Drug Information Center

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Frequently Asked Questions

What medications currently have restricted access programs?

The first restricted access program in the United States was developed in 1972 to limit access to methadone.1 Since that time the use of many other medications has been restricted due to concerns about serious adverse effects, teratogenicity, potential for abuse, and a desire to ensure appropriate prescribing that minimizes patient risk. Access to most of these products is limited as a joint effort between pharmaceutical manufacturers and the Food and Drug Administration (FDA).

The most recent FDA effort to manage medication risk is the Risk Evaluation and Mitigation Strategy (REMS) initiative.2 The FDA may require manufacturers of drugs with safety concerns to submit a REMS program at the time a new drug is approved. These programs may contain any combination of 5 criteria (Medication Guide, Communication Plan, Elements to Assure Safe Use, Implementation System, and Timetable for Submission of Assessments). Restricted access programs are considered Elements to Assure Safe Use. A current list of medications with REMS programs is available via the following link:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Table 1 provides information about the medications that currently have a restricted access program. The scope of these programs varies greatly. Some programs require registration of the patient, prescriber, and pharmacy and require that the pharmacy confirm appropriateness of the prescription by calling the program before dispensing, while others are limited to a one-time training of the physician. While the requirements of some programs may be inconvenient, their aim is to encourage safe and appropriate medication use.

Table 2 provides information about the medications that are currently limited in their distribution. Limited distribution programs are generally not mandated by the FDA. These programs are developed by manufacturers to fulfill various functions including facilitating access to specialty pharmaceuticals, providing assistance with obtaining insurance coverage, and providing patient counseling services. Distribution of these medications is usually from select specialty pharmacies directly to the patient, caregiver, or institution.

Pharmacists in all practice settings should be familiar with medications that have restricted access and limited distribution programs in order to ensure safe medication use, access, and continuity of patient care.3

Table 1. Medications with restricted access programs.4-37

Medication Safety concern Enrollment Program details Contact information
Alglucosidase alfa (Lumizyme) Rapid progression of Pompe disease in patients less than 8 years old
Anaphylaxis and immune-mediated reactions
  • Prescriber
  • Patient
  • Healthcare facility
  • Lumizyme ACE program
· Must complete infusion confirmation form with every administration
800-745-4447
http://www.lumizyme.com/ace/default.asp
Alosetron
(Lotronex)
Ischemic colitis
  • Prescriber
  • Prescribing Program for Lotronex (PPL)
  • Rx must be handwritten
  • Blue sticker must be affixed to Rx
888-423-5227 http://www.lotronexppl.com/
Ambrisentan
(Letairis)
Hepatotoxicity
Teratogenic effects
  • Prescriber
  • Patient
  • Letairis Education and Access Program (LEAP)
  • Distribution to patient
· Monitoring of liver function and pregnancy every month
866-664-LEAP
http://www.letairisrems.com/ REMS_Program.aspx
Bosentan
(Tracleer)
Hepatotoxicity
Teratogenic effects
  • Prescriber
  • Patient
  • Tracleer Access Program (T.A.P.)
  • Distribution to patient

