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ABSTRACT
Traditionally, governments have dealt with prescription drug
development separate from the practice of medicine and post- approval use of
prescription drugs. Government approval of prescription drugs relies largely
on the scientific method (placebo-controlled, double-blinded clinical studies
of statistically significant patient populations); the practice of medicine,
while often informed by science, is inherently individualized, and often seen
by its practitioners as an art. As a result, the separation of drug
development and medical practice makes methodological sense. Increasingly
though, government agencies are being asked to evaluate prescription drug
safety and efficacy both before the drugs are approved for marketing as well
as after approval. A recent report on the post-approval safety monitoring of
prescription drugs commissioned by the Health Council of Canada looked at
current pharmacovigilance systems used in North America, Europe, and New
Zealand. After considering the strengths and weaknesses of each system,
the Council report suggested that the current Canadian post-market safety
surveillance system is severely limited due to reliance on voluntary reports
of adverse drug reactions, significant underfunding of
publicly-sponsored pharmacovigilance research, and barriers to robust
data for independent evaluation of real-world prescription drug use. In
response to these systemic shortcomings, the report recommended, in part,
that Canada adopt legislation increasing pharmacovigilance funding and
authority for Health Canada, similar to provisions of the U.S. Patient
Protection and Affordable Care Act (PPACA) passed earlier this year and the
U.S. Food and Drug Administration Amendments Act of 2007 (FDAAA).
While PPACA and FDAAA provide the U.S. Department of
Health and Human Services significant authority and resources to use the
real-world patient data in the national health care system for drug safety
monitoring, the government databases were designed primarily for
reimbursement of health care services and products,
not pharmacovigilance research. In my forthcoming article, The
Short-Sighted Value of Inefficiency: Why We Should Mind the Gap in the
Reimbursement of Outpatient Prescription Drugs,
I identify an information gap in the recently-expanded U.S. federal health
care programs which, if bridged, could provide robust data to improve public
health by better informing drug safety monitoring. Specifically, I propose a
simple regulatory requirement for the health care billing systems for
outpatient prescription drugs – require patient diagnosis codes (also known
as ICD-9 or ICD-10 codes) for reimbursement of outpatient prescription drugs.
BIOGRAPHY
Jennifer Herbst is an Abraham L. Freedman Teaching Fellow
at Temple University Beasley School of Law in Philadelphia, Pennsylvania.
Prior to her fellowship, Jen practiced health law in Philadelphia
representing major pharmaceutical companies, hospitals, and physicians.
During her years of private practice, she also taught bioethics courses to
bioengineering students at Drexel University, addressing common bioethical
dilemmas and how those issues translate into law and policy affecting the
pharmaceutical, biomedical, and health care industries. She received her J.D.
and Master of Bioethics degree from the University of Pennsylvania and
her A.B. in biochemistry and molecular biology from Dartmouth College.
Her current research delves into the creation and use of patient health
information at the nexus of law, medicine, and money.
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