Pharmacovigilance: an evaluation on the practice of pharmacists acting in pharmacies and drugstores

Abstract Pharmacists acting in pharmacies and drugstores stores are some of the most accessible healthcare providers and the last to intervene before the patient takes their medicine. This puts the pharmacist in a position of authority that should be harnessed for the benefit of health. Thus, this professional is strategic for performing pharmacovigilance. Our objective of this study was to interrogate the practice of pharmacists in relation to pharmacovigilance activities, and to identify difficulties and possible stimuli for the improvement these activities in pharmacies and drugstores. The information was collected through an online questionnaire via Survey Monkey®. The data were analyzed statistically using SPSS software. Responses were received from 5174 pharmacists: mostly young women within five years of graduation and experience in pharmaceutical retail. 81% of them reported having identified suspected substandard medicines, but only 16% used the Brazilian notification system Notivisa. More than 85% of pharmacists agreed with the importance of pharmacovigilance and the recognition of reporting services as part of pharmacist duties and pharmaceutical care. The main barriers to making notifications were the lack of access and knowledge about Notivisa. Pharmacists agreed that simplifying the system would be a stimulus for notifications, and requested more feedback from notifications, as well as material and courses to understand the notification process. Pharmacists have important data to feed into pharmacovigilance systems, recognize their responsibilities and are willing to contribute, but still demonstrate low compliance. Simplification of the system and training on it are likely to increase notifications.

Skills and practices of pharmacy staff for dispensing of drugs with fiscalized substances in drugstores and pharmacies

ABSTRACT OBJETIVE To evaluate the skills and practices of pharmacy staff during the dispensing of tramadol (drug with fiscalized substance) in drugstores and pharmacies in Medellin, Colombia. METHODS A cross-sectional study was performed. The simulated patient technique was used. The main outcomes included the information provided on the dispensed drug (tramadol), the use of tools to provide information, and the information provided on drug precautions and use recommendations. RESULTS We visited 305 drugstores and pharmacies. The average dispensing time was 2.3 min (SD 1.1 min). In nine drugstores and pharmacies (3.0%), tramadol was not dispensed because it was not in stock. In 17 drugstores and pharmacies (5.7%), the simulated patients were actively informed by the dispensing pharmacy staff; of these, 16 provided oral information and one provided oral and written information. Eight patients (2.7%) received information regarding tramadol use. However, 99% of patients were not informed about tramadol side effects such as dependence, sedation, or hypnosis, and none of the simulated female patients were informed on the precautions related to tramadol use during pregnancy or lactation. CONCLUSIONS Communication skills and appropriate practices of pharmacy staff are critical to patient self-care. However, this study shows their difficulty in counseling about precautions and use recommendations of drugs with fiscalized substances. These outcomes could inform future studies focusing on the rational use of these drugs in drugstores and pharmacies. It is necessary to improve the pharmacy staff competencies through continuing education programs, to facilitate access to information and training.

Literature Study and Suggestions on the Development Situation of Online Drugstores in China / 中国药房

OBJECTIVE：To p rovide policy suggestions for the development and supervision of online drugstores in China. METHODS：By literature review ，the relevant literatures and policy documents about the development of online drugstores were searched，screened and sorted out to summarize the development process of China ’s internet drug trading mode and policy ，analyze the development status of China ’s online drugstores ；on the basis of the development experience of some developed countries ，the suggestions were put forward for China ’s relevant policies. RESULTS & CONCLUSIONS ：China’s medical e-commerce started relatively late ，and the policies related to online drug trading were basically released during last 20 years. The number of online drugstores showed a growing trend. The online drugstores were geographically allocated widely but unevenly. They sold many varieties，and policies on selling prescription medicines were gradually liberalized. These online drugstores provided diverse payment and delivery choices ，but their pharmaceutical service needed to be improved. The development models of online drugstores in the United Kingdom ，the United States and Germany could be referred. According to the current situation of online drugstores in China ， combined with the development mode and operation strategy in foreign countries ，it is suggested to improve relevant laws and regulations，and strengthen legal support ；strengthen the government supervision to ensure drug safety ；use the industrial power to standardize medicine operation behavior ；set up the third part trading platform to promote medical insurance payment.

