BILL ANALYSIS Ó
SENATE COMMITTEE ON PUBLIC SAFETY
Senator Loni Hancock, Chair A
2011-2012 Regular Session B
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2
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AB 1280 (Hill) 0
As Amended May 26, 2011
Hearing date: June 21, 2011
Health and Safety Code
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PSEUDOEPHEDRINE SALES:
ELECTRONIC TRACKING
HISTORY
Source: Author
Prior Legislation: AB 1455 (Hill) - Held is Senate Judiciary
Committee
AB 162 (Runner) - Ch. 978, Stats. 1999
Support: Alameda County Sheriff's Office; Bayer HealthCare;
BIOCOM; Calaveras County Sheriff; California Chamber
of Commerce; California District Attorneys Office;
California Healthcare Institute; California Retailers
Association; California Medical Association;
California Pharmacists Association; California State
Sheriffs' Association; Consumer Healthcare Products
Association; California Manufacturers and Technology
Association; Johnson & Johnson; Kern County Sheriff;
Lassen County Sheriff; National Association of Chain
Drug Stores; National Federation of Independent
Business; The Neurology Center; Orange County Business
Council; Orange County Sheriff; Peace Officers
Research Association of California; Pfizer Reckitt
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Benckiser; Rite Aid; Sacramento County Sheriff; San
Joaquin County Sheriff; Sanofi-Aventis; Santa Clara
County Medical Association; Santa Cruz County Sheriff;
Shasta County Sheriff; Siskiyou County Sheriff; Valley
Industry and Commerce Association; Walgreens; Yolo
County Sheriff; California Primary Care Association;
California Black Health Network; Community Clinic
Association of LA County
Opposition:American Civil Liberties Union, unless amended;
California Department of Justice; California Narcotics
Officers' Association; California Public Defenders
Association; National Narcotics Officers' Association
Coalition; Privacy Rights Clearinghouse, unless
amended
Assembly Floor Vote: Ayes 79 - Noes 0
KEY ISSUES
SHOULD STATE LAW PROVIDE THAT A PERSON MAY BUY NO MORE THAN 3.6
GRAMS OF PSEUDOEPHEDRINE<1> IN A SINGLE OVER-THE-COUNTER TRANSACTION
AND NO MORE THAN 9 GRAMS IN ANY 30-DAY PERIOD?
SHOULD ANY PSEUDOEPHEDRINE BUYER BE REQUIRED TO PROVIDE VALID
IDENTIFICATION AND SIGN A LOG THAT RECORDS THE TRANSACTION DATE,
AMOUNT PURCHASED AND THE NAME AND ADDRESS OF THE PURCHASER?
SHOULD SALES OF PSEUDOEPHEDRINE BE MONITORED THROUGH THE NATIONAL
PRECURSOR LOG EXCHANGE (NPLEx) - AN ELECTRONIC RECORDING SYSTEM
ACCESSIBLE TO LAW ENFORCEMENT?
SHOULD RETAILERS BE REQUIRED TO CONFIRM THROUGH NPLEx THAT THE SALE
OF A PRODUCT DOES NOT EXCEED STATUTORY LIMITS?
---------------------------
<1> For convenience and brevity, a reference in this analysis to
"pseudoephedrine" shall also include related chemicals that are
covered by this bill. This bill would make California law on
sales limits consistent with federal law.
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SHOULD VIOLATION BY A RETAILER OF THE LIMITS OR PROCEDURES FOR SALES
OF PSEUDOEPHEDRINE BE A MISDEMEANOR, WITH A FINE OF UP TO $10,000
FOR REPEATED CONVICTIONS?
SHOULD RETAILERS BE SUBJECT TO SPECIFIED CONFIDENTIALITY RULES
CCONCERNING USE OR HANDLING OF THE SALES DATA?
SHOULD THE DEPARTMENT OF JUSTICE (DOJ) EXECUTE A MEMORANDUM OF
UNDERSTANDING WITH THE NATIONAL ASSOCIATION OF DRUG DIVERSION
INVESTIGATORS (NADDI) BEFORE DOJ CAN RECEIVE WEEKLY TRANSACTION
RECORDS AND BEFORE LAW ENFORCMENT CAN HAVE REAL-TIME ON-LINE
ACCESS TO THE DATA, AS SPECIFIED?
PURPOSE
The purposes of this bill are to provide the following: 1)
retail sales of pseudoephedrine are limited to 3.6 grams per
transaction and 9 grams in any 30-day period; 2) a
pseudoephedrine purchaser shall provide a valid identification
and sign a transaction log; 3) retailers shall electronically
record the purchaser's name, birthdate, address, and purchase
amount in National Precursor Log Exchange (NPLEx) system and
inform purchasers that the information will be provided to law
enforcement; 4) retailers shall maintain a purchaser's data no
longer than two years; 5) law enforcement shall have electronic
access to the data when Department of Justice (DOJ) enters into
a memorandum of understanding (MOU) with the National
Association of Drug Diversion Investigators (NADDI); 6) law
enforcement officers shall have access to NPLEx through a unique
identifier; 7) sales data shall be subject to specified
confidentiality rules and penalties; and 8) a law enforcement
investigation flowing from a single denied transaction shall be
supported by probable cause.
Existing law generally prohibits disclosure of medical
information without the authorization of the patient, unless
disclosed pursuant to a court order or a warrant, or pursuant to
another specified exception. Medical information can also be
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disclosed "when otherwise specifically required by law." (Civ.
