Regulatory and Informational Gaps in the Over-the-Counter Eye Care Product Industry-Over the Counter, Under the Radar.

This Viewpoint describes the limitations of regulatory oversight for over-the-counter eye care products and challenges in providing clinical recommendations.

Study on Chinese patent medicine based on major component analysis and quality control evaluation: A case study of Jizhi Syrup.

Jizhi Syrup (JZS) is a popular Chinese patent medicine (CPM) for the treatment of respiratory diseases in clinical practice, especially acute or chronic bronchitis. JZS is a complex formula composed of 8 kinds of herbs and lack of comprehensive researches on chemical components. To further define its components, ultra-performance liquid chromatography-quadrupole-time of flight-mass spectrometry (UPLC-Q-TOF-MS) and headspace-solid phase microextraction-gas chromatography-mass spectrometry (HS-SPME-GC-MS) were utilized to identify and classify the chemical components of JZS. A total of 178 chemical compounds encompassing the 8 herbs of JZS were identified and the chemical components were comprehensively explicit. It made up for the gap that volatile components were not studied in the previous study. Based on this, a new method for the quality control of JZS based on its characteristic components was established by fingerprints, multi-component quantitative analysis and quantity transfer of JZS. A dual-wavelength high-performance liquid chromatography (HPLC) fingerprints were established at 210 nm and 260 nm. Four volatile components (linalool, bornyl acetate, 2-undecanone and α-terpineol) and eight nonvolatile components (ephedrine hydrochloride, protocatechuic acid, 5-caffeoylquinic acid, 4-hydroxybenzoic acid, naringin, neohesperidin, glycyrrhizic acid and praeruptorin A) were quantitated by HS-SPME-GC-MS and HPLC-diode array detection (DAD). Meanwhile, six exclusive nonvolatile components were studied for the quantity transfer of Herbs-Intermediate-CPM and all the transfer rates were between 55.23% and 89.20%. This study is the first comprehensive study of the major components in JZS, and its results can be useful to standardize the quality control and provide a valuable reference for other CPMs.

Attack on Sunscreens Continues.

The Food and Drug Administration (FDA) was required to issue and put into effect a final sunscreen monograph by November 26, 2019. On March 27, 2020, President Donald Trump signed into effect H.R. 748, the "Coronavirus Aid, Relief, and Economic Security Act" (CARES). This bill eliminated the November 2019 requirement. The CARES Act includes legislative reforms that modernize the way over-the-counter (OTC) monograph drugs are regulated in the United States. Under this Act, sunscreens will be considered generally recognized as safe and effective (GRASE), if they meet conditions newly defined by the FDA. In addition, the FDA is required to issue a proposal to revise the sun-screen requirements for GRASE not later than 18 months after enactment and will sunset by the end of the fiscal year 2022. The CARES Act also addresses the requirement for a new drug application (NDA).1-7.

Discovery of minor quality evaluation marker compounds for Chinese patent medicine products using a two-leveled metabolomics strategy.

Chinese patent medicines (CPMs) are popularly used in clinical practice. Though the composition is complex, the quality of CPM is usually evaluated by the contents of a few main compounds. In this study, a two-leveled metabolomics strategy was proposed to discover minor marker compounds for different CPM products. Zhenqi Fuzheng (ZQFZ) granule was studied an example, where 15 batches from 3 producers were analyzed. The samples were separated using UHPLC on an Acquity UPLC® HSS T3 column, and then detected using Q-Orbitrap-MS. In the first level, 1475 common peaks were extracted and 95 compounds were identified using diagnostic ions and a homemade database. In the second level, the data were subjected to a two-way hierarchical clustering analysis and screened by variable importance value. In total 14 marker compounds were discovered which were responsible for the grouping of different ZQFZ products. Echinacoside (22), oleoside (13), loganic acid (5), salidroside (7), ligustrosidic acid (42), 6α-hydroxygeniposide (28), and oleoside 11-methyl ester (15) could be used to reflect the quality difference for ZQFZ granule products. The proposed strategy could also contribute to the discovery of quality control markers for other CPMs.

Over the Counter Products for Acne Treatment and Maintenance in Latin America: A Review of Current Clinical Practice.

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.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.