Investigation and Analysis of the Current Operation Situation o f Online Drugstores in China / 中国药房

OBJECTIVE： To investigate the current situation and existing problems of online drugstores in China and put forward corresponding countermeasures and suggestions， so as to provide a basis for promoting and improving the standardization of online drugstores in China. METHODS： The number of online drugstores was counted by inquiring about the online drugstores in all provinces， autonomous regions and municipalities directly under the central government published by the “Public inquiry” column on the official website of the previous China Food and Drug Administration （CFDA）. According to the administrative division， stratified sampling of online drugstores was conducted. The website domain names of sampled online drugstores and their Taobao stores， Jingdong stores， Wechat public accounts， Wechat small programs and other platforms were retrieved to analyze their operation methods. At the same time， the online drugstores which actually had online trading behavior were investigated and analyzed from three aspects， including business scope， propaganda behavior and service behavior. RESULTS & CONCLUSIONS： A total of 693 online drugstores were obtained from the official website of CFDA， and the domain names of only 14 （41.2％） of 34 online drugstores selected by stratified sampling were their corresponding online drugstores. Other online drugstores had some problems， such as domain name could not be opened or was not related websites. There were 14 online drugstores dealing in drugs through their own websites， of which 12 also operated on third-party platforms such as Taobao， Jingdong and Wechat. The problems of 27 drugstores with online online trading behavior mainly included non-standard operating varieties， illegal sale of prescription drugs， disunity of qualification mark，false propaganda，untimely online customer service response and imperfect drug distribution system， etc. It is suggested that relevant supervisory and administrative departments strengthen supervision， standardize the management of domain names and trading platforms of online drugstores， and vigorously crack down on and control illegal online transactions. Online drugstores should improve their service levels， standardize their own website construction， improve the level of real-time customer service and drug distribution services， so as to improve the current operation situation of online drugstores in China.

The empirical study on the methodology of increasing the designated medical insurance drug-stores:Ideas,steps and effect forecasts / 中国卫生政策研究

Objective:Using an area in east of China as a case,the paper exploit the methodology to define and visualize the scope of the medical insurance pharmacy service through using ArcGIS and its function modules to analy-zing the basic data including this area's population distribution,address of drugstores,administrative districts,road network and soon.Plan A based on the 15-minute walk distance norm for defining the scopes, shows that this area need to increase 548 medical insurances designated drugstore,the effect of which was service area can be increased by 12.36%,service population can be increased by 10.82%, designated drugstore healthy competition rate can be increased by 8.36%;Plan B based on the 10-minute walk distance norm for defining the scopes, displays that this area need to increase 1197 medical insurance designated drugstore, the effect of which was service area can be in-creased by 15.23%,service population can be increased by 20.49%,designated drugstore healthy competition rate can be increased by 19%.

A layout planning methodology of increasing the designated medical insurance drugstores guided by fairness and efficiency / 中国卫生政策研究

Objective: This paper develops a methodology for steady and orderly expansion of the designated medical insurance drugstores. Methods:With the help of grid management ideology, the paper uses ArcGIS and its function modules to define and visualize the scope of the medical insurance drugs service with the guidance of fairness and efficiency through analyzing the basic data including population distribution, the physical distribution of drug-stores and soon. Results:In order to figure out the procedure of the methodology,the key problems were all solved, including defining and visualizing the scope of the medical insurance drugs service area,,checking and ratifying the scope that need to supplement or increase the medical insurance drugstores, making measures for the annual imple-mentation and confirming a selection principle for designated medical insurance drugstores. Conclusion:The Method-ology guided by fairness and efficiency of the medicare designated pharmacy layout planning is practical and feasible, which can probably provide a reference for increasing the designated medical insurance drugstores steadily and orderly.

