Literature DB >> 19148880

Adverse drug reaction monitoring: comparing doctor and patient reporting for new drugs.

N Jarernsiripornkul1, W Kakaew, W Loalukkana, J Krska.   

Abstract

PURPOSE: To compare the frequency of adverse drug reactions (ADRs) recorded by doctors with perceived ADRs reported by patients during hospitalization and post-discharge and to compare both to formal reporting in Thailand.
SETTING: Tertiary teaching hospital, North-East Thailand.
METHODS: Over a 6-month period doctors were requested to record ADRs to 13 recently marketed index drugs, occurring during hospitalization and after discharge, using specific forms. Patient perceived ADRs were detected by daily pharmacist interviews during hospitalization and a symptom checklist questionnaire after discharge.
RESULTS: In total, 203 in-patients were prescribed an index drug and interviewed. Doctors recorded 13 ADRs in these patients, resulting in seven drugs being stopped. In-patients reported 15 further symptoms, but 12 were assessed as unlikely to be an ADR. Of 160 patients who continued the index drug after discharge, 152 accepted questionnaires and 88 (58%) were returned. Patients identified 249 symptoms, of which the pharmacist assessed 190 (76%) as probably or possibly ADRs, using a previously developed method. Only 26 symptoms were noted in out-patient department (OPD) records, although most patients claimed to have informed doctors about them. Doctors recorded only five symptoms on ADR forms, all associated with drug discontinuation. During the study period, four reports were received by the Thai FDA on these 13 drugs, none from this hospital.
CONCLUSIONS: Forms encouraging doctors to identify ADRs may be an effective method of increasing recording, particularly in the in-patient setting. A combination of methods including patient reporting may enable pharmacists to increase formal ADR reporting. (c) 2009 John Wiley & Sons, Ltd.

Entities:  

Mesh:

Year:  2009        PMID: 19148880     DOI: 10.1002/pds.1708

Source DB:  PubMed          Journal:  Pharmacoepidemiol Drug Saf        ISSN: 1053-8569            Impact factor:   2.890


  12 in total

1.  Comparing adverse event rates of oral blood glucose-lowering drugs reported by patients and healthcare providers: a post-hoc analysis of observational studies published between 1999 and 2011.

Authors:  Liana Hakobyan; Flora M Haaijer-Ruskamp; Dick de Zeeuw; Daniela Dobre; Petra Denig
Journal:  Drug Saf       Date:  2011-12-01       Impact factor: 5.606

2.  Resident and nurse reports of potential adverse drug reactions.

Authors:  Tinne Dilles; Bart Van Rompaey; Peter Van Bogaert; Monique M Elseviers
Journal:  Eur J Clin Pharmacol       Date:  2015-04-24       Impact factor: 2.953

3.  Statin adverse effects: patients' experiences and laboratory monitoring of muscle and liver injuries.

Authors:  Nataporn Chaipichit; Janet Krska; Thongchai Pratipanawatr; Narumol Jarernsiripornkul
Journal:  Int J Clin Pharm       Date:  2015-01-29

4.  Do Parkinson's disease patients disclose their adverse events spontaneously?

Authors:  Santiago Perez-Lloret; María Verónica Rey; Nelly Fabre; Fabienne Ory; Umberto Spampinato; Jean-Louis Montastruc; Olivier Rascol
Journal:  Eur J Clin Pharmacol       Date:  2011-12-29       Impact factor: 2.953

5.  [The importance of patient perspective in drug surveillance systems].

Authors:  L Gäwert; F Hierse; A Zink; A Strangfeld
Journal:  Z Rheumatol       Date:  2010-11       Impact factor: 1.372

6.  Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study.

Authors:  Roberto Leone; Ugo Moretti; Paola D'Incau; Anita Conforti; Lara Magro; Riccardo Lora; Giampaolo Velo
Journal:  Drug Saf       Date:  2013-04       Impact factor: 5.606

7.  A qualitative study to explore how patients identify and assess symptoms as adverse drug reactions.

Authors:  Nataporn Chaipichit; Janet Krska; Thongchai Pratipanawatr; Verawan Uchaipichat; Narumol Jarernsiripornkul
Journal:  Eur J Clin Pharmacol       Date:  2014-02-16       Impact factor: 2.953

Review 8.  A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients.

Authors:  Liana Hakobyan; Flora M Haaijer-Ruskamp; Dick de Zeeuw; Daniela Dobre; Petra Denig
Journal:  Health Qual Life Outcomes       Date:  2011-09-29       Impact factor: 3.186

9.  Spontaneous reporting of adverse drug reactions through electronic submission from regional society healthcare professionals in Korea.

Authors:  Jae-Hyun Lee; Kyung Hee Park; Hyun Joo Moon; Yong Won Lee; Jung-Won Park; Chein-Soo Hong
Journal:  Yonsei Med J       Date:  2012-09       Impact factor: 2.759

Review 10.  Eliciting adverse effects data from participants in clinical trials.

Authors:  Elizabeth N Allen; Clare Ir Chandler; Nyaradzo Mandimika; Cordelia Leisegang; Karen Barnes
Journal:  Cochrane Database Syst Rev       Date:  2018-01-16
View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.