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Rx substitution by pharmacists-State Legislation

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Condition-specific Drug Substitution Legislation: Epilepsy

 

Published May 2009; Updated March 2013

The issue of prescription drug substitution - using a generic product to replace a brand name product, or using a brand name when an exact generic is available - has been a an issue for state legislatures for more than a decade.  The actual medical efficacy and equivalency of individual pharmaceutical products is primarily the responsibility of the U.S. Food and Drug Administration (FDA).  The FDA promulgates official lists of drugs that are chemically equivalent and separately those that are therapeutically equivalent.

For certain medical conditions, there continue to be debates and legislative initiatives, to specify the use of particular drugs, brand name or generics.  It some cases legislation seeks to encourage, facilitate or prefer use of generic substitutes or replacements.  In other cases legislation seeks to protect original brand name products from substitution of a generic by a different manufacturer.

NEW: The federal Affordable Care Act of 2010 now requires Medicare requires coverage of all drugs for six treatment classes. [Reported below]

Between 2007 and 2011 at least 24 states had about 40 pieces of legislation specific to drugs prescribed for epilepsy or for the treatment of seizures.  A common example of such legislation includes:

 

  Would prohibit a pharmacist from substituting or interchanging any anti-epileptic drug, brand or generic, without notification to both the prescribing physician and the patient or the patient's representative.   Variations include
1) requiring written consent from the prescriber
2) requiring written and/or signed and/or informed consent from the patient.
 

Other Substitution Restriction Bills

Another 29 bills filed for 2007-08 sought to carve out immunosuppressant drugs commonly used for transplant patients.  The discussion of these or similar bills naming specific medical conditions bring the actual practice of medicine into state capitols, with legislators implicitly asked to practice a kind of medicine.  At the same time, patient advocacy organizations and patients themselves sometimes seek such change as a consumer protection or right.

2013 Legislation: A new trend focused on biological medicines

With the growing use of "biologics," which are complex and costly specialty drugs generally manufactuered from live cells rather than chemical pills, there is some concern about the future substitution of one biologic, perhaps a generic copy, instead of the original.  As a result, there is a new wave of bills filed for 2013 session seeking to define and in part restrict the substitution of a "biosimilar" or generic version of one product for another.  As of 2013, there are no such generic or biosimilar products approved for sale in the United States.  However, the filed legislation is in anticipation of future approval by the FDA.  As of early March there are bills proposed in at least 17 states, including a total of 24 bills.

Background: Regulations for Biosimilars: As biologic drug patents begin to expire, generic versions will hit the market—but how will they be regulated? The Scientist, June 2012
 

Signed laws Restricting Epilipsy Drug Substitution: 

  • Hawaii was the first state to pass a signed law, in 2003.
  • Illinois (2007) rejected the "model" restriction, and substituted a policy  based on a doctor's initial conclusion, stating that only if prescribing physicians write "may not substitute" on the original prescription, pharmacists must obtain prescriber and patient consent; passed in October 2007. 
  • Tennessee  enacted a notification to prescriber and patient law in June 2007. 
  • Utah enacted a notification to prescriber law in March 2008.

EPILEPSY:

Approximately 3.2 million Americans suffer from Epilepsy, including 40% who are women of childbearing age.

 

ARCHIVE Epilepsy Drug Substitution Bills, 2007-2010:  Legislation: 


As of  2010, 13 bills on restricting substitution of epilepsy brand name drugs had been filed in eight states (CT, GA, IA, MA, MI, MN, NJ & NY) while another five states are considering restricting switches of immunosuppressants (FL, GA, IL, MA & TN).
State

Description/ Summary/ Status

Sub-topics

AL
H 429, S 302
Sen. Coleman

Would prohibit a pharmacist from substituting or interchanging any anti-epileptic drug, brand or generic, without notification to both the prescribing physician and the patient or the patient's representative.          
(Failed to pass by end of 2008 session)

Brand, Generic,
Epilepsy

AL
HJR 597
Rep. Johnson
 
Epilepsy Patients and Medication Interchange Joint Interim Legislative Commission, established to study all facets of the issues involving the protection of epilepsy patients from medication interchange.
(Adopted and signed by Governor, 5/19/08)
Epilepsy
AK
HB 208, S 114
Committees
 
