Investigation of the Legislation of Crimes Concerning Endangering Drug Safety in China

Zhao Hui 원광대학교 법학연구소 2023 圓光法學 Vol.39 No.2

The protection and improvement of drug safety is a major and realistic issue of concern to Chinese society and the public at present. Thus, the crimes concerning endangering drug safety are one of the key areas of Chinese criminal law. The Criminal Law of the People's Republic of China has been regulating crimes concerning endangering drug safety since 1979, and special activities have been carried out in practice to combat crimes concerning endangering drug safety. Although the criminal legislation on crimes concerning endangering drug safety changes frequently in China, its spirit of legislation and the developmental sequence is clear. Firstly, the main legislative form is the criminal code, supported by administrative laws and regulations. Secondly, the scope of criminal law shows a trend of gradual expansion, which is mainly reflected in the expansion of the object of crime and the scope of regulatory act. Thirdly, the time-point of intervention has been brought forward by the criminal law. Fourthly, the punishment tends to be more severe. In criminal legislation of China, the specific content of the crimes concerning endangering drug safety is mainly concentrated on the core crimes related to the act of producing or selling of counterfeit and substandard drugs. This article carried out a detailed analysis of the constituent elements and the controversial issues about these core crimes such as the crime of producing, selling or providing counterfeit drugs, the crime of producing, selling or providing substandard drugs, the crime of disrupting drug administration, the crime of neglecting duties in drug regulation, and other relevant crimes.

Safety Management Status among Nurses Handling Anticancer Drugs: Nurse Awareness and Performance Following Safety Regulations

Jeong, Kyeong Weon,Lee, Bo-Young,Kwon, Myung Soon,Jang, Ji-Hye Asian Pacific Journal of Cancer Prevention 2015 Asian Pacific journal of cancer prevention Vol.16 No.8

This study identified the actual conditions for safe anticancer drug management among nurses and the relationship between level of awareness and performance of anticancer drug safety regulations in terms of preparation, administration, and disposal. The respondents were 236 nurses working with chemotherapy in wards and outpatient clinics in five hospitals in and near Seoul. Safety regulations provided for the anticancer drug the Occupational Safety Health Administration (OSHA, 1999), as modified for an earlier study, were used. The results showed that the level of awareness and performance on the anticancer drug safety regulations indicate their preparation ($3.38{\pm}0.55$, $2.38{\pm}0.98$), administration ($3.52{\pm}0.46$, $3.17{\pm}0.70$), general handling and disposal ($3.33{\pm}0.54$, $2.42{\pm}0.90$) on a scale 0 to 5. Also, there were significant differences in job positions, work experience, type of preparation, and continuing education and a positive relationship between the level of awareness and nursing performance. Thus, nurses should receive continuing education on the handling of anticancer drugs to improve the level of performance following safety regulations.

식품의약품안전청의 의약품안전사용정보방 웹사이트 구축을 위한 컨텐츠 개발

지은희(Eunhee Ji),박효영(Hyo Yung Park),노혜진(Hyejin Noh),이동은(Dong Eun Lee),한나영(Nayoung Han),정소현(Sohyun Jeong),김인화(In-Wha Kim),신완균(Wan Gyoon Shin),오정미(Jung Mi Oh) 대한약학회 2012 약학회지 Vol.56 No.3

The purpose of this study was to construct database for a drug safety information website to serve as an access point of up-to-date resources for a wide variety of drug-safety information helping patients and healthcare professionals make well-informed decisions about medication use. All the contents developed were confirmed by the council of advisors who were the experts in drug safety. The detailed contents of database on frequently prescribed drug including 9 NSAIDs, 19 antibiotics, 24 cardiovascular, 21 metabolic, 14 respiratory, 20 digestive, 22 hormonal, 10 genitourinary, 10 anti-allergic, 27 antifungal/antiviral, and 71 neuropsychiatric agents were developed based on the approved drug labeling of the Korean FDA. A separately searchable database of drug-specific safety information for patients and health professionals was constructed for users in need of different depth of knowledge on using medications safely. The safety information on highly prevalent chronic diseases and drug classes was also developed. Finally the most recent global drug safety news was provided. The consumer directed information was developed in layman’s terms as means of proving user-friendly information. The creation of this type of website is part of the Korean FDA’s ongoing initiative to address and promote the safe use of medications for the public.

