Fiscal impact
reports (FIRs) are prepared by the Legislative
Finance Committee (LFC) for standing finance committees of the NM Legislature. The
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Current FIRs (in HTML & Adobe PDF formats) are available on the
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Previously issued FIRs and attachments may
also be obtained from the LFC in
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SPONSOR |
Park |
DATE TYPED |
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HB |
466 |
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SHORT
TITLE |
Cancer Drug Repository Act |
SB |
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ANALYST |
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APPROPRIATION
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Appropriation
Contained |
Estimated
Additional Impact |
Recurring or
Non-Rec |
Fund Affected |
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FY04 |
FY05 |
FY04 |
FY05 |
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Narrative |
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LFC Files
Responses
Received From
Department
of Health (DOH)
Regulation
and Licensing Department ( RLD –NM Board of Pharmacy)
Commission
on Higher Education (CHE)
SUMMARY
Synopsis of Bill
House Bill 466 allows for unused and
unadulterated cancer drugs to be donated for use by an eligible individual or
entity. It would place the responsibility for developing and implementing the
“repository program” with the Department of Health (DOH). HB466 would specify
that hospitals, nonprofit clinics and pharmacies could voluntarily accept and
dispense the donated cancer drugs to eligible state residents.
HB466 would require medications to be in their
original, sealed, tamper evident, unit-dose packaging. An exception would allow
the packaging to be opened, but the unit dose seal must still be intact.
Medications accepted into the program would be required to have an expiration
date longer than six months away.
DOH would be given the responsibility to
promulgate recipient eligibility criteria, to develop participation criteria
for hospitals, nonprofit clinics and pharmacies that volunteer and to create
standards and procedures for accepting, storing and inspecting the donated
drugs. Additionally DOH would develop and distribute: recipient identification
cards and liability waiver forms; forms for donors to verify ownership or
representation of owner; a list of cancer drugs that are acceptable or unacceptable
for donation and the reasons for unacceptability.
Significant
Issues
RRD- the Board of Pharmacy relayed the
following concerns with the bill:
q
Guaranteeing the integrity of the drugs would
be problematic unless a laboratory analysis is performed, which is an expensive
procedure.
q
The Food and Drug Administration may have
issues with this practice, since the agency requires manufacturers to perform
additional tests to prolong the life of products.
DOH acknowledges that cancer
treatment is very expensive and some individuals may not be able to receive
treatment due to lack of resources.
HB466 would provide a necessary option for treating these individuals.
DOH indicates that overseeing
a program to collect and redistribute “cancer drugs”, which can cover a broad
range of pharmaceutical categories and delivery methods, would be a complex initiative. Issues related to whether collected
pharmaceuticals have been properly stored or tampered with, and whether they
are “in date” have implications regarding efficacy and safety to the persons receiving
these products. Monitoring changes in
eligibility status of recipients and the tracking systems that would have to be
developed in order to locate and transport appropriate products within the system
to meet specific patient needs could also require significant resources to be
developed and deployed.
FISCAL IMPLICATIONS
HB466 does not contain
an appropriation. Since the program
would require funds to staff, develop, administer or monitor this drug repository
program, it is not clear how this initiative would be accomplished without
detracting from other DOH efforts.
ADMINISTRATIVE
IMPLICATIONS
The drug repository program, as described in
HB466, would require significant expertise and staff time to accomplish.
Without new resources, this would become the responsibility of existing DOH
staff, which may not have the capacity or expertise to undertake this
initiative.
Some of the duties
required as per this legislation would be to track all drugs, to dispense, to
perform analysis, and to maintain patient and drug records.
The proposed initiative would require resources
and expertise that may not currently be available in DOH.
TECHNICAL
ISSUES
DOH notes there may be
a conflict with Section 16.19.6.14 of the Board of Pharmacy regulations that
prohibit the resale of drugs and indicate that drugs are not to be accepted for
return or exchange after taken from the pharmacy where they were sold or
distributed.
The Board of Pharmacy would need to promulgate
new rules so that pharmacies would be able to accept the donated cancer
medications.
OTHER SUBSTANTIVE
ISSUES
Patient safety is a priority in most health care
professionals' practice. The thought of dispensing a medication where the
handling of it could not be tracked may violate the rules of a safe, professional
practice.
Cancer patients tend to be some of the most
vulnerable patients. Many times their immune systems are severely compromised
from the cancer medications and treatment.
Even a slight error or alteration of their medication could have a
devastating, negative effect.
However, these challenges must be balanced
against the importance of HB466, including the potential to save lives and
reduce the need to dispose of thousands of dollars of cancer drug medication.
ALTERNATIVES
An alternative could be a memorial to study the
issue in the interim and/or perhaps include limited funding for a HB466 “pilot
program” on a small-scale basis to better assess feasibility and capacity
issues.
POSSIBLE
QUESTIONS
BD/lg:yr