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01-16-2005

To RxLink,

from: E. R. Doctor of Pharmacy Candidate 2007  –  Washington State University School of Pharmacy

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.

 

 

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From: D. S.   @   WSU

02/07/2005

It’s amazing how we start out as a single helpless cell and grow into a multicellular, living, breathing organism. Everyday our bodies know which cells need to divide and which shouldn’t and the rate at which this takes place. Our cells know just what to do with the food we take in and allow us to run, jump , and dance the night away. But in some of us, our cells get confused and grow rapidly causing us to get the life threatening condition known as cancer.

This is where I come into the picture. I plan to become a nuclear pharmacist. I want to be able to help those rebel cells and save people’s lives. I want to be a part of the answer to the questions on how to stop the spread and maybe one day we will have the answer to all the types and degrees of cancer. My knowledge will have doctors coming to me with all their questions and I can explain to the patients and their families what the options are and exactly what the drug is doing to help them regardless of the side effects. I will be their hope and sunshine. And to keep myself sane dealing with such tough cases, I plan to be a mom and an aerobics instructor.

When I become old and gray and the kids are off on their own, I plan to teach and do research in either the area of cancer or diabetes therapies. Making sure our children have a good education is always a worthwhile endeavor and I want to put in mu two cents for the future. I also have lots of questions about cancer and diabetes and sometimes, the bets way to get the answer is to go and find out for yourself. Hopefully, I will be able to help the millions of people that suffer from these conditions and provide a sound future for them by teaching their future doctors.

I know what I plan to do will be tough but if I work hard I will be able to achieve my dreams and hopefully make the dreams of several families come true in the process.

 

RxLink, LLC   Pharmacy Franchise Management & Pharmacy Business Development

 

From: Ortho McNeil Re: Topamax                                    12-2003

Important Drug Warning

The Prescribing information for Topamax (topiramate/topiramate capsules) Tablets/Sprinkle Capsules has been revised to include a warning that TOPAMAX causes hypercloremic, non-anion gap metabolic acidosis (decreased serum bicarbonate). TOPAMAX is approved and marketed for the adjunctive treatment of partial-onset seizures, generalized tonic-clonic seizures associated with the Lennox-Gastaut syndrome in adults and children two years of age and older.

Data on hyperchloremic, non-anion gap metabolic acidosis are derived from placebo-controlled trials and post-marketing experience in over 2.5 million patients. In clinical trials, the rate of occurrence of a persistently decreased serum bicarbonate ranges from 23-67% for patients treated with topiramate and 1-10% for placebo. The incidence of markedly low serum bicarbonate in clinical trials ranges from 3-11% for topiramate and 1 to <1% for placebo.

Generally, decreases in serum bicarbonate occur soon after initiation of topiramate, although they can occur at any time during treatment. Bicarbonate decrements are usually mild-moderate, with an average decrease of 4mEQ/L at daily doses of 400 mg in adults and approximately 6 mg/kg/day in pediatric patients. Rarely, patients can experience decrements to values below 10 mEq/L.

Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, surgery, ketogenic diet, or drugs) may be additive to the bicarbonate lowering effects of topiramate.

Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such s fatigue and anorexia, or more sever sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. A reduction in growth rate may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone-related sequelae has not been systematically investigated.

Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue patients on topiramate in the face of persistent acidosis, alkali treatment should be considered.

The following has been added to TOPAMAX prescribing information.

Under WARNINGS

Metabolic Acidosis

Hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with topiramate treatment. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of topiramate on carbonic anhydrase. Such electrolyte imbalance has been observed with the use of topiramate in placebo-controlled clinical trials and in the post-marketing period. Generally, topiramate-induced metabolic acidosis occurs early in the treatment although cases can occur at any time during treatment. Bicarbonate decrements are usually mild-moderate (average decrease of 4mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10mEq/L. Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, surgery, ketogenic diet, or drugs) may be additive to the bicarbonate lowering effects of topiramate.

In adults, the incidence of persistent treatment-emergent decreases in serum bicarbonate (levels of <20 mEq/L at two consecutive visits or at the final visit) in controlled clinical trials for adjunctive treatment of epilepsy was 32% for 400 mg/day, and !% for placebo. Metabolic acidosis has been observed at doses as low as 50 mg/day. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value <17mEq/L and >5 mEq/L decrease from pretreatment) in these trials was 3% for 400 mg/day, and 0% for placebo. Serum bicarbonate levels have not been systematically evaluated at daily doses greater than 400 mg/day.

