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.

Making OTC Oral Contraceptives Available for All Women.

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

¿Cuál es el impacto de permitir la venta de medicamentos sin prescripción médica fuera de farmacias? / What is the impact of allowing the sale of medicines without a prescription outside of pharmacies?

INTRODUCCIÓN: El acceso a medicamentos es un elemento fundamental para avanzar en la cobertura universal de la salud. Dentro de este concepto, el precio es un elemento esencial para contribuir a mejorar el acceso a medicamentos, lo que podría lograrse a través del aumento de la competencia dentro del mercado farmacéutico. Con el objetivo de reducir los precios de los medicamentos e introducir competencia en este mercado, el Ministerio de Salud está intentando impulsar una política para permitir que fármacos sin necesidad de una prescripción médica, puedan ser comercializados en establecimientos diferentes a una farmacia. Esta síntesis rápida de evidencia pretende aportar con la evidencia disponible que sobre este tipo de intervenciones. METODOLOGÍA: resúmenes fueron seleccionados por un único revisor. No se encontraron revisiones sistemáticas que evaluaran la pregunta formulada, por lo que se buscaron estudios primarios. Se excluyeron estudios que evaluaran el impacto de cambiar medicamentos en cuanto a su obligatoriedad de ser comercializados con prescripción, así como también la venta de medicamentos que no están autorizados a venderse sin prescripción (antibióticos, opioides, etc.). . RESULTADOS: De un total de 10 estudios primarios seleccionados originalmente, se seleccionaron finalmente 2 publicados en 2016 y 2017. CONSIDERACIONES: Considerando el tiempo en el cual fue solicitado esta síntesis, no se presentan los resultados con la evaluación de la certeza en la evidencia de cada uno de los desenlaces encontrados, de acuerdo al sistema GRADE (ver recuadro). Los hallazgos son separados por el país en el cual se encontró la intervención.

Trends in Non-prescription Drug Recalls in Japan.

Recalls of non-prescription drugs can contribute to preventing harm to human health, however, they also interrupt the supply of medicines to the market. The aim of the present study was to investigate the trends in non-prescription drug recalls in Japan. Class I, II, and III recalls reported from April 2009 to March 2014 were obtained from the websites of the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. Each drug recall was classified according to year, dosage form, therapeutic category, and reasons for the recall. The trends over the 5 year period were assessed for each class. A total of 220 recalls were reported in the 5-year study period. The numbers of drug recalls were 21, 16, 80, 58, and 45 in 2009, 2010, 2011, 2012, and 2013, respectively. The drugs recalled consisted of 177 internal medications, 35 topical agents, and 8 others. Drug recalls were observed in 12 therapeutic categories of drug effects. The largest number of recalls was for Chinese herbal medicines and crude drugs. Of all the drug recalls in 2011, Chinese herbal medicines and crude drugs produced by one manufacturer accounted for 84%. Slightly more than half (54%) of drug recalls were due to a violation of the regulations. One manufacturer recalled many drugs because of non-compliance with the standard regulations for manufacturing drugs after 2011. In conclusion, non-prescription drug recalls can occur for any drug regardless of the dosage form and therapeutic category.

Emergency Contraception.

Emergency contraception (EC) may help prevent pregnancy in various circumstances, such as contraceptive method failure, unprotected sexual intercourse, or sexual assault, yet it remains underused. There are 4 approved EC options in the United States. Although ulipristal acetate requires a provider's prescription, oral levonorgestrel (LNG) is available over the counter for women of all ages. The most effective method of EC is the copper intrauterine device, which can be left in place for up to 10 years for efficacious, cost-effective, hormone-free, and convenient long-term primary contraception. Ulipristal acetate tends to be more efficacious in pregnancy prevention than is LNG, especially when taken later than 72 hours postcoitus. The mechanism of action of oral EC is delay of ovulation, and current evidence reveals that it is ineffective postovulation. Women who weigh more than 75 kg or have a body mass index greater than 25 kg/m(2) may have a higher risk of unintended pregnancy when using oral LNG EC; therefore, ulipristal acetate or copper intrauterine devices are preferable in this setting. Providers are often unaware of the range of EC options or are unsure of how to counsel patients regarding the access and use of EC. This article critically reviews current EC literature, summarizes recommendations, and provides guidance for counseling women about EC. Useful tips for health care providers are provided, with a focus on special populations, including breast-feeding women and those transitioning to long-term contraception after EC use. When treating women of reproductive age, clinicians should be prepared to counsel them about EC options, provide EC appropriately, and, if needed, refer for EC in a timely manner.

