A quality audit of the medicinal package insert information of drugs marketed in India

Background: A package insert (PI) accompanying medicinal products is a concise and accessible source of evidence-based information for health professionals and consumers alike. In India, the supplied information should be adequate and fulfill the statutory regulations of the Drug and Cosmetics Rules (1945) to ensure the safe and effective drug use. Aim and Objectives: The present observational study aimed to evaluate the uniformity and adequacy of information on PIs available in India. Materials and Methods: PIs of approved and marketed drugs were collected from pharmacies and analyzed with the help of a 30-item checklist comprising of components of statutory guidelines and other quality indicators. Each item was assigned a weightage of two points if the information was complete, one if inadequate, and 0 if absent. The total score was calculated for each PI. Results: The median score of the 150 analyzed PIs was 41 (Inter quartile range, 36.00–45.25) out of a maximum value of 60. The major deficiencies observed were in providing missed dose instructions (91.33%), further reading resources (84.67%), supporting references (83.33%), and drug disposal instructions (76%). Other notable missing information were laboratory parameter interference (68.67%), clinical trial data (62%), adverse drug reaction reporting contact information (56.67%), and list of excipients (49.33%). Conclusion: There are important inadequacies in the clinical information provided in Indian PIs which can affect patient health and hinder rational drug use. Thorough evaluation and revision of the PIs is warranted to make them more reliable and popular among users.

The Medical Economic Effects of Two Pharmacists Checking Patient Medications Brought to Hospitals by Part of Inpatient Pharmaceutical Services / 医薬品情報学

Objective: Pharmacists in inpatient pharmaceutical services are required to evaluate the medications that patients bring with them to the hospital when admitted and to make recommendations to physicians about these medications' proper use. Many hospitals perform such inpatient pharmaceutical services. Studies have found that pharmacists with insufficient years of experience are often put in charge of this practice. This has resulted in patients continuing to take inappropriate medications. We hypothesized that the involvement of another pharmacist in checking outpatient medications brought to the hospital might lower the rate of inappropriate use. We initiated the rechecking of medications brought to the hospital by the drug information (DI) pharmacist, based on the need for cooperation between the DI pharmacist and ward pharmacists.Methods: We initiated rechecks by DI pharmacists of medications brought to the hospital and first checked by ward pharmacists, and estimated the medical economic impact of pharmaceutical intervention between 1 May 2019 and 30 April 2020.Results: Within one year, the DI pharmacist suggested 15 interventions, including four interventions related to digitalis products and three related to direct oral anticoagulants. The medical economic impact was estimated to be 10,175,000 yen.Conclusion: Our findings suggest that checking by another pharmacist of outpatient medications brought to the hospital is a useful addition to the check by ward pharmacists.

COVID-19: como informações baseadas em evidências auxiliaram um hospital terciário durante o primeiro ano pandêmico / COVID-19: how evidence-based information supported a tertiary hospital during the first pandemic year

Introdução: Durante a pandemia de COVID-19, a necessidade por uma informação confiável, rápida e precisa desafiou os profissionais de saúde de todo o mundo. O objetivo deste trabalho foi avaliar e comparar as solicitações dos profissionais da saúde realizadas a um Centro de Informação Sobre Medicamentos (CIM) em um ano pré-pandêmico e durante o primeiro ano pandêmico. Métodos: Trata-se de um estudo quantitativo e retrospectivo, que analisou as perguntas realizadas ao CIM do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (ICHCFMUSP) quanto ao seu assunto, classificação ATC dos medicamentos envolvidos e profissionais solicitantes. Resultados: Os resultados demonstram que, de maneira geral, durante o primeiro ano pandêmico houve um aumento de 454 perguntas (66,13%; p < 0,01). As dúvidas se referiam principalmente a questões de administração, estabilidade/compatibilidade e padronização do medicamento na instituição, sendo o farmacêutico o profissional que realizou maior número de questionamentos. Ao seccionar as perguntas, verificou-se que a maioria das informações solicitadas se referiram a agentes infecciosos, agentes que atuam no sangue/órgãos hematopoiéticos e sistema nervoso. Conclusão: Considerando o cenário pandêmico, com sobrecarga dos serviços de saúde, contratação em massa de novos profissionais e pouca disponibilidade de informações com embasamento científico, as evidências fornecidas pelo CIM, aliadas ao entendimento do quadro clínico de cada paciente, com certeza auxiliaram em um melhor desfecho clínico, bem como foram essenciais no uso racional de medicamentos no combate a pandemia de COVID-19.