In pediatric patients (<16 years of age), the incidence of persistent treatment-emergent decreases in serum bicarbonate in placebo-controlled trials for adjunctive treatment of Lennox-Gastaut Syndrome or refractory partial onset seizures was 67% for TOPAMAX (at approximately 6 mg/kg/day), and 10% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value <17mEq/L and >5mEq/L decrease from pretreatment) in these trials was 11% for TOPAMAX and 0% for placebo. Cases of moderately severe metabolic acidosis have been reported in patients as young as 5 months old, especially at daily doses above 5 mg/kg/day.

Although not approved for the prophylaxis of migraine, the incidence of persistent treatment-emergent decreases in serum bicarbonate in placebo-controlled trials for adults for prophylaxis of migraine was 44% for 200 mg/day, 39% for 100 mg/day, 23% for 50 mg/day, and 7% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value<17 mEq/L and >5mEq/L decrease from pretreatment) in these trials was 11% for 200 mg/day, 9% for 100 mg/day, 2% for 50 mg/day, and 1% for placebo.

Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as Rickets in pediatric patients) and / or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. A reduction in growth rates may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone related sequelae has not been systematically investigated.

Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue patients on topiramate in the face or persistent acidosis, alkali treatment should be considered.

Under Precautions:

Laboratory Tests

Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended ( see WARNINGS).

Pediatric Use:

Safety and effectiveness in patients below the age of 2 years have not been established. Topiramate is associated with metabolic acidosis. Chronic untreated metabolic acidosis in pediatric patients may cause osteomalacia (rickets) and may reduce growth rates. A reduction  in growth rate may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone-related sequelae has not been systematically investigated (see Warnings).

Under OVERDOSE:

Topiramate overdose has resulted in severe metabolic acidosis (see WARNINGS).

You can further our understanding of adverse events by reporting all cases to Ortho-McNeil at the contact numbers listed below or to the FDA MedWatch Program by phone (1-800 FDA 1088), by fax (1-800-FDA-0178, by mail (using postage paid form to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787) or via www.accessdata.fda.gov/scripts//medwatch/.

A copy of the full Prescribing Information is enclosed for your reference. If you have any questions regarding TOPOMAX tablets and TOPOMAX Sprinkle Caplets, please feel free to call Ortho-McNeil Medical Affairs Division at 1-800-682-6532

Sincerely,

Joseph Hulihan, MD

Group Director, CNS Research

Ortho-McNeil Pharmaceutical, Inc. 1000 Route 202, PO Box 300 Raritan, NJ  08869-0602       908-218-6000 Telephone

 


 

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From: J. M.                              03/02/2005

Graduate Student in Department of Pharmacy Healthcare Administration University of Toledo College of Pharmacy

What Contribution Will I Make To My Profession When I Graduate?

Pharmacy is not just counting pills. It’s a significant and honorable occupation that reaches into almost all aspects of health care. Pharmacists contribute to patients care in a variety of settings. They are the trustworthy link between physicians and patients. Their expertise in the field of medicine helps in preventing many drugs side effects. They not only educate consumers on the medications use, but also ensure that the patients are getting the best health care benefits available for them.

Health science has made very high quality progress and has been effective in reducing health problems and death rates, but its dividends have not been equally shared among the different racial and ethnic groups. A perfect metaphor would be to view the world as a rich and complex tapestry of colors, backgrounds and interests. Understanding this tapestry and its implications on health disparities can enable a health practitioner reduce a number of preventable disease among the multicultural population groups. Finding ways to eliminate such disparities in community healthcare has become one of the major research issues in the field of pharmacy. One of the ways to assist in the noble cause of eliminating minority health disparities is by producing quality pharmacy health professionals who with their knowledge will be able to capitalize on the new opportunities, make use of the quality healthcare resources and deliver quality health care solutions to the future population.

A person’s knowledge and education increases when he spreads it to others. Based on this thinking, my personal interests, and considering the importance of producing quality future health care professionals, my contribution to the profession of pharmacy when I graduate will be in the form of a good professor and advisor for the future pharmacy students.