Code § 56.10.)
Existing law provides that every health care provider, health
care service plan, pharmaceutical company or contractor that
creates, maintains, stores, destroys or disposes of medical
records shall maintain the confidentiality of the information
therein. Where one of these entities is negligent with regard
to these records, specified fines and penalties, as set out in
Civil Code Section 56.36, shall apply. (Civ. Code § 56.101.)
Existing law provides that a violation of medical information
privacy, storage or destruction rules that results in economic
loss or personal injury to a patient is a misdemeanor, is
punishable by a jail term of up to six months, a fine of up to
$1,000,or both. (Civ. Code § 56.36, subd. (a).)
Existing law includes the following civil penalties and remedies
for negligent or intentional violations of medical privacy
rules:
A person whose medical information was negligently
released may bring an action for damages against the
responsible person or entity. Recoverable damages include:
o Nominal damages of $1,000 in the absence of
proof of actual damages
o The amount of actual damages
A person or entity that negligently discloses medical
information is subject to a civil penalty of up to $2,500
per violation.
Any person, other than a licensed health care
professional, who knowingly obtains, discloses or uses
medical information, is liable for a civil fine of up to
$2,500 for the first violation, a civil fine of up to
$10,000 for a second violation and a civil fine of up to
$25,000 for a third or subsequent violation.
A person, other than a health care professional, who
discloses or uses medical information for financial gain is
liable for a civil fine of up to $250,000 per violation,
and is subject to disgorgement of any proceeds of the
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misuse.
A health care professional who discloses or uses medical
information for financial gain is subject to a civil fine
of up to $5,000 for the first violation, up to $25,000 for
the second, and up to $250,000 for a third or subsequent
violation.
Any person without permission to receive medical
information, who knowingly obtains, discloses or uses
medical information, is liable for a civil penalty of up to
$250,000, according to factors relevant to the seriousness
of the violation, as specified. The penalty shall be
assessed and recovered in a court action filed by the
Attorney General, a district attorney or other designated
local government attorney. The proceeds of the fine shall
be paid to the county or city treasurer, or both, or to the
county treasurer and the California General Fund in an
action by the AG, as specified. (Civ. Code § 56.36, subds.
(b)-(c).)
Existing provisions of the California Constitution state that
all people have inalienable rights, including the right to
pursue and obtain privacy. (Cal. Const. Art. I, § 1.)
Existing law classifies controlled substances in five schedules
according to their dangerousness and potential for abuse.
(Health & Saf. Code §§ 11054-11058.)
Existing law includes the CURES (Controlled Substance
Utilization Review and Evaluation System) system to require
electronic monitoring of the prescribing of Schedule II, III and
IV controlled substances. Under CURES, Schedule II, III and IV
prescription data are electronically transmitted to the
Department of Justice (DOJ) when prescriptions are dispensed.
(Health & Saf. Code § 11165.)
Existing law includes a detailed scheme regulating production
and distribution of specified chemicals that may be precursors
to controlled substances, including pseudoephedrine. (Health &
Saf. Code § 11100.)
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Existing law provides that it is unlawful for a retailer to sell
more than three packages, or 9 grams, of a product that he or
she knows to contain pseudoephedrine in a single transaction.
The offense is a misdemeanor. (Health & Saf. Code § 11100, subd.
(g)(3).)
Existing federal law includes the Health Insurance Portability
and Accountability Act of 1996 (HIPAA) which, subject to
specified exceptions and procedures, provides that medical
information shall be confidential. (Pub. Law 104-191; 45 CFR
160, 164.)
Existing federal law (21 USC § 830 (e) and 844 (a).) -- the
Combat Methamphetamine Epidemic Act (CMEA) - includes
restrictions and requirements for over-the-counter sale of
pseudoephedrine. Restrictions include:
No more than 3.6 grams in a single transaction.
No more than 9 grams per customer in a one-month period.
Seller must maintain a written or electronic logbook of
each sale, including the date of the transaction, the name
and address of the purchaser and the quantity sold.
Purchaser must present valid identification and the
seller must verify the identification.
Purchaser must sign a paper or electronic logbook, as
specified.
Seller must maintain these documents, as specified.
Law enforcement has access to the data pursuant to U.S.
DOJ regulations.
Existing federal law provides the following penalties:
Violation of the 9 gram purchase limit is a misdemeanor.
Violation of record-keeping laws is a misdemeanor, with
specified exceptions.
Violation of distribution limits is punishable by prison
term of up to five years.
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Distribution of pseudoephedrine with knowledge that it
will be used to manufacture a controlled substance, or
intentional evasion of recording or reporting rules, is
subject to imprisonment for up to 10 or 20 years, as
specified. (21 USC § 841 (c) and 844 (a).)
Existing federal law exempts purchases of a single package
containing not more than 60 milligrams<2> of pseudoephedrine
from reporting rules. (21 USC § 841 (e)(1)(A)(iii).)
Existing federal law requires retailers to retain purchase
information for at least two years. (21 USC § 841 (v)(6).)
Existing federal regulations provide the following as to the
privacy of retail pseudoephedrine transactions recorded in
logbooks:
The information shall be disclosed as appropriate
to the Administration and to State and local law
enforcement agencies.
