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.     

Nurses are increasingly involved in pharmacovigilance in Sweden

INTRODUCTION: In Sweden, voluntary adverse drug reaction (ADR) reporting started over 40 years ago to detect rare, serious, unexpected adverse, mainly type B, reactions. During the period 1965-2004, 92,000 reports were assessed. Since certain nurses are licensed to prescribe a limited number of drugs, nurses also form part of the reporting team. AIM: To analyse the ADR reporting by nurses in Sweden. METHODS: All reports by nurses and other health-care personnel entered into the Swedish ADRs database SWEDIS (Swedish Drug Information System) were retrieved for the 10-year period 1995-2004 (Swedish population: 9 million). The intention was to analyse the nurses' reports from a quantitative and qualitative point of view. RESULTS: The total number of ADR reports has gradually increased during the past 10 years from 3000 to over 4000 in 2004 (465 per million inhabitants), an increase by 28%. All ADR reports originate from health care personnel. The nurses' contribution to the ADR reporting increased from 2-3% in the mid-90s to 12% in 2004. The most common drugs involved in the nurses' reporting were various kinds of vaccines. Skin reactions dominated among the nurses' ADR reports. The ADRs reported by nurses were, as a consequence of many vaccine reports, compared to all reports, not so often classified as serious, but were on the other hand more often assessed with a causal relationship. CONCLUSIONS: Nurses, in their position as drug administrators who record signs and symptoms of the patients, play an increasingly important role for detection of suspected ADRs and are now contributing to a significant amount of the ADR reporting in Sweden.     

Improving adverse-drug-reaction reporting in ambulatory care clinics at a Veterans Affairs hospital.

The detection of adverse drug reactions (ADRs) by a traditional passive reporting system and by a method involving patient and provider interviews was studied. The study sample consisted of randomly selected outpatients seen by their primary care provider during scheduled appointments in January and February 2001 at a Veterans Affairs medical center. After ambulatory care clinic sessions, patients and providers were asked (by telephone and in person, respectively) to identify potential ADRs. Also obtained were demographic data, information about drug regimens, and the severity and management of each ADR. A standardized ADR-assessment tool was used to determine the severity of each reported reaction and its causal relationship with the medication. A total of 198 patients were included. Of these, 51 (26%) had one or more ADRs. The patient and provider interviews identified a total of 83 ADRs, compared with 1 ADR identified by the passive reporting system. When providers were made aware of the ADRs they had not identified, changes were made to the patient's medication regimen in 34% of cases. The risk of an ADR was not associated with age, number of medications, or provider type. Direct patient and provider interviews yielded a significantly higher rate of ADR detection in an ambulatory care setting than did a passive ADR-reporting system.     

Adverse reactions induced by NSAIDs and antibacterials: analysis of spontaneous reports from the Sicilian regional database.

OBJECTIVES: To (i) evaluate the suspected adverse drug reactions (ADRs) related to NSAIDs and antibacterials that were reported to Sicilian local health officers by healthcare professionals; and (ii) to detect new or serious potential signals of alarm related to these two widely used drug categories. METHODS: We selected all the spontaneous reports of ADRs sent between January 1998 and June 2004 and analysed those attributed to NSAIDs and systemic antibacterials, applying proportional reporting ratio (PRR) methodology. PRRs >2, chi(2) >4 and >3 ADRs were regarded as signals. RESULTS: During the period considered, 1585 reports of ADRs were received overall (42.6% serious), with an annual reporting rate of approximately 49.1 reports per million inhabitants on average; 351 referred to systemic antibacterials, and 179 to NSAIDs. There were 174 (49.6%) reports of serious ADRs associated with antimicrobials and 108 (60.3%) associated with NSAIDs. Disproportionality was observed, in particular for anaphylactic shock induced by ceftriaxone (all reports were associated with off-label use of the drug), photosensitivity reaction induced by lomefloxacin (administered in the summer), hepatitis induced by nimesulide (three cases leading to liver transplantation) and vasculitis induced by nimesulide. CONCLUSION: Our analysis highlighted several signals of alarm deserving further investigation or measures to influence prescribing. This study underlines the value of a regional centre in identifying local factors (such as prescribing patterns) that may increase the prevalence of serious ADRs.     

