BILL ANALYSIS Ó
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|Hearing Date:April 15, 2013 |Bill No:SB |
| |445 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 445Author:Price
As Introduced: February 21, 2013 Fiscal:Yes
SUBJECT: Pharmacies: advertising: controlled substances.
SUMMARY: Prohibits pharmacies from advertising the sale of controlled
substances.
Existing law:
1) Provides for the licensure and regulation of pharmacies,
pharmacists and wholesalers of dangerous drugs or devices by the
Board within the Department of Consumer Affairs (DCA).
2) Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a person
from furnishing any dangerous drug or device except upon the
prescription of a physician, dentist, podiatrist, optometrist,
veterinarian or naturopathic doctor. (Business and Professions
Code (BPC) § 4059)
3) Requires advertisements for prescription drugs to be limited to
quantities consistent with good medical practice and include the
strength, dosage form and effective dates of the advertised price.
(BPC § 4121)
4) Clarifies that the provisions do not apply to a hospital pharmacy
that is only accessible to hospital medical staff and personnel.
(Id.)
This bill: Prohibits an advertisement that promotes the sale or
dispensing of any controlled substances.
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FISCAL EFFECT: Unknown. This bill is keyed fiscal by Legislative
Counsel.
COMMENTS:
1. Purpose. The Author is the Sponsor of this bill. According to the
Author, there currently are no prohibitions on the advertisement of
controlled substances and this bill will play an important part in
limiting drug seeking behavior at pharmacies by prohibiting the
advertisement of controlled substances. The Author is concerned
about rising numbers of prescription drug abuse in California and
throughout the nation. The Author is also concerned that
concurrent with increased rates of prescription drug abuse there
are increased instances of crime, particularly robberies at
pharmacies, which are targeted for their inventories of
prescription painkillers, anti-anxiety drugs and other controlled
medications. National data shows that since 2006, pharmacy
robberies have increased 82%. Unfortunately, pharmacies have
become targets, often jeopardizing the safety of pharmacy staff and
patrons, for individuals seeking drugs for either personal use or
for sale on the streets (single pills can be worth up to $80 on the
black market).
These types of robberies have occurred in California as recently as
this year. In January, there were three separate pharmacy
robberies - two in South San Francisco and one in Amador County.
In the fall of 2010, there was a pharmacy robbery in Sacramento
County in which two pharmacy workers were shot and one ultimately
died.
2. Controlled Substances. Through the Controlled Substances Act of
1970, the federal government regulates the manufacture,
distribution and dispensing of controlled substances. The act
ranks into five schedules those drugs known to have potential for
physical or psychological harm, based on three considerations: (a)
their potential for abuse; (b) their accepted medical use; and, (c)
their accepted safety under medical supervision.
Schedule I controlled substances have a high potential for abuse
and no generally accepted medical use such as heroin, ecstasy, and
LSD.
Schedule II controlled substances have a currently accepted medical
use in treatment, or a currently accepted medical use with severe
restrictions, and have a high potential for abuse and psychological
or physical dependence. Schedule II drugs can be narcotics or
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non-narcotic. Examples of Schedule II controlled substances
include morphine, methadone, Ritalin, Demerol, Dilaudid, Percocet,
Percodan, and Oxycontin.
Schedule III and IV controlled substances have a currently accepted
medical use in treatment, less potential for abuse but are known to
be mixed in specific ways to achieve a narcotic-like end product.
Examples include drugs include Vicodin, Zanex, Ambien and other
anti-anxiety drugs.
Schedule V drugs have a low potential for abuse, a currently
accepted medical use and are available over the counter.
The three classes of prescription drugs that are most commonly
abused are: opioids, which are most often prescribed to treat pain;
central nervous system (CNS) depressants, which are used to treat
anxiety and sleep disorders; and, stimulants which are prescribed
to treat the sleep disorder narcolepsy and attention-deficit
hyperactivity disorder (ADHD). Each class can induce euphoria, and
when administered by routes other than recommended, such as
snorting or dissolving into liquid to drink or injection, can
intensify that sensation. Opioids, in particular, act on the same
receptors as heroin and, therefore, can be highly addictive.
Common opioids are: hydrocodone (Vicodin), oxycodone (OxyContin),
propoxyphene (Darvon), hydromorphone (Dilaudid), meperidine
(Demerol), and diphenoxylate (Lomotil).
