BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 315
AUTHOR: Wright
INTRODUCED: February 14, 2011
HEARING DATE: January 11, 2012
CONSULTANT: Chan-Sawin
SUBJECT : Ephedrine and pseudoephedrine.
SUMMARY : Eliminates over-the-counter (OTC) sales of
products containing ephedrine (EPH), pseudoephedrine (PSE),
norpseudoephedrine and phenylpropanolamine; and instead
requires the sale or distribution of such products to be
made pursuant to prescription only. Creates an exemption
for pediatric liquids containing such drugs from the
prescription requirement. Provides that any person who
obtains such products, unless upon prescription of a
physician, dentist, podiatrist, or veterinarian licensed by
the state, is guilty of an infraction or a misdemeanor.
Existing federal law: Establishes the Combat
Methamphetamine Epidemic Act of 2005 (CMEA), which includes
detailed restrictions and requirements for retail sale of
EPH, PSE, norpseudoephedrine or phenylpropanolamine,
including:
A retailer may sell no more than 3.6 grams in a
single transaction;
A retailer may sell no more than 7.5 grams per
customer in a one-month period;
Products containing EPH/PSE shall be kept behind
the counter, and sold only after an appropriate form
of identification is provided by the purchaser;
The seller must maintain a written or electronic
logbook of each sale, including the transaction date,
the name and address of the purchaser and the quantity
sold; and
The purchaser must sign a paper or electronic
logbook, as specified.
Existing state law:
1.Defines a "dangerous drug" as one that is unsafe for
self-use, including any drug that under federal or state
law must be obtained by a prescription, and classifies
such controlled substances into five schedules. A
Continued---
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controlled substance may be possessed or dispensed only
through prescriptions, as specified.
2.Provides the following restrictions and requirements for
the sale of EPH, PSE, norpseudoephedrine or
phenylpropanolamine in OTC retail transactions, which
differ from the federal requirements:
A retailer in a single transaction may sell no
more than three packages of a product containing
these chemicals;
A retailer may sell no more than nine grams of
EPH, PSE, norpseudoephedrine or phenylpropanolamine
per customer in a one month period;
A first violation of these restrictions is a
misdemeanor, punishable by a jail term of up to six
months, a fine of up to $1,000, or both; and
A second or subsequent violation is a
misdemeanor, punishable by a jail term of up to one
year, a fine of up to $10,000, or both.
1.Requires any manufacturer, wholesaler, retailer, or any
other person or entity in this state that sells,
transfers, or otherwise furnishes OTC drugs containing
EPH, PSE, norpseudoephedrine or phenylpropanolamine to a
person or business entity in this state or any other
state, or who obtains from a source outside of the state
any such substances to submit an application to, obtain a
permit for, and submit reports on the conduct of such
business from the Department of Justice (DOJ).
2.Defines "pediatric liquid" to mean a nonencapsulated
liquid whose unit measure, according to product labeling,
is stated in milligrams, ounces, or other similar measure
and the dosage unit does not exceed 15 milligrams of
phenylpropanolamine or PSE per five milliliters of liquid
product, with certain exceptions.
This bill:
1.Requires the sale or distribution of EPH, PSE,
norpseudoephedrine and phenylpropanolamine to be made by
prescription only, and eliminates statutory provisions
controlling OTC sale of such products.
2.Creates an exemption from prescription requirements for
pediatric liquids containing such drugs, as defined.
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3.Makes any person who obtains EPH/PSE or related products,
unless upon prescription of a physician, dentist,
podiatrist, or veterinarian licensed by the state, guilty
of an infraction or a misdemeanor.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. According to the author,
methamphetamine (meth) labs pose a serious threat to
public safety and the problem is getting worse. PSE is
the essential precursor being used to fuel California and
the rest of the nation's meth labs. Oregon and
Mississippi have passed similar legislation and both
states have significantly reduced meth labs seizures (95%
reduction in Oregon and 70% reduction in Mississippi).
