A successful community hospital program for monitoring adverse drug reactions

All health care professionals are responsible for reporting ADRs. The physician records these events in the patient's medical record. In the monitoring program at Meriter Hospital, pharmacy responsibilities include review and assessment of all reported ADRs. When appropriate, the ADR is reported to the FDA. The pharmacy department maintains ADR statistics, reports quarterly to the P&T committee, and disseminates information to appropriate hospital committees and departments. The P&T committee supports the ADR monitoring program and policy. This committee reviews all ADRs and recommends action plans. The ADR monitoring program has successfully increased the number of ADRs reported, and actions resulting from ADR reports have had a positive impact on patient care.     

Multidisciplinary program for detecting and evaluating adverse drug reactions

An adverse drug reaction (ADR)-reporting program involving detection of charted ADRs by quality assurance nurses and data collection and causality assessment by staff pharmacists is described. The voluntary ADR-reporting mechanism used in a 900-bed, university-based hospital complex produced less than one ADR report per month. The newly implemented system depends on nurses to detect and report documented ADRs through concurrent chart review. Staff pharmacists are then responsible for follow-up chart review, data collection, and causality assignment based on two published algorithms. An inservice education program designed to increase the awareness and understanding of ADRs was provided to the department of pharmacy and the quality assurance nurses. The clinical staff provides quality assurance through weekly ADR committee meetings. Drug information center personnel complete the causality algorithms by using the data collected by the staff pharmacists. The ADR committee then compares the algorithm results of the two assessors. Discrepancies in scoring are evaluated to determine whether a change in the system is necessary. An FDA report is generated if the staff pharmacist assessor and the drug information center assessor obtain results of "probable" for both algorithms. An ADR-reporting program that relies on quality assurance nurses to detect charted ADRs and on staff pharmacists to evaluate reported ADRs increased the average number of ADRs reported from 0.4 to 20 per month.     

Improved reporting of adverse drug reactions

A program using satellite pharmacists to improve adverse drug reaction (ADR) reporting in an 1100-bed teaching hospital is described. Because relying on physicians to report ADRs had met with little success (only six reports in seven years), the pharmacy department proposed that pharmacists in satellite pharmacies on patient-care units be called upon to identify and report ADRs. To begin this program, an ADR team composed of a physician, pharmacist, and nurse made weekly rounds of the satellite pharmacies to assist pharmacists in identifying potential ADRs. The FDA definition of an ADR was adopted. Also, inservice education programs about ADR reporting were conducted for pharmacists and nurses. Currently, suspected ADRs are reported to the satellite pharmacist, who forwards a completed drug reaction report form to the assistant director for clinical pharmacy services. Reports are discussed quarterly by the ADR subcommittee of the pharmacy and therapeutics committee; the sub-committee members determine whether any follow-up action is needed. In the first three years after implementation of this program, 306 ADRs were reported; 90% of the reports were filed by pharmacists. An ADR reporting system based on reporting by staff pharmacists has been effective in increasing the number of reported reactions and pharmacist involvement in monitoring patients for ADRs.     

Use of standardized screening procedures to identify adverse drug reactions

The development of an adverse drug reaction (ADR)-monitoring program using standardized screening procedures in a 650-bed hospital is described. A concurrent ADR-reporting system that relied on health-care professionals to report observed ADRs to the pharmacy had generated just two ADR reports during the previous year. The pharmacy developed a program that used standardized procedures to screen for ADRs. The Technicon computer was programmed to screen the previous day's orders for antidotes or "tracer" drugs. In addition, pharmacists screened all laboratory reports of serum drug concentration determinations and positive tests for Clostridium difficile toxin. Spontaneous reporting of ADRs by nurses and physicians was strengthened by use of a revised notification form, newsletters, and inservice-education programs. During the first seven months of the program, 298 ADRs were identified, 15 of which were submitted to FDA. The standardized screening procedures accounted for 149 reports. Pharmacists reviewed an average of 21 reports of high serum drug concentrations each month; on average, 11 of these reports involved ADRs. Screening of microbiology laboratory reports identified 29 ADRs. Physicians reported ADRs infrequently and were likely to report only serious or unexpected reactions. Nurses and pharmacists identified reactions sporadically. Quality assurance auditors were consistent in screening ADRs, but not all reported reactions proved to be ADRs. The use of standardized screening procedures was effective in this pharmacy-based ADR-monitoring program.     

