Kathy Shostek, Vice President Healthcare Risk Management contributed a recent post about the management of drug samples in physician offices. The blog outlined the need for strategies for documentation and management of drug samples for reducing risks to patient safety. I would like to look at another element of this important issue for both patients and providers.
Although the provision of pharmaceutical samples is nothing new, the emphasis on transparency in the Affordable Care Act has strengthened the importance of reporting this service. As previously reported in the Sedgwick Connection, physicians and healthcare organizations have extensive record keeping and reporting requirements under the Prescription Drug Marketing Act (PDMA) of 1987. This law was established to help prevent the use of “misbranded, expired and adulterated pharmaceuticals.” No longer can drug or device representatives drop by a physician’s office with samples to hand out. Now physicians must request the samples and document their receipt and distribution. The presence of sales representatives in patient-care areas can be considered a HIPAA violation and these vendors may not access patient information without prior written authorization from the patient.
Section 6002 of the ACA, the Physician Payments Sunshine Act requires manufacturers of pharmaceuticals, biologics and medical devices to provide detailed reporting to the Centers for Medicare and Medicaid Services (CMS) on “Transfer of Value” that they provide to healthcare providers. In addition to the documentation of providing samples, these transfers of value should include everything from sponsored meals to research activities and apply to medical students, hospitals, physicians and other healthcare professionals. The reporting format keeps a separate record for each address maintained by a physician to whom samples were provided. Therefore, a doctor with three office locations would have three separate files maintained. Under the Paperwork Reduction Act, the US Food and Drug Administration (FDA) has provided an electronic gateway to make it easier for providers and receivers to comply with reporting of the 13-item list of information requirements for each “transfer of value.”
In addition to the reporting mandates under Sec. 6002 of the ACA, Sec. 6004 of the Act also requires both manufacturers and distributors of drug samples to submit extensive data to the FDA documenting:
- Identity and quantity of drug samples requested
- Identity and quantities of drug samples distributed
- Identifying information, including name, address and professional designation of the person(s) making the request or signing for it
- “Any other information as required” by the Secretary of Health and Human Services
Although there are no prohibitions against the provision and use of company-provided samples, some healthcare organizations are opting to reject or forego pharmaceutical promotional efforts citing concerns of conflict of interest and perceived loss of integrity in research. One complaint cited about the use of physician drug samples is related to generics versus name brand drugs. “Free” physician drug samples are typically new, name-brand drugs and are promotional offerings for the latest treatment options. Critics of this practice complain that using promotional samples of these new drugs creates a disincentive to use cheaper, scientifically established generics. Organizations such as No Free Lunch (www.nofreelunch.org) discourage the acceptance of all industry gifts, including pens, notepads, food, and of course, medical samples. Instead, they encourage the use of Patient Assistance programs directly between the patient and the manufacturer.
Healthcare organizations such as The National Physician’s Alliance support full disclosure of use not only of drug samples but all other transfers of value such as educational materials, fees for speaking engagements, research grants and travel. Their position is that patients and the public should be fully informed in order to make decisions as to whether these practices could impact their care. Some large academic systems have also banned the acceptance of these “gifts” in order to avoid concerns of perceived conflict, but the National Physician’s Alliance has urged the CMS to clarify and strengthen guideline language to promote detailed descriptions of, and accounting for research funding at teaching institutions.
Many healthcare providers and institutions find the management and reporting obligations associated with medications and materials provided by the pharmaceutical and medical device industries to be a daunting task, but there are solutions and assistance available. For more information on reporting, please see the FDA website at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm292040.htm.
For more information on Sedgwick’s capabilities in this area, please email HealthcareRM@Sedgwick.com.
April Clemens
Business Relationship Manager-PL
Sedgwick