Managing Medication Recalls with ADLT™
Whether you are a pharmacist, wholesaler, or manufacturer, you realize that the medication recall process requires drastic improvement.
As described by Dr. Darryl Glover, Pharm. D MBA: “I have experienced this first hand as a pharmacist. There were several times when patients would come to the pharmacy and tell me they heard their medication was recalled; I hadn’t even received a fax notification about this. It is difficult to know what to do in those situations, or if the information the patient understood, was even accurate.
Here are some recent notices that I received regarding medication recalls:
1. Date Product Shipped: November 2014
Issue: Inactive ingredients listed on the label not included in the product formulation.
2. Date Product Shipped: November 2015
Issue: Presence of black particles in the syrup
3. Date Product Shipped: April 2016
Issue: Incorrect expiration date identified on the container label
The questions that come to mind are: why did it take almost 2 years for some these recalls to occur? how much time will it take for me to go through my prescription and invoice records to see if I ordered the product?, how will I know if I even dispensed the lot number in question?
These issues are compounded by the fact that not all pharmacies have inventory management systems and if they do how certain can they be that all of the data required to identify who may have received a recalled lot is in the system. Even if I could find the patient, how do I find out if they are ok two years after the fact without damaging my credibility? Not one of these recall notices requires any member of the supply chain to gather patient data and report it.”
The Drug Supply Chain Security Act begins to address this issue by allowing more targeted recalls as the pharmacy systems will track the serial numbers of the medications in inventory and what serial number (s) was dispensed to what patient. However, the requirement does not mention that importance of bidirectional communication across all points of the supply chain.
ADLT™ allows the bidirectional transmission of information so that the number of patients that actually received the medication is known along with a more accurate and targeted dissemination of recall information. There is no reason to disrupt all pharmacies across the US regarding a recall if they never ordered the medication and if they did not receive the affected lots. The pharmacy then would have the ability to only contact or respond to patient inquires with confidence that they received the affected lots. This also gives pharmacies the opportunities to identify and report via ADLT™ any adverse effects noted from those patients that actually took the medication being recalled.
When combined with serialization, ADLT™ becomes the bridge to ensure that the right information reaches the right individuals at the right time and to efficiently report the impact of a recall on both patients and the manufacturers business. Also, with the use of ADLT™ as an integral part of the Supply Chain from API to Patient, manufacturers’ may be able to more quickly identify potential problems and accurately report the impact to the FDA due to their improved visibility of their global supply chain.
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