3. Prescription Drug Abuse. For the past number of years, abuse of
prescription drugs (taking a prescription medication that is not
prescribed, or taking it for reasons or in dosages other than as
prescribed) to get high has become increasingly prevalent. Federal
data shows that the abuse of prescription pain killers now ranks
second, just behind marijuana, as the nation's most widespread
illegal drug problem. According to the 2008 National Survey on
Drug Use and Health (NSDUH), approximately 52 million Americans
aged 12 or older reported non-medical use of a psychotherapeutic at
some point in their lifetimes, representing 20.8% of the population
aged 12 or older. The National Institute on Drug Abuse's (NIDA)
research report, Prescription Drugs: Abuse and Addiction, states
that the elderly are among those most vulnerable to prescription
drug abuse or misuse because they are prescribed more medications
than their younger counterparts. Persons 65 years of age and above
comprise only 13 percent of the population, yet account for
approximately one-third of all medications prescribed in the United
States. Older patients are more likely to be prescribed long-term
and multiple prescriptions, which could lead to unintentional
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misuse. The report also notes that studies suggest that women are
more likely (in some cases, 55 percent more likely) than men to be
prescribed a prescription drug which potentially could be abused,
particularly narcotics and antianxiety drugs. A 2010 report,
Monitoring the Future Study, showed that as many as 4 percent of
high school students and 3 percent of young adults say they have
used OxyContin in the past year.
Abuse can stem from the fact that prescription drugs are legal and
potentially more easily accessible, as they can be found at home in
a medicine cabinet. Data shows that individuals who misuse
prescription drugs, particularly teens, believe these substances
are safer than illicit drugs because they are prescribed by a
health care professional and thus are safe to take under any
circumstances. NIDA data states that in actuality, prescription
drugs act directly or indirectly on the same brain systems affected
by illicit drugs, thus, their abuse carries substantial addiction
liability and can lead to a variety of other adverse health
effects.
The Senate Committee on Labor held a hearing on March 20, 2013
entitled, Opioids and the Workers Compensation System: A Discussion
on Mitigating Abuse and Ensuring Access, during which the committee
reviewed a series of studies conducted by the California Workers'
Compensation Institute (CWCI) which highlighted a rise in opiod
prescriptions by physicians in the state workers' compensation
system. The studies identified trends in widespread, potential use
of Schedule II drugs by patients with low back pain, significant
growth in the prescribing of all Schedule II drugs in the workers'
compensation system, and found that 6.7 percent of all
prescriptions in the system for the first half of 2011 alone were
for opiods.
4. Prescription Drug Deaths. A recent Centers for Disease Control
(CDC) analysis found that drug overdose deaths increased for the
11th consecutive year in 2010 and prescription drugs, particularly
opiod analgesics, are the top drugs leading the list of those
responsible for fatalities. According to CDC, 38,329 people died
from a drug overdose in 2010, up from 37,004 deaths in 2009, and
16,849 deaths in 1999. CDC found that nearly 60 percent of the
overdose deaths in 2010, involved pharmaceutical drugs, with opiods
associated with approximately 75 percent of these deaths. Nearly
three out of four prescription drug overdoses are caused by opioid
pain relievers. CDC recommends the use of Prescription Drug
Management Programs (PDMPs), with a focus on both patients at
highest risk in terms of prescription painkiller dosage, numbers of
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prescriptions and numbers of prescribers, as well as prescribers
who deviate from accepted medical practice and those with a high
proportion of doctor shoppers among their patients. CDC also
recommends that PDMPs link to electronic health records systems so
that the information is better integrated into health care
providers' day-to-day practices. CDC believes that state benefits
programs like Medicaid and workers' compensation should consider
monitoring prescription claims information and PDMP data for signs
and inappropriate use of controlled substances. The organization
also acknowledges the value of PDMPs in taking regulatory action
against health care providers who do operate outside the limits of
appropriate medical practice when it comes to prescription drug
prescribing.
A current Los Angeles Times series, "Dying For Relief," has
highlighted the role of prescription drugs in overdose deaths as
determined through the examination of coroners' reports. Reporters
conducted an analysis of coroners' reports for over 3000 deaths
occurring in four counties (Los Angeles, Orange, Ventura and San
Diego) where toxicology tests found a prescription drug in the
deceased's system, usually a painkiller, anti-anxiety drug or other
narcotic; coroners' investigators reported finding a container of
the same medication bearing the doctor's name, or records of a
prescription; the coroner determined that the drug caused or
contributed to the death. The analysis found that in nearly half
of the cases where prescription drug toxicity was listed as the
cause of death, there was a direct connection to a prescribing
physician. The Times created a database, the first of its kind,
linking overdose deaths to the doctors who prescribed drugs. They
also found that more than 80 of the doctors whose names were listed
on prescription bottles found at the home of or on the body of a
decedent had been the prescribing physician for 3 or more dead
patients. Their analysis found that one doctor was linked to as
many as 16 dead patients. The approach that these reporters have
taken is unique in that they are specifically talking about abuse
and subsequent death to patients taking drugs prescribed by their
doctors.
