Identifying over-the-counter information to prioritize for the purpose of reducing adverse drug reactions in older adults: A national survey of pharmacists.

BACKGROUND: Over-the-counter (OTC) medication use is associated with risks of adverse drug reactions (ADRs), particularly among older adults. The Drug Facts Label (DFL) is supposed to provide consumers with information that would avoid ADRs, yet research suggests that consumers frequently fail to interact with this critical information. We postulate that emphasizing critical information by placing it on the front of the package may increase its usage. Before doing so, the most critical information from the DFL needs to be identified. OBJECTIVES: This study aimed to determine which information from the DFL is most critical in reducing ADRs at the time of purchase or use by older adults. METHODS: A national survey of practicing pharmacists knowledgeable about OTC medication use by older adults asked participants to rank order the importance of the DFL sections to reduce ADRs in older adults. Open-ended questions focused on identifying ways of improving OTC medication labeling. Quantitative rankings were used to calculate the content validity ratio and analyzed using Wilcoxon signed rank tests. Qualitative results were categorized into themes. RESULTS: A total of 318 responses (12% response rate) were analyzed. There was high consensus that uses and purpose, active ingredient, warnings, and directions for use were the most important sections of the DFL. Within the warning section, 2 specific warnings, "Do not use" and "Ask a doctor or pharmacist," were deemed most important. Similarly, qualitative themes focused on seeking health care provider assistance or were specific to age-related precautions. CONCLUSIONS: Prioritizing warnings that highlight the importance of possible drug-drug and drug-disease precautions and the need to seek medical advice before taking OTC medications were deemed most critical. Moving this type of information to the front of the package may help reduce ADRs among older adults.

[Promoting responsible self-medication in the context of Parkinson's disease: Development of a practical guide for drug-drug interactions and assessment by patients and community pharmacy professionals]. / Sensibilisation à l'automédication responsable au cours de la maladie de Parkinson : réalisation de fiche sur les interactions médicamenteuses et évaluation par les patients et les professionnels de l'officine.

CONTEXT: Parkinson disease is a neurodegenerative disorder characterized by motor and non-motor symptoms. Symptomatic treatment is based on dopaminergic medications. In case of self-medication practices, there may be drug-drug interactions between over-the-counter medication and dopaminergic medications. Thus, the aim of our work was to develop a practical guide summarizing drug-drug interactions and assess it by patients and community pharmacy professionals. METHODS: We performed a systematic analysis of drug-drug interactions between OTC medications available in France and antiparkinsonians (ATC Class N04) using Theriaque® and Drugs® databases, and summarized the results in a practical guide. We assessed patients' satisfaction by a questionnaire administered to hospitalized patients in a French expert center for Parkinson's disease. We estimated the impact of the guide on community pharmacy professionals through a survey online, by satisfaction, knowledge acquisition and estimated awareness in professional context. RESULTS: We identified 16 OTC medication, related to seven symptoms, interacting with antiparkinsonians. We obtained 67 responses from patients, expressing high satisfaction. We obtained 101 responses from professionals, reporting high satisfaction, knowledge acquisition and increased awareness in professional context. CONCLUSION: Our results highlight the relevance of the guide and suggest that we may increase its dissemination to patients and community pharmacies.

Recommendations for Using Over-The-Counter Products as Adjunctive Acne Care in Asian Phototypes: Improving Treatment Outcomes and Managing Side Effects.

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.

Melatonin Use in Psychiatry-Quo Vadis?

Melatonin use in clinical psychiatry is currently rife, and the trend of utilization is on the rise. Efficacy coupled with safety and lack of abuse potential render melatonin an attractive therapeutic option. Data from neuroscience accrue speaking to the idea of a pluripotent molecule beyond a mere sleeping aid. Here, authors would shed some light on melatonin use in psychiatry while examining the extant evidence.

Choosing the Right Partner: Complementing Prescription Acne Medication With Over-the-Counter Cleansers and Moisturizers.