Investigation of Internet Drug Retail Business in China and Cognition,Attitude and Behavior of the Shang-hai Citizens / 中国药房

OBJECTIVE:To provide reference for further development of Internet drug transaction services in China. METH-ODS:The data of online drugstores with top 20 approvals data and sales amount were collected bu the Internet,the normative man-agement was evaluated. Meanwhile,questionnaire was conducted to survey and analyze the cognition,buying drugs and correspond-ing requirements of some Shanghai citizens for Internet drug retail. RESULTS:By Jun. 12,2015,totally 307 retail chain drug-stores(online drugstores)had got the License of Internet Drugs Transaction,only 62 online drugstores(20.2%)were in full compli-ance with the normative management;the top 19 online drugstores supplied averagely 1 072±815 OTC medicines,including 259± 165 chemical drugs and 813 ± 650 Chinese traditional medicines,and the top 3 were jianke.com (3 658 species),J1.com (2 071 species)and 360 kad.com(1 523 species). Totally 216 questionnaires were sent out,and 183 were effectively received with effec-tive recovery of 84.7%. The 183 surveyed citizens showed high cognition in distinguishing the authenticity of online drugstores (75.4%) and the authenticity of drugs (67.1%),but low cognition in online drugstore opening qualifications and Internet selling drugs;only 22.4% had the experience of buying drugs online,the degree of satisfaction towards online shopping,from the highest to the lowest,were drug price(62.5%),professional consultation of pharmacists(50.0%),variety of drugs(45.0%),quality of drugs(37.5%),delivery time(35.0%),etc.;the most probably purchased medicine category were vitamins and minerals(63.9%) and medicines for common diseases(40.4%). CONCLUSIONS:Currently the demands and confidence of online drugs shopping of Shanghai citizens are still scarce. Though the access of retailing prescription drugs would spur the Internet drug business,the condi-tion is still immature. It is suggested to sell prescription drugs in a limited way and improve their access threshold,promote Medi-care settlement to multi-faceted promote the orderly development of Internet drug transaction services.

Trabalho em saúde: vigilância sanitária de farmácias no município de Salvador (Bahia, Brasil) / Work in health: sanitary surveillance of drugstores in Salvador (state of Bahia, Brazil)

A farmácia é um estabelecimento de interesse da saúde onde são dispensados medicamentos, tecnologia terapêutica mais utilizada na prática médica. Este trabalho objetiva descrever e analisar a vigilância sanitária de farmácias. A partir da teoria do processo de trabalho em saúde, realizou-se um estudo sobre a vigilância sanitária em farmácias de Salvador (Bahia, Brasil), segundo as categorias analíticas agentes e atividades. Os dados foram coletados por meio da observação, análise documental e entrevistas. No processamento, utilizou-se o software QSR N Vivo. Verificou-se multiprofissionalidade no quadro técnico, profissionais com pouco tempo de serviço em vigilância sanitária de farmácias e insuficiente capacitação técnica para o exercício das atividades. Foram observadas deficiências de ordem gerencial no serviço, que ainda não incorporou práticas de planejamento e avaliação. As atividades estão direcionadas à concessão da licença sanitária, priorizando-se o atendimento à demanda espontânea, configurando um modelo tecnológico de intervenção baseado na inspeção sanitária. Revelou-se a necessidade de modernização do serviço e utilização de tecnologias diversificadas para propiciar o controle do risco, dado que a evolução tecnológica oferece medicamentos cada vez mais potentes, porém com maior grau de risco.

A drugstore is an establishment of interest in health, from which medication is dispensed, namely the therapeutic technology most broadly used in the practice of medicine. The scope of this study is to describe and analyze the sanitary surveillance of drugstores. Based on the theory of working processes in healthcare, a case study was conducted on the sanitary surveillance of drugstores in Salvador (Bahia, Brazil), examining 2 analytical categories: agents and activities. Data were collected through observation, analysis of documents and interviews, and QSR N Vivo software was used for data processing. Personnel of the surveillance service were found to have varied professional and educational backgrounds, with limited experience in the sanitary surveillance of drugstores, and insufficient technical training for the performance of the tasks assigned. Deficiencies of a managerial nature were detected in the service. Its operation is primarily focused on granting drugstore licenses, prioritizing attendance to spontaneous demand, thereby configuring a technological model of intervention based on sanitary inspection. The findings revealed a need for updating the service and the adoption of technologies to enhance control of risk, given that technological evolution provides drugs that are increasingly more potent, with a concomitant rise in levels risk.