The logbook information shall not be accessed,
used, or shared for any purpose other than compliance
with this title or to facilitate a product recall.
A regulated seller who in good faith releases
information in a logbook to Federal, State, or local
law enforcement authorities is immune from civil
liability for the release unless the release
constitutes gross negligence or intentional, wanton,
or willful misconduct. (21 CFR § 1314.45.)
This bill repeals existing statutory provisions for
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<2> By way of illustration, a single 12-hour extended release
allergy-decongestant tablet typically contains 120 milligrams of
pseudoephedrine.
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over-the-counter sales of pseudoephedrine<3> and replaces them
with new purchase limits and electronic tracking of purchases
and includes a January 1, 2018 sunset.
This bill provides that a violation of either the sales limits
or required procedures for a pseudoephedrine transaction is a
misdemeanor, punishable on a first conviction by a fine of up to
$1,000, a jail term of up to six months, or both. Upon a
subsequent conviction, the maximum jail term is one year and the
maximum fine is $10,000.
This bill includes the following procedures and sales limits:
A retailer must store pseudoephedrine products in a
locked cabinet or behind the counter.
A retailer may sell no more than 3.6 grams of
pseudoephedrine within 24 hours and no more than 9 grams in
a 30-day period.
Data recording shall not apply to sale of a single
package containing no more than 60 milligrams of a product
containing pseudoephedrine.
The user must present valid photo identification.
The retailer must record the following at the time of
making a transaction:
o The date of the transaction.
o The type and number of the buyer's
identification, and the issuing agency.
o The name, date of birth and address of the
purchaser.
o The name and quantity product sold, including
gram weight.
o The name or initials of the person making the
sale.
The retailer shall immediately transmit the information
about the sale and the purchaser to the National Precursor
Log Exchange (NPLEx) electronic monitoring system
administered by the National Association of Drug Diversion
--------------------------
<3> Pseudoephedrine is the most commonly sold of the chemicals
or drugs covered by this bill. References to pseudoephedrine
alone in this analysis include the other chemicals covered by
the terms of this bill. - ephedrine, norpseudoephedrine or
phenylpropanolamine
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Investigators (NADDI) for the purpose of determining
whether or not the sale would exceed statutory limits.
The retailer's duty arises when the NPLEx system is
available to retailers without cost.
The purchaser must provide valid identification, as
specified.
The purchaser must sign a written or electronic log.
This bill provides that a retailer shall not maintain a separate
copy of the transaction information, except as required by
federal law.
This bill provides that in the event of a failure of the
electronic data system, records shall be maintained in a written
log or in alternative electronic form.
This bill requires the retailer to notify customers that
identification and purchase data will be provided to law
enforcement pursuant to this bill and federal law.
This bill states that the Legislature finds that probable cause
is necessary before law enforcement can begin an investigation
based on a single transaction made in violation of
pseudoephedrine purchase limits.
This bill provides that data collected on over-the-counter sales
of pseudoephedrine shall be maintained for no longer than two
years.
This bill provides that the retailer need not keep records of
pseudoephedrine transactions in a separate log or location from
those required by federal law.
This bill provides retail distributors shall, pursuant to Civil
Code Section 56.101, preserve the confidentiality of the
information in the system.
This bill shall not apply to a health care practitioner
authorized to write prescriptions.
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This bill provides that upon execution of a memorandum of
understanding (MOU) between DOJ and NADDI concerning system
access, NADDI shall supply NPLEx data to DOJ on a weekly basis
and give law enforcement real-time access to the data through an
NPLEx on-line portal, as authorized by DOJ.
This bill provides that law enforcement access to the database
system shall be through a unique code for each person using the
system. Access records shall be maintained by DOJ.
This bill provides that the system shall give retailers an
immediate real-time alert if a person attempts to purchase
pseudoephedrine in violation of the limits and procedures in
this bill.
This bill provides that the data system shall conform to the
Federal Bureau of Investigation's Criminal Justice Information
Systems security standards and may be audited annually.
This bill provides that neither the DOJ nor any state agency
shall bear any cost for developing, installing or maintaining
the system.
This bill provides that the MOU shall require that a retail
distributor's access to the database shall be limited to sales
by that distributor, and solely for complying with federal
(CMEA) or California data collection law, a court order or an
authorized law enforcement request.
This bill provides no party to the MOU, nor any entity under
contract to provide the system, may use the data for any purpose
other than set forth in this bill, the federal CMEA or
regulations pursuant to this bill or the CMEA.
This bill provides that the system operator may access data for
the sole purpose of assessing and improving the operation and
efficiency of the system.
This bill provides that the Board of Equalization, by September
1, 2012, shall notify retailers of the requirement to report all
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covered transactions to NPLEx.
This bill preempts all local ordinances or regulations
concerning the over-the-counter sale of pseudoephedrine
products.
RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION
For the last several years, severe overcrowding in California's
prisons has been the focus of evolving and expensive litigation.
As these cases have progressed, prison conditions have
continued to be assailed, and the scrutiny of the federal courts
over California's prisons has intensified.