Food and Drug Administration monitoring of adverse drug reactions

Food and Drug Administration requirements for reporting adverse drug reactions (ADRs), processing of ADR reports, and actions in response to these reports are described. FDA requires that drug manufacturers report ADRs to the FDA Division of Epidemiology and Surveillance; 90% of the ADR reports received are from manufacturers. Of the remaining 10%, one third are from pharmacists. FDA regulations were revised in 1985 to specifically define reportable ADRs and procedures for reporting; manufacturers are required to report within 15 days reactions that are serious and unlabeled. For newly approved drugs, reports on ADRs must be submitted quarterly for three years; subsequently, annual reporting is required. Any increase in the frequency of serious, labeled reactions must be reported. Serious reactions not listed in the product labeling must be reported for products marketed before 1962 for which new drug applications or abbreviated new drug applications were not filed. ADR information received by FDA is coded into standard terms and entered in a computerized database for evaluation by reviewers. If an important reaction is suspected, the report is entered in a tracking system for further monitoring. ADR reports may result in requirements for changes in product labeling, "Dear Doctor" letters, requirement of further study by the manufacturer, or withdrawal of the product. Information about ADRs is communicated to health-care practitioners in product labeling and in the literature. Pharmacists are encouraged to report suspected serious and unlabeled reactions to FDA so that the medical community and the public can benefit from current information about drug safety.     

Pharmacy-coordinated program that encourages physician reporting of adverse drug reactions

A pharmacy-coordinated program for encouraging physician reporting of adverse drug reactions (ADRs) is described. The ADR surveillance program at the Medical Center Hospital of Vermont, a 500-bed tertiary-care hospital, is in its fifth year. Key elements are close interaction between physicians and pharmacists, feedback, program promotion, and financial incentive. The program is promoted chiefly to house staff physicians. A physician may identify a suspected ADR, or he or she may be alerted by a pharmacist. The physician completes the first part of a form, which requests information on the patient, the severity of the reaction, the actions taken, and any predisposing factors. A pharmacist reviews the incident independently and in consultation with the reporter and then completes the second part of the form, which asks the pharmacists to assess the probability that the drug caused the ADR and to classify the reaction. A summary is sent to the physician and may be reported to the FDA and the manufacturer. Each report earns the reporter a $5 stipend. Information from the ADR forms is entered into a dBASEIII PLUS computer program for later retrieval and analysis. During a 12-month period, 175 ADR reports (out of a total of 249 reports) were received from house staff members, compared with about 4 voluntary reports received annually before the program began. The ADR surveillance program has increased physician reporting of ADRs and produced a reliable database that can be used to influence hospital policy and promote education.     

Adverse drug reaction reporting system: developing a well-monitored program.

The spontaneous reporting of adverse drug reactions (ADRs) at the St. John's Hospital and Memorial Medical Center was well below that reported in the literature. After review of procedures for reporting of ADRs at these institutions, the authors developed a system that was approved by their joint P & T Committee. The ADR reporting program developed uses concurrent monitoring of most hospital inpatients and a retrospective review of all emergency room patients. In the year after program implementation, 162 ADR reports were documented. From this program, a group of serious ADRs to one agent was identified and reported, both to the Food and Drug Administration and to the manufacturer. A well-developed ADR monitoring program may lead to heightened physician and nurse awareness and early problem identification, possibly decreasing morbidity for hospitalized patients.     

Program coordinated by a drug information service to improve adverse drug reaction reporting in a hospital

A program coordinated by a drug information service to improve adverse drug reaction (ADR) reporting in a hospital is described. At a 520-bed teaching hospital, the drug information service was asked to design a new adverse drug reaction reporting system that would encourage clinicians to report ADRs. A new system was implemented on a general medical unit: A physician, pharmacist, or nurse telephoned the drug information service when an adverse drug reaction was suspected, and drug information personnel followed up on the report, completing all subsequent investigation and documentation. A standard algorithm was used to evaluate causality of the reported reactions. Pertinent data were entered on a form and retained in the drug information service. The primary physician's approval was obtained before a reaction could be reported on an FDA drug-experience form. Drug information service personnel reviewed the ADR data monthly to detect any trends that clinicians should be aware of and to prepare a report for the pharmacy and therapeutics committee. Nurses, physicians, and pharmacy personnel were oriented to the new system before its implementation and were subsequently informed about reported ADRs and use of the system through newsletters and meetings. In the initial three-month period, 23 ADRs involving 19 drugs were reported from the medical unit; in a six-month period before development of the new system, no ADRs had been reported. This ADR reporting system developed and implemented by the drug information service was effective in improving reporting of adverse drug reactions.     

A description of a successful computerized adverse drug reaction tracking program

The University of Illinois Hospital Drug Information Center recently began using a database software program (File Express, Version 4.0, Redmond, WA) for storing and retrieval of reported adverse drug reactions (ADRs). Important features of the software program include the capability of easily generating reports, rapid sorting of data, large storage capability, minimal startup cost, and a user friendly menu system. The number of reported ADRs increased from 24 in 1987 to 124 in 1988 due, in part, to increased educational efforts, revision of the ADR reporting form, and cooperation from the medical records department in identifying reported ADRs during chart review. Overall, pharmacists were found to report most of the ADRs. Retrospective analysis of the ADR reports may help identify trends in ADRs based on the drug and route of administration. A decrease in the incidence of some ADRs and, thus, improved patient care, may result as the information obtained from the computer-based ADR reporting system is shared among healthcare professionals.     