Emergency Contraception for Adolescents: A Political Battle.

The political debate for adolescents to have access to emergency contraception that is available over the counter has been going on for years. Since 1999, Levonorgestrel, Plan B One Step®, has been used in the United States as an emergency contraception but with a prescription at the time. The FDA has done years of research and testing with Barr Laboratories, the manufacture of Plan B One Step®, to make it safe for females of all ages. In 2003, the FDA recommended the over the counter use of Plan B One Step® for all ages, yet this did not occur. In pharmacies across our nation young women find it impossible to purchase this product whether they be of age or not. Politics is making the choices for our young females, not medical evidence. How long are we going to let this continue?

[Reliability of OTC advertisement Relevance and quality of cited literature]. / Quelle est la fiabilité de la publiciteé pour les produits non soumis à prescription? Pertinence et qualité de la littérature mentionée.

Introduction Pharmacist receive a lot of publicity for OTC products. Often one or more literature references are mentioned to support the advertising claims. Objective In this study we examine: [1) whether the advertising claim is consistent with what is stated in the literature references mentioned on the leaflet and [2] whether these literature references are trustworthy. Method Through 60 randomly selected community pharmacies, pharmacist-directed advertisements for OTC products I= medicines, medical devices, dietary supplements and parapharmacy) with at least one bibliographic reference, were collected. The literature references listed in these leaflets were assessed in terms of content [= is the claim consistent with the information in the reference) and technically [= evaluation of the quality of the references]. Results The 85 collected OTC advertisements made 214 claims that referred to 243 references. Of these, 128 references did not support the promotional claim. The remaining 84 references did support the corresponding claim. From 31 references no full text was obtained. Of the 84 supporting references 44 were of dubious quality. The remaining 40 references were found to be reliable. Conclusion This study shows that the literature references in advertising leaflets for OTC-products are not a reliable source of information on the advertised product. Pharmacists should deal critically with this information and should be encouraged to consult reliable scientific sources.

Multifaceted determinants of online non-prescription drug information seeking and the impact on consumers' use of purchase channels.

The growing importance of the Internet as an information and purchasing channel is drawing widespread attention from marketing decision makers. Nevertheless, the relevance of the Internet to the so-called self-medication market in Germany has been paid barely enough attention. Our study aims to contribute insights concerning the penetration of the Internet in this market, as well as to give an overview of the critical determinants of Internet use for non-prescription drug information seeking, such as the accessibility of professional information, trust in health professionals' opinion and the ability to search online, as well as the perceived usefulness and credibility of online non-prescription drug information. Furthermore, we demonstrate that the preferred use of the Internet as a non-prescription drug information source positively influences the choice of unconventional purchase channels for non-prescription drugs and negatively affects the use of stationary pharmacies.

Treatment of vitamin D deficiency: divergence between clinical practice and expert advice.

BACKGROUND: Current recommendations for the treatment of vitamin D deficiency vary from calciferol 800 IU per day to loading doses of vitamin D followed by maintenance therapy of up to 2000 IU per day. OBJECTIVE: To assess the preparations and doses of vitamin D used to load and maintain patients with serum 25-hydroxyvitamin D (25OHD) <25 nmol/l. METHODS: We examined all requests for serum 25OHD over a 12-month period, from September 2009 to 2010 in southwest Scotland. We wrote to all 33 general practices asking whether they usually started replacement therapy with a loading dose and/or recommended over-the-counter maintenance preparations. We accessed the Emergency Care Summary for all patients with serum 25OHD <25 nmol/l to determine whether they had been prescribed maintenance therapy. RESULTS: Serum 25OHD was requested in 1162 patients. Levels were <25 nmol/l in 282 (24%) patients, only 173 (61%) of whom were receiving vitamin D replacement therapy 3-15 months after diagnosis. Only four (1.4%) were prescribed a loading dose. One hundred and fifty-three (54%) were treated with cholecalciferol or ergocalciferol and 19 (7%) with alfacalcidol or calcitriol. The median dose of chole/ergocalciferol was 800 IU per day, usually in combination with 1200 mg calcium per day. CONCLUSIONS: We have shown a divergence between clinical practice and even the most conservative expert advice for vitamin D replacement therapy. Possible explanations are conflicting advice on treatment and difficulty obtaining suitable vitamin D preparations, particularly high dose vitamin D and vitamin D without calcium, in the UK.