On June 30, 2005, in a class action lawsuit filed four years
earlier, the United States District Court for the Northern
District of California established a Receivership to take
control of the delivery of medical services to all California
state prisoners confined by the California Department of
Corrections and Rehabilitation ("CDCR"). In December of 2006,
plaintiffs in two federal lawsuits against CDCR sought a
court-ordered limit on the prison population pursuant to the
federal Prison Litigation Reform Act. On January 12, 2010, a
three-judge federal panel issued an order requiring California
to reduce its inmate population to 137.5 percent of design
capacity -- a reduction at that time of roughly 40,000 inmates
-- within two years. The court stayed implementation of its
ruling pending the state's appeal to the U.S. Supreme Court.
On May 23, 2011, the United States Supreme Court upheld the
decision of the three-judge panel in its entirety, giving
California two years from the date of its ruling to reduce its
prison population to 137.5 percent of design capacity, subject
to the right of the state to seek modifications in appropriate
circumstances.
In response to the unresolved prison capacity crisis, in early
2007 the Senate Committee on Public Safety began holding
legislative proposals which could further exacerbate prison
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overcrowding through new or expanded felony prosecutions.
This bill does not appear to aggravate the prison overcrowding
crisis described above.
COMMENTS
1. Need for This Bill
According to the author:
AB 1280 provides teeth to existing federal law
limiting the sales of pseudoephedrine (PSE) products.
Federal law in place since 2006 has imposed both daily
and monthly limits on quantities of products
containing PSE that can be purchased. Consumers must
specifically ask for the products (only available
behind the counter), provide identification and sign a
log book prior to completing a sale. Limits on PSE
quantities were imposed as it is a primary ingredient
in the manufacture of methamphetamine.
However, the paper logs maintained by each store or
pharmacy are independent. As such, there is no way
for a retailer to know if an individual has already
met or exceeded the federal limit. A criminal could
easily go from one store to another and hence
accumulate large quantities of PSE.
AB 1280 requires California retailers selling PSE
products over the counter to enter the purchase into
an electronic log prior to completing the sale. The
networked, unified, electronic log will immediately
alert retailers if the customer has exceeded the
federal limits. If so, retailers would be required to
stop the sale.
The electronic log in AB 1280 will be both consumer
and retailer friendly. The interaction for the
consumer would be the same as under current law. The
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retailer would simply enter the information into an
electronic log (i.e. a web-based interface) as opposed
to the existing paper log. Retailers will know in
real-time whether or not the purchase will exceed the
federal limits.
The electronic log in AB 1280 would be both
anti-criminal and pro-consumer. Criminals will have a
much harder time violating federal law if each store
he or she approaches knows immediately whether or not
the purchase is legal. Simultaneously, AB 1280 will
protect access to effective medication for the
millions of California allergy sufferers.
2. Standard Packages of Pseudoephedrine - How Much are 3.6 Grams
and 9 Grams?
A standard pseudoephedrine tablet contains 30 milligrams.
Tablets are typically sold in blister packages of 24, 48 and 96.
The recommended dose is up to two tablets every four to six
hours, but no more than eight tablets a day. The Mayo Clinic
website<4> warns not to continue taking the medicine for more
than 7 days if symptoms do not improve.
Under federal law, a person may in a single transaction buy no
more than 3.6 grams, or approximately two boxes of 48 tablets
and a box of 24 tablets, or 120 tablets. At the recommended
maximum dose of 8 tablets per day, 3.6 grams is a 15-day supply.
The maximum monthly purchase amount - 9 grams - is
approximately 306 tablets, a 38-day supply.
3. Decongestant Medications - Efficacy Comparisons
Many consumers rely on over-the-counter pseudoephedrine products
to ease nasal congestion because they are effective and readily
available to those without access to physicians. In recent
years, because of restrictions on the sale and distribution of
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<4>
http://www.mayoclinic.com/health/drug-information/DR601759/DSECTI
ON=precautions-
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pseudoephedrine, alternative or substitute products have been
developed. These substitute decongestants are kept on open
shelves in drug stores and other retail shops, while
pseudoephedrine products must be kept behind the counter or in a
locked cabinet.
The most commonly used substitute is phenylephrine. A recent
article by Gayle Nicholas Scott, Pharm. D.,<5> reviewed the
relative efficacies of pseudoephedrine and phenylephrine. She
concluded: "Phenylephrine appears to have less decongestant
activity than pseudoephedrine." She also noted that
phenylephrine must be used more frequently than pseudoephedrine.
4. Restrictions on Pseudoephedrine in Other States
According to the 2010 Drug Threat Assessment by the U.S.
Department of Justice, 45 states have enacted pseudoephedrine
restrictions. (2010 Threat Assessment, USDOJ, pp. 66-67.)
Twenty states have made pseudoephedrine a controlled substance,
typically with an exception for over the counter sales
consistent with federal law. Forty-three states have imposed
point-of-sale restrictions, and 26 have pseudoephedrine tracking
laws. (Ibid.)
Oregon has required a prescription for any pseudoephedrine
purchase since 2006. Mississippi has required a prescription
since July, 2010. It appears that the following states have
some sort of electronic tracking of pseudoephedrine sales:
Alabama, Arkansas, Florida, Illinois, Iowa, Kansas, Kentucky,
Louisiana, Missouri, Oklahoma, South Carolina, and Washington.
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<5> Dr. Scott wrote the article as a consultant to Sportpharm, a
company that supplies medical supplies and drugs to athletic
organizations. Sportpharm is relied upon by organizations such
as USA Track and Field, the national governing body for track
and field, including anti-doping issues.
