Over-the-counter Research Articles

Whole-Genome Deep Sequencing of the Healthy Adult Nasal Microbiome.

This study aimed to determine shifts in microbial populations regarding richness and diversity from the daily use of a popular over-the-counter nasal spray. In addition, the finding of nasal commensal bacterial species that overlap with the oral microbiome may prove to be potential probiotics for the "gateway microbiomes". Nasal swab samples were obtained before and after using the most popular over-the-counter (OTC) nasal spray in 10 participants aged 18-48. All participants were healthy volunteers with no significant medical histories. The participants were randomly assigned a number by randomizing software and consisted of five men and five women. The sampling consisted of placing a nasal swab atraumatically into the nasal cavity. The samples were preserved and sent to Northwestern University Sequencing Center for whole-genome deep sequencing. After 21 days of OTC nasal spray use twice daily, the participants returned for further nasal microbiome sampling. The microbial analysis included all bacteria, archaea, viruses, molds, and yeasts via deep sequencing for species analysis. The Northwestern University Sequencing Center utilized artificial intelligence analysis to determine shifts in species and strains following nasal spray use that resulted in changes in diversity and richness.

Long-Term Outcomes of Self-Fit vs Audiologist-Fit Hearing Aids

With rising interest in over-the-counter (OTC) hearing aids as an alternative to traditional audiologist-fit devices, understanding their long-term efficacy is crucial. However, given the novelty of the US Food and Drug Administration category of OTC hearing aids, minimal evidence currently supports their long-term efficacy. To compare the long-term self-reported outcomes at 8 months of self-fit OTC hearing aids to the same hearing aids fit by audiologists. Building on a previous randomized clinical trial, this follow-up comparative effectiveness research study reassessed a number of the original participants that were not lost to follow-up. Participants were initially divided into those with self-fit OTC hearing aids and those with audiologist-fit devices. Approximately 8 months after fitting, participants completed self-reported questionnaires. Missing data were addressed through multiple imputation. The original noninferiority trial was conducted at the University of Pretoria in South Africa from April 2022 to August 2022. The current analysis took place between July 7, 2023, to November 20, 2023. In the original trial, participants in the self-fit device group received a pair of OTC hearing aids and independently fit them with remote support as needed. The audiologist-fit device group received the same hearing aids fit by a certified audiologist using best practices. The main outcomes were self-reported hearing aid benefit, measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the International Outcome Inventory for Hearing Aids (IOI-HA). Of 64 participants in the trial, 44 participants were included in the extension study (21 [47.7%] in the audiologist-fit group; 23 [52.3%] in the self-fit group). The mean (SD) age of these participants was 63.0 (13.2) years, and 21 (47.7%) were male. At the long-term follow-up, self-fit and audiologist-fit groups showed no significant differences in the APHAB global score (mean difference, 0.02 [95% CI, -7.1 to 7.1]; Cohen d, 0.01 [95% CI, -0.5 to 0.5]) or the IOI-HA total score (mean difference, 1.5 [95% CI, -1.4 to 4.4]; Cohen d, 0.3 [95% CI, -0.2 to 0.8]). From 6 weeks to 8 months, no clinically meaningful group-time interaction was found between groups for the APHAB global score (Cohen d, 0.1 [95% CI, -0.2 to 0.3]), but a significant interaction for the IOI-HA total score was found (Cohen d, -0.6 [95% CI, -0.8 to -0.3]), with the self-fit group generally performing better. This comparative effectiveness research study demonstrated that self-fit OTC hearing aids can offer comparable long-term benefits to audiologist-fit hearing aids for individuals with mild to moderate hearing loss.

