Background
Discussion
Fueling the Debate
Bioequivalence Versus Therapeutic Equivalence
Challenging the status quo
Strength of the Literature
The Patient Perspective
Discuss with your physician whether you are a suitable candidate for AED substitution or may be at risk for seizure breakthrough. |
Learn the typical signs of over and under treatment with your AED or a substituted agent: |
• Over treatment |
- Dizziness, sedation, rash |
• Under treatment |
- Breakthrough seizures, auras |
Honesty is the best policy! Accurately report dosing history, including missed doses, to your physician and any associated side effects or breakthrough seizures. To assist with this effort, keep a diary to record seizures and side effects. |
If possible, frequent the same pharmacy to fill your prescriptions and become familiar or friendly with the neighborhood pharmacist. |
"Know your pills" whether branded or generic versions – the size, the color – and inspect your medication and its label before leaving the pharmacy. Ask questions, if necessary! |
Per the "Patient's Bill of Rights," know you have a right to receive the medication you expect to receive; if you have been given a medication (i.e., generic substitution) that is not what you expected and you feel uncomfortable accepting, it is within your right to purchase the exact pills you have been taking. Buy just one pill if necessary to make it through to your next dose and give yourself time to consult your physician. |
Learn the details of your insurance policy. If it has been determined by your physician that you remain on a branded drug not covered by your policy, it is your right to request the drug be approved and added, and if necessary, appeal a decision if request is initially rejected. |
Learn your state's laws regarding generic substitution and "DAW" prescriptions, and if necessary, call your legislator or write a letter to your congressperson in cases where you feel state laws must either be enacted or changed. (Visit http://www.epilepsy.com for more information about state laws governing AEDs.) |
Inform your doctor of side effects and breakthrough seizures following AED substitution and ask that they be reported to MedWatch, the FDA's safety information and adverse event reporting program. (For information, call 1-800-FDA-1088 or visit the web site at http://www.fda.gov/medwatch.) |
Communicating Practical Advice to Your Patient
Level 1: Patient/Physician Relationship
Challenges
Tell your patient
Keeping Your Patient Safe
Level 2: Patient/Pharmacy Interaction
Challenges
Tell your patient
Appreciating a Patient's Residence
Level 3: Regional Differences
Type of Law | States and Territories |
---|---|
Mandatory/permissive substitution: States generally either permit or mandate that the pharmacist substitute a generic version of a prescribed drug if all prescription requirements are met. | Mandatory: FL, KY, MA, MN, MS, NJ, NY, PA, PR, RI, WA, WV Permissive: AL, AK, AZ, AR, CA, CO, CT, DE, DC, GA, GU, HI, ID, IL, IN, IA, KS, LA, ME, MD, MI, MO, MT, NE, NV, NH, NM, NC, ND, OH, OR, SC, SD, TN, TX, UT, VT, VA, WI, WY |
State Drug Formulary: Some states provide a positive (drugs are equivalent and interchangeable) or a negative (drugs are not equivalent and not interchangeable) formulary to guide appropriate substitution. |
Positive: DE, DC, FL, HI, IL, MA, NE, NV, NH, NJ, NY, TN, UT, VA, WI,
Negative: AR, KY, MN, MO, NC |
Patient consent/notification requirement: Most states require patient consent for, or notification of, substitution. |
Required: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, ME, MD, MI, MN, MS, MO, MT, NE, NV, NH, NY, ND, OH, PA, PR, SC, SD, TX, UT, VT, VA, WV, WI, WY
Not Required: AL, AR, GU, LA, MA, NJ, NM, NC, OR, RI, TN, WA
|
Cost savings requirement: Most sates require that the drug dispensed be less or no more expensive than the drug prescribed and that some of the cost savings be passed on to the purchaser. |
Less or no more expensive: AK, AR, CA, DC, GA, GU, HI, ID, IL, KS, KY, ME, MD, MA, MS, MO, NV, NH, NJ, NY, NC, ND, OH, OR, PA, PR, RI, TN, TX, VT, VA, WI, WY
Savings passed on: CO, CT, DE, FL, IN, IA, ME, MD, MI, MN, MT, NE, NM, RI, TN, WA, WV
Requirement not mentioned: AL, AZ, LA, ME, PR SC, SD, UT |
NTI drugs recognized as special category |
Recognizes NTI: KY, NC, PA, SC, TN |