Along with the understanding of the subjects like pharmacology, medicinal chemistry, pharmaceutics. I feel pharmacists should also have the knowledge of different culture and be culturally competent so that they can educate and counsel their patients of diverse populations in a healthier way. I feel it is imperative for the future pharmacists to have knowledge of the different cultures to assist in the noble cause of eliminating minority health disparities. My contribution in this will be make use of my research interests and my knowledge and education in the field of cultural competence to improve the quality of life for the entire population irrespective of their ethnicity/race.

 

 

 

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To: RxLink
“What contribution will I make to my profession when I graduate?”       12/17/04

From: C Q

Washington State University

PharmD candidate 2006

My contribution to my future profession is a gift that stems from my family and my experience from different pharmacy related fields. The experience began three years ago when pharmacy school began to challenge and expand my horizons. When I first entertained the idea of applying to pharmacy school I was a technician at a local independent retail/compounding/infusion pharmacy. After working there for only a few months, I realized the massive potential that the career held. My store not only consisted of retail and compounded bio-identical hormones; they had cornered every pharmacy related niche including: durable medical equipment, oxygen therapies, CPAP and BIPAP therapies, and motorized wheelchairs. I realized that t there was a whole lot more to pharmacy than counting pills by five and counseling on antibiotics. I soon took a pharmacology class at the local university to augment my pharmacy interest; I began applying to pharmacy schools and was soon accepted at Washington State University. The first summer back from school I immediately found a job at the local hospital learning about the acute care setting. I went on rounds with pharmacists and learned even more about the diverse roles of a clinical pharmacist. I interacted with patients and learned about specific drug related protocols. In one specific case I was running an errand in the hospital and this man approached me. He was contemplating suicide and needed to talk to someone. I asked my supervisor if I could take my break early. I bought the man a candy bar and simply listened to him and his story. That day I realized the importance of becoming a healthcare professional.

The second year of school was exciting. The classes became more saturated with useful and practical knowledge. January of that year I had applied for an internship at Biogen-idec Inc. Spring came soon enough and finals were just around the corner, I didn’t think I would hear from Biogen-idec but sure enough the phone rang. The lady said, “I am offering you the internship, how would you like to work in Cambridge:. I was enthused about the job and immediately thought about working in England! After talking to the lady from Biogen-idec she informed me that there job was not at their UK site, but rather in Cambridge, Massachusetts. Nonetheless, I was still excited and within a week after finals my bags were packed and I traveled 3,000 miles away to Cambridge. I was eager to learn about the pharmaceutical industry. I reported tot he Regulatory Affairs department and I was handed a number of projects to accomplish and present before the summers end. I went through training on the drug development process from discovery to FDA approval. I learned the ins and outs of the companies’ drugs and what the extensive regulations were when developing a drug. Our group worked on the drug Tysabri, also then known as Antigen. It was undergoing phase III trials at the time and it was very exciting times for the company and the world of Multiple Sclerosis. As of today the FDA has approved Tysabri and it will soon begin to reshape the current therapy for Multiple Sclerosis.

After my fascinating and educational summer, my brother was unfortunately diagnosed with Multiple Sclerosis. The news impacted our family and we naturally formed a support network to embrace the impact of the illness. In many ways it has made our family grow stronger. Professionally, it also helped me grow as now I can better appreciate and relate to the impact of disease on a more personal level. My brother will be one of the first patients in our area to receive Tysabri. He will receive the drug at the infusion center I once worked for.

The beginning of my third year in pharmacy school I looked at my career path with a whole new light. I decided to volunteer at the Spokane hospice. I have been assigned to a patient and help out whenever I am available. I also make pharmacy recommendations with the guidance of a hospice nurse on general health and wellness. My peers and even my professors were skeptical of my new outlook on volunteering and always wondered what was influencing me. I respond to these people, “I do it, simply because I care and have the ability to help out”.

I have realized through my experience what the great potential and rewards this career has to offer. One of the greatest rewards, however, comes from the satisfaction received from caring, My pharmacy experience has taught me that whatever pharmacy setting I choose I can make a difference by caring. When I graduate and become a pharmacist I will continue to care for my patients in the same fashion as I do for my brother and family. Hopefully others, including my fellow colleagues, will realize their greater potential and together we will enhance the care-giving potential of our profession. Caring, in my eyes, makes us better people and is the greatest powerful contribution anyone can make.

 

 

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