Xyrem Success Program
Overview
Due to the abuse reports and adverse events surrounding GHB in the past, legal efforts to control the sale and distribution of GHB and its analogues nearly prevented the clinical development of sodium oxybate for narcolepsy in the USA. However, after discussion with stakeholders, the solution was the development of a restricted drug distribution system, which led to the Xyrem Success Program. This program is intended to promote the safe use of sodium oxybate, and to alleviate concerns regarding the possibility of drug diversion and abuse.
The Xyrem Success Program, developed by the manufacturer of Xyrem, includes recommendation to doctors and pharmacists for educating patients on the effective, safe and proper use of Xyrem. Through the Xyrem Success Program, educational materials are provided by the doctor or pharmacist to the patient.
Before the patient is dispensed sodium oxybate for the first time, the physician is required to confirm with the patient that he or she has read and understood these materials. During the course of therapy with sodium oxybate, the physician should follow up with the patient every three months, and document any side effects that the patient may have experienced.
The following answers the 5 W's of the Xyrem Success Program.
Who:
Pharmacy personnel (Pharmacists/pharmacy technicians): Are responsible for receiving filling, shipping and tracking prescriptions. They receive extensive training about narcolepsy and the therapeutic application of sodium oxybate. They are able to provide comprehensive drug information and drug counseling support for physicians and patients. They also maintain a central registry of all physicians currently prescribing sodium oxybate (and their records) and all patients currently receiving the medication.
Physicians
- Must have authority and privileges to prescribe sodium oxybate through completion of the Physician Success Program
- Xyrem should only be prescribed by physicians who meet the following requirements:
o Experience in treating cataplexy in patients with narcolepsy
o Completion of the Xyrem Physician Success Program
- Physicians are encouraged to evaluate patients and re-write prescriptions every 3 months and to report all adverse events related to sodium oxybate using special forms
- By completing the special prescription for each patient, the physician confirms that they:
o Have read and understand the Physician Success Program materials
o Have provided sodium oxybate dosing, preparation and administration counseling to their patient
o Understand that sodium oxybate is approved for the treatment of cataplexy in patients with narcolepsy
o Understand their responsibility regarding participation in the Xyrem Post Marketing Evaluation Program
What
Components of the program include a centralized distribution and dispensing system, a physician and patient registry, compulsory educational materials for patients and physicians, a specially trained pharmacy staff, a method for tracking prescription shipments, and an initial post-marketing surveillance program.
The Xyrem Success Program is a Risk Management Program founded on the following core components that provide for the safe and effective use of the drug, and limit the potential for drug diversion and abuse:
1. Implementation of a program to educate physicians, pharmacists and patients about the risks and benefits of XYREM, including critical information necessary for the safe use, storage and handling of the drug.
2. Implementation of a restricted distribution program for Xyrem through a single wholesale distribution company that will ship the drug directly to pharmacies on an as-needed basis after patients have presented with an initial legitimate prescription.
3. Filling of the initial prescription only after the prescriber, pharmacist and patient have received and read the educational materials.
4. Maintenance of a registry of Xyrem Success Program trained physicians, pharmacies and patients.
When
- Diagnosis of narcolepsy with cataplexy and prescription for sodium oxybate for a patient
- Refill prescriptions for sodium oxybate
- Distribution or dispensing of sodium oxybate to a patient
Where
- The use of a centralized pharmacy eliminates the need to have the product distributed by several wholesalers and stocked by retail pharmacies, minimizing the potential for theft and diversion.
- The design and function of a centralized pharmacy has several unique aspects designed to maximize product security
Why
- This system has created a unique opportunity to provide both physician and patient education and ongoing patient counseling, promoting greater drug safety and enhanced patient compliance
- Provides a viable model for the responsible distribution of beneficial medications to small patient populations when they are associated with a significant element of risk for abuse, theft, or diversion
How
The components of the Xyrem Risk Management Program work together to ensure appropriate dispensing and use of sodium oxybate in the following manner:
1) To prescribe sodium oxybate, physician receives Xyrem Success Program materials through the manufacturer and reviews and completes the materials
2) The physician then sends the prescription for sodium oxybate form to the central pharmacy for dispensing
3) Upon receiving the prescription, the pharmacy verifies the credentials of the physician for prescribing privileges
a. If the physician’s credentials are approved, the patient is mailed the Xyrem Success Program materials and the reimbursement process is started.
b. If any relevant disciplinary actions against the physician are identified, the enrolment form is returned to the physician with a cover letter explaining why the prescription cannot be filled. The patient is also sent a letter instructing them to contact their physician
4) The pharmacy contacts the patient to confirm that the educational materials were received and read by the patient and to address any questions.
a. If the patient indicates that the Patient Success Program has been read, the pharmacist will counsel the patient and schedule the prescription for delivery.
b. If the patient has not read the materials, the importance of doing so is emphasized and another call is scheduled to complete the patient counseling process before the drug is shipped.
5) The shipment must be sent by an overnight delivery service to the patient or patient designate. Each shipment is tracked from the time it leaves the pharmacy until it is received by the patient or designate.
6) Following shipment, the patient is called to confirm that the prescription was received.
7) Within 8 days before the prescription is scheduled to be finished, the pharmacy contacts the patient to arrange for shipment of the next prescription refill.
a. If the patient is not reached, they are left a message to return the call using a telephone number provided.
b. If the patient is reached, shipment of the prescription refill is scheduled
8) With each refill, the pharmacist evaluates the patient’s compliance with therapy and any evidence of possible product diversion, misuse or overuse.
9) A pharmacist contacts the patient to ensure that prescriptions have been received, to provide ongoing communication to monitor patient safety, and to offer support as needed to maximize the benefits from their prescribed therapy.
References
1. Fuller DE et al. The Xyrem Risk Management Program. Drug Safety 2004; 27(5): 293 – 306
2. Valeant Canada Ltd. Xyrem (sodium oxybate) Product Monograph. Sept 2009. Accessed June 3, 2012 from http://webprod3.hc-sc.gc.ca/dpd-bdpp/dispatch-repartition.do?lang=eng
Images:
careerbear.com http://bouldersleeptherapy.com/disorders/narcolepsy.php/
autoimmunediseasesa2z.com
www3.unil.ch
2. Valeant Canada Ltd. Xyrem (sodium oxybate) Product Monograph. Sept 2009. Accessed June 3, 2012 from http://webprod3.hc-sc.gc.ca/dpd-bdpp/dispatch-repartition.do?lang=eng
Images:
careerbear.com http://bouldersleeptherapy.com/disorders/narcolepsy.php/
autoimmunediseasesa2z.com
www3.unil.ch