Paediatric adverse drug reactions reported to the Spanish Pharmacovigilance System from 2004 to 2009

Purpose

This study was conducted to evaluate relevant new information about ADRs reported in the Spanish paediatric population over a 6-year period.

Methods

Adverse drug reactions (ADRs) for individuals aged 0–17?years reported to the Spanish Pharmacovigilance System from 2004 to 2009 were analysed with respect to time, age and sex, category of ADR [System Organ Class (SOC)], seriousness, suspected medicines [level 2 of the Anatomical Therapeutic Chemical (ATC) Classification System] and type of reporter.

Results

In total, 4,279 ADR reports corresponding to 8,196 ADRs were analysed, approximately two ADRs per report. The rate of paediatric ADR reports in 2009 was 165 per million, of which nearly half (46?%) were for children (age group 2–11?years). Similar total numbers of ADRs were reported for boys and girls. The most frequent ADRs reported were from the following SOCs: general disorders and administration site conditions (34?%); skin and subcutaneous tissue disorders (15?%); nervous system disorders (14?%). Reports encompassed medicines from various ATC groups: vaccines and anti-infectives for systemic use (67?%); nervous system (9?%); respiratory system (9?%). On average, 37?% of ADRs were classified as serious. There were 33 fatal ADRs, and 35?% of the paediatric population associated with the ADR notifications required hospitalization or extended hospital stay.

Conclusions

In Spain, ADR reporting rate in the paediatric population has increased since 2004. The proportion of suspected ADR reports related to vaccines was predominant, which highlights the important role played by nurses. ADR notification of congenital malformations in newborn infants highlights the need for joint action between the Spanish System of Pharmacovigilance of Medicines for Human Use (SEFV-H) and paediatricians, obstetricians and gynaecologists. The publication of safety reports by regulatory agencies is determinant for the increased number of ADR notifications.     

近年我国药品不良反应报告与监测总体情况分析

目的了解我国近年来药品不良反应报告的现状,找出存在的问题,为加强药品不良反应报告和监测管理提出建议。方法收集2010~2014年连续5年国家药品不良反应监测年度报告,采用内容分析、二次分析、对比分析等方法对药品不良反应报告情况进行了探讨。结果我国药品不良反应报告的数量逐年增加,新的和严重的药品不良反应数量较少;药品不良反应报告主体是医疗机构,药品生产经营企业的报告比例较低,抗感染药品的药品不良反应仍居首位。结论加强药品不良反应报告管理依然是业内关注的重要问题之一。建议:提高新的、严重的不良反应报告率;强化药品生产、经营企业药品不良反应报告工作;重视抗感染药品的不良反应;促进药品不良反应的信息共享。     

Attitudes of community pharmacists in the Netherlands towards adverse drug reaction reporting

Objective — To gain insight into the attitude and behaviour of community pharmacists in the Netherlands with respect to the reporting of adverse drug reactions (ADRs). Method — A questionnaire survey was conducted among a stratified random sample of 200 community pharmacists from the membership list of the Royal Dutch Society for the Advancement of Pharmacy. The structured questionnaire covered knowledge of the Dutch ADR reporting system, attitudes to involvement in reporting ADRs and self‐reported behaviour. Demographic details were requested and used to assess the representativeness of responders in relation to the total population of Dutch community pharmacists. The number of self‐reported ADR reports was compared with those actually received by the nation's ADR centre. Key findings — The response rate was 73 per cent (n=147) after one reminder. Community pharmacists regarded the reporting of ADRs as an integral part of their professional duties and they did not report experiencing any major barriers to reporting. This is reflected in the frequency and number of ADR reports received by the national pharmacovigilance centre. Comparison of pharmacists' self‐reported numbers of ADR reports with actual reports received indicated that pharmacists overestimated the number of reports they made. The most frequently mentioned barriers to reporting were: the adverse effect assumed to be already known (32 per cent), the reporting procedure too time consuming (25 per cent), and uncertainty concerning the causal relationship between ADR and drug (25 per cent). Feedback was mentioned most commonly as the chief impetus for reporting, and this referred both to feedback on the report submitted and general feedback as provided in publications. Although consultation with the attending clinician before submitting a report is not compulsory in the Netherlands, 55 per cent of the pharmacists saw this as an important aspect in the reporting process. Conclusions — Community pharmacists in the Netherlands are knowledgeable about reporting ADRs and highly motivated to do so. This positive attitude towards reporting adverse events is based on the established tradition of pharmacist reporting in the Netherlands.     