Would prohibit a pharmacist from substituting or interchanging an equivalent drug product for a drug prescribed for epilepsy or for the treatment of seizures unless the pharmacist first obtains the oral or written agreement of the prescriber.
(Failed to pass by end of 2008 session)

Brand, Generic,
Epilepsy

CA
SB 1504
Sen. Ridley-Thomas
Would prohibit a pharmacist filling a prescription order for an anti-epileptic drug, prescribed by its trade, brand, or generic name for the treatment of prevention of epileptic seizures, from substituting a drug product without prior notification of the prescriber and the signed consent of the patient.
(Filed  2/21/08; failed to pass by end of 2008 session)

Brand, Generic,
Epilepsy

CO
H 1262
Rep. Kerr
Would allow a pharmacist who is filling a prescription for the treatment of epilepsy to substitute the prescribed drug with an equivalent drug product only with authorization from the prescribing physician and patient.
(Filed and sent to committee 1/31/08; failed to pass by the end of 2008 session)

Brand, Generic,
Epilepsy

CT
S 654
Would prohibit a pharmacist from substituting or interchanging an equivalent drug product for a drug prescribed for epilepsy or for the treatment of seizures unless the pharmacist first obtains the oral or written agreement of the patient's prescriber.
(Filed  3/6/08; amended and passed Senate 4/30/08; did not pass House by end of 2008 session)
 Brand, Generic,
Epilepsy
FL
H 811, S 2414
Sen. Rich
Would prohibit a pharmacist from interchanging an anti-epileptic drug without prior notification and consent from the prescribing practitioner and the patient or the patient's parent, guardian.
(Died in committee 5/2/08)
 Brand, Generic,
Epilepsy
GA
H 127
Rep. Byrd
Would prohibit a pharmacist from substitution of anti-epileptic drugs except under certain conditions.
(Filed and sent to committee 1/24/07; carried over to 2008 and resent to committee 1/14/08; did not pass by end of '08 session)
 Brand, Generic,
Epilepsy
HI
§328-92
§328-92 Drug product selection (3)(c) "The pharmacist shall not substitute an equivalent generic drug product for any prescription for an anti-epileptic drug, except upon the consent of the practitioner and the patient or the patient's parent or guardian. This narrow exception for epileptic patients shall not be construed as a policy decision to make exceptions for any other conditions." (Enacted as 2003, c 56, §6) Brand, Generic,
Epilepsy

IL
S 509
Sen. Link

When the prescribing physician has indicated on the original prescription "may not substitute", prohibits a pharmacist from interchanging an anti-epileptic drug for the treatment of epilepsy without notification and documented consent of the prescribing physician and the patient or the patient's parent, legal guardian, or spouse.
     Restates as policy that, otherwise, “a generic drug determined to be therapeutically equivalent by the United States Food and Drug Administration (FDA) shall be available for substitution.”
(Filed and sent to committee 2/8/07; passed Senate and House, signed into law by governor as Public Act No. 95-689, 10/29/07)

Brand, Generic,
Epilepsy

IA
HSB 172,
HSB 626,
SSB 1154
House Veterans Affairs

Would prohibit a pharmacist from interchanging an anti-epileptic drug prescribed for the treatment of seizures, including epilepsy, without prior notification of and the signed informed consent of that selection from both the authorized prescriber and the patient or the patient's representative.
(Filed and sent to committee 2/12/08; did not pass by the end of 2008 session)

Brand, Generic,
Epilepsy

KS
H 2907
House Health and Human Services

Would prohibit a pharmacist from interchanging an anti-epileptic drug, brand or generic, for the treatment of seizures or epilepsy without prior notification of and the signed informed consent of such interchange from the prescribing physician and patient, or the patient's parent, legal guardian or spouse.

(Filed and sent to committee 2/15/08; failed to pass by the end of 2008 session)

Brand, Generic,
Epilepsy

LA
H 660

Would prohibit a pharmacist from interchanging an anti-epileptic drug for the treatment of epilepsy without the prescribing physician or patient, or a patient's parent, legal guardian, or spouse, be notified by a pharmacist prior to any interchange.

