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An 87-year-old man with a history of osteoarthritis presented with worsening knee pain. He was prescribed acetaminophen with codeine. A few days later, he developed a rash on his right buttock and proximal thigh, similar to a rash he experienced in the past when he took over-the-counter (OTC) acetamenophen and an unknown lozenge to treat a presumed viral illness. A fixed drug eruption (FDE) was diagnosed and the patient was asked to avoid Tylenol and other OTC lozenges. Tylenol was entered as an allergy in the electronic medical records. However, since Tylenol, not acetaminophen was listed in the allergy profile, the order for acetaminophen and codeine did not generate an alert for the prescribing physician. Additionally, the dispensing pharmacist did not question the prescribing physician and the patient, unaware that acetaminophen in the pain medication is the same drug as Tylenol, took it and developed recurrent FDE.

Background:The use of Potentially Inappropriate Medications (PIMs) is common and negatively affects elderly health and disease prognosis.Objective:This study aims to analyze the frequency of PIMs in the elderly health records registered to a family health center and to identify risk factors, prescription/nonprescription distribution, distribution by healthcare institutions, number of doctors visits, and health literacy.Methods:In this cross-sectional study, a stratified sampling method was used to select individuals aged ≥ 65 years. The health records of the participants up to the last 12 months were examined, and medicines used by participants were evaluated according to Beers 2019 criteria.Results:Most of the participants (89.7%, n:183) had PIMs in health records. The mean number of PIMs used by the elderly was 2.9±1.9 (min:0, max:8). A positive linear relationship was observed between multimorbidity and the number of PIMs (p=0.001). There was no significant difference in terms of PIMs frequency among healthcare institutions. Prescription and non-prescription PIMs were found to belong to the same drug groups (Pain relievers and stomach medications). A linear and significant correlation was found between the number of PIMs and doctor visits (p=0.047).Conclusion:The doctor should examine prescription and over-the-counter medications used by the elderly during the visit. It will be useful to establish a warning system stating that PIMs are available while registering the medications in the electronic system. So, it will be possible for health authorities to re-evaluate the treatment and replace PIMs with rational drug options.

A healthy multiparous woman presented at 35 weeks and 4 days’ gestation with threatened preterm labour on multiple occasions. An incidental finding of severe hypokalaemia (2.4 mmol/L) was detected on routine blood tests. The cause of this hypokalaemia was not initially obvious. It was eventually linked to overuse of over-the-counter antacids for pregnancy-associated heartburn. The patient was managed with parenteral and then oral electrolyte replacement which corrected a pH of 7.55, bicarbonate of 36.7 mEq/L and a base excess 13.1. In this case report we consider whether hypokalaemia could be linked to uterine irritability and threatened preterm labour, whether antacids were being abused in the context of an eating disorder and the importance of taking a full drug history.

Background Pharmacists are positioned to play important roles in implementing evidence-based prevention and harm reduction approaches for opioid misuse and related health care outcomes such as human immunodeficiency virus (HIV) and hepatitis C. More research is needed to understand how best to facilitate harm reduction practices among pharmacists. Objectives This hypothesis-generating study investigated (1) whether subgroups (latent classes) were observable among pharmacists based on self-reported comfort with specific harm reduction behaviors, (2) whether having reported expertise in key content areas was associated with any latent classes that might be identified, and (3) whether comfort and training were associated with actually having dispensed syringes for likely nonprescription drug use. Methods This was a statewide census of community managing pharmacists in Arizona conducted from December 2018 to May 2019. Participants reported their degree of comfort with 10 harm reduction behaviors, their expertise (e.g., recent continuing pharmacy education or specialization) in selected content areas, and their syringe dispensing behavior. Additional sociodemographic information was also collected. Subgroups related to harm reduction were computed using latent class analysis, and associations between study variables were assessed using the Fisher's exact tests. Results Data suggested the existence of 4 latent, comfort-based harm reduction classes: high comfort, moderate comfort, and clinical comfort, and opioid prevention only. Reported expertise in pre-exposure prophylaxis for HIV was likely associated with harm reduction class. However, class membership was not associated with reporting having dispensed nonprescription syringes, although the single comfort item for syringe dispensing, by itself, was associated therewith. Conclusion Comfort with harm reduction likely clusters, so pharmacists may be broadly comfortable with topics or methods of harm reduction; however, comfort with a specific harm reduction pharmacy practice may be a better predictor of engaging in that behavior than harm reduction comfort class. In contrast, strategies to improve comfort, such as intervention development, might successfully be informed by pharmacists’ latent class.

Knowledge about current trends and epidemiology in poisonings is important to maintain quality in diagnostics, treatment and prevention. We performed a cross-sectional study of all cases (n = 261) admitted with drug poisoning to Aalborg University Hospital during 1 year in 2017–2018. Median age was 30 (22–49) years, and 58% were female. Fifty percent were suicide attempts. In most cases, involved drugs were identified by history taking; blood analysis barely revealed any additional paracetamol and salicylicate poisonings. Drugs prescribed to the patient or available over the counter were involved in nearly two thirds of cases. Weak analgesics dominated by paracetamol (n = 91, 35%) was the most frequently involved group of drugs followed by opioids and benzodiazepines. Gender differences were observed with respect to involvement of weak analgesics and central stimulants. A higher prevalence of unidentified involved drugs was observed in 26 cases (10%) in which the length of admission exceeded 2 days and/or intensive care was needed. No deaths, cardiac arrhythmias or physical complications occurred. Thus, current handling of the acute poisoning seems effective in most cases. However, a more tailored use of blood analyses including a toxicological screen in selected cases may represent an opportunity for improvement.

Background Adults aged 65+ (older adults) disproportionately consume 30% of over-the-counter (OTC) medications and are largely responsible for making OTC treatment decisions because providers lack awareness of their consumption. These treatment decisions are complex: older adults must navigate age-related body/cognitive changes, developed comorbidities, and complex medication regimens when selecting the right OTC. Yet little is known about how older adults make such decisions. Objectives This study characterizes older adults' cognitive decision-making process when seeking to self-medicate with OTCs from their community pharmacy, and demonstrates how hierarchical task analysis (HTA) can be used to evaluate a pharmacy intervention's impact on their decision-making. Methods A pre-/post-implementation approach, using a think-aloud interview process, was conducted with older adults within a community pharmacy setting as they completed a hypothetical scenario to treat either pain, sleep, or cough/cold/allergy symptoms. HTA developed a conceptualization of older adult decision-making regarding OTC selection and use before/after Senior Section implementation. Results An HTA constructed from 12 purposefully-selected interviews (pre-n = 9/post-n = 3), consisting of 8 goals/15 sub-goals. While selecting an OTC, older adults considered quantity, cost, form, regimen, safety, strength, appropriateness of OTC safety, generic/name-brand, past experiences, and ingredients. The intervention reduced by half the number of factors considered. Implications Older adult decision-making is more complex than just selecting OTC medication from a pharmacy shelf. HTA-informed decision profiles can provide pharmacists critical insights into safety issues that older adults may not be considering (e.g., factors related to safety, strength, or appropriateness of OTC for symptoms) so that pharmacists can support their decision-making.

This meta-analysis was performed to evaluate the clinical efficacy and safety of Chinese patent medicines in the treatment of subacute thyroiditis (SAT).Chinese databases were searched using a combination of "patent Chinese medicine", "traditional Chinese medicine", "traditional Chinese and western medicine", "sub-thyroiditis", and "subacute thyroiditis". Studies that set Chinese patent medicine treatment of SAT as the experimental group were selected. Then, meta-analysis was performed by RevMan 5.3.A total of 12 studies were included, and most of them had a high risk of bias (low quality). The heterogeneity test results of clinical efficacy showed that Chi2=6.21, df=7, P=0.520.1, and I2=0%50%. Then, the fixed effects model (FEM) was used, with OR =2.80; 95% confidence interval (CI): 1.89-4.13. The heterogeneity test of recurrence rate showed that Chi2=10.69, df=9, P=0.300.1, and I2=16%50%. The heterogeneity test of erythrocyte sedimentation rate showed that I2=97%, P0.00001, MD =-10.02; 95% CI: -12.88 to -7.16, and P0.00001. The heterogeneity test of free triiodothyronine showed that Chi2=500.75, I2=99%50%, P0.00001, MD =-2.88; 95% CI: -3.85 to -1.91; Z=5.83, and P0.00001. The heterogeneity test of free thyroid hormone showed that Chi2=25.15, I2=72%50%, P=0.0007, MD =-2.48; 95% CI: -3.69 to -1.26; Z=3.99, and P0.0001. The heterogeneity test of the occurrence of adverse reactions showed that Chi2=11.28, df=11, P=0.420.1, and I2=3%50%, and the combined effect size was Z=6.49 and P0.00001, with OR =0.21; 95% CI: 0.13-0.34.The meta-analysis of this study confirms that Chinese patent medicines have considerable clinical effects in the treatment of SAT. They can reduce the recurrence rate, adjust the levels of free triiodothyronine and free thyroid hormone, and have good safety.

