Objectives. Hospital Pharmacy Strategies for REMS. Evolution of FDA Drug Safety Programs. REMS: Definition. Evolution of FDA Drug Safety Programs

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1 Objectives Hospital Pharmacy Strategies for REMS SCSHP Fall Meeting October 28, 2010 John Pearson, PharmD, BCNSP, BCPS Manager, Pharmacy Clinical Services Greenville Hospital System University Medical Center Define and describe REMS Differentiate between REMS, black box warnings, controlled access programs and patient education requirements Review the current medications that require a REMS Review strategies hospital pharmacies can implement to comply with REMS requirements REMS: Definition Risk Evaluation and Mitigation Strategies Medication safety program developed by the FDA as part of the FDA Amendment Act (FDAAA) of 2007 Evolution of FDA Drug Safety Programs Patient Education Guides/PPI - Estrogen Clozaril Patient Management System s Risk Minimization Action Plans (RiskMAPs) Isotretinoin, thalidomide RiskMAPs High risk medications requiring additional safety processes Part of approval process Risk/Benefit May have restricted distribution system Evolution of FDA Drug Safety Programs Institute of Medicine 2006: The Future of Drug Safety: Promoting and Protecting the Health of the Public Critical of FDA for medications withdrawn from the market due to safety Clarify FDA authority on postmarket monitoring Shane R. Am J Health Syst Pharm Dec 15;66(Suppl 7):S

2 FDAAA 2007 Title IX Enhanced Authorities Regarding Postmarket Safety of Drugs Sec Postmarket t studies and clinical i l trials regarding human drugs; risk evaluation and mitigation strategies. Sec Enforcement FDA Authority - REMS Pre and Post Marketing Implementation Reassessment 18 months, 3 and 7 years Enforcement - $250,000/violation $1 million maximum per single proceeding Prevent sale of drug (Accessed 09/18/2010) Shane R. Am J Health Syst Pharm Dec 15;66(Suppl 7):S6-12. FDAAA 2007 To REMS or Not To REMS Considerations in Determining the Need for Risk Evaluation and Mitigation Strategies before FDA Approval of a Drug Product Estimated size of the population likely to use the drug Seriousness of the disease or condition for which the drug will be used Expected benefit from the drug with respect to the disease or condition Expected or actual duration of treatment with the drug Seriousness of any known or potential adverse events related to use of the drug and background rate of such events in the population likely to use the drug Whether the drug is a new molecular entity Components of a REMS Medication Guides or Patient Package Inserts Communication plan to health care providers Elements to assure safe use (ETASU) Meyer B. Am J Health Syst Pharm Dec 15;66(Suppl 7):S3-5. Elements to assure safe use (ETASU) Special training, experience, or certification of health care providers who prescribe the drug Special certification of pharmacies, practitioners, or health care settings that dispense the drug Dispensing of the drug to patients only in certain health care settings, such as hospitals Dispensing of the drug to patients with evidence or other documentation of safe-use conditions, such as laboratory test results Use of special monitoring for each patient receiving the drug Enrollment of each patient receiving the drug in a registry Where are we now? Black Box Warnings Over 400 medications with black box warnings Nearly doubled in last 3 years Non-REMS Combined with REMS programs Meyer B. Am J Health Syst Pharm Dec 15;66(Suppl 7):S3-5. 2

3 Patient Package Inserts Over 200 medications Patient Package Inserts Non - REMS Inpatient versus Outpatient? Non-REMS Part of labeling Combined with REMS programs Not necessarily part of labeling CFR 21 Part 208 Each authorized dispenser of a prescription drug product for which a Medication Guide is required under this part shall, when the product is dispensed to a patient (or to a patient's agent), provide a Medication Guide directly to each patient (or to the patient's agent) (Accessed 09/25/10) Patient Package Inserts Non - REMS CFR 21 Part 208 Definitions (a)authorized dispenser means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice. (b)dispense p to patients means the act of delivering a prescription p drug product to a patient or an agent of the patient either: (1) By a licensed practitioner or an agent of a licensed practitioner, either directly or indirectly, for self-administration by the patient, or the patient's agent, or outside the licensed practitioner's direct supervision; or (2) By an authorized dispenser or an agent of an authorized dispenser under a lawful prescription of a licensed practitioner Patient Package Inserts REMS (Accessed 09/25/10) (Accessed 09/25/10) RiskMAPs Old RiskMAPs originally grandfathered Restricted Drug Distribution Systems (RDDS) Specialty Pharmacies High Cost Abarelix Alosetron Ambrisentan Bosentan Clozapine Dofetilide Eculizumab Fentanyl PCAa Isotretinoin Lenalidomide Mifepristone Natalizumab Smallpox (vaccinia) vaccine, live Sodium oxybate Thalidomide Non REMS REMS Only Ambrisentan continued with REMS Brown Bagging 3

4 Medications that have a REMS program 151 different REMS programs 127 require medication guide and/or communication plan 24 have elements to assure safe medication use Long acting opioids ongoing review Medications that have a REMS program Alvimopan Ambrisentan Bosentan Buprenorphine transderm/sublingual Certolizumab pegol Darbepoetin/epoetin alfa Eculizumab Lenalidomide Olanzapine Extended-Release Injection Romiplastin Sacrosidase Thalidomide Vigabatrin Strategies for hospital pharmacies Medications All erythropoiesis-stimulating agents () include epoetin alfa (Epogen, Procrit) and darbepoetin (Aranesp) Assisting Providers and cancer Patients with Risk Information for the Safe use of (ESA APPRISE) Oncology Program (Accessed 09/25/10) (Accessed 09/25/10) Components of REMS medication guides communication plan elements to assure safe use implementation system timetable for submission of assessments of the REMS Elements to assure safe use (ETASU) Special training, experience, or certification of health care providers who prescribe the drug Special certification of pharmacies, practitioners, or health care settings that dispense the drug Dispensing of the drug to patients only in certain health care settings, such as hospitals Dispensing of the drug to patients with evidence or other documentation of safe-use conditions, such as laboratory test results Use of special monitoring for each patient receiving the drug Enrollment of each patient receiving the drug in a registry (Accessed 09/25/10) Meyer B. Am J Health Syst Pharm Dec 15;66(Suppl 7):S3-5. 4

