BILL ANALYSIS �
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 315
S
AUTHOR: Wright
B
AMENDED: As Introduced
HEARING DATE: May 4, 2011
3
CONSULTANT:
1
Chan-Sawin
5
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.
CHANGES TO EXISTING LAW
Existing federal law:
Establishes the Combat Methamphetamine Epidemic Act of 2005
(CMEA), which includes detailed restrictions and
requirements for retail sale of PSE, EPH,
norpseudoephedrine or phenylpropanolamine. These
restrictions include, in part:
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
Continued---
STAFF ANALYSIS OF SENATE BILL 315 (Wright) Page
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customer in a one-month period;
Products containing PSE/EPH 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:
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.
Classifies controlled substances into five schedules, with
the most restrictive limitations placed on controlled
substances classified in Schedule I, and the least
restrictive limitations placed on substances classified in
Schedule V. A controlled substance in any of the schedules
may be possessed or dispensed only through prescriptions,
as specified.
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.
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
STAFF ANALYSIS OF SENATE BILL 315 (Wright) Page
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the dosage unit does not exceed 15 milligrams of
phenylpropanolamine or PSE per 5 milliliters of liquid
product, with certain exceptions.
Requires any manufacturer, wholesaler, retailer, or any
other person or entity in this state that sells, transfers,
or otherwise furnishes any such restricted substance
specified in existing law (including PSE and related
substances) 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).
This bill:
Specifies that the sale or distribution of EPH, PSE,
norpseudoephedrine and phenylpropanolamine shall be made by
prescription only and eliminates statutory provisions
controlling OTC sale of such products.
Creates an exemption from prescription requirements for
pediatric liquids containing such drugs, as defined.
Provides that any person who obtains" PSE or related
products, unless upon prescription of a physician, dentist,
podiatrist, or veterinarian licensed by the state, is
guilty of an infraction-misdemeanor.
FISCAL IMPACT
According to the Senate Appropriations Committee analysis
of SB 484 (Wright) of 2009, which contained substantially
similar provisions to SB 315:
Fiscal Impact (in thousands)
-----------------------------------------------------------
|Major Provisions |2009-10 |2010-11 |2011-12 |Fund |
-----------------------------------------------------------
-----------------------------------------------------------
|Potentia|Sales |$435-4,350|$435-4,350|$435-4,350|General |
|l |Tax | | | | |
|revenue | | | | | |
|loss | | | | | |
STAFF ANALYSIS OF SENATE BILL 315 (Wright) Page
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| | | | | | |
-----------------------------------------------------------
------------------------------------------------------------
| |PERS |Unknown, potential indirect costs to |
| | |premiums |
| | | |
------------------------------------------------------------
-----------------------------------------------------------
|Potentia|CDCR |($1,989-$3|($1,989-$3|($1,989-$3|General |
|l | |,979) |,979) |,979) | |
|savings | | | | | |
| | | | | | |
-----------------------------------------------------------
| |Toxic |($500-1,00|($500-1,00|($500-1,00|General |
| |Substanc|0) |0) |0) | |
| |e | | | | |
| |control | | | | |
|--------+--------+----------+----------+----------+--------|
| |Bureau |($500-1,20|($500-1,20|($500-1,20|General |
| |of |0) |0) |0) | |
| |Forensic| | | | |
| | | | | | |
| |Services| | | | |
| | | | | | |
-----------------------------------------------------------
BACKGROUND AND DISCUSSION
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. The
author cites similar legislation in Oregon and Mississippi,
and points out that both states have significantly reduced
meth lab seizures (95 percent in Oregon and 70 percent in
Mississippi). The author further points out that there
have been no negative consequences in either Oregon or
Mississippi, including no public outcry. In these states,
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 department
visits, and the uninsured have not been adversely impacted.
STAFF ANALYSIS OF SENATE BILL 315 (Wright) Page
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The author asserts that, due to the ineffectiveness of
current state and federal laws, meth is being manufactured
throughout California in increasing amounts. The author
cites that the Drug Enforcement Agency (DEA) El Paso
Intelligence Center reports, since 1998, California has led
the nation in the number of meth seizures, and more than 85
percent of the meth in the United States comes from super
labs (a lab capable of making more than 10 pounds of meth)
in California and Mexico. While criminals use a number of
easily obtained substances to manufacture meth, the one
ingredient they cannot do without is EPH/PSE. The author
believes that the problem is drug dealers who manufacture
meth circumvent the daily legal purchasing limit by
'smurfing' these products, something the law did not take
into account. An accomplished 'smurfer' (someone who makes
numerous purchases of PSE or related products for the
purpose of manufacturing meth) can abuse the California
system by purchasing enough PSE-based products in one day
to allow for the production of one pound of meth. The
author argues that smurfers use co-conspirators, relatives,
as well as paying homeless people, to purchase these
products, and California spends millions of dollars each
year arresting, prosecuting, and incarcerating meth
manufacturers.