Introduction: During the COVID-19 pandemic the need for reliable, fast and accurate information challenged healthcare professionals around the world. The aim of this study was to evaluate and compare the requests made by health professionals to a Drug Information Center (DIC) in a pre-pandemic year and during the first year of the pandemic. Methods: This is a quantitative and retrospective study that analyzed the solicitations made to the DIC of the Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (ICHCFMUSP) regarding its subject, ATC classification of drugs involved and requesting professionals. Results: The results show that, in general, during the first pandemic year there was an increase of 454 questions (66.13%; p < 0.01). The questions referred mainly to issues of administration, stability/compatibility and standardization of the medicines in the institution, being the pharmacist the professional who asked the most number of questions. When sectioning the questions, it was found that most of the information requested referred to infectious agents, agents that act on the blood/hematopoietic organs and the nervous system. Conclusion: Considering the pandemic scenario, with an overload of health services, large number of hires of new professionals and lack of availability of scientifically based information, the evidence provided by the DIC, combined with the understanding of clinical condition of each patient, certainly helped in a better outcome for each patient, as well as being essential in the rational use of medicines in the fight against the COVID-19 pandemic.

Descripción de la disponibilidad y normas para el uso de las benzodiacepinas en algunos países de América Latina, 2022 / Description of benzodiazepines availability and regulation in several countries of Latin America, 2022 / Descrição da disponibilidade e regulamentação para o uso de benzodiazepínicos em alguns países da América Latina, 2022

Resumen: Introducción: las benzodiacepinas constituyen un grupo farmacológico de amplia prescripción a nivel mundial desde su aparición en la década de 1960. El objetivo del presente estudio fue identificar la disponibilidad, las modalidades de prescripción y dispensación de benzodiacepinas en diferentes países de América Latina, según reglamentación vigente en cada país participante del estudio. Materiales y métodos: estudio observacional, descriptivo y transversal, realizado con los datos disponibles al año 2022 de todos los países miembros de la Red de Centros de Información de Medicamentos de LatinoAmérica y el Caribe (Red CIMLAC) que fueron parte del estudio. Se utilizaron las bases de datos de las agencias regulatorias, la reglamentación vigente y otros documentos necesarios para obtener la información sobre la dispensación y prescripción en cada país. Resultados: doce de los 20 países de la Red CIMLAC completaron el estudio. El total de benzodiacepinas disponible en cada país varió entre 6 y 12 (media: 9). De ellas, en promedio 5 estaban incluidas en listados de medicamentos esenciales nacionales. La mayoría de los países cuentan con combinaciones a dosis fijas con benzodiacepinas. En todos los países se realiza la prescripción por receta especial. Más de la mitad de los países cuentan con recomendaciones nacionales. Conclusiones: la amplia disponibilidad de benzodiacepinas comercializadas, la existencia de combinaciones a dosis fijas y la falta de recomendaciones nacionales pueden ser factores que contribuyan al uso irracional de este grupo terapéutico.

Summary: Introduction: benzodiazepines constitute a widely prescribed group of drugs around the world, since they appeared in the sixties. This study aims to identify the availability, prescription modalities and dispensing of benzodiazepines in different countries around Latin America, as per the legal provisions in force in each of the countries participating in the study. Method: observational, descriptive, transversal study based on the information available in 2022 about all the member countries of the Network Medicines Information Centers of Latin America and the Caribbean (CIMLAC Network) that were part of the study. The databases of regulatory authorities were used and the legal provisions in force and relevant documents were consulted in order to obtain information on benzodiazepines dispensing and prescription in each country. Results: twelve out of the 20 CIMLAC Network member countries completed the study. The total number of benzodiazepines available in the study ranged from 6 to 12 (mean was 9), and 5 of them on average were included in the national essential medications lists. Most countries have benzodiazepines fixed dose combinations and in all countries a special medical prescription is needed. More than half of the countries have national recommendations. Conclusions: the wide availability of benzodiazepines in the market, the existence of fixed-dose combinations and the lack of national recommendations may constitute factors that contribute to the irrational use of this group of drugs.