Emergency contraceptive (EC) pills are used to prevent pregnancy after unprotected sexual intercourse. Levonorgestrel is an EC pill, which has been only approved in Japan; it is more effective the sooner it is used after intercourse and safe without serious side effects. EC pills are already available at accessible community pharmacies in more than 90 countries around the world. In Japan, citizens have signed a petition calling for the sale of emergency contraceptives at community pharmacies. However, little is known about the thoughts of pharmacists who engage with patients and sell medicines at pharmacies. Therefore, we conducted a web-based cross-sectional survey to determine the level of preparation in community pharmacies and the awareness of pharmacists regarding the sale of EC pills. A total of 1338 pharmacists responded to the survey from November 7, 2020, to December 16, 2020. In terms of the level of preparation for selling EC pills at pharmacies, 1067 (83.9%) respondents cited "lack of preparation of medical questionnaires and explanatory materials", and 975 (76.7%) respondents cited "lack of knowledge of pharmacists" as the most common reasons that were "barriers to EC pill sales at pharmacies". In terms of confidence level, only 289 (22.7%) respondents were confident about conducting the necessary checks while administering medicine. On the other hand, 944 (74.3%) respondents agreed to be able to sell EC pills at their pharmacies. The survey revealed that most of the pharmacists who participated in the survey believe that it is possible to sell EC pills in pharmacies.

BACKGROUND The French Ministry of Health scheduled opioid cough suppressants as prescription-only drugs on July 12th , 2017. The present study assessed the impact of this regulation on the diversion modalities of the concerned drugs and the related drug pholcodine by analysing the national OSIAP (Ordonnances suspectes indicateur d'abus possible) database. METHODS Medical prescriptions with at least one mention of codeine, dextromethorphan, ethylmorphine, noscapine or pholcodine for cough suppression recorded in 2013-2019 were extracted from OSIAP. Annual mentioning rates were estimated by dividing numbers of mentions over those of prescriptions recorded the year considered. A descriptive analysis compared the characteristics of prescriptions before and after July 12th , 2017. RESULTS Overall, 832 mentions of the requested drugs were retrieved on 827 prescription forms. Codeine was the most frequent (n=809, 8.7%) with 6 additional mentions of codeine/ethylmorphine combination, followed by dextromethorphan (n=11, 0.1%) and pholcodine (n=6, 0.1%). There was no mention of noscapine. Annual mentioning rates varied between 0 and 0.3% for all drugs except codeine. Codeine mentioning rates ranged between 0.3% (n=2) and 0.7% (n=9) before July 12th , 2017 and increased to 10.1% (n= 61) thereafter in 2017, 16.1% (n=314) in 2018, and 19.8% (n=414) in 2019. The profile of subjects evolved accordingly with an arisen male/female ratio (10.0 versus 1.5 before), a younger age (23 years versus 40 before, p

Objectives To assess the financial impact of self-medication enhancement through a potential expansion of the over-the-counter (OTC) drug list in Greece. Methods An analysis consisting of two scenarios was conducted. The first scenario estimated the financial effects of hypothetically switching 5% of the volume of the total sales of reimbursed drugs in Greece to OTC, while the second scenario estimated the effects of switching to OTC the total sales volume of a set of active substances (which are currently reimbursed), facilitated by a consensus panel meeting. The analysis was conducted from the third-party payer, individual and societal perspectives. Data and costs refer to the year 2019. Key findings Switching 5% of the volume of the total sales of reimbursed drugs to OTC was estimated to lead to total annual savings of 227.57 million euros. The annual savings from the third-party payer, individual and societal perspectives were estimated at 97.06 million euros, 91.81 million euros and 38.69 million euros, respectively. Switching the total sales volume of the reimbursed drugs of the active substances which emerged from the consensus panel meeting was estimated to lead to total annual savings of 567.57 million euros. The annual savings for the third-party payer, individuals and society were estimated at 232.91 million euros, 241.01 million euros and 93.65 million euros, respectively. Conclusions Although the present analysis is model-based, and thus did not incorporate some potentially significant parameters, it demonstrated the financial savings which a potential expansion of the OTC drug list could produce for the third-party payer, individuals and society in Greece.

BACKGROUND Acne vulgaris (acne) is a common inflammatory skin disorder prevalent among all ethnic groups. This review aimed to investigate the current literature regarding the potential benefit of over-the-counter (OTC) adjuncts (eg, moisturizers, cleansers) for acne patients focusing on Asian phenotypes. METHODS An online procedure was employed to review the role of adjunctive OTC acne treatment. A panel consisting of dermatologists with expertise in treating Asian acne patients participated in a pre-meeting survey that collected information regarding their recommendation habits for OTC products in acne patients. Recommendations on using OTC products as an adjunct for treating acne in Asians are based on the pre-meeting survey results, evidence from literature presented during a series of plenary lectures, and discussions conducted during a stepwise program of sessions. RESULTS Many topical treatments have been associated with adverse events (AEs) (eg, skin dryness, erythema, scaling, stinging, burning, pruritus). Multiple studies on topical acne treatments have found that Asians display greater sensitivity and less tolerability than Caucasians to acne treatment. Skincare as an adjunct to acne treatment may reduce dryness or irritation, particularly important in Asians with acne. CONCLUSIONS Advisors agreed that cleansers and moisturizers should be considered for their beneficial adjunctive role in the armamentarium of acne treatment and maintenance strategies. J Drugs Dermatol. 2021;20(11): 1213-1221. doi:10.36849/JDD.6259.

Background Efficiency and transparency of pricing and reimbursement (P&R) rules and procedures as well as their implementation in South-eastern Europe (SEE) lag substantially behind Western European practice. Nevertheless, P&R systems in SEE are rarely critically assessed, warranting a detailed and wider-encompassing exploration. Objective Our study provides a comparative assessment of P&R processes for patent-protected medicines in ten SEE countries—EU member states: Croatia, Slovenia, Hungary, Romania and Bulgaria ; and non-EU countries: Albania, Montenegro, Serbia, North Maceodina, Bosnia and Herzegovina. P&R systems are compared and evaluated through a research framework that focuses on: (1) public financing of patent-protected medicines, (2) definition of benefit packages, (3) requirements for the submission of reimbursement dossiers, (4) assessment and appraisal processes, (5) reimbursement decision making, (6) processes that occur post reimbursement, and (7) pricing. The study aims to contribute to the discussion on improving the efficiency and quality of P&R of patent-protected medicines in the region. Methods We conducted a non-systematic literature review of published literature, as well as policy briefs and reports on healthcare systems in the SEE region along with legal documents framing the P&R procedures in local languages. The information gathered from these various sources was then discussed and clarified through structured telephone interviews with relevant national experts from each SEE country, mainly current and former senior officials and/or executives of the funding and assessment/ appraisal bodies (total of 20 interviews conducted in late 2019). Results Capacity building through sharing knowledge and information on successful reforms across borders is an opportunity for SEE countries to further develop their P&R policies and increase (equitable) access to patent-protected medicines (especially expensive medicines), increasing affordability and containing costs. Simple yet robust and systematic decision-making frameworks that rely on international health technology assessment (HTA) procedures and are based on the pursuit of transparency seem to be the most cost- effective approach to strengthening P&R systems in SEE. Conclusions Further reforms aiming to develop transparent and robust national decision-making frameworks (including oversight) and build institutional HTA- related and decision-making capacity are awaited in most of SEE countries, especially the non-EU members. In non-EU SEE countries, these efforts could increase access to patent-protected medicines, which is—at the moment —very limited. The EU-member SEE countries operate more developed P&R systems but could further benefit from developing their procedures, oversight and value- for-money assessment toolbox and capacity, hence further improving the transparency and efficiency of procedures that regulate access to patent- protected medicines.