(Filed and sent to committee 5/13/08; failed to pass by the end of 2008 session)

Brand, Generic,
Epilepsy

LA
HCR 198
Rep. Henry
Concurrent  non-binding resolution to urge and request the Louisiana Board of Pharmacy to convene its Regulation Revision Committee to consider changes to the rules and regulations of the board to expressly prohibit a pharmacist from interchanging an antiepileptic drug or a formulation of an antiepileptic drug for the treatment of epilepsy without the prior notification of both the prescribing physician and the patient.
(Adopted by House and Senate 6/11/08)
Epilepsy

MA
S 1296
Sen. Moore

Would prohibit a pharmacist from interchanging an anti-epileptic drug, brand or generic, for the treatment of seizures (epilepsy) without prior notification of and the signed informed consent of such interchange from the prescribing physician and patient, or patient's parent, legal guardian or spouse of such person.”
(Filed 1/10/07; held in committees 11/5/07; failed to pass by the end of the 2008 session)

Brand, Generic,
Epilepsy

MI
H 5077,
S 926
Rep. Espinoza,
Sen. Gleason

Would prohibit a pharmacist from interchanging an anti-epileptic drug, brand or generic, for the treatment of epilepsy without prior notification of and the signed informed consent to the interchange by the prescribing physician and patient or the patient's parent, legal guardian, spouse, or other legal representative.
(Filed and sent to committee 8/1/07, 11/29/07; failed to pass by the end of 2008 session)

Brand, Generic,
Epilepsy

MN
H 2510
Rep. Abeler

Would prohibit a pharmacist from interchanging an anti-epileptic drug, brand or generic, for the treatment of epilepsy without prior notification of and the signed informed consent to the interchange by the prescribing physician and patient or the patient's parent, legal guardian, spouse, or other legal representative.
(Filed and sent to committee 1/28/08; failed to pass by the end of 2008 session)

Brand, Generic,
Epilepsy

MO
H 1879,
S 1094
Rep. Sutherland,
Sen. Loudon

Would prohibit a pharmacist from interchanging an anti-epileptic drug.
(Referred to committee 2/28/08; S 1094 placed on informal calendar 5/16/08; failed to pass by the end of 2008 session)

Brand, Generic,
Epilepsy

NE
LB 631
Would prohibit a pharmacist from interchanging an anti-epileptic drug without prior notification and the signed, informed consent of the prescribing practitioner and the patient or the patient's parent, legal guardian, or spouse.
(Filed 1/17/07; did not pass by end of regular session 5/31/07) |
 

NY
A 9303,
S 5016
Sen. Hannon

Would prohibit a pharmacist from substituting any anti-epileptic drug for the prescribed anti-epileptic drug without notification of and the informed consent of the prescriber and patient or such patient's parent, guardian or spouse.
(Filed 6/20/07;A 9303 held in committee 6/08; S5016 referred to committee 1/9/08; failed to pass by the end of 2008 session

Brand, Generic,
Epilepsy

OH
H 99,
S 114
Sen. Coughlin

Would prohibit a pharmacist from substituting or interchanging a prescribed epilepsy drug without notifying the prescriber and receiving a signed statement consenting to the interchange from the prescriber and either the patient or the patient's parent, legal guardian, or spouse.
(Filed 3/6/07; failed to pass by the end of 2008 session)

Brand, Generic,
Epilepsy

PA
HB 98,
SB 119

Would prohibit a pharmacist from substituting or interchanging a prescribed epilepsy drug; Requires notification and signed, informed consent of from the physician and patient or patient's parent or guardian.
(Filed 3/7/07; HB 98 - sent to committee 9/15/08; SB 119 - referred to committee 3/7/07; failed to pass by the end of the 2008 session)

Brand, Generic,
Epilepsy

SD
H 1311
Rep. Pitts

Would prohibit a pharmacist from substituting or interchanging anti-epileptic drugs without prior notification and consent.
(Filed 1/23/08; did not pass by the end of the 2008 session)