Resumo: Introdução: os benzodiazepínicos constituem um grupo farmacológico amplamente prescrito em todo o mundo desde seu surgimento na década de 1960. O objetivo deste estudo foi identificar a disponibilidade, prescrição e modalidades de dispensação de benzodiazepínicos em diferentes países da América Latina, de acordo com as regulamentações vigentes em cada país participante do estudo. Materiais e métodos: estudo observacional, descritivo e transversal, realizado com os dados disponíveis até o ano de 2022 dos países membros da Rede de Centros de Informação sobre Medicamentos da América Latina e do Caribe (Red CIMLAC) que faziam parte do estudo. As bases de dados das agências reguladoras, normas vigentes e outros documentos necessários foram utilizados para obter informações sobre dispensação e prescrição em cada país. Resultados: doze dos 20 países da Rede CIMLAC completaram o estudo. O número total de benzodiazepínicos disponíveis em cada país variou entre 6 e 12 (média: 9). Destes, uma média de 5 foram incluídos nas listas nacionais de medicamentos essenciais. A maioria dos países tem combinações de dose fixa com benzodiazepínicos. Em todos os países é necessário prescrição especial. Mais da metade dos países têm recomendações nacionais. Conclusões: a ampla disponibilidade de benzodiazepínicos comercializados, a existência de combinações em doses fixas e a falta de recomendações nacionais podem ser fatores que contribuem para o uso irracional desse grupo terapêutico.

Treatment of patients with neuropathic pain and provision of drug information by clinical pharmacists

Abstract Patient's satisfaction with healthcare services has an influence on pain management, which can be improved by patient education. Therefore, this study was aimed at identifying primary care health service opportunities in the treatment of neuropathic pain and assessing patients' satisfaction with the provision of drug information by clinical pharmacists. This was a cross- sectional, prospective study conducted at a pain unit during March-May 2017. Patients aged >18 years; diagnosed with neuropathic pain; and who used amitriptyline, gabapentin, pregabalin, or duloxetine were included. They were verbally informed about drug treatment by a clinical pharmacist, and their satisfaction was evaluated after 1 month. In all, 90 patients were included. The median duration for which the patients experienced pain until hospital admission was 3.6 years; furthermore, this duration was longer among women (p < 0.05). However, the median time to seeking advice from doctors was 3 months. The patients (15.6%) were less likely to admit pain unit initially and 46.7% had visited different units before being admitted to a pain unit. More than 95% of the patients indicated that they had received information from a pharmacist at a clinic and were satisfied with the provision of information (median duration, 8.5 min). Thus, the involvement of pharmacists in multidisciplinary pain management may help improve health- related outcomes at hospitals and/or in community care settings

Perceptions and Attitudes of Hospital' Prescribers towards Drug Information Sources and Prescribing Practices

Abstract Healthcare professionals use a variety of drug information sources to fulfill their clinical needs and medical practice. The aim of present study was to assess the sources of drug information among hospital' prescribers and evaluate their prescribing behavior in Saudi hospitals. A cross-sectional survey was conducted among randomly selected hospital' prescribers using a self-administered questionnaire. The response rate to the survey was 64.29%, with a ratio of 76.44% male and 23.56% female. The internet 137(60.89%) and textbooks 86(38.22%) were the prevalent sources for drug information used. Up-To-Date 107(47.56%), Medscape 105(46.67%) and FDA 74(32.88%) were the common electronic drug sources used. About 151(67.11%) of hospital' prescribers considered the pharmacist as a reliable drug information source. The most favored drug requests by hospital' prescribers from the pharmacists were drug alternatives 110(48.89%) followed by drug interactions 94(41.78%), side effects 78(34.67%) and indications 60(26.67%). Therapeutic efficacy 168(74.67%) and drug availability 73(32.44%) were the main factors contributed to the selection of drugs. This study shows some differences in hospital prescribers' perceptions of sources of drug information depending upon their background and clinical practice. Therefore, knowing appropriate drug information used by hospital' prescribers is fundamental for drug efficacy and safety in clinical practice.

