1. Kori Talbott, PharmD PGY1 Pharmacy Resident Eastern States May 2013 Incorporation of REMS (Risk Evaluation and Mitigation Strategies) into daily clinical practice in the inpatient hospital setting: results of an online survey

2. Study Objectives  Determine how many institutions are compliant with REMS guidelines  Based on four areas of compliance, assess if the presence of policies and procedures regarding REMS would help hospitals to achieve compliance with REMS requirements  Determine current practice regarding REMS in an inpatient hospital setting

3. Background  Food and Drug Administration Amendments Act of 2007 –Response to Vioxx recall in 2004 –Intent is to “ensure that the benefits of a drug or biological product outweigh its risks” –Civil, criminal, and administrative liabilities  Potential REMS program components: –Communication Plan –Medication Guide –Implementation System –Elements to Assure Safe Use (EASU) “Approved Risk Evaluation and Mitigation Strategies (REMS)” Postmarket Drug Safety Information for Patients and Providers. Food and Drug Administration, 25 February 2013. Web. 18 March 2013.. Traynor, Kate. "Experts Say REMS Assessments Need Work." ASHP Pharmacy News [White Oak, MD] 15 July 2012, n. pag. Web. 23 Aug. 2012.

4. Background  Potential Elements to Assure Safe Use (EASU) Program Components “Approved Risk Evaluation and Mitigation Strategies (REMS)” Postmarket Drug Safety Information for Patients and Providers. Food and Drug Administration, 25 February 2013. Web. 18 March 2013. http://www.fda.gov.http://www.fda.gov

5. Background  Pharmacy News in ASHP: Experts say REMS Assessments Need Work – July 2012 –Lack of official FDA policies on REMS programs, goals, and implementation  Common REMS drugs and programs –Tikosyn: Tikosyn In Pharmacy Systems (TIPS) Program –Alglucosidase alfa: Lumizyme ACE Program –Fentanyl: Transmucosal Immediate-Release Fentanyl (TIRF) Program Traynor, Kate. "Experts Say REMS Assessments Need Work." ASHP Pharmacy News [White Oak, MD] 15 July 2012, n. pag. Web. 23 Aug. 2012.

6. Methods  Study Design –IRB Approved –Expert Reviewed –Anonymous, 25 question web-based survey –Distribution through LISTSERVS and targeted emails to local hospital pharmacies –Survey data collected via REDCap  Time period –November 2012 – January 2013 Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.

7. Methods  Inclusion Criteria –Completed surveys  Exclusion Criteria –Incomplete surveys –Institutions did not indicate dispensing of any listed REMS drugs  Statistical Tests –Pearson Chi Square –Fisher Exact Test –P-values less than 0.05 considered significant

8. Methods  Survey questions – Presence of policy and procedures –REMS drugs dispensed –Extent of compliance with various REMS standards –Responsibilities for implementation –Implementation tools –Procedures for auditing for compliance

9. Results  50 surveys returned  Data analysis based on 48 surveys  Policy and Procedures (P&P) pertaining to REMS Number (n = 48)Percent Institutions with P&P 3470.8% Institutions with out P&P 1429.2%

10. REMS Medications Dispensed

11. Results REMS requirements based on dispensed medications Compliance n = 48 Provision of mandatory Medication Guide 39.6% M andatory prescriber enrollment/training 79.2% Mandatory patient enrollment/acknowledgement 77.1% Mandatory pharmacy/hospital enrollment 93.8% Compliance with all four areas35.4%

12. Overall Compliance With P&P n = 34 (%) Without P&P n = 14 (%) Overall n = 48 (%) How many institutions are compliant with all four elements? Compliant with zero elements01 (7.1%)1 (2.1%) Compliant with one element3 (8.8%)2 (14.3%)5 (10.4%) Compliant with two elements5 (14.7%)4 (28.6%)9 (18.8%) Compliant with three elements12 (35.3%)4 (28.6%)16 (33.3%) Compliant with all four elements 14 (41.2%) 3 (21.4%) 17 (35.4%) Pearson Chi SquareP = not calculated (“n” too low) Fisher Exact TestTwo tailed P = 0.27

13. Results – Areas of Survey Consensus >50% Respondent Agreement Policies and Procedures Pharmacy primarily responsible for development. REMS alerts Multiple alerts: order entry/verification and administration process. Medication Guides The nurse and/or prescriber reviews prior to the first dose. Prescriber Enrollment Only certain prescribers are enrolled and pharmacy verifies enrollment. Patient Enrollment Prescribers ensure enrollment and pharmacy verifies enrollment. Restricted Drug Distribution Programs Pharmacy management is responsible for enrolling pharmacy

14. Results – Areas of Survey Disparities <50% Respondent Agreement Updates and Releases Who is responsible for maintaining updates and releases? How often should updates be reviewed? Medication Guides How are paper copies generated?

15. Discussion  Barriers: –Lack of knowledge –Complex programs –Moving target  Potential Solutions: –Create a policies and procedures –Designate individuals or task force –Advocate for enforcement

16. Study Limitations  Survey study design can innately have limitations –Anonymity –Respondent  Small number of responders likely did not allow for significant findings

17. Conclusions  Two-thirds of institutions are non-compliant with REMS requirements  Statistically, the presence of a policies and procedures did not significantly impact overall compliance

18. Acknowledgements  Elora Hilmas, PharmD, BCPS  Joseph Peoples, PharmD  Robert Akins Jr., PhD, FAHA

19. Kori Talbott, PharmD PGY1 Pharmacy Resident Eastern States May 2012 Questions? Please e-mail: ktalbott@nemours.org