kori talbott, pharmd pgy1 pharmacy resident eastern states may 2013 incorporation of rems (risk...
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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
epoe
tin/da
rbepo
etin alf
a
mycoph
enola
te (C
ellCep
t)
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
is)
OLANZap
ine inj
(Zyp
rexa)
algluc
osida
se (L
umizy
me)
lenalid
omide
(Rev
limid)
trans
-muc
osal I
R fenta
NYL
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
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