International Journal of Risk & Safety in Medicine - Volume 25, issue 1

Authors: KC, Santosh | Tragulpiankit, Pramote | Edwards, I. Ralph | Gorsanan, Sarun

Article Type: Research Article

Abstract: OBJECTIVE: To investigate the knowledge about ADRs and ADR reporting among healthcare professionals working at four regional pharmacovigilance centers (RPCs) of Nepal. METHODS: It was a cross sectional study, done by a survey using a validated self-administered structured questionnaire. The questionnaire was distributed to 450 healthcare professionals working at four RPCs. RESULTS: The overall response rate was 74%. Only 53% and 38% of respondents knew about the existence of National Pharmacovigilance Centre (NPC) and RPC, respectively. Among the respondents, 29% and 33% did not know what a Type A and Type B ADR was. Similarly, 30% and 45% were not …aware of the common types of ADRs or the thalidomide tragedy. Only, 9% knew about Uppsala Monitoring Centre (UMC) and only 10% answered correctly about the Naranjo algorithm as a causality assessment tool for ADRs. Of the respondents, only 19% knew about spontaneous reporting system and only 18% were aware about its drawbacks. The overall mean score on knowledge about ADR among healthcare professionals was 7.64 ± 2.38 out of the maximum possible score of 12. Whereas, the overall mean score of knowledge about ADR reporting was 3.95 ± 1.78 out of maximum possible score of 11. CONCLUSION: Healthcare professionals working at four RPCs of Nepal have some knowledge about ADRs themselves but limited knowledge about ADR reporting. There is an urgent need of action to be taken by RPCs at the regional level and NPC at the national level to improve knowledge and ADR reporting by healthcare professionals. Show more

Keywords: Adverse drug reaction, knowledge, healthcare professionals, Nepal

DOI: 10.3233/JRS-120578

Citation: International Journal of Risk & Safety in Medicine, vol. 25, no. 1, pp. 1-16, 2013

Authors: Tanti, Amy | Camilleri, Miriam | Bonanno, Patricia Vella | Borg, John-Joseph

Article Type: Research Article

Abstract: AIM: To identify medication errors in the Maltese pharmacovigilance database and describe the frequency and characteristics of these events. METHOD: A retrospective analysis of the Adverse Drug Events (ADEs) reported over 5 years in Malta was conducted. Medication errors were identified by comparing use against the product's Summary of Product Characteristics (SmPC) and then classified by type of medication error, seriousness and the stage of the medication use chain at which they occurred. RESULTS: 319 consolidated ADE reports met the inclusion criteria and were analysed. 56/319 consolidated ADEs were associated with serious patient harm. The 80–89 and the 50–59 age …groups were associated with most medications used in error. 65% of errors originated in the community. Errors were identified in prescribing (52%), therapeutic monitoring (26%), patients' own (12%), dispensing (7%) and administration (3%) stages. The non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics were most commonly used in errors involving wrong doses, lack of therapeutic monitoring, interactions; contra-indications, prescribing for an unlicensed indication as well as an inappropriate duration of therapy. CONCLUSION: Pharmacovigilance databases are a useful source of information on medication errors and can be used to detect risks associated with the use of medicinal products. Show more

Keywords: Pharmacovigilance, medication errors, pharmacovigilance database

DOI: 10.3233/JRS-120582

Citation: International Journal of Risk & Safety in Medicine, vol. 25, no. 1, pp. 17-27, 2013

Authors: Herxheimer, Andrew

Article Type: Research Article

DOI: 10.3233/JRS-130583

Citation: International Journal of Risk & Safety in Medicine, vol. 25, no. 1, pp. 29-31, 2013

Authors: O'Keeffe, Nikki | Gavin, Blanaid | McNicholas, Fiona

Article Type: Research Article

Abstract: AIM: To examine the prevalence and nature of critical incident reports at a generic child and adolescent mental health service. METHOD: This is a retrospective survey of all critical incident reports completed at a community based child and adolescent mental health service between 2008 and 2011. Information was obtained about the nature of incidents and actions taken. RESULTS: In a three year period, only eighteen incident report forms were completed. Staff were most frequently the victims of the incidents (50%, n = 9), followed by clients (38.8%, n = 7) and parents of clients (11.1%, n = 2). Falls were …the most common incident reports (44.4%, n = 8). Two incidences were related to physical aggression and threatening behaviour by clients. CONCLUSION: Critical incident reporting was found to be uncommon overall. Most of the recorded incidents involved staff members and were of minor significance. Specific training for staff regarding incident reporting should be provided to ensure an acceptable standard of investigation is consistently carried out for all significant incidents. Show more

Keywords: Critical incidents, child and adolescent mental health service

DOI: 10.3233/JRS-120579

Citation: International Journal of Risk & Safety in Medicine, vol. 25, no. 1, pp. 33-38, 2013

Authors: Marks, Donald H.

Article Type: Review Article

Abstract: BACKGROUND AND OBJECTIVE: The impetus for this review was recent increased warnings of cardiovascular toxicity, fractures and bladder cancer associated with glitazone use. METHODS: A drug utilization review was performed regarding the use of Actos (pioglitazone) and Avandia (rosiglitazone) at Cooper Green Mercy Hospital (CGMH), an inner city safety net hospital in Birmingham, Alabama. Pharmacy records were reviewed hospital-wide to determine usage patterns of all anti-diabetic medications. Medline and the FDA websites were searched for articles on safety and efficacy of pioglitazone and rosiglitazone. Considerations were relative utilization profile, comparative efficacy, indications, relative cost, and safety profile of the two …available medications in this drug class. RESULTS: On the basis of all of these factors, a hospital-wide switch of all rosiglitazone prescriptions to all pioglitazone was implemented, which was estimated to result in savings of $83,000 for the first year. No episodes of worsening of control of diabetes were anticipated, nor were episodes of decreased efficacy or adverse effects as a result of automatically switching patients from rosiglitazone to pioglitazone at the time of prescription filling. CONCLUSIONS: The conclusions can be summarized in a number of key points. • Clinicians should follow the American Diabetes Association guidelines [1] for treatment. • The basis for diabetic control is weight loss, diet and exercise. • Initial medication management for type II Diabetes Mellitus includes metformin and insulin. • There are no circumstances in which use of glitazone medications is preferable to other medication groups, and there are no clinical circumstances in which use of glitazone medications is absolutely necessary, as opposed to other classes of diabetic medication. • There are significant contraindications, warnings and precautions to use of glitazones, which must be taken into consideration before use in every individual patient. • Glitazones in particular should not be used in the following circumstances: congestive heart failure (CHF), concurrent bladder cancer or severe osteoporosis. Show more

Keywords: Diabetes, thiazolidinediones, glitazone, Actos, pioglitazone, Avandia, rosiglitazone

DOI: 10.3233/JRS-120581

Citation: International Journal of Risk & Safety in Medicine, vol. 25, no. 1, pp. 39-51, 2013

Authors: Rajesh, Radhakrishnan | Vidyasagar, Sudha | Varma, Danturulu Muralidhar | Naik, Anand | Hegde, Brahmavar Mohandas | Guddattu, Vasudeva | Kamath, Asha

Article Type: Research Article

Abstract: BACKGROUND: There are no studies performed in India on the safety of highly active antiretroviral therapy (HAART) combinations which focus on the base-line CD4+ T-cell count. Further, no data on risk factors for Adverse drug reactions (ADRs) to HAART and there is a lack of data on CD4+ T-cell count recovery after HAART. OBJECTIVES: The aim of this study was to assess risk factors for ADRs to HAART. We also compared the efficacy of HAART combinations with respect to base-line CD4+ T-cell count and CD4+ T-cell counts recovery in Indian HIV positive patients. METHODS: A prospective …active surveillance study was adopted at the Antiretroviral Therapy (ART) Centre, District Government Hospital, Udupi, India. HIV-infected patients were intensively monitored to identify risk factors associated with ADRs to HAART from August 2009 to May 2012. The study protocol was approved by the University ethics committee. Baseline CD4+ T-cell count before initiation of HAART and thereafter at every six months of regular follow-up up to 24 months duration was included for comparison. Multivariate logistic regression analysis was used to identify predictors of high risk factors of ADRs. CD4+ T-cell count recovery after HAART from base-line CD4+ T-cell count in different HAART groups was analyzed by test of between-subject effects. P-value <0.05 was considered as statistically significant. RESULTS: A total of 1982 HIV positive patients were enrolled with 1181 (59.6%) males, and 801 (40.4%) females. On multivariate logistic regression analysis, four factors were found to be predictors of high-risk factors for ADRs to HAART: 1) CD4+ T-cell counts, 2) female gender, 3) polypharmacy and 4) opportunistic infections. Between HAART groups, a mean increase of 98 cells/μl of CD4+ T-cell counts recovery was seen in the 3TC + NVP + D4T group (p < 0.001) at 24 months of regular follow-up. CONCLUSION: In India, Clinician should take into consideration all possible risk factors associated with the use of HAART in order to avoid and minimize ADRs. As initial CD4+ T-cell count and age of patient decides the rise of CD4+ T-cell counts with HAART. HAART should be initiated at the earliest age in order to attain maximum CD4+ T-cell counts recovery. Show more

Keywords: Pharmacovigilance, highly active antiretroviral therapy, human immunodeficiency virus, adverse drug reaction, CD4$^+$ T-cell count

DOI: 10.3233/JRS-130580

Citation: International Journal of Risk & Safety in Medicine, vol. 25, no. 1, pp. 53-65, 2013