A Systematic Review of Antibiotic Use in Humans in Nigeria and Its Potential Contribution to Rising Antimicrobial Resistance

INTRODUCTION: The value of medicines is lost when these resources are not used rationally. Out of 12 developing countries, Nigeria has the third highest percentage of antibiotic prescriptions, at 48%. Antibiotic misuse results in limited efficacy, which can lead to the emergence of antimicrobial resistance. We conducted a systematic review to synthesise the evidence on antibiotic use in humans in Nigeria. METHODS: We conducted a systematic review of medicine use behaviour by patients and prescription behaviour by health workers, which were searched for in articles published in English from 2000 to 2017. Data was entered into purpose-built templates. Key quantitative indicators were extracted and summarised as frequencies and proportions, while free-text responses were synthesised. RESULTS: The systematic review determined that the median prevalence of persons using antibiotics without prescription is 46.7%. The drivers of irrational antibiotic use included poor regulation of medicines and premises, a chaotic medicine distribution system, limited licensed medicine prescribers, over-the-counter (OTC) sales of antibiotics, patients’ demand for antibiotics, and access to health insurance. DISCUSSION: Irrational antibiotic use is widespread in humans and animals. We recommend that the government enforce regulations on antibiotic sales to humans and animals and increase awareness of irrational antibiotic use and AMR in Nigerian communities through a whole-of-society approach. The collated information was used to develop a National Action Plan on AMR in 2017.

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

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. 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. 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). OTC naloxone first became available for sale at community pharmacies in September 2023. 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. 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). 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.

Modelling lethality and teratogenicity of zebrafish (Danio rerio) due to β-lactam antibiotics employing the QSTR approach

ABSTRACT Nowadays, β-lactam antibiotics are one of the most consumed OTC (over-the-counter) medicines in the world. Its frequent use against several infectious diseases leads to the development of antibiotic resistance. Another unavoidable risk factor of β-lactam antibiotics is environmental toxicity. Numerous terrestrial as well as aquatic species have suffered due to the excessive use of these pharmaceuticals. In this present study, we have performed a toxicity assessment employing a novel in silico technique like quantitative structure–toxicity relationships (QSTRs) to explore toxicity against zebrafish (Danio rerio). We have developed single as well as inter-endpoint QSTR models for the β-lactam compounds to explore important structural attributes responsible for their toxicity, employing median lethal (LC50) and median teratogenic concentration (TC50) as the endpoints. We have shown how an inter-endpoint model can extrapolate unavailable endpoint values with the help of other available endpoint values. To verify the models’ robustness, predictivity, and goodness-of-fit, several universally popular metrics for both internal and external validation were extensively employed in model validation (single endpoint models: r 2 = 0.631 − 0.75, Q 2 F1 = 0.607 − 0.684; inter-endpoint models: r 2 = 0.768 − 0.84, Q 2 F1 = 0.678 − 0.76). Again, these models were engaged in the prediction of these two responses for a true external set of β-lactam molecules without response values to prove the reproducibility of these models.

Self-medication as an Initial Treatment and its Associated Complications in Ophthalmic Patients at Al-Khidmat Teaching Hospital, Mansoorah, Lahore, Pakistan

Purpose: To identify self-medications used by patients as initial treatment for various eye problems and to analyze associated complications. Study Design: Cross sectional. Place and Duration of Study: Al-Khidmat teaching hospital, (University of Lahore) from October 2021 to September 2022. Method: This study included 117 patients using traditional eye medications (TEM) and over the counter (OTC) ophthalmic drugs before presenting in ophthalmic outdoor. A semi structured questionnaire was used as a tool to collect the data. All patients aged 18 years and above were directly questioned. For patients below 18 years, responses were collected from the patients themselves when possible; otherwise, the accompanying parent provided the information. Age, gender, educational status and area of residence were recorded. The symptoms compelling the use of TEM/OTC or both, the source and type of medication, diagnosis and any complications that resulted due to self-medication were documented. Complete ocular examination was done. MS Excel was used to record and analyze data. Results: There were 48% males and 52% females. Rosewater was the most frequently used TEM by 54.7%. Steroids-antibiotic combination eyedrops/ointments were used by 31.6%. Symptoms for which self-medication was done, were redness (64.1%), watering (35.9%), itching (32.5%) and discharge (26.5%). Symptoms did not improve in 54.7%, 26.5% required ophthalmic consultation and only 18.8% had temporary relief. Twelve percent developed complications. Conclusion: Self-medication with TEM or OTC drugs should be discouraged as these can cause detrimental effects on eyes.

