Adhere to Drug Sample Policy
The distribution of drug samples or starter doses to patients is highly regulated by the state Department of Public Health and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).
About half of BWH’s primary care practices adhere to BWH’s policy by choosing not to distribute drug samples. Any physician or practice that uses drug samples must adhere strictly to BWH’s starter medication policy as well as state regulations and JCAHO standards. It is important for practitioners to understand these regulations and standards are intended to ensure that drug samples are dispensed to patients by prescribers with the same requirements and safety checks mandated to pharmacists.
The BWH policy includes conditions when the samples may be given to patients, as well as requirements for labeling and dispensing the samples, documenting the process and managing inventory.
“Drug samples should be used only if the practitioner or practice is willing to comply with the hospital policy,” said Bill Churchill, MS, RPh, director of Pharmacy. “The reason for these strict requirements is that we need to ensure a safe process for dispensing starter doses or samples to our patients that includes all safety checks for allergies and drug interactions as well as ensuring that patients have the proper drug information provided to them at the time of dispensing. Practitioners who dispense starter supplies also must make sure that the medications that they dispense to patients are not recalled or expired.”
It is vitally important that any physician giving a patient a sample must provide the patient with key information about drug interactions, risks and side effects—the same information the patient would receive if he or she got the medication from a pharmacy.
Churchill recommends that physicians and practices do not give samples to patients as regular practice. “There are times when the use of starter supplies can be beneficial for the patient, but, in general, it’s best for patients to get their medications from a licensed, fully-operational pharmacy,” he said.
Anyone who uses drug samples in their practice should review BWH’s policy, especially as an upcoming, unannounced JCAHO survey will review medication management through the tracer method. If a JCAHO surveyor sees a physician give a patient a sample, he or she will check to make sure the physician complied with BWH’s policy on starter medications.
View the policy at www.bwhpikenotes.org/PatientCareServices/Pharmacy/PolicyProc/PT07.htm