Pharmacists' practices for non-prescribed antibiotic dispensing in Mozambique

BACKGROUND: Antibiotics are the most frequently used medicines worldwide with most of the countries defining these as prescription-only medicines. Though, dispensing non-prescribed antibiotics represent one of the chief causal factors to the irrational use of antibiotics that paves the way to the development of antimicrobial resistance. OBJECTIVE: We aimed at describing the practices and the enablers for non-prescribed antibiotic dispensing in Maputo city, Mozambique. METHODS: A qualitative study was conducted, between October 2018 and March 2019, in nine private pharmacies randomly selected across Maputo city. Eighteen pharmacists were contacted and seventeen enrolled through snowball sampling. In-depth interviews were conducted, audiotaped, and transcribed verbatim. Transcripts were coded and analysed though thematic analysis with guidelines from Braun and Clark. The Consolidated Criteria for Reporting Qualitative Studies (COREQ) checklist by (Tong, 2007) was performed. RESULTS: Out of seventeen, fifteen pharmacists admitted non-prescribed dispensing of antibiotics. Common antibiotic dispensing practices included; dispensing without prescription, without asking for a brief clinical history of patients, without clear explanation of the appropriate way of administering, without advising on the side effects. Reasons for non-prescribed antibiotic dispensing are linked to patients' behaviour of demanding for non-prescribed antibiotics, to the patients expectations and beliefs on the healing power of antibiotics, to the physicians' prescribing practices. Other reasons included the pressure for profits from the pharmacy owners, the fragile law enforcement, and absence of accountability mechanisms. CONCLUSIONS: The practices of non-prescribed antibiotic dispensing characterize the 'daily life' of the pharmacists. On the one hand, the patient's demand for antibiotics without valid prescriptions, and pharmacist's wish to assist based on their role in the pharmacy, the pressure for profits and on the understanding of the larger forces driving the practices of self-medication with antibiotics - rock. On the other hand, pharmacists are aware of the legal status of antibiotics and the public health consequences of their inappropriate dispensing practices and their professional and ethical responsibility for upholding the law - hard place. Highlighting the role of pharmacists and their skills as health promotion professionals is needed to optimizing antibiotic dispensing and better conservancy in Mozambique

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Evaluating interventions to improve test, treat, and track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS) in some rural communities of Fanteakwa North district, Ghana: study protocol for a cluster randomized controlled trial.

BACKGROUND: The World Health Organization initiated test, treat, and track (T3) malaria strategy to support malaria-endemic countries in their efforts to achieve universal coverage with diagnostic testing, antimalarial treatment, and strengthening surveillance systems. Unfortunately, T3 is not adopted by over-the-counter medicine sellers (OTCMS) where many patients with malaria-like symptoms first seek treatment. Sub-Saharan African countries are considering introducing and scaling up RDTs in these outlets to reduce malaria burden. In this context, this study is aimed at improving implementation of the T3 among OTCMS using a number of intervention tools that could be scaled-up easily at the national level. METHODS/DESIGN: The interventions will be evaluated using a two-arm, cluster randomized trial across 8 rural communities (4 clusters per arm), in two adjacent districts (Fanteakwa North and Fanteakwa South districts) of Ghana. A total of 8 OTCMS in the intervention arm and 5 OTCMS in the control arm in the selected communities will participate in the study. In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately. Supervision, technical assistance, feedbacks, and collection of data will be provided on a regular basis at the participating medicine stores. The primary outcome is the proportion of children under 10 years with fever or suspected to have malaria visiting OTCMS and tested (using mRDT) before treatment. Secondary outcomes will include adherence to national malaria treatment guidelines and recommended mRDT retail price. Outcomes will be measured using mainly a household survey supplemented by mystery client survey and a surveillance register on malaria tests conducted by the OTCMS during patient consultations. Data collected will be double entered and verified using Microsoft Access 2010 (Microsoft Inc., Redmond, Washington) and analyzed using STATA version 11.0. DISCUSSION: The trial will provide evidence on the combined effectiveness of provider and community interventions in improving adherence to the T3 initiative among OTCMS in rural Ghana. ETHICAL CLEARANCE: NMIMR-IRB CPN 086/18-19 TRIAL REGISTRATION: ISRCTN registry ISRCTN77836926 . Registered on 4 November 2019.

Reality and Legality: Disentangling What Is Actual from What Is Tolerated in Comparisons of Hemp Extracts with Pure CBD.

Manufacturers of hemp-based cannabidiol products have argued that their products should be federally regulated as dietary supplements in the U.S. The justifications offered for this suggestion often focus on a variety of assumptions that either are commonly invoked in marketing strategies of the cannabis/hemp industry or are codified in the 1994 Dietary Supplement Health Education Act. Three such assumptions are addressed herein and are characterized as: 1) the false dichotomy of herbs vs drugs, 2) the entourage fallacy, and 3) the false equivalence of incomparable evidence. An argument is presented which is intended to persuade that the legality or mere composition of phytochemical products do not speak to the reality of their pharmacological effects. It is further argued that non-prescription cannabidiol and hemp extracts should not be afforded regulatory protection by designation as dietary supplements.

Impact of guideline awareness in public pharmacies on counseling of patients with acute or chronic constipation in a survey of pharmacy personnel.

