Speaker
Description
Background
For many years it was argued that there may be gender based differences in adverse drug reactions. This assumption was based on the presence of gender related pharmacokinetics, pharmacodynamics, hormonal and behavior variations. The dissimilarities were not clearly identified since the females are underrepresented in the clinical trials. Individual case safety reports database available on Iraqi Pharmacovigilance Centre is a good source of information that can be utilized to capture any differences between both genders.
Objective
The primary aim of this study was to assess the extent of possibly relevant gender differences in drug–adverse drug reactions regarding causality, severity, preventability, seriousness, expectedness and outcome. While the secondary aim was to assess for which group of drugs and for which adverse drug reactions gender differences are identified most often.
subjects and Methods
The study is a retrospective in nature. The data included consisted of 3833 individual case safety reports, extracted from the Iraqi Pharmacovigilance Centre database, for adult patients during a 3 years’ period (from 1st January 2017 to 31st December 2019). Those cases were statistically analyzed to identify any significant differences regarding numerous parameters.
Results
The reported adverse drug reactions in females (60.84 %) were found to be much more than those of males (39.16 %). Females had shorter durations of adverse drug reaction experiences (2.75 ± 12.8 days). In addition, significant differences in age group distributions were found, females in their reproductive age were found to have more adverse drug reactions (63.6 %) compared with (55.5 %) for males from the same age group. While the older males were more likely to suffer adverse drug reactions if compared with the same age group of females. The highest type of adverse drug reactions for both genders were those that fall in the skin and subcutaneous tissue disorders (26.4 % in females) and (22.6 % in males) with statistically significant difference them. While the highest group to cause adverse drug reactions was the systemic anti-infective agents with a greater chance ‘statistically significant’ in females to suffer a side effect from this group of medications (40.8 %) compared to male gender (35.5 %). The frequency of serious adverse drug reactions was significantly more prevalent in females (45.4 %) than for males (41.3 %) while the fatal outcome was significantly more observed in males (0.8 %) as compared with females (0.2 %). Causality assessment shows that female gender had higher Probable category (68.5 %) while the Possible category was greater in males (31.4 %) than those categories from the opposite gender. Severity levels show some variation in level 3 which favors the female side (9.2 %) and Level 7 which prefers the male side (0.8 %). The expectedness and preventability analysis gave the finding that for each gender, the chances were nearly equal. Route of administration for suspected drugs were greater intravenous (48.1 %) in females and intramuscular (10.1 %) and oral (44.0 %) in males.
Conclusions
There are possibly relevant differences between genders in the adverse drug reactions spontaneously reported to the Iraqi Pharmacovigilance Centre. Indicating that gender may be a risk factor for (development of adverse drug reactions for some classes of drugs, some types of adverse drug reactions, seriousness, severity as well as the outcome of these adverse drug reactions). Further work is required to elucidate the mechanisms explaining the differences observed. In addition, more efforts are required from Iraqi Pharmacovigilance Centre to improve the awareness and quality of Individual case safety reports.
| Has the manuscript been published? | Accepted for published |
|---|---|
| Journal name , year , Volume, Issue and Article link | Iraqi Journal for Pharmaceutical Science, not published yet |
| Journal name | Iraqi Journal for Pharmaceutical Science |
