Drugs, Oncology, Pharmacovigilance
Conditions
Keywords
Oncology, Drugs, Active pharmacovigilance
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.
Interventions
None listed
Sponsors
IRCCS Burlo Garofolo
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
No minimum to 25 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactMarta Paulina Trojniak, PharmD
Outcome results
None listed