الفهرس 
Title pageOnly 14 pages are availabe for public view
 |  | from | 97 |  |  |
| | | from | 97 | | |
Abstract
Pharmacovigilance (PV) plays an important role in the rational use of medicines by
providing information about adverse drug reactions (ADRs) in the general population.
Knowledge of the adverse effects of drugs is important for effective treatment.
Communicating the potential harm of drug-use to patients is a matter of high priority and
should be carried out by every prescriber.
Pharmacovigilance as defined by World Health Organization (WHO) ―the science and
activities relating to the detection, assessment, understanding and prevention of adverse
effects or any other drug related problems. WHO defines ADRs as ―any response to the drug
which is noxious and unintended, and which occurs at doses normally used in man for the
prophylaxis, diagnosis or therapy of disease or for modification of physiological function.
Pharmacovigilance plays an important role in reporting ADRs in oncology.The most
frequently used PV model, the spontaneous notification of ADRs, has proven relatively
inefficient because it usually results in under-reporting. In many countries, pharmacists
concerned with PV have demonstrated an important role in the notification of suspected
ADRs by providing information and instructions on the safe and appropriate use of medicines,
in addition to reducing the prevalence of ADRs and under-reporting. Information from
various sources used for PV include: Spontaneous ADR reporting schemes e.g. The Yellow
Card Scheme, Pharmaceutical companies, Clinical and epidemiological studies, Worldwide
published medical literature, Worldwide regulatory authorities and Morbidity and Mortality
Databases e.g. CDC through MMWR .
Study design: A retrospective record based study.
Study setting: This study was conducted in pediatric Oncology departments affiliated
with Alexandria University hospitals mainly Borg El-Araband Smouha hospital.
Study population: Pediatric oncology patients admitted to Alexandria University
Hospitals.
Sample size calculation: 450 pediatric cancer patients registered in Alexandria
University Hospitals.
Inclusion criteria:
1. In-patients of either gender who are on chemotherapy for treatment of cancer at
Alexandria University Hospitals.
2. Pediatric patients of age < 18 years old at the time of admission.
Exclusion criteria:
1. Records of patients on treatment other than chemotherapy.
2. Incomplete patient’s records.
Data collection:
A predesigned questionnaire will be utilized for data collection from the records of
pediatric patients who were admitted and treated in the oncology department and developed
ADRs. The data will be extracted from patient’s record to cover the compartment of the
yellow Card about:
1) Patients data; which will include: socio-demographic characteristics and diagnosis,
2) Suspected Drugs; which will include: name, use, dose, route, frequency, date of start
and date of end,
3) SuspectedAdverse Drug Reactions (ADRs); which will include: type, site, degree
and date of onset, date of stop and seriousness of ADRs.
4) Naranjo’sscale algorithm; to assess causality of ADRs and classify it into: certain,
probable, possible and doubtful,
5) Modified Hartwig scale; to assess severity of ADRs and classify it into:mild,
moderate, severe.
Statistical Analysis:
Data were analyzed using the Statistical Package for Social Sciences (SPSS ver.25
Chicago, IL, USA)
For all statistical tests, level of significance of .05 used
Disproportionality Analysis included calculation of ROR and corresponding 95% CI
with very similar design of ROR and PRR calculation in case control study but it is
called case non case analysis helping to interpret three criteria : ROR should be >1,
chi sequare (x2) test value >4 and the lower 95% CI >1.
The study included 476 ADRs reported among 450 children with mean age of 10.1± 6.1
years. Males were (63.3%), body surface area mean was 1±0.4 and body weight mean 31.2±19.7
By system; tumors of Hematological system constituted (34.9)%, Nervous System
included (21.7%) of study cases, Bone (19.7%), Muscular and Soft tissue (13.9%) and
Lymphoid system was (9.5%).The most common 5 tumors were ALL (29.1%) followed by
Ewing Sarcoma(10.4%), OS (9.3.%), MB (6.7%) and RMS (5.8%).
The most frequent 5 ADRs were Nausea/Vomiting (25.0%), Neutropenia (22.7%), Oral
Mucositis (10.3%), Infection (8.4%) and Anemia (7.1%).
According to Naranjo’s probability scale; (49.2%) were definite, (47%) were probable
and only 18 ADRs (3.8%) were possible.
Hartwig scale for severity demonstrated mild severity accounted (24.3%), moderate for
(71.2%) and severe constituted (4.4%).
Assessment of preventability by Schmuch and Thorntonscale reported Type (A) among
cases were (88%) and Type (B) (12%).
The top 3 signals were Diarrhea with Irinotican, Peripheral Neuritis with Vincristin,
Alopecia with Cytarabineas revealed by DPA.
The interventional methods to face ADRs included blood/platelets transfusion,
hospitalization, dose reduction and supportivedrugs.