The author believes that SB 315 is common-sense legislation
that will severely reduce the meth lab problem in
California, thereby increasing public safety and saving the
state money. The author further cites a 2008 RAND
Corporation study, which found that the economic cost of
meth use in the United States was $23.4 billion in 2005,
including the burden of addiction, drug treatment, and
premature death. The author asserts that with recent
increases in the number of meth labs, and the increase in
the amount of PSE imported into the United States, these
costs will only increase. Returning PSE to its
prescription status that existed prior to 1976 will save
lives and save California millions of dollars.
Pseudoephedrine (PSE) and related compounds in OTC
decongestants
PSE and related compounds, such as EPH, norpseudoephedrine
and phenylpropanolamine, are active ingredients found in
many OTC products used to relieve nasal or sinus congestion
caused by the common cold, sinusitis, and respiratory
STAFF ANALYSIS OF SENATE BILL 315 (Wright) Page
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allergies. PSE and related compounds are also found in
prescription products, in which they are combined with
prescription-only drugs.
Many consumers rely on such products to ease nasal
congestion due to colds, allergies and related maladies.
These decongestants commonly decrease congestion by causing
blood vessels to constrict and reduce blood flow to the
nasal passage. The active ingredient in most oral
decongestants sold on the market is PSE or phenylephrine.
Common side effects include temporary nervousness,
dizziness, sleeping problems, heart palpitations, or high
blood pressure. A prescription is not required in
California for such medications, and they are readily
available to people without medical insurance or
non-emergency access to physicians.
Phenylephrine, a PSE alternative
The federal Food and Drug Administration (FDA) approved
both phenylephrine and PSE for nasal congestion in 1976.
Unlike EPH or PSE, phenylephrine cannot be easily converted
to meth. Until 2004, PSE was the most common 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 primary side effect of phenylephrine is hypertension,
and hypertensive patients must monitor their blood pressure
when on this medication. Phenylephrine is less likely to
cause other side effects such as central nervous system
stimulation, insomnia, anxiety, irritability, and
restlessness common with PSE.
FDA regulation of decongestants
According to the FDA, an OTC drug is a drug whose use does
not require oversight by a health care professional. In
January 1972, the FDA began the OTC Drug Review, also known
as the OTC Monograph, to regulate OTC products, including
PSE and phenylephrine products. Through a scientific
review and a notice-and-comment rulemaking process, this
program determines which OTC drugs can be deemed "Generally
Recognized as Safe and Effective." As part of this
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process, the FDA convenes an advisory panel of clinical
experts to evaluate the existing safety and efficacy data
for OTC cold, cough, allergy, bronchodilator, and
anti-asthmatic drugs. Products marked under an OTC
Monograph are not subject to FDA approval prior to
marketing.
The panel's recommendations on safety, efficacy and use
conditions were published in September 1976, which
established FDA approval for PSE for purchase without a
prescription. The FDA also approved the 10 milligram (mg)
oral dose of phenylephrine as safe and effective at
relieving congestion, making it possible for companies to
use the ingredient without conducting additional studies.
The FDA published a Tentative Final Monograph in January
1985, and a Final Monograph for nasal decongestant drugs in
August 1994.
In 2006, two University of Florida researchers, in a
peer-reviewed letter to the editor of the Journal of
Allergy and Clinical Immunology, challenged the FDA ruling,
stating that phenylephrine is poorly absorbed into the
bloodstream and does not work as well as medications
containing PSE. The researchers point out that, at the 10
mg dose approved by the FDA, oral phenylephrine is
extensively metabolized by an enzyme naturally occurring in
the gastrointestinal tract and liver. Therefore, compared
to orally-taken PSE, it is less readily absorbed by the
body. The researchers also point out that phenylephrine
does not effectively relieve nasal stuffiness at this dose,
noting that the FDA points to 4 tests demonstrating
efficacy at the 10 mg dosage, 2 of which were unpublished
and sponsored by drug manufacturers, while 6 tests
demonstrated no significant difference between
phenylephrine and a placebo. The researchers further
contend that a higher dose may work, but no research has
been published regarding safety at higher doses.
