BILL ANALYSIS �
-----------------------------------------------------------------------
|Hearing Date:May 2, 2011 |Bill No:SB |
| |632 |
-----------------------------------------------------------------------
SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 632Author:Emmerson
As Amended:March 24, 2011 Fiscal: Yes
SUBJECT: Pharmacy.
SUMMARY: Prohibits a pharmacist from substituting "tamper resistant"
opioid analgesics, as defined, for other drug products, including
generic drugs, if the prescription orders one of the "tamper
resistant" types opioid analgesics. Requires the Board of Pharmacy
(Board) to establish a list of "tamper resistant" opioid analgesics
according to certain qualifications. Authorizes a pharmacist to
substitute a prescribed opioid analgesic for one that is on the list
created by the Board. Requires a pharmacist to obtain consent from a
physician or surgeon via phone or other electronic communication prior
to a substitution, if the opioid analgesic is not on the Board's list.
Existing law, The Pharmacy 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, or
veterinarian. (Business and Professions Code (BPC) � 4059)
3) Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to substitute
generic drugs for orders if the generic contains the same active
chemical ingredients of equivalent strength and duration of
therapy, subject to a patient notification and bottle labeling
SB 632
Page 2
requirement, unless the prescriber specifies that a pharmacist may
not substitute another drug product by either indicating on the
form submitted for the filling of the prescription drug orders "Do
not substitute" or words of similar meaning or selecting a box on
the form marked "Do not substitute". (BPC � 4073)
4) Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to substitute a
drug product with a different form of medication with the same
active chemical ingredients of equivalent strength and duration of
therapy as the prescribed drug product when the change will improve
the ability of the patient to comply with the prescribed drug
therapy, subject to a patient notification and bottle labeling
requirement, unless the prescriber specifies that a pharmacist may
not substitute another drug product by either indicating on the
form submitted for the filling of the prescription drug orders "Do
not substitute" or words of similar meaning or selecting a box on
the form marked "Do not substitute". (BPC � 4052.5)
This bill:
1)Sets forth findings and declarations detailing the use and abuse of
pain management drugs as follows: (1) The potential misuse for
opioids has long been a concern of manufacturers, law enforcement,
health care providers, legislators and regulators; (2) Addicts crush
or break time-released capsules into a form that can be snorted or
injected for a more intense high;
(3) Formulations that make it more difficult to crush these products
may mitigate the potential for abuse; (4) Pharmaceutical
manufacturers have invested resources in creating new technologies
that may deter inappropriate use of medications; (5) The Food and
Drug Administration (FDA) is reluctant to claim that opioids with
"tamper resistant" technologies mitigate the potential for abuse
without additional research which takes many years; (6) The
Legislature should approve policies that encourage manufacturers to
develop "tamper resistant" opioid products; (7) Health care
providers should have the ability to write prescriptions for tamper
resistant opioid products when those prescriptions are medically
necessary.
2)Defines "opioid analgesic drug" as a drug in the opioid
analgesic drug class prescribed to treat moderate to severe pain
in immediate or extended release form that may or may not be
combined with other drug substances to form a single tablet or
other dosage form.
3)Defines "opioid analgesic drug incorporating a tamper resistant
SB 632
Page 3
technology" as one on a list created by the Board.
4)Requires the Board to create a list (Board list) of opioid
analgesic drugs that incorporate a "tamper resistant" technology
according to the following:
a) The drug manufacturer or distributor submits evidence to
the Board that the opioid analgesic drug incorporates a
"tamper resistant" technology.
b) The drug is FDA approved, pursuant to an application with
at least one study on human tampering or abuse potential or a
laboratory study comparing the tamper or abuse resistance of
the drug to one or more other opioid analgesic drugs approved
by the FDA.
5)Requires the Board list to include a determination of which
opioid analgesic drugs with "tamper resistant" technology
provide substantially similar tamper resistant properties, based
solely upon studies submitted by the drug manufacturer.
6)Specifies that drugs on the Board list do not have to have a
label claiming reduction of tampering, abuse or potential abuse.
