The Medical Advisory Panel for the Veterans Health Administration Pharmacy Benefits Management Strategic Healthcare Group (PBM SHG) coordinates the development of guidelines for the pharmacological management of common disease states treated within the Veterans Affairs (VA) system. These documents are based on nationally recognized treatment guidelines and current literature with the purpose of assisting primary care practitioners in clinical decision-making. As a result, if drug therapy is standardized, patient outcomes improve and the use of cost-effective medication is enabled.
Current guidelines for the treatment of GERD follow a step-wise, or step-up, approach. Thetab first tier consists of nonphar-macological modalities, including lifestyle changes and behavior modification (Table 1). If a patient does not experience symptomatic relief after a trial of nonpharmaco-logical measures, an antacid is recommended on an as-needed basis. A histamine receptor antagonist (H2RA) is then initiated at a standard dose, titrated to the manufacturer’s recommended maximum dose. If symptoms persist with a maximum dose of an H2RA, a prokinetic agent or a once-daily dose of a proton pump inhibitor (PPI) is recommended to replace the H2RA. Although it is the standard practice in some institutions to increase the PPI dose to twice daily after unsuccessful once-daily dosing, no published recommendations are available for routine treatment of uncomplicated GERD with twice-daily dosing of PPIs. canadian cialis online
Table 1 Lifestyle Modifications for Patients with Gastroesophageal Reflux Disease
1. Elevate the head of the bed six inches.
2. Avoid fatty foods.
3. Eat smaller meals.
4. Avoid eating for at least three hours before lying down.
5. Lose weight.
Other treatment guidelines, including JNC VI and the Expert Panel Report 2 outline a step-down approach to medication management after a patient’s hypertension and asthma, respectively, are stabilized. In contrast, there is no consensus about therapeutic step-down treatment for GERD.
To assess the appropriateness of twice-daily dosed PPIs, a retrospective medication use evaluation (MUE) was completed at the Kansas City Veterans Affairs Medical Center during September 1999 and was then compared with the PBM SHG guidelines. The guidelines suggest twice-daily PPIs and include (1) treatment of complicated GERD, Barrett’s esophagus, GERD refractory to alternate regimens, and hypersecretory conditions and (2) therapy as part of Helicobacter pylori infection. For this MUE, the PBM SHG randomly selected 45 patients from a population of 309 at our facility whose prescriptions had been filled, during April 1999, for either oral delayed-release capsules of omeprazole generic (Prilosec tablet, AstraZeneca) or oral delayed-release capsules of lansoprazole (Prevacid generic, TAP), administered twice daily. By means of the electronic medical record system, patients’ charts were reviewed for indications, endoscopic findings, and previous medications prescribed for the treatment of GERD.
Sixty percent (n = 27) of the patients reviewed had an accepted indication for the use of PPIs twice daily. Extrapolated to the whole population of 309, these data indicate that 186 of those patients (60%) whose PPI prescriptions were filled in April 1999 also had acceptable indications for the use of PPIs twice a day.
It is unclear whether the remaining 40% (n = 123) of the total population (n = 309) could have benefited from a dose reduction. If patients could tolerate such a reduction, and assuming that most patients were taking lansoprazole canadian, the institution could potentially save more than $60,000 annually in direct drug costs by stepping down therapy in this remaining 40%.
To provide continual symptom control of GERD while minimizing costs, a protocol was developed locally to implement step-down therapy in patients with uncomplicated GERD who were receiving PPIs twice a day.