BACKGROUND: Constipation is often self-managed by patients and guidelines are available to aid healthcare professionals in the counseling of patients for self-management. Therefore, we have explored the knowledge and attitude of pharmacy personnel towards guidelines for the management of acute and functional chronic constipation and how they affects their recommendations. METHODS: An online survey was conducted among 201 pharmacists and pharmacy technicians from an existing panel. They were presented with two typical cases, a 62-year old woman with functional chronic constipation and a 42-year old woman with travel plans. For each case, they were asked about their treatment recommendations and the underlying rationale. Thereafter, they were provided with contents from an applicable national guideline and asked again about their recommendations and the underlying rationale. In line with the exploratory nature, data were analyzed in a descriptive manner only. RESULTS: Before exposure to guideline content, the most frequent recommendations for chronic constipation were macrogol, fiber and lactulose and for acute constipation sodium picosulfate, bisacodyl and enemas. Following guideline exposure, the most frequent recommendations for chronic constipation were macrogol, bisacodyl and sodium picosulfate and for acute constipation bisacodyl, sodium picosulfate and macrogol (all three equally recommended by the guideline for the management of acute and chronic constipation). Correspondingly, the rationale behind the recommendations shifted with guideline conformity becoming a leading reason. CONCLUSIONS: Awareness of the content of an applicable guideline on the management of constipation was poor among pharmacy personnel. Accordingly, recommendations in many cases were not in line with the guideline. Greater awareness of guideline content is desirable to enable more evidence-based recommendations in the management of constipation.

Drug-related problems and pharmacy interventions in non-prescription medication, with a focus on high-risk over-the-counter medications.

Background The risks associated with over-the-counter medication are often underestimated by consumers. The incorrect use of certain medications can lead to significant patient harm. Inappropriate use can be prevented by pharmaceutical counselling. Objective To determine the number and nature of drug-related problems in over-the-counter medication with a special emphasis on high-risk over-the-counter medications. Setting Fifty-two community pharmacies in Finland. Method This observational study was conducted as a questionnaire survey. The pharmacists working in participating pharmacies documented the observed drug-related problems and pharmacy interventions in over-the-counter medication during 1 week using an electronic study form based on the Westerlund drug-related problem classification system. Main outcome measure The prevalence of drug-related problems and problem types in different medication categories. Results The 52 community pharmacies documented 339 drug-related problems in 0.6% of over-the-counter customers, the most common problem being "Uncertainty about the indication for the drug" (39.2%). A significant proportion of the documented problems (26.3%) concerned high-risk over-the-counter medications, and the majority of these cases were associated with non-steroidal anti-inflammatory drugs (21.8%). In total, pharmacies made 641 interventions to resolve the drug-related problems. For majority of drug-related problems (87%), pharmacist's intervention involved counselling. In more than half of the problem cases, the pharmacy intervention was precautionary. Conclusion Pharmacists intervene in and prevent problems related to over-the-counter medications, including high-risk medications like analgesics, in which inappropriate use due to consumers' lack of knowledge can lead to severe consequences. As the selection and use of over-the-counter medications is continuously increasing, pharmaceutical counselling should be readily available and actively provided for consumers to achieve safer self-medication.

[Reporting standards for expert consensus on clinical practice of Chinese patent medicines of China Association of Chinese Medicine].

In 2018,Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine to discuss and draft a series of standards for expert consensus on clinical practice of Chinese patent medicines. These standards have been made by reference to the published standards for developing expert consensus and clinical practice guidelines. These standards were made based on full consideration of the current evidence status and the history of clinical practice of Chinese patent medicines. These standards were composed of four parts,namely information summary items,normative general items,normative technical items and information supplementary items,including cover,content,preface,introduction,title,scope,basic Information of Chinese patent medicine,suggestions for clinical application,safety,conflict of interest,appendix,and references,so as to provides reference for improving the quality of expert consensus-based compilation and enhancing the applicability of expert consensus.

[Guidance of instructions for compiling expert consensus on clinical practice of Chinese patent medicine of China Association of Chinese Medicine].

The expert consensus on clinical practice of Chinese patent medicines shall be regarded as the same with clinical practice guidelines,which shall be concise,readable and applicable. Therefore,a formal expert consensus is unable to contain the whole compilation process and the content of its important process documents. It is necessary to write instructions for continuation,expansion and publicity. In 2018 Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine drafted a series of standards for expert consensus on clinical practice of Chinese patent medicines,including the guidance for compilation the instructions. It will be useful for readers of expert consensus to understand the work behind the compilation,so as to make the compilation process more transparent and standardized. We proposed nine requirements for compilation the instructions,namely content and requirements,work overview,main technical content,compilation process,process and basis for handling major disagreements,expert consensus implementation requirements and measure suggestions,other issues need to be explained,appendix and format for instructions.

