RPhLink - Novartis - Distribution changes for Lamprene

09/13/04

From: Novartis

Distribution Changes for Lamprene

Pharmacist:

As a regular dispenser of Lamprene (clofazimine), you may already be aware that Novartis has joined with the World Health Organization (WHO) to eradicate leprosy. As part of this commitment, we will provide Lamprene free of charge to patients around the world.

In the United States, our partner in this effort is the National Hansen's Disease Programs (NHDP), a unit of the US Department of Health and Human Services, based in Baton Rouge, Louisiana. When US wholesalers, pharmacy chains and individual pharmacies deplete their inventories of Lamprene later this year, the product will no longer be sold in pharmacies and will only be distributed under an Investigational New Drug (IND) application held by NHDP.

Beginning approximately July 1, 2004, or whenever you can no longer acquire Lamprene through your normal supplier, any requests that you receive for Lamprene for the treatment of leprosy should be directed to :

Renee Painter

Administrative Officer

Laboratory Research Branch

RPAINTI@LSU.EDU

Skip Bertman Drive

Baton Rouge, LA 70803

Phone: 225-578-9861

Fax: 225-578-9856

To receive Lamprene for use in the treatment of leprosy, a physician will need to register as an investigator under the IND held by NHDP. Ms. Painter will provide physicians with the necessary paperwork for this process.

In addition, the FDA has requested that Lamprene be available for the treatment of multi-drug resistant tuberculosis (MDRTB). For this purpose, Lamprene will be distributed via single patient INDs administered by the Food and Drug Administration (FDA). All requests for use of Lamprene (clofazimine) for the treatment of MDRTB must be directed to:

Division of Special Pathogen and Immunologic Drug Products (HFD-590)

Center for Drug Evaluation and Research

Food and Drug Administration

301-827-2127

Upon Approval of the patient IND, the FDA will request NHDP to distribute Lamprene directly to the Prescriber.

If you have any questions about this process, please contact Novartis at 1-888-NOW-NOVA between 9:00AM and 5:00PM Eastern Standard Time, Monday through Friday

Sincerely,

Stephen Cunningham, MD

Vice President and Head

US Clinical Development & Medical Affairs

Novartis Pharmaceuticals Corporation

01-16-2005

By: E. R. Doctor of Pharmacy Candidate 2007 - Washington State University

As a country that once enjoyed free enterprise silently succumbs to the rule of giant corporations, providing an acceptable level of care is becoming increasingly difficult for the pharmacist. Pharmacy students are graduating with large debts that are hard to pay off without surrendering their careers to a nationwide chain that cares less about the patients than the bottom line. These corporations see patients as mere consumers and enact policies that force their pharmacists to do the same. Fortunately, pharmacy is one of the few fields in which the independent businessman still has a fighting chance. I have had several experiences that have inspired me to pursue my goal of self-employment in retail pharmacy. That will enable me to work free of corporate policies that would otherwise compromise my service.

Growing up in the small farming community of Ritzville, Washington, I was inspired at an early age to become a pharmacist. The only pharmacy in our town was independent and the owner was a friend of my family. As I grew up, I saw what an integral part of the community he was. He was always friendly and offered his services with a genuine caring attitude that I have yet to see in any other profession. He was well respected by the community, and people came from miles out of town to get their prescriptions at this store.

During my second year of pharmacy school, I was fortunate enough to attend the National Community Pharmacists Association (NCPA) convention where I learned about the various opportunities available to a pharmacist in the retail setting. During the convention, I conversed with several pharmacy owners from various locations around the country. Some were from large cities like Chicago and Boston. Others were from small towns like the one in which I grew up. Despite their diverse backgrounds, they all shared the same passion for their work.

As an intern, I have worked in two pharmacies so far, one independent and one run by a nationwide chain. The large chain for which I worked only hired a skeleton crew to run its store, often forcing one lone pharmacist to take on over two hundred prescriptions each day. Without much of a supporting staff, the store had gained a reputation for poor service throughout the town. Most of the patients we saw were forced by their insurance companies to buy their prescriptions from us. They were the victim of a deal made between the two corporations that made us a "preferred provider". My internship ended when the district manager decided to eliminate several internship positions in our area to help improve the district's financial situation.

As bad as this experience was, it failed to turn me off to retail pharmacy. I realized that, despite these corporate problems, there were many aspects of my job that I enjoyed. My preceptor was wonderful. She has done all she could to give me a good experience. I had also enjoyed the patient interaction. I decided to try to find a job in a store similar to the one I remembered back home. That week I drove over five hundred miles searching out independent pharmacies in the area. As I applied to stores throughout the area, I was amazed at the diversity. Each one specialized in a niche market in order to compete with the larger chains.

I decided on an internship at an independent pharmacy located in a medical center. Working for an independent pharmacy was a wonderful experience. Even though the daily prescription count was comparable to that of a chain, the staff was much bigger. There was usually more than one pharmacist working and plenty of technicians to keep the store running smoothly. All of the regular patients were on a first name basis with the staff. I saw them receive a level of care that was beyond comparison. Many even commented about our service being better than the other pharmacies in town. My preceptor was able to spend more time with me, teaching me about counseling patients, quizzing me about drugs, and answering all my questions about ownership and management. My experience was further enhanced by the pharmacy's location in a large Medical Center. Doctors who were good friends with my preceptor would come down to chat. This gave me exposure to a variety of professionals in the medical field.

These experiences have inspired me to become an advocate for independent business, especially in pharmacy. When I graduate, I will continue this advocacy by seeking out a job in a locally owned, community pharmacy. After graduation, I will continue to be active in organizations that help independent pharmacies through legislation and networking. One day, when I have gained enough experience to take on the challenge, I hope to become a pharmacy owner. Throughout my career, I will do my best to provide to my patients the same level of service that I have seen in independent pharmacies so far.