Deregulation of nonprescription medicines in Sweden-a look at the control system.

BACKGROUND: Sales of nonprescription medicines (NPMs) in retail outlets in Sweden have been permitted since 2009. The conditions are that sales are reported to the Medicine Product Agency (MPA) and that the owners of the retail outlets fulfill legal requirements. The MPA has an overall supervisory function, whereas municipalities are responsible for the actual control. This is mainly executed through inspections. OBJECTIVE: The aim of the study was to explore some aspects of control performed by Swedish authorities of NPM sales in retail outlets. METHODS: Telephonic interviews were conducted with inspectors from a heterogenic sample of municipalities in Sweden during autumn of 2010. A semistructured interview guide was designed, which included questions on inspections and deviations found in inspections. Interviews were documented in writing, and a deductive content analysis was performed. RESULTS: Inspectors in 15 municipalities participated. In 8 of the municipalities, at least 1 inspection had been conducted. Seven inspectors had used a checklist designed by the MPA, although a majority found it difficult to use. Deviations found were mainly minor; they included lack of signs regarding age limits and prohibition of illegal sales, unlocked/open drug cabinet doors, nonexistent self-inspection programs, erroneous display of NPMs, and broken drug packages. Two serious deviations were found and reported to the MPA; these were negligence in reporting of sales statistics of NPM and 1 case where the inspector had not been allowed to conduct any inspection. CONCLUSION: The restructuring of the sale of NPMs in Sweden, permitting sale outside pharmacies, has not been accompanied by satisfactory control procedures from authorities according to our findings. Work is still needed to make sure that optimal drug use and patient safety issues are kept in focus.

Current management and recommendations for access to antiviral therapy of herpes labialis.

Herpes labialis is a common skin infective condition, worldwide, which is primarily caused by HSV-1. Recurrent episodes of herpes labialis, also known as cold sores, can be frequent, painful, long-lasting and disfiguring for infected patients. At present, there are two types of antivirals for the treatment of herpes labialis, topical and oral, which are available over the counter or as prescription-only. The aim of antiviral therapy is to block viral replication to enable shortening the duration of symptoms and to accelerate healing of the lesions associated with herpes labialis. This review examines the evidence for the effectiveness of current topical and oral antivirals in the management of recurrent episodes of herpes labialis. In most countries, oral antivirals for herpes labialis are available as prescription-only. However, in early 2010, the oral antiviral famciclovir was reclassified from prescription-only medicine to pharmacist-controlled status in New Zealand. The benefits and risks associated with moving an antiviral therapy for herpes labialis from prescription-only to pharmacist-controlled status are reviewed here, and the implications for patients, general physicians and pharmacists are considered.

[Over the counter drugs--a new era in Israel].

The reformation in the marketing of non-prescription medicinal products has been launched. As of May 10th 2005, the pharmacist regulations 2004 (marketing of over-the-counter (OTC) drugs outside of pharmacies, as well as not by a pharmacist) will be in effect. This change aLlows the marketing of medicines outside of pharmacies, as has been the custom in the U.S.A., England and some of the European Union countries for many years. This reformation is incorporated in a policy that encourages self-medication by the use of non-prescription drugs. The self-medication policy originates from the point of view of the consumers who wish to be responsible for their own health and save precious time wasted on doctor visits; and the government's assumption that self-medication of OTC medicines by citizens wiLL decrease expenses for the HMOs in both doctor's billings as well as medication costs. In order to regulate the marketing terms of these medicinal products, regulations and complimentary guidelines were written and published. These documents encompass the following issues: the list of OTC medicines, marketing reguLations, packaging regulations, Licensed marketing Locations, storage regulations as well as display regulations, advertising regulations, monitoring and control. The medicinal products in this category only included medicines containing "safe" active ingredients with restrictions regarding the strength/concentration and packaging size; this category does not include medicines requiring special storage conditions (such as refrigeration or freezing), medicines containing an active ingredient that is addictive, medicines containing an active ingredient with danger of poisoning if misused, and medicines containing an active ingredient that has the potential to harm. The implementation of the regulations and guidelines will improve the consumer's ability to diagnose and treat oneself when sick with minor ailments, without consulting a doctor.

How are drugs approved? Part 1: the evolution of the Food and Drug Administration.