Brand, Generic,
Epilepsy

TN
HB 121,
SB 442
Rep. DeBerry

Requires notification of patient and prescriber before interchanging or substituting for a prescribed anti-epileptic drug; violation is a misdemeanor.  Effective date 7/1/2007.  An initial requirement for consent from patient and provider was deleted from the final bill.
(Filed 1/30/07; HB 121 passed House 95y-1n, 4/30/07; passed Senate 5/14/07; signed into law by governor as Chapter 370, 6/7/07)

Brand, Generic,
Epilepsy

UT
H 361
Rep. Hutchings
Requires a pharmacist or pharmacy intern who substitutes a drug product equivalent for an epilepsy drug prescribed to a patient to treat or prevent seizures to notify the prescribing practitioner prior to the substitution.
(Filed 1/31/08; signed into law by governor  3/17/08)
 
Brand, Generic,
Epilepsy
WI
A 150,
S 71
Would prohibit a pharmacist from substituting a drug product equivalent if the drug prescribed is a drug for treating epilepsy or for treating convulsions, unless the pharmacist obtains and documents the consent of the prescribing practitioner and the patient or the patient's parent, spouse, or legal guardian.  Refills also require the same drug product, from the same manufacturer.
(Filed 2/26/07; carried over; did not pass by end of 2008 session)
 Brand, Generic,
Epilepsy

WY
HB 317
Rep. Millin

Would prohibit the substitution of any anti-epileptic drug, prescribed for the treatment of seizures, without the written consent of the prescribing physician.
(Filed 1/07; Died in committee 2/28/07)

Brand, Generic,
Epilepsy

       Note: List may not be comprehensive, but is representative of state laws that exist.  NCSL appreciates additions and corrections.

The Federal Affordable Care Act (ACA) of 2010  (updated December 2010)

The federalhealth reform law has a separate provision for Medicare Part D benefits that requires coverage of all drugs for six treatment classes: anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants for the treatment of transplant rejection.’’

PRO AND CON ARGUMENTS ON SUBSTITUTION     
(Excerpt from Alabama legislative and media debate)

 

 CON ARGUMENTS (In favor of adding some restrictions to the use of generics instead of brand-name products)  PRO ARGUMENTS  (In favor of existing laws allowing substitution and use of generics)
 
The Pharmaceutical Research and Manufacturers of America (PhRMA) strongly believes that the final decision on all drug selection (brand or generic) should be left up to a patient's prescribing physician, not government or health plans. The use of pharmacy benefit management techniques, such as mandatory generics and step therapy, has been in use for well over two decades and everyone in the field is keenly aware of the pros and cons of all those techniques.
 
• PhRMA believes in the appropriate use of generic drugs - generics are, after all, copies of drugs that have reached the end of their patent life after being developed by research-based pharmaceutical and biotechnology companies. For many patients, generic drugs can provide the appropriate therapy. However, there is indeed variability within the chemical makeup of a generic drugs that is permitted by the FDA, and the patient and physician groups that have begun advocating for improved therapeutic options (brand or generic) within certain disease states have not chosen to take on these issues arbitrarily or lightly. The advocacy of those patients and doctors is a direct result of what they have seen in patient health outcomes in certain disease states over the past two decades.
 
• In the 25 years since the passage of the Hatch-Waxman amendments in 1984, use of generic drugs nationally has increased to more than 70 percent. For every generic drug in the market there are numerous manufacturers of those generics and each of those manufacturers creates a generic product that, while within the bioequivalence standards of the FDA, may be slightly different from other generics. For those physicians treating patients who suffer from diseases with high levels of sensitivity to drug dosing regimens, many feel that this variability does patients harm and the consistent switching of patients between different versions of a drug by both health plans and pharmacies can present significant risk for patients.
 
• Prescription drugs are intended to provide a therapeutic benefit to patients. They should not be viewed as a commodity where the cheapest option offered is the default for a pharmacy and a health plan. Prescription drugs are a key part of a patient's therapeutic regimen and should be treated with careful consideration. Physicians should be permitted flexibility in their drug prescribing options to ensure that their patients are treated in the most appropriate manner.
  
