answered "always" or "usually", whereas only 19 of 161 participants (11.8%) working without full-time pharmacists answered "always" or "usually". More than half of the registered salespersons thought that cooperation with a pharmacist was necessary when they were "asked about concomitant use with prescription drugs" or "told that side effects happened." CONCLUSIONS:The results of this study show that experienced registered salespersons selling OTC drugs are more likely to collect information from consumers and to provide information to consumers. It appears to be important for registered salespersons to cooperate with pharmacists in order to provide and collect appropriate information about concomitant medications.
Project description:PurposeNonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most common medications reported in pregnancy. NSAIDs directly impact prostaglandin pathways and have been proposed as potential risk factors for spontaneous abortions (SABs, gestation <20 weeks). SAB risk and drug response across several medications differ by race; therefore, we evaluated whether associations between NSAIDs and SAB risk differ by race.MethodsWomen were enrolled in the Right from the Start (2004-2010) prospective cohort. Data regarding over-the-counter NSAIDs up to the sixth week of pregnancy were obtained from interviews. Race was self-reported. Cox proportional hazards regression models were used to estimate the association between NSAID exposure and SAB, adjusted for confounders.ResultsAmong 2493 pregnancies, 12% were African American and 88% were Caucasian. NSAID exposure was reported by 40% (n = 124) of African Americans and 43% (n = 945) of Caucasians. Race-stratified analyses showed protection from SAB among African Americans (adjusted hazard ratio [aHR], 0.84; 95% confidence interval [CI], 0.73-0.96) but no effect in Caucasians (aHR, 1.01; 95% CI 0.88-1.16).ConclusionsOur findings suggest that risk for SAB due to over-the-counter NSAIDs in early pregnancy is modified by race. Further investigation of dose, timing in gestation, and indication may help to further reconcile the relationship between race, NSAIDs, and SAB.
Project description:Designing an over-the-counter medication electronic health record (OTC-EHR) may help improve OTC usage. An online survey for the conceptual OTC-EHR design examined participant characteristics, attitudes towards obtaining user-shared OTC medication information, health-related application usage, and the inclination to share anonymized health information. Descriptive statistics, tests to assess statistical significance, and text mining were used to analyze the results. The findings revealed that Japanese consumers, particularly those with high eHealth literacy and women, possess relatively positive attitudes towards obtaining user-shared OTC medication information than those with low eHealth literacy (t (280.71) = -4.11, p < 0.001) and men (t (262.26) = -2.78, p = 0.006), respectively. Most consumers own smartphones but do not use health-related applications. A minority held positive attitudes about sharing anonymized health information. The perceived helpfulness of OTC-EHR was positively associated with the usage of health-related applications (χ2 (4) = 18.35, p = 0.001) and attitude towards sharing anonymized health information (χ2 (3) = 19.78, p < 0.001). The study findings contribute towards OTC-EHR's design to enhance consumers' self-medication and reduce risks, while the psychological barriers to sharing anonymized health information should be improved by increasing the OTC-EHR's penetration rate and engaging in appropriate information design.