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Kentucky is the state most often mentioned as concerns
electronic tracking. The Kentucky State Police have recently
reported a sharp increase in methamphetamine labs from 2008
through 1010 of 429 to 1078. 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.
5. Funding for and Development of the Electronic Tracking System
The bill does not specifically provide who will pay for the
NPLEx system. The bill does state that retailers' duty to
submit data to the system created by the bill does not arise
until the system (NPLEx) operates without cost to retailers.
Industry representatives have stated that manufacturers
(including those who re-label products as their own) will pay
for the system and that retailers would need no more than an
Internet connection to access the system. Existing electronic
systems could be integrated into the database.
WILL MANUFACTURERS OF PSEUDOEPHEDRINE AND RELATED PRODUCTS FUND
THE ELECTRONIC TRACKING SYSTEM IMPLEMENTED UNDER THIS BILL?
6. Issue whether this Bill could a Part of a National
Pseudoephedrine Tracking System - Access to California Data by
Out-of-State Law Enforcement
The bill creates a system for tracking California
over-the-counter sales of pseudoephedrine under which sales will
be electronically recorded in the National Precursor Log
Exchange NPLEx. It appears that any person or entity authorized
to review data collected under the federal CMEA may access the
data in the system created by this bill. Thus, a law
enforcement officer in one of the 14 - and soon to be 16 -
states that use NPLEx would likely have instant access to
California pseudoephedrine purchase data.
The bill states that law enforcement officers may only have
access to the system through a unique identifier. The bill also
states that California DOJ shall maintain and audit each user of
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the system. However, it would appear that California law would
not have jurisdiction to require users in other states to access
the system through a unique identifier. It also is unclear
whether DOJ could effectively monitor users in other states and
take action if misuse occurs.
Arguably, law enforcement in states that border California would
have valid reasons to access California data. Methamphetamine
manufacturers near the California border in Oregon, Nevada and
Arizona could perhaps be expected to make purchases from
numerous stores in California to obtain sufficient product to
make methamphetamine. (Making small purchases to make
methamphetamine is called smurfing.) Smurfers would more likely
be successful if databases in California and neighboring states
were not accessible to law enforcement in all of these states.
However, law enforcement in states such as Kentucky and Missouri
would appear to have little use for such data. If law
enforcement suspected that large scale methamphetamine makers
were obtaining pseudoephedrine in far-flung states, a warrant
for any relevant information in the databases would likely be
readily available. As such, the privacy interests of
pseudoephedrine purchasers in California would, consistent with
California privacy laws, appear to outweigh the relatively
slight interest law enforcement in non-bordering states would
have in the data.
IS THIS BILL INTENDED TO BE PART OF A NATIONAL SYSTEM TO
ELECTRONICALLY TRACK PSEUDOEPHEDRINE SALES?
SHOULD OUT-OF-STATE LAW ENFORCEMENT HAVE ACCESS TO CALIFORNIA
PSEUDOPHEDRINE PURCHASE DATA?
COULD ACCESS TO CALIFORNIA DATA BY OUT-OF-STATE LAW ENFORCEMENT
BE MONITORED AND CONTROLLED?
7. Privacy Concerns from Recording Pseudoephedrine Sales in a
Database That can be Accessed by Law Enforcement and
Pseudoephedrine Retailers
California law requires relatively stringent medical privacy.
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Without an exception, such as a court order, medical information
can only be disclosed with the authorization of the patient.
The federal Health Insurance Portability and Accountability Act
(HIPAA) require confidentiality of medical information. Medical
information may be disclosed to law enforcement officials so as
to comply with court orders, identify suspects or witnesses,
find missing persons and for other specified purposes.
The federal Combat Methamphetamine Epidemic Act (CMEA) provides
that pseudoephedrine purchase information shall be disclosed "as
appropriate" to federal, state or local law enforcement. For
other than law enforcement, the information shall not be
accessed, used, or shared for any purpose other than to ensure
compliance with the CMEA or to protect public health and safety
in a product recall. CMEA regulations grant civil immunity
where information is released to law enforcement. There is no
immunity for a release that constitutes intentional misconduct
or gross negligence. (21 CFR § 1314.45.)
This bill requires retailers to electronically record personal
information from each purchaser of pseudoephedrine or related
products. The information is then entered into a database that
can be accessed in real time by law enforcement. A retailer can
retain the information for no more than two years, except as
required under the CMEA and cannot keep a copy of the
information.
The bill states that a retail distributor's use of the system is
subject to Section 56.101 of the Civil Code. That statute
provides that a health care provider, health plan,
pharmaceutical company, or contractor that creates, uses, stores
or maintains, or destroys medical records shall preserve the
confidentiality of the information in the records. Negligence
as to medical records by an entity subject to Section 56.101
makes the entity liable, pursuant to Section 56.36, for a
misdemeanor, administrative penalties and suits for money
damages.
Federal law requires retailers to record the same information as
is required by this bill, and federal law provides that the
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information can be electronically recorded. However, federal
law does not include a single database into which all
transactions are recorded. According to a July, 2007 story
published by MSNBC, privacy advocates in Kentucky raised
concerns about a system through which law enforcement<6> can
access data about drug store customers. The advocates stated
that the vast majority of pseudoephedrine purchases are
legitimate and that there was no reason for law enforcement to
have information about people making such purchases. Law
enforcement representatives responded that the system is simply
an investigative tool.