Provided by PhRMA 5/13/2009

Pharmacetical Care Management Association (PCMA)

Proposed carve-out measures would prevent pharmacists from substituting a generic for its brand equivalent in certain drug classes unless consent is first obtained from the prescriber, even when the prescriber has not indicated that the brand is medically necessary. Some proposals go further and require pharmacists to maintain written documentation of contacts with prescribers to obtain consent. Such time-intensive requirements could cause harmful delays in the delivery of patient care and impose costly administrative burdens on prescribers and pharmacists. Therefore, this type of legislation is not only redundant and unnecessary, it impedes patient access to safe and affordable generic drugs.


Since Congress passed legislation creating a streamlined approval process for generic drugs in 1984, the FDA has approved thousands of generic medications, all of which are manufactured and inspected under the same strict quality guidelines as brands. Prior to 1984, all products evaluated by the FDA had to undergo extensive clinical trials even if they contained exactly the same active ingredient as an already-approved product.


Generic Carve-Out Legislation Contradicts FDA Policies The FDA has repeatedly emphasized the safety and substitutability of generic drugs and encourages their use. Generic carve-out legislation runs counter to these policies.

 

-Report publlished September 2008

Alabama Legislative Debate:
To Restrict Substitutions
Alabama Legislative Debate:
To Allow Substitutions
     Advocates for epilepsy patients are promoting a bill in the health committee of the Alabama House that would require pharmacists to notify patients and their physicians before substituting generic versions for brand-name anti-epilepsy drugs.
     Mitch Garrett, executive director of the Epilepsy Foundation of Alabama, says notification of patient and doctor is important because epilepsy patients are especially sensitive to small changes in their drugs and could suffer dangerous seizures as a result. If a generic is chosen for cost savings, the doctor should know to check the level of medication in the patient's blood.  "You have to maintain certain levels in your bloodstream," Garrett said. "Even subtle changes can lead to breakthrough seizures or side effects."
     Timothy Welty, a Samford University pharmacy professor, said insurance companies often pressure doctors to write the prescription indicating that generics may be substituted. He said the U.S. Food and Drug Administration allows generic substitutes to have anywhere from 80 percent to 125 percent the absorption rate in the bloodstream as the brand-name drug. Generics on the lower end of the range may cause patients a problem, Welty said. And patients may be dispensed different generic versions each month.  "If you have a drug change from month to month to month, it becomes very difficult to control and manage that patient," said Welty.
     The Alabama Pharmacy Association opposes the bill, which already has passed out of the Senate's health committee but has not been voted on by the full Senate.

Louise Jones, executive director of the Alabama Pharmacy Association, said epilepsy groups are pushing similar bills across the country, as they did without much success last year. She said her group is strongly opposed. If doctors believe a patient needs the brand-name medication and not a generic equivalent, they can sign their names next to a line on the prescription that says "dispense as written," meaning substitutions are not allowed. Otherwise, they sign next to a line that says "may substitute," Jones said. 
     "It's redundant," she said. "We're relying on that physician's knowledge of that patient." 
     Jones said those are issues for the FDA to take up, not individual state legislatures. If the epilepsy bill passes, she believes other groups will push for similar bills.  "We feel like that's opening Pandora's box," she said.

-Source: The Birmingham News. "Epilepsy patient supporters push notification bill."  March 26, 2008

   

 

 

Generic vs. Brand Name

While the lion's share of prescriptions filled are generic, most of the money spent is on brand name medicines. That gap has increased over time.

Total Prescriptions dispensed:
  • 2003:
    Generic: 54.1 percent
    Brand name: 45.9 percent
  • 2008:
    Generic: 71.percent
    Brand name: 28.2 percent
Prescription dollars spent
  • 2003:
    Generic: 17.2 percent
    Brand name: 82.8 percent
  • 2008:
    Generic: 21.9 percent
    Brand name: 78.2 percent

 

IN THE NEWS:
"Bill would allow pharmacists to substitute drugs: Generic vs. brand prescriptions" - Athens (GA) Online. 8/3/08.
Sources: National Conference of State Legislatures 

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