Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions / 中国中药杂志

Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".

Interpretation of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions / 中国中药杂志

Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine. They were officially released on July 23 and implemented on July 31,2021. The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings. The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions. The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process. This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of " medicine-pharmacy-management-law-enterprise" have been gathered therein to reach a consensus. With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.

Construction of model for multidimensional evaluation of value and risk of Chinese patent medicine / 中国中药杂志

It is the core of the development for Chinese patent medicine enterprises to cultivate large varieties of Chinese patent medicine, and the selection of potential "seed" products is the prerequisite for the cultivation strategy. By constructing the evaluation model from multiple dimensions of value and risk, we can conduct specialized evaluation of Chinese patent medicines to effectively, professionally and objectively select the "seed" products with large variety cultivation potential. In this paper, the establishment of a multidimensional evaluation system would be discussed from the aspects of drug naming and prescription composition, safety risk and supply guarantee of raw materials and medicinal materials, competition situation, access to policy catalogue, scientific and technological support, clinical evidence and recognition, systematical and standardized collection of information on product instructions, quality standards, policy catalogue, scientific and technological literature, market competition and clinical application of Chinese patent medicines. Through the objective evaluation index and the range of objective index, the multi-dimensional evaluation model on values and risks of Chinese patent medicine products was discussed. Based on this model, a batch of Chinese patent medicine products can be quickly and comprehensively analyzed, and quantitative comparison can be formed among different types and fields of products. According to the evaluation results of the model and the comprehensive evaluation of experts, high-quality "seed" products can be selec-ted, laying a solid foundation for the next step of large variety cultivation. With use of this model, we can further clarify the external competitive advantages and internal priority levels of each product, and provide support for enterprises to optimize product structure and improve product strategic layout.

Adverse drug reactions & their risk factors among Indian ambulatory elderly patients.

Background & objectives: Several studies have reported adverse drug events ranging from 5 to 35 per cent in all age group from outpatient setting. However, adverse drug reactions (ADRs) particularly among a large sample of ambulatory elderly patients in India has not been reported. This study has attempted to identify ADRs and assessed their causality, preventability and severity, and also their risk factors in Indian ambulatory elderly patients. Methods: A 2 year long term prospective study included 4005 ambulatory elderly patients (60 yr or above; either sex) at a public teaching hospital. Suspected ADRs were assessed for causality, preventability and severity using Naranjo's probability scale, modified Schumock and Thornton's criteria, and modified Hartwig's criteria, respectively. Results: Of the total 4005 prescriptions, 406 were identified with ADRs, giving the occurrence of 10 per cent ADRs in elderly. The total number of ADRs was 422 in 406 prescriptions. Type A ADRs accounted for 46 per cent of the total ADRs. Majority of the ADRs (88.6%) were classified as ‘probable’. The definitely preventable reactions were 22 per cent. The percentage of moderate reaction was 16 per cent. Only 1.6 per cent ADRs was severe in nature. The most common type of ADR was peripheral oedema. The most commonly offending class of drug was cardiovascular drugs (57.6%). Using logistic regression analysis, the risk factors which contributed to ADRs were age above 80 yr (OR=1.7), prescription of multiple drugs (OR=1.8), longer duration of treatment (OR=2.28) and multiple diagnoses (OR=1.8). Interpretation & conclusions: In this study, 10 per cent ambulatory elderly patients were found to have ADRs. This indicates that the elderly patients should be closely monitored for ADRs, to avoid clinically significant harmful consequences. The awareness of risk factors of ADRs would help physicians to identify elderly patients with greater risk of ADRs and, therefore, might benefit from ADRs monitoring and reporting programme.