5 Elements to assure safe use (ETASU) Special training, experience, or certification of health care providers who prescribe the drug Special certification of pharmacies, practitioners, or health care settings that dispense the drug Dispensing of the drug to patients only in certain health care settings, such as hospitals Dispensing of the drug to patients with evidence or other documentation of safe-use conditions, such as laboratory test results Use of special monitoring for each patient receiving the drug Enrollment of each patient receiving the drug in a registry ETASU Detail Healthcare providers who both prescribe and dispense () for patients with cancer in private practice settings will be specially certified Healthcare providers who prescribe () for patients with cancer in hospitals will be specially certified Hospitals that dispense () for patients with cancer will be specially certified under Meyer B. Am J Health Syst Pharm Dec 15;66(Suppl 7):S3-5. ETASU Prescriber requirements Must complete ESA APPRISE Oncology Program Training Enroll in the ESA APPRISE Oncology Program by submitting a completed ESA APPRISE Oncology Program Enrollment Form to the ESA APPRISE Oncology Program Call Center Prescriber Requirements i. I have reviewed the current prescribing information for (). ii. I understand that shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers. iii. I understand that in order to decrease these risks, the lowest dose of should be used to avoid red blood cell transfusion. iv. I understand that are indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for red blood cell transfusions in patients with metastatic, non-myeloid malignancies, receiving chemotherapy. Prescriber Requirements v. I understand that are not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy. vi. I understand that are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure. vii. I understand that ESA use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being. Hospital Requirements Hospitals that dispense () are certified through the hospital site level enrollment in the ESA APPRISE Oncology Program. To obtain site level enrollment as a hospital, the hospital designee (e.g., pharmacy director, Head of Hematology/Oncology, or other appointed designee) must complete and sign the ESA APPRISE Oncology Program Enrollment Form for Hospitals 5

6 Hospital Requirements I attest to the following on behalf of my hospital: I have completed the ESA APPRISE Oncology Program Training Module. I understand that if healthcare providers in my hospital prescribe () to patients with cancer, failure of the staff to comply with enrollment requirements will lead to suspension of access to () for my hospital. I will inform all () prescribers at my hospital of the ESA APPRISE Oncology Program training and oncology prescriber certification requirements. Hospital Requirements I will establish or oversee the establishment of a system, order sets, protocols, or other measures designed to ensure that, in my hospital: (ESA) is only dispensed to patients with cancer after verifying: that the healthcare provider who prescribed (ESA) for patients with cancer has enrolled in the ESA APPRISE Oncology Program; and that the discussion between the patient and ESA APPRISE Oncology Program-enrolled prescriber on the risks of (ESA) therapy is documented by patient and prescriber signatures on the ESA APPRISE Oncology Program Patient and Healthcare Professional (HCP) Acknowledgement Form prior to initiation of each new course of (ESA) therapy. Hospital Requirements I am authorized to oversee compliance with program monitoring and auditing to assess the effectiveness of the ESA APPRISE Oncology Program. I will maintain evidence of compliance with the ESA APPRISE Oncology Program for monitoring and auditing purposes, as follows: a list of each healthcare provider in my hospital who prescribes (ESA) for cancer patients documentation (i.e., unique enrollment ID number) that each healthcare provider in my hospital who prescribes (ESA) for patients with cancer is enrolled in the ESA APPRISE Oncology Program documentation of the risk:benefit discussion between certified prescriber and patient by archival storage of the ESA APPRISE Oncology Program Patient and Healthcare Professional Acknowledgment Form for each cancer patient for whom an (ESA) prescription was filled (Accessed 09/25/10) Process Flows Private Oncology Clinics Adult Oncology Group Hospital Inpatient Pediatric Oncology Group Hospital Oncology Clinics Private Physicians Hospital Designee Hospital Enrollment Prescriber Enrollment Patient Education Patient and prescriber signature Documentation and Auditing Re-enrollment 6

7 Patient Prescribers Nursing Pharmacy Pharmaceutical Company Identify Stakeholders Outpatient clinics Private clinics Private pharmacies Medical records IS Risk management Hospital legal Hospital Designee/Hospital Enrollment One designee for system or one per hospital Physician i (Medical Director of Oncology) Pharmacists Director of Pharmacy Pharmacy Manager Oncology Clinical Pharmacist, Drug Information Other Consider one REMS overseer Prescriber Enrollment Employed physicians Pi Private physicians i Other prescribers New practitioners Credentialing process Patient Education Required for all patients? Repeated? Patient and Prescriber signature Initiated as outpatient Identification of appropriate patient, t indication Order set CPOE Verification prior to initiation of therapy Documentation Documentation and Auditing Maintaining files Medical record Paper Electronic 7

8 Policies and Procedures Distribution of medication guides Patient enrollment, laboratory testing, and monitoring i Communications and reporting Provider certification Dispensing and administration Documentation Summary REMS evolution of FDA safety programs FDAAA 2007 Increased in black box warnings and other safety communications Some overlap between legacy programs and REMS (Accessed 09/25/10) Summary Number of medications that have a complex REMS program are likely to increase Long acting opioids Hospital pharmacies will need to implement new strategies to handle complex REMS programs 8