Opportunities for interprofessional collaboration between pharmacists and hearing professionals in Pennsylvania: A descriptive geographic information system study

BackgroundIn 2022, the Food and Drug Administration finalized regulations for over-the-counter (OTC) hearing aids, available without professional hearing services and without a prescription. As a result, community pharmacies now serve as locations where adults seek self-care solutions for hearing loss such as OTC hearing aids. ObjectivesWe conducted a geographic information systems (GIS) analysis to identify Pennsylvania counties served by community pharmacies and hearing aid dispensaries, the practice locations of hearing professionals. MethodsWe obtained addresses of Pennsylvania pharmacies from the National Council for Prescription Drug Programs. Hearing aid dispensaries were obtained from the Pennsylvania Department of Health. GIS software was used to plot locations of pharmacies and hearing aid dispensaries. The number of pharmacies and hearing aid dispensaries was visualized on a Pennsylvania map, by county. Mean straight-line distances, in miles, from a hearing aid dispensary to its nearest pharmacy in any county and vice versa were calculated. This analysis was performed in early 2022. ResultsIn Pennsylvania, there were more community pharmacies (2769) than hearing aid dispensaries (945). All 67 Pennsylvania counties had more pharmacies than hearing aid dispensaries. Pharmacies outnumbered hearing aid dispensaries by 1 in some rural counties to 382 in urban Philadelphia County. The mean straight-line distance from a hearing aid dispensary, starting point, to the nearest pharmacy, end point, was 0.63 miles. The mean straight-line distance from a pharmacy, starting point, to the nearest hearing aid dispensary, end point, was 3.24 miles. ConclusionThis GIS analysis supports the participation of pharmacists in initiatives such as OTC hearing aids that increase population access to hearing care.

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

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

Vényköteles (Rx), vény nélkül kapható (OTC) gyógyszerek és étrend-kiegészítők vásárlási mintázata magyar fogyasztók körében

Over-the-Counter (OTC) medicines and food supplements plays an important role in healthcare. It is generally accepted that, when used properly, OTC medicines save consumers time and money. In this paper we looked into the purchasing behavior of the Hungarian population regarding OTC drugs and food supplements, highlighting the significance of self-medication. Using a quantitative online survey in March 2022 with a national representative sample, the research aimed to measure the out-of-pocket health expenditures, focusing on OTC drugs and food supplements. The analysis showed that the population spends more money on OTC drugs and food supplements than the co-payment of prescription (Rx) drugs, and the combined expenditures on OTC drugs and food supplements significantly contribute to the household's total healthcare costs, representing 45% of this budget. Three hypotheses were formulated to investigate the relationships between the spending on Rx medications, OTC drugs, food supplements, and various demographic factors. The analysis showed significant correlations, indicating that as expenditures on Rx medications increase, so do the purchases of OTC drugs and food supplements. Demographic analysis indicated that the younger demographic age group (18-35 years) tends to spend the least on both Rx, OTC drugs and food supplements, while the 36-50 age group exhibits the highest expenditure on food supplements. However, no significant difference in OTC drug purchases was found among those older than 36 years. The study raises further questions regarding the purchasing behavior of chronic patients, the differentiation between OTC drugs and food supplements by consumers, the influence of minors in the household on purchasing decisions, and whether the primary target demographic for these products should be expanded beyond the 35-50 aged women as it is defined nowadays.JEL Codes: I11, I12, M31

Factors influencing muslims’ purchase intention of halal-certified over-the-counter (OTC) medicines in Bekasi, Indonesia

Self-medication in Indonesia has recently increased; consumers can easily purchase non-prescription medicines, many people use over-the-counter (OTC) medicines as an alternative for self-medication. In this study, the researchers have chosen to address the gap in the literature pertaining to purchase intention on halal pharmaceuticals, whereas, the focus is on purchase intention of halal certified OTC medicines. This study was conducted in Bekasi, Indonesia. 325 Muslim consumers in Bekasi, Indonesia, participated in this study. The information was gathered using questionnaires with convenient sampling techniques. Through utilizing the theory of consumption value, which consists of the factors of functional value (price), functional value (quality), social value (pharmacist advice), emotional value (halal logo), conditional value, and epistemic value of respondents' intentions to purchase halal-certified OTC medicines. The findings of this study, three factors: functional value (quality), emotional value, and epistemic value, have a significant relationship with the purchase intention of halal-certified OTC medicines in Bekasi, Indonesia.