Corticosteroid nonprescription use: a cross-sectional hospital-based study in Basrah

To study the prevalence and attitude of using nonprescription corticosteroids [oral or parenteral formulation of glucocorticosteroids] in Basrah, Iraq. A face-to-face model structured interview was used to collect information from 682 patients between January 2006 and December 2008. The following information was obtained: age, gender, marital status, smoking, drinking of alcohol, occupation, educational level, social class and place of residence. Of the 682 [2.6%] subjects using nonprescription corticosteroids most were females: 471 [69%]; married: 567 [83%]; of low social class: 430 [63.1%]; lived in the city center: 475 [69.6%]. The majority [569, 83.5%] thought that corticosteroid use was safe and 463 [68.0%] did not feel guilty for using such medications. About half of them [377, 55.3%] were still using drugs at the time of presentation. Three hundred and fifty-seven [52.4%] reported that physicians advised them for the first time to use corticosteroids and the remaining 325 [42.2%] used it to become beautiful or marry. Three hundred and sixty-four [53.4%] patients obtained the drug from the pharmacy and 252 [36.9%] from street vendors. Weight gain was the main indication for use in 342 [50.1%] patients. Almost all had some features of corticosteroid side effects. This study showed high use of nonprescription corticosteroid in Basrah, Iraqi. We therefore recommend educational programs to alert the population of the untoward side effects of corticosteroids

Over-the-counter whitening agents: a concise review

Tooth discoloration is commonly found in the dental clinic and tooth bleaching has been considered the preferred esthetic alternative, being more conservative, safe and with predictable results. Supervised home-use of 10 percent Carbamide Peroxide (CP) bleaching with custom-trays is the most common bleaching procedure dispensed by dentists to their patients. The good results obtained with this technique stimulated the flourishing of new products and techniques. Over-the-counter (OTC) bleaching products appeared as a low-cost alternative to bleach discolored teeth without dentist supervision. Different OTC products are available in supermarkets, drug stores or on the Internet, including rinses, paint-on brushes, toothpastes, chewing guns, dental floss, and whitening strips. There is lack of clinical evidence regarding the safety and effectiveness of these products, being most of the studies supported by the manufacturers'. Basically, toothpastes, chewing gums, and dental floss are removal agents of superficial stains. Rinses and paint-on brushes with low levels of hydrogen peroxide have some whitening effect, but without clinical relevance. Strips present similar esthetic results and side-effects, compared to bleaching with 10 percent CP using trays; however, the studies have financial support from the manufacturers and were based on short term evaluations. Legislation varies widely in different countries regarding OTC dental bleaching. Concerns have appeared due to the potential abusive use of these self-medication agents, especially in young patients, with potential harmful results. Dentists should be acquainted with this kind of products to be able to inform their patients. In conclusion, there is a need for independent clinical trials to provide sufficient evidence regarding the use of OTC bleaching products.

Nuevas etiquetas de medicamentos para apoyar la automedicación en México: el caso de un analgésico pediátrico / New medicine label to support self-medication in Mexico: the case of a children’s analgesic

OBJETIVO: Se presenta el método para diseñar etiquetas de medicamentos centrados en el usuario, aplicado a un analgésico pediátrico. MATERIAL Y MÉTODOS: El Communication Research Institute (CRI) de Australia desarrolló este método, consistente en seis etapas que cubren todos los aspectos relacionados con el diseño de una etiqueta. Para aplicarlo por primera vez al analgésico pediátrico en México, y en sociedad con el CRI, el Centro de Estudios Avanzados de Diseño realizó diversos ajustes, como la modificación del nivel de desempeño o la inclusión de preguntas al protocolo. RESULTADOS: La aplicación de este método a la etiqueta del analgésico mejoró sustancialmente la localización y comprensión de la información del medicamento en "usuarios en riesgo", lo cual garantiza que el público general obtendrá la información adecuada para automedicarse correctamente. CONCLUSIONES: La aplicación del método llevó a firmar, en 2005, las Guías de etiquetado para medicamentos de libre acceso en México.