There have been no negative consequences in either Oregon
or Mississippi: no public outcry; the cost of PSE has not
increased; health coverage costs have not increased;
doctors have not seen an appreciable increase in office
visits - including emergency departments; and the
uninsured have not been adversely impacted. PSE is
contraindicated for several prevalent ailments (heart
disease, liver disease, and hypertension). According to
the PSE manufacturers' warning label, after using PSE for
seven days, if symptoms persist, patients should consult
with a doctor. Returning PSE to its prescription status
that existed prior to 1976 will save lives (especially
young children who do not have the choice of living with
meth labs) and save California millions of dollars.
2.PSE and related compounds in OTC decongestants. PSE and
related compounds, such as EPH, are active ingredients
found in many OTC products used to relieve nasal or sinus
congestion caused by the common cold, sinusitis, and
respiratory allergies. A prescription is not required in
California for such medications sold in retail settings
behind the counter, where they are readily available to
people without medical insurance or non-emergency access
to physicians.
Unlike EPH or PSE, phenylephrine cannot be easily
converted to meth. Until 2004, PSE was the most common
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active ingredient in decongestant products in the United
States. In recent years, many manufacturers have
reformulated their decongestant products to use
phenylephrine to avoid restrictions on sales, and
phenylephrine is now the most commonly sold decongestant
in oral form, nasal sprays, and eye drops.
The federal Food and Drug Administration (FDA) approved
both phenylephrine and PSE for nasal congestion in 1976,
and both are "Generally Recognized as Safe and
Effective." The FDA notes, however, that PSE and
phenylephrine differ in duration of action, and
recommends that PSE be dosed every 4 to 6 hours, while
phenylephrine, which has a shorter duration of action, be
dosed every 4 hours. Thus, while the FDA considers both
to be safe and effective for certain intended uses,
phenylephrine users must take more of the medication more
frequently.
A statement released by the FDA Office of National Drug
Control Policy Director Gil Kerlikowske in testimony
before the U.S. Senate at the hearing on "The Status of
Meth: Oregon's Experience Making PSE Prescription Only"
dated April 19, 2010:
Any additional measures restricting the sale of PSE to
reduce the likelihood of product misuse must be
balanced with the need to maintain access for
legitimate and safe use. Requiring an allergy or cold
sufferer to obtain a prescription may make it more
difficult to access safe and effective products that
are intended, when used properly, to treat symptoms
that can be self-diagnosed by a consumer. Individuals
respond differently to medications, some getting more
benefit from a specific ingredient than others.
Having access to different ingredients without the
need for obtaining a prescription from a health care
professional allows consumers to obtain medications
quickly and will not delay access to symptomatic
benefit. Additional consideration should be given to
the idea that requiring a prescription could increase
health care costs for those who prefer PSE.
3.Methamphetamine. Meth is a psychostimulant drug that
impacts the central nervous system, is highly
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addictive, and can be synthesized with a basic
understanding of chemistry. A principal ingredient in
illegal meth production is PSE, and its related
compounds. The drug has limited medical uses for the
treatment of narcolepsy, attention deficit disorders,
and obesity; however it is seldom prescribed by
doctors. Although meth can be prescribed by a doctor,
its medical uses are limited, and the doses that are
prescribed are much lower than those typically used
illegally. According to the National Institute on Drug
Abuse (NIDA), the immediate effects of meth include
increased activity and decreased appetite. Long-term
abuse has many negative health consequences, including
extreme weight loss, severe dental problems, anxiety,
confusion, insomnia, mood disturbances, and violent
behavior. Chronic meth abusers can also display a
number of psychotic features, including paranoia,
visual and auditory hallucinations, and delusions. The
psychotic symptoms can last for months or years after
meth use has ceased.
Due to its high potential for abuse, meth is classified
as a Schedule II drug and is available only through a
prescription that cannot be refilled. Most of the meth
abused in this country comes from foreign or domestic
superlabs, although it can also be made in small,
illegal laboratories, where its production endangers
the people in the labs, neighbors, and the environment.
According to the Senate Public Safety Committee
analysis, if obtained through legal OTC purchases, it
would take 1583 packages (each containing 96 tablets,
each tablet containing 30 mg of PSE), purchased through
1266 separate transactions, to make 10 pounds of meth.
Traditional meth cooking methods create serious risks
of explosion, and produce relatively large amounts of
waste chemicals that are often dumped illegally.