Identification of sulfonamide-like adverse drug reactions to celecoxib in the World Health Organization database

BACKGROUND: The selective COX-2 inhibitor celecoxib has a sulfonamide structure and is contraindicated for patients with known sulfa allergy. However, there is currently no standard available for the identification of sulfonamide-related adverse drug reactions (ADRs) and the occurrence of such ADRs with celecoxib has not been established. THE AIMS OF THIS STUDY WERE: (1) to identify the typical pattern of sulfonamide ADRs from literature and verify this pattern in the World Health Organization (WHO) ADR database; and (2) to examine whether these sulfonamide ADRs occur more frequently with celecoxib than with the non-sulfonamide, COX-2 inhibitor rofecoxib. METHODS: A sulfonamide ADR pattern was derived from the most extensive textbook source of ADRs and applied to the WHO database for the three groups of sulfonamide drugs: short- and intermediate-acting sulfonamides, and sulfasalazine. ADRs reported three or more times for each of these groups were included in a 'sulfonamide template' comprising 19 ADRs relating to the skin, the blood, the liver, and anaphylaxis. This template was then applied to celecoxib and rofecoxib. RESULTS: Overall, the relative reporting rate of a sulfonamide-type ADR with celecoxib was 80% higher than with rofecoxib, whether this was based on total number of reports (RR 1.8, 95% Cl 1.6-1.9) or restricted to reports that listed coxibs as the sole suspected drugs (RR 1.8, 95% Cl 1.6-1.9). There were numerically more ADRs for celecoxib than for rofecoxib in 15 of the 19 terms. Within the ADRs in the sulfonamide template, relative reporting rate of fatal reactions was 80% higher with celecoxib (RR 1.8, 95% Cl 0.9-4.0). Even though serious sulfonamide reactions are rare, their clinical impact on patient safety warrants close monitoring as more data becomes available. Physicians should be aware of possible sulfonamide allergy when prescribing celecoxib.     

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.     

A small economic inducement to stimulate increased reporting of adverse drug reactions—a way of dealing with an old problem?

Purpose To assess the effect of a small economic inducement on the rate of spontaneous reporting of adverse drug reactions (ADRs) and the attitudes of general practitioners and physicians towards reporting of ADRs.Method One intervention and one control county were selected for the study. Written information about the main purpose of spontaneous reporting of ADRs was personally addressed to all physicians in the two counties. The information was identical, except for the addition that during a period of 6 months two lottery tickets would be given to the receivers in the intervention area with the standard personal feedback to the reporter of the ADR. After the 6-month study period, the actual number of reported ADRs and the seriousness of the reported ADRs were assessed. To investigate the attitude towards this stimulation of reporting, a questionnaire was addressed to all physicians within the intervention area (IA).Results From the IA a total number of 57 ADR reports were received containing 62 suspected ADRs, 40% of which were assessed as serious reactions. From the control area (CA), 49 reports containing 50 suspected ADRs were received, 32% of which were assessed as serious reactions. The increase of ADR reports from the IA compared to the same time period the previous year was 59% as compared to an unchanged reporting from the CA. Of those responding to the questionnaire, 80% did not believe that a small economic bonus would be a useful tool to improve the reporting rate.Conclusion A small economic inducement is associated with an increase in the reporting of suspected ADRs.     

