Our physician office business for medical and laboratory products is now part of Henry Schein Medical — the world’s largest provider of health care products and services for office-based medical, dental, and animal health practitioners.
We offer a range of cost-efficient, clinician-preference items with low clinical differentiation.
We deliver the essential pharmaceuticals that care providers need to keep their patients healthy.
We give providers access to products and help manufacturers bring products to market effectively.
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Ensure the specific safety needs of your therapy are met
Our risk evaluation and mitigation strategy (REMS) programs include centralized regulatory and compliance services for the collection and maintenance of all data elements that will be reported back to the FDA. Services include:
Meeting the communication requirements of REMS is imperative and challenging. We can help you educate, inform and raise awareness of a drug’s risk by disseminating information to healthcare providers and professional societies as well as educating prescribers on key safety measures and serious risks to assure safe use.
If your therapy is dispensed through a specialty or retail pharmacy, we help ensure that each dispense includes your medical guide detailing the seriousness of the drug-specific risks.
The most extensive component of a REMS program is the elements to assure safe use (ETASU), which are intended to reduce a specific serious risk listed in the labeling of the drug. We support these requirements through prescriber training, reporting on evidence of safe use conditions, patient monitoring and registry enrollment.
Maintaining a central database of patients who are prescribed your therapy is a critical role to tracking the safe use of your drug as well as quickly identifying any problems that may arise. We can build and maintain this database so that you can submit your findings to the FDA regularly.
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