Fiscal impact
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standing finance committees of the NM Legislature. The LFC does not assume
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in
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SPONSOR |
Sanchez, B. |
DATE TYPED |
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HB |
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SHORT
TITLE |
Drug & Device Info In English &
Spanish |
SB |
124 |
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ANALYST |
Geisler |
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APPROPRIATION
|
Appropriation
Contained |
Estimated
Additional Impact |
Recurring or
Non-Rec |
Fund Affected |
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|
FY04 |
FY05 |
FY04 |
FY05 |
||
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|
|
|
Unknown |
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(Parenthesis
( ) Indicate Expenditure Decreases)
Regulation and Licensing Department Board of
Pharmacy (PB)
SUMMARY
Synopsis of Bill
Information provided on the outside container or
wrapper of a prescription (dangerous drugs) or device relating to the drug’s or
device’s efficacy, safety, suitability, side effects or interactions shall be
provided in Spanish and English to be labeled with side effects on the outside
of each container or wrapper in English and Spanish.
Significant Issues
PB provides that there
is not ample space on the outside of a prescriptions container to attach a
label that would list all of these effects and side effects. The PB provides alternatives to accomplish
the objectives of the bill below under Alternatives and Amendments.
FISCAL IMPLICATIONS
PB provides that it is possible that the cost of
dispensing prescription drugs from state hospitals and pharmacies will increase
due to additional requirements and programming to implement printing of labels
in both languages. It is possible that
this could also apply to the private sector.
TECHNICAL
ISSUES
The
Board of Pharmacy does not license the dispensers of devices unless it is from
a business that also handles dangerous (prescription) drugs. The legislature
could require the dispensers of any device to have written supplemental
information available for the public,. (See amendments)
The proposed changes to the Drug, Device, and
Cosmetic Act should be place in NMSA 26-1-16B. (see amendments)
ALTERNATIVES
The New Mexico Board of Pharmacy could adopt
regulations requiring supplemental information for dangerous drugs dispensed,
by a pharmacy or licensed clinics, be available in English and Spanish.
Other states do require supplemental drug
information but they do not specify English or Spanish.
AMENDMENTS
The Board of Pharmacy
suggests two alternative amendments:
Option
1
The suggested underlined changes, to NMSA 26-1-16B, to require the
availability of written supplemental drug information:
B. Practitioners licensed
in this state may prescribe, provide samples of and dispense any dangerous drug
to a patient where there is a valid physician-patient relationship. A record of
all such dispensing shall be kept showing the date the drug was dispensed and
bearing the name and address of the patient to whom dispensed. It is the duty
of every licensed physician, dentist, veterinarian, pharmacist or person
holding a limited license issued under Subsection B of Section 61-11-14 NMSA
1978, when dispensing any dangerous drug, to mark on the dispensing container
the name of the patient, the date dispensed, the name and address of the person
dispensing the drug, the name and strength of the drug, expiration date where
applicable, adequate directions for use and the prescription number when
applicable. All official compendium requirements for the preservation,
packaging, labeling and storage of dangerous drugs are applicable where drugs
are held for dispensing to the public, whether by a pharmacy, clinic, hospital
or practitioner. Written supplemental drug information, that includes major drug-drug interactions, drug-food interactions, major
side-effects, and proper use, shall be available to the public, in Spanish and
English, from the dispensers of any dangerous drug.
The suggested addition to NMSA
26-1-3. Prohibited acts.
The following acts are prohibited:
K.
the dispensing of any device with out having written information
concerning major side effects and proper use in both Spanish and English, available to the public.
Option 2
New section of NMSA Drug, Device and Cosmetic Act
26-1-16.1 Dangerous Drug and Device Supplemental Information
A.
The dispensers of any dangerous drug or device shall have written
supplemental information available for the patient in Spanish and English. Such
information shall contain:
1.
for a device; written information concerning major side effects, cautions for use,
and proper use.
2.
for a dangerous drug; major drug-drug interactions, major drug-food interactions, major
side-effects, missed dose, cautions for use, and proper use.
GGG/dm