7)Allows a pharmacist to substitute an opioid analgesic drug brand
or generic for another opioid analgesic drug only if it is on
the Board list.
8)For opioid analgesic drugs not on the Board list, requires a
pharmacist to obtain written or electronic consent from the
prescribing physician and surgeon to substitute drugs.
FISCAL EFFECT: Unknown. This measure is keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1. Purpose. This bill is sponsored by Endo Pharmaceuticals .
According to the Author, current law recognizes differences between
long-acting and short-acting forms of medications with the same
chemical ingredients but substitution between these can occur. The
Author states that this bill is "necessary to prevent non
tamper-resistant drugs from being substituted for those drugs that
are prescribed that incorporate a tamper-resistant technology."
The Author believes that through this bill, which promotes the use
SB 632
Page 4
of tamper-resistant opioid analgesics, it is possible to reduce the
abuse of these drugs by those who crush pills into a powder form
and attempt to either snort or inject the product. The Author
asserts that "studies show that people who divert from the intended
purpose of the drugs often crush pills into a powder form to allow
for snorting or other abuse. By doing this the body absorbs the
chemical ingredients more rapidly, resulting in an increased
euphoria."
2. Rising Rates of Prescription Drug Abuse. For the past number of
years, abuse of prescription drugs (taking a prescription
medication that is not prescribed for you, or taking it for reasons
or in dosages other than as prescribed) to get high has become
increasingly prevalent. Federal data shows in the past year 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 any 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 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 an abusable prescription drug, 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
SB 632
Page 5
liability and can lead to a variety of other adverse health
effects.
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 inject, can
intensify that sensation. Opioids, in particular, act on the same
receptors as heroin and, therefore, can be highly addictive.
Common opioid are: hydrocodone (Vicodin), oxycodone (OxyContin),
propoxyphene (Darvon), hydromorphone (Dilaudid), meperidine
(Demerol), and diphenoxylate (Lomotil).
3. Development of Tamper Resistant Formulations for Drugs. Research
shows that sales of prescription opioids surged to $6.37 billion in
2009 last year, a 52 percent gain from 2002. Use of these drugs
has many legitimate purposes, including pain management for
sufferers of chronic pain as well as pain related to cancer and the
treatments for cancer and disease.
A number of the opioid manufacturers have developed and are in the
process of implementing new technology aimed at preventing the
manipulation of drugs for purposes of abuse. This "tamper" or
"abuse" resistant technology seeks to limit the effects of certain
products when they are crushed or dissolved; common actions taken
by prescription drug abusers seeking a more immediate high. There
are a number of different "tamper resistant" formulations used on
some of the most commonly abused medications, including:
The newly designed polymer system for OxyContin, developed by
manufacturer Purdue, makes it more difficult for addicts to
crush, melt, or inject the pill. When the new formulated pill is
mixed with water, it becomes a sticky gel that is difficult to
inject. Additionally, the polymer is able to still surround the
active ingredient even when forcefully crushed.
A formulation for Remoxy developed by Pain Therapeutics, King
Pharmaceuticals and Pfizer contains oxycodone in a manner
designed to make it more difficult to manipulate. A gummy pill
becomes gooey in solvents such as water or alcohol, making it
difficult to convert into a form that can be injected or snorted.
SB 632
Page 6
Embeda contains an inactive drug within the active morphine
pill that counteracts the effects of the active drug if is
tampered with. The extended-release morphine pill has a kernel
of sequestered naltrexone, an opioid receptor antagonist that
competes for and prevents the binding of morphine, in the center.
When taken as directed, Embeda's long acting pellets release
morphine, while the naltrexone core passes out of the body
without effect. If Embeda is crushed, chewed or extracted, the
naltrexone releases and mixes with morphine and neutralizes its
effects.
