Documentation Of Adverse Drug Reactions Research Articles

Exploring the knowledge, perception, and practice of community pharmacists in Saudi Arabia toward pharmacovigilance and adverse drug reaction reporting. A nationwide survey

One of the significant worldwide health problems associated with pharmacovigilance is the under-reporting of adverse drug reactions (ADRs). Reporting suspected ADRs is essential to ensure patient safety, medicine safety, and healthcare quality. The new policy in Saudi Arabia emphasizes pharmacists taking a new clinical role, which may facilitate and improve the documentation of ADRs. Therefore, this study aimed to assess the knowledge and perception of community pharmacists towards the ADRs and their reporting practice in Saudi Arabia. A cross-sectional study using a structured self-administered questionnaire was administered to community pharmacists working in Saudi Arabia. Data were analyzed using descriptive and inferential statistics to identify the association between perceptions and ADR reporting practices. A P value < of 0.05 was considered statistically significant. A response rate of 43% (n = 163) was achieved, of whom 55.2% demonstrated knowledge of PV. Only 16% of community pharmacists were aware of the responsible center for monitoring and collecting ADRs in Saudi Arabia. The key facilitator was offering incentives to pharmacists, and the lack of time was found to be a key barrier among reporter community pharmacists. Positive attitudes toward pharmacovigilance and ADR reporting were expressed by community pharmacists. The findings of this study emphasize the further need for education and training programs and simplifying the ADR reporting process used in Saudi Arabia to enhance the reporting practice.

Clarification of adverse drug reactions by a pharmacovigilance team results in increased antibiotic re-prescribing at a freestanding United States children's hospital.

Documentation of adverse drug reactions (ADRs) is a key factor in guiding future prescribing. However, incomplete documentation is common and often fails to distinguish implicated drugs as true allergies. This in turn leads to unnecessary avoidance of implicated drug classes and may result in sub-optimal prescribing. Pharmacovigilance (PV) programs utilize a systematic approach to clarify ADR documentation and are known to improve patient safety. Yet it remains unclear if PV alters prescribing. Or, if the existence of the ADR documentation itself continues to prompt avoidance of implicated drugs. To address this, our work presents a retrospective cohort study assessing if clarification of antibiotic ADRs by a hospital-wide PV team was associated with future, safe, re-prescribing at a freestanding pediatric hospital in the midwestern United States. First, we compared the likelihood of future prescribing in an antibiotic class with an active ADR, as compared to alternative drug classes, between PV-clarified and non-clarified patients. Second, we assessed differences in adverse event rates 30-days after future prescribing based on PV clarification status. For robustness, analyses were performed on patients with ADRs in four antibiotic classes: penicillin-based beta-lactams (n = 45,642), sulfonamides/trimethoprim (n = 5,329), macrolides (n = 3,959), and glycopeptides (n = 622). Results illustrate that clarification of an ADR by PV was associated with an increased odds of future prescribing in the same drug class (Odds Ratio [95%-CI]): penicillin-based beta-lactams (1.59 [1.36-1.89]), sulfonamides/trimethoprim (2.29 [0.89-4.91]), macrolides (0.77 [0.33-1.61]), and glycopeptide (1.85 [1.12-3.20]). Notably, patients clarified by PV experienced no increase in the rate of adverse events within 30-days following the prescribing of antibiotics in the same class as an active ADR. Overall, this study provides strong evidence that PV reviews safely increase the rate of re-prescribing antibiotics even in the presence of an existing implicated drug ADR.

