Kori Talbott, PharmDPGY1 Pharmacy ResidentEastern 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

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:– 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– 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– 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

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tin/da

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etin alf

a

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te (C

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ER/LA op

ioid an

alges

ics

bose

ntan (

Traclee

r)

dofet

ilide (

Tikosyn

)

thalido

mide (T

halom

id)

natali

zumab

(Tysa

bri)

eculiz

umab

(Solir

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OLANZap

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algluc

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umizy

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lenalid

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vigab

atrin (

Sabril)

alvimop

an (E

ntereg

)

mifepris

tone (

Mifeprex

)

ambri

senta

n (Le

tairis)

alose

tron (

Lotro

nex)

vand

etanib

(Cap

relsa

)05

101520253035404550

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&Pn = 34 (%)

Without P&Pn = 14 (%)

Overalln = 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

Kori Talbott, PharmDPGY1 Pharmacy ResidentEastern States May 2012

Questions?

Please e-mail: ktalbott@nemours.org