· Monitoring of liver function and pregnancy every month

866-228-3546
http://www.tracleer.com/patient/services-and-support.asp
Buprenorphine
(Subutex)
Buprenorphine/ Naloxone
(Suboxone)
Abuse potential
Law requires certification of providers who treat opioid dependence
  • Prescriber certification
· Must confirm physician certification prior to dispensing
  • Special DEA number used
800-BUP-CSAT
http://www.suboxone.com/hcp/certification/
http://www.buprenorphine.samhsa.gov/
Buprenorphine transdermal (Butrans) Overdose with abuse, overdose in non-opioid tolerant patients, addiction potential
  • Prescriber
  • Butrans REMS Education Program
888-726-7535
http://www.butransrems.com/
Clozapine
(Clozaril)
Neutropenia
Aplastic anemia
  • Prescriber
  • Pharmacy
  • Clozaril National Registry
  • Monitoring of WBC every 2-4 weeks
· Prescriber must provide results to pharmacy before dispensing
800-448-5938
http://www.clozaril.com/ hcp/tools/download_forms.jsp
https://www.clozarilcare.com/care/Splash.jsp
Darbepoetin (Aranesp) Cardiovasular events
Stroke
Increased mortality
Tumor progression
  • Prescriber
  • Dispensing hospital
  • ESA APPRISE Oncology Program
· Patient must sign a form indicating understanding of risk
866-284-8089
https://www.esa-apprise.com/
Deferasirox
(Exjade)
None
  • Prescriber
  • Patient
  • EPASS Advantage
  • Distribution to patient
888-90-EPASS
http://www.us.exjade.com/patient/epass-advantage.jsp
Dofetilide
(Tikosyn)
QT prolongation
  • Prescriber education
  • Pharmacy
  • Tikosyn in Pharmacy System (T.I.P.S.)
  • Pharmacy must verify prescriber enrollment
877-TIKOSYN
800-788-7353
http://www.tikosynrems.com/
Eculizumab
(Soliris)
Meningococcal infection
  • Prescriber
  • Patient
  • OneSource Safety Support Program
· Distribution to office, clinic, hospital, or specialty pharmacy
· Patient must receive meningococcal vaccine 2 weeks prior to therapy initiation
888-SOLIRIS
http://www.solirisrems.com/
Eltrombopag
(Promacta)
Hepatotoxicity
Bone marrow reticulin/
fibrosis
Thrombotic/
thromboembolic events
Hematological malignancy
  • Prescriber
  • Patient
  • Pharmacy
  • PROMACTA CARES
  • Pharmacy must call program before dispensing
  • Must track inventory for auditing purposes
877-9PROMACTA
http://www.promactacares.com/dispense.html
Epoetin alpha
(Epogen, Procrit)
Cardiovasular events
Stroke
Increased mortality
Tumor progression
  • Prescriber
  • Dispensing hospital
  • ESA APPRISE Oncology Program
· Patient must sign a form indicating understanding of risk
866-284-8089
https://www.esa-apprise.com/
Etonogestrel implant
(Implanon)
Improper insertion/
removal
  • Prescriber education
  • Distribution to office, clinic, or hospital
877-IMPLANON
http://www.implanon-usa.com/hcp/ orderingandbilling/index.asp?svarqvp2=0
Fentanyl buccal
(Onsolis)
Overuse, abuse, addiction potential
Respiratory depression in non-opioid tolerant patients
  • Prescriber education
  • FOCUS program for Onsolis
  • Distribution only through authorized distributors
877-4ONSOLIS
http://www.onsolisfocus.com/index.html
Fentanyl buccal tablet
(Fentora)
  • Prescriber (outpatient)
  • Pharmacy (outpatient or inpatient)
  • ACTIQ and FENTORA REMS program
  • Distribution only through authorized distributors
888-688-6885
https://www.actiqandfentorarems.com
Fentanyl nasal spray
(Lazanda)
  • LAZANDA REMS program
  • Distribution only through authorized distributors
855-841-423
https://www.lazandarems.com
Fentanyl transmucosal lozenge
(Actiq)
  • ACTIQ and FENTORA REMS program
  • Distribution only through authorized distributors
888-688-6885
https://www.actiqandfentorarems.com/
Fentanyl transmucosal tablet
(Abstral)
  • ASBTRAL REMS program
  • Distribution only through authorized distributors
1-888-ABSTRAL
https://www.abstralrems.com
Gefitinib
(Iressa)
Lack of evidence for clinical benefit
Only for patients taking before September 2005 with clinical response
  • Prescriber
  • Patient
  • IRESSA Clinical Access Program