As noted in the "Purpose" section above, prescriptions for
pseudoephedrine would still be available if the NPLEx system is
implemented for over-the-counter purchases. As pseudoephedrine
is not a controlled substance under California law,
prescriptions would not be electronically tracked by the
existing CURES system. (See Comment # 9 for a discussion of the
CURES system.) Thus, for those have access to physicians, this
bill would arguably present little or privacy concerns.
ARE PRIVACY AND ABUSE CONCERNS LIMITED BY THE REQUIREMENT THAT
EACH LAW ENFORCEMENT OFFICER MUST ACCESS THE DATABASE WITH A
UNIQUE IDENTIFIER THAT SHALL BE RETAINED AND MAY BE AUDITED BY
DOJ?
ARE PRIVACY CONCERNS LIMITED BY THE PROVISION IN THE BILL THAT
PROBABLE CAUSE IS REQUIRED FOR A LAW-ENFORCEMENT INVESTIGATION
BASED ON A SINGLE DENIED PSEUDOEPHEDRINE PURCHASE?
WOULD THE AVAILABILITY OF A PRESCRIPTION FOR PSEUDOEPHEDRINE
LIMIT OR ELIMINATE PRIVACY CONCERNS FOR THOSE WHO HAVE ACCESS TO
---------------------------
<6> Industry representatives have explained that data in the
system would not be accessible to a retail clerk. (This appears
to be based on the experience of the Appriss Company system used
in Kentucky.) The only information provided by the system to
the clerk at the time of a sale is whether or not a sale is
prohibited. The system does not reveal the reason for the
prohibition.
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PHYSICIANS?
8. National Association of Drug Diversion Investigators (NADDI)
The bill essentially provides that the National Association of
Drug Diversion Investigators (NADDI) will develop the tracking
system. NADDI is a non-profit organization that "facilitates
cooperation between law enforcement, healthcare professionals,
state regulatory agencies and pharmaceutical manufacturers in
the investigation and prevention of prescription drug abuse and
diversion?" NADDI, based in Maryland, has 21 state chapters,
including California. <7>
SHOULD THE NATIONAL ASSOCIATION OF DRUG DIVERSION INVESTIGATORS
(NADDI) HAVE A MAJOR ROLE IN DEVELOPING THE NPLEx SYSTEM?
9. The CURES Program - Electronic Monitoring of Controlled
Substance Prescriptions
The CURES program was established in 1997 by AB 3042 (Takasugi).
CURES was initially designed to electronically monitor the
prescribing and dispensing of Schedule II controlled substances.
CURES provides for real-time electronic transmission of
specified prescription data to DOJ. Essentially the data is
analyzed for indications that controlled substances are being
improperly prescribed, or that drug abusers are obtaining
prescriptions from many doctors (doctor shopping). Physicians
and pharmacists, in addition to law enforcement, have access to
the data. Atlantic Associates, a private contractor, collects
CURES data for DOJ. DOJ is currently implementing a transition
to the Prescription Drug Monitoring Program (PDMP) that will
provide real-time Internet access to CURES data for registered
prescribers and pharmacists. Under SB 360 (De Saulnier) -
pending in the Assembly - all prescribers and pharmacists will
eventually be required to access data in this manner.
---------------------------
<7>
http://naddi.associationdatabase.com/aws/NADDI/pt/sp/Home_Page
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DOES THE EXISTING CURES SYSTEM FOR ELECTRONIC TRACKING OF
CONTROLLED SUBSTANCE PRESCRIPTIONS CREATE A PRECEDENT FOR
ELECTRONIC TRACKING OF PSEUDOEPHEDRINE?
10. New "Shake and Bake" Method for Making Small Batches of
Methamphetamine
A new small-scale process for making methamphetamine - the
"shake and bake" or "one pot" method - is increasingly popular.
One mixes crushed pseudoephedrine tablets, 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 pseudoephedrine, an amount within the
monthly legal limit. It appears that the method produces enough
for only a "few hits."
One-pot cooking may create less public danger than traditional
methods. While there is a danger that a bottle used to make
one-pot methamphetamine could explode, the danger is mainly to
the cooker and persons in the immediate vicinity, although
one-pot cooking can cause particularly intense fires, including
residence fires.<8> Traditional cooking is truly dangerous.
There are reports of entire apartments exploding. (WKRG.com,
July 7, 2009.) Traditional methods also produce toxic waste
chemicals that are often dumped into the environment.
DOES USE OF THE "SHAKE AND BAKE" METHAMPHETAMINE METHOD, WHICH
USES RELATIVELY SMALL AMOUNTS OF PSEUDOEPHEDRINE, MAKE IT MORE
DIFFICULT TO PREVENT DIVERSION OF PSEUDOEPHEDRINE?
11. National Rise in Laboratory Discoveries Derive from the
One-Pot Method; Most Superlabs (10 lb. Capacity) are
Found in California
The 2010 Methamphetamine Threat Assessment published by the U.S.
---------------------------
<8> See
http://www.msnbc.msn.com/id/32542373/ns/us_news-crime_and_courts/
.
