Issue link: http://viewer.e-digitaledition.com/i/441611
E VEN THOUGH THE sample prescrip- tion drugs are packaged and labeled by the manufacturer, physicians still have certain record keeping obligations when physicians dispense these sample prescription drugs directly to their patients. A physician should document the following information for certain drugs dispensed to directly patients: + Medication name + Dosage + Number dispensed + Lot number + Expiration date + Dispenser's name and date, and + Name and address of the person to whom or for whose use This information may be contained in the patient's permanent medical record. However, in addition to these record keep- ing requirements, federal law requires physicians to have a documentation system in place to facilitate medication recalls. The documentation should facilitate a rapid response and, if necessary, per- mit a physician to immediately contact all those patients who have received the recalled prescription drug. It is best practices to maintain a separate log of all sample drugs received and dispensed. The prescription log should contain the following information: + Manufacturer + Medication + Dosage + Lot number + Expiration date + Date received + Patient's name and address + Dispensing practitioner's name + Date dispensed The log allows a physician to accurately track the receipt of sample medications from the physician to the patient. The log also enables the physician a straight- forward mechanism to evaluate a recall plan and contact the necessary patients. Physician offices may be required to act upon a recall plan. For example, last year, Novartis recalled about 5.3 million bottles of sample drugs provided as free samples to physician offices. NOTE: This general summary of the law should not be used to solve individual problems since slight changes in the fact situation may require a material variance in the applicable legal advice. Laura A. Brady is an attorney with the law firm of Krugliak, Wilkins, Griffiths & Dougherty Co., LPA, in Canton, OH. ■ Documentation Cannot be Dispensed with when Dispensing Sample Drugs By Laura A. Brady, Esq. ++++++++++++++++++ + +++ + +++ ++++++++++++++++++ LEGAL-EASE 2 0 1 5 JA N UA RY/ F E B R UA RY ■ M D N E W S . CO M ■ MD NEWS Cleveland/Akron/Canton | 2 3