BACKGROUND: Acne is the most common dermatological disorder. An impaired barrier function in acne vulgaris has been reported, as well as decreased amounts of epidermal ceramides. Also, many of the systemic and topical medications prescribed for the treatment of acne exacerbate these skin barrier disruptions and can lead to irritation and dry skin conditions. AIM: The review explored the importance of maximizing adjunctive skincare, such as over-the-counter products for managing acne and avoiding adverse effects. METHODS: A literature review was conducted and included clinical acne guidelines, clinical studies, and review articles on acne prevention, treatment, and maintenance. Searches were made in PubMed and Google Scholar for English-language literature published between Jan 1, 2010, and Apr 1, 2020. Two clinicians manually reviewed selected publications. RESULTS: Seventy-four articles were included in the analyses. A variety of specialized cleansers and moisturizers are available as suitable adjunctive therapies for acne-prone skin. Lipid-free cleansers were found to be the most appropriate type of cleanser for acne-prone skin as they were associated with a low risk of skin irritation, and a near-physiological stratum corneum pH. Moisturizers typically included ingredients such as humectants, emollients, oil absorbers, and those with anti-inflammatory and/or barrier replenishing properties. Given the various adjunctive products available, decision frameworks were created for clinicians to use when selecting over-the-counter cleansers and moisturizers for acne-prone patients. CONCLUSION: Informing clinicians about skin barrier dysfunction in acne and the benefits of adjunctive skincare may help them to choose the right product(s) to complement prescription therapy. J Drugs Dermatol. 2020;19(11): doi:10.36849/JDD.2020.5536.

Introduction to Medication Effects on Male Reproduction.

The over-arching goal of this volume is to help infertility practitioners evaluate and manage their patients with poor semen quality. Medications can negatively impact on male reproduction and these effects are of increasing concern. People world-wide are using more medications than in the past, including men of childbearing age. In addition, men are fathering children later in life than previously, which is associated with greater medication use in the reproductive population. Finally, people are experiencing more chronic disease at earlier ages, particularly in developed countries. Taken together, these factors have increased the number of prescribed and over-the-counter (OTC) drugs being taken by men attempting fatherhood. There is some evidence in the literature that medications, even some common OTC medications, can negatively impact male reproduction, and yet, medication use is inadequately addressed in the evaluation of male infertility and fertility plans are rarely considered by providers before prescribing medications. In this volume, we systematically consider medications being used world-wide, focusing on those that might cause poor semen quality in men with otherwise idiopathic infertility. Extensive tables are provided in this volume that summarize the research for each specific medication, and it is our hope that these tables will be useful in day-to-day counseling of infertility patients and of men desiring fertility. Although some specialist practitioners are aware that there are pharmacological negative effects on male fertility, most practitioners are not, and the published evidence is surprisingly sparse. We hope that this volume will encourage our readers to conduct robust, well-designed studies to inform clinical practice.

[Medicaments and oral healthcare 5. Adverse effects of -medications and over-the-counter drugs on teeth]. / Serie: Medicamenten en mondzorg 5. Bijwerkingen van medicamenten en zelfzorg­middelen op gebitselementen.

Intrinsic tooth discoloration may occur as an adverse effect of fluoride and tetracyclines. Extrinsic tooth discoloration may occur as superficial staining or as discoloration of the superficial pellicle and/or biofilm due to chlorhexidine, liquid iron salts, essential oils, some antibiotics and stannous fluoride. Inhibition of orthodontic tooth movement has been reported due to the use of prostaglandin synthetase inhibitors. If medications or over-the-counter drugs induce hyposalivation or contain much sucrose, caries may develop. Erosion may occur if the acidity of medications or over-the-counter drugs is excessive. Attrition is a well-known adverse effect of serotonin reuptake inhibitors, antiparkinson agents, and antipsychotics. Congenital dysplasia is observed following childhood treatment with cytostatic drugs. External cervical root resorption is an adverse effect of internal teeth-whitening products. Prenatal exposure to antiepileptic drugs and childhood treatment with cytostatic drugs may cause dental agenesis. Antiseptic drugs applied for external teeth-whitening and toothpastes with additional ingredients to prevent extrinsic discoloration and creation of calculus, may cause tooth hypersensitivity.

Clinical management of medications in pregnancy and lactation.

Prescription and over-the-counter medication use during pregnancy and lactation is exceedingly common. There are many available resources to gather information and guide patient counseling. These include primary literature, online resources, professional society recommendations, and drug labels. One must consider both disease and drug characteristics when making decisions on medication use during pregnancy and lactation. Providers can then use this information to balance the risks of fetal or neonatal exposure against the potential benefits of maternal treatment and the risks of untreated disease.