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DOJ National Drug Intelligence Center noted that an increasing
proportion of "laboratory" seizures or incidents result from
one-pot or shake and bake manufacturing:
Domestic methamphetamine laboratory seizures increased
from 3,096 ... in 2007 to 3,950 in 2008 to 5,308 in
2009. ?ÝT]he increase ? primarily is due to an
increase in the prevalence of small-scale "one pot,"
or "shake and bake" ... method. ?Domestic superlab
seizures did not change significantly during this
period. The number of superlabs Ýcapable of producing
10 lbs. or more of the drug in a cycle] seized
increased only slightly from 2007 (11) to 2008 (17)
before decreasing in 2009 (14). ? 13 Ýsuperlabs] were
seized in California and one in Georgia. (Italics on
superlabs in California added.)
DO MANY OF THE METHAMPHETAMINE LABORATORIES FOUND IN RECENT
YEARS REFLECT USE OF THE SMALL-SCALE SHAKE AND BAKE METHOD?
12. US DOJ Reports Increased "Smurfing" - Obtaining
Pseudoephedrine for Methamphetamine through Numerous
Purchases of Legal Amounts - in California
Smurfing involves purchases of small amounts of pseudoephedrine
from numerous drug stores. Law enforcement representatives
argue that even where smurfers violate federal law in purchasing
more than 9 grams in a month, law enforcement lacks adequate
resources to review electronic and paper purchase logs. Law
enforcement opponents of state-wide electronic tracking systems
for pseudoephedrine sales, such as is employed in Kentucky,
argue that such systems can be defeated by relatively common use
of false identification and fraud.
As noted in Comment # 11 above, the National Drug Intelligence
Center (NDIC) has reported that superlabs have used smurfed
pseudoephedrine. The 2009 report stated: "Mexican criminal
groups and some independent operators Ýacquire] bulk quantities
of pseudoephedrine through smurfing." The report stated that
some pseudoephedrine smurfed in California was sent to Mexico
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for methamphetamine production. If obtained through legal
over-the-counter purchases, the amount of pseudoephedrine
packages required to make 10 pounds of methamphetamine is nearly
mind-boggling. To assemble 10 pounds of pseudoephedrine would
require 1583 of the largest packages - 96 tablets of 30 mgs. -
of pseudoephedrine. Such an amount would require a large and
sophisticated smurfing operation. Representatives of the
Attorney General report that smurfing schemes have involved
around 100 persons.<9>
The difficulty of obtaining large amounts of pseudoephedrine by
smurfing raises the question of whether methamphetamine
superlabs obtain bulk pseudoephedrine through diversion of
legitimate product or fraud. Laboratories have been found with
great piles of pseudoephedrine retail packages. That does not
explain how the meth makers obtained so many packages.
IS A LARGE AND RELATIVELY SOPHISTICATED OPERATION REQUIRED TO
SMURF THE AMOUNT OF PACKAGES (NEARLY 1600 96-TABLET PACKAGES) TO
OBTAIN 10 POUNDS OF PSEUDOEPHEDRINE?
HAVE SUPERLAB OPERATORS OBTAINED PSEUDOEPHEDRINE THROUGH
DIVERSION AND FRAUD?
13. Oregon Law Requires a Prescription for
Pseudoephedrine; Prescription Proponents Attribute the Drop
in Oregon Meth Labs to the Law: Related Mississippi Data
Proponents of the 2006 Oregon law that requires a prescription
for pseudoephedrine attribute the dramatic reduction of
---------------------------
<9> The number of purchases needed to obtain 10 pounds of
pseudoephedrine is 1266. One person can purchase 3.6 grams at a
time. There are 4560 grams in 10 pounds. 4560 divided by 3.6
is 1266. 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 now track pseudoephedrine sales electronically. The
larger chains have begun to coordinate their systems.)
Nevertheless, a very large number of separate purchases would be
required to obtain the pseudoephedrine necessary to make 10
pounds of methamphetamine.
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methamphetamine laboratory incidents in Oregon to the
prescription law. They argued that the law prevents "smurfing"
of pseudoephedrine through multiple over-the-counter purchases
of the drug in an amount allowed by law.
Mississippi has required a prescription for pseudoephedrine
since July 2010. A March 16, 2011 AP story noted: "Mississippi
Bureau of Narcotics statistics show meth lab busts ? have
decreased significantly? From July 2009 through February 2010,
607 meth labs were seized. From July 2010 to February Ý2011]
the number dropped to 203, a nearly 67 percent decrease."<10>
Meth Lab Incidents<11> in Oregon 2003-2010
Oregon Population: 2010: 3,831,074 (US Census Data)0.23 labs per
100,000
The following table illustrates data for California:
Meth Lab Incidents in California, 2003- 2010
California Population 2010: 37,253,956 (US Census Data)
0.45 labs per 100,000
14. Oregon Methamphetamine Situation: Concerns over Continuing
Demand for Methamphetamine; Mexican Drug Trafficking
Organizations; National Issues
Oregon Methamphetamine Issues since Enactment of Pseudoephedrine
Prescription Law
As long as demand for the drug is high, eliminating or reducing
---------------------------
<10> See
http://wcbi.com/article.php?subaction=showfull&id=1300296084&arch
ive=&start_from=&ucat=2,4,5 , 45&.
<11> A laboratory "incident" is defined by the DEA as including
labs, dumpsites and chemical or glassware seizures. Thus, the
number of laboratory incidents does not necessarily reflect the
number of labs actually producing methamphetamine.