However, a new small-scale process - the "shake and
bake" or "one pot" method - has become increasingly
popular due to the fact that it is less dangerous than
traditional cooking methods and only call for about 200
tablets of PSE. While there is substantial danger that
the bottle used under this method could explode, the
danger appears to mainly be to the cooker and persons
in the immediate vicinity, although one-pot cooking can
cause particularly intense fires.
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4.Methamphetamine use nationally and in California. The
Drug Abuse Warning Network (DAWN) is a national public
health surveillance system that monitors drug-related
emergency department (ED) visits in the United States and
is a source for monitoring meth use. Results from the
August 2010 DAWN report, also compiled by Substance Abuse
and Mental Health Services Administration (SAMHSA),
indicate that, in 2004, 8.2 percent (or 132,576 visits)
of all ED visits involving drug misuse or abuse were
related to meth use. However, by 2008, only 3.3 percent
(or 66,308 visits) of such ED visits involved meth.
The California Department of Alcohol and Drug Programs
(DADP), which monitors publicly funded treatment
programs, reported in February 2011 that meth is the top
reported primary drug for both men and women admitted to
California drug treatment programs. However, for women,
the percent of admissions for meth is much higher than it
is among men; 39.8 percent versus 30.9 percent,
respectively, in state fiscal year (SFY) 2007-08. DADP
also reports that, while admissions to meth treatment
programs peaked in SFY 2005-06, they declined to the
lowest level in six years in SFY 2007-08.
5.The federal Combat Methamphetamine Epidemic Act. In
2006, the federal CMEA was enacted to restrict the retail
sale of PSE and related products. The CMEA placed many
requirements on retail OTC sales of PSE, including daily
sales limits and monthly purchase limits, placement of
products out of direct customer access, sales logbooks,
customer identification requirements, employee training,
and self-certification of regulated sellers. States have
also enacted limits on purchases of pseudoephedrine,
imposed point-of-sale restrictions, or enacted
pseudoephedrine tracking laws. Oregon and Mississippi
are the only two states that currently require a
prescription for pseudoephedrine purchases.
6.Double referral. This bill was heard in the Senate
Public Safety Committee on April 26, 2011, and passed
with a 5-2 vote.
7.Related legislation. SB 260 (Wright) makes any person or
entity who possesses one-half pound or more of PSE, or a
specified related chemical, or one-half pound of a
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substance containing PSE or a related chemical, as
specified, guilty of a felony, punishable by a prison
term of 2, 4, or 6 years and a fine of up to $10,000,
unless enhancements apply based on the weight or volume
of the substance. Held in Senate Public Safety
Committee.
AB 1280 (Hill) is an alternative measure designed to
limit illicit meth manufacturing and abuse by mandating
an electronic tracking system for purchases of PSE. Any
retailer of PSE would be required to participate in the
system and enter a purchaser's information into the
system. Attempted purchases beyond the federal monthly
limit would trigger a notice to the retailer to not
complete the sale. Law enforcement would have access to
the system. Held in Senate Appropriations Committee on
the suspense file.
8.Prior legislation. AB 1455 (Hill) of 2010 was
substantively similar to AB 1280 (Hill), and would have
also repealed existing statutory provisions for OTC sales
of PSE and related products and replaced them with new
sales limits consistent with federal law. Failed passage
in the Senate Judiciary Committee.
SB 484 (Wright) of 2009 was substantially similar to this
bill. Failed passage in the Assembly Public Safety
Committee.
SB 1299 (Speier), Chapter 646, Statutes of 2006, makes it
a felony, as specified, to possess specified chemicals
that are precursors to meth or PCP when the person in
possession has the intent to sell, transfer, or otherwise
furnish to another person with the knowledge that they
will be used to manufacture meth or PCP.
AB 283 (Koretz) of 2005 would have required that the
dispensing, sale, or distribution at retail of any
compound, mixture, or preparation containing any
detectable quantity of EPH, PSE, or any derivative of EPH
or PSE to be subject to specified additional
requirements. AB 283 would have required the retailer to
store and display the product in a locked cabinet or as
specified, and required the transaction to be made by a
retailer or employee of a retailer who meets specified
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requirements. These provisions were amended out of the
bill.