Queixa ocular X condutas nas farmácias de Pelotas, RS: o que mudou em 12 anos / Eye complaints X clerks' conducts in drugstores of Pelotas, RS: changes in twelve years

Introdução: Investigar a conduta dos balconistas de farmácia frente a um caso simulado de olho vermelho e comparar com os resultados de pesquisa similar ocorrida há 12 anos na mesma cidade, bem como avaliar a associação entre a localização do estabelecimento farmacêutico com indicação de consulta médica. Métodos: Através de estudo transversal, investigaram-se 146 farmácias em Pelotas, RS, por meio de um questionário padronizado e pré-codificado. O entrevistador chegava ao estabelecimento com a suposta queixa: “Ao acordar nesta manhã venho sentindo ardência ocular e lacrimejamento, além de perceber o olho vermelho, o que posso fazer?”. Caso a resposta do balconista fosse diversa da orientação da procura de atendimento médico, era feita a seguinte pergunta: “Você acha que devo procurar um médico?”. As associações foram estudadas através do teste qui-quadrado. Resultados: As principais condutas foram: 89 (60,9%) atendentes indicaram o uso de descongestionantes oculares, 17 (11,6%) o uso de lágrima artificial ou soro fisiológico, 12 (8,2%) o uso de colírio antisséptico, 9 (6,2%) o uso de antibióticos. Além disso, 10 (5,8%) atendentes indicaram a procura do médico. Em comparação com estudo similar realizado em 1997, houve significativo aumento na indicação de lágrimas artificiais e diminuição na indicação de descongestionantes e antibióticos. Ademais, o estudo atual demonstrou que uma maior proporção de indicações de procura médica associou-se a farmácias da área central da cidade. Conclusão: Sugerem-se iniciativas que contemplem a fiscalização mais rigorosa do comércio de medicamentos oftalmológicos, fomento à educação populacional e maior acesso aos cuidados básicos de saúde.

Introduction: To investigate the conduct of drugstore clerks in the face of a simulated case of red eyes, and to compare the results with those of a similar research performed 12 years ago in the same city, as well as to evaluate the association between the location of the drugstore and an indication of a medical visit. Methods: In a cross-sectional study we investigated 146 drugstores in South Brazil through a standardized pre-coded questionnaire. The interviewer reached the store and told the clerk: “When I woke up this morning my eyes were burning and tearing and red; what can I do about it?” If the clerk’s response was other than referral to medical care, we asked the following question:” Do you think I should see a doctor?” Associations were studied using the chi–square test. Results: The main suggested courses of action by the clerks were: 89 (60.9%) indicated the use of ocular decongestants, 17 (11.6%) the use of artificial tears or saline, 12 (8.2%) the use of a topical antiseptic, and 9 (6.2%) the use of antibiotics. In addition, 10 (5.8%) clerks advised seeking medical care. Compared with a similar research conducted in 1997, there was a significant increase in the indication of artificial tears and a decrease in the indication of decongestants and antibiotics. Moreover, the current study showed that a higher proportion of indications of seeking medical care was associated with drugstores in the downtown area. Conclusion: We suggest initiatives that provide for a stricter control of the trade of eye care drugs, promotion of population education, and increased access to basic health care.

Comércio formal e perfil de consumidores de plantas medicinais e fitoterápicos no município de Itaqui - RS / Formal trade and profile of consumers of medicinal plants and phytomedicine in Itaqui Municipality, Rio Grande do Sul State, Brazil

O presente trabalho visou realizar um diagnóstico sobre os consumidores de plantas medicinais e fitoterápicos, abordando também alguns aspectos relacionados à comercialização, no município de Itaqui-RS. A coleta de dados foi efetuada em duas etapas complementares, centrada nos consumidores e estabelecimentos de comercialização, mais especificamente farmácias. Primeiramente diagnosticou-se o perfil dos usuários de plantas medicinais, através de questionário semi-estruturado que foi aplicado a 183 pessoas abordadas em áreas de circulação de moradores de todos os bairros do município; na segunda etapa, avaliou-se a comercialização e visão do comércio formal nas oito farmácias do município. De acordo com os resultados das entrevistas para a construção do perfil dos usuários de plantas medicinais observou-se que 71 por cento dos entrevistados ficaram na faixa etária de 21 a 60 anos e que a grande maioria apresenta renda mensal de até três salários mínimos; quanto ao uso de plantas na medicina popular, cerca de 82 por cento afirmaram terem obtido eficiência e que em caso de problemas de saúde 47 por cento procuram pelas plantas; quanto ao cultivo, 55 por cento dos entrevistados às cultivam em suas residências. Na segunda etapa realizada em farmácias, observou-se que a compra de fitoterápicos e plantas medicinais era realizada praticamente por mulheres, das quais 75 por cento adultas e 25 por cento idosas. Os chás mais vendidos foram principalmente os emagrecedores e digestivos e o valor gasto com esse tipo de produto ficou na faixa de R$ 1,00 a R$ 3,00. Conclui-se que existe mercado para plantas medicinais e fitoterápicos e necessidade de maiores informações referentes à forma de cultivo, correta identificação botânica, informações ao consumidor, qualidade e eficácia dos produtos e seu uso.