ObjectivesThis pilot study examines effectiveness of an innovative pharmacy design change on over-the-counter (OTC) medication misuse in older adults (ages ≥65). Few interventions have attempted to decrease older adult OTC misuse, and none have addressed system barriers. A structural redesign of the pharmacy (the Senior Section™) was conceptualized to increase awareness of higher-risk OTC medications. The Senior Section contains a curated selection of OTC medications (for pain, cough/cold, allergy, sleep) and is close to the prescription department to facilitate pharmacy staff/patient engagement to reduce misuse.MethodsA pre-/post-implementation design was used to recruit 87 older adults from three pharmacies. Using a hypothetical scenario, participants selected an OTC medication, which was compared to their medication list and health conditions, and their reported use was compared against the product labeling. Four misuse outcomes were determined: (1) Drug/Drug, (2) Drug/Disease, (3) Drug/Age, and (4) Drug/Label with five sub-types. Patient characteristics were collected and compiled into a propensity-score matching logistic regression model to estimate their effects on the Senior Section’s association with misuse outcomes at pre-/post-implementation.ResultsPatient characteristic were uniform between pre-/post-implementation and, once entered into a propensity-score matching model, Drug/Disease Misuse significantly lessened over time (z=-2.09, p=0.037). The Senior Section reduced Drug/Drug Misuse, but not significantly. Drug/Label Misuse varied according to the sub-type, with reduced Daily-Dosage (z=-2.42, p=0.016) and Single-Dosage misuse (z=-5.82, p=0.001); however, Timing/Frequency misuse increased (z=2.16, p=0.031).ConclusionsThese nascent outcomes support a well-conceived pharmacy-based OTC aisles redesign as valuable for reducing older adult OTC medication misuse. The Senior Section, when broadly implemented, would create new permanent structures and processes to assist older adults in accessing risk information for confidently selecting safer OTC medications.

Objective. To explore OTC (over-the-counter drugs) in Chinese community pharmacies often causes ADE (adverse drug event) in elderly patients. Methods. Use the drugs in the Beers Criteria 2019 potentially inappropriate medication use (PIM) list as search terms. Search for drugs registered on the National Medical Products Administration of China website before December 2019 to determine the drugs containing PIM active ingredients and, then, search the Chinese OTC selection and conversion catalog database to determine it as OTC. Two databases are considered to be the same drug if they have the same drug composition. Results. The incidence of PIM in elderly patients in our community is relatively high, and the management of OTC may be related to risk factors. Statistics found that 71 OTC contained the Beers Criteria ingredients, including 65 chemicals and six Chinese patent medicines. Varieties of compound preparations accounted for 78.9% and cold medicines accounted for 47.9%. Conclusions. The high detection rate of the Beers Criteria in Chinese OTC suggests that medical practitioners in China, especially community pharmacists, should pay attention to the rational use of OTC in the elderly.

As the cosmeceutical market for nail products is growing, there is an emerging need for dermatologists to provide patients with evidence-based information regarding over-the-counter products and supplements for nail growth. By law, there is no required efficacy and safety assessment by the Food and Drug Administration prior to these products being made available to consumers. This carries financial and health consequences for patients seeking affordable and effective over-the-counter products to improve their nail conditions. In this comprehensive review, we discuss available oral nail growth products, their mechanisms of action, and side effects.

Background Non-prescription antibiotic use at community is a main driver of antimicrobial resistance. Cough is a common condition and prevalent in all townships, including China. This study aims to investigate the non-prescription antibiotic use for cough in China and explore to which extent antibiotic use knowledge was correctly instructed in communities. Methods A probability-proportionate-to-size sampling method was adopted to survey from all 14 townships in Yiwu city, China. All participants were investigated by face-to-face interview on Portable Android Devices. The continuous variables were presented by mean and standard deviation or medium and inter-quartile range (IQR). The categorical variables were presented using percentage or constituent ratio. Chi-square test for univariate analysis and logistic regression for multivariate analysis were conducted to assess the odds ratios and 95% confidence intervals, respectively. Results A total of 3034 respondents across all the 14 townships and the 50 natural villages/streets completed all key items of the questionnaire. Of 2400 (79.10%) respondents stated that they experienced cough in the past 12 months with the medium age of 36.5 (IQR: 26–49) and 12.21% (293/2400) respondents had the non-prescription antibiotic use behavior. Among those 293 respondents, the proportion of non-prescription antibiotic use for cough peaked at around 16% among people aged 30–39 years old. The major sources of antibiotics were pharmacy (77.70%) and/or family storage (43.92%). Conclusions Non-prescription antibiotics use for cough is prevalent in the community, especially among people in their thirties. Strengthened drug purchase regulation and well-trained professional pharmacists would be promising alternatives to ameliorate AMR. Moreover, penetrating antibiotics knowledge to common citizens and is an urgent task to alleviate antimicrobial resistance. Therefore, proactive policies and regulations should be made to improve current situations.

Background: Most U.S. patient and health care provider surveys with regard to nasal allergy treatments were conducted before sublingual immunotherapy (SLIT)-tablets and allergy immunotherapy (AIT) shared decision-making tools were available. Objective: Patient and health care provider surveys with regard to current perceptions of nasal allergy burden, symptoms, and treatments were conducted to compare with previous surveys and provide insight into the use of SLIT-tablets and AIT shared decision-making tools. Methods: From November-December 2019, adults (N = 510) diagnosed with nasal allergies and health care providers (N = 304) who treated nasal allergies in the United States completed surveys with regard to nasal allergy management. Results: Of the patient respondents, 42% reported that their symptoms were only somewhat controlled and 48% had avoided activities because of their nasal allergies. In all, 38% were using only over-the-counter (OTC) medications for treatment, and 42%, 7%, and 8% had ever received subcutaneous immunotherapy (SCIT), sublingual allergy drops, or SLIT-tablets, respectively; 56% and 85% reported that they had never discussed SCIT or SLIT, respectively, with their health care provider. Of the health care provider respondents, 45%, 58%, and 20% were very likely to discuss OTC medications, SCIT, or SLIT, respectively. Allergists were more inclined to discuss SCIT with their patients than other health care providers (82% versus 33%, respectively). Most allergists (67%) and other health care providers (62%) reported that they did not use an AIT shared decision-making tool, primarily because of unawareness. Conclusion: The patients with nasal allergies continued to report inadequate symptom control and activity impairment. SLIT-tablets and AIT shared decision-making tools were underused. In the coronavirus disease 2019 era, social distancing may limit office visits, which impacts SCIT administration and prompts increased use of telemedicine and a possible advantage for at-home‐administered SLIT-tablets over SCIT.

Objectives To explore the current perceived relationship between older adults with varying levels of frailty and healthcare needs and community pharmacists. Methods This qualitative study conducted a thematic analysis of focus groups with older adults and older adult caregivers and community pharmacist participants. Participants were recruited following a maximum variation sampling technique. Verbatim transcripts were inductively coded using NVivo to develop key findings. Key findings Four major themes emerged: (i) Pharmacy Landscape, (ii) Prescription and Non-Prescription Drug Safety, (iii) Patient–Pharmacist Relationship and (iv) Recommendations for Pharmacy Practice. Themes demonstrate three key findings: (1) older adults approach drug information with a key focus on safety and cost of both prescription and non-prescription drugs, (2) there is a demonstrated opportunity, recognized by older adults and practitioners, for community pharmacists to expand their role in the care of older adults, (3) community pharmacists are able, interested and/or have already incorporated frailty assessments into their practice to better support their care of the older adult population with varying levels of frailty. Conclusions The results demonstrate a reason for the community pharmacist role to shift. The unique knowledge and skills of community pharmacists, coupled with their accessibility and strong patient–clinician relationship, have the potential to better support older adults with varying levels of frailty.

