Relationship between Drug-Induced Photosensitivity and Ultraviolet-Visible Absorption Spectrum and Structure / 医薬品情報学

Objective: To clarify the background difference between drug-induced photosensitivity and ultraviolet-visible absorption spectrum or structure and to construct useful information for prevention and prediction of drug-induced photosensitivity. Methods: We investigated whether, for 457 drugs for which the ultraviolet-visible absorption spectrum is listed in the Japanese Pharmacopoeia, there were absorption maxima in the UVA (320 nm or more and less than 400 nm), UVB (280 nm or more and less than 320 nm), or UVA and UVB (280 nm or more and less than 400 nm). Structure was investigated for the existence of “conjugated”, carbonyl, sulfone, nitro and fluorine. The case drug group was taken to be those drugs for which photosensitivity was listed as a side effect on the medical drug package insert. Using statistical software, SPSS statistics ® 24 (IBM), we performed univariate logistic regression analysis, and multivariate logistic regression analysis with a stepwise increment method (likelihood ratio) combining items with p＜0.2, and calculated the odds ratio (hereinafter: aOR). The significance level was taken as 0.05. Results: There were 85 drugs in the case drug group, and 372 drugs in the control drug group. As a result of multiple logistic regression analysis, in Model 1, we placed sulfone (aOR: 4.55, 95% C.I.: 2.22-9.35), fluorine (aOR: 3.66, 95% C.I.: 1.82-7.39) and nitro (aOR: 4.46, 95 % C.I.: 1.73-11.48) in this order. In Model 2, we placed sulfone (aOR: 4, 40, 95% C.I.: 2.12-9.15), fluorine (aOR: 3.81, 95% C.I.: 1.87-7.76), UVA (aOR: 2.40, 95% C.I.: 1.37-4.18) and nitro (aOR: 3.61, 95% C.I.: 1.39-9.40) in this order. Conclusion: When a drug is developed, its ultraviolet-visible absorption spectra and structure become clear, and from this information,measures can be taken which bear the potential risk of photosensitivity in mind.

Association between the Current Situation of Adverse Reactions Caused by Non-prescription Drug Abuse and Patient Backgrounds / 医薬品情報学

Objective:In this study,we explored adverse reactions and patient background and performed a case/non-case study on a database of adverse reaction case reports in order aid the prevention of non-prescription drug abuse.Study Design:We conducted a case/non-case study on a database of adverse reaction case reports.Methods:We studied case reports of adverse reactions and addiction in Japan and extracted adverse reaction cases associated with taking antipyretic analgesics,antitussive drugs,antitussive expectorant drugs,hypnotic and sedative drugs,anti-anxiety drugs,and purgative drugs. We divided the extracted cases into an abuse case group (adverse reactions associated with non-prescription drug abuse,and divided its intended purpose or the purpose of abuse at the initial dose)and non-case group(other adverse reactions). We performed univariate logistic regression analysis on each item of investigation in the abuse case group and non-case group and calculated the odds ratio,p-value,and 95%confidence interval.Results:There were many abuse case reports of women 20-40 years old in the antipyretic analgesics abuse case group and many of them had liver/biliary lesions and chronic urological impairment. The most common reason reported for taking the initial dose of each drug was for its intended purpose.Discussion:It is important for pharmacists at community pharmacies and drugstores to be able to recognize the characteristics of patients who might be at risk of abuse and the adverse reactions and patient backgrounds elucidated in this study could be helpful in identifying them.

Characteristics of Adverse Events in Pregnant Women / 医薬品情報学

<b>Purpose: </b>The purpose of this study is to elucidate the characteristics of adverse events in pregnant women, the offending drugs, and patient backgrounds from reports of adverse events.  We performed a case series study.<br><b>Methods: </b>We used CARPIS, a database of adverse events and toxication reported in Japan spanning from 1987 to 2014 and created by the Drug Information Center, Meijo University.  We extracted cases of adverse events in pregnant women, their fetuses, and newborns and investigated the age, primary disease, and history of allergies of the women and the intended use of/offending drugs, therapeutic category, and names for adverse events.<br><b>Result: </b>We collected 434 cases of adverse events in pregnant women, and 251 pediatric cases with adverse events.  The most frequent offending drug in both groups was ritodrine hydrochloride.  The most frequent adverse event in pregnant women was pulmonary oedema due to the administration of ritodrine hydrochloride.  The most frequently reported adverse events in pediatric cases were transient hypothyroidism and withdrawal symptoms in newborns and birth abnormalities in fetuses and newborns, all of which were caused by drugs given for the underlying diseases of their mothers.<br><b>Discussion: </b>We elucidated serious adverse events in pregnant women caused by the administration of ritodrine hydrochloride.  Frequent factors for adverse events were the onset of physiological factors in pregnant women and complicated factors of the mechanism of action of ritodrine hydrochloride.  We need to monitor both mothers and fetuses during the drug administration.  It is suggested that adverse events in pediatric cases are associated with drugs given for underlying diseases in mothers.  Thus, it is necessary to give appropriate information and communicate the risks of taking these drugs before pregnancy.  We believe the results could be helpful in the early detection of adverse events in the future.

Risk Factors and Subjective Symptoms of Drug-Induced Thrombocytopenia / 医薬品情報学

<b>Objective: </b>The present study investigated risk factors and subjective symptoms associated with drug-induced thrombocytopenia.<br><b>Methods: </b>We selected 361 patients with drug-induced thrombocytopenia from the Case Reports of Adverse Drug Reactions and Poisoning Information System (CARPIS) database of over 65,000 case reports of adverse drug reactions and assigned these patients to a case group.  We also randomly selected 794 cases of adverse drug reactions not associated with thrombocytopenia as a control group.<br><b>Results: </b>Data were compared between the case and control groups, and results were analyzed using logistic regression analysis.  We identified type of infection (non-viral) and renal failure as risk factors for drug-induced thrombocytopenia.  In addition, administration of carbamazepine, methotrexate, interferon alpha, ticlopidine or valproic acid significantly increased the risk of drug-induced thrombocytopenia.  Significant associations were also found between drug-induced thrombocytopenia and purpura, fever, and mucosal bleeding.<br><b>Conclusion: </b>These findings provide helpful information for early detection and prevention of thrombocytopenia as a serious adverse drug reaction.