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California manufacturing of methamphetamine arguably will not
diminish use if the drug remains available from other sources,
such as Mexico. For example, use of methamphetamine is still
quite prevalent in Oregon, despite a substantial decrease in
laboratory discoveries. The Oregon Addictions and Mental Health
Services Department website states: "For a decade, Oregon has
led the nation in methamphetamine-treatment admissions per
100,000 people; treatment admissions for methamphetamine are
second only to those for alcohol." However, in 2007, a year
after Oregon required a prescription for pseudoephedrine, the
Oregon Health Science University reported that emergency room
visits for meth were down from 2006-2007. While that data is
still widely cited, numerous reports found that meth from Mexico
had increasingly replaced locally made meth in Oregon by 2009.
That could affect more recent data.
The 2011 Threat Assessment by the Oregon High Intensity Drug
Trafficking Area (HIDTA) organization (a combination of federal
and state agencies) essentially found that abuse or
methamphetamine remained a very serious problem in Oregon. The
data was mixed and sometimes contradictory. For example,
methamphetamine prison sentences were up sharply, but arrests
were down. The report noted that arrests would be expected to
decline with a reduction in labs, as investigation of
trafficking of finished meth is much harder than making arrests
at labs.
WHAT IS THE OREGON EXPERIENCE WITH METHAMPHETAMINE AFTER
ENACTMENT OF A PRESCRIPTION REQUIREMENT FOR PSEUDOEPHEDRINE?
Concerns in the Midwest over Mexican Drug Trafficking
Organizations and Methamphetamine after Enactment of
Pseudoephedrine Restrictions
Policy changes resulting in an increased methamphetamine from
Mexico, even a law that reduces illicit laboratories, would have
adverse consequences. Law enforcement and media sources have
noted an increase in violence by Mexican drug trafficking
organizations (DTOs) in the United States and increased health
and social problems arising from very potent DTO product.
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(Mexican Drug Cartel Violence Spills Over, Alarming U.S., New
York Times, March 22, 2009.)
15. 2010 U.S. Department of Justice National Methamphetamine
Analysis: Dominance by Mexican DTOs, Reduced Domestic
Production
The 2010 U.S. DOJ Methamphetamine Threat Assessment was
published in the New York Times without release by the National
Drug Intelligence Center. The Times stated that the report was
likely not publicly released because of concerns over offending
the Mexican government. The Times stated that the assessment
"portrays drug cartels as easily able to circumvent the Mexican
government's restrictions on the importing of chemicals used to
manufacture meth, which has reached its highest purity and
lowest price in the United States since 2005." (U.S. Delays
Report tying Meth to Mexico, New York Times, June 8, 2010.)
The report noted increased smuggling of pseudoephedrine into
Mexico and use of non-pseudoephedrine methods of making
methamphetamine, particularly the P2P (phenyl-2-propanone)
method. P2P methamphetamine is less potent than methamphetamine
made with pseudoephedrine, thus reducing some of the harm caused
by methamphetamine abuse.
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The report states:
ÝM]ethamphetamine availability is high and increasing,
as evidenced by supplies of the purest methamphetamine
available in U.S. markets since 2005, at prices that
currently reflect a 5-year low. As Mexican
methamphetamine production increases ? domestic
production will decrease. Preliminary first-quarter
2010 data on methamphetamine laboratory seizures
reflect a downward trend in domestic production -- the
result of the restored availability of Mexico-produced
methamphetamine?. (DOJ 2010 Meth. Threat Assess.,
p.1, italics added.)
The amount of methamphetamine shipped into the U.S. by Mexican
DTOs in 2009 exceeded the amount shipped in 2005, the year that
pseudoephedrine restrictions began in Mexico. The DOJ
attributed much of the increase in Mexican production to the use
of the P2P method. However, The United Nations - International
Narcotics Control Board (INCB) - has noted that Mexican DTOs
have contracted with Asian pseudoephedrine manufacturers.
(Precursors, INCB 2008 Report, pp. 7-8.) The INCB reported that
Mexican DTOs established operations in Africa and the Middle
East to obtain precursors, with Mexico as the final destination.
(Precursors, INCB 2008 report, pp. 7-8.) Further, the 2009 DOJ
threat assessment noted that Mexican DTOs have little difficulty
obtaining pseudoephedrine in Central and South America. (2009
National Drug Threat Assessment, DEA, pp. 13-16.)
TO WHAT EXTENT IS DOMESTIC METHAMPHETAMINE PRODUCTION DECREASING
AS A RESULT OF METHAMPHETAMINE PRODUCED IN MEXICO?
16. Drug Demand and Treatment Issues
It has been argued that the only lasting solution for the
problems created by methamphetamine use and manufacturing is to
reduce demand through treatment. While funding for treatment
programs is very limited, it is also costly to incarcerate
methamphetamine offenders. UCLA analyzes the Substance Abuse
and Crime Prevention Act (SACPA - Prop. 36 in 2000). UCLA
researchers concluded that SACPA has save $2.00 for every $1.00
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spent on the program. Where a person completed the program,
every $1.00 spent saved $4.00. The UCLA researchers found that
progress has been made in treating methamphetamine abusers. The
2008 report concluded: "Proposition 36 substantially reduced
incarceration costs and resulted in greater cost savings for
some eligible offenders than for others." (UCLA SACPA Report,
2008, p. 11.)
SHOULD THE STATE CONCENTRATE METHAMPHETAMINE CONTROL EFFORTS ON
REDUCING DEMAND FOR THE DRUG?
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