Best Practices and Innovations for Managing Codeine Misuse and Dependence.

PURPOSE: Promoting and ensuring safe use of codeine containing medicines remains a public health issue given the rise in reporting of misuse and dependence particularly in countries where available over-the-counter (OTC). The aim of this unique study was to identify best practices in management of opioid abuse and dependence, particularly codeine, and innovations to meet challenges surrounding safe and compliant use, patient awareness-raising, reducing health harms and enhancing successful treatment of dependence. METHODS: A mixed methods approach using three data points was used that included : (1) analysis of data from existing scoping reviews to identify potential areas for innovation (2) interviews with key national stakeholders from public health, pharmaceutical, regulatory, primary care and addiction practice in three distinct regulatory regimes (Ireland, United Kingdom and South Africa); and (3) a circular email request for information on potential innovations to members of the European Medicine's Agency European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP). Data from these three sources were analysed to identify best practices and opportunities for innovation. RESULTS: Best practices and potential innovations were identified under the nine headings: (1) manufacture; (2) product information and public education; (3) responsible prescribing; (4) monitoring and surveillance; (5) dispensing, screening and brief interventions in community pharmacies; (6) safety in the workplace and on the road; (7) internet supply of codeine and online support; (8) treatment of codeine dependence; and (9) learning resources and training for health professionals. CONCLUSIONS: Challenges ensuring availability of codeine containing medicines for legitimate therapeutic use, while minimising misuse, dependence and related health harms warrant consideration of new innovations. Most promising innovative potential lies across the products' retail lifecycle from manufacture to prescriber and community pharmacy practitioner.This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

Factors influencing pharmacists' roles in preventing prescription and over-the-counter opioid misuse: a systematic review and narrative synthesis.

BACKGROUND: The prescribing rate of opioids is increasing and is a main contributor to opioid misuse. Community pharmacists can help reduce opioid misuse rates by carrying out prescription and over-the-counter (OTC) opioid misuse prevention services. Understanding the barriers and facilitators to community pharmacists' involvement has the potential to improve these services. OBJECTIVE: To review the literature on the barriers and facilitators of community pharmacists' involvement in prescription and OTC opioid misuse prevention. METHODS: A systematic review of primary research was carried out in MEDLINE, Embase, Scopus, Web of Science, CINAHL, and APA PsycINFO from January 2022 to March 2022. Narrative synthesis underpinned by the COM-B model was used to analyse findings from the included articles. Studies were included if they used qualitative or mixed methods; published in English and focussed on OTC or prescription opioids. RESULTS: Ten studies were included in the review. Barriers and facilitators were grouped into individual, environmental, and system-level factors. Based on the COM-B model, these factors were classified as capabilities (knowledge and skill), opportunities (e.g. relationship with prescribers, time), and motivation (pharmacists' attitude). CONCLUSION: Improving pharmacists' capabilities and opportunities might improve pharmacists' motivation to offer opioid misuse services. This could improve pharmacists' behaviour, that is, their role in preventing prescription and OTC opioid misuse. The findings of this review were based on information obtained from primary evidence from qualitative studies; However. further empirical work is needed to identify how pharmacists can be supported.

Implications of over-the-counter proton pump inhibitors for patient counseling by pharmacists.

The article reviews the literature on the role of the pharmacist in patient counseling and discusses how that role may apply to patients with frequent heartburn who are seeking an over-the-counter (OTC) treatment. Searches of the National Library of Medicine PubMed database were conducted using the terms "heartburn," "nonprescription," "therapy," "pharmacist," and "counseling," supplemented by additional searches on counseling for prescription products, and by the author's knowledge of pharmacy practice and the scientific literature. Accurate recognition of the signs of heartburn are an important first step in counseling a patient on the appropriate OTC medication; immediate referral to a health care provider is mandatory if cardiac pain or certain gastrointestinal symptoms are present. When counseling a patient about treatments for heartburn, the pharmacist should practice effective listening in an environment that is conducive to communication by the patient. Proton pump inhibitors are effective for the treatment of heartburn; the histamine2 receptor antagonists and antacids should also be considered for appropriate patients. Adverse events have been noted with proton pump inhibitors; however, overall the benefits significantly outweigh the risks and problems are unlikely to arise during the 2-week duration of OTC treatment of heartburn. Pharmacists can provide valuable services to patients with frequent heartburn, particularly with regard to counseling about the condition and appropriate OTC therapy. The availability of numerous OTC products, including antacids, histamine2 receptor antagonists, and proton pump inhibitors, enables pharmacists to fulfill an important clinical role and improve patient satisfaction.

