Prescription-Event Monitoring: New Systematic Approach of Adverse Drug Reaction Monitoring to New Drugs

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Adverse Drug Reaction Monitoring to Antiepileptic Drugs by Patient Self Reports

Background: Spontaneous reporting of suspected ADRs is depending on voluntary reporting by health professionals. Under-reporting is a major problem. Patient self-reporting of ADRs might be a new useful and feasible method of ADRs monitoring which would result in an increased reporting rate of ADRs.Objective: To determine the frequency of the symptoms identified by patients as perceived ADRs and to evaluate the accuracy of patient attribution of reported symptoms to antiepileptic drugs.Method: Questionnaires were distributed by researcher at the Srinagarind Hospital during July 16 to September 16, 2007 and by post to the outpatients during October 1 to December 30, 2007.Population: Patients of Outpatient Department who were prescribed with phinytoin, carbamazepine and valproic acid during July 1, 2006 to September 30, 2007.Design: Retrospective descriptive study Setting: Srinagarind Hospital, Khon Kaen UniversityResults: Forty-four percents response rate was obtained (170/384) and 216 respondents were collected data at the Srinagarind Hospital with 358 (n=386) respondents (97.2%) reporting at least one symptom. The majority of patients were female (52.3%), with the mean age of 41.13+16.2 years. Thirty-six percent of respondents reported fewer than five symptoms. Number of underlying diseases, number of concomitant drugs and gender were significantly associated with frequency of reporting at least one symptom (p=0.041, p=0.032 and p=0.004, respectively). Dizziness was the most frequent symptoms reported in phenytoin-treated patients (43.4%), loss of memory was most frequent symptoms reported in carbamazepine and valproic acid treated patients (32.7% and 39.6%, respectively). The majority of symptoms were classified as being possibly (45.5% of all symptoms reported) and all reparted symptoms were related to drug studied 63.3%. Age, level of education and number of symptoms were significantly associated with symptoms potentially caused by study drugs (p=0.033, p=0.046, and p=0.000 respectively).Conclusion: This study indicated that patient perceptions of potential ADRs are relevant and patient self-reporting are an useful additional method for examining the occurrence of ADRs.Keywords: Adverse drug reaction, antiepileptic drugs, patient self-reporting

Knowledge, Understanding of Drug Allergy and Drug Allergy Card Carrying Behavior of Drug Allergic Patients in Srinagarind Hospital

Background and Objective: The recurrence of drug allergy was classified as preventable drug related problem might result in life-threatening allergic symptoms. The difference in drug allergy knowledge and understanding might lead to an awareness of drug allergy and drug allergy card carried by patients. The aim of the study was to assess the knowledge, understanding of drug allergy and drug allergy card carrying behavior of patients with drug allergy in Srinagarind Hospital.Methods: A 3-month cross-sectional descriptive study was conducted. Self-administered questionnaires was distributed by post to drug allergic patients from pharmacy database and patients who were diagnosed with anaphylaxis, maculopapular rash, erythema multiforme, Stevens- Johnson syndrome and toxic epidermal necrolysis.Results: A total of 288 questionnaires were evaluated. There were 137 patients (47.9%) had moderate knowledge level (mean+S.D.=3.19+1.03; total score of five).Moreover, 38.8% of the patients were unable to address the name of allergic drug and 85.7% of them answered the importance of drug allergy card incorrectly. The management of drug allergy was answered correctly in 86.4% of the patients. The majority of patients (76.1%) always carried their drug allergy cards and about 73.3% of the patient always showed their drug allergy card at health care services. Furthermore, 40.3% of the patients had received their drugs from non- healthcare professionals. Conclusion: Most of the patients knew the management of drug allergy. However, one-third of patients failed to recall the name of allergic drug and neglected to carry drug allergy card all the time. The continuing patient education might improve drug allergy knowledge and drug allergy card carrying behavior.Keywords: knowledge, understanding, behavior, drug allergy, drug allergy card