Remote Working among Hospital Pharmacists: A New Way of Working / 社会薬学

Home-based and in hospital pharmacists at our hospital pharmacy participated in this study. A survey of the home-based pharmacists’ work contents was tabulated from November 2019 to May 2021. Furthermore, a questionnaire survey was administered within the pharmacy in May 2020. 90% of the hospital pharmacists would consider some drug information management to be able to work from home. Moreover, evaluation of the questionnaires revealed that more than 90% of the in-hospital pharmacists were “satisfied” or “somewhat satisfied” with deliverables of home-based pharmacists. The in-hospital pharmacists found communication tools (e.g., social networking services, telephone, and web-conferencing systems) to be useful for facilitating collaboration with the home-based pharmacist. Therefore, it is necessary to improve the internet environment to work from home. Moreover, it is important to create an environment where pharmacists can work from home according to their desire and needs in cases such as childcare, nursing care, during treatment, and during a pandemic. This study indicates that hospital pharmacists can carry out their responsibilities and demonstrate their work abilities not only in the hospital pharmacy setting but also in a remote working environment.

Actual Use of Internet by Patients with Diabetes to Find Drug Information / 医薬品情報学

Objectives: It is important for patients to make correct use of drug information (DI) to promote the proper use of medicines. Many patients use the Internet to find DI, but awareness about the websites of public institutions that provide DI is low. This study aimed to identify the actual use of the Internet for DI and associated problems to inform development of a comprehensive DI website for patients.Method: Patients with diabetes were set as a model case for patients who take medicines and need DI. A questionnaire survey was conducted among patients with diabetes who visited community pharmacies in Kagoshima City from March 2019 to October 2019. The survey covered Internet use, DI needs, methods of sourcing DI, and problems obtaining DI via the Internet.Results: There were 349 valid respondents (median age 64 years), of which 52.1% used the Internet at least once a week. Around half of the Internet users searched for DI on the Internet. More than half of these respondents chose a DI acquisition site because it “appeared at the top of search results” and was “easy to understand.” However, around half of these respondents felt that “there is too much information on the internet and I don’t know what is correct.”Conclusion: This study suggests that older patients with a long history of diabetes use the Internet to obtain DI. However, patients face various problems accessing DI via the Internet. It may be necessary to construct a comprehensive website that is easy to use and enhance public health literacy to support the proper use of medicines by patients.

Japanese Medical Academic Organizations Surveyed on the Current Situation of Medical Information Providedto the Public on the Internet / 医薬品情報学

Objective: The internet isflooded with drug information; however, some of it isinappropriate and thisinadequate information could expose the public to health hazards. Therefore, we conducted research on the idea of transmitting drug information to the public via the internet and the current state of the information currently provided by each academic society relevant to the field of Medical Informatics.Methods: A questionnaire was mailed to the website managers for the website of 129 specialist medical societies, all members of the Japanese Association of Medical Sciences. We conducted our research between October to November 2018. We investigated each website administrator’s opinion about offering drug information for consumers via the internet and what information each academic society is currently providing.Results: The effective response rate was 43.4% (56/129 groups). Most respondents thought that drug information overflowed in the current Internet society. Moreover, more than half of the respondents thought that the quality of drug information transmitted to the public wasinadequate. Currently, 30 of the academic groupssurveyed are providing information to the public. When providing information, they did not refer to the “Drug Guide for Patients” much. More than 80% of respondents said they would cooperate with linking to the information provided to the public. However, each academic society felt there would be many problems with doing so such as the need for a system to check the contents of the information provided and a system to perform maintenance.Conclusion: The results showed that the website administrators recognized that there is a need to improve the quality of and system for providing drug information to the public. We believe that an integrated information system can be constructed by aggregating the drug information held by each academic society. However, this cannot be realized without first solving many problems.