The Risk of Severe Fibromyalgia, Depression, Anxiety, and Insomnia Symptoms in Arab Women: An Implication of Self-Medication with Analgesics? A Cross-Sectional Study.

Background and Objectives: The investigation of the psychosomatic symptoms in women residing in developing countries is still emerging. To be precise, the prevalence and correlates of severe fibromyalgia, depression, anxiety, and insomnia are understudied in Arab women, as these symptoms could relate to improper self-medication. This study mainly investigated the association between self-medication with analgesics and fibromyalgia, depression, anxiety, and insomnia symptoms among a community-based cohort of females in Jordan. Materials and Methods: We used a web-based cross-sectional study design. Fibromyalgia, depression, anxiety, and insomnia were assessed using validated scales. The used over-the-counter (OTC) painkillers were recorded. Results: Data were analyzed from 741 women, and fibromyalgia was screened in 16.4%, depression in 37.4%, anxiety in 27.8%, and insomnia in 38.3%. Fibromyalgia was associated with "married" (OR = 1.5, 95% CI = 1.017-2.305), "using OTC acetaminophen" (OR = 1.75, 95% CI = 1.15-2.69), "using herbal remedies" (OR = 2.02, 95% CI = 1.33-3.07), and "using antiseizure medications" (OR = 2.43, 95% CI = 1.38-4.28). Severe depression was significantly associated with "age" (OR = 0.97, 95% CI = 0.96-0.99), "high school education" (OR = 1.90, 95% CI = 1.21-2.98), "smoking" (OR = 1.72, 95% CI = 1.15-2.56), "OTC acetaminophen" (OR = 1.40, 95% CI = 1.02-1.92), "OTC non-steroidal anti-inflammatory drugs" (OR = 1.75, 95% CI = 1.15-2.65), and "antiseizures" (OR = 2.19, 95% CI = 1.30-3.70). Severe anxiety was significantly associated with "smoking" (OR = 2.08, 95% CI = 1.40-3.12), "OTC acetaminophen" (OR = 1.48, 95% CI = 1.06-2.06), and "antiseizure medications" (OR = 2.04, 95% CI = 1.22-3.41). Severe insomnia was significantly associated with "age" (OR = 0.98, 95% CI = 0.96-0.99), "high school education" (OR = 1.58, 95% CI = 1.01-2.47), "smoking" (OR = 1.51, 95% CI = 1.01-2.25), "OTC non-steroidal anti-inflammatory drugs" (OR = 1.74, 95% CI = 1.13-2.64), "antiseizure medications" (OR = 1.84, 95% CI = 1.09-3.11), and "No analgesics" (OR = 0.48, 95% CI = 0.32-0.71). Conclusions: Self-medication with analgesics is associated with a high burden of psychosomatic symptoms in Arab women, and awareness campaigns are required to guide self-medication behavior.

Mercury Levels in Selected Medicines and Dietary Supplements in Poland.

Current trends are promoting youth, beauty, health, and fitness. Individuals often seek out remedies, such as medicines or dietary supplements (DS), to achieve these goals. However, highly processed foods, chronic stress, and environmental pollution contribute to the development of civilization diseases. The aim of this study was to evaluate the mercury (Hg) content in medicines and DS that are available in Poland. A total of 139 preparations were tested (75 drugs, 64 DS). The medicines contained preparations belonging to antibacterial, antiviral, antifungal; analgesic, antipyretic, and anti-inflammatory; heart and blood vessel disease preventatives; respiratory tract infections treatment; diuretics; aiding digestion; supplements; antidiarrhoeals; anti-allergics; anti-rheumatics; antibiotics; and others. The tested dietary supplements had an effect on the following: improve the condition of skin, hair, and nails; vitamins; minerals; probiotics; weight loss; special for women; and others. The Hg content of the samples was determined using atomic absorption spectrometry (AAS). The Hg content of all the preparations varied widely (0.1-57.4µg/kg), with a median Hg concentration of 1.2µg/kg. The median Hg concentration for medicines was 0.8µg/kg, prescription medicines having higher Hg concentrations (0.9µg/kg) than over-the-counter (OTC) drugs (0.5µg/kg). For DS, the Hg content was found to be higher than for drugs, at 2.0µg/kg. The herbal preparations showed the highest Hg content among the individual DS groups (3.4µg/kg). The Hg concentrations in the tested drug and DS samples did not exceed acceptable standards. However, if multiple pharmaceutical preparations are taken simultaneously over a long period of time, and there is existing environmental exposure, there is a possibility of Hg concentration accumulation and adverse health effects.