In December 2007, the FDA held a public advisory committee
meeting to review the current safety and efficacy data for
phenylephrine, and found that, while additional studies
would be useful to evaluate higher doses, the 10 mg
phenylephrine dose currently included in the OTC Monograph
is effective. The FDA did note, however, that PSE and
phenylephrine differ in duration of action, and recommended
STAFF ANALYSIS OF SENATE BILL 315 (Wright) Page
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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 recent article by Gayle Nicholas Scott, Pharm. D.,
reviewed the relative efficacies of PSE and phenylephrine.
Dr. Scott concurred with the FDA that phenylephrine appears
to have less decongestant activity than PSE and that
phenylephrine has a shorter half-life than PSE, thus
requiring more frequent use.
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.
Methamphetamine
Meth is a highly addictive central nervous system stimulant
that can be injected, snorted, smoked, or ingested orally.
Meth users feel a short yet intense "rush" when the drug is
initially administered. The immediate effects of meth
include increased activity and decreased appetite. The drug
has limited medical uses for the treatment of narcolepsy,
attention deficit disorders, and obesity; however it is
seldom prescribed by doctors. Long-term meth abuse can
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cause addiction, anxiety, insomnia, mood disturbances, and
violent behavior. Additionally, psychotic symptoms such as
paranoia, hallucinations, and delusions can occur. The
psychotic symptoms can last for months or years after meth
use has ceased. The following bullets contain further
information on meth use and processing:
National methamphetamine use. Both the Monitoring
the Future (MTF) survey funded by the National
Institute on Drug Abuse, and the National Survey on
Drug Use and Health (NSDUH) produce estimates of meth
use. The 2009 MTF found that meth use among teens
appears to have dropped significantly in recent years.
The 2009 NSDUH, released by the federal Substance
Abuse and Mental Health Services Administration
(SAMHSA), found that the number of past month meth
users decreased between 2006 and 2008, but then
increased in 2009. Both surveys showed declines in
past year and past month use of meth between 2002 and
2009, with no indication of increases between 2008 and
2009, although past month meth use decreased in the
MTF.
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 another source for monitoring
meth use. Results from the August 2010 DAWN report,
also compiled by 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.
Methamphetamine use in California. 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 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 admissions to meth treatment programs peaked in
SFY 2005-06 and in SFY 2007-08, they declined to the
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lowest level in six years.
Ingredients and process. Ingredients for meth
production are commonly found and include EPH or PSE,
acetone (nail polish remover), iodine, anhydrous
ammonia, hydrochloric acid (pool chemicals), lithium
(batteries), red phosphorus (matches or road flares),
sodium hydroxide (lye), sulfuric acid (drain cleaner),
and toluene (brake fluid). Traditional cooking
methods create serious risks of explosion. In
addition, traditional methods produce relatively large
amounts of waste chemicals that are often dumped
illegally.
Recently, 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. One mixes crushed PSE
tablets, a substance such as ammonia nitrate, lithium
battery strips, drain cleaner (or similar product) and
water in a container such as a 2-liter bottle.
Recipes call for about 200 tablets of PSE, an amount
within the monthly legal limit. An August 2009
Associated Press story stated that the method produces
enough for only a "few hits." 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.
The 2010 Methamphetamine Threat Assessment, published
by the U.S. DOJ National Drug Intelligence Center,
notes that an increasing proportion of laboratory
seizures or incidents resulted from "one-pot" or
"shake-and-bake" manufacturing in 2009, but domestic
super lab seizures did not change significantly during
this period. A laboratory "incident" is defined by
the DEA to include labs, dumpsites and chemical or
glassware seizures. Thus, the number of laboratory
incidents does not necessarily reflect the number of
labs actually producing meth.
Amount of PSE needed for 10 pounds of meth. Super
labs are meth labs that have the ability to make 10
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pounds of meth at a time. According to the Senate
Public Safety Committee analysis, if obtained through
legal OTC purchases, the number of PSE packages (each
containing 96 tablets with each tablet containing 30
mg of PSE) that is required to make 10 pounds of meth
is 1583. Such an amount would require a large and
sophisticated smurfing operation (representatives of
the Attorney General report that such smurfing schemes
have involved around 100 persons each). The number of
purchases needed to obtain 10 pounds of PSE is 1266,
given the 3.6 gram per purchase limit. Such purchases
would likely exceed monthly limits, but smurfers can
exceed the monthly maximum if they buy from stores
that do not have a single tracking system. (Most
chain stores track PSE sales electronically and larger
chains have begun to coordinate their systems.)
Nevertheless, a very large number of separate
purchases would be required to obtain enough PSE
necessary to make 10 pounds of meth.
