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Perspectives | Finding Seizure Drugs Anywhere in the World
Dr. Fisher's professional goal is to derive new treatments for previously untreatable seizure disorders by merging information from research laboratories with clinical practice. He is author or co-author of over 120 peer-reviewed publications in medical journals, two books on epilepsy and two monographs. He frequently chairs symposia and meetings, speaks at national or international conferences on subjects related to seizure disorders, has been on review boards for national grant applications, and currently serves on the editorial board of several epilepsy and EEG-related journals. He has won research awards from the Klingenstein Foundation, the Epilepsy Foundation of America and the national Institutes of Health. His peers named him to be listed 1996-2003 in Best doctors in America. He was given the Ambassador Award from the International League Against Epilepsy.
Dr. Fisher has served as President of the Epilepsy Society of Arizona; founding chair of the AES Public Education Committee and of the Research Committee; chair of the EFA Research Initiative Campaign, EFA Research Grants and Fellowships Committee, and the EFA Advocacy Committee; EFA Executive committee and as a member of the AES Research Awards Committee and AES Secretary for three years. He is Past-President of the American Epilepsy Society, and currently serves on the Board of the International League Against Epilepsy and Editor-in-Chief of the Journal, Epilepsia.
Epilepsy Medications Around the World
Throughout the world medications have different names. We may find it daunting and confusing, but nations maintain the right to approve or not approve marketing of pharmaceuticals in their own country. As physicians, however, we are often called upon to prescribe or help find medications for patients from other countries, particularly travelers. As such, at epilepsy.com we have an International AED database to help out.
When patients become frustrated as to why there are so many names, there are no simple answers. But here are a few key reasons.
Some countries, such as those in the European Union, have adopted common rules that apply to all members of the group, but more commonly a decision is made on a country-by-country basis. Rules for testing a new drug prior to marketing may differ among different countries. For example, in the United States, a seizure medication must be shown to be more effective than either a placebo or an existing standard seizure medication. In Europe, a drug may be approved for marketing if it is shown to be safe and equivalent in effectiveness to an existing standard seizure medication.
Regulatory agencies in one country may consider a drug useful and in another country not so useful, depending upon whether or not they are available in each country. Industry may have gone to the effort and expense of documenting safety and efficacy of a drug in one country, but not in another.
A family of drugs and side effects
An example of this is clobazam, a benzodiazepine in the same family as diazepam, lorazepam, clonazepam and others. Clobazam is considered to be a mainstay of epilepsy therapy in Canada and in other countries, but has so far not been approved for use in the United States. This may, however, change in the near future.
Sometimes, significant side effects of a medication become evident after a medicine is in use in some countries, and this may limit approval of that drug in other countries. An example of this is vigabatrin (Sabril), which was found to have retinal (eye) toxicity after being marketed in multiple countries. Because of this, the medication is not presently marketed in some geographic regions, including the United States.
For all these reasons, availability of different seizure medications is a patchwork in different parts of the world. You cannot assume that a medicine that you take in one country will be available during your travels to another. This is particularly true for new medications. The old standbys, such as phenobarbital, phenytoin, carbamazepine, valproic acid, diazepam and clonazepam are much more likely to be available in different countries.
Medications usually have three names, a brand name (sometimes called trade name), a generic name, and a chemical formula name. Consumers and physicians use the brand and generic names, while the chemical formula name is mainly useful for research purposes. Carbamazepine, for example, is a generic name. A brand name would be Tegretol, but another brand name refers to the long-acting form, Carbatrol.
If you get carbamazepine in Germany, it may be called "Carba," or in Kenya, "Carbadac." Brand names are generated by companies manufacturing the medication. In the years after a new drug is released to the world, patent rights may limit a generic drug to one brand name used by the company that developed the medication. However, companies often use different names in different countries, because words mean different things in different cultures (witness, for instance, the drug “Tegretol-retard”!).
When patents expire, as they do so at different time intervals in countries around the world, then multiple companies can market the generic medication, either under the generic name or its own brand name. Therefore, when you generate a list of medications for your physician, it is best to do so with generic names. The brand name may not be known to the physician.
FDA and importing medications from other countries
Physicians in the United States are not allowed to prescribe medications that are not licensed in the United States, even if they are legal and useful in other countries. Exceptions to this usually require specific approval of an Investigator Drug Exemption test protocol by the Food and Drug Administration (FDA), granted to a specific physician.
According to the website of the FDA ". . . the interstate shipments of any prescription drug that lacks required FDA approval is illegal. Interstate shipment includes importation - bringing drugs from a foreign country into the United States." But the FDA grants some practical leniency to individuals importing medication for their own condition. This does not apply to importation by physicians, hospitals, pharmacies or pharmaceutical companies.
Policy on personal use
A policy on personal use was formulated in 1988 in response to the need for some individuals to obtain medications only available elsewhere for treatment of serious conditions. As guidance for FDA personnel, the agency has declared that individuals may bring in a three month supply of medication for their own use for the following reasons:
Clarification of this murky area and proposals to allow legal importation of less expensive international medications will require new legislative, executive and political actions.
The epilepsy.com international drug name database
This database was derived and provided to address the difficulties mentioned above. If you know the brand name of a medication, you can look up that brand to find the generic name in the countries in which it is available. If you know a generic name, you can generate a list of brand names. Should you be traveling to a particular country, you can click on the country box to see which seizure medications are available in that country. No single source provides a truly comprehensive database of all individual and combination medications, but this database represents a starting point. It should grow and become more accurate over time with feedback from knowledgeable consumers, medical personnel and industry in different countries. We trust that it will be a help to all physicians whose patients from other countries have a need.
Submitted by Rita Watson, MPH, May 26, 2007
Edited by Steven C. Schachter, MD
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