식품의약품안전청 약물유해반응 보고자료 분석

유기연,이숙향 한국임상약학회 2011 한국임상약학회지 Vol.21 No.2

In order to minimize such adverse drug reactions, governments and international organs have been on the watch for them. Also in South Korea, a system has been established in order that adverse drug reactions may be reported to Korea Food and Drug Administration(KFDA). This study is to analyze drugs to cause adverse reactions, the adverse reactions and patients concerned on the authority of the data of Korea FDA, which is expected to be the preliminary data on preventable adverse reactions. This study was conducted on the 74,037 cases of adverse drug reactions reported to Korea FDA between January 2007 and June 2010. Fentanyl, iopromide and tramadol caused adverse reactions with high frequencies. Oseltamivir showed a high frequency between 2009 and 2010 due to the influence of the new influenza A. Also, OTC drugs accounted for approximately 5% of the adverse reactions. In 2009, adverse drug reactions remarkably increased (2,106 cases; 10.1%) in infants and children due to the new influenza-A(H1N1). The patients aged between 31 and 64 accounted for approximately 55% during the given period. There was no significant intergender difference. In relation to regions, the adverse reactions most frequently occurred in the gastrointestinal system and the integumentary system for three and half years. In addition to anticancer drugs and immunosuppressive drugs that are known to cause adverse reactions frequently, not a few of OTC drugs and external preparations caused such reactions. In particular, the drugs containing specific ingredients caused adverse reactions more frequently than others from 2007 until the first half of 2010. It is advisable for prescribers to acquaint themselves with such adverse reactions and to prescribe drugs other than them. They also have need to sensibly cope with adverse drug reactions just in case they have no substitute drugs. In addition, patients also need to be trained to understand possible adverse reactions in order that they can sensibly accommodate them or choose healthcare services. The results of this study are expected to be helpful to minimize adverse drug reactions.