Adverse Drug Reactions in the Bipolar Disorder Patients Treated With Mood Stabilizers

Abstract Background: Bipolar disorder is a chronic illness requiring long-term use of mood stabilizers such as lithium and sodium valproate. The adverse drug reactions (ADRs) of these medicines can severely affect the quality of life of the patients. A comparative study of ADR profile of lithium and valproate in terms of prevalence, severity, and causality has not been done in the rural population of India. Methodology: A cross-sectional, observational study was done in the psychiatry outpatient department of a tertiary health care center. The bipolar disorder patients on lithium carbonate or divalproate monotherapy were chosen for documentation of ADRs after informed consent. The Naranjo causality algorithm and Modified Hartwig and Siegel scale for severity assessment were applied to all participants. The data obtained were statistically analyzed using Epi Info open-source software. Results: The study participants having mean age of 33.83 ± 12.02 years comprised nearly equal number of males and females. Tremors (19.4%), polyuria (11.5%), and polydipsia (11.2%) were the most common ADRs due to lithium, whereas nausea (12.6%), anorexia (10.6%), and sedation (9.1%) were more commonly seen in patients on valproate. Most of the ADRs had a mild severity and were categorized as possible in the Naranjo causality algorithm. Conclusion: Although ADRs are common in bipolar disorder patients treated with lithium or valproate, they are often mild and well tolerated by the patients.

Exploring pharmacovigilance practices and knowledge among healthcare professionals: A cross-sectional multicenter study.

Healthcare professionals' awareness of adverse drug reaction reporting and pharmacovigilance practices differ by country. The study assesses healthcare professionals' knowledge, practice, and potential barriers to pharmacovigilance-related practices and reporting adverse drug reaction. A cross-sectional investigation was conducted in government and private healthcare settings. The study included licensed physicians, pharmacists, and nurses. To examine knowledge, practice, and potential barriers to pharmacovigilance-related practices and adverse drug reaction reporting, a 22-item validated questionnaire was used. The final analysis included 311 healthcare professionals. Most healthcare professionals, 59% (N = 182), mentioned encountering patients with adverse drug reactions during the last year. On the other hand, most healthcare professionals, 54% (n = 167), mentioned that they had not reported adverse drug reactions. A good proportion of respondents mentioned that it is essential to report adverse drug reactions (N = 288, 92.6%), availability of adverse drug reactions reporting forms in practice sites (N = 216, 69.5%), had awareness regarding how to report adverse drug reactions (N = 221, 71.1%), the necessity of reporting minor/less important adverse drug reactions (N = 265, 85.2%), and were trained on how to report adverse drug reactions (N = 201, 64.6%). Adverse drug reaction reporting program in the United Arab Emirates (N = 148, 47.6) was known to many healthcare professionals. Lack of time was the major impediment to reporting adverse drug reactions at 42.7% (N = 133). The predictor variable work experience does add to the model (p < 0.05) concerning association with filling of adverse drug reaction forms (Estimate = 0.380; SE = 0.452; p = 0.400), professional role (Estimate = 0.454; SE = 0.673; p = 0.500). In addition, the predictor variable practice setting adds to the model (p < 0.05) concerning the knowledge regarding the availability of adverse drug reaction reporting forms (Estimate = -1.229; SE = 0.298; p = 0.000), training on how to report adverse drug reactions (Estimate = -0.660; SE = 0.294; p = 0.025), and awareness regarding the adverse drug reaction reporting program in the United Arab Emirates (Estimate = -1.032; SE = 0.280; p = 0.000). Pharmacists had the most knowledge regarding adverse drug reaction reporting and pharmacovigilance. The underreporting of adverse drug reactions was documented among physicians and nurses. Lack of time was the most significant barrier to reporting adverse drug reactions, followed by uncertainty and complicated adverse drug reaction documentation forms.

Impact of targeted education on adverse drug reaction documentation in cancer center sites.