The difficulty of obtaining large amounts of PSE by
smurfing raises questions of whether meth super labs obtain
bulk PSE through diversion of legitimate product, or
through other means involving fraudulent purchases or
transfers. Labs have been found with great piles of PSE
retail packages, but it is unclear how the meth makers were
able to obtain so many packages.
PSE restrictions in other states
According to the 2010 Drug Threat Assessment by the U.S.
DOJ, forty-five states have enacted PSE restrictions.
Twenty states have made PSE a controlled substance,
typically with an exception for OTC sales consistent with
federal law. Forty-three states have imposed point-of-sale
restrictions, and twenty-six have PSE tracking laws.
Oregon has required a prescription for any PSE purchase
since 2006. Mississippi has required a prescription since
July 2010. In addition, a few cities in Missouri
(including, most recently, Dexter) have also passed laws
requiring a prescription for purchase of PSE products.
Faced with the limitations of handwritten log books, some
states have turned to an electronic log book system. The
following states have some sort of electronic tracking of
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PSE sales: Alabama, Arkansas, Florida, Illinois, Iowa,
Kansas, Kentucky, Louisiana, Missouri, Oklahoma, South
Carolina, and Washington.
Kentucky is the state most often mentioned among states
with electronic tracking. The Kentucky State Police have
recently reported an increase in the number of meth labs
from 429 in 2008 to 1078 in 2010. Industry representatives
have argued in hearings and meetings that the electronic
tracking law has helped law enforcement find labs that
would have otherwise gone undetected. Critics say the
system is easy to circumvent and produce multiple false
identifications. Proponents of the tracking system state
that thousands of attempted purchases have been blocked,
and that electronic tracking has led to 70 percent of the
meth lab busts in several Kentucky counties. Proponents
also contend that the system needs time to work, and that
they are now able to identify the location of more meth
labs because of the electronic tracking database.
Law enforcement reports on meth production
According to the U.S. DOJ, National Drug Intelligence
Center's National Drug Threat Assessment 2009, EPH and PSE
import restrictions in Mexico contributed to a decrease in
meth production in Mexico and reduced the flow of meth from
Mexico to the United States in 2007 and 2008. In 2008,
however, small-scale domestic meth production increased in
many areas, and some Mexican drug trafficking organizations
(DTOs) shifted their production operations from Mexico to
the United States, particularly to California. The rise in
domestic meth production was fueled by an increase in
domestic PSE trafficking by individuals and criminal groups
circumventing national retail PSE sales restrictions.
These individuals and criminal groups often make PSE
product purchases at or below the allowable purchase limit
from multiple retail outlets. The report stated that some
PSE smurfed in California was sent to Mexico for meth
production, and appears to support a conclusion that the
percentage of labs or manufacturing sites that were super
labs increased in 2008 and 2009, although the total number
of incidents fell.
As of January 2008, the Mexican government banned the
importation of PSE and EPH into the country. Sellers of
PSE products were required to deplete their remaining
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supplies by 2009, and the use of these products has been
illegal in Mexico since then. However, the DEA has
reported that Mexican DTOs are increasingly circumventing
chemical sale and import restrictions in Mexico by
diverting EPH and PSE from illicit sources in South
America. Mexican DTOs are increasingly using South America
as a source and transshipment zone for EPH and PSE
shipments destined for meth laboratories in Mexico as well
as to laboratories tied to Mexican DTOs that are located in
South American countries. Seizure data from 2007 and 2008
indicate that EPH and PSE are smuggled from South American
sources in containerized cargo, aboard commercial flights
by couriers, and by mail delivery services.
Cases of meth lab incidents in California
The following table illustrates meth lab incidents data in
California (a lab "incident" is defined by the DEA to
include labs, dumpsites and chemical or glassware
seizures):
Meth Lab Incidents in California, 2003-2010
-----------------------
| 2003 | 1,281 |
|-----------+-----------|
| 2004 | 767 |
|-----------+-----------|
| 2005 | 468 |
|-----------+-----------|
| 2006 | 353 |
|-----------+-----------|
| 2007 | 221 |
|-----------+-----------|
| 2008 | 346 |
|-----------+-----------|
| 2009 | 264 |
|-----------+-----------|
| 2010 |170 |
| | |
-----------------------
As explained by the U.S. DOJ, "In recent years, there has
been a decrease in the number of meth labs seized in
California and an increase in the number of meth labs just
south of the border in Mexico. Rural areas in the Central
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Valley are the source of much of the meth produced in
California and seized elsewhere. As the supply of PSE from
Canada has diminished after successful law enforcement
operations, there has been a noticeable increase in PSE and
EPH seized that originated from China. Restrictions on PSE
importation into Mexico, balance-of-power issues among
rival Mexican cartels, and increased enforcement efforts by
the current Mexican government have all significantly
impacted meth manufacturing and the smuggling of finished
product into the Los Angeles area."