A 2001 U.S. Government Accountability Office (GAO) report indicated 8 of 10 drugs withdrawn from the U.S. market between 1997 and 2000 posed greater risk to women than men. We examined drugs withdrawn from the market for safety-related reasons from January 1, 2001, to January 1, 2018. To be included, drugs must be listed as discontinued on Drugs@FDA and either listed in the Federal Register or cited in literature as being withdrawn for safety-related reasons. Biologics, over-the-counter products, and medical devices were excluded. During the 17-year time span, 19 drugs were withdrawn from the market for safety-related reasons, fewer drugs per year compared to the 3-year period examined in the GAO report. Food and Drug Administration (FDA) has not recommended the market removal of any drug approved since 2005 due to the time from the start of the Q wave to the end of the T wave (QT) interval prolongation resulting in torsades de pointes (TdP) or other abnormal heart rhythms. Furthermore, no drugs approved after the implementation of FDA's 2009 guidance on drug-induced liver injury (DILI) have been withdrawn because of hepatoxicity. All, but one of the drugs discontinued from the market for safety-related reasons during the period examined were approved between 1957 and 2002. TdP and DILI are two relevant examples of drug-induced adverse events posing greater risk to women than men. FDA has made measurable progress incorporating consideration of sex and gender differences into drug trial development and FDA review of these data, supporting inclusion of women in clinical trials, providing a comprehensive drug safety review, and advancing postmarket surveillance and risk assessment, thus strengthening FDA's ability to protect public health.

Background Currently, opioids are the standard of care for postoperative pain management. Avoiding unnecessary opioid exposure in patients is of current interest because of widespread abuse. Methods This is a prospective cohort study in which wide-awake, local anesthesia, no-tourniquet (WALANT) technique was used for 94 hand/upper extremity surgical patients and compared to patient cohorts undergoing similar procedures under monitored anesthesia care. Patients were not prescribed opioids postoperatively but were instead directed to use over-the-counter pain relievers. Pain scores on a visual analogue scale were collected from patients preoperatively, and on postoperative days 1 and 14. WALANT visual analogue scale scores were compared to those of the two patient cohorts who either did or did not receive postoperative opioids after undergoing similar procedures under monitored anesthesia care. Electronic medical records and New York State's prescription monitoring program, Internet System for Tracking Over-Prescribing, were used to assess prescription opioid-seeking. Information on sex, age, comorbidity burden, previous opioid exposure, and insurance coverage was also collected. Results Decreased pain was reported by WALANT patients 14 days postoperatively compared to preoperatively and 1 day postoperatively, with a total group mean pain score of 0.37. This is lower than mean scores of monitored anesthesia care patients with and without postoperative opioids. Only two WALANT patients (2.1 percent) sought opioid prescriptions from outside providers. There was little evidence suggesting factors including sex, age, comorbidity burden, previous opioid exposure, or insurance status alter these results. Conclusion WALANT may be a beneficial technique hand surgeons may adopt to mitigate use of postoperative opioids and reduce risk of abuse in patients. Clinical question/level of evidence Therapeutic, II.

BackgroundNon-prescription dispensing of antibiotics, one of the main sources of antibiotic misuse or over use, is a global challenge with detrimental public health consequences including acceleration of the development of antimicrobial resistance, and is facilitated by various intrinsic and extrinsic drivers. The current review aimed to systematically summarise and synthesise the qualitative literature regarding drivers of non-prescribed sale of antibiotics among community drug retail outlets in low and middle income countries.MethodsFour electronic databases (PubMed, CINAHL, Scopus and Google Scholar) and reference lists of the relevant articles were searched. The Joanna Briggs Institute’s Critical Appraisal Checklist for qualitative studies was used to assess the quality of included studies. The enhancing transparency in reporting the synthesis of qualitative research statement was used to guide reporting of results. Data were coded using NVivo 12 software and analysed using both inductive and deductive thematic analysis.ResultsA total of 23 articles underwent full text review and 12 of these met the inclusion criteria. Four main themes were identified in relation to facilitators of non-prescribed sale of antibiotics among community drug retail outlets: i) the business orientation of community drug retail outlets and tension between professionalism and commercialism; ii) customers’ demand pressure and expectation; iii); absence of or a lax enforcement of regulations; and iv) community drug retail outlet staff’s lack of knowledge and poor attitudes about antibiotics use and scope of practice regarding provision.ConclusionsThis review identified several potentially amendable reasons in relation to over the counter dispensing of antibiotics. To contain the rise of antibiotic misuse or over use by targeting the primary drivers, this review suggests the need for strict law enforcement or enacting new strong regulation to control antibiotic dispensing, continuous and overarching refresher training for community drug retail outlet staff about antibiotic stewardship, and holding public awareness campaigns regarding rational antibiotic use.

Background Concerns about the misuse of codeine led to the introduction of guidance restricting the supply of over-the-counter (OTC) codeine-containing products in Ireland in 2010. The aim of this study was to examine the impact of this guidance on the national rate of hospital-presenting self-harm involving codeine-related intentional drug overdose (IDO). Methods Presentations involving IDO to Irish general hospitals between 1 January 2007 and 31 December 2013, as recorded by the National Self-Harm Registry Ireland, were analyzed. Event-based rates per 100 000 were calculated using national population data. Poisson regression models were used to assess rate changes between pre- and post-guidance periods and to calculate excess presentations. Results Between January 2007 and December 2013, a total of 57 759 IDOs were recorded, with 4789 (8.3%) involving a codeine-containing product. The rate of codeine-related IDOs was 20% lower in the period following implementation of the guidance (incidence rate ratio: 0.80; 95% CI: 0.75 to 0.85), representing a total of 509 (95% CI: −624, −387) fewer codeine-related IDOs in that period. Reductions were observed across all ages and were more pronounced for females (0.76, 0.71 to 0.82) than males (0.87, 0.79 to 0.97). The rate of IDOs involving other drugs decreased by 3% in the same period (0.97, 0.95 to 0.98). Conclusion Our findings indicate that the rate of codeine-related IDOs was significantly lower in the period following the implementation of the guidance. There is a large body of evidence supporting the restriction of potentially harmful medication as an effective strategy in suicide prevention.

BACKGROUND AND AIMS Over-the-counter codeine products were up-scheduled to prescription only in Australia from February 2018. This trend study aimed to identify changes in codeine supply before and after the February 2018 implementation. DESIGN, SETTING AND CASES Time-series regression analysis of monthly medicine supplies in Australia from 2014 to 2018. The February 2018 up-scheduling was pre-specified as the intervention; outlier analysis was used to detect automatically sudden unexpected changes before February 2018. MEASUREMENTS Per-capita supplies based on national data for pharmaceutical wholesales and population exposure. Weight of supplies in milligrams for low-dose codeine (≤ 15 mg per tablet or ≤ 1.92 mg per ml, originally sold over the counter but up-scheduled after February 2018), high-dose combination codeine (30 mg per tablet, prescription only throughout the study period) and all codeine. FINDINGS Several level shifts in supply occurred during the 5 years, led by one of -4.4% [95% confidence interval (CI) = -6.6 to -2.1%] in high-dose codeine in 2015, followed by shifts in low-dose codeine of -40.0% (CI = -46.9 to -32.3%) and -82.2% (CI = -84.3 to -79.9%), respectively, before and after February 2018. High-dose codeine supply increased by 4.4% (CI = 1.8-7.1%) immediately after up-scheduling. Also detected were transient increases and decreases in 2016 and 2017. Compared with pre-2015 levels, the February 2018 up-scheduling was associated with reductions of 45.7% (CI = 43.2-48.0%) and 89.3% (CI = 87.9-90.6%), respectively, in all and low-dose codeine supply but no change in high-dose codeine supply. The level shifts and transient changes were located around various regulatory activities, including public announcements and expert advisory meetings on up-scheduling. CONCLUSION Up-scheduling of over-the-counter codeine products in Australia in 2018 appears to have been associated with a near halving of Australia's national codeine supply. The transition occurred in multiple forms and phases.

Over-the-counter (OTC) drugs have many benefits but also carry risks, such as adverse drug reactions, which are more prevalent in older adults. Because these products do not require the oversight of a physician or pharmacist, labeling plays a key role in communicating information required for their safe and effective use. Research suggests that current labels are not terribly effective at communicating potential risk. One reason for their lack of effectiveness is that few consumers attend to critical information (active ingredients and warnings) when making purchases. In two experiments, we used a change detection task to objectively evaluate how novel label designs that employ highlighting and a warning label placed on the package’s front impact attention to critical information among older participants (65 and older). The change detection task is a unique form of visual search which allowed us to assess the attentional priority of critical information among participants who were not explicitly instructed to search for this critical information. This unique aspect of the task is important given research suggesting that consumers rarely have the explicit goal of seeking out warnings and active ingredients when making OTC selections. Our results provide empirical support that both highlighting critical information and positioning it on the package’s front increase its attentional prioritization relative to current, commercial practice. Given that attending to the critical information is prerequisite to utilizing that information, strategies that elicit attention in this way are likely to reduce medication errors.