395 Background: Allergic and infusion-related reactions represent a significant portion of reported adverse drug reactions (ADRs) at The University of Kansas Health System (TUKHS) Cancer Center sites. According to the TUKHS Allergy Documentation policy, all observed reactions are required to be documented in the electronic health record (EHR) and reported to the responsible provider. Insufficient documentation may result in preventable patient harm due to continued exposure to medications after known ADRs. An audit of patient EHRs demonstrated notable variability in documentation practices, which served as the impetus to implement a standardized ADR documentation workflow at Cancer Center sites. Methods: This multi-center, retrospective study included patients with ADRs submitted via safety reports from July 1st, 2022 to April 1st, 2023. Categorical data was analyzed using the chi-squared test. Duplicate reports and ADRs identified as side-effects were not included in the final analysis. Targeted education was provided via two online video modules, a workflow tips sheet, and an educational infographic. The primary outcome was frequency of allergy lists updated following submission of a safety event report. Secondary outcomes included frequency of standardized progress note writing, note routing, and accurate reaction type differentiation. Results: Targeted education significantly improved allergy list updating from 34.2% to 84.0% (P &lt; 0.001), use of a standardized progress note from 47.4% to 64.2% (P = .008), and correct differentiation of reaction type from 57.7% to 76.4% (P = .02). Progress notes were routed to the responsible provider 58.5% of the time. Smaller community-based Cancer Center sites were significantly less likely to update allergy lists (7.5% vs. 24.5%, P = .017) and more likely to document incorrect reaction types (35.0% vs. 14.3%, P = .022). Conclusions: Targeted education for a standardized documentation workflow increased adherence to ADR documentation, ensuring future treatment plans are updated for patients with a history of reaction and the EHR accurately reflects ADR history. There is an opportunity to strengthen targeted education surrounding ADR documentation workflows for smaller community-based sites.

Pattern of Adverse Drug Reactions among Pregnant Women and Pediatric Patients in a Tertiary Care Hospital.

Adverse drug reactions (ADRs) among pregnant women and pediatric patients are a significant public health concern. ADRs monitoring and documentation are considered essential practices to decrease the chances of ADRs and ensure the safe use of drugs. Therefore, the study was designed to evaluate the pattern of adverse drug reactions among pregnant women and pediatric patients in a tertiary care hospital. The study was conducted at Kalpana Chawla Government Medical College and Hospital, Karnal, Haryana, for a period of 2 years. During this period, ADRs reported by the healthcare professionals of gynecology and pediatric department to the ADRs monitoring centre of our institute were included in the study. Out of 54 total ADRs, 40 ADRs occurred among pregnant women, and 14 ADRs were reported in pediatric patients. The majority of the ADRs were observed in the age group of 21-30 years (pregnant women) and 3-5 years (pediatric patients). Antibiotics were most commonly implicated in ADRs among pregnant women (60%) and pediatric patients (79%). In our study, the dermatological system was mostly affected among pregnant women and pediatric patients. Urticaria, contact dermatitis, and erythematous rash were the most commonly reported ADRs among pregnant women and pediatric patients. Over-prescribing and irrational use of antibiotics make these vulnerable populations more susceptible to ADRs and antibiotic resistance. Therefore, there is a need to create awareness among health care professionals regarding the spontaneous reporting of ADRs for ensuring drug safety and reducing morbidity and mortality among pregnant women and pediatric patients.

Upping our game when documenting adverse reactions

Healthcare professionals’ documentation of adverse drug reactions is sometimes suboptimal, but it is important to take time to detail the nature of these reactions and their timing and severity to ensure patients’ safety and trust in the healthcare system.

An evaluation of a collaborative pharmacist prescribing model compared to the usual medical prescribing model in the emergency department.

Workforce reform has placed a significant focus on the role of non-medical prescribers in the healthcare system. Pharmacists are trained in pharmacology and therapeutics, and therefore well placed to act as non-medical prescribers. To assess the safety and accuracy of inpatient medication charts within a pharmacist collaborative prescribing model (intervention), compared to the usual medical model (control) in the emergency department (ED). Another objective compared venous thromboembolism (VTE) risk assessment and prescribing, between intervention and control groups. Adult patients in ED referred for hospital admission were randomised into control or intervention by a block randomisation method, until the required sample size was reached. Medication charts were audited retrospectively by an independent auditor, using validated audit forms. Intervention group medication charts contained significantly fewer prescribing errors, omissions and discrepancies compared to the control group, and improved documentation of adverse drug reactions. VTE risk assessment and prescribing had higher guideline concordance in the intervention group compared to the control group. This collaborative prescribing trial showed excellent results in safety and accuracy of pharmacist prescribing when compared to the usual medical model of prescribing. The admitting medical practitioner and extended scope pharmacist prescriber worked as a collaborative team in emergency, which improved Australian national prescribing safety indicators.