Acurox, a short-acting oxycodone formulation, was developed by
Acura Pharmaceuticals and King Pharmaceuticals in a formulation
composed of gel forming agents to make it more difficult to
dissolve and subsequently inject. Acurox also contains nasal
tissue irritants that discourage snorting. A previous version of
Acurox contained niacin, a vitamin that causes flushing if taken
in excess so that if potential abusers sought to get high from
swallowing excessive tablets, the dose of niacin would cause
flushing but was rejected by the FDA.
1. The Prescription Drug Pinch on Californians' Wallets. Costs of
prescription medication have skyrocketed over the past number of
years. According to a 2008 report issued by the Kaiser Family
Foundation on prescription drug trends, spending in the U.S. for
prescription drugs was $216.7 billion in 2006, more than 5 times
the $40.3 billion spent in 1990. In response, many consumers are
turning to a variety of methods to reduce their prescription costs
including requesting cheaper drugs or generic drugs from their
physicians and pharmacies, using the Internet and other sources to
make price comparisons, using the Internet to purchase drugs,
buying at discount stores, buying over-the-counter instead of
prescribed drugs, buying drugs in bulk and pill-splitting, using
mail-order pharmacies, and using pharmaceutical company or state
drug assistance programs. The report stated that 62% of physicians
say they switch patients to less expensive drugs after discussing
out-of-pocket costs of medicines with patients. This financial
burden leads to many patients with legitimate chronic illnesses to
forgo prescribed medications and adversely affect their health.
California, with its 7 million uninsured, has the largest total
number of uninsured residents in the nation; a situation
exacerbated by the economic downturn and rising unemployment.
These individuals without drug coverage are especially hard hit by
rising costs of prescription drugs. Many uninsured patients, even
if they are able to finally see a doctor, do not fill a needed
SB 632
Page 7
prescription due to the cost.
2. Arguments in Support. According to the Sponsor, Endo
Pharmaceuticals , formulations that make it more difficult to crush
or otherwise manipulate drug products mitigate their potential for
abuse. The Sponsor states that SB 632 protects health care
providers' ability to prescribe a drug without it being
substituted.
Reckitt Benckiser Pharmaceuticals, Inc. , supports this bill,
stating that it institutes procedures that will decrease the risks
associated with misuse, abuse and diversion of certain opioid
analgesic drugs.
3. Arguments in Opposition. The California Association of Health
Plans (CAHP) is opposed to SB 632, stating that the price
disparities between brandname and generic drugs can be vast and
that the national average price of a brandname drug (where a
generic is available) is $171.94 while the national average price
of a generic drug is $22.29. CAHP believes this cost difference
incurred by consumers a4.nd payers would be substantial with this
bill. CAHP also notes that current law already allows a prescriber,
when issuing prescriptions to patients, to indicate whether a
pharmacist may or may not engage in generic substitution.
The California Pharmacists Association (CPhA) opposes this bill,
noting that this legislation "would, in essence, create a
prescribing system that prioritizes these tamper resistant drugs
over their less costly, FDA-approved, therapeutically equivalent
counterparts" and that by doing so, the measure would impede access
and substantially increase consumers' and the state's growing
medical costs. CPhA believes that this bill will add another step
to the process of substituting generics by requiring a pharmacist
to receive signed confirmation that substituting a non-tamper
resistant generic drug would be acceptable, resulting in less time
for a pharmacist to spend with a patient and additional wait times
for patients.
The California Retailers Association (CRA) and National Association
of Chain Drug Stores (NCADS) write in opposition to this bill,
arguing that it negatively impacts patient care, creates
unnecessary provider requirements, increases general health care
costs and assigns the Board a task that is beyond their mission,
authority and expertise.
CVS/Caremark , one of the nation's largest pharmacy benefit
SB 632
Page 8
management companies states that prescribers make the determination
as to whether a pharmacist may substitute for a generic and there
is no benefit or improvement in care achieved by requiring a
pharmacist to contact a prescriber to obtain consent to substitute.
CVS believes this bill creates barriers that unnecessarily
increase patient and overall health care costs.
Rite Aid believes this bill interferes with the federal regulatory
process, infringes upon a pharmacist's professional training and
judgment and imposes new responsibilities on the Board.