9.Support. The Attorney General (AG), the sponsor of SB
315, argues that this measure will make it much more
difficult for criminals to obtain EPH and PSE, and cites
the enormous impact of meth on human life, public safety
and health costs. The AG states that California leads
the nation in the amount of meth seized in the past few
years. In 2008 alone, California seized 119 meth labs,
by far the highest total in the Western U.S.; 15 out of
17 superlabs seized in the U.S. were located in
California.
The County Alcohol and Drug Program Administrators
Association of California argues that meth continues to
be a significant problem in California, and demand and
supply data suggest that the meth epidemic is rebounding
after several years of decline. This is due to meth
producers and users having found ways around federal
anti-meth laws, through alternative production methods
and organized smurfing efforts, where producers hire a
network of individuals to purchase PSE in legal
quantities at multiple locations.
The California Narcotic Officers Association and the
California Police Chiefs Association argue that, in
contrast with the state's failing system, Oregon has
shown the way to deal with the meth lab issue in
California. They also point out that, upon enactment of
the Oregon law, most Oregonians have simply purchased
some of the other cold medications that did not contain
EPH or PSE, and those who continued to use EPH products
supported passage of the Oregon law. The State Sheriffs'
Association concurs and states that the current statutory
system includes no way to limit sales when purchasers buy
from multiple retail chains.
The California State Conference of the National
Association for the Advancement of Colored People (NAACP)
writes in strong support that this bill addresses a
pressing need to minimize the proliferation of meth
through the state. California led the nation by a wide
margin in the amount of meth created, trafficked and
seized during the last few years. By limiting the
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prevalence of meth, the California State Conference of
the NAACP believes the state can reduce the number of
drug-related arrests and incarcerations in California
that disproportionately affect the African American
community.
10.Opposition. The California Chamber of Commerce states
that SB 315 could increase the cost of health care
coverage for everyone by forcing individuals to obtain a
prescription for products which are now available without
a prescription. By eliminating reasonable access to PSE,
this bill imposes a new cost to health insurers to pay
for increased doctor visits to obtain the prescription,
as well as paying for the cost of the medication as a
prescription.
The California Retailers Association and the National
Association of Chain Drug Stores concur and point out
this will result in unnecessary delay of treatment for
patients, increased costs for employers due to lost
employee time, and increased costs to the health care
system as the number of visits to the doctor's offices
rises. Patients who do not have health insurance will
have to pay out-of-pocket for doctor visits.
Alternatively, those who cannot afford to see a physician
may be forced to seek care from an emergency department,
increasing the burdens on the emergency system and
further raising health care costs.
The California Grocers Association (CGA) states that the
bill could have unintended consequences that are
significantly detrimental to California's already
struggling economy. Shifting PSE products to
prescription-only status will significantly decrease
sales tax revenues for state and local governments as
California's sales tax does not apply to prescription
medications. CGA argues that the shift will also
significantly increase costs to Medi-Cal by forcing
participants to use a physician visit to obtain relief
from what are generally considered to be relatively minor
medical conditions. Medi-Cal will also be required to
pay for this new category of prescriptions at a time when
reimbursement rates for both physicians and pharmacies
are being reduced and the program is undergoing
significant funding cuts. CGA further points out that
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Mexico has already shifted PSE to prescription-only
status and yet the country remains the leading source of
meth for the United States.
The Consumer Healthcare Products Association (CHPA)
argues that PSE is a safe and effective active ingredient
in leading cold and allergy medicines that provide
congestion relief. CHPA states that an estimated 16
million Americans purchase PSE annually, and points to 12
states that have enacted laws requiring electronic
tracking systems for PSE sales, which unifies the
logbooks across stores and prevents criminals from
skirting the limits by visiting multiple stores. CHPA
believes that an electronic tracking system strikes the
proper balance between preventing illegal diversion while
preserving access to needed medications.
11.Author's Amendments. SB 315 was heard in Senate Public
Safety where the author agreed to take the following
amendments in the Committee on Health:
a. Sunset the provisions of this bill in five years.
b. Require DOJ to conduct a study as to the
effectiveness of the bill in reducing meth labs and
incidents, and in reducing meth crimes, to be provided
to the Legislature by July 1, 2018.
c. Allow minors to obtain and possess PSE by
prescription.