식품안전법제의 문제점과 개선방향

문상덕(MUN, Sang-Deok) 행정법이론실무학회 2013 행정법연구 Vol.- No.37

인간의 생존 유지와 건강 보호를 위하여 일상적으로 섭취하는 식품은 최소한 생명이나 신체에 대한 위험으로부터 자유로워야 한다는 조건을 충족해야 한다. 그런 까닭에 식품이 생산되어 소비되기까지의 전 과정에서 식품의 안전성을 확보하는 것은 국민 전체의 건강 및 안전과 직결되는 문제로서 최상위의 공익 중의 하나이고, 국가와 지방자치단체는 국민의 건강과 안전을 지키는 막중한 책임을 감당하면서 이를 담보하기 위한 고도의 식품안전법제와 시스템의 보완ㆍ개선에 진력하여야 한다. 본 논문에서는, 먼저 우리나라의 식품안전 관련 법제의 전개와 그 현황을 개관해 보았는데, 식품안전법제는 헌법을 정점으로 하여 국민의 생명과 건강의 보호라는 식품안전의 공익을 확보하기 위하여 기본법으로서의 식품안전기본법과 중심법인 식품위생법을 필두로 하여, 여러 분야의 식품관련 법제가 계속하여 제정ㆍ정비되는 등 상당히 체계적인 법제 발전을 이루어 왔다. 한편 식품안전법제에 기초하여 식품안전관리조직의 정비ㆍ일원화도 추진되었는바, 국무총리를 위원장으로 하는 식품안전정책위원회의 구성과 국무총리 소속의 식품의약품안전처의 확대ㆍ승격이 그 주요 내용이라 하겠다. 이어서 최근 새로 제정된 식품안전기본법에 관한 법적 검토를 시도하였는데, 이것은 향후 식품안전기본법의 발전적인 보완ㆍ개선을 통하여 한층 체계적이고 완비된 기본법으로서의 지위와 역할이 필요하다고 보았기 때문이다. 이 부분에서는 식품안전기본법의 기본법으로서의 위상과 역할에 부합하는 기본이념과 지도원칙 등을 보다 더 선명하게 제시할 필요가 있고, 식품안전정책위원회 구성상 한계를 극복하기 위하여 식품관련 위험평가의 객관성ㆍ공정성을 제고하는 방향으로 운영될 필요가 있으며, 산하 위원회 조직 등을 통하여 그에 관한 미비점들을 실질적으로 보완하여야 한다고 보았다. 마지막으로 식품안전기본법의 규정내용들이 식품위생법을 비롯한 식품안전관련 여타 법률(실시법)들과 체계조화적 관점에서 일부 중복 내지 혼선의 가능성이 있는 것으로 보이므로 이를 해소하는 차원에서 추가적인 법제정비가 필요하다고 보았다. 다음으로 식품안전법제에 있어서 필자 나름으로 선정한 주요 문제점과 개선사항을 제언하였는데 그 기본방향으로서, 식품안전관리의 체계성과 통일성ㆍ합리성을 도모하기 위하여 사전예방의 강화, 위해분석을 통한 과학적ㆍ객관적 접근, 현장 중심의 관점 중시, 정보공개와 공유를 통한 식품행정의 투명성ㆍ공정성ㆍ신뢰성 제고, 시민참여 유도와 민ㆍ관ㆍ사업자의 소통ㆍ협력을 증진하는 거버넌스(Governance)체제 확대 등을 설정하였다. 이어서 신고제 중심의 식품업체 진입규제를 식품안전 확보의 관점에서 재검토할 필요성을 지적하였고, 글로벌화에 따른 수입식품 안전조치의 강화책을 강구하도록 하며, 건강기능식품에 관한 법제 미비점 개선의 촉구, 첨단 식품안전시스템의 도입ㆍ활용과 법제 정비의 필요성, 식품관련 분쟁조정절차의 도입 등 식품분쟁해결절차의 보완 등을 제언하였다. 이러한 다양한 문제의식과 방책들을 통하여, 향후 우리나라의 식품안전법제가 종전의 단순한 위생ㆍ안전 중심에서 질병예방, 건강까지 아우르는 생애주기별 영양ㆍ식생활 관리로 식품안전의 패러다임이 전환되어야 함을 강조하였다. It is very important to secure the food safety to protect human life and health. Central and local governments which have policy-making and legal control power of food are responsible for it and they should make efforts to improve the legal systems of food safety. In this research, I tried to analyze the present situation and problems of the food safety laws and policies in KOREA. And I also tried to suggest several legal or legislative improvements for better food safety law system. First of all, I gave an overview of the food safety laws and policies in Korea. Mainly, Framework Act on food safety, The committee of Food Safety Policy, The Ministry of Food and Drug Safety(MFDS) etc. Second, I reviewed the legal or legislative problems in Framework Act on food safety such as the obscurity of basic ideas and leading principles, the overlap or confusion between Framework Act on food safety and Food Sanitation Act. Third, I suggested several improvement measures in food safety law systems. They are the tightening (up) of the entry regulation for food company and the safety measures of imported food. And I also suggested the legal improvements of health functional food and the introduction of dispute conciliation system of food.

천연물신약 개발에 대한 법적 규제의 적절성에 관한 소고

백경희(Baek, Kyoung Hee) 충북대학교 법학연구소 2019 과학기술과 법 Vol.10 No.2

While the economic and time costs of developing new drugs are so high that we can t imagine them, the success rate to final commercialization is extremely small. Natural Product-Derived Drugs discussed in this paper is to develop medicines using natural products extracted from living plants or animals. Natural products have been used as drugs used in human life on the level of traditional medicine during the history of humankind, so the safety and effectiveness of the human body have been confirmed. Therefore, the development of medicines using natural products has the advantage of shortening the development process required for general medicines. In addition, Korea has classified oriental medicine as a separate academic system within the dual system of the medicine, and excellent talents have received the education and are licensed as a oriental medical doctor. Therefore, Korea has an environment suitable for systematic and leading development of Natural Product-Derived Drugs from traditional Korean medicine compared with other countries. Nevertheless, within the current legislation, the definitions of natural products, herbal medicines, and crude drug preparations are different and their scope is unclear, and there are limitations in the development of Natural Product-Derived Drugs by specialists such as oriental medical doctors using traditional Korean medicine. In addition, Korea has deleted the existing preferences that have been granted to the Natural Product-Derived Drugs development process since 2017. For this reason, the current Natural Product-Derived Drugs development process is the same as the general new drug development process, and the situation of slowing down the speed of development Natural Product-Derived Drugs is occurring. This paper examines the process of developing Natural Product-Derived Drugs and the regulations on them, compares the US case with that of Korea, and examines the direction of proper regulation of Natural Product-Derived Drugs development process. In particular, Korea has a legislative system for nurturing oriental medicine with a dual medicine system. Therefore, we will examine how this situation interacts with the legislation on the development of Natural Product-Derived Drugs.