OBJECTIVE: This study presents the application of a method to design medicine labels centred in the user and applied to a Mexican children's analgesic. MATERIAL AND METHODS: The method was developed by the Communication Research Institute (CRI) of Australia and consists of six stages that thoroughly consider all aspects related to medicine labels. This method was applied for the first time in Mexico by CRI and by the Centre for Advanced Studies in Design (CEAD), but it required a number of modifications to adjust it, like modifying the label's performance requirements and incorporating different questions to the protocol. RESULTS: The application of this method to the children's analgesic improved significantly the localization and comprehension of the information by "users at risk", which guarantees that the general public will get adequate information for correct self-medication. CONCLUSIONS: The application of this method led to sign the Guides for OTC labels in Mexico in 2006.

The Survey for the Actual Condition of Drug Medication and Development of Health Care Cost Associated with Toxic Liver Injury in Korean; A Multicenter Study for the Detection and the Development of Nationwide Reporting System of Toxic Liver Injury / 대한간학회지

BACKGROUNDS/AIMS: In Korea, interests in health and health care costs have been increased along with the increase of mean survival rate and income level. The aim of this study is to investigate the actual condition of drug medication and burden of health care cost. METHODS: A total of 1,434 subjects in four tertiary medical centers were enrolled in this study. The questionnaires were obtained between March 2005 and September 2005. Based on this information, the actual condition of drug medication and health care cost were analyzed. RESULTS: The mean age of the subjects was 55.0+/-11.4 years (16-87 years). The male and female ratio was 1.74:1. The subjects with drug medication except for doctor's prescription are presently 26.6% and were 40.9% in the past. Traditional medicine (39.6%) and health food (29.9%) are more frequently used than herbal medicine (5.8%) and medical supplies (4.2%) now. In the past, herbal medicine (14.6%) was more frequently used compared with the present. The side effects of drug medication were developed in 90 subjects (7.5%). The total mean health care costs were 895,000 won/year, the herbal medicine, 834,000 won/year, the health food, 950,000 won/year, and the traditional medicine, 324,000 won/year. CONCLUSIONS: In this study, the subjects with other drug medications without doctor's prescription were as high as ever. The frequency of the use of the herbal medicine was decreased. However, the frequency for the use of the health food and traditional medicine have relatively increased. The side effects and additional large amounts of health care costs were occurred.

An overview of over the counter drugs in pregnancy and lactation.

Over the counter (OTC) drugs are commonly used by pregnant women. Most OTC drugs are safe in pregnancy but some have unproven safety and may adversely affect the growing foetus. The safety profile of some of the medication may change according to the gestational age of the foetus. Because an estimated 10% or more of the birth defects results from maternal drug exposure, the US Food and Drug Administration (FDA) has assigned a risk category to each drugs. Among the commonly used OTC drugs Acetaminophen, Chlorpheniramine, Kaolin and Pectin preparations and most antacids have a good safety record. The drugs like H2 blockers; Pseudoephedrine and Atropine/Diphenoxylate should be used with caution. The risk and benefit while using OTC drugs in pregnancy has to be assessed.

Avaliação do enquadramento dos laxativos na categoria de Venda Sem Prescrição Médica / Evaluation of the classification of laxatives in the category

Os laxativos disponíveis no mercado brasileiro são enquadrados pela legislação em vigor na categoria de Venda Sem Prescrição Médica. Os consumidores, consequentemente, realizam automedicação de laxativos, sem considerarem as diferenças no diagnóstico da constipação e a segurança dos laxativos. Avaliar o enquadramento dos laxativos na categoria de Venda Sem Prescrição Médica, mediante revisão bibliográfica sobre constipação e segurança dos laxativos, considerando as especialidades farmacêuticas existentes no Brasil em 2003. Levantamento das especialidades farmacêuticas laxativas existentes no Brasil em 2003, através de publicações específicas. Revisão bibliográfica sobre constipação, segurança dos laxativos e categoria de venda dos medicamentos, através da Internet e livros da farmacologia. Em 2003 estão disponíveis 61 especialidades farmacêuticas laxativas no Brasil, todas enquadradas nas categorias de "Venda Sem Prescrição Médica". O tratamento ideal da constipação depende do entendimento da fisiopatologia desta condição. Foram encontrados dados controversos sobre a associação entre o uso de laxativos estimulantes e câncer colorretal ou disfunção neuromotora do intestino. Os dados controversos são preocupantes diante do número elevado de laxativos encontrados no mercado, além de serem considerados pela legislação atual, que enquadra todos os laxantes na categoria de Venda Sem Prescrição Médica, independentemente do modo de ação

Treatment of the common cold.

