Transcript Results - Eastern States Conference for Pharmacy Residents and

Incorporation of REMS (Risk Evaluation
and Mitigation Strategies) into daily clinical
practice in the inpatient hospital setting:
results of an online survey
Kori Talbott, PharmD
PGY1 Pharmacy Resident
Eastern States May 2013
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
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:
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–
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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.
<http://www.fda.gov>.
Traynor, Kate. "Experts Say REMS Assessments Need Work." ASHP Pharmacy News [White Oak, MD]
15 July 2012, n. pag. Web. 23 Aug. 2012.
Background
 Potential Elements to Assure Safe Use (EASU) Program Components
Prescriber enrollment
Patient enrollment
Medication Guide
Informed Consent
Hospital/Pharmacy Enrollment
“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.
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.
Methods
 Study Design
–
–
–
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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.
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
Methods
 Survey questions
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–
–
–
–
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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
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
34
70.8%
Institutions with out P&P
14
29.2%
REMS Medications Dispensed
50
45
40
35
30
25
20
15
10
5
0
Results
REMS requirements based on dispensed medications
Compliance
n = 48
Provision of mandatory Medication Guide
39.6%
Mandatory prescriber enrollment/training
79.2%
Mandatory patient enrollment/acknowledgement
77.1%
Mandatory pharmacy/hospital enrollment
93.8%
Compliance with all four areas
35.4%
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 elements
0
1 (7.1%)
1 (2.1%)
Compliant with one element
3 (8.8%)
2 (14.3%)
5 (10.4%)
Compliant with two elements
5 (14.7%)
4 (28.6%)
9 (18.8%)
Compliant with three elements
12 (35.3%)
4 (28.6%)
16 (33.3%)
Compliant with all four elements
14 (41.2%)
3 (21.4%)
17 (35.4%)
Pearson Chi Square
P = not calculated (“n” too low)
Fisher Exact Test
Two tailed P = 0.27
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
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?
Discussion
 Barriers:
– Lack of knowledge
– Complex programs
– Moving target
 Potential Solutions:
– Create a policies and procedures
– Designate individuals or task force
– Advocate for enforcement
Study Limitations
 Survey study design can innately have limitations
– Anonymity
– Respondent
 Small number of responders likely did not allow for
significant findings
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
Acknowledgements
 Elora Hilmas, PharmD, BCPS
 Joseph Peoples, PharmD
 Robert Akins Jr., PhD, FAHA
Questions?
Please e-mail:
[email protected]
Kori Talbott, PharmD
PGY1 Pharmacy Resident
Eastern States May 2012