Needs And Utilization Of Drug-Information Resources Of Healthcare Providers In An Academic Tertiary Care Center

Objective: To investigate the drug-related information needs of healthcare providers (HCPs), their utilization of drug information resources as well as the main factors influencing the selection of resources. Methods: A total of 393 HCPs were conveniently selected and invited to complete a questionnaire. Stratified sampling was used for the three subpopulations of physicians, pharmacists, and nurses. The questionnaire was coded, validated, and analyzed using the Statistical Package for the Social Sciences (SAS version 9.2). Results: Of 450 HCPs approached, 393 completed the questionnaire (response rate 87%). Information related to drug dosage/administration, indications, and interactions is the most frequently required, 47%, 44%, and 34%, respectively. The majority of the sample perceived the Internet (69.47%) and electronic databases (67.43%) as “very useful.” Printed materials (46.56%) and Personal Digital Assistants (PDAs) (44.78%) or calling the pharmacy (43.26%) were also useful resources of information followed by using electronic books and journals (38.42%) and asking colleagues (32.32%). The majority (53.18%) described consulting a clinical pharmacist as “very useful.” However, 16% of the nurse group and 35% of the physician group were not aware of the existence of the Drug Information Center (DIC) and more than 8% of the participants consider calling the DIC about drug-related information “not useful”. Conclusion: Digital resources are used by HCPs more frequently than traditional resources, consulting a clinical pharmacist or calling the DIC. Providing reliable electronic resources and raising the awareness of HCPs regarding the role of a clinical pharmacist and DIC for patient-specific therapies should be instituted.

Trusting The Pharmacist In Delivering Medication Information: A Community-Based Perspective

Objective: Optimal disease management is influenced by a solid patient-health provider relationship; which includes trust in the provider. The study compares respondents’ trust in pharmacists and physicians for the delivery of drug information. Methods: Residents of 3 rural communities in Lebanon, aged 40 and above, were invited to participate in the study, 760 accepted. Participants were asked who they trust the most with information about their medication: their physician or their pharmacist. Results: Of the total sample, 154 chose the pharmacist as their most trusted source of medication information (20%). Characteristics associated with choosing the pharmacist were: being a male (29.3% vs 16.2% p<.001), of younger age (31.5% among<50 y, 18.8% among 50-64 y, and 14.6% among 65+years p<.001), single (31.6% vs 21.9% married and 9.3 others, p=0.023), working (39.2% vs15.7% p<.001), and insured (2.3% vs 16.4% p=0.048). The multivariate logistic regression model revealed that having a family member with hypertension (OR=1.86 95% 1.23-2.82), or cardiovascular (OR=3.39 95%CI 1.55-7.45) increased the likelihood of trusting pharmacists over medical doctor. On the other hand, a self-report of cardiovascular disease (OR=0.34 95% CI 0.12-0.95) and taking medication (OR=0.41 95% CI 0.25-0.67) were associated with a decrease in the trust in the pharmacist in favor of the physician. Conclusion: Although pharmacists are the drug specialists, the majority of the Lebanese rural community residents reported higher trust in their physicians with information about their medication(s).

What Kind of Information Do Patients and Consumers Want from the Internet About Medicines? / 社会薬学

The purpose of this study was to examine how pharmacists can help patients and consumers to obtain appropriate drug information online. We clarified what kind of information about medicines patients and consumers were seeking online. “Yahoo! Chiebukuro”, the largest knowledge sharing community in Japan, was surveyed. We extracted questions related to drugs and healthcare posted in the period of August 1-7, 2017. The survey period was from January to April 2019. Questions that could not be answered by the pharmacist’s clinical judgment were excluded. The content of the extracted questions was analyzed.The extracted 283 posts included 345 questions. Questions related to prescribed drugs comprised 69.0% of questions and questions related to over-the-counter drugs comprised 17.2% of questions. Overall, 69.9% of the questions required expert judgment to be answered properly, although 80% of questions were posted within the pharmacy opening hours. The breakdown of 180 questions on prescribed drugs included 48 (26.7%) questions on drugs that affect the nervous system and sensory organs, 28 (15.6%) questions on drugs against pathogenic microorganisms, and 27 (15.0%) questions on analgesic/anti-inflammatory/allergic drugs. With regard to annual turnover, it was revealed that an estimated 15,000 medical and health care consultations were made online. A pharmacist should give instructions for taking prescribed drugs based on the assumption that patients and consumers will search for information on the internet.

