Pharmacy Consulting on Drug Recall Policies & Procedures

Recently in the news have been several cases where pharmacies throughout the nation have had to institute drug recalls or notify patients regarding errors in their prescriptions dispensed. Several examples include:

– Martin Avenue Pharmacy in Naperville, Illinois has issued a voluntary recall of compounded medications prepared at their pharmacy after inspectors brought up concerns regarding compounding sterility and compounding procedures at their facility. The pharmacy which prepares customized medications for both patients and pets is recalling all “in-date compounded sterile preparations” according to sources at the pharmacy. Martin Avenue Pharmacy in Naperville issued the voluntary recall of the medications that were prepared on site after inspectors recently brought up concerns about sterile procedures. “The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance,”  the pharmacy said in a statement. This follows an FDA inspection that occurred between June 30th and July 21st that listed 15 observations about the drug preparation procedures and their sterility.

– Abrams Compounding Pharmacy based in Dallas, Texas recalled all of its unexpired sterile products according to an FDA news release. The products include IV medications, eye drops, nasal sprays and pellet implants that were shipped to patients, physicians and healthcare facilities between June and December of 2013. The company recalled their products after a patient who received one of their compounded medications had an adverse effect according to the FDA.

– In August the FDA recalled all sterile products from ApotheCure, Inc. (A compounding pharmacy located in Dallas, Texas). This was based on the fact that 15 patients in two Texas hospitals became seriously ill resulting in bacterial bloodstream infections.

Although in each case the pharmacies involved may have not violated any laws or be found guilty of any wrongdoing, the point is that all pharmacies need to have policies and procedures in place to handle such situations. Does your pharmacy have them? If the answer is no then we strongly urge you to contact HCC today to get the process started. Healthcare Consultants has over 25 years experience in Pharmacy Consulting and has been assisting retail, hospital, specialty and compounding pharmacies establish the necessary procedures and policies to deal with such situations should they arise. This is a definite example of the old cliche “an ounce of prevention is worth a pound of cure” being important for your pharmacy business. Call us today at 800-642-1652 for a free consultation with one of our in-house experts to see how HCC can make sure your pharmacy business is prepared for any emergency.

Bob Miller
9/11/2014


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