Evaluation of knowledge, attitude and practices of second year MBBS students about over the counter drugs

Background: The utilization of over-the-counter (OTC) drugs among medical students during academic exams has raised concerns about health risks and potential implications. This cross-sectional study aimed to estimate the prevalence of OTC drug utilization among medical students. Methods: A cross-sectional study was conducted using pre-validated questionnaire. The data obtained was tabulated, analysed and the results were calculated in percentages.150 students had participated in this study of which 100 were selected by simple random sampling. Results: The use of OTC drugs was common amongst undergraduate students. Majority of students (92%) who participated in the study had used OTC drugs at some point in their life. Commonly used OTCs were antacids (73%) and the most common indications for use of OTCs was cough and cold (92%). 87% of students preferred OTC drugs due to ease and convenience while 44% preferred OTC drugs due to lack of time to consult the doctor. Doctors (32.3%) followed by family and friends; textbook/journals were found to be the most common source of information on OTC drugs. Conclusions: A tendency to choose self-medication over doctor’s consultation by most of the undergraduate medical students was consistently seen in the present study. This unrestrained use of OTC drugs certainly possesses several health risks. Awareness should be created among undergraduate medical students to restrict the use of OTC drugs and efforts should be undertaken to increase the sale of drugs without prescription.

Counselling with a focus on product and price transparency for over-the-counter headache medicines: A simulated patient study in community pharmacies in Munich, Germany.

In Germany, over-the-counter (OTC) medicines may only be dispensed by community pharmacies (CPs). German CPs must ensure 'adequate' counselling, including the cost of medicines. Along with information gathering and advice giving as classic aspects of counselling, the aim was also to investigate counselling indicators of product and price transparency. The cross-sectional study was based on the covert simulated patient (SP) methodology and was conducted in a random sample of CPs stratified by districts in the major German city of Munich. Each of the 178 selected CPs was visited once by one of five trained female students. They simulated a symptom-based sub-scenario 1 with a request for an OTC medicine for a headache and a sub-scenario 2 with standardised information regarding product and price transparency. The assessment, completed immediately postvisit by the SPs, included a total of 23 items. All 178 scheduled visits were completed successfully. The median counselling score with the classic items was 3.0 out of 12 points (interquartile range [IQR] 4.25) and when expanded by items for product and price transparency the score was 4.0 out of 14 points (IQR 4.00). A selection of medicines was offered unsolicited in 38.2% of the visits and in 5.6% of the visits voluntary price information was provided before the transaction. A request for a cheaper medicine led to a significant price reduction (Wilcoxon signed-rank test; p<0.001, r=0.869). Due to the below-average level of counselling, the regional chambers of pharmacists are recommended to initiate measures for improvement. There is also potential for optimisation with regard to product and price transparency as an important extension of the classic counselling aspects. It is therefore recommended that the government raise customers' awareness of the cost of medicines.

