Transcript BECAUSE DRUGS CAN HARM

BECAUSE DRUGS CAN HARM
MEDICATION RISK REDUCTION
SOFTWARE & SERVICES
Prescription drug spending
40 billion (1990) to 271.1
billion (2013)
2 Million
Americans harmed by drug safety
issues annually.
100,000
Deaths / Year
http://www.prweb.com/releases/2014/01/prweb11486304.htm
Emergency Department Visits Related to Drug
Misuse or Abuse - United States, (2004–2010)
SAMHSA. Highlights of the 2010 Drug Abuse Warning Network (DAWN) Findings on Drug-Related ED Visits, 2011
Motor Vehicle Traffic, Poisoning, and Drug Poisoning
(overdose) Death Rates, US (1980-2010)
Drug Overdose Deaths by Major Drug Type, US
(1999-2010)
Preventable medication errors
cost
$21 billion (2010)
16.4 billion inpatient
4.2 billion outpatient
1. http://www.wolterskluwerlb.com/health/resource-center/articles/2012/10/economics-health-care-quality-and-medicalerrors
Risk Evaluation Mitigation Strategies
Programs to
ensure drug
benefits
outweigh drug
risks
Drug Company
Beyond
traditional
drug
labeling
108 REMS Drugs
REMS
Approved
drugs for
which REMS
is
unnecessary.
>20% Opioid
Narcotics
Drugs
that would
not receive FDA
approval to remain
on the market
because the risk
outweighs the
benefit
Average Risk of Drug
Prescription drugs would not be available or
remain on the market without a REMS
REMS PROGRAMS
drug company required to audit and
maintain
Train
Engage
Manage
Success
Requirements for:
Physicians / Prescribers
Hospitals & Healthcare Facilities
Pharmacies
83,264
REMS DRUG DEATHS
Voluntary reporting to the FDA estimated to
represent only 10% of actual events
1,439,849
ADVERSE EVENTS
for 42(39%) of 108 REMS Drugs (2005 2013)
REMS DRUG LITIGATION
Product Liability Claims
Victoza (2015 - ongoing) diabetes drug with risk of
pancreatitis
Testosterone (2015 - ongoing) multidistrict litigation
Oxycontin (2014 - ongoing) Purdue Pharma vs KY (1 Billion)
Mycophenolate (2011) - Patient awarded $500,000 medical
expenses plus undisclosed amount for general damages
Accutane (Feb 2011) - Up to 50 Million paid out for claims
Avandia - More than 50,000 lawsuits filed against
GlaxoSmithKline
(2010 - 520 Million)
(2011 - 250 Million)
(2012 - 3 Billion)
REMS DRUGS INCREASING
Number of REMS Drugs
137.5
110
97
82.5
55
108
70
27.5
0
September 2012
February 2013
January 2015
PROBLEM: LOW REMS
COMPLIANCE
Non-Compliant
Compliant
Confusing Burdensome
14%
Certification
Provider training
Elements to Assure Safe Use (ETAS
Restricted distribution
Laboratory tests Patient enrollment
Informed consent…
https://oig.hhs.gov/oei/reports/OEI-04-11-00510.asp
What is REMS Compliance?
Prescribers, healthcare orgs, pharmacies are required to adhere with FDA
drug programs to maintain the necessary legal permissions to prescribe
and dispense. The following are requirements that must be met to be
considered compliant.
Prescriber
REMS Requirements
Education/Certification
Certification renewals
Informed consent
Counseling documents
Appropriate use
assessments
Laboratory monitoring
Medication guide
distribution
Patient education
Patient enrollment
© 2015 REMS
Logic, LLC. All
rights reserved.
Prescriber
enrollment
Health Care Organizations
& Pharmacy REMS
VerifyRequirements
prescriber certification
Verify patient registration
Monitoring/management
Medication guide distribution
Facility enrollment
Restricted distribution
Staff education
Documentation (inventory, dispensing)
Drug loan/borrow
Drug ordering
Audits
Why is REMS Compliance so
low?
FDA imposes a large
burden on
prescribers due to vast amount of
REMS requirements that
prescribers are expected to know
FOR EXAMPLE
25 of the REMS drugs
have more than 100
requirement details to
remember!!!
Without a tool to assist providers,
the expectation may be considered
unrealistic
© 2015 REMS Logic, LLC. All rights reserved.
Medication Risk
Exposure to risk happens each
time a REMS drug is:
• ordered by the doctor
• dispensed from the
pharmacy
• given to the patient
This could be thousands of
times per month, maybe
millions of times per year!!!
© 2015 REMS Logic, LLC. All rights reserved.
Medication Risk
In its current state,
Prescriptions are being issued
WITHOUT adherence to REMS
program requirements
Patients, healthcare
employers and payers may
be UNAWARE
© 2015 REMS Logic, LLC. All rights reserved.
Do you currently manage REMS
Data?
… if YES,
•
•
•
•
•
•
How are you doing it?
What resources are required?
How much time does it take?
How often do you update data?
When was your last audit?
How do you track prescriber compliance?
© 2015 REMS Logic, LLC. All rights reserved.
Did you have all the answers?
… if NO,
With our solution, there is
no need to manage your
own REMS data
– we manage it for you!
© 2015 REMS Logic, LLC. All rights reserved.
Solution: Single Source for REMS Requirements
REMS
™
LOGIC
SOLUTION
•
Informs clinicians and patients of drug risk and
what measures to take to prevent harm
•
Reduces prescriber liability
REMS Logic standardizes complex
federally-mandated programs making
information manageable for end users
© 2015 REMS Logic, LLC. All rights reserved.
REMS
™
Logic
Data Standardization &
Management
Standardizes 60+ data elements per drug into 5
categories
Quickly navigate drugs by REMS
requirement
© 2015 REMS Logic, LLC. All rights reserved.
Benefits of REMS Logic™
Our system reduces risk by…
• Providing a mechanism for prescriber training
activity
• Prescribers can document completion of drug
requirements
• Minimizes
- Drug harm cost
- Healthcare intervention cost
- Liability insurance cost
- Litigation cost
© 2015 REMS Logic, LLC. All rights reserved.
Benefits of REMS Logic™
FOR
DOCTORS
•
•
•
•
Ease of use!
All REMS information in a single resource
1 to 2 click access to requirements
Customized dashboard for commonly used
drugs
• Documentation of training status
• Reduces doctor risk and liability
© 2015 REMS Logic, LLC. All rights reserved.
Benefits of REMS Logic™
FOR HOSPITAL/HEALTH CARE ORGANIZATIONS
• Added QUALITY
• Prevent adverse drug
events
• Drug harm cost avoidance
• Increased patient safety
• Reduces risk and liability
• Compliance tracking
• Audit protection
© 2015 REMS Logic, LLC. All rights reserved.
HIGH RISK DRUG THERAPY.
ZERO HARM.
www.remslogic.com