Background In 2014, Nigeria issued the task-shifting/sharing policy for essential health services, which aimed to fill the human resource gap and improve the delivery of health services across the country. This study focuses on the characteristics, spread, and family planning (FP) stocking practices of medicine vendors in Lagos and Kaduna, assessing the influence of medical training on the provision and stocking of FP services and commodities by vendors. Methods We conducted a census of all Patent Medicines stores (PMS) followed up with a facility assessment among 10% of the mapped shops, utilizing an interviewer-administered questionnaire. Bivariate analysis was conducted using the Chi-square test, and multiple logistic regression was used to estimate the adjusted odds ratio (OR) and confidence intervals (CI) for the test of significance in the study. Results A total of 8318 medicine shops were enumerated (76.2% urban). There were 39 shops per 100,000 population in both states on average. About half (50.9%) were manned by a medicine vendor without assistance, 25.7% claimed to provide FP services to > 2 clients per week, and 11.4% were not registered with the regulatory body or any professional association. Also, 28.2% of vendors reported formal medical training, with 56.3% of these medically trained vendors relatively new in the business, opening within the last 5 years. Vendors utilized open drug markets as the major source of supply for FP products. Medical training significantly increased the stocking of FP products and inhibited utilization of open drug markets. Conclusion Patent and Proprietary Medicines Vendor (PPMVs) have continued to grow progressively in the last 5 years, becoming the most proximal health facility for potential clients for different health services (especially FP services) across both Northern and Southern Nigeria, now comprising a considerable mass of medically trained personnel, able to deliver high-quality health services and complement existing healthcare infrastructure, if trained. However, restrictions on services within the PPMV premise and lack of access to quality drugs and commodities have resulted in poor practices among PPMVs. There is therefore a need to identify, train, and provide innovative means of improving access to quality-assured products for this group of health workers.

Introduction Constipation is commonly treated with over-the-counter (OTC) products whose efficacy and safety remain unclear. We performed a systematic review of OTC therapies for chronic constipation and provide evidence-based recommendations. Methods We searched PubMed and Embase for randomized controlled trials of ≥4-week duration that evaluated OTC preparations between 2004 and 2020. Studies were scored using the US Preventive Services Task Force criteria (0-5 scale) including randomization, blinding, and withdrawals. The strengths of evidence were adjudicated within each therapeutic category, and recommendations were graded (A, B, C, D, and I) based on the level of evidence (level I, good; II, fair; or III, poor). Results Of 1,297 studies identified, 41 met the inclusion criteria. There was good evidence (grade A recommendation) for the use of the osmotic laxative polyethylene glycol (PEG) and the stimulant senna; moderate evidence (grade B) for psyllium, SupraFiber, magnesium salts, stimulants (bisacodyl and sodium picosulfate), fruit-based laxatives (kiwi, mango, prunes, and ficus), and yogurt with galacto-oligosaccharide/prunes/linseed oil; and insufficient evidence (grade I) for polydextrose, inulin, and fructo-oligosaccharide. Diarrhea, nausea, bloating, and abdominal pain were common adverse events, but no serious adverse events were reported. Discussion The spectrum of OTC products has increased and quality of evidence has improved, but methodological issues including variability in study design, primary outcome measures, trial duration, and small sample sizes remain. We found good evidence to recommend polyethylene glycol or senna as first-line laxatives and moderate evidence supporting fiber supplements, fruits, stimulant laxatives, and magnesium-based products. For others, further validation with more rigorously designed studies is warranted.

To describe trends in abuse, misuse, and suicide attempts involving diphenhydramine (DPH).We analyzed intentional DPH exposures of individuals ≥10 years old reported to U.S. Poison Control Centers using data from the National Poison Data System, 2005-2016.There were 158,774 intentional DPH exposures in our dataset. The rate of intentional exposures increased 63% over the 12-year study period for all ages combined. Suicide attempts involving DPH showed a bimodal distribution-increasing 263% among children 10-14 years of age, and 126 and 143% among those 55-64 and ≥65 years of age, respectively. Older adults in both the 55-64 and ≥65-year-old age groups had about a 230% increase in rates of misuse. Major adverse clinical effects increased by 91%. There were 745 total reported deaths with a 3.6% increase across all age groups.Intentional DPH exposures among individuals ≥10 years old have been increasing since 2005. Increasing rates of suicide attempts among children ages 10-14 and increasing misuse among individuals ≥65, coupled with a trend toward greater severity of overdoses, highlight the significant public health impact of this commonly available over-the-counter drug.

Health literacy is defined as the ability to obtain, evaluate, and scrutinize health information and make appropriate decisions and actions. The spread of the Internet means that medical and drug information is becoming increasingly accessible to patients. However, there is also a large amount of inappropriate and biased medical- and drug-related information on the Internet. Therefore, patients require a high level of health literacy to ensure the effectiveness and safety of pharmacotherapy. In particular, outpatients need a high level of health literacy because they use their own medications without the supervision of healthcare professionals. In this article, I discuss the situation of health literacy and access to pharmaceutical information on the Internet in Japan. Furthermore, issues related to providing drug information to specific populations are explained using the example of chronic kidney disease. It is essential for all pharmaceutical information stakeholders to work together to solve these problems.

Purpose: The purpose of this study was to determine the prevalence and correlates of nonprescription hormone use among Brazilian trans women. Methods: This study is a cross-sectional survey of trans women in São Paulo, Brazil, recruited by respondent-driven sampling in 2017–2019. Results: Of 790 trans women, 36.8% were taking nonprescribed hormones. Nonprescribed hormone use was higher with younger age, lower education, homelessness, and using estrogen plus progesterone. Lower use was associated with accessing health care and having trans-specific health needs met. Conclusion: Marginalized Brazilian trans women exhibit high use of nonprescription hormones, which may have health consequences and requires further examination and research.

Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 mThe primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.NCT02063100 on ClinicalTrials.gov.

Dry eye disease is a common but underdiagnosed disorder in the United States, and its prevalence is likely to increase as the nation's population ages. Although still regarded as little more than a nuisance by many clinicians and payers alike, dry eye disease is known to have both clinical consequences for ocular health and effects on vision-related quality of life in many people, impairing their ability to function well in vocational and social settings. Pharmaceutical treatments consist mainly of over-the-counter ocular lubricants ("artificial tears") and a few prescription drugs that address the inflammatory component of dry eye disease through immunomodulation and/or inhibition of T-cell activity. In September 2020, Oyster Point Pharma, Inc (Oyster Point Pharma), convened a panel-consisting of 7 managed care executives with experience in management of dry eye disease treatments and 2 eye care practitioners with expertise in dry eye disease-to discuss how the growth of knowledge about dry eye disease in the past 2 decades has altered their thinking about and approach to dry eye disease, as well as how they would like to see the field advance. They pointed to an existing unmet need in knowledge and therapeutics that can address the underlying causes of dry eye disease. Oyster Point Pharma supported the authorship of this article; the authors were members of the panel, and all panelists were compensated by Oyster Point Pharma. This article provides an overview of dry eye disease and summarizes the panel discussion.

Background For older adults, health risks from inappropriate use of over-the-counter (OTC) medications represent a prevalent clinical and public health challenge. Focus groups with pharmacists led to the identification of a number of systems barriers to pharmacists supporting the safe selection and use of OTC medications by this population. Such feedback informed the development of the Senior Section™, a physical redesign that located a curated inventory of lower-risk OTC medications proximal to the prescription department. Objectives To determine whether implementation of the Senior Section resulted in improvements to the ability of pharmacy staff to engage with older adult patients to support OTC medication safety issues. Methods A qualitative approach, in which pharmacy staff from 4 pharmacies within a single chain participated in a semi-structured interview, was used to evaluate the implementation of the Senior Section in their pharmacies. Interview transcripts underwent a deductive and iterative content analysis. Results Eight pharmacists and 5 technicians were interviewed. They viewed the Senior Section as contributing to notable improvements in proximity, medication safety, convenience, and patient selection behaviors. The Senior Section's safer OTC inventory and its sectional layout, its relationship to the prescription department, and its signage served to enhance its usefulness as an OTC safety improvement intervention. Moreover, it functioned beneficially while streamlining the coordination of services with between pharmacists and technicians, and did not interfere with existing pharmacy workflows. Conclusions Pharmacy staff believed that the Senior Section facilitated their ability to engage with older adults to support safe OTC selection and use and thus to reduce OTC-related harms.

