Clinical trial NCT02888834: Serious Adverse Drug Reaction and Their Preventability
Official title: Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Reaction
Keywords: elderly
adverse drug reactions
hospitalized subjects
community-dwelling
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne.

Brief summary: Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%.

Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability.

Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.

Detailed description: Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%. Age itself is not a risk factor for ADRs but is a factor of severity of ADR. According to the World Health Organization (WHO), more than half of all ADRs are considered to be preventable in elderly subjects. They are most often the result of a mistake during the prescription phase, or the monitoring phase, or may be due to poor compliance or inappropriate self-medication. Drug prescription is based on guidelines derived from clinical trial that have not included elderly subject with multiple comorbidities. Data regarding drug safety from clinical trials alone are insufficient, hence the need to continue the monitoring of ADR after drug marketing.

Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability.

Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.

Eligibility criteria: Inclusion Criteria:

* Patients aged over 65 years
* Patients who presented a serious adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne

Primary outcomes:
measure: The different type of serious ADR were coded according to Medical Dictionary for Regulatory Activities (MedDRA version 16.0) according to lowest-level terms (LLTs), and then grouped by system organ class (SOC).
timeFrame: 9 months
Secondary outcomes:
measure: Drugs involved in the occurrence of serious ADR
timeFrame: 9 months
measure: Evolution were classified as "recovered", "not yet recovered", "recovered with sequelae" , "death" , "unknown"
timeFrame: 9 months
measure: Preventability was assessed by using the preventability French scale.
timeFrame: 9 months
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
citation: Kanagaratnam L, Abou Taam M, Heng M, De Boissieu P, Roux MP, Trenque T. [Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years]. Therapie. 2015 Sep-Oct;70(5):477-84. doi: 10.2515/therapie/2015029. Epub 2015 Jun 26. French.