의약품 부작용 피해구제제도의 검토

류광해 忠南大學校 法學硏究所 2021 法學硏究 Vol.32 No.2

A man who is injured by side effects of drugs, can be relieved by liability system on Civil Act. But A lot of problems lie in these system, such as difficulty in presentation of evidences. Furthermore generally it is said that every drug may have side effects. So in case of using drugs normally, the liability system on Civil Act cannot be applied, because there is no error in using drugs. Another liability system on Product Liability Act also cannot be applied in case of using drugs normally. Because when drugs are made safely based on technolygical level and economical efficiency of the time, it can be estimated that there is no defect in drugs. So in case of using drugs normally, the liability system on Product Liability Act also cannot be applied, because there is no defect in drugs. So the relief system on Pharmaceutical Affairs Act is enacted to solve these problems. I made a general survey on the relief system on Pharmaceutical Affairs Act, and investigated problems and improvement programs of the relief system on Pharmaceutical Affairs Act. As a result I concluded as follows: Firstly it is needed to enact clearly the concept of side effects of drugs. The concept of side effect of drus should be interpreted not only when causal relationship between drugs’ side effects and sufferer’s injury is clear, but also the relationship is obscure in order to relieve sufferers. Secondly I concluded that relief decision is made by a organ or council belong to The Institute of Drug Safety and Risk Management, not by Deliberative Council on Side Effects of Drugs under the jurisdiction of the Ministry of Food and Drug Safety. Thirdly it is needed to improvement the members and decision quorum of Deliberative Council on Side Effects of Drugs. Fourthly I think that the defendant in lawsuit is a president of the Institute of Drug Safety and Risk Management, not the Institute itself. Fifthly I think that medical specialist must attend the administrative adjudication counsel which is dealing a concrete legal case. In the corona 19 pandemic situation, I hope this study contribute to improvement the relief system of injury from side effects of drugs. 의약품 부작용으로 피해를 입은 사람을 구제하는 법적 제도로 먼저 생각할 수 있는 것은 불법행위책임 등 민법상의 구제제도와 제조물책임법상의 구제제도를 생각해 볼 수 있다. 먼저 민법상의 책임으로는 불법행위 책임, 채무불이행 책임, 하자담보책임, 불완전이행 책임 등을 생각할 수 있는데, 이러한 책임이 인정되려면 의사나 약사의 고의·과실이 인정되어야 하는데 이를 인정하기가 현실적으로 매우 곤란하다는 점이 가장 큰 문제점이다. 특히 의약품의 경우 정상적으로 사용하는 경우에도 부작용이 발생할 수 있다는 점이 일반적으로 인정되고 있는데, 이러한 부작용의 경우 의사나 약사의 위법성, 고의·과실, 인과관계를 인정하기가 사실상 불가능하고, 이를 가지고 하자라고 볼 수 없다. 따라서 민법상의 여러 제도는 의약품 부작용에 따른 피해 구제에 한계가 있으며, 나아가 약물유해반응의 경우 그 구제가 불가능하다는 근본적 문제가 있다. 다음 제조물책임법상의 책임에 대해서 보면, 제조물책임이 인정되려면 결함’이 인정되어야 하는데, 의약품의 정상적인 사용으로 인한 부작용을 결함으로 볼 수 있는가 라는 점에서 근본적인 문제점이 생긴다. 의약품 유통 당시의 기술 수준과 경제성이 비추어 기대가능한 범위 내의 안전성과 내구성을 갖추었으나 전혀 예상하지 못한 부작용이 발생한 경우 이를 가지고 제조물책임의 요건인 결함으로 평가하기가 힘들기 때문이다. 제조물책임법도 의약품 부작용, 특히 약물유해반응의 경우 피해구제에 별 도움이 되지 못한다고 평가된다. 약사법상의 피해구제제도는 이러한 민법 또는 제조물책임법상의 문제점을 해결하기 위해 만들어졌다. 이 논문은 민법과 제조불책임법상의 구제제도의 한계를 먼저 살펴보고, 약사법상의 피해구제제도를 개관한 다음 현재 시행되고 있는 약사법행 약사법상의 피해구제제도의 개선점에 대하여 살펴보았다. 먼저 약사법상이 피해구제제도의 개선점으로 생각된 것은 의약품 부작용의 개념이다. 의약품과 피해 사이의 인과관계가 분명한 경우에만 의약품 부작용으로 볼 것인지 아니면 인과관계가 불분명한 경우에도 부작용으로 볼 것인지가 문제된다. 인과관계 입증의 어려움, 판례의 완화된 태도 등을 고려하면 의약품 부작용의 개념을 넓게 해석하여 의약품과 피해 사이에 인과관계가 불분명한 경우에도 의약품 부작용으로 보아 피해구제를 받을 수 있도록 해야 한다는 결론에 이르렀다. 그 외 약사법상 피해구제제도의 개선점으로는 피해구제급여의 결정기관을 현행 식품의약품안전처 산하의 의약품 부작용 심의위원회나 중앙약사심의위원회가 아닌 독립 법인인 의약품안전관리원 산하의 기관으로 변경할 필요가 있으며, 현행 의약품 부작용 심의위원회의 구성과 의결정족수를 개선할 필요가 있고, 해석상 항고쟁송의 피고는 의약품안전관리원의 장이 되어야 하며, 의약품 부작용 관련 행정심판에는 의료전문가인 의사가 반드시 참여하도록 관련 법이 개정되어야 한다는 결론에 이르렀다. 코로나 팬데믹 상황에서 이 연구가 의약품 부작용 피해구제제도의 개선에 다소나마 기여할 수 있을 것이라고 생각된다.