Related bills
SB 260 (Wright) provides that any person or entity who
possesses one-half pound or more of PSE, or a specified
related chemical, or one-half pound of a substance
containing PSE or a related chemical, as specified, is
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. Set for
hearing on May 3, 2011 in Assembly Public Safety Committee.
Prior legislation
AB 1455 (Hill) of 2010 was substantively similar to AB 1280
(Hill). 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 SB
315. Failed passage in the Assembly Public Safety
Committee.
SB 1299 (Speier), Chapter 646, Statutes of 2006, provides
that it is 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
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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 provided 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 shall
be subject to specified additional requirements. Also
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 requirements. These
provisions were amended out of the bill.
Arguments in 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 super labs 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 both 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
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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 leads the nation by a wide margin in the amount
of meth created, trafficked and seized during the last few
years. By limiting the 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.
Arguments in opposition
The California Chamber of Commerce (CalChamber) 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.
While well intentioned, CalChamber believes that SB 315
would further exacerbate the problem of rising health care
costs and make insurance less affordable, resulting in an
increased number of uninsured.
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 a doctor's 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
STAFF ANALYSIS OF SENATE BILL 315 (Wright) Page
17
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 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 strike the proper balance between preventing illegal
diversion while preserving access to needed medications.
COMMENTS
1. Amendments agreed to in Public Safety Committee. SB
315 was heard in Senate Public Safety where the author
agreed to take the following amendments in Senate Health:
a. Five-year sunset. Amendments would sunset the
provisions of the bill in December 31, 2018.
b. DOJ study. Amendments would 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. Exemption to allow minors to obtain and possess
PSE by prescription. Allows minors to obtain and
possess PSE by prescription by striking page 7,
STAFF ANALYSIS OF SENATE BILL 315 (Wright) Page
18
lines 13-15.
2. Implications for Medi-Cal beneficiaries. The recently
enacted budget bill, AB 97, implemented of a "soft cap" of
seven provider visits per month 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. It is
unclear to what extent Medi-Cal beneficiaries may be
impacted by SB 315, but it is possible that a Medi-Cal
beneficiary may either use up visits simply for obtaining a
prescription for PSE, or run out of visits before needing a
prescription for such medications. It is unclear to what
extent the need for obtaining a prescription for PSE
products would qualify for the exemption from the seven
visit cap.
3. Alternative proposal to limit PSE diversion. AB 1280
(Hill) is an alternative measure introduced this year
designed to limit illicit meth manufacturing and abuse by
mandating an electronic tracking system for purchases of
PSE and EPH drugs. The bill requires all retailers of such
drugs to participate by entering the information of anyone
purchasing such drugs into the electronic tracking 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. If
implemented appropriately, this proposal may provide an
alternative method that curbs meth labs in the state
without incurring potential barriers to access and
additional costs to the system.
4. Impact on health care 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 has estimated that the nation
will face a shortage of approximately 21,000 primary care
physicians in 2015. By requiring consumers to seek a
STAFF ANALYSIS OF SENATE BILL 315 (Wright) Page
19
prescription for PSE and EPH medications, SB 315 may limit
or deny access to this medication for Californians who do
not have ready access to a health care provider. Not all
patients have a standing relationship with a provider, and
not all providers will be willing to provide prescriptions
without an in-person consultation. If more provider time
is spent in consultations related to provision of
prescriptions for PSE, there is less time to see other
patients and provide other services. There is also
evidence to suggest that those who are unable to access
routine medical care often turn to the ED to receive needed
health care services.
5. Impact on cost. Many plans and insurers 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.
POSITIONS
Support: California Department of Justice (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
Two individuals
Oppose: Association of California Life and Health
Insurance Companies
Asthma & Allergy Foundation of America,
California Chapter Bayer HealthCare
BIOCOM
STAFF ANALYSIS OF SENATE BILL 315 (Wright) Page
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California Association of Health Plans
California Chamber of Commerce
California Grocers Association
California Healthcare Institute
California Manufacturers & Technology Association
California Primary Care Association
California Retailers Association
Consumer Healthcare Products Association
Drug Policy Alliance
Health Net
Insurance and Benefits Trust of the Peace
Officers Research Association
Los Angeles Society of Allergy, Asthma & Clinical
Immunology, Inc.
National Association of Chain Drug Stores
Peace Officers Research Association of California
Rite Aid
Walgreens
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