Provider Update
Volume 16, Issue 6
December 1999
DHH Secretary on Y2K
Over the past several months, a great deal has been written and broadcast regarding Y2K and whether computer systems will recognize dates past December 31, 1999. The Department of Health and Hospitals (DHH), has been working diligently since 1997 to prepare for the Y2K challenge.
While I am confident that our systems are ready for business in 2000 and into the next millennium, it is my pleasure to report to you that an independent team of external consultants retained by HCFA reviewed both our major claims payment system and our eligibility system and rated these systems a low risk with respect to Y2K issues. This means that these systems, which are critical for the payment of our claims, are ready and that HCFA feels comfortable with our ability to service providers. It also means that even if disruptions occur, DHH is ready with contingency plans to ensure that payments for medical services will be made into the next millennium.
Whether you are worried about Y2K or simply fascinated with the technological challenges, I invite you to read the Provider Update articles on our Y2K preparations and measures you can take to be Y2K ready.
David Hood
Secretary of the Department of Health and Hospitals
Helpful Hints for Y2K
During the past year, DHH has endeavored to share Y2K information and the status of our Y2K efforts with the medical community. Our goal was to ensure that we are prepared for business as usual in the year 2000
As we finalize the journey through the last check points of the Y2K process, DHH and Unisys want to thank you for the excellent job you are doing in providing a consistent level of excellence in serving your patients, the Medicaid recipients. Thank you for your cooperation during the time we took to test our systems to ensure Y2K readiness. We realize that you are preparing for Y2K, also.
While we do not anticipate systems malfunctions due to the change in year from 1999 to 2000, should there be a period of time during which Medicaid eligibility information is not accessible, we ask Medicaid providers to not refuse medically necessary services to persons who identify themselves as having Medicaid coverage. Such persons could have in their possession a Medicaid swipe card or other documents indicating coverage could exist and should be used to document services rendered in good faith.
Through past newsletter articles, we have attempted to keep you informed of all additional steps being taken to achieve a smooth transition to the Year 2000. At this time, we would like to share with you some Y2K Helpful Hints for dealing with your business partners and
clientele.
Y2K Helpful Hints
� Corporate or home offices should be certain to distribute Y2K information to any and all satellite or service locations that may need it. All major Y2K experts agree that it is extremely important to ensure that anyone within your organization who may need this information receives
it.
� If you rely on another entity (i.e., billing service, clearinghouse, etc.) to bill claims or reconcile accounts on your behalf, please share Y2K information with them. If these entities are not informed and/or are not Y2K ready, it could cause additional difficulty for
you.
� Everyone should have a Y2K contingency plan. Simply stated, a contingency plan is the actions one would implement should, for example, your electrical systems fail. If you do not have such a plan, you may want to prepare one and share it with anyone in your organization who would needs this information. Approach the preparation of a Y2K contingency plan as you would a disaster preparedness
plan.
� Check with manufacturers of any essential electronic equipment (computers, faxes, telephones, etc.) in your office to ensure that the equipment is Y2K
ready.
� Ensure that all vehicles used to transport patients are filled with gas. This measure will help reduce possible disruptions in normal transports. Also, you should be prepared to work with alternate routes and/or
schedules.
� Order ample supplies to ensure that you can provide services to your patients should vendor difficulties
arise.
� If you use a nationally recognized claim form such as a UB-92 or HCFA 1500 to bill Medicaid services, please ensure that you have an ample supply in the event hardcopy (paper) submission is required to render
payment.
Y2K Patient Assistance Tips
If you receive calls from Louisiana Medicaid recipients concerning Y2K readiness issues, please refer them to the Louisiana Medicaid Recipient Hotline toll-free number (800) 834-3333 on the back of their ID card. The following are recommendations you can make to patients who might be
vulnerable.
� Make an emergency information list to include medical emergency contact information; names and numbers of relatives or friends to be contacted in an
emergency.
� Make a list of the names and numbers of your medical providers.
� Attach a copy of all medical cards to the emergency information list.
� Make a list of medication used, including any allergies or sensitivities.
� Make a list of any medical equipment used; be sure to have extra supplies (batteries, etc.) on hand if
needed.
� Keep a seven-day supply of all essential medication with you.
� Identify safe places indicated in your community to go if needed (i.e., emergency
shelters).
� Ask your local emergency management offices if transportation services will be available in case of an
emergency.
� Obtain additional information from the Red Cross or Civil Defense Headquarters regarding suggestions for essential supplies (i.e., food, water, first aid kits, etc.)
We hope this information is useful to you in preparