Massachusetts - SB 1296: Protecting AED Prescriptions
Massachusetts Senate Bill 1296 would prevent pharmacists from substituting one AED for another without the informed consent of the prescribing doctor and patient. Substitution of AEDs can have devastating consequences. Fortunately, this bill would protect Massachusetts physicians’ autonomy to make treatment decisions for their patients with epilepsy.
We are currently expecting the bill here inMassachusettsto come before the full Senate for a floor vote and then, if passed by the Senate to go over to the House.
Les Brody, Executive Director of the Epilepsy Foundation of Massachusetts and Rhode Island, is spearheading the local efforts to get this bill passed. He may be contacted at email@example.com . The Executive Board of your MNA has voted to support this effort. We encourage any and all members (and any interested parties: physicians, nurses and other caregivers, and patients) to contact your legislator(s) on this matter. First up: a Senate vote as soon as Tuesday, February 5th. If passed, it will next be taken up by the House Ways and Means Committee.
Letters, faxes, emails to your State Senator (later, Representatives) are strongly encouraged ASAP. There will be several stages in this effort, and persistence (and repeat contacts) will offer the best chance of passage.
Tools for sending an email can be found following this link:
Talking Points from the American Epilepsy Society
National Health Council’s "Corporate Relations Guidelines For Advocacy" and
"Guiding Principles for Voluntary Health Agencies in Corporate Relationships".
- The FDA encourages people with epilepsy and physicians to report breakthrough seizures resulting from switching formulations of a product to the FDA’s Medwatch program. For more information call 1-800-FDA-1088 or go online at
- We should encourage patients to request that their pharmacists note in their record that they will not substitute any AED prescription without prior notification to the patient and prescribing physician.
What to do until this problem is solved?
- Additional information:
Epilepsy Foundation’s "Ethical Principles for Fundraising, Co-Ventures, and Strategic Alliances With Organizations With Business Interest In Epilepsy And Other Business Organizations".
- We are a nonprofit organization funded by a diverse cross-section of the general public, that includes individuals, corporations, foundations, and federal and state governments. A portion of our funding comes from corporations with a commercial interest in epilepsy, and we welcome their support of our mission and goals.
- Given that informed consent is necessary to assure public & personal safety and the number of people with epilepsy, asking doctors and patients for permission prior to changing an AED prescription or seizure product manufacturer is not an unreasonable burden.
- Physicians Report that "Dispense As Written" Legislation As Currently Interpreted and Enforced Does Not Adequately Protect Against Unapproved Switches or Changes in Product Manufacturer of Epilepsy Drugs at the Pharmacy
- For the more than 3 million Americans living with epilepsy, medication is the most common and most cost effective treatment for controlling and/or reducing seizures.
- This legislation does not prohibit substitution; it simply prevents switching among various formulations of the same epilepsy medication without both physician and patient informed consent before switching is allowed.
- This legislation helps to assure compliance and monitoring. If prescribing physicians are made aware of any substitution at the point of sale, they can monitor blood levels if necessary, adjust doses, and monitor their patient for adverse incidents.
- It also allows for truly informed decision making and prospective monitoring of potential problems.
- This bill does not promote name brands over generics. It promotes people with epilepsy getting the same formulation of the medicine that is working for them.
The Epilepsy Foundation is not and has never been opposed to generic medications. Cost of medications is a very significant issue for people with epilepsy, and the Foundation welcomes generics versions of medicine for the opportunity to lower overall costs for individuals and for society. However, because over the years we have heard from hundreds of people with epilepsy who have experienced unexpected seizures and side effects when they attempted to switch to different manufacturer’s versions of their medication, we hold the position that medications must not be switched at the pharmacy level without the advance informed consent of the patient and their physician
- The goal of this legislation is patient safety and awareness – of the physician, the patient, and the pharmacist – to monitor the results of switching if it is agreed to; to prevent the switching if it would be dangerous for the individual or against medical advice
Aren’t sufficient protections already in place?
- Current Dispense as Written instructions only prevents switching from a brand to generic drug and not from one generic manufacturer to another manufacturer where there is potential for even greater variance.
- Many physicians are not expert in the treatment of epilepsy and are not aware that for some patients with seizures, changing among different versions or formulations of the product can cause unacceptable side effects and/or break through seizures.
- It has been reported that even where a physician has written Dispense As Written, at times the prescription has been substituted with a generic version of the product, or another manufacturers’ version of a product.
- Epilepsy Prescription Protection Legislation Does Not Conflict with Existing Medicaid Law
Neither State nor Federal Medicaid law require generic substitution.
Medicaid law does create reimbursement incentives for use of generic products, but the physician approval process in the proposed legislation provides an avenue for obtaining the documentation necessary for the pharmacy to receive adequate reimbursement should the physician direct dispensing of a brand product.
State and Federal Medicaid laws address only the reimbursement rates for products with generic competitors, and do not require generic substitution.
Federal law specifically recognizes the need for and appropriateness of brand medically necessary prescriptions.
- Medicaid law Supports and Does Not Prevent the Sharing of Information About Medication Changes with the Patient.
Doesn’t this bill cause undue hardship on the pharmacist?
- Epilepsy and chronic seizures affect at most 1 percent to 2 percent of the population. Out of the billions of dollars spent on pharmaceutical products and the massive volume of drugs being dispensed every day, the number of people who rely upon antiepileptic medications to maintain seizure control and an acceptable quality of life is a tiny proportion of the overall dollars and volume of medications dispensed. There is no evidence that it creates an undue burden to pharmacists to ask for permission of both the patient and the doctor prior to changing product manufacturer of medications used to treat seizures. Pharmacists contact physicians every day about their patients’ prescriptions; they also talk to patients and offer their advice.
- The pharmacist is an integral part of promoting patient safety. Pharmacists with experience in epilepsy know that achieving optimal seizure control with the least side effects is the goal – not saving money at the expense of an individual’s health. In most instances, however, the expertise of pharmacists and non-specialty practitioners is extremely limited with respect to the care of epilepsy patients as these practitioners rarely actively manage the treatment of an epilepsy patient. This is almost always true for the 40% of the epilepsy population who suffer from refractory seizures where achieving adequate seizure control can be a constant, ongoing struggle.
- Given today’s advanced communication systems, it is also safe to assume that when a pharmacist does not have a particular manufacturer’s product in stock it can be obtained within a relatively short time frame.
Will this drive up healthcare costs even more?
- There is No Evidence of a Negative Fiscal Consequence to This Legislation
- Federal Medicaid law Recognizes that the Best Interests of the Patient May Require that Drugs Get Dispensed As Written, or as the Physician Decides is Medically Necessary.
- Because Medicaid law currently provides that any medication that is medically necessary must be available, there is no increased cost to the Medicaid system as a result of this legislation.
- It is not a bill that requires all people with epilepsy to be dispensed brand name products; it is not a bill that requires all people with epilepsy to be dispensed the most expensive product on the market.
- It is a bill that requires the physician and the patient to be informed when a switch is proposed by a pharmacist or by an insurer, and allowed to make a choice whether to do so based upon their personal experience, situation, and medical advice.
- Because there is a strong incentive for people with epilepsy and for physicians to prescribe the generic in order to lower health costs, the bias is towards individuals switching to generics, not towards using brand name products.
- However, if an individual has had adverse experiences, has successfully obtained seizure control on a brand name drug, or is concerned about switching based upon the physician’s advice and recommendation, the option is given to the individual and the physician to stay on the medically necessary medication.
- If someone is going to have difficulty with a switch to a different version of a medication, the difficulties, whether break through seizures, increased side effects, will show up within the first few weeks of use. If anything, this legislation saves money in unnecessary doctor visits, emergency room visits, potentially more serious consequences to the individual and others that could occur as a result of an unauthorized switching of antiepileptic or antiseizure medications.
Why doesn’t the FDA fix the problem?
The Epilepsy Foundation established its Advisory Committee on the Substitution of Epilepsy Medications comprised of physicians representing the Foundation’s Professional Advisory Board, the American Academy of Neurology, and the American Epilepsy Society. This Advisory Board recently completed its white paper "Recommendations for Patient Safeguards in Policies Governing the Substitution of Antiepileptic Drugs; Recommendations from the Epilepsy Foundation’s Advisory Committee on the Substitution of Epilepsy Medications".
The paper includes recommendations for action by among others, the FDA. For the sake of patient and public safety, it’s critically important for the FDA fully address the recommendations and reports that it hears from patients, physicians, and advocates like the Foundation, to ensure that everything that can be done to promote individual safety has taken place. The Epilepsy Foundation will provide whatever support is necessary to make it happen, quickly, before more people experience unexpected seizures. Until the matter is resolved, the Foundation fully supports the right of people with epilepsy and their physicians to advance knowledge and informed consent before a switch of their medication occurs at the pharmacy.
Are you getting support from organizations with business interests in epilepsy?