BACKGROUND The FDA approved bimatoprost ophthalmic solution 0.03% for treatment of eyelash hypotrichosis in 2008. Consumer concern persists regarding potential side effects of this product. OBJECTIVE To identify gaps in the safety information associated with the use of prostaglandin eyelash growth products. MATERIALS AND METHODS Literature searches were performed using PubMed, Embase, and Nexis Uni databases without restriction to publication date, language, or study setting. RESULTS The literature pertaining to bimatoprost for treatment of eyelash hypotrichosis is dominated by industry-sponsored clinical trials. Study design choices create gaps in our understanding of the clinical safety of these products. CONCLUSION Because of study design choice, clinical trials of bimatoprost for eyelash growth may have systematically underreported the incidence of drug application discomfort and prostaglandin-associated periorbitopathy. The risk of increased iris pigmentation remains inadequately investigated. Consequently, there is an ongoing need to educate and monitor patients who choose to use these products.

OBJECTIVE: The purpose of this systematic review is to evaluate the available evidence for safety and efficacy of over-the-counter (OTC) sleep aids used for the treatment of insomnia in older people. DATA SOURCES: PubMed, EBSCO, and International Pharmaceutical Abstracts. STUDY SELECTION: Five studies were included that involved humans 65 years of age and older being evaluated on OTC sleep aids in the outpatient setting. DATA EXTRACTION: Data extraction from each study included primary and secondary efficacy endpoints, such as differences in the mean total sleep time, sleep latency, sleep efficiency, and number of awakenings, along with safety endpoints, such as psychomotor ability, cognitive ability, and adverse effect profiles. Both subjective and objective measures of changes in sleep and adverse effects were included. DATA SYNTHESIS: Diphenhydramine had a statistically significant increase in sedation and decrease in number of awakenings but was not shown to be any less or more safe than compared products. Despite lacking safety issues, valerian was found to have no effect on subjective or objective sleep outcomes. Overall, melatonin had the most evidence and was found to have a statistically significant positive impact on sleep measures without safety issues. CONCLUSION: Diphenhydramine and melatonin appear to be efficacious in improving some sleep measures while causing minimal adverse effects. However, there are very few studies that examine the use of over-the-counter sleep aids in those 65 years of age and older with primary insomnia. Additional studies are needed in this population.

Background The prevalence and clinical presentation of acne vulgaris in Latin America are comparable to that in Europe and the United States. This review aims at insight into the role of Over the Counter (OTC) products in acne treatment and maintenance in Latin America. Methods A panel of dermatologists from Latin America employed an online procedure to answer questions on this topic: What is used, by whom, when, how, and why? Before the meeting, a survey was completed by dermatologists from Latin America on OTC products for acne recommended by the panel in their clinical practice. The survey information and a literature review on Latin American acne guidelines and clinical studies were used to address this topic. Results The survey responders' choices on OTC products for monotherapy comprised alpha-hydroxy acid and beta-hydroxy acid-containing serum, ceramides-containing foaming cleanser, a soap-free exfoliating cleanser, adapalene, and benzoyl peroxide-containing products. The clinicians recommended OTC cleansing products mainly for younger patients at a starter level and for women with adult acne. The use of these OTC products is similar to practice described in therapeutic acne guidelines and algorithms for Latin American countries, Spain and Portugal, Europe, and the United States. Conclusions Advisors agreed that OTC products and skincare recommendations, in addition to the use of prescription medications, are a crucial part of successful acne therapy. Participants noted that the use of quality OTC products could improve acne symptomatology and severity. J Drugs Dermatol. 2021;20(3):244-250. doi:10.36849/JDD.2021.5779 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL fTEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

AimIn Mexico, many pharmacies sell oral contraceptives (OCs) over the counter (OTC); however, little is known about the background characteristics of OTC pill users. The primary objective of this study was to understand the characteristics of OTC OC users in Mexico, including whether there were differences by age, urbanicity, and insurance status. This information is instructive as other countries explore allowing OTC access to OCs.MethodsWe analysed the nationally representative 2014 Mexican National Survey of Demographic Dynamics (ENADID) among a sample of OC users aged 15–54 years (n=1970). We performed multivariable logistic models to understand the characteristics associated with OTC access, with age, urbanicity, and insurance status as our primary predictors of interest. Additionally, we descriptively explored knowledge of how frequently to take OCs by pill source and age.ResultsSome 54% of pill users, including 66% of those aged 15–17 years, obtained their OCs OTC. In multivariable regression we found no differences in OTC access by age. However, being uninsured (adjusted odds ratio (AOR) 1.86, 95% CI 1.23 to 2.82) (compared with employer-based public insurance) and living in an urban area (AOR 4.73, 95% CI 3.37 to 6.66) (compared with rural area) were associated with a higher odds of OTC access among pill users. Women’s knowledge of how frequently to take OCs was similar between OTC and prescription users within age groups.ConclusionsThese findings point to the importance of OTC availability of OCs for pill users of all ages and uninsured and urban women in Mexico in particular.

Background: Tuberculosis (TB) is a major cause of ill-health and death globally but a serious challenge to its control is low case notification. In low- and middle-income countries, most patients with symptoms of the disease first seek care from patent medicine vendors (PMVs) who are not formerly trained to manage TB. The practices of PMVs toward presumptive TB are pivotal to control of TB. Aim: The aim of this study was to describe the pattern of practices toward presumptive TB and assess their determinants among PMVs. Method: The study was carried out in Ebonyi State Nigeria using descriptive cross-sectional design. Through a multistage sampling, 250 PMVs were selected and interviewed. Data were collected using pretested interviewer-administered questionnaire and analyzed with IBM SPSS Statistics for Windows, version 22 (IBM Corp., Armonk, N.Y., USA). Chi-square test and binary logistic regression were used to determine factors associated with practices toward presumptive TB with P value set at 0.05 for statistical significance. Results: Almost half (48.8%) of the respondents engaged in poor practices by inadequate referral of clients (45.2%), delayed referral (69.6%), and unstandardized treatment with antibiotics (56.4%). There was no statistically significant association between independent variables and practice and none of the variables significantly predicted practice. Conclusions: There were poor practices toward presumptive TB shown in inadequate referral, delayed referral, and unstandardized treatment of clients. We recommend that PMVs should be trained and regularly sensitized about TB to improve their practices and that regulatory authorities should enforce policies on antibiotics distribution and sale.

Background The elderly population deals with multimorbidity (three chronic conditions) and increasinged drug use with age. A comprehensive characterisation of the medication – including prescription and over-the-counter (OTC) drugs – of elderly patients in primary care is still insufficient. Objectives This study aims to characterise the medication (prescription and OTC) of multimorbid elderly patients in primary care and living at home by identifying drug patterns to evaluate the relationship between drugs and drug groups and reveal associations with recently published multimorbidity clusters of the same cohort. Methods MultiCare was a multicentre, prospective, observational cohort study of 3189 multimorbid patients aged 65 to 85 years in primary care in Germany. Patients and general practitioners were interviewed between 2008 and 2009. Drug patterns were identified using exploratory factor analysis. The relations between the drug patterns with the three multimorbidity clusters were analysed with Spearman-Rank-Correlation. Results Patients (59.3% female) used in mean 7.7 drugs; in total 24,535 drugs (23.7% OTC) were detected. Five drug patterns for men (drugs for obstructive pulmonary diseases (D-OPD), drugs for coronary heart diseases and hypertension (D-CHD), drugs for osteoporosis (D-Osteo), drugs for heart failure and drugs for pain) and four drug patterns for women (D-Osteo, D-CHD, D-OPD and drugs for diuretics and gout) were detected. Significant associations between multimorbidity clusters and drug patterns were detectable (D-CHD and CMD: male: ρ = 0.376, CI 0.322–0.430; female: ρ = 0.301, CI 0.624–0.340). Conclusion The drug patterns demonstrate non-random relations in drug use in multimorbid elderly patients and systematic associations between drug patterns and multimorbidity clusters were found in primary care.