This study aimed to make a diagnosis of consumers of medicinal plants and phytomedicine, also addressing some aspects related to trade in Itaqui Municipality, Rio Grande do Sul State, Brazil. Data collection was performed in two complementary stages focusing on consumers and stores, especially drugstores. First, the profile of medicinal plant users was diagnosed through a semi-structured questionnaire which was applied to 183 people approached in areas frequently visited by inhabitants from different villages of the municipality; in the second stage, the trade and the view of formal trade was evaluated in the eight drugstores of the municipality. The results of interviews to build the profile of medicinal plant users showed that 71 percent interviewees were between 21 and 60 years old and most of them had monthly income of up to three minimum wages; as to the use of plants in folk medicine, around 82 percent stated to have had efficiency and, in cases of health problems, 47 percent searched for these plants; as regards cultivation, 55 percent interviewees cultivated medicinal plants in their houses. The second stage, carried out in drugstores, also indicated that phytomedicines and medicinal plants were purchased mostly by women, 75 percent adults and 25 percent elderly. The most sold teas were slimming and digestive teas, and the value paid for this type of product was between R$ 1.00 and R$ 3.00. In conclusion, there is market for medicinal plants and phytomedicine and there is also the need for further information related to their cultivation form and proper botanical identification, as well as information to users, quality and efficacy of products, and their use.

Analysis on the Role of Drugstores in the Drugs Reclaiming and Its Relevant System / 中国药房

OBJECTIVE: To provide reference for the establishment of system about remaining drugs reclaimed by designated drugstores.METHODS: The distribution characteristics and professional service of drugstores in China were analyzed as well as the drugs reclaiming in recent years.The system about designated drugstores reclaiming drugs was designed.RESULTS & CONCLUSIONS: Designated drugstores network should be established according to the principle of convenience and professional standards.The surplus drugs of households should be reclaimed by designated drugstores for free and disposed by special agency.The cost-sharing system should be established and education of drugs reclaiming should be carried out to promote continuous implementation of drugs reclaiming system.

Pharmaceutical Care in Drugstores from the Perspective of Drug Administration / 中国药房

OBJECTIVE: To explore approaches for further development of pharmaceutical care in retail drugstores by strengthening drug administration. METHODS: The main problems occurred in pharmaceutical care were analyzed from the perspective of drug administration. RESULTS & CONCLUSIONS: The main problems occurred in pharmaceutical care were the absence of laws and regulations related to pharmaceutical care,misalignment between the access criteria for retail pharmacy and the necessary conditions for pharmaceutical care. The development of pharmaceutical care could be promoted by perfecting current law system,enhancing the access criteria for running retail drugstore,and strengthening drug administration etc.

Premium Approaches for Private Brand of Chain Drugstores / 中国药房

OBJECTIVE: To provide references for Chinese drugstores to carry out private brand strategy. METHODS: The problems existing in the practice of private brand in Chinese drugstores were analyzed,and the basic conditions and effective premium approaches for private brand of pharmaceutical chain store were studied through a detailed analysis of consumer’s psychology and action. RESULTS & CONCLUSIONS: The problems existing in the practice of private brand in Chinese drugstores included the non-guaranteed quality assurance ability results from low price marketing and enterprise’s lack of cohesiveness results from enforcement on salesman to recommend products for customers etc. The main conditions to promote premium on private brand were to possess a consummate quality assurance system for products and services. The main approaches toward premium are to construct product line with drug brand image as foundation and to optimize the organization mode of the private brand management.