Development and Evaluation of a Consolidated Drug Information Management and Sharing System / 医薬品情報学

Objective: In this study, we aimed to develop a new system that can centrally manage and share drug information, and also evaluated its usefulness.Methods: Using PHP v5.3.3 as the programming language and MySQL v5.1.73 as the database, we built a web application that constantly runs on the server. Various drug information was registered in this system, and its usage status was analyzed based on the access log.Results: The system was accessed 31,678 times during the survey period (October 1 to December 31, 2019). The information sought included: basic drug information (ordering category of drugs, dosage forms and strengths, drug price, etc.) (13,962 times, 44.1%),question and answer records (7,221 times, 22.8%), pharmaceutical documents (package inserts, interview forms, documents regarding compatibility of injections, etc.) (7,172 times, 22.6%), notifications regarding new and discontinued drugs (727 times, 2.3%), websites (676 times, 2.1%), PreAVOID reports (663 times, 2.1%), pharmaceutical safety information (525 times, 1.7%), information regarding off-label drug use (409 times, 1.3%), and bibliographic information and guidelines (323 times, 1.0%). Among the users (62 pharmacists), 59.7% accessed the system only via a personal computer (PC), 38.7% via a PC and smart device (smartphone or tablet),and 1.6% via only a smart device. The median number of accesses to this system was significantly higher in pharmacists in charge of wards (190 [9-1,435]) or drug information (3,750 [2,957-5,548]) than dispensing pharmacists (68.5 [3-193]) (p＜0.001).Conclusion: This system allowed the central management and sharing of various drug information on the web, permitting access regardless of device type. Since this system was frequently used by pharmacists in charge of wards or drug information, this system was considered particularly useful in hospital pharmacist ward services and drug information services.

Assessment and Utilization of a Pharmacist-Assisted Drug and Poison Information Centre in Pakistan

Objective: To evaluate the utilization of the pharmacist-operated Drug and Poison Information Center (DPIC) services in Pakistan. Methods: All queries from 2015-2017 were retrieved from PharmAssist DPIC database and were retrospectively analyzed. The variables obtained for analysis were call types (drug or poison), type of callers, type of drug queries, and type of poison queries. Results: A total of 2209 queries were analyzed. The highest queries in the year 2015, 2016 and 2017 came from general public as 44.0%, 56.3%, and 80.6%, followed by consultants as 11.4%, 7.3%, 4.4%, general physicians as 7.20%, 3.40%, and 3.85%. Students and interns show least usage with students 2.20%, 2.30%, 0.29% and interns 0.27%, 0.23%, 0.09% in the year 2015, 2016 and 2017 respectively. The most frequent queries received at PharmAssist DPIC were related to miscellaneous queries (14.7%), indications (13.6%), strength (13.4%) and drug availability (12.1%). The majority of poison calls were for ingestion (80.3%), followed by animal bite (6.6%), dermal contact (5.5%), injection (2.2%) and inhalation (2.2%). Conclusion: It was concluded that as the awareness of our service enhanced, the utilization also increased. In order to have enhanced usage of the service, more frequent awareness activities need to be performed to have improved patient care.

Cost Analysis of Activities for Network Drug Information Centers at the Ministry of Health Hospitals in Saudi Arabia

Objectives: In this study, we aimed to analyze the cost of network drug information services at the Ministry of Health (MOH) hospitals in Saudi Arabia. Method: In this study, we simulated the 2-month cross-sectional survey data of all drug information centers at the MOH hospitals. Any drug store that has provided services to the healthcare professionals and the public participated in the questionnaire. National, regional and local drug information centers in the healthcare institutions participated in this survey. All type of hospitals or primary care centers (e.g. public, pediatric, maternity and psychiatry) were included in this study. The survey consisted of two parts: the first part collects demographics data and the second part analyzes the cost of activities of drug information centers. The clinical activities were derived from the model of the American College of Clinical Pharmacy (ACCP). The type cost consisted of related central drug information activities, the cost of the patient-centered drug information activity and the cost of Administrative drug information activities. All cost used US dollar currency. Results: The survey was distributed to 60 drug information centers and a total of 46 centers responded to the survey; the response rate was 76.66%. Most of the hospitals (11 (23.9%)) had 100–199 beds and the others (11 (23.9%)) had 200–299 beds. The total daily cost of drug information activities was 6,002.18 USD. The highest cost of drug information activities was central drug information activities (2,654.69 USD (44.23%)) followed by the administration of drug information activities (2,280.59 USD (37.99%)) and patient-specific drug information activities (1,066.9 USD (17.77%)). The highest daily cost of drug information activities among central drug information center was responding to drug information inquiries ((536.24 USD)) followed by the residential training ((9274.46 USD)) and pharmacist’s training ((263.14 USD)). Conclusion: The central activities of drug information centers costed the highest. Expanding the services to patient-specific activities will decrease morbidity, mortality and justify cost analysis at MOH hospitals in Saudi Arabia.