5. Prescription Drug Monitoring and CURES. With rising levels of
abuse, PDMPs are a critical tool in assisting law enforcement and
regulatory bodies with their efforts to reduce drug diversion.
Forty-nine states currently have monitoring programs. California
has the oldest prescription drug monitoring program in the nation.
Of these 50 programs throughout the nation, seven are or will be
housed at the state's Department of Justice, 18 are or will be
housed at a state Department of Health or substance abuse agency
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and 25 are or will be housed at a state Board of Pharmacy or state
professional licensing agency. There is currently momentum to
share data across these programs from state to state.
In California, the Controlled Substance Utilization Review and
Evaluation System (CURES) is an electronic tracking program that
reports all pharmacy (and specified types of prescriber) dispensing
of controlled drugs by drug name, quantity, prescriber, patient,
and pharmacy. Data from CURES is managed by DOJ to assist state
law enforcement and regulatory agencies in their efforts to reduce
prescription drug diversion. CURES provides information that
offers the ability to identify if a person is "doctor shopping"
(when a prescription-drug addict visits multiple doctors to obtain
multiple prescriptions for drugs, or uses multiple pharmacies to
obtain prescription drugs). Information tracked in the system
contains the patient name, prescriber name, pharmacy name, drug
name, amount and dosage, and is available to law enforcement
agencies, regulatory bodies and qualified researchers. The system
can also report on the following: (1) top drugs prescribed for a
specific time period;
(2) drugs prescribed in a particular county; (3) doctor prescribing
data; (4) pharmacy dispensing data; and, is a critical tool for
assessing whether multiple prescriptions for the same patient may
exist. CURES data can be obtained by the Medical Board of
California, Board of Pharmacy, Dental Board of California, Board of
Registered Nursing, Osteopathic Medical Board of California and
Veterinary Medical Board.
Since 2009, more than 8,000 doctors and pharmacists have signed up
to use CURES, which has more than 100 million prescriptions. The
system also has been accessed more than
1 million times for patient activity reports and has been key in
investigations of doctor shoppers and nefarious physicians.
According to the AG's office, CURES assisted in targeting the top
50 doctor shoppers in the state, who averaged more than 100 doctor
and pharmacy visits to collect massive quantities of addictive
drugs and the crackdown led to the arrest of dozens of suspects.
CURES also provided information with the prescribing history of a
Southern California physician accused of writing hundreds of
fraudulent prescriptions to feed his patients' drug addictions,
seven of whom died from prescription-drug overdoses. The system
has also been successful in alerting law enforcement and licensed
medical professionals to signs of illegal drug diversions,
including a criminal ring that stole the identities of eight
doctors, illegally wrote prescriptions, stole the identities of
dozens of innocent citizens who they designated as patients in
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order to fill the fraudulent prescriptions, resulting in the group
obtaining more than 11,000 pills of highly addictive drugs like
OxyContin and Vicodin.
6. Related Legislation. SB 62 (Price) requires coroner's reports to
be transmitted to various health practitioner boards in the event
that cause of death is determined to be prescription drug overdose.
The bill is also up for consideration in this Committee today.
SB 670 (Steinberg) provides the Medical Board of California with
additional authority to inspect medical records and to limit the
prescribing ability of physicians during a pending investigation if
there is a reasonable suspicion the physician has engaged in
overprescribing of controlled substances that resulted in a
patient's death. The bill is also up for consideration in this
Committee today.
SB 809 (DeSaulnier and Steinberg) is an urgency measure that makes
various changes to the funding and operation of the Controlled
Substances Utilization Review and Evaluation System (CURES)
Prescription Drug Monitoring Program (PDMP) including the
following:
(1) requiring practitioners and pharmacists to enroll in and
consult the CURES PDMP;
(2) increased licensing fees for prescribing health practitioners,
dispensers and wholesalers of controlled substances for the purpose
of providing ongoing funding to maintain the CURES PDMP; (3) a
one-time tax assessment on health insurance plans and workers
compensation insurers to fund the CURES modernization upgrade; and,
(4) annual taxes on drug manufacturers of Schedule II, III, and IV
controlled substances doing business in California to maintain the
CURES PDMP. The bill is also up for consideration in this
Committee today.
SUPPORT AND OPPOSITION:
Support:
None on file as of April 9, 2013
Opposition:
None on file as of April 9, 2013
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Consultant:Sarah Mason