基于总处方量的不良反应报告分析西地那非用药安全性研究

目的：基于枸橼酸西地那非（万艾可）上市来总处方的不良反应报告分析,评估其安全性,进一步促进临床规范用药。方法：查阅世界卫生组织药品不良反应数据库,检索并分析和比较枸橼酸西地那非的不良反应报告。结果：枸橼酸西地那非药品不良反应报告主要集中在心血管、神经、消化等系统,各个系统不良反应表现形式各异,但都比较轻微,基于总处方量（至少1.7亿）来讲,不良反应报告率极低,严重不良反应少见。结论：枸橼酸西地那非治疗勃起功能障碍的安全性高,该药物对肺动脉高压、神经再生、女性性功能障碍等病症的应用研究应该继续深入。     

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.     

Identification of Sulfonamide-like Adverse Drug Reactions to Celecoxib in the World Health Organization Database

Summary

Background: The selective COX-2 inhibitor celecoxib has a sulfonamide structure and is contraindicated for patients with known sulfa allergy. However, there is currently no standard available for the identification of sulfonamide-related adverse drug reactions (ADRs) and the occurrence of such ADRs with celecoxib has not been established.

The aims of this study were: (1) to identify the typical pattern of sulfonamide ADRs from literature and verify this pattern in the World Health Organization (WHO) ADR database; and (2) to examine whether these sulfonamide ADRs occur more frequently with celecoxib than with the non-sulfonamide, COX-2 inhibitor rofecoxib.

Methods: A sulfonamide ADR pattern was derived from the most extensive textbook source of ADRs and applied to the WHO database for the three groups of sulfonamide drugs: short- and intermediate-acting sulfonamides, and sulfasalazine. ADRs reported three or more times for each of these groups were included in a ‘sulfonamide template’ comprising 19 ADRs relating to the skin the blood the liver and anaphylaxis. This template was then applied to celecoxib and rofecoxib.

Results: Overall, the relative reporting rate of a sulfonamide-type ADR with celecoxib was 80% higher than with rofecoxib, whether this was based on total number of reports (RR 1.8, 95% CI 1.6-1.9) or restricted to reports that listed coxibs as the sole suspected drugs (RR 1.8, 95% CI 1.6-1.9). There were numerically more ADRs for celecoxib than for rofecoxib in 15 of the 19 terms. Within the ADRs in the sulfonamide template, relative reporting rate of fatal reactions was 80% higher with celecoxib (RR 1.8, 95% CI 0.9-4.0). Even though serious sulfonamide reactions are rare, their clinical impact on patient safety warrants close monitoring as more data becomes available. Physicians should be aware of possible sulfonamide allergy when prescribing celecoxib.     

Characteristics and quality of adverse drug reaction reports by pharmacists in Norway

PURPOSE: To evaluate the characteristics and quality of adverse drug reaction (ADR) reports submitted by pharmacists, and thereby assess the possible contribution of pharmacists to the spontaneous reporting system for ADRs in Norway. METHODS: An open, prospective study was conducted where dispensing pharmacists from 39 pharmacies were encouraged to report ADRs over a 3-month period. The submitted ADR reports were compared to reports by physicians from the same time period. All reports were evaluated for selected characteristics, that is distribution of Anatomical Therapeutic Chemical (ATC) classification codes of suspected drugs, distribution of ADRs according to system-organ classes and the quality of the reports. RESULTS: A total of 118 reports covering 274 ADRs received from the pharmacists were compared to 109 ADR reports with 304 ADRs submitted by physicians. Pharmacists more often reported ADRs related to cardiovascular drugs, alimentary tract and metabolism drugs and respiratory drugs, whereas physicians more frequently reported ADRs related to musculoskeletal drugs and antineoplastic and immunomodulating agents. ADRs reported by pharmacists more frequently described gastrointestinal reactions while physicians reported more ADRs in relation to the cardiovascular and blood system. Whereas 68% of the physicians' reports were classified as serious, only 5% of the pharmacists' reports were serious. More than 50% of the reports submitted by pharmacists concerned ADRs following a generic substitution, in contrast to only 2% of the physicians' reports. The pharmacists' reports were found to be of a lower documentation grade. However, there was no substantial difference in a subjective assessment of the quality of information in the reports submitted by the two categories of health professionals. CONCLUSIONS: Pharmacists submit valuable ADR reports which provide information complimentary to physicians' reports. This emphasises that pharmacist ADR reporting might constitute an important addition to the spontaneous reporting system.     

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.