TITLE

Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians: a model process

AUTHOR(S)

Whitstock, Margaret T.; Pearce, Christopher M.; Ridout, Stephen C.; Eckermann, Elizabeth J.

PUB. DATE

January 2011

SOURCE

BMC Public Health;2011, Vol. 11 Issue 1, p361

SOURCE TYPE

Academic Journal

DOC. TYPE

Article

ABSTRACT

Background: The study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients. Methods: The study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked deidentified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug. Results: Applying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug. Conclusions: Clinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest. Note: The terms 'adverse drug reaction' and 'adverse drug event' have come to be used interchangeably in the current literature. For consistency, the authors have chosen to use the wider term 'adverse drug event' (ADE).

ACCESSION #

63971097

 

Related Articles

• Westminster diary. Dalyell, Tam // New Scientist;5/7/2005, Vol. 186 Issue 2498, p47 

  The article presents the author's views on drug side effects. He says when it comes to detecting side effects, most trials are too small to find anything less than decimation. He says he would be pushing up the daisies were it not for pharmaceutical advances in the past 10 years, and owes his...

• Post-marketing surveillance. Sullman, Susan // Journal of the Royal Society of Medicine;Jan1979, Vol. 72 Issue 1, p65 

  The article reports on the plan of the government to organize a national scheme for the regulation the pharmaceutical industry in Great Britain. The initiative was aimed to detect adverse reactions to novel bioactive compounds which have been granted a product licence and which can be freely...

• Antiaging drug may stiff patients. Carey, Benedict; Chen, Ingfei // Health (Time Inc. Health);Jul/Aug96, Vol. 10 Issue 4, p28 

  Reports on a study by Maxine Papadakis, which shows that the antiaging human growth hormone causes stiff joints for the elderly. Loss of body weight for those who took the drug.

• Nine Reasons Older Adults Are More Likely to Have Adverse Drug Reactions.  // Health Letter;Jul2013, Vol. 29 Issue 7, p4 

  A reprint of the article "Nine Reasons Older Adults Are More Likely to Have Adverse Drug Reactions" which appeared in the February 2005 issue of the magazine "Health Letter" is presented.

• Innovation! Vaughan, Roger D. // American Journal of Public Health;Aug2008, Vol. 98 Issue 8, p1353 

  The article discusses various reports published within the issue, including one fractional factorial experimental designs and another on the design of more-efficient, longer-term randomized controlled trials and other data management and statistical techniques to help detect adverse drug events...

• Underrecognition of adverse effects. Kuritzky, Louis // Alternative Medicine Alert;Aug2010 Supplement, p15 

  The article discusses research by M. Zimmerman published in the "Journal of Clinical Psychiatry" which investigated why adverse effects related to medication are usually undetected in clinical trials.

• Identification of adverse reactions to new drugs. IV--Verification of suspected adverse reactions. Venning, Geoffrey R. // British Medical Journal (Clinical Research Edition);2/12/1983, Vol. 286 Issue 6364, p544 

  Examines the verification of suspected adverse reactions through the identification of adverse reactions to drugs in Great Britain. Characteristics of different methods of verification; Importance on the design of clinical trials of drugs; Assessment of the voluntary reporting systems.

• Which AEs to collect for supplemental indications?  // Reactions Weekly;12/11/2010, Issue 1331, p3 

  The article discusses research being done on the gathering of adverse event (AE) data in cancer clinical trials, which references a study by L. D. Kaiser and colleagues in the October 4, 2010 issue of the "Journal of Clinical Oncology."

• Pharmacovigilance & Regulatory News.  // Reactions Weekly;5/28/2011, Issue 1353, p2 

  The article reports on the draft guidance released by the Indian Central Drugs Standard Control Organization (CDSCO) in May 2011 geared toward the tightening of requirements for the reporting of serious adverse events occurring during clinical trials.

Read the Article