Journal of Research in Pharmacy Practice

Abstract Drug therapeutic failures (TFs) are included in pharmacovigilance reporting, as some authors consider them a type of adverse drug reaction. Given their high frequency in Colombia, we studied their importance as a cause of admission to an intensive care unit (ICU). Methods: This was a cross-sectional observational study. Clinical records of patients who arrived at the emergency service of a third-care level university hospital were reviewed. Information was collected by a resident in clinical toxicology, and each case was validated and analyzed by a research team using the algorithm proposed by Vaca González and Schumock and Thornton criteria for preventability to evaluate the existence of possible medication errors. Findings: In total, 697 clinical records were evaluated and 18 patients presented TFs (2.6%, 95% confidence interval 1.5%–4.1%) as the cause of admission to the ICU. The most frequent TFs were seizures (56%) and hypertension (28%). The most commonly associated medications were valproic acid (28%) and losartan (28%). Ten cases (56%) were associated with drug misuse and the same number of cases was preventable, according to Schumock and Thornton criteria. Conclusion: This is the first study assessing TFs as a cause of admission to the ICU in the Colombian population. The frequency of TFs in our study was similar to that described in the literature; being the most common cause the inappropriate drug use, particularly for drugs with complex kinetics, such as antiepileptic drugs.

Abstract Objective: To characterize adverse drug reactions (ADRs) reported by European (EU) 
consumer for antineoplastic and immunomodulating medications.
Methods: ADRs reported by consumers of antineoplastic and immunomodulating 
medications (anatomical therapeutic chemical [ATC]) group L from 2007 to 2011 and 
located in the EU ADR database, EudraVigilance, were analyzed. Data were categorized 
with respect to age and sex, category, and seriousness of reported ADRs and medications. 
The unit of analysis was one ADR.
Findings: We located 9649 ADRs reported for antineoplastic and immunomodulating 
medications, which approximately 15% of were serious, including 26 deaths. Less than 5% 
of ADRs were reported in children. Totally 73% of ADRs were reported for women and 
27% for men. The majority of ADRs were of the type “general disorders and administration 
site conditions” (54% of total ADRs), followed by “skin and subcutaneous disorders” 
(7% of total ADRs), and “infections and infestations” (6% of total ADRs). Reports 
encompassed medicines from the therapeutic groups: Imunosupressants (ATC group L04) 
(90% of all ADRs), immunostimulants (ATC group L03) (6% of all ADRS), and antineoplastic 
agents (ATC group L01) (4% of all ADRs). Many ADRs were reported for etanercept (Enbrel®), 
Interferon beta (Betaferon®/Extavia®), and imatinib (Glivec®) with only few being serious.
Conclusion: In general, consumers reported a high number of ADRs from the use of 
antineoplastic and immunostimulant medications and many of these were classified as 
non‑serious. This indicates that consumers are interesting in reporting ADRs, but since 
the investigated substances potentially have the risk of causing many ADRs, we expected a 
higher number of serious ADRs.