The discovery, development, and marketing of drugs for clinical use is a process that is complex, arduous, expensive, highly regulated, often criticized, and sometimes controversial. In the United States, the Food and Drug Administration (FDA) is the governmental agency responsible for regulating the development and marketing of drugs, medical devices, biologics, foods, cosmetics, radiation-emitting electronic devices, and veterinary products, with the objective of ensuring their safety and efficacy. As part of a broad overview of the drug development process, this article will describe the historical evolution of the FDA. This will provide background for two subsequent articles in this series, which will describe the ethical foundations of clinical research and hethe stages of drug development.

Medicine sellers and malaria treatment in sub-Saharan Africa: what do they do and how can their practice be improved?

Medicine sellers are widely used for fever and malaria treatment in sub-Saharan Africa, but concerns surround the appropriateness of drugs and information provided. Because there is increasing interest in improving their services, we reviewed the literature on their characteristics and interventions to improve their malaria-related practices. Sixteen interventions were identified, involving a mixture of training/capacity building, demand generation, quality assurance, and creating an enabling environment. Although evidence is insufficient to prove which approaches are superior, tentative conclusions were possible. Interventions increased rates of appropriate treatment, and medicine sellers were willing to participate. Features of successful interventions included a comprehensive situation analysis of the legal and market environment; buy-in from medicine sellers, community members and government; use of a combination of approaches; and maintenance of training and supervision. Interventions must be adapted to include artemisinin-based combination therapies, and their sustainability and potential to operate at a national level should be further explored.

An in-depth study of patent medicine sellers' perspectives on malaria in a rural Nigerian community.

BACKGROUND: Malaria remains a major cause of mortality among under five children in Nigeria. Most of the early treatments for fever and malaria occur through self-medication with antimalarial drugs bought from medicine sellers. These have led to increasing calls for interventions to improve treatment obtained in these outlets. However, information about the current practices of these medicine sellers is needed before such interventions. This study aims to determine the medicine sellers' perspectives on malaria and the determinants that underlie their dispensing patterns of antimalarial drugs. METHODS: The study was conducted in Ugwugo-Nike, a rural community in south-east Nigeria. It involved in-depth interviews with 13 patent medicine sellers. RESULTS: A majority of the medicine sellers were not trained health professionals and malaria is recognized as a major health problem by them. There is poor knowledge and poor dispensing behaviour in relation to childhood malaria episodes. Although referral of severe malaria is common, there are those who will not refer. Verbal advice is rarely given to the care-givers. CONCLUSION: More action research and interventions to improve prescription and referral practices and giving verbal advice to care-givers is recommended. Ways to integrate the drug sellers in the health system are also recommended.

Implementación y Evaluación del Sistema de Suministro de Medicamentos en el Centro de Salud 2 de Quito / Implementation and Evaluation of the System of Supply of Medications in the Center of Health 2 of Quito

La presente investigación se centra en el manejo de medicamentos en el Centro de Salud 2 de Quito, unidad de atención primaria del Ministerio de Salud y tiene tres momentos: un diagnóstico de base, un proceso de implementación del Sistema integrado de manejo de medicamentos y una evaluación final.La investigación inicial reveló que el manejo de medicamentos en el Centro de Salud era ineficiente, no satisfacía a los clientes externos, y no propiciaba las buenas prácticas de prescripción ni el uso racional de los medicamentos.En la fase de intervención, que duró diecisiete meses, se implementó y monitorizó cada componente del Sistema integrado de manejo de medicamentos se planificó y ejecutó un proceso de educación continua dirigido a prescriptores

Nonprescribed antimicrobial drugs in Latino community, South Carolina.

We investigated in a sample of Latinos the practices of antimicrobial drug importation and use of nonprescribed antimicrobial drugs. In interviews conducted with 219 adults, we assessed health beliefs and past and present behaviors consistent with acquiring antimicrobial drugs without a prescription in the United States. Many (30.6%) believed that antimicrobial drugs should be available in the United States without a prescription. Furthermore, 16.4% had transported nonprescribed antimicrobial drugs into the United States, and 19.2% had acquired antimicrobial agents in the United States without a prescription. A stepwise logistic regression analysis showed that the best predictors of having acquired nonprescribed antimicrobial drugs in the United States were beliefs and behavior consistent with limited regulations on such drugs. Many persons within the Latino community self-medicate with antimicrobial drugs obtained without a prescription both inside and outside the United States, which adds to the reservoir of antimicrobial drugs in the United States.