Issue 17 January 2004
MAP Helps to Provide Over $4.9 Million to Transplant Recipients   New Medications Prilosec OTC (omeprazole)
MAP Helps to Provide Over $4.9 Million to Transplant Recipients

The Medication Access Program (MAP) is a statewide program, available at no cost, for solid-organ transplant recipients in Georgia that offers information about programs that can increase transplant recipients’ accessibility to medications (e.g., Medicare, Medicaid, pharmaceutical manufacturer-sponsored medication assistance programs). The mission of MAP is to increase access to medications for solid-organ transplant recipients who reside in the State of Georgia. In addition to identifying medication assistance programs, MAP also provides assistance to transplant recipients in the enrollment process necessary to participate in these programs. MAP is available through a grant from the Carlos and Marguerite Mason Trust and the University of Georgia College of Pharmacy.

Financial circumstances resulting from a lack of insurance for medication coverage may force transplant recipients to become noncompliant with medications. Noncompliance with immunosuppressants and other critical transplant medications may lead to organ rejection, increased health care cost, and decreased quality of life. MAP provides information about and enrollment services into assistance programs concerning immuno-suppressant medications and other medications for concomitant disease states that may develop in transplant recipients. These disease states include, but are not limited to, hypertension, diabetes, pulmonary diseases, and lipid disorders. Additionally, MAP is a valuable resource to healthcare professionals and transplant recipients by providing the most up-to-date information regarding available medication assistance programs.

From October 1999 through September 2003, MAP has aided over 380 Georgia solid-organ transplant recipients. Through MAP’s services, these recipients have received over $4.9 million in medications, based on average wholesale prices. We encourage all transplant recipients and healthcare professionals to contact MAP. MAP personnel may be reached Monday through Friday from 9:00 AM to 5:00 PM by calling (706) 721-0131 or 1-800-736-2273 ext. 0131.

New Medications Prilosec OTC (omeprazole)

Prilosec OTC® (omeprazole) is a proton pump inhibitor (PPI) manufactured by AstraZeneca and marketed by Procter & Gamble. The active ingredient of the drug suppresses gastric acid secretion by inhibiting the parietal cell H+/K+ ATP pump, and is indicated for treatment of frequent heartburn.

Prilosec OTC® is in the same class as the prescription products Nexium® (esomeprazole), Aciphex® (rabeprazole), Prevacid® (lansopra-zole), and Protonix® (pantoprazole). It is, however, the first PPI to be available over the counter (OTC), and it is the same medication that is contained in prescription Prilosec®. Omeprazole has been used for 15 years in more than 450 million patient treatments worldwide. It has been proven safe in more than 1,350 clinical trials, and its safety has been reconfirmed in more than 15 new OTC clinical trials.

Omeprazole reaches peak plasma concentrations in 0.5 - 3.5 hours, has a plasma half-life of 0.5 - 1 hour, and is 95% protein bound. It is approximately 77% eliminated in the urine as metabolites with the remainder being biliary excreted. Prilosec OTC® is recommended specifically for frequent heartburn, which is heartburn two or more days a week. Dosing is a once daily 20 mg tablet that treats heartburn for 24 hours as part of a 14-day course of therapy. Prilosec OTC® should be taken daily for 14 days to ensure proper treatment of frequent heartburn. Treatment should not be repeated for 4 months after use. Tablets should be swallowed whole; do not chew or crush tablets.

Prilosec OTC® has some reported adverse reactions which include abdominal pain (5.2%), diarrhea (3.7%), flatulence (2.7%), nausea (4%), vomiting (3.2%), and headache (2.9%).

Wellbutrin XL (bupropion HCl)

Wellbutrin XL® (bupropion HCl) is an extended-release anti-depressant tablet manufactured by Glaxo-SmithKline and approved by the FDA in August of 2003. Bupropion, the active ingredient, is a relatively weak inhibitor of the neuronal uptake of norepinephrine, serotonin, and dopamine, and does not inhibit monoamine oxidase. The mechanism of action is unknown, but it is presumed that the action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is indicated for treatment of depression and smoking cessation.

Prilosec OTC® has some reported adverse reactions which include abdominal pain (5.2%), diarrhea (3.7%), flatulence (2.7%), nausea (4%), vomiting (3.2%), and headache (2.9%).

The active ingredient of Wellbutrin XL® reaches peak plasma concentrations in approximately 5 hours and food does not affect absorption. The mean elimination half-life of bupropion after chronic dosing is 21 hours, and steady-state plasma concentrations are reached within 8 days. Bupropion is extensively metabolized in humans by the cytochrome P450 isoenzyme, CYP2B6, therefore there is a potential for drug interactions. While the CYP2D6 isoenzyme is not responsible for metabolism, drug interactions can also occur when bupropion is co-administered with drugs that are metabolized via the CYP2D6 isoenzyme. Bupropion is almost 100% eliminated in the urine and feces as metabolites.

Wellbutrin XL® is indicated for the treatment of major depressive disorder as defined by the APA Diagnostic and Statistical Manual (DSM). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 other symptoms must be present to define a depressive episode.

Dosing of Wellbutrin XL® is once a day with either a 150 mg or 300 mg tablet. Dosages should be titrated from 150 mg up to 300 mg if tolerated. Dosages above 300 mg should be avoided due to an increase in potential side effects. Tablets should be swallowed whole, taken at the same time each day, and may be taken with or without food. Wellbutrin XL® is contraindicated in persons having a seizure disorder, prior diagnosis of bulimia or anorexia nervosa, concurrent use of monamine oxidase inhibitor (MAOI), and in those who are taking Zyban®, Wellbutrin®, or Wellbutrin SR®. Adverse effects include tachycardia, agitation, dizziness, headache, insomnia, sedation, constipation, nausea, vomiting, tremor, and blurred vision.

For information about Wellbutrin's assistance program, contact the MAP office at (706) 721-0131, GlaxoSmithKline 'Bridges to Access' patient assistance programs at 1-866-728-4368, or their website at www.wellbutrin-xl.com.

Authored by Josh Morris


Medication Access Program
University of Georgia at the
Medical College of Georgia
Clinical Pharmacy Program
CJ-1020
Augusta, Georgia 30912-2450
706-721-0131 or 800-736-2273 ext. 0131 or e-mail us at: map@mapuga.com


  
The MAP newsletter is published quarterly to present topics of interest to the transplant
community. If you would like to submit material to be considered for publication in the
newsletter, please contact MAP at:
Medication Access Program
University of Georgia at the Medical College of Georgia
Clinical Pharmacy Program
CJ-1020
Augusta, Georgia 30912-2450
(706) 721-0131 or 1-800-736-2273 ext. 0131
E-mail -
map@mapuga.com
The Medication Access Program is a statewide program for solid-organ transplant patients in Georgia that offers information about medication assistance programs and helps with the enrollment into these programs.