Current challenges in reporting and documentation of adverse drug reactions in homoeopathy Pharmacovigilance practice: A review

Pharmacovigilance deals with detection, assessment, understanding and prevention of adverse drug reactions. Though the homoeopathic treatment deemed to be safest, few adverse reactions were reported which are basically, due to use of medicines without the prescription, guidance or without supervision of a qualified physician. Homoeopathy, regarded as the second largest system of treatment, is catching on popularity and extensively practiced all over the world. ADRs are poorly reported and documented in homoeopathy when compared to conventional system of medicine. It may be either because of carelessness on the part of doctor or non-development of ADR at all. Through this review an effort has been done to find out possible challenges and solutions in reporting and documentation of ADRs in Homoeopathy practice.Methods: An intense literature study has been done on the concerned websites, databases, related journals, about implementation of pharmacovigilance in Homoeopathy. Available Publications till May 2022 along with literatures of Homoeopathy were analysed.Results: Challenges in reporting and documentation of ADRs from confounding illness, counterfeit drugs, Web – based medications, self-medication, clinical trials were identified along with lack of awareness among Health care professionals in pharmacovigilance practice was noticed which include how to report, where to report, how to fill the form, how to identify ADRs and importance of ADRs reporting and documentation etc. Possible Solutions like conducting regular CME programmes for Health care professionals which will help them in pharmacovigilance practice and providing proper incentives or awards by government which will encourage them in ADRs reporting and documentation.

Heterogeneity of Drug Allergies and Reaction Lists in Two U.S. Health Care Systems' Electronic Health Records.

Health care institutions have their own "picklist" for clinicians to document adverse drug reactions (ADRs) into the electronic health record (EHR) allergy list. Whether the lack of a nationally standardized picklist impacts clinician data entries is unknown. The objective of this study was to assess the impact of defined reaction picklists on clinical documentation and, therefore, downstream analytics and clinical research using these data at two institutions. ADR data were obtained from the EHRs of patients who visited the emergency department or outpatient clinics at Brigham and Women's Hospital (BWH) and University of Colorado Hospital (UCH) from 2013 to 2018. Reported drug class ADR prevalences were calculated. We investigated the reactions on each picklist and compared the top 40 reactions at each institution, as well as the top 10 reactions within each drug class. Of 2,160,116 patients, 640,444 (30%) had 928,973 active drug allergies. The most commonly reported drug class allergens were similar between BWH and UCH. BWH's picklist had 48 reactions, and UCH's had 160 reactions; 29 reactions were shared by both picklists. While the top four reactions overall (rash, GI upset/nausea/vomiting, hives, itching) were identical between sites, reactions by drug class exhibited greater documentation diversity. For example, while the summed prevalence of swelling-related reactions to angiotensin-converting-enzyme inhibitors was comparable across sites, swelling was represented by two terms ("swelling," "angioedema") at BWH but 11 terms at UCH (e.g., "swelling," "edema," by body locality). The availability and granularity of reaction picklists impact ADR documentation in the EHR by health care providers; picklists may partially explain variations in reported ADRs across health care systems.

Safety and effectiveness of recombinant factor XIII‐A2 in congenital factor XIII deficiency: Real‐world evidence

BackgroundRegular factor XIII (FXIII) prophylaxis is standard treatment for congenital FXIII A‐subunit deficiency (FXIII‐A CD). Recombinant factor XIII‐A2 (rFXIII‐A2) was extensively evaluated in the mentor trials. ObjectiveTo assess real‐world safety and treatment effectiveness of rFXIII‐A2 prophylaxis from the mentor 6 trial. Patients/Methodsmentor 6 was a noninterventional, postauthorization safety study investigating rFXIII‐A2 prophylaxis in FXIII‐A CD. rFXIII‐A2 treatment was observed for 2 to 6 years per patient. The primary end point was documentation of adverse drug reactions (including anti‐FXIII antibody development). Secondary end points were serious adverse events (SAEs), medical events of special interest (MESIs), and annualized bleeding rate (ABR). ResultsAmong 30 patients (mean age, 25.5 years), there were 44 adverse events (AEs) (30 mild, 13 moderate, 1 severe). Eleven AEs were possibly/probably related to rFXIII‐A2. Of four MESIs, two were unlikely related to rFXIII‐A2 (accidental overdose, deep vein thrombosis), and two were possibly/probably related (nonneutralizing anti‐FXIII antibody, decreased therapeutic response). All 10 SAEs were unlikely related to rFXIII‐A2. Over a follow‐up of 75.4 patient‐years, there were six treatment‐requiring bleeds (all trauma‐related with no spontaneous bleeds), giving a treatment‐requiring ABR of 0.066; five bleeds were treated successfully with rFXIII‐A2. Eight of nine minor surgeries performed during rFXIII‐A2 prophylaxis reported successful hemostatic outcomes (one missing evaluation). ConclusionsThese data confirm that rFXIII‐A2 prophylaxis is well tolerated as long‐term care. There were no spontaneous bleeds, ABR was low, and rFXIII‐A2 successfully treated bleeds in patients receiving rFXIII‐A2 prophylaxis.

Completeness and accuracy of adverse drug reaction documentation in electronic medical records at a tertiary care hospital in Australia.

Background: A large proportion of patients presenting to hospitals have experienced a previous adverse drug reaction (ADR). Electronic medical records (EMRs) present an opportunity to accurately document ADRs and alert clinicians against inadvertent rechallenge where there is a pre-existing reaction. However, EMR systems are imperfect and rely on the accuracy of the data entered. Objective: To ascertain the completeness of ADR documentation and the accuracy of the classification of ADRs as allergy versus intolerance in the EMR at a major metropolitan hospital in Australia. Method: Cross-sectional audit of the ADR field of the EMR for a sample of patients on four different wards over 3weeks to ascertain the completeness of ADR documentation and the accuracy of classification of ADRs. Results: Of the 264 patients assessed, 102 (38.6%) had a total of 210 ADRs documented in the EMR. Of these, 105 (50%) were considered to have complete documentation; 63/210 (30.0%) were missing a reaction description and 88/210 (41.9%) were missing severity information. For those ADRs with a reaction description (n = 147), 97 (66.0%) were considered to be appropriately classified as allergy or intolerance. Conclusion: Incomplete and inaccurate ADR documentation was common. These findings highlight a need for optimising ADR documentation to improve appropriate medication use in hospital. Implications: Improved EMR design and education of healthcare workers on the importance of complete and accurate documentation of reactions are needed to improve completeness and accuracy of ADR classification.

Documentation of adverse drug reactions to opioids in an electronic health record.

Allergy to opioids is the second most common drug allergy label in electronic health records (EHR). Adverse drug reactions (ADR) to opioids cause significant morbidity and contribute to healthcare costs, while incorrect opioid allergy labels may unnecessarily complicate patient management. To examine the documentation of opioid ADR in a large-scale hospital-based EHR. A cross-sectional retrospective review of EHR documentation of opioid ADR at four public hospitals in South Australia was conducted. Data were extracted from all ADR entries including the reported allergen, ADR category (allergy or intolerance) and reaction details. Expert criteria were used to determine consistency of ADR categorisation as allergy or intolerance. Of 86 727 unique ADR reports, there were 13 781 ADR to opioids with most being entered as allergy (n=8913, 64.7%) rather than intolerance (n=4868, 35.3%). The most commonly documented reactions were nausea/vomiting (n=3912, 28%), rash (n=647, 5%), itch (n=642, 5%) and hallucinations (n=527, 4%). There were 362 (3%) ADR labels of anaphylaxis. Of those ADR containing a reaction description (n=11 868), 89% of reports entered as allergy had a reaction description that was consistent with intolerance and 8% of the entered intolerances had descriptions consistent with allergy when assessed using predefined criteria. This large EHR-based study demonstrates the high rate of opioid ADR labels in EHR. The majority of these labels were for symptoms suggestive of pharmacological intolerance. Reactions consistent with true allergy were uncommon. Systematic review of ADR by a dedicated clinical service would improve the accuracy of documentation.

Innovation to reduce medication‐related harm

Innovation to reduce medication‐related harm

Integrating pharmacists into aged care facilities to improve the quality use of medicine (PiRACF Study): protocol for a cluster randomised controlled trial

BackgroundMedication management in residential aged care facilities is an ongoing concern. Numerous studies have reported high rates of inappropriate prescribing and medication use in aged care facilities, which contribute to residents’ adverse health outcomes. There is a need for new models of care that enhance inter-disciplinary collaboration between residential aged care facility staff and healthcare professionals, to improve medication management. Pilot research has demonstrated the feasibility and benefits of integrating a pharmacist into the aged care facility team to improve the quality use of medicines. This protocol describes the design and methods for a cluster randomised controlled trial to evaluate the outcomes and conduct economic evaluation of a service model where on-site pharmacists are integrated into residential aged care facility healthcare teams to improve medication management.MethodsIntervention aged care facilities will employ on-site pharmacists to work as part of their healthcare teams 2 to 2.5 days per week for 12 months. On-site pharmacists, in collaboration with facility nurses, prescribers, community pharmacists, residents and families will conduct medication management activities to improve the quality use of medicines. Aged care facilities in the control group will continue usual care. The target sample size is 1188 residents from a minimum of 13 aged care facilities. The primary outcome is the appropriateness of prescribing, measured by the proportion of residents who are prescribed at least one potentially inappropriate medicine according to the 2019 Beers Criteria. Secondary outcomes include hospital and emergency department presentations, fall rates, prevalence and dose of antipsychotics and benzodiazepines, Anticholinergic Cognitive Burden Score, staff influenza vaccination rate, time spent on medication rounds, appropriateness of dose form modification and completeness of resident’s allergy and adverse drug reaction documentation. A cost-consequence and cost-effectiveness analysis will be embedded in the trial.DiscussionThe results of this study will provide information on clinical and economic outcomes of a model that integrates on-site pharmacists into Australian residential aged care facilities. The results will provide policymakers with recommendations relevant to further implementation of this model.Trial registrationACTRN12620000430932. Registered on 1 April 2020 with ANZCTR

The adverse drug effects of dapsone therapy in leprosy: a systematic review

Objectives: To establish the rate of adverse drug reactions (ADR) when dapsone is given in leprosy multi-drug therapy (MDT). This paper reviews the reporting of ADRs by systematic review of the databases Ovid Medline, Ovid Embase and Global Health according to pre-specified eligibility criteria. Results: The search identified 5859 relevant citations. These publications were divided into two data sets and reviewed for their documentation of ADRs. One hundred and fourteen publications reported ADR as the primary outcome and 98 papers reported the efficacy of treatment. Of the 114 papers included, 79 were case reports, 23 retrospective studies, 7 prospective studies and 7 literature reviews. Dapsone Hypersensitivity Syndrome (DHS) was reported most frequently as an adverse effect, then anaemia (haemolytic and not otherwise specified), cutaneous eruptions, gastrointestinal disturbance and hepatitis. Eleven studies report a mean rate of DHS as 1.22% and an average fatality rate in 8 studies of 11.24%. Of the 98 papers reporting treatment efficacy, 33 papers reported ADRs to medications other than dapsone and 36 publications had no documentation of adverse effects. Conclusion: Most publications report ADRs in case reports, many from India. DHS was the most commonly reported ADR, followed by individual features of the syndrome. Many studies lack patient information with many not reporting ADRs. Our findings show that improved prospective monitoring of adverse events associated with dapsone is needed. We propose that all patients should be tested with a full blood count before starting MDT and repeated after 4–8 weeks with mandatory follow-up. This would facilitate detecting ADRs including DHS and dapsone-associated anaemias.

