Pharmacovigilance Newsletter Jan/Feb 2011

Anonymous

Dear fellow healthcare professional,
Thank you for your warm & positive response to the newsletters. I am now in the process of administering the “ Pharmacovigilance Awareness Questionnaire”, the main purpose of which is to assess your knowledge & attitude toward adverse drug reaction reporting & pharmacovigilance. To date I have received responses from a total of 155 physicians, pharmacists & dentists. I still need more responses to ensure that the study is statistically powered. So listen/look out, you may be hearing from or seeing me soon ! Thanks to all who have responded to the questionnaire. I appreciate your time, patience & willingness to help me collect data for my research. You will be informed of the results in due course.

The following is an article that I found interesting:
February 8, 2011 — The US Food and Drug Administration (FDA) has released its latest list of drugs to monitor based on potential signs of serious risks or new safety information identified in the agency's Adverse Event Reporting System (AERS).The quarterly watch list consists of 13 drugs that treat a wide range of conditions, including cough, angina, diabetes, cancer, and bipolar disorder. The FDA is studying the 13 drugs to determine whether they are causally linked to the possible risks reported through AERS from July to September 30, 2010. The drugs are considered pharmacologically innocent until proven guilty. According to the FDA physicians should not stop prescribing these drugs, nor should patients stop taking them. Among the 13 drugs are Lithium citrate (Eskalith ), Lopinavir/Ritonavir oral solution (Kaletra) & Pioglitazone HCl (Actos). According to the article, Lopinavir/Ritonavir has been associated with serious adverse events in neonates, Pioglitazone with rhabdomyolysis & Lithium citrate with Brugada syndrome (a hereditary syndrome that causes sudden unexpected cardiac death in apparently healthy young males). For more information go to http://www.medscape.com/viewarticle/737056?src=mpnews&spon=18
Have any of your patients experienced adverse reactions to drugs? You don’t have to be sure that a drug is causing an ADR, just be suspicious. Please report all serious reactions to medicines even if they are known. These reports can provide useful information on new risk factors or interactions with other medicines or foods. Reports can be submitted using the Ministry of Health’s “PharmWatch” form, a copy of which is attached to this document. To report an ADR, complete the form, save it, then E mail it to me at jaki@cwjamaica.com. This form can be downloaded from the Ministry of Health’s (Jamaica) website www.moh.gov.jm All ADR reports will be handled confidentially.
Best regards,
Dr. Jacqueline E. Campbell 428-4065 (mobile)