Impact of the development of a multidisciplinary adverse drug reaction committee

A multidisciplinary Adverse Drug Reaction (ADR) committee consisting of pharmacists, nurses, and physician was formed. The committee developed an ADR Reporting Form and a 24-hour ADR Reporting Hotline to simplify ADR Reporting throughout the hospital. An ADR Newsletter and an extensive inservice education program was also implemented. Suspected ADRs are investigated by a pharmacist and presented to committee. A formal report is then forwarded to the Pharmacy and Therapeutics Committee, as well as the clinical departments within the hospital. The establishment of a formalized multidisciplinary ADR committee was successful in generating 2.1 ADR reports per 100 hospital admissions. These ADRs were reported from a variety of healthcare professionals.     

Hospital pharmacy compliance with JCAHO standards and ASHP guidelines for reporting adverse drug reactions.

The extent to which institutional pharmacies comply with the accreditation standards of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and the ASHP guidelines for reporting adverse drug reactions (ADRs) was evaluated. A survey was mailed to directors of pharmacy at 444 randomly selected hospitals to collect information on their institutions' ADR programs; the survey addressed each point in the JCAHO accreditation standards and the ASHP guidelines. The 176 usable responses indicated that 89.8% of the institutions met all three of the JCAHO standards and 98.9% met at least two of them; 28.4% of the institutions complied with all 11 of the ASHP guidelines, and 89.2% complied with at least eight of them. Approximately 97% of the institutions had policies for ADR reporting. Respondents reported an average of 70.5 ADRs per hospital during 1989, of which 6.8 per hospital were reported to the FDA. More than 95% of all respondents indicated that they most frequently identified ADRs through voluntary reporting by health-care professionals. Respondents indicated methods and individuals responsible for reporting ADRs, notifying the physician and the FDA, and assessing severity and causality. Sixty-seven percent of the respondents indicated that they did not have a formal ADR committee for monitoring and evaluating ADRs. Almost 90% of the surveyed hospitals complied with all of the JCAHO standards for ADR reporting programs and at least 8 of the 11 ASHP guidelines for ADR monitoring and reporting.     

Quality assurance through adverse drug reaction reporting: improving hypnotic prescribing

While adverse drug reactions (ADRs) contribute to excessive health care costs through increased patient morbidity and mortality, most hospital ADR reporting programs are ineffective in documenting the adverse reactions to drugs that occur in their institutions. Furthermore, the ADR reporting programs have an untapped potential as a quality assurance (QA) tool; ADR reports provide a means of identifying potential problems in patient care. If 10-20% of hospitalized patients develop adverse effects while taking medications and over 50% of the iatrogenic events are avoidable, educational strategies and prospective monitoring could reduce this significant cause of patient morbidity. At Memorial Hospital (Ormond Beach, FL), routine QA screening detected a potential problem with the use of Halcion (triazolam). A plan of action, which included a drug use evaluation (DUE), educational efforts, and hypnotic prescribing guidelines was developed to address and resolve the concerns raised by initial ADR reports.     

眼耳鼻喉科专科医院药品不良反应报告调查

目的：研究我院药品不良反应报告的特点,以期对临床安全用药提供参考。方法：收集我院上报国家药品不良反应网络的报告250例,对报告来源、ADR表现、怀疑药物、潜伏期、类型、识别方式等进行统计分析。结果：药师报告占67.2%,高于医生（9.2%）和护士（23.6%）;＂新的＂报告15例（6.0%）,＂严重的＂报告11例（4.4%）。皮肤及其附件反应占63.2%,居于首位,胃肠系统反应占13.0%,列第二位。从ADR涉及的怀疑药物统计,全身用抗菌药物列于首位,占48.8%,眼科用药列于第二位17.7%,主要为眼科诊断试剂。具有药源性特征强、潜伏期短以及背景发生率低的ADR报告比例列于前位,更容易被识别上报。结论：进一步加强医务人员的对于ADR知识的培训,并结合我院的专科特点,积极探索ADR发掘的途径,了解ADR发生的特点,提高对ADR识别、判断能力,从而加强ADR监测和临床用药安全。     