  • Distribution to patient
877-283-0955
Hydromorphone ER (Exalgo) Overdose with abuse, overdose in non-opioid tolerant patients, addiction potential
  • Prescriber
  • Exalgo REMS Education Program
1-888-9EXALGO
http://www.exalgorems.com/
Icodextrin intraperitoneal solution
(Extraneal)
Drug-device interaction with some glucose monitoring systems
  • Dialysis clinic staff
  • Dialysis Clinic Training Program
888-736-2543
http://www.glucosesafety.com/us/index.html
Isotretinoin
(Accutane and other brands)
Teratogenic effects
  • Prescriber
  • Patient
  • Pharmacy
  • iPLEDGE
  • Monthly verification of 2 negative pregnancy tests
  • Patient must use 2 forms of contraception
866-495-0654
https://www.ipledgeprogram.com/
Lenalidomide
(Revlimid)
Teratogenic effects
  • Prescriber
  • Patient
  • Pharmacy
  • RevAssist
· Monthly verification of negative pregnancy tests by prescriber and pharmacy
  • Patient must use 2 forms of contraception
888-423-5436
http://www.revlimid.com/hcp/hcp-revassist-pre.aspx
Mifepristone
(Mifeprex)
Use in inappropriate clinical situations
  • Prescriber
  • Distribution to office, clinic, or hospital
877-432-7596
http://www.earlyoptionpill.com/ section/health_professionals/order
Naltrexone XR injection
(Vivitrol)
Use in appropriate clinical situations
  • Prescriber
  • Patient
  • Touchpoints program
  • Distribution to office, clinic, or hospital
800-VIVITROL
http://www.vivitrol.com/hcp/ Vivitrol_Info/what_is_vip.aspx
Natalizumab
(Tysabri)
Progressive Multifocal Leucoenceph-alopathy (PML)
  • Prescriber
  • Patient
  • Pharmacy
  • Infusion center
  • TOUCH Prescribing Program
  • Must complete pre-infusion patient checklist
800-456-2255
http://www.tysabri.com/tysbProject/ ....
Olanzapine ER injection (Zyprexa Relprevv) Post-injection delirium/ sedation syndrome (PDSS)
  • Prescriber
  • Patient
  • Pharmacy
  • Healthcare facility
  • Zyprexa Relprevv Patient Care Program
877-772-9390 https://www.zyprexarelprevvprogram.com /public/registration_forms.aspx
Oxycodone CR (Oxycontin) Overdose with abuse, overdose in non-opioid tolerant patients, addiction potential
  • Prescriber
  • Oxycontin REMS Educational Program
888-726-7535
http://www.oxycontinrems.com
Romiplostim
(Nplate)
Hepatotoxicity
Bone marrow reticulin/
fibrosis
Thrombotic/
thromboembolic events
Hematologial malignancy
  • Prescriber
  • Patient
  • Nplate NEXUS Program
  • Verify enrollment prior to dispensing
  • Direct distribution or order from wholesaler
877-NPLATE
http://www.nplatenexus.com/enrollment.html
Rosiglitazone
(Avandia, Avandamet, Avandryl)
Myocardial infarction
  • Prescriber
  • Patient
  • Avandia-Rosiglitazone Medicines Access Program
  • Distribution to patient
800-282-6342
https://www.avandia.com/
Sodium oxybate
(Xyrem)
Overuse, abuse, addiction potential
  • Prescriber
  • Patient
  • Physician Success Program
  • Patient Success Program
  • Distribution to patient
866-997-3688
http://www.xyrem.com/healthcare-professionals/
Tapentadol
(Nucynta ER)
Overdose with abuse, overdose in non-opioid tolerant patients, addiction potential
  • Prescriber
· Nucynta ER Healthcare Professional Education Program 800-526-7736 http://www.nucyntaerrems.com
Thalidomide
(Thalomid)
Teratogenic effects
  • Prescriber
  • Patient
  • Pharmacy
· System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) Program
  • Rx must have authorization number
  • Pharmacy must call program before dispensing
888-423-5436
http://www.thalomid.com/steps_program.aspx
Vandetanib
(Caprelsa)
QT prolongation
  • Prescriber
  • Pharmacy
  • CAPRELSA REMS Program
· Distribution to pharmacy, hospital, or long-term care facility
800-236-9933
http://www.caprelsarems.com/
Vigabatrin (Sabril) Irreversible vision loss
  • Prescriber
  • Patient
  • Support, Help and Resources for Epilepsy (SHARE)
· Vision must be assessed at baseline and every 3 months
  • Distribution to patient
888-45-SHARE
http://www.lundbeckshare.com/ pg512_important_steps.aspx

