Does your practice store and dispense sample prescriptions? Rules and regulations to consider before doing so.

As always, one should research your state’s pharmacy and medical licensing board’s regulations, concerning the storage, dispensing and labeling of prescription medications (such as drug samples), some other organizations have their own recommendations and policies concerning drug samples that you should follow to minimize your professional liability. A few of these organizations include;

1. The Joint Commission (TJC)
2. Institute for Safe Medication Practices (ISMP)
3. The National Coordinating Council (member ship includes the FDA and TJC)

State licensing board’s rules are concerned with obvious things like the proper storage, tracking and labeling of prescription medications. Labeling typically requires that the patient name, drug name and strength, quantity provided, directions, date dispensed, and drug expiration date and lot number be affixed to the packaging. Everyone needs to follow these regulations to minimize their legal liability. Of the three organizations listed the TJC Medication Management Standards for hospital affiliated physician offices and clinics are the most important to follow. Everyone wants to avoid receiving Requirements for Improvements (RFIs) after a survey during your Exit Conference.

TJC recommendations for sample prescriptions can be found at the Joint Commission Website

Some of the Medication Management Standards for Sample Prescriptions are:

• Medications are dispensed safely. Note:  This standard is applicable to all practices that dispense medications, including those practices that dispense sample prescriptions. Quantities of medications are dispensed and minimize diversion yet are still consistent with the patient’s needs. (Standard MM.4.40 B1)
• Procedures supporting safe medication prescribing or ordering address the following: Ordering, procuring, storing, controlling, labeling, preparing, and dispensing medications according to law or regulation (Standard MM.5.30 B1)
• Medication orders must be written clearly (MM.3.20)
• Medication orders or prescriptions are clear and accurate (MM.04.01.01)
• The patient record contains information that reflects the patients care, treatment or services (RC.02.01.01)
• Medications are appropriately labeled, Element of Performance #3 at a minimum – this information is usually included on the container (MM.4.30)
• The organization follows a process to retrieve recalled or discontinued medications (MM.0501.17).
• Medications dispensed by the practice are retrieved when recalled or discontinued by the manufacturer or the Food and Drug Administration for safety reasons. (Standard MM.4.70) B 4. The practice has procedures for retrieving and safely disposing of recalled medications including the following:

1) Identifying each patient who is receiving or has received recalled medications

2) Identifying the source of the medication

3) Providing for the retrieval and safe disposal of medications subject to recall

4) Providing for external reporting of medication product defects

• The organization responds to actual or potential adverse drug events, significant adverse drug reactions, and medication errors (MM.07.01.03).
• If the patient is transferred to another Provider, setting, level of care, a complete list of current medications, must be communicated (National Patient Safety Goal 8B).
• Look-alike/sound-alike drugs are identified (NPSG 3, Requirement 3C). I.e., Drug Sample uses tall man lettering.

MEDeRx Software Solutions for Dispensing Sample Prescriptions

One of the many benefits of using MEDeRx’s software is that the software provides immediate compliance with many of the above requirements. For example, inventory, labeling, recall information, external reporting, patient demographics, medication orders, etc., are provided and housed within our software.

If your practice does or is considering dispensing sample prescriptions, choose the right software, choose MEDeRx.