한의약품 제조규제의 강화

선정원(Sun Jeong Won) 행정법이론실무학회 2012 행정법연구 Vol.- No.32

의약품은 질병으로 야기된 신체의 비정상성을 교정하는 기능을 갖기 때문에 식품과 달리 일상적으로 복용하거나 잘못 복용하면 오히려 건강을 해치게 된다. 의약품의 이러한 특성은 한의약품의 경우에도 타당하지만 우리나라에서 양약과 달리 한의약품의 제조에 관해서는 전통을 그대로 수용하였을 뿐 현대 과학기술사회에 적합한 규제가 거의 이루어지지 못했다. 대법원은 최근 당뇨병환자가 한약을 복용하여 간손상을 입고 손해배상소송을 제기한 사건에서, “한약의 위험성은 한약의 단독작용으로 발생할 수도 있지만 환자가 복용하던 양약과의 상호작용에 의하여 발생할 수”도 있다고 판시하였다·(대법원 2011.10.13. 선고 2009다102209 판결) 이 판결은 의료계에서 의사와 환자들 사이에서 오랫동안 다투어지던 어떤 종류의 한의약품의 간손상위험성을 국가 기관이 최초로 인정한 것으로 한의약품 제조규제의 현대화 필요성을 우리 사회에 강력하게 시사한 것이라고 평가할 수 있을 것이다. 경험을 기반으로 형성된 한의학을 과학적 실험의 기초위에서 규제를 하는 것은 자칫 급진적이어서 한의학의 소중한 자산을 죽이는 악영향을 미칠 우려도 있다. 때문에 현실을 충분히 고려하면서도 단계적으로 규제를 강화해가야 한다. 1906년 미국의 최초 식품의약법은 식품과 의약품의 제조 및 유통의 금지를 위한 개입기준으로 불량조성(Adulteration. 不良組成)과 부정표시(Misbranding)를 규정하고 의약품의 표준과 규격으로서 약전을 제정하여 유사의약품의 범람으로부터 의약품의 균질성을 보호하려 하였다. 미국의 1906년 식품의약법에서 의약품규제와 관련하여 현대과학지식에 근거를 두고 도입 된 이 규제기준들과 과학적 지식위에서 약전을 제정한 입법적 실험은 우리 한의약품의 제조규제의 설계와 한약전의 현대화를 위해서도 중요한 시사를 준다고 할 것이다. Most of pharmaceuticals, dissimilar to foods, have poison in a certain degree. When someone takes wrong-made pharmaceuticals or makes a mistake in taking them, they can be very harmful to his health. Korean traditional drugs can have poisons, but nevertheless, they have been sold by korean oriental doctor without making permission prior to marketing them. Korean Supreme Court decided recently, "korean traditional drugs can do damage to one"s health by them alone or with western drugs which patients take", in the case, that sugar diabetes patient took a korean traditional drug, and suffered injury of liver.(Korean Supreme Court decision 2009 Da 102209 Delivered on October 13, 2011) This decision has a huge historical meaning, that the Korean Supreme Court admitted, some of korean traditional drugs have liver damaging effect. Korean traditional drugs must be scientifically tested about their safety and efficacy prior to selling them in the market. U.S. Federal Food and Drugs act of 1906 regulated adulteration and misbranding as criteria for prohibition of drug making and marketing. The act enacted a provision about the drug formulary, and tried to protect homogeneity of drugs. Korean traditional drug formulary is very old-fashioned, and too short to protect safety and efficacy of korean traditional drugs. The formulary is too short of explanation about components of drugs, and does not include explanation about side effect of drugs. Korean National Assembly must introduce scientific regulation of traditional drug making, and modernize korean traditional drug formulary.

