Active Pharmacovigilance of Anti-cancer Medicines

Active Pharmacovigilance of Anti-cancer Medicines in Pediatric and Young Adult Patients.

Pharmacovigilance (PV), defined by the World Health Organization (WHO) as the "science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problem", aims to improve patient safety and quality of life. There are several objectives of PV, starting with the collection and management of safety data, to promote the safe and effective use of medicines. PV also aims to provide information on drug safety to health professionals and patients, and it contributes to updating drug labels. Finally, it is active in risk management, risk minimization and the prevention of adverse effects and other drug-related problems. As defined by WHO, an adverse event (AE) is "any untoward medical occurrence that may be present during treatment with a medicine, but which does not necessarily have a causal relationship with this treatment". When there is a causal relationship with the treatment, an AE is classified as an adverse drug reaction (ADR). The collection and reporting of AEs is a process that starts from the drug development phase and proceeds continuously throughout the life cycle of the drug, and it aims to assess the benefits-to-toxicity ratios (in other words, the safety and efficacy) of all medicines. Reports of ADRs must accurately describe the case and be meaningful to health professionals worldwide. The aim of this project is to evaluate the impact of an active prescription surveillance of anti-cancer drugs carried out by the clinical pharmacist in pediatrics and young adults.

Study Overview

• Status: Recruiting
• Conditions: Oncology; Drugs; Pharmacovigilance

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Marta Paulina Trojniak, PharmD; Phone Number: +390403785111; Email: martapaulina.trojniak@burlo.trieste.it

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Recruiting
    • IRCCS Materno Infantile Burlo Garofolo
    • Contact: Marta Trojniak; Phone Number: +390403785111; Email: marta.trojniak@burlo.trieste.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pediatric and young adult patients requiring the administration of anticancer drugs

Description

Inclusion Criteria:

• patients aged <25 years;
• receiving cytotoxic, targeted-therapy, immunotherapy drugs for the treatment of solid and hematologic cancers
• giving consent to study participation

Exclusion Criteria:

• presence of cognitive problems

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To quantify the number of grade 3-5 ADRs reported during the active surveillance period	ADRs grades will be standardized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.3.	Through study completion, an average of 3 years
To compare the number of grade 3-5 ADRs reported during the active surveillance period with the number of grade 3-5 ADRs reported in the previous years	Period of equal length will be compared	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Principal Investigator: Marta Trojniak, PharmD, IRCCS Materno Infantile Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Oncology; Drugs; Active pharmacovigilance
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: AIFA FVG 2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No