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RESTRICTED ACCESS PROGRAMS
A Verifiable Link to Drug Safety
 A few products need stringent interventions to maintain a favorable benefit/risk ratio. Sentrx designs and implements Restricted Access programs that ensure a product is prescribed by qualified physicians, dispensed by eligible pharmacies, used by appropriate patients, and shipped by authorized distributors.
Sentrx Restricted Access programs begin with OnTrak™ Controller, configured to your product’s requirements. Patients, physicians, pharmacists, and/or distributors register to use, prescribe, dispense or ship your product. Information such as patient history, concomitant medications or lab test results is collected to confirm eligibility of patients to receive the drug. Your Restricted Access program can then be configured to include one or
more of the following:
- Informed consent, obtained via phone, digital fax, Web or e-mail, and stored in the online registry to document that physicians and patients are aware of potential adverse events and the importance of monitoring for and reporting them
- Creation of a unique patient identification number and prescription number in the online registry, which the pharmacist compares to verify eligibility before dispensing the drug
- Creation of a unique physician or hospital pharmacy identification number in the online registry, which authorized distributors of your product check to ensure those entities are certified to receive the drug
As with all Sentrx solutions, Restricted Access programs are built for ultra-secure Web access and backed by the Sentrx Safety Response Center.
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