Making OTC Oral Contraceptives Available for All Women.

Sensible legislation has been introduced. It's time to pass it.

[Application of DNA metabarcoding technology in identification of Chinese patent medicines].

Metabarcoding technology is a research method derived from the combination of traditional DNA barcodes and highthroughput sequencing technologies. It can quickly,easily and efficiently identify and restore biological samples from multiple species.Biological species are currently widely used in environmental biology research. In the market of traditional Chinese medicines,adulteration and quality instability have severely restricted the sustainable development of the related industries. This article introduced the background of the metabarcoding technology and its preliminary application in the identification of Chinese patent medicines. It also outlined the possible problems in the research process and prospected to the development of the DNA metabarcoding technology.

Ingestion of Over-the-Counter Liquid Medications: Emergency Department Visits by Children Aged Less Than 6 Years, 2012-2015.

INTRODUCTION: Unintentional medication ingestions by young children lead to nearly 60,000 emergency department visits annually; 15% involve oral liquid medications. Safety packaging improvements have been shown to limit liquid medication ingestions. Estimated rates of emergency department visits for pediatric ingestions by product were calculated to help target interventions. METHODS: Frequencies and rates of emergency department visits for unintentional pediatric ingestions were estimated using adverse event data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project and retail sales/pharmacy dispensing data from Information Resources, Inc. and QuintilesIMS (collected 2012-2015; analyzed 2017). Rates of emergency department visits for ingestions of over-the-counter liquid medications were compared with those for prescription solid medications. RESULTS: From the results of 568 cases, an estimated 6,427 emergency department visits (95% CI=4,907, 7,948) were made annually after a child aged <6 years accessed one of the four most commonly implicated over-the-counter liquid medications without caregiver oversight. Nearly two thirds (63.8%) of these visits were made by children aged ≤2 years and 9.0% resulted in hospitalization. Acetaminophen was the most commonly implicated over-the-counter liquid medication (2,515 estimated emergency department visits annually). Rates of emergency department visits for liquid diphenhydramine and acetaminophen ingestions (8.1 and 7.4 emergency department visits per 100,000 bottles sold) were higher than rates for other common over-the-counter liquids and comparable to high-rate prescription solid medications (clonidine and buprenorphine/naloxone: 11.1 and 10.5 emergency department visits per 100,000 dispensed prescriptions, respectively). CONCLUSIONS: Product-specific rates of emergency department visits for unintentional ingestions can help prioritize preventive interventions, such as enhancing safety packaging with flow restrictors.

[Research on evaluation criteria over quality as core index of high grade Chinese patent medicine].

"One drug was produced by many companies" is common in Chinese patent medicines. The quality and price of products from different manufacturers varies widely, and the efficacy is inconsistency. In order to ensure the quality of Chinese patent medicines and promote "Healthy national program" implementation, it is necessary to study the current status of Chinese patent medicines and carry out the evaluation criteria over quality as the core management of high grade Chinese patent medicines, which is set up to reflect the evaluation strategy and method of Chinese patent medicines from raw material, production, quality control, reevaluation and competitive power to the whole chain of brand construction. It aims to reveal the quality discrepancy from different manufacturers over the same Chinese patent medicines. The research and application will select a serials of high grade quality products, and provide reference basis for the scientific and reasonable price formation mechanism of Chinese patent medicines and purchasing drugs by centralized bidding, guide healthy competition in the market and promote the implementation of "healthy China 2030 program".

Profile of drugs used for self-medication by elderly attended at a referral center.

OBJECTIVE: To determine the profile of medications used for self-medication by the elderly. METHODS: A cross-sectional study based on interviews with elderly seen at a reference center for Elderly Health of a teaching hospital, from July 2014 to July 2015. Clinical, demographic and pharmacotherapeutic data were collected. RESULTS: A total of 170 elderly were interviewed, 85.9% female, and the median age was 76 years. The frequency of self-medication was 80.5%. The most used medications for self-medication were central acting muscle relaxants, analgesics and antipyretics, non-steroidal anti-inflammatory and antirheumatic agents. Among the elderly who practiced self-medication, 55.5% used drugs that were inappropriate for the elderly, according to Beers criteria of 2015, and 56.9% used medications that showed therapeutic duplicity with the prescribed drugs. We identified 57 drugs used for self-medication, of which 30 (52.6%) were classified as over-the-counter and 27 (47.4%) as prescription drugs. Approximately 68.6% of elderly had at least one interaction involving drugs prescribed and those used for self-medication. CONCLUSION: The practice of self-medication was frequent in the elderly studied. The widespread use of over-the-counter drugs and/or potentially inappropriate medications for elderly increases the risk of drug interactions and adverse events.