BACKGROUND: Common colds are usually treated by the patients themselves with over-the-counter (OTC) cold medications. Many cough and cold remedies are available and sold freely without prescription. The authors conducted a study to compare the efficacy, adverse effects, the quality of life (QOL) and the patient's opinion and appreciation on the drugs (POD) between Dayquil/Nyquil and Actifed DM plus paracetamol syrup. METHOD: In this prospective, investigator-blinded clinical trial, 120 patients, aged between 15 and 60 years old, with common colds within 72 hours, who accepted the trial and gave informed written consent, were randomized into two treatment groups. One patient was excluded due to evidence of bacterial infection. Fifty-nine patients were treated with Dayquil/Nyquil (D/N group), while the other 60 patients had Actifed DM plus paracetamol (ADM/P group) for three days. On day 1 the patient's demographic data (sex, age, body weight, blood pressure, co-existing diseases/conditions, drug use, and allergy to any drugs), the most prominent symptoms and its duration were recorded. All patients were screened for bacterial infection by physical examination, complete blood count and sinus radiographs. The symptoms (nasal obstruction, rhinorrhea, sneezing, cough, sore throat, fever and headache) and signs (injected nasal mucosa, nasal discharge and pharyngeal discharge) were scored, based on 4-point scale (0 to 3), on days 1 and 4. Changing of the symptoms and QOL were recorded on the diary card. The patient's opinion and appreciation on the drugs (POD) was assessed on day 4. The effectiveness (the ability to lessen the symptoms and signs), QOL and POD between two treatments were compared. RESULTS: The demographic data between the two groups were similar. The four most common prominent symptoms of common colds in our series were cough (47.9%), sore throat (26.17%), rhinorrhea (8.4%) and headache (8.4%). However, both treatments were equally effective in lessening the symptoms (P = 0.426) and signs (P = 0.716) of common cold from days 1 to 4. The adverse effects were significantly higher in ADM/P group than in D/N group (p = 0.006). In contrast, QOL in terms of alertness, freshness and sound sleep improved from day 1 to day 3 in both treatments, but the overall day-3 score was significantly higher in the D/N group than the ADM/P group (1.85 +/- 1.83; 1.25 +/- 1.94: p = 0.024). POD in terms of convenience, flavour of drug, effectiveness of the drug and a need to repeat the drug assessed on day 4, was also significantly higher in the D/N group than the ADM/P group (10.68 +/- 2.56; 8.92 +/- 2.27: p < 0.001). CONCLUSION: Dayquil/Nyquil are as effective as Actifed DM plus paracetamol in controlling the symptoms and signs of the common cold, but have fewer adverse effects. The quality of life assessed during the use of the drugs was significantly higher in the Dayquil/Nyquil group, and according to the patients, they prefered Dayquil/Nyquil more than Actifed DM plus paracetamol.

Aquisição de medicamentos em farmácias sem prescrição médica: uma prática comum. Otite média aguda / Acquisition of drugs without medical prescription in drugstores: a common practice: Acute otitis media

O presente estudo objetivou analisar a conduta dos balconistas de 25 farmácias da zona urbana de Santa Maria (RS), escolhidas aleatoriamente, em relaçäo ao tratamento da otite média aguda em crianças, patologia frequente na prática diária do otorrinolaringologista e do pediatra. Os resultados mostraram que em apenas oito farmácias foi dada orientaçäo para procurar um médico (32 por cento). No entanto, em sete desses casos o balconista se propôs a vender alguma medicaçäo. Das 24 farmácias onde houve indicaçäo de medicamentos, apenas três balconistas "prescreveram" antibióticos (12,5 por cento). Desses, nenhum o fez de forma totalmente correta. Os autores concluem ser fundamental que haja uma maior conscientizaçäo da populaçäo e dos próprios balconistas em relaçäo aos riscos que podem advir do tratamento inadequado da otite média aguda.