1.Policy concerns.
a. Potential impact on health care access and cost.
In a widely cited 2007 survey by the Commonwealth
Fund, only 27 percent of adults could easily contact
their physician over the telephone, obtain care or
medical advice after hours, and experience timely
office visits. As more Americans become insured and
begin accessing coverage through implementation of
federal health reform, concerns continue to be raised
about the number and availability of providers. The
Association of American Medical Colleges estimates
that the nation will face a shortage of approximately
21,000 primary care physicians in 2015. By requiring
consumers to seek a prescription for PSE and EPH
medications, SB 315 may further limit or deny access
to this medication for Californians who do not have
ready access to a health care provider.
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In addition, many health plans and insurers also
require patients to pay a co-pay to see a provider for
non-preventive services. The prescription
requirements in this bill may increase overall cost to
the health care system due to such additional costs
for outpatient consultations.
b. Medi-Cal implications. Last year's budget trailer
bill, AB 97 (Committee on Budget), Chapter 3, Statutes
of 2011, implemented a "soft cap" of seven provider
visits per year for Medi-Cal beneficiaries (under both
Medi-Cal fee-for-service and managed care). Any
visits exceeding the cap will require certification by
the physician, or medical professional under the
supervision of a physician, attesting that one or more
of certain specified circumstances are applicable.
According to the Department of Health Care Services,
if a Medi-Cal patient does not have a pre-existing
relationship with a physician, or if the relationship
was not such that the physician felt comfortable
calling in a prescription without first seeing the
patient, then the patient would need to see the
physician for a prescription of a drug containing PSE
or EPH. Any such visits would count towards any
limitation on the number of visits allowed under the
program. It is unknown how many Medi-Cal
beneficiaries have a pre-existing relationship with a
doctor.
c. Alternative proposal to limit PSE diversion. AB
1280 (Hill) is an alternative measure introduced last
year designed to limit illicit meth manufacturing and
abuse by mandating an electronic tracking system for
purchases of PSE and EPH drugs. The following states
have electronic tracking of pseudoephedrine sales:
Alabama, Arkansas, Florida, Illinois, Iowa, Kansas,
Kentucky, Louisiana, Missouri, Oklahoma, South
Carolina, and Washington. Ten of these twelve states
use the National Precursor Log Exchange (NPLEx),
funded by the manufacturers of pseudoephedrine
products, to electronically track pseudoephedrine
sales. If implemented appropriately, this proposal
may provide an alternative method that curbs meth labs
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in the state without incurring potential barriers to
access and additional costs to the system.
SUPPORT AND OPPOSITION :
Support: Attorney General (sponsor)
Allergy & Asthma Network, Mothers of Asthmatics
California District Attorneys Association
California Narcotic Officers Association
California Police Chiefs Association
California State Conference of the National
Association for the Advancement of Colored
People
California State Sheriffs' Association
County Alcohol and Drug Program Administrators
Association of California
Los Angeles County District Attorney's Office
Mississippi Independent Pharmacies Association
Oregon Chapter, American College of Emergency
Physicians
Oregon State Pharmacy Association
Three individuals
Oppose: Aging Services of California
Alameda Health Consortium
Association of California Life and Health
Insurance Companies
Asthma & Allergy Foundation of America,
California Chapter
Bayer HealthCare
BIOCOM
California Alliance for Retired Americans
California Association of Health Plans
California Chamber of Commerce
California Grocers Association
California Healthcare Institute
California Manufacturers & Technology Association
California Pharmacists Association
California Primary Care Association
California Professional Firefighters
California Retailers Association
Community Clinic Association of Los Angeles
County
Consumer Healthcare Products Association
Drug Policy Alliance
Health Net
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Healthy African American Families II
Kaiser Permanente
Los Angeles Society of Allergy, Asthma & Clinical
Immunology, Inc.
National Association of Chain Drug Stores
Reckitt Benckiser
Rite Aid
Sanofi
Valley Industry and Commerce Association
Walgreens
Three individuals
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