临床药师对我院呼吸科药品不良反应监测和处置的影响

目的：根据我院呼吸科药品不良反应（ADR）报表,分析专职临床药师对临床药品不良反应的监测和处置的影响。方法：自我院药品不良反应监测中心调取2006年4月-2008年3月ADR报告,对呼吸科临床药师参与临床常规工作前后的ADR情况进行回顾性调查与分析。结果：临床药师参与临床常规工作前（第一阶段）ADR报表为8例,且均为一般ADR。临床药师参与临床常规工作后（第二阶段）ADR报表增至43例,其中由临床药师上报的占67.44%,一般和严重ADR分别占72.41%和27.59%。51份ADR涉及的可疑药物以抗肿瘤和抗感染居多,分别占39.22%和23.53%;静脉途径给药发生的ADR占总计的66.66%。结论：专职临床药师参与临床常规工作后,提高了ADR的监测水平,有助于及时应对ADR,促进合理用药。     

2009—2011年224例药品不良反应报告分析

目的:探索医院药品不良反应(ADR)报告和监测工作规律和新模式。方法:回顾2009—2011年ADR报告共224例,从不同角度分析比较各年度ADR报告特点。结果:报告数量逐年增加;医生是报告的主要群体;内科报告数量高于外科数量;224例ADR中,男女比例为1∶1.21;21～30岁和>70岁年龄段患者发生ADR数量居多,并有男女比例的差异;>70岁患者发生ADR报告数量占每年的报告总数比例最大。结论:医院ADR报告数量与医院收治数量不匹配,需要通过多种途径,提高监测员队伍的综合素质和积极性;应用新方法、新模式进行数据的采集和分析,推进医院ADR监测工作。     

我院291例药品不良反应报告描述性分析

目的：研究我院药品不良反应（ADR）发生特点,掌握ADR监测工作现状,规避临床用药风险。方法：以Excel电子表格形式从国家ADR监测网络下载我院2007年12月1日-2008年11月30日ADR报告表,对有关数据进行适当转换后,进行统计分析。结果：291份ADR报告中抗感染药物所占比例最大,其次为抗肿瘤药和营养药;ADR累及器官或系统主要为全身性损害、消化系统损害、皮肤及其附件损害;240例（82．5％）ADR由静脉给药途径所致;新的、严重的报告共涉及22种药品。结论：应重视对新的、严重的ADR报告分析,及时筛选信号、展开调研、发布预警,形成有效信息流,降低临床用药风险。     

Development of a hospital-based adverse drug reaction reporting program.

The development of an adverse drug reaction (ADR) reporting program at a university hospital is described in this article. Critical steps in the development process included identifying the personnel responsible for the program, defining ADRs and reportable ADRs, developing an ADR data form, promoting the program, and providing feedback to the health care professionals of the institution. A standing ADR subcommittee was formed to develop, implement, and coordinate the program. Two approaches to data collection were used: the standard format of voluntary reporting and a targeted drug method (targeting specific agents, typically newly approved drugs or those in which new, or potentially serious adverse reactions have been noted). The program was promoted through memorandums to department chairpersons and through a P & T Committee newsletter. The number of ADRs reported per quarter steadily increased from nearly zero to approximately 60 cases per quarter. Details on the implementation of this ADR program, its limitations and successes, are described.     

System for voluntary reporting of adverse drug reactions in a university hospital

The development and implementation of a system to improve voluntary reporting of adverse drug reactions (ADRs) is described. A preliminary study comparing three concurrent voluntary reporting systems at a 327-bed university teaching hospital demonstrated the ability of medical records personnel to identify ADRs that were documented in the medical record but not reported under the voluntary system. It was concluded that a concurrent voluntary reporting system would be coupled with a medical record review process that would focus reporting on clinically important and unexpected ADRs. Failures to report ADRs would be handled through existing procedures of staff privilege allocation and peer review. The baseline ADR rate was determined. A telephone reporting system was established for the medical staff. After review of reported reactions by pharmacy, feedback was provided to ADR reporters and the medical staff. During the first three months under the new system, 9 of 114 documented ADRs were reported, compared with none in the three months before the program began. All ADRs defined as reportable were reported. An ADR-reporting system designed to encourage voluntary reporting of selected reactions, monitor the baseline rate of ADR occurrence, and assess compliance with reporting criteria appears to operate satisfactorily.     

An ADR surveillance program: increasing quality, number of incidence reports

An Adverse Drug Reaction Surveillance Program (ADRSP) was implemented by the pharmacy department of the University of Maryland Medical System to address the institution's underreporting of adverse drug reactions. The program aims were to increase the number and quality of significant adverse drug reaction (ADR) reports by facilitating and standardizing the reporting process, to more actively involve the pharmacy staff, and to create a comprehensive database, thus enabling the intervention of future untoward events. During the program's first 2 years, the number of ADR reports more than doubled, primarily due to increased pharmacists' participation. The ADRSP has facilitated the reporting process, enhanced the submission of ADR reports to the FDA, and helped prevent ADRs.