국내 항암제의 임상현황 및 항암제 임상시험 가이드라인

박인숙,김동섭,최기환,왕소영,임화경,오우용,김소희,강주희,방영주,김주일,Park, In-Sook,Kim, Dong-Seop,Choi, Ki-Hwan,Wang, So-Young,Lim, Hwa-Kyung,Oh, Woo-Young,Kim, So-Hee,Kang, Ju-Hee,Bang, Yung-Jue,Kim, Joo-Il 대한임상약리학회 2002 臨床藥理學會誌 Vol.10 No.2

The enormous cost, intensive time, and constant efforts are required the drug discovery and development of bringing new drug products to the marketplace. The past several years, KFDA approved new drugs developed by local pharmaceutical industries; that is Sunppla, Factive etc. In addition to, investigational new drug application (IND) was established to accelerate new drug development and harmonize with international standards in 2002. At this point of time it is urgent problem to develop ability of reviewing new drug applications (NDAs) scientifically and appropriately to ensure that new drugs are safe and effective. There are many scientific issues embedded in new drug approval process from non-clinical studies to phase 3 clinical trials; 1) sample size, 2) application of end point, 3) statistical method, and etc. However the overall relation between protocols/reports of clinical trials and the characteristics of domestic medical system has fully not been studied. There is also, no references or data for the point to be considered in drug approval process. On this background, the objectives of this study are introduction of guidelines for the requirement for approval or evaluation of safety/efficacy in other countries and presentation how to practice clinical trial for new oncologic products in the present situation of clinical trial. We hope that the guidelines contribute to providing methods of clinical trials and procedures, and evaluating method to develop chemotherapeutic agents.

의료기관 의약품 부작용 발생 공유 및 중재, 약물안전카드 발급시스템 현황 조사

두고은,석정연,조윤숙,조윤희,강래영,김현지,진현정,박소영,최민정,서영은,문보경,최지홍,강민규,강민경,민미나,김우경,강균화,이경은,김수진,이재천,김윤희,김홍태,유기동,서윤이,이경운,손현아,이영희,아영미,이주연 한국병원약사회 2022 병원약사회지 Vol.39 No.3

Background : This study aimed to investigate the current status of adverse drug event (ADE) history sharing, intervention, and drug safety card issue system in medical institutions. Methods : A total of 126 member hospitals of the Korean Society of Health-System Pharmacists (response rate 25.9%) participated in this survey. Results : The survey results showed that 87.3% of the respondents had an ADE report system and most of them assessed causality (83.9%) and severity/seriousness (67.8%). About 85.6% of hospitals had a clinical alert or information system for prescriptions related to previous ADE history. Hard stop, soft stop, and passive alerts (information only) were generated in 11.0%, 38.1%, and 62.7% of the respondent hospitals, respectively. The criteria for generating alerts were mostly based on causality or severity/seriousness. Among hospitals with an ADE report system, 41.5% had a system issuing drug safety cards (Adverse drug reactions card, ADRs card). Among hospitals issuing ADR cards, 71.4% and 51.0% used causality and severity/seriousness assessment on the decision to issue, respectively. Frequent drug classes for which ADR cards were issued were contrast agents, antibiotics, and non-steroidal anti-inflammatory drugs. Identified barriers to implementing the ADR card issue system were the absence of standard guidelines, lack of awareness, and shortage of manpower. Conclusion : ADE report system was well established in 87% of respondent hospitals but around 40% of them had a system for issuing ADR cards. To extend the issuance and use of ADR cards, it is necessary to develop a standard procedure for recording, reporting ADRs, and issuing ADR cards.