Teva Pharmaceuticals, USA , the largest generic pharmaceutical
manufacturer in the U.S., argues that his bill will not serve the
purpose outlined in the bill's findings and declarations but will
actually limit access to medications for suffering patients. Teva
adds that the purpose of this bill is to protect brand products
market share from generic competition which harms patients.
5. Policy Issues and Questions .
a) Use of term "Tamper resistant" is problematic. This bill uses
the term "tamper resistant", which is not defined, to capture
certain products as those described above. Terms like "tamper
resistant," "abuse resistant" or "abuse deterrent" are used
interchangeably, but are not defined as such by the FDA. Use of
the term in California statute may be premature until an accepted
and uniformly used defined term is established to describe these
technologies. Additionally, "tamper resistant" is typically used
to refer to drug packaging , rather than the formulation of drugs.
Use of the term "tamper resistant" in California statute alone
to describe drug product may cause confusion. The codification
of this term may also have the unintended consequence of
preventing future technologies, which may be labeled something
else, from being on the Board's list and available to consumers.
b) Restriction on substitution of specified opioid analgesic
drugs may be unnecessary. This bill may be unnecessary to ensure
that certain drugs are not substituted by pharmacists. Current
law already authorizes providers to specify "Do Not Substitute"
if they believe a certain type of drug is necessary. A health
care provider who has an established relationship with a patient
is already able to determine if certain drugs, or certain
formulations of drugs would better suit that patient and can
specify such on a prescription order. Providers also have the
ability to gain additional awareness about their patients as it
relates to controlled substances through the Attorney General's
SB 632
Page 9
Office of Bureau of Narcotic Enforcement, Controlled Substance
Utilization Review and Evaluation System (CURES), which recently
launched a real-time access Prescription Drug Monitoring Program
(PDMP) allowing access to data about use of controlled
substances.
c) This measure may raise costs to consumers for specified drugs.
As discussed above, Californians experience tremendous costs for
prescription drugs. This bill may increase costs for consumers
and other vulnerable populations such as seniors and economically
disadvantaged families by removing the ability for pharmacists to
substitute generic drugs which are typically much less expensive
than their brand name counterparts. In discussions with
Committee staff, the Sponsor noted that the difference may only
be $10 or $20 per prescription, but even that amount may have
great impacts on certain groups and communities in the state.
d) This measure may be premature since it is not clear from FDA
what impact "tamper resistant" opioid analgesic drugs will have
on human tampering or abuse potential. The FDA has not yet ruled
on the impact that these new technologies will have in terms of
minimizing abuse potential, nor has the organization ruled to
allow manufacturers to include labeling on "tamper resistant"
products asserting their ability to minimize abuse potential.
Language in the bill states that the FDA has not determined
whether "tamper resistant" formulations actually mitigate the
potential for abuse, pending additional research and studies so
it may be difficult for the Board to implement this measure in
California. The Board will be relied upon to determine, prior to
formal FDA advice, what products are in fact "tamper resistant"
and eligible for the Board's list. Circumventing the FDA and
allowing for approval as "tamper resistant" only in California
may not be appropriate at this time.
e) This measure may create a more competitive advantage in
California for certain pharmaceutical manufacturers. Without
specifying certain technology in California, the market may
naturally give an advantage to certain, more preferable types of
drugs. While California has a long history of success and
promoting research and development of manufacturing, this bill
creates a preference for a select number of manufacturers that
may not be appropriate to codify nor necessary given the
advantage superior products will naturally gain in the
marketplace.
SB 632
Page 10
SUPPORT AND OPPOSITION:
Support:
Endo Pharmaceuticals (Sponsor)
Reckitt Benckiser Pharmaceuticals, Inc.
Opposition:
California Association of Health Plans (CAHP)
California Pharmacists Association (CPhA)
California Retailers Association (CRA)
CVS/Caremark
Express Scripts Inc.
National Association of Chain Drug Stores (NACDS)
Rite Aid
Teva Pharmaceuticals
Consultant: Sarah Mason