Cost Efficiency of National Drug Information Center Services Through Ministry of Health Hotline Calling Center (937) in Saudi Arabia

Objective: Since January 2013, the national drug information center (NDIC) has started providing services and since December 2013, it is answering all the public and professional inquiries made through the Ministry of Health (MOH)-Hotline Calling Services (937). Therefore, in this study, we explored the cost avoidance analysis of national drug information inquiries by the hotline services in Saudi Arabia. Methods: We simulated the drug information inquiries related to the adults and children for the duration of 12 months of 2014 through MOH-hotline calling services (937). At least 10 on-call clinical pharmacists and expert trained pharmacists were receiving calls made from public and professionals inquiring about drug information. The data were collected in the drug information data collecting form through manual documentation system of drug information inquiries. Results: The drug information pharmacist implicated that the high-cost avoidance at the public side came from the dose standardization (30,310 USD (37.5%)) of the total cost avoidance followed by the drug administration and adverse drug reaction (16,532 USD (20.45%) and 9,347.5 USD (11.56%), respectively), which represent more than 50% of the total cost avoidance from the public side. With regard to professional inquiries, the drug information pharmacist implicated that the highest cost avoidance was through inquiries related to drugs in pregnancy, which was around 7,527.50 USD (26%) of the total cost followed by the drug administration, drug–drug interaction and drug identification (4,792 USD (16.5%); 4,141.50 USD (14.3%); and 4,135.50 USD (14.2%), respectively), which represent more than 50% of the total cost avoidance from the professional side. Conclusion: NDIC was the first in calculating cost avoidance from answering drug information inquiries from professional and public separately in the Middle Eastern countries. It is highly implicated in the drug information services in the healthcare organization in the Kingdom of Saudi Arabia.

Study on the Problems and Countermeasures of the Construction of Drug Inform ation Traceability System in China / 中国药房

OBJECTIVE： To provide reference for the improvement of drug information traceability system in China. METHODS： Using “drug information traceability”“drug traceability”“electronic drug supervision” as keywords， related literatures，relevant laws and regulations about drug information traceability were retrieved from PubMed， CNKI， Wanfang database， VIP， Drug Supervision Department or Health Administration websites of USA， EU and China from Jan. 2014 to Apr. 2019. Compared with USA and EU， the problems of drug information traceability system in China were analyzed to put forward the countermeasures and suggestions. RESULTS & CONCLUSIONS：A total of 31 literatures were included. The drug information traceability system was established in USA， EU and China. USA and EU have the advantages of coding to be in line with international standards， making full use of third-party platforms to avoid forming monopoly， etc. Drug information traceability system was still in a crucial stage of improvement in China. There were still many problems， such as more specific operating standards and guidelines are needed， too many supply chain participants， uneven information level， drug information traceability system independent of the transaction， reimbursement and other information systems， and insufficient coordination. It is suggested to improve the relevant laws and regulations on drug information traceability system by drug supervision department as soon as possible， and give full play to the role of third-party platform， and establish drug information traceability platform based on drug trading platform so as to ensure the system to play an important role in deepening the reform of medical and health system， ensuring the supply of shortage drugs， promoting rational drug use and comprehensive supervision.