Background: Self-medication, a worldwide practice, has both benefits and risks. Many countries have regulated non-pre- scription medications available for use in self-medication. However, in countries such as Rwanda, where prescriptions are not required to purchase medications, prescription, non-prescription and traditional medications have been used for self-medi- cation. Objectives: To determine the reported self-medication use in Rwanda and to determine attitudes and reasons associated with parental decisions to self-medicate their children. Methods: A cross-sectional multi-center questionnaire based quantitative study of 154 parents/caregivers of children under ten years undertaken in private and public health facilities. Results: The use of self-medication was reported to be 77.9%. Among these parents/caregivers, 50.8% used modern self-medication only, 15.8% used traditional self-medication only and 33.3% used both types of self-medication. Paraceta- mol was the most commonly used drug in modern self-medication; the traditional drugs used were Rwandan local herbs. Parents/caregivers who used modern medicines had slightly more confidence in self-medication than self-medication users of traditional medicines (p=0.005). Parents/caregivers who used modern self-medication reported barriers to consultation as a reason to self-medicate more frequently than those who used traditional drugs. Having more than one child below 10 years of-age was the only socio-demographic factor associated with having used self-medication (AOR=4.74, CI: 1.94- 11.58, p=0.001). Being above 30 years (AOR= 5.78, CI: 1.25-26.68, p=0.025) and living in Kigali (AOR=8.2, CI: 1.58-43.12, p=.0.012) were factors associated with preference of modern self- medication compared to traditional self-medication. Conclusion: Self-medication is common in Rwanda. Parents/caregivers are involved in this practice regardless of their socio-demographic background. Keywords: Self-medication; medicines; parents; caregivers; children; Nonprescription Drugs; Rwanda.

Study Objective This study describes menstrual dysfunction and treatment among adolescent and young adult (AYA) females with congenital heart disease (CHD). Design Data collected from a 1-time survey completed by AYA females (and mothers if AYA unable). Setting Participants were recruited from pediatric cardiology clinics. Participants Female AYA with CHD, aged 14-21 years (N = 114). Interventions None. Main Outcome Measures The questionnaire assessed sexual and reproductive health (SRH) concerns, behaviors, and management. Outcome measures were self-reported menstrual complaints, use of over-the-counter (OTC) pain relief medications for dysmenorrhea, reported visits with a clinician for a menstrual problem, and reported use of hormones for menstrual problems or birth control. Results Mean age was 17.0 years (SD = 2.2). The majority of participants (83%) reported 1 or more menstrual complaints (67.5% cramping, 42.1% irregular menses, 46.5% heavy periods), and 88% reported any history of taking OTC medications for pain relief. Increased menstrual complaints were not associated with level of cardiac complexity, reported transplantation, or reported use of hormonal contraception. However, 32% of participants reported use of hormonal contraception for menstrual dysfunction. Combined oral contraceptive pills (COCs) were the most common; 2 of these women carried contraindications to estrogen. Conclusions A large majority of AYA females with CHD reported menstrual dysfunction. Use of OTC medication for menstrual pain and inappropriate use of estrogen creates concerns that menstrual disorders may be unaddressed or addressed inappropriately. Thus, gynecological needs of adolescents with CHD may need to be specifically targeted by providers who feel comfortable with this population and their complex needs.

Srinivas R Nalamachu,1 Rebecca L Robinson,2 Lars Viktrup,3 Joseph C Cappelleri,4 Andrew G Bushmakin,4 Leslie Tive,5 Jennifer Mellor,6 Niall Hatchell,6 James Jackson6 1Mid America PolyClinic, Overland Park, KS, USA; 2Patient Outcomes and Real-World Evidence, Eli Lilly and Company, Indianapolis, IN, USA; 3Lilly Bio-Medicines Core Team, Eli Lilly and Company, Indianapolis, IN, USA; 4Statistics, Pfizer Inc, Groton, CT, USA; 5Medical Affairs, Pfizer Inc, New York, NY, USA; 6Real World Research, Adelphi Real World, Bollington, Cheshire, UKCorrespondence: Rebecca L RobinsonEli Lilly and Company, Lilly Research Labs, Lilly Corporate Center, Indianapolis, IN 46285, USATel +1 317-224-5833Fax +1 317-277-0490Email rlrobinson@lilly.comPurpose: The purpose of this study was to assess how patient-reported pain is related to osteoarthritis (OA) treatment patterns in routine clinical practice.Patients and Methods: Data were collected between February and May 2017 from 153 United States (US) primary care physicians, rheumatologists, and orthopedic surgeons. Each invited up to nine consecutive patients to rate their OA pain in the last week. Physicians provided demographic, clinical, and treatment information for patients, including nonpharmacologic therapies ever recommended, currently recommended over-the-counter (OTC) medications, and currently and ever prescribed medications for the management of OA. Findings for patients with mild (0─3), moderate (4─6), and severe current pain (7─10) were compared using appropriate statistics.Results: Among the 841 patients (61% female; mean 65 years; 57% knee OA), 45% reported mild, 36% moderate, and 19% severe current OA pain. Current treatment modalities differed by pain severity (P< 0.05). Most patients (70%) had been recommended nonpharmacologic therapy and 40% were currently recommended OTC medications. More patients with moderate (81%) or severe pain (78%) currently received prescription medications, with or without nonpharmacologic therapy, versus those with mild pain (67%). Overall, 47% of patients currently received just one prescription drug, while 49% had received one prescription drug ever. Nonsteroidal anti-inflammatory drugs (NSAIDs) were the most common current (58%) and ever received (88%) prescriptions. Current NSAID prescriptions were not associated with pain severity. Acetaminophen recommendations, opioid prescriptions (current and ever), and multiple prescription medications tried were numerically highest in the severe pain group (all P< 0.05 by pain severity). In all groups, > 80% of treatment switches were due to lack of efficacy.Conclusion: Real-life treatment patterns for OA in the US are significantly associated with current patient-reported pain. Combining nonpharmacologic and pharmacologic treatments is common but higher pain ratings are associated with multiple failed prescription treatments. Current use of acetaminophen and opioids, but not NSAIDs, increases alongside pain severity.Keywords: nonprescription drugs, prescription drugs, therapeutics, pain management, practice patterns, physicians

Background The quality of life of chronically ill individuals, such as hay fever sufferers, is significantly dependent on their health behavior. This survey aimed to explain the health-related behavior of allergic individuals using the protection motivation theory (PMT) and the transtheoretical model (TTM). Methods The influencing variables stated by PMT were operationalized based on data from semistructured pilot interviews and a pretest with 12 individuals from the target population. The final questionnaire inquired perceived seriousness and severity of hay fever, response efficacy, response costs, self-efficacy, and the use of various hay fever management measures in relation to the TTM stages. Multivariate logistic regression was performed to investigate the relationships between the PMT constructs and the examined health behavior. Results A total of 569 allergic individuals completed the online questionnaire. Only 33.26% of allergic individuals were in the maintenance stage for treatment under medical supervision, and almost 60% preferred hay fever self-management. A total of 67.56% had a well-established habit of taking anti-allergic medication, but only 25.31% had undergone specific immunotherapy. The likelihood of seeking medical supervision was positively influenced by perceived severity (OR = 1.35, 95% CI: 1.02–1.81), perceived seriousness (OR = 2.12, 95% CI: 1.56–2.89), and self-efficacy (OR = 4.52, 95% CI: 3.11–6.65). The perceived severity of symptoms predicted the practice of hay fever self-management (OR = 1.60, 95% CI: 1.21–2.11), as well as anti-allergic medication intake (OR = 1.65, 95% CI: 1.16–2.35). The latter measure was also positively influenced by self-efficacy (OR = 1.52, 95% CI: 1.01–2.28) and hay fever self-management (OR = 4.76, 95% CI: 2.67–7.49). Undergoing specific immunotherapy was significantly predicted only by medical supervision (OR = 9.80, 95% CI: 8.16–13.80). Allergen avoidance was a strategy used by allergic individuals who preferred hay fever self-management (OR = 2.56, 95% CI: 1.87–3.52) and experienced notable symptom severity (OR = 2.12, 95% CI: 1.60–2.81). Conclusion Educational interventions that increase the awareness of health risks associated with inadequate hay fever management and measures to increase self-efficacy might be beneficial for the promotion of appropriate hay fever management among allergic individuals.