Table 2. Medications with limited distribution programs.38-45

Medication Program details Contact information
Alpha-1 proteinase inhibitor (human) (Prolastin)
  • Prolastin Direct
  • Distribution to patient
800-305-7881 http://www.prolastin.com/5.0.0_cons_howto.aspx
Alpha-1 proteinase inhibitor (human) (Aralast NP, Glassia)
  • Alpha-1 AATmosphere Program
  • Distribution to patient
866-272-5278 http://www.aatmosphere.com/
Alvimopan (Entereg)
  • E.A.S.E. Program
  • Distribution to hospital
866-4ADOLOR http://www.entereg.com/content/rems/
Dalfampridine (Ampyra)
  • Distribution to patient
888-881-1918 http://ampyra-hcp.com/hcp/physician_resources/presc_service_requests/
Iloprost (Ventavis)
  • PAH Pathways
  • Distribution to patient
866-ACTELION https://www.pahpathways.com/hcp/hcp_sub_ventavis_enrollment.asp
Mecasermin (Increlex)
  • PACE Program
  • Distribution to patient
866-867-2422 http://www.increlex.com/hcp-home.asp
Sacrosidase (Sucraid)
  • Distribution to patient
866-740-2743 877-599-7748 (hospital distributor) http://www.sucraid.net/
Sorafenib (Nexavar)
  • REACH Program
  • Distribution to patient
866-NEXAVAR 800-746-6273 (hospital distributor) https://www.nexavar-us.com/scripts/pages/en/hcp/hcc/patient-support/reach-program/enrolling-in-reach/