- Because we recognize that there is the potential for conflicts of interest when donors have an economic interest, we, like all nonprofit and public corporations, have policies and guidelines in place for ourselves and our affiliates, to ensure that all our programs, positions and activities are solely for the interest and benefit of people with epilepsy
Epilepsy Prescription Protection Legislation
A pharmacist may not interchange an anti-epileptic drug or formulation of 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.
What are the issues?
- Since the mid 1980’s the Epilepsy Foundation has been opposed to the mandatory substitution of medications for epilepsy from brand to generic, generic to brand, and among generic and brand, or different formulations of a product, unless the physician and the patient have agreed in advance to the change.
- Patient and public safety is the basis for the Epilepsy Foundation’s long-standing position.
- Epilepsy is unique in light of the grave consequences of therapy failure. When any kind of substitution is made, formulation differences could cause a patient to become under-medicated, causing a breakthrough seizure, or could cause toxic side effects from blood levels that are too high.
- Many people with epilepsy report regularly to the Epilepsy Foundation that they have experienced breakthrough (unexpected) seizures, after long periods of seizure control, when a formulation of their customary medication was changed. This might occur when a brand name product becomes generic, or when a new version of a product is developed; or when different manufacturers produce the same therapeutically equivalent drug, and the pharmacist changes manufacturers that it uses to obtain that product.
- Specialists in epilepsy acknowledge that their patients have had this experience; many will not switch some of their patients from brand to generic because of their clinical experience that, for this patient, switching would risk seizures.
- Many new products for epilepsy came on the market in the 90s. Within the next couple of years, several of them will go off patent and generic versions will become available.
- Studies have documented that the FDA’s acceptable therapeutic range for generic versions of drugs may be too broad for antiepileptic medication. Differences do exist and these differences may result in breakthrough seizures, unacceptable side effects and, in turn, increased expense.
- The FDA already recognizes some AED’s as narrow therapeutic drugs. Yet some individual patients may have even narrower differences between efficacy and toxicity requiring strict adherence and monitoring of the medications making apparent the need for consistency of product. The problem can be more acute for the many patients on more than one AED where drug interactions and changes in serum concentration of one drug may lead to changes in serum concentration of other medications.
- Seizures have the potential to be life-threatening, and can endanger the individual and others, particularly if they occur without warning, while the individual is engaged in the various activities of daily living.
- To risk the occurrence of seizures by switching products without the guidance of the individual’s physician, when it is known that breakthrough seizures could occur, is a matter of both public and individual safety.
- The person who has a breakthrough seizure, or many breakthrough seizures, incurs significant expenses, ambulance, emergency room, and doctor visits that far outweigh the monthly expense of keeping that individual on their prescribed medication.
- Of particular concern is the different rate and extent of absorption (bioavailability) between different generic versions of branded products. The FDA’s standard for bioequivalence of generics to brand name allows a range of _+ 80 to 120 percent of the mean level of therapeutic product. It also does not address the other materials with which drugs are made, inert or active, which may affect the rate of absorption of medication. Even varying excipients and colorants may pose potential problems.
- The variance in generic drugs allowed by the FDA may result in unacceptable therapeutic ranges and serum concentration for many patients.
- For anticonvulsant drugs, small variations in concentrations between name brands and their generic equivalents can cause toxic effects and/or seizures when taken by patients with epilepsy.
- Because two formulations of the same medication are bioequivalent does not mean they are therapeutically equivalent. For most conditions, this difference may not be meaningful, but for epilepsy patients small changes in therapeutic equivalence could result in a breakthrough seizure or in toxic side effects.
- In addition, differences in generic names and appearance may lead to confusion and compliance concerns for the patient.
- For patients already on generic AED’s, continuity of supply is essential. Many concerns about effectiveness, side effects and possible breakthrough seizures, could be minimized by assurance of a single source generic during initiation, titration and maintenance of therapy.
- Recent surveys suggest that 15 to 20 percent of people with epilepsy report problems with switching among different manufacturers’ versions of a therapeutic product.
- The American Epilepsy Society, comprised of clinicians, scientists investigating basic and clinical aspects of epilepsy, and other professionals interested in seizure disorders, has established a task force looking specifically at this continuity of supply issue.
- Groups such as the American Academy of Neurology, the National Hispanic Caucus of State Legislators and the National Black Caucus of State Legislators have recognized the problems associated with switching formulations of anticonvulsants and issued statements opposing mandatory substitution without prior informed consent by physician and patient.