Active Pharmacovigilance of Anti-cancer Medicines
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- To quantify the number of grade 3-5 ADRs reported during the active surveillance period [Through study completion, an average of 3 years]
ADRs grades will be standardized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.3.
- 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 [Through study completion, an average of 3 years]
Period of equal length will be compared
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients aged <25 years;
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receiving cytotoxic, targeted-therapy, immunotherapy drugs for the treatment of solid and hematologic cancers
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giving consent to study participation
Exclusion Criteria:
- presence of cognitive problems
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS materno infantile Burlo Garofolo | Trieste | Italy | 34137 |
Sponsors and Collaborators
- IRCCS Burlo Garofolo
Investigators
- Principal Investigator: Marta Trojniak, PharmD, IRCCS materno infantile Burlo Garofolo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AIFA FVG 2019