Analyses of oxycodone-induced adverse effects based on the Japanese Adverse Drug Event Report Database

　Recently, the amount of oxycodone used for palliative care in the medical setting has markedly increased in Japan. As the beneficial effects and pharmacokinetic profile of oxycodone are dependent on patient characteristics such as gender and age, it is important to understand the relationships between adverse effects and patient characteristics when administering oxycodone therapy to patients suffering from cancer-related pain. Therefore, we used the Japanese Adverse Drug Event Report Database administered by the Pharmaceuticals and Medical Devices Agency, Japan, to analyze the frequencies of adverse events associated with oxycodone therapy. Furthermore, the statistical significance of the associations between adverse effects and background parameters, such as age and gender, was determined using Fisher’s exact test and odds ratio. As a result, it was found that delirium, nausea, and vomiting are the most common adverse events seen after oxycodone administration. These symptoms are also caused by morphine and fentanyl. Nausea and diarrhea in female and interstitial lung disease in male reported more frequently. On the other hand, somnolence and delirium in elderly patients reported more often than in young patients. These findings might be helpful for managing the adverse effects of pain therapy on an individual basis.

Hospital-wide "opioid surveillance" audit led by palliative care team pharmacists to monitor pain management with opioids

Background: Previous surveys have demonstrated that a significant proportion of inpatients did not receive adequate pain management at an acute care hospital in Japan. Aim: The aim of this study was to evaluate the usefulness of a hospital-wide audit for assessing pain management with opioids according to the electronic medical records (EMRs) Methods: The subjects of this audit were inpatients receiving strong opioids who had not been consulted by the pallia. tive care team (PCT). The PCT held a weekly pharmacist-led conference to evaluate the adequacy and appropriateness of analgesics, including opioids, as well as drugs administered for adverse effects according to information collected by the PCT pharmacists. The PCT subsequently recorded the advisory comments in the EMRs. Each week, the PCT monitored whether the suggestions had been accepted by primary physicians and whether the pain and/or adverse effects had improved. Results: Among a total of 4,978 cases evaluated during the 3-year survey period, 888 (17.8％) had inadequate pain and/or adverse effect management. Symptoms improved in 82.3％ of cases for which PCT proposals were accepted. Conclusion: The results suggest that this hospital-wide audit may be useful for improving pain management with opioids at an acute care hospital.

Analyses of opioid-induced adverse effects based on Japanese Adverse Drug Event Report database：Distinctive tendencies of the adverse events induced by morphine, fentanyl and oxycodone

Potent opioid analgesics are applicable for the treatment of severe pain, especially in cancer patients. Management of opioid-induced adverse effects is important to continue treatment with opioids because these drugs are associated with a variety of kinds of adverse effect, such as deliria and respiratory depression. However, information regarding these adverse effects in Japanese patients is limited. Therefore, we searched and analyzed a database for drug-induced adverse effects in Japan, the Japanese Adverse Drug Event Report database（JADER）, to acquire information related to the adverse effects induced by potent opioids such as morphine, fentanyl, and oxycodone. Cases with adverse effects associated with medications for palliative care were extracted from JADER, and types and frequencies of the events for each analgesic were analyzed. As a result, a lot of common adverse effects were found among the three opioids. However, the orders of their frequency differed among the analgesics. In principal component analysis, the property of morphine was intermediate between those of fentanyl and oxycodone. These findings may contribute to safe and effective pain control for patients receiving medical treatment with potent opioid analgesics.

Effects of Information Provided by Pharmacists on Pharmacotherapy / 医薬品情報学

<b>Objective: </b>There are only a few studies evaluating the effects of drug information services on pharmacotherapy.  We, therefore, studied the effects of providing drug information such as the effectiveness and safety of aliskiren on its pharmacotherapeutic efficacy by comparing before versus after drug information provision.<br><b>Methods: </b>Pharmacists provided drug information such as the effectiveness and safety of aliskiren coadministered with either ACE-I (angiotensin converting enzyme inhibitor) or ARB (angiotensin receptor blocker) to physicians and other healthcare professionals.  We compared the number of patients for whom aliskiren was prescribed, the proportion of diabetic patients taking both aliskiren and ACE-I (or ARB), the proportion of patients with low eGFR (estimated glomerular filtration rate), and the proportion of patients with hyperkalemia and related conditions, before versus after providing the drug information to the healthcare professionals.<br><b>Results: </b>The number of patients for whom aliskiren was prescribed decreased.  The proportion of patients taking both aliskiren and ACE-I (or ARB) decreased significantly after providing the drug information (<i>p</i>=0.007).  The proportion of diabetic patients taking both aliskiren and ACE-I (or ARB), the proportion of patients with low eGFR, and the proportion of patients with hyperkalemia also decreased, after providing the drug information.<br><b>Conclusion: </b>This study showed the drug information service to be clinically beneficial, achieving better pharmacotherapy.  Pharmacists should evaluate and provide information on the effectiveness and safety of drugs announced by authorities in a timely manner to achieve optimal patient care.