Enhancing Pediatric Adverse Drug Reaction Documentation in the Electronic Medical Record.

Adverse drug reactions (ADRs) often go unreported or are inaccurately documented in the electronic medical recorded (EMR), even when they are severe and life-threatening. Incomplete reporting can lead to future prescribing challenges and ADR reoccurrence. The aim of this study was to evaluate the documentation of ADRs within the EMR and determine specific factors associated with appropriate and timely ADR documentation. Retrospective data were collected from a pediatric hospital system ADR reports from October 2010 to November 2018. Data included implicated medication, type, and severity of reaction, treatment location, the presence or absence of ADR documentation in the EMR alert profile within 24 hours of the ADR hospital or clinic encounter discharge, ADR identification method, and the presence or absence of pharmacovigilance oversight at the facility where the ADR was treated. A linear regression model was applied to identify factors contributing to optimal ADR documentation. A total of 3065 ADRs requiring medical care were identified. Of these, 961 ADRs (31%) did not have appropriate documentation added to the EMR alert profile prior to discharge. ADRs were documented in the EMR 87% of the time with the presence of pharmacovigilance oversight and only 61% without prospective pharmacovigilance (P < .01). Severity of ADR was not a predictor of ADR documentation in the EMR, yet the implicated medication and location of treatment did impact reporting. An active pharmacovigilance service significantly improved pediatric ADR documentation. Further work is needed to assure timely, accurate ADR documentation.

Analysis of Reporting Adverse Drug Reactions in Paediatric Patients in a University Hospital in the Netherlands.

AimsThe risk to develop adverse drug reactions (ADRs) is high for paediatric patients. This is, amongst other reasons, due to the inevitable use of off-label and unlicensed medicines. Moreover, there is limited knowledge on ADRs in children. Thus, adequate recognition may be challenging. The lack of dedicated studies and the voluntary nature of pharmacovigilance systems used to gain insight into the characteristics of ADRs contribute to this problem. The goal of this study is to identify whether ADRs in paediatric patients are adequately documented by the medical team and whether they are subsequently reported to the national pharmacovigilance system.MethodsAll patients admitted to the paediatric medium care of the Radboudumc Amalia Children’s hospital during 1 month, and using one or more drugs, were included. Two researchers analysed retrospectively and independently the number of possible ADRs in the medical records. The ADRs were listed per paediatric subspecialty, to evaluate any differences in documentation and reporting of the ADRs. Subsequently, the causality, severity, and seriousness of the ADRs were assessed. The ADRs were categorised by system organ class and drug class. The national pharmacovigilance centre was consulted to check if there were any reports coming from our hospital and to collect the total number of reports.ResultsThe medical records of 301 patients were analysed, 81 patients were suffering from one or more ADRs. In total 132 suspected ADRs were found, divided among 19 different paediatric subspecialties. Numbers were too small to investigate the differences in ADR documentation. Of these found ADRs, 55% were not explicitly noted as such in the medical records by the treating physician. None of the ADRs were reported to the national pharmacovigilance centre. Most ADRs scored ‘possible’ in the causality assessment, were mild or moderate, and a small number were serious. The ADRs occurred in 25 different organ systems. In total 25 different drug classes were involved.ConclusionsThe results of the present study show that a large number of ADRs are not registered in the medical records and are not reported to the national pharmacovigilance system. Furthermore, it is shown that the number of ADRs occurring at our centre is much higher than the number reported to the national pharmacovigilance centre. Only an average of 513 ADRs in paediatric patients are reported per year nationwide, suggesting that there is extensive underreporting.