Elevating Safe Use of Over-The-Counter Medications in Older Adults: A Narrative Review of Pharmacy Involved Interventions and Recommendations for Improvement.

Over-the-counter (OTC) medications are products that have been made easily accessible to allow patients to treat common ailments without a prescription and the cost of a doctor's visit. These medications are generally considered safe; however, there is still a potential for these medications to lead to adverse health outcomes. Older adults (ages 50+) are especially susceptible to these adverse health outcomes, due to age-related physiological changes, a higher prevalence of comorbidities, and prescription medication use. Many OTC medications are sold in pharmacies, which provides pharmacists and technicians with the opportunity to help guide safe selection and use for these medications. Therefore, community pharmacies are the ideal setting for OTC medication safety interventions. This narrative review summarizes the findings of pharmacy-involved interventions that promote safe OTC medication use for older adults.

Use of analgesics in Denmark: A national survey.

People suffering from pain constitute a sizeable and heterogeneous patient group. Conventional oral analgesics are considered a cheap and safe first-line treatment. These drugs are used on both a regular and 'as needed' basis and are often obtained over-the-counter (OTC). We explored patient-reported patterns of use and adverse effects of analgesics in a community pharmacy questionnaire. Eight pharmacies invited persons aged ≥18 years requesting analgesics via prescription or OTC to complete an electronic questionnaire. A total of 2410 participants completed the questionnaire (68% female; 50% ≥ 60 years). Most participants filled a prescription for paracetamol (61%; n = 842) and non-steroidal analgesics (n = 363; 26%). Among OTC users, most obtained paracetamol (61%). Among prescription users, 73% (n = 1114) had their analgesic prescribed for daily use; however, of these only 61% (n = 630) reported using it daily, while 35% (n = 363) reported 'as needed' use. Of all prescriptions, 80% (n = 898) were labelled with the standardized indication 'against pain'. Self-reported indications showed that back pain and muscle/joint pain were the most common indications. Among non-new users of OTC analgesics (n = 841), 17% (n = 141) used their medication daily. Finally, 90% (n = 1658) of all participants reported not experiencing adverse effects. Our findings suggest a need for continuous assessment of analgesic patterns of use after treatment initiation to inform counselling in community pharmacies and elsewhere.

Over the Counter Pain Medications Used by Adults: A Need for Pharmacist Intervention.

BACKGROUND: The safety of pharmacotherapy for geriatric patients is an essential aspect of the demographic perspective in view of the increasing size of this population. Non-opioid analgesics (NOAs) are among the most popular and often overused over-the-counter medications (OTC). The reasons for drug abuse are common in the geriatric population: musculoskeletal disorders, colds, inflammation and pain of various origins. The popularity of self-medication and the ability to easily access OTC drugs outside the pharmacy creates the danger of their misuse and the incidence of adverse drug reactions (ADRs). The survey included 142 respondents aged 50-90 years. The relationship between the prevalence of ADRs and the NOAs used, age, presence of chronic diseases, and place of purchasing and obtaining information about the mentioned drugs were evaluated. The results of the observations were statistically analyzed using Statistica 13.3. The most commonly used NOAs among the elderly included paracetamol, acetylsalicylic acid (ASA) and ibuprofen. Patients consumed the medications for intractable headaches, toothaches, fevers, colds and joint disorders. Respondents indicated the pharmacy as the main location for purchasing medications, and the physician as the source of information for selecting the therapy. ADRs were reported most frequently to the physician, and less frequently to the pharmacist and nurse. More than one-third of respondents indicated that the physician during the consultation did not take a medical history and did not ask about concomitant diseases. It is necessary to extend pharmaceutical care to geriatric patients that includes advice on adverse drug reactions, especially drug interactions. Due to the popularity of self-medication, and the availability of NOAs, long-term measures should be taken to increase the role of pharmacists in providing effective, safe health care to seniors. We are targeting pharmacists with this survey to draw attention to the problem of the prevalence of selling NOAs to geriatric patients. Pharmacists should educate seniors about the possibility of ADRs and approach patients with polypragmasy and polypharmacy with caution. Pharmaceutical care is an essential aspect in the treatment of geriatric patients, which can contribute to better results in their existing treatment and increase the safety of medication intake. Therefore, it is important to improve the development of pharmaceutical care in Poland in order to enhance patient outcomes.