References

  1. Gabay MP, Costianis R. Restricted drug distribution programs. Am J Health Syst Pharm. 2003;60(15);1525-1530.
  2. U.S. Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategies (REMS). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm . Accessed November 1, 2011
  3. Evans JD, Evans EW. Review of eight restricted-access programs and potential implications for pharmacy. Am J Health Syst Pharm. 2007;64(12):1302-1310.
  4. Genzyme Corporation. Lumizyme ACE program. http://www.lumizyme.com/ace/default.asp. Accessed November 1, 2011.
  5. Prometheus Laboratories, Inc. Prescribing Program for Lotronex (PPL). http://www.lotronexppl.com/. Accessed November 1, 2011.
  6. Gilead. The Risk Evaluation and Mitigation Strategy (REMS) Program for Letairis. http://www.letairisrems.com/REMS_Program.aspx. Accessed November 1, 2011.
  7. Actelion Pharmaceuticals US, Inc. Tracleer (bosentan) Services and Support. http://www.tracleer.com/patient/services-and-support.asp. Accessed November 1, 2011.
  8. Reckitt Benckiser Pharmceuticals, Inc. Suboxone certification. http://www.suboxone.com/hcp/certification/. Accessed November 1, 2011.
  9. U.S. Department of Health and Human Services Substance Abuse and Mental Health Services Administration. Buprenorphine. http://www.buprenorphine.samhsa.gov/. Accessed November 1, 2011.
  10. Purdue Pharma, LP. Butrans Risk Evaluation and Mitigation Strategy. http://www.butransrems.com/. Accessed November 1, 2011.
  11. Novartis Pharmaceuticals Corporation. Clozaril. http://www.clozaril.com/hcp/tools/download_forms.jsp. Accessed November 1, 2011.
  12. Amgen and Centocor Ortho Biotech Products. ESA Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs (APPRISE) Oncology Program. https://www.esa-apprise.com. Accessed November 1, 2011.
  13. Novartis Pharmaceuticals Corporation. EPASS Advantage. http://www.us.exjade.com/patient/epass-advantage.jsp. Accessed November 1, 2011.
  14. Pfizer, Inc. Tikosyn Risk Evaluation and Mitigation Strategy (REMS). http://www.tikosynrems.com/. Accessed November 1, 2011.
  15. Alexion Pharmaceuticals. Risk Evaluation and Mitigation Strategy (REMS). http://www.solirisrems.com/. Accessed November 1, 2011.
  16. GlaxoSmithKline. PROMACTA CARES. http://www.promactacares.com/dispense.html. Accessed November 1, 2011.
  17. Schering Corporation. Implanon. http://www.implanon-usa.com/HCP/prescribingImplanon/index.asp?C=78737400968057291667 . Accessed November 1, 2011.
  18. MEDA Pharmaceuticals. The FOCUS Program for Onsolis. http://www.onsolisfocus.com/index.html. Accessed November 1, 2011.
  19. Cephalon, Inc. Actiq and Fentora REMS Program. https://www.actiqandfentorarems.com. Accessed November 1, 2011.
  20. Archimedes Pharma. The Lazanda REMS Program. https://www.lazandarems.com. Accessed November 1, 2011.
  21. Prostrakal, Inc. ABSTRAL REMS. https://www.abstralrems.com. Accessed November 1, 2011.
  22. Covidian. Exalgo REMS Education Program. http://www.exalgorems.com/. Accessed November 1, 2011.
  23. Baxter Healthcare. Extraneal. http://www.glucosesafety.com/us/index.html. Accessed November 1, 2011.
  24. iPLEDGE Program. https://www.ipledgeprogram.com/Default.aspx. Accessed November 1, 2011.
  25. Celgene Corporation. RevAssist for prescribers. http://www.revlimid.com/hcp/hcp-revassist-pre.aspx. Accessed November 1, 2011.
  26. Danco Laboratories LLC. Mifeprex. http://www.earlyoptionpill.com/section/health_professionals/order. Accessed November 1, 2011.
  27. Alkermes, Inc. Vivitrol. http://www.vivitrol.com/hcp/Vivitrol_Info/what_is_vip.aspx. Accessed November 1, 2011.
  28. Elan Pharmaceuticals Inc. The Tysabri TOUCH Prescribing Program. http://www.tysabri.com/tysbProject/tysb.portal/_baseurl/threeColLayout/SCSRepository/en_US/tysb/home/treatment-with-tysabri/touch-prescribing-program.xml . Accessed November 1, 2011.
  29. Lilly, LLC. Zyprexa Relprevv Patient Care Program. https://www.zyprexarelprevvprogram.com/public/Default.aspx. Accessed November 1, 2011.
  30. Purdue Pharma LLP. Oxycontin REMS website. http://www.oxycontinrems.com/. Accessed November 1, 2011.
  31. Amgen Inc. Nplate NEXUS Program. http://www.nplatenexus.com/about.html. Accessed November 1, 2011.
  32. GlaxoSmithKline. Avandia-Rosiglitazone Access Medications Program. https://www.avandia.com/. Accessed November 1, 2011.
  33. Jazz Pharmaceuticals Inc. Xyrem. http://www.xyrem.com/healthcare-professionals/. Accessed November 1, 2011.
  34. Janssen Pharmaceuticals. Nucynta ER Risk Evaluation and Mitigation Strategy (REMS). http://www.nucyntaerrems.com. Accessed November 1, 2011.
  35. Celgene Corporation. S.T.E.P.S. Program. http://www.thalomid.com/steps_program.aspx. Accessed November 1, 2011.
  36. AstraZeneca. CAPRELSA REMS Program. http://www.caprelsarems.com/. Accessed November 1, 2011.
  37. Lundbeck, Inc. Support, Help and Resources for Epilepsy (SHARE). http://www.lundbeckshare.com/. Accessed November 1, 2011.
  38. Talecris Biotherapeutics Inc. Prolastin Direct. http://www.prolastin.com/5.0.0_cons_howto.aspx. Accessed November 1, 2011.
  39. Baxter Healthcare. Alpha-1 AATmosphere. http://www.aatmosphere.com/. Accessed November 1, 2011.
  40. Adolor Corporation. Risk Evaluation and Mitigation Strategy (REMS) Program for Entereg. http://www.entereg.com/content/rems/. Accessed November 1, 2011.
  41. Acorda Therapeutics, Inc. Ampyra Prescription and Service Requests. http://ampyra-hcp.com/hcp/physician_resources/presc_service_requests/ . Accessed November 1, 2011.
  42. Actelion Pharmaceuticals US, Inc. Ventavis (iloprost) Services and Support. https://www.pahpathways.com/hcp/hcp_sub_ventavis_enrollment.asp. Accessed November 1, 2011.
  43. Tercica Inc. Increlex. http://www.increlex.com/hcp-home.asp. Accessed November 1, 2011.
  44. QOL Medical Inc. Sucraid. http://www.sucraid.net/. Accessed November 1, 2011.
  45. Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc. Enrolling patients in REACH. https://www.nexavar-us.com/scripts/pages/en/hcp/hcc/patient-support/reach-program/enrolling-in-reach/. Accessed November 1, 2011.

Updated 11/2011