Introduction Recent austerity experiences in Greece suggest a plausible link between extensive use of over-the-counter (OTC) medicines and socio-economic peculiarities of life. Commentary During the economic crisis in Greece, accessibility to healthcare services has been impacted, particularly for people with low income. However, this fact has not been systematically analyzed in conjunction with an observed increase in use of OTC medicines. Gaining a better understanding of the reasons leading to self-care may help to answer additional questions. Further research is needed to assess the gap between self-care and medically assisted care/treatment by designing pilot monitoring actions and focusing on behaviours related to OTC medicine use. Primary care can offer more collaboration between primary care physicians, community pharmacists, patients, and their families. Implications It is crucial to create a multimodal research plan to gain a better understanding of motivational reasons that eventually lead to increasing use of OTC medicines. Efforts should be made to develop data collection techniques that will elicit information from various social groups that focus on changeable behaviours and perceived needs in relation to medicine consumption., Highlights • Self-care empowerment may be beyond citizens' free choice; • OTC medicine use shows traits of increasing; • Perceived needs and OTC medicine use remain unexplored; • Manuscript Header = Commentary

OBJECTIVE: This study assesses the rate of providerrecommended aspirin use through the National Ambulatory Medical Care Survey (NAMCS) database versus self-reported aspirin use through the Behavioral Risk Factor Surveillance System (BRFSS) database and identifies factors that predict initiation of aspirin. This study provides insight into the rate of providerrecommended aspirin use versus self-reported aspirin use prior to the 2016 United States Preventive Service Task Force primary prevention recommendation update. DESIGN: Retrospective, cross-sectional analysis of US population data obtained from medical records (NAMCS) and community-dwelling residents in four states (BRFSS) in 2015. SETTING: Physician offices (NAMCS) and households or telephone (BRFSS). PATIENTS, PARTICIPANTS: NAMCS: visits made by patients 40 years of age or older to physicians who permitted federal employees to abstract officevisit data. BRFSS: household or telephone interview respondents 40 years of age or older. INTERVENTIONS: Comparisons of persons with (secondary prevention) versus without (primary prevention) cardiovascular disease. MAIN OUTCOME MEASURED: Recommended (NAMCS) or self-reported (BRFSS) use of aspirin. RESULTS: The sample included 19 170 patients (NAMCS), with 2 205 having a history of cardiovascular disease and 14 872 respondents (BRFSS) with 2 024 having a history of cardiovascular disease. For both primary and secondary prevention, respondents from BRFSS reported higher rates of aspirin use (27.7% primary, 65.6% secondary prevention) compared with prescribed rates from NAMCS (11.7% primary, 45.6% secondary prevention). CONCLUSIONS: Study results highlight the value of obtaining a complete medication history, including aspirin use, from all patients.

Hemorrhoids are a common anorectal disease. Epidemiological studies on medication trends and risk factors using information from real-world databases are rare. Our objective was to analyze the relationship between hemorrhoid treatment prescription trends and several risk factors using the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) Open Data Japan and related medical information datasets. We calculated the standardized prescription ratio (SPR) based on the 2nd NDB Open Data Japan from 2015. The correlation coefficients between the SPR of antihemorrhoidals and those of "antispasmodics," "antiarrhythmic agents," "antidiarrheals, intestinal regulators," "purgatives and clysters," "hypnotics and sedatives, antianxietics," "psychotropic agents," and "opium alkaloids preparations" were 0.7474, 0.7366, 0.7184, 0.6501, 0.6320, 0.4571, and 0.4542, respectively. The correlation coefficient between the SPR of antihemorrhoidals and those of "average annual temperature," "percentage of people who were smokers," and "percentage of people who drank regularly" were -0.7204, 0.6002, and 0.3537, respectively. The results of cluster analysis revealed that Hokkaido and Tohoku regions tended to have low average annual temperature values and high percentage of people who were smokers and had comparatively high SPRs of "antispasmodics," "antiarrhythmic agents," "antidiarrheals, intestinal regulators," "purgatives and clysters," "hypnotics and sedatives, antianxietics," "psychotropic agents," and "opium alkaloids preparations." Antihemorrhoidals are frequently used in Hokkaido and Tohoku, Japan; thus, it is important for these prefectural governments to focus on these factors when taking measures regarding health promotion.

Numerous pharmaceutical options are available over-the-counter (OTC) for the relief of sinonasal symptoms. Patients typically utilize these drugs in an unsupervised manner, without appreciation of their relative efficacy or potential for adverse effects. This review covers the scope and regulation of the OTC drug market, the pros and cons of OTC availability, and specific concerns that surround the most common classes of OTC sinonasal drugs. Suggestions are provided for the improvement of patient care and public health.MEDLINE publications and market reports.Literature review.Some of the most commonly used OTC sinonasal remedies, including decongestants and first-generation antihistamines, are less effective than alternative drugs and pose potential safety concerns.Clinicians should advocate to their patients for the appropriate use of alternative agents, such as intranasal corticosteroids and newer-generation antihistamines, and discourage the unsupervised use of oral and topical decongestants. Furthermore, health care practitioners should encourage dialogue with their patients about the use of OTC sinonasal remedies, with the goals of optimizing individual health and health care delivery.

There exist limited strategies to address the issue of topical medication without prescription (MWP) use.A survey with pre-coded questionnaires was conducted with 210 patients following up in the dermatology clinic of a tertiary care center. The knowledge and attitude scores were regressed against demographics and exploratory practice questions, and latent class analysis was carried out to check any particular set of characteristics associated with study subpopulations.Forty-seven (22%) participants were found using topical antimicrobial containing MWP. Participants with good knowledge score had 3.41 (95% C.I. = 1.68-7.33), 2.99 (1.37-6.73), and 2.49 (1.26-5.15) times association with opting of distance as the prime reason for availing topical MWP, habit of always reading the accompanying drug leaflet, and understanding that OTC topical medication may change the effect of the already prescribed drugs. Participants with good attitude score showed 2.76 (1.50-5.13) times association with limiting the use of steroid containing topical MWP. Latent class analysis identified one subset of participants having lesser knowledge and attitude scores and quoted financial reasons for the procurement of MWP; however, it was found to have greater income as compared to remaining participants.The strategy to identify the target patient audience so as to deliver patient education intervention programs, regarding safe and effective use of MWP was built.

Jin-tang-ning (JTN), a Chinese patent medicine, mainly comprised of Bombyx moriL., has been proved to show α-glucosidase inhibitory efficacy and clinically effective for the treatment of type 2 diabetes (T2DM). Recently, we have reported that JTN could ameliorate postprandial hyperglycemia and improved β cell function in monosodium glutamate (MSG)-induced obese mice, suggesting that JTN might play a potential role in preventing the conversion of impaired glucose tolerance (IGT) to T2DM. In this study, we evaluated the effect of JTN on the progression of T2DM in the pre-diabetic KKAy mice. During the 10 weeks of treatment, blood biochemical analysis and oral glucose tolerance tests were performed to evaluate glucose and lipid profiles. The β cell function was quantified using hyperglycemic clamp at the end of the study. JTN-treated groups exhibited slowly raised fasting and postprandial blood glucose levels, and also ameliorated lipid profile. JTN improved glucose intolerance after 8 weeks of treatment. Meanwhile, JTN restored glucose-stimulated first-phase of insulin secretion and induced higher maximum insulin levels in the hyperglycemic clamp. Thus, to investigate the underlying mechanisms of JTN in protecting β cell function, the morphologic changes of the pancreatic islets were observed by optical microscope and immunofluorescence of hormones (insulin and glucagon). Pancreatic protein expression levels of key factors involving in insulin secretion-related pathway and ER stress were also detected by Western blot. Pre-diabetic KKAy mice exhibited a compensatory augment in β cell mass and abnormal α cell distribution. Long-term treatment of JTN recovered islet morphology accompanied by reducing α cell area in KKAy mice. JTN upregulated expression levels of glucokinase (GCK), pyruvate carboxylase (PCB) and pancreas duodenum homeobox-1 (PDX-1), while down-regulating C/EBP homologous protein (Chop) expression in pancreas of the hyperglycemic clamp, which indicated the improvement of mitochondrial metabolism and relief of endoplasmic reticulum (ER) stress of β cells after JTN treatment. These results will provide a new insight into exploring a novel strategy of JTN for protecting β cell function and preventing the onset of pre-diabetes to T2DM.