Hemoptysis under diclofenac and antiplatelet doses of aspirin.

A previously healthy 60-year-old man receiving aspirin for primary prevention of cardiovascular disease presented with hemoptysis after 1 week of treatment for his back pain with diclofenac. He had not suffered from any bleeding episode in the past and his family history was negative for hemorrhagic disorders. He had been a heavy smoker until his thirties, but had stopped smoking since then. After extensive workup, other pulmonary and nonpulmonary causes of hemoptysis were ruled out. Thus, in this case, because of the temporal relationship between exposure to the drug and the onset of symptoms, diclofenac was considered as the most probable cause of hemoptysis either alone or as a result of its pharmacodynamic interaction with aspirin. The adverse reaction was considered probable according to the Naranjo scale. Diclofenac treatment was discontinued and occasional use of acetaminophen for the back pain was recommended. Regular use of antiplatelet doses of aspirin was also discontinued.

Cryosurgical treatment of warts: dimethyl ether and propane versus liquid nitrogen - case report and review of the literature.

For years, dermatologists have relied on cryotherapy with liquid nitrogen as a safe and effective treatment for warts. More recently, several over-the-counter (OTC) wart-freezing therapies have become available. Manufacturers have substituted liquid nitrogen with dimethyl ether and propane (DMEP), and marketed these new preparations to be safe and effective alternatives to in-office cryotherapy with liquid nitrogen. However, data from in vitro studies and comparative studies in humans refute manufacturers' claims that these products reproduce in-office cryotherapy.

Dimenhydrinate use for children with vomiting.

QUESTION: Dimenhydrinate is an over-the-counter drug that is commonly used for the treatment of nausea and vomiting. Many of my adult patients use it, but is it safe and useful in the pediatric population? ANSWER: Dimenhydrinate appears to be safe for use in the pediatric population. While little literature has been published about adverse effects of this medication, family physicians need to identify the cause of the vomiting before considering if the drug will be effective and need to ensure that patients safely use the medication and avoid potential interaction of the drug with other products.

Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin.

BACKGROUND: Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) are common in men, considerably affecting quality of life. AIMS: The self-directed use of over-the-counter (OTC) tamsulosin (0.4 mg) and potential safety risks were evaluated in an open-label, uncontrolled, exploratory, 8-week OTC-simulated study. METHODS: Men (≥ 18 years) were recruited via mass advertising about bothersome LUTS. In a working retail environment, respondents reviewed the product and decided whether it was appropriate for them to use (self-selection phase). After purchasing the product, participants' ability to use it as directed by the proposed drug facts label (DFL) was assessed (home-use phase). RESULTS: Of 1446 eligible men, 679 completed the self-selection phase, and 73.9% (502/679) self-selected to use tamsulosin correctly according to the DFL. Of 369 participants who purchased tamsulosin and entered the home-use phase, 321 took one or more doses of tamsulosin and participated in at least one telephone interview. In total, 85.4% (274/321) of participants adhered to the 'Stop Use' and 'Directions' instructions in the DFL. Overall, 139 (39.6%) participants experienced one or more adverse events (AEs); 65 (18.5%) were deemed drug-related, including dizziness (11 [3.1%]), ejaculation disorder (6 [1.7%]), and semen volume decrease (6 [1.7%]). No unexpected AEs were reported. CONCLUSIONS: Of the men interested in self-managing their LUTS, a majority had moderate-to-severe LUTS of long duration. Most men were able to appropriately self-select and use tamsulosin in concordance with DFL instructions and directions. No unexpected AEs were reported during self-directed use. With further label refinement, an over-the-counter tamsulosin option might be feasible. TRIAL REGISTRATION: ClinicalTrials.gov NCT01726270.

Revised product labels for pediatric over-the-counter cough and cold medicines.

October 7, 2008, the Consumer Healthcare Products Association announced that the leading manufacturers of pediatric over-the-counter cough and cold medicines would voluntarily modify the labels on these products to state that they should not be used in children aged <4 years.