Pharmacy distribution of advice, symptomatic treatment and antimicrobial drugs to patients with cough

It i an accepted fact that, in many countries, pharmacies are the predominat source of medical advice over-the-counter drugs, and supplies of "prescription-only" drugs for sale without a prescription. To assess the activities conducted by pharmacists or pharmacy counter assistants in response to a common health problem, a cross-sectional study was done at 114 pharmacies in Porto Alegre, Brazil. A fictitious case-history of cough was used by trained personnel entering the pharmacy and the subsequent activities by the pharmacist or pharmacy counter assistant were analyzed. Some kind of medication was provided in 101 (88.5 percent)of the pharmacies. Pharmacists gave medication in 80 percent of pharmacies, and pharmacy assistants in 95.5 percent (p<0.03). The class of medication most frequently dispensed was the expectorants (97 times, 92.4 percent), however, systemic antibiotics were provided in 11 pharmacies (10.5 percent). Of note, the pharmacists provided antibiotics more frequently than did pharmacy assistants (p=0.016). We conclude that pharmacy advice and symptomatic medical care (expectorants) are very common and that pharmacy assistants are more likely than pharmacists to provide medication. Of concern, when pharmacists were the drug dispensers of antibiotics which should be provided by prescription only, drugs were provided without proper diagnosis, and often incorrect dosages. This reflects a pontentially dangerous practice in need of careful evaluation, education and supervision.

Prescrição leiga de medicamentos em farmácias de Passo Fundo, RS / Lay prescription of medication at drugstores in Passo Fundo, RS-Brazil

Os autores realizaram pesquisa em 27 farmácias de Passo Fundo, apresentando duas situações clínicas fictícias: um caso de diarréia em adulto e um caso de rinite alérgica em criança de 4 anos. De todos os balconistas consultados, apenas 8 (29,6 por cento) orientaram procurar um médico. Vinte e três (85,19 por cento) prescreveram tratamento para rinite alérgica e somente um deixou de receitar medicação para diarréia...

Del síntoma al tratamiento: compra de medicamentos sin prescripción médica / From sympton to treatment: buying of drugs without medical prescription

Con el objetivo de investigar la magnitud de la prescripción de medicamentos en las farmacias sin receta médica se realizó la visita a 50 establecimientos farmacéuticos de la ciudad de Corrientes seleccionados al azar. La investigación consistió en la simulación de una enfermedad por un grupo de alumnos de la Cátedra de Semiotecnia y Fisiopatología, que concurrían a las farmacias solicitando un tratamiento. Del análisis de los resultados obtenidos se observó que en 45/50 (90 por ciento) farmacias se realizó una prescripción de medicamentos, y solo 5/50 (10 por ciento) indicaron específicamente una consulta médica. Ante la requisitoria, 10 de las 45 que medicaron (20 por ciento) indicaron la consulta luego de un período de tratamiento. Del análisis de las indicaciones, 42 de las 45 (93,33 por ciento) son de medicamentos catalogados como de "venta bajo receta". 86,67 por ciento fueron de antibióticos, en monodrogas o en combinaciones fijas, siendo la indicación más frecuente la de una asociación de uno o dos antibióticos con un analgésico urinario. Las drogas más indicadas fueron combinaciones de dos drogas un quimioterápico con una analgésico urinario (37,78 por ciento), y una combinación de tres drogas o dosis fijas (35,55 por ciento), de dos quimioterápicos con un analgésico urinario. No se pudo establecer una relación de costo con la indicación, ya que los medicamentos indicados no eran los más costosos. Se analizan aspectos relacionados al problema estudiado y se realizan propuestas a fin de tratar de conseguir una utilización más racional de los medicamentos