Perspectives: An Opinion on Names of Epilepsy Medications

Dr. Fisher is Maslah Saul MD Professor of Neurology and Director of the Stanford Comprehensive Epilepsy Center. He received his PhD in the Neurosciences in 1976 and a MD in 1977, from Stanford University. He then took specialty training in internal medicine at Stanford and in neurology at Johns Hopkins, where he was Co-Director of the Epilepsy program for eleven years. He formerly was Chairman of the Department of Neurology, Chief of the Epilepsy Center at Barrow Neurological Institute in Phoenix, and Newsome Professor of Clinical Neurology at the University of Arizona.

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.

Why in the World So Many Names?

Why in the world are there so many names for the same medication around the world? The answer is not always a simple one. However, we are trying to make it easier to locate medications anywhere in the world through a new feature on the epilepsy.com website. Under the section on "Seizure Medicines" you will find a subheading called "International AED Name Database". This section allows you to broaden your search on epilepsy medications to most countries around the world. My perspective is that there should be just one simple name – but there are many, and here is why.

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.

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.

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.

Medication names

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.

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. This policy is spelled out on the FDA website.

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. Individuals may bring in a three month supply of medication for their own use for the following reasons:

• If it is for a serious condition for which effective treatment is not available in the US;
• If the product does not represent an unreasonable risk;
• If a US physician supervises the patient taking the medication; and
• If a supply is for three months or less, and not for resale.

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