Effectiveness and tolerability of intravenous pentamidine for Pneumocystis carinii pneumonia prophylaxis in adult hematopoietic stem cell transplant patients: a retrospective study

BackgroundPneumocystis carinii pneumonia (PCP) prophylaxis is recommended after hematopoietic stem cell transplantation (HSCT). In patients who are unable to take first-line prophylaxis, trimethoprim/sulfamethoxazole, aerosolized pentamidine is recommended. This drug may not, however, be available at all institutions, and its administration requires special techniques. Therefore, intravenous pentamidine (IVP) has been used in adult patients as an alternative, despite limited data. We evaluated the effectiveness and tolerability of IVP for PCP prophylaxis in adult patients who had undergone HSCT.MethodsA single-center retrospective study was conducted of adult patients who had undergone allogenic or autologous HSCT between January 2014 and September 2018 and had received at least three doses of IVP for PCP prophylaxis. The IVP dose was 4 mg/kg administered monthly. Data on PCP infection and adverse reactions were collected from both patients’ electronic medical records and the pharmacy adverse drug reactions documentation system. Patients were followed from the start of IVP up to 6 months after discontinuation of therapy. A confirmed PCP infection was defined as radiographic evidence of PCP and positive staining of a respiratory specimen. Descriptive statistics were used to analyze the study outcomes.ResultsDuring the study period, 187 patients were included. The median age was 36.4 years (range, 18–64), 58% were male, and 122 (65%) had received allogeneic HSCT while the remainder autologous HSCT. The median number of IVP doses administered per patient was 5 (range, 3–29). During the study period, none of the patients had evidence of confirmed PCP infection. However; there were two cases with high clinical suspicion of PCP infection (i.e. required anti-pneumocystis therapy) and one reported case of central nervous system toxoplasmosis while receiving IVP for PCP prophylaxis. Only one case of nausea associated with IVP administration was reported.ConclusionsIn a cohort of adult patients with HSCT who received IVP for PCP prophylaxis, there was no evidence of confirmed PCP infection, and the treatment appeared to be well tolerated. Prospective studies should be conducted to confirm the efficacy and tolerability of IVP.

Documentation of antipsychotic-related adverse drug reactions: An educational intervention.

BackgroundAntipsychotic agents are associated with harmful adverse reactions which impact negatively on patient adherence and clinical management. Accurate and complete documentation of signs and symptoms in the clinical notes is an important means of communication between healthcare providers, and an essential component in the management of antipsychotic-induced adverse drug reactions.AimTo determine the impact of an educational intervention on the incidence and extent of antipsychotic-induced adverse drug reaction documentation in patient medical records.SettingThe research was conducted in an acute care, public sector psychiatric facility in the Eastern Cape province of South Africa.MethodsA quasi-experimental, before and after method was used, which focused on an educational intervention. The study design consisted of three phases: pre-intervention, intervention and post-intervention. A clinical audit was conducted, reviewing 102 patient medical records in the pre-intervention phase and a further 102 patient medical records in the post-intervention phase, in order to determine the impact of the intervention on the frequency and extent of documentation of suspected antipsychotic-induced adverse drug reactionsResultsFollowing the educational intervention, documentation of adverse drug reactions to antipsychotic drugs increased from 66 instances in the pre-intervention phase to 82 instances in the post-intervention phase. A statistically significant increase (Pearson’s Chi-square p < 0.05) was observed in the number of patient medical records that identified suspected adverse drug reactions.ConclusionThe educational intervention was found to increase the incidence of documentation of adverse drug reactions, and increased awareness of the potential adverse drug reactions associated with antipsychotic drugs following the intervention.