The Use of Over-The-Counter Drugs and Its Health Implications in Awka South LGA, Anambra State, Nigeria

This work examined the use of over-the-counter drugs and its health implications in Awka South LGA of Anambra State, Nigeria. The objective of the study is to empirically interrogate the prevalence of over-the-counter drug use in Awka South LGA of Anambra State, Nigeria; the factors influencing it, and its health implications. The study used a mixed methods research approach, with 204 respondents selected through a multistage sampling procedure. The structured questionnaire and In-Depth Interview (IDI) guide acted as data-gathering tools. The quantitative data were coded and processed with SPSS version 20. Frequency tables were utilized to evaluate, characterize, and show the data, whereas quantitative data were manually transcribed and analyzed using content analysis. Two study hypotheses were developed and tested using chi-square inference statistics. This study revealed that various factors influence the use of OTC drugs in Awka South LGA. The study equally found that the use of OTC drugs is very prevalent in Awka South LGA. Moreover, the study also found that abusing OTC drugs has health implications. Based on these findings, this study recommended that the government should regulate the production, sale, and advertisement of OTC drugs. The study also recommended that sensitization and awareness programs should be carried out periodically to teach people when and when not to use OTC drugs.

Sensitivity Differences in Testing of Polyurethane Condoms’ Lubricant Compatibility

Abstract Over-the-counter (OTC) personal lubricants (PLs) generally have less potent effects on condoms’ mechanical properties than do appropriate positive controls. Therefore, to assess the compatibility of OTC PLs with condoms, a test method must be more sensitive than those employed to capture the effect of a strong positive control. Using various percent compositions of selected common ingredients in commercial PLs, we attempted to differentiate between the sensitivities of different methods for testing lubricant effects on polyurethane (PU) condoms. After discrete applications of each composition, we studied induced stresses and stress-to-strain ratios at various strain rates, and stress reduction at a constant stretch, in PU condom coupons at 37°C. Swelling was studied at room temperature (RmT). Changes in the induced stress and stress-to-strain ratio because of low percent composition of a potent surrogate component were detectable only at low strain rates. A few low percent compositions of potent ingredients – though they induced insignificant changes in the material as detected by tensile testing and did not swell the PU material – noticeably reduced the percent stress at a constant stretch. Slower strain rates in tensile testing were necessary to detect the effects of low potency combinations, whereas stress reduction was the most efficient detector of change at a constant physiologically relevant strain. Absence of swelling and insignificant changes in tensile properties at high strain rates did not guarantee an absence of interactions. Manufacturers now have a more sensitive method for capturing the interactions of PU condoms with OTC PLs, which are generally less potent than appropriate positive controls.

Analyzing Potential Interactions Between Complementary and Alternative Therapies, Over-the-Counter, and Prescription Medications in the Older Population.

The escalating use of complementary and alternative medicine (CAM) raises concerns, particularly among geriatric patients taking multiple medications. Notably, the doubled chance of major drug interactions between prescription and over-the-counter (OTC) drugs in older adults underscores the need for further research. This study aimed to evaluate clinically significant CAM and prescription medication interactions in a geriatric clinic, emphasizing the growing importance of understanding CAM implications in health care. A 2-year cross-sectional study, approved by the Institutional Review Board, enrolled 420 participants aged 65 and older from a geriatric primary care clinic. Participants completed a survey, and pharmacy students conducted chart reviews to evaluate potential CAM products and prescription medication interactions. Among the 420 participants-who were predominantly White females and who were taking supplements, OTC medications, or both-15.6% experienced potential drug interactions. Ginkgo biloba, garlic, and calcium were common contributors to major, moderate, and minor interactions, respectively, among supplements. Meanwhile, ibuprofen was among the contributors to major and moderate interactions among OTC medications. Most supplements and OTC medications were disclosed to health care professionals. However, there was a lack of investigation by health care professionals regarding CAM use, emphasizing a discrepancy between patient-reported and physician-inquired CAM usage. This study highlighted the significant use of CAM and/or OTC medications, particularly among vulnerable older adults, revealing a concerning 15.6% rate of potential drug interactions. The findings emphasized the need for awareness among health care practitioners and standardized CAM surveys to enhance accuracy and patient safety.

Bioanalytical HPLC method with fluorescence detector for determination of Entresto™ when co-administered with ibuprofen and fexofenadine: a pharmacokinetic study.