Survey of the Description of “Medication Guides for Patients” and “Early Post-Marketing Phase Vigilance” on Additional Risk Minimization Activities of Risk Management Plans / 医薬品情報学

Objective: The risk management plan (RMP) is a useful information source for healthcare professionals, including pharmacists, to ensure drug safety. The “risk minimization activities” (RMA) of the RMP are especially important elements for healthcare professionals. It is known that “Medication Guides for Patients” (MGP) and “Early post-marketing phase vigilance” (EPPV) are items listed as part of the RMA. However, the creation of MGPs and the implementation of EPPVs are not performed for all medicines. In a previous study, it was difficult to evaluate this sufficiently with the safety specifications. The aim of this investigation was to evaluate RMAs, especially MGPs and EPPVs, not in terms of the safety specifications of RMP.Methods: The previously published RMPs of 177 drugs were obtained on February 22,2016, and used in the analysis. The relationship between the creation of the MGP and the description in the RMA and the relationship between the conduct described in the EPPV and the description in RMA was investigated for each medicine.Results: An MGP was created in 151 of the analyzed drugs. Of these, it was not listed in the RMA of 40 drugs. In contrast, EPPV was not listed in RMA in 2 out of 33 drugs when underway. EPPV was described in the RMA of 33 of the EPPV finished drugs. The time lag from the end of EPPV until the revision of the RMP was 4.5 month son average.Conclusion: MGPs and EPPVs are created especially for drugs requiring patient education, information provision, or safety monitoring. Therefore, for drugs for which MGPs or EPPVs are required, they should be listed in the RMA. In this study, the time lag of RMP revision was also highlighted as a problem. In order to promote the utilization of RMP by pharmacists, these issues should be resolved.

The Safety Using Ritodrine for Long-Term Tocolysis / 医薬品情報学

Objective: Ritodrine, a β agonist, is a uterine tocolytic agent used to suppress preterm labor. In 2013, the European Medicines Agency (EMA) recommended that short-acting β agonists should be used for a maximum of 48 h. However, in Japan, they are widely used for long-term therapy (＞48 h). The EMA recommendation was informed to physicians by pharmacists. We retrospectively evaluated the safety of ritodrine by comparing outcomes before and after the provision of drug information (DI). We investigated whether the physicians' knowledge of the DI of ritodrine influenced performance, and affected the dose administered and the number of side effects reported.Methods: Women administered ritodrine for preterm labor between November 2011 and December 2015 were included in this single-centered retrospective study, which comprised two groups: before (Pre, from November 2011 to November 2013) and after (Post, from December 2013 to December 2015) DI provision. The frequency of cardiovascular side effects was the primary endpoint and the rate of long-term use was the secondary endpoint. The chi-squared test was used for statistical comparison and p＜0.05 was considered to indicate a significant difference.Results: The study comprised 91 patients administered ritodrine for preterm labor: 43 in the Post and 48 in the Pre. The frequency of cardiovascular side effects was 48.8 and 45.8 % in the Post and Pre, respectively (p＝0.64). The rate of long-term use was 65.1 and 79.2 % in the Post and Pre, respectively (p＝0.13).Conclusion: The DI provided by pharmacists increased physicians’ awareness of ritodrine use, which may have improved the safety of the drug. Thus, the provision of DI by pharmacists may enhance patient safety by promoting behavioral change in physicians.

Assessment and evaluation of drug information services provided by drug information centre at a multispecialty hospital in Erode, Tamil Nadu, India

Background: To evaluate the performance of Drug Information Centre (DIC) in providing quality drug information services to the health care professionals.Methods: It was a prospective study carried out for a period of six months (June-November 2017). The drug information services provided by the pharmacist at the DIC during ward rounds, direct access, telephone and mail were documented in the drug information request and documentation forms. The quality of drug information provided was assessed with the help of feedback questionnaire which was filled by receivers.Results: A total of 283 queries were received, with a maximum from ward rounds 140(49.47%). On evaluation, it was found that most of the queries were from physicians 207 (73.14%) followed by nurses 33(11.66%), pharmacists 26 (9.18%), patients 17 (6.07%). Among that 178 (62.89%) queries were received from department of general medicine. Most of the queries were intended to update knowledge 110 (38.86%) and for the purpose of better patient care 90 (31.81%). The time frame for an authentic reply ranged from minutes to 24 hours, where a maximum of 110 (38.86%) queries had sent a 24 hours deadline. The majority of the queries were for adverse drug reactions [ADR-60 (21.20%)] and most preferred resources were primary 188 (66.43%).Conclusions: The DIC has always presented and offered itself to be an impressive resource, which is used routinely as an information source by all levels of professionals involved in the health system, in addition to the patients themselves.