Entresto™ (LCZ696) has been approved globally for heart failure management. However, its lifelong use alongside over-the-counter (OTC) drugs like ibuprofen (IBU) and fexofenadine (FEX) necessitates an in-depth investigation of potential pharmacokinetic interactions, as they share the same metabolic and elimination pathways. This study aimed to develop a bioanalytical HPLC method with a fluorescence detector (FLD) to quantify LCZ696 analytes (valsartan, VAL; sacubitril, SAC; and sacubitril active metabolite, LBQ657) in rat plasma. Additionally, an in vivo study was performed to investigate the pharmacokinetic interactions of LCZ696 with IBU and FEX. Utilizing HPLC with a gradient-mode mobile phase of acetonitrile and 0.025 M phosphate buffer (pH 3), the study demonstrated a significant increase in the bioavailability of LCZ696 analytes (VAL and LBQ657) when co-administered with IBU (C max 0.23 ± 0.07 and 0.53 ± 0.21 μg mL-1, respectively) compared to the control (0.17 ± 0.03 and 0.33 ± 0.14 μg mL-1). A more significant increase in C max was noticed with FEX (0.38 ± 0.01 and 0.77 ± 0.18 μg mL-1, respectively). Moreover, a decrease in the clearance (Cl/F) of VAL and LBQ657 was observed (18.05 ± 1.94 and 12.42 ± 2.97 L h-1 kg, respectively) with a more pronounced effect in the case of FEX (30.87 ± 4.29 and 33.14 ± 9.57 L h-1 kg, respectively) compared to the control (49.99 ± 7.31 and 51.19 ± 9.12 L h-1 kg, respectively). In conclusion, our study underscores the importance of cautious administration and appropriate dose spacing of IBU and FEX in patients treated with LCZ696 to prevent elevated serum concentrations and potential toxicity. The novelty of this work lies in its dual contribution: developing a highly sensitive HPLC-FLD method and comprehensively elucidating significant pharmacokinetic interactions between LCZ696 and common OTC drugs.

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

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. 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. 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. 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.

The Effect of Palmitoylethanolamide (PEA) on Skeletal Muscle Hypertrophy, Strength, and Power in Response to Resistance Training in Healthy Active Adults: A Double-Blind Randomized Control Trial

BackgroundPalmitoylethanolamide (PEA) has analgesic/anti-inflammatory properties that may be a suitable alternative to over-the-counter (OTC) non-steroidal analgesics/anti-inflammatories. While OTC pain medications can impair strength training adaptations, the mechanism of action of PEA is distinct from these and it may not negatively affect skeletal muscle adaptations to strength training.MethodsThe primary aim of this study was to investigate the effects of daily PEA supplementation (350 mg Levagen + equivalent to 300 mg PEA) combined with 8-weeks of resistance training on lean body mass with secondary aims addressing strength, power, sleep, and wellbeing compared to placebo (PLA) in young, healthy, active adults. In a randomized, controlled, double-blinded trial, 52 untrained, recreationally active participants aged 18–35 y were allocated to either the PEA or PLA groups. Participants consumed either 2 × 175 mg Levagen + PEA or identically matched maltodextrin capsules during an 8-week period of whole-body resistance training. This trial assessed the pre- to post- changes in total and regional lean body mass, muscular strength (1-RM bench, isometric mid-thigh pull), muscular power [countermovement jump (CMJ), bench throw], pain associated with exercise training, sleep, and wellbeing compared with the PEA or PLA condition.Results48 Participants were included in the final intention to treat (ITT) analysis and we also conducted per protocol (PP) analysis (n = 42). There were no significant between-group differences for total or regional lean muscle mass post-intervention. There was a significantly higher jump height (CMJ) at week 10 in the PEA group compared to the PLA (Adjusted mean difference [95% CI] p-value; ITT: − 2.94 cm [− 5.15, − 0.74] p = 0.010; PP: − 2.93 cm [− 5.31, − 0.55] p = 0.017). The PLA group had higher 1-RM bench press post-intervention compared with the PEA group (ITT: 2.24 kg [0.12, 4.37] p = 0.039; PP: 2.73 kg [0.40, 5.06] p = 0.023). No significant treatment effects were noted for any of the other outcomes.ConclusionPEA supplementation, when combined with 8 weeks of strength training, did not impair lean mass gains and it resulted in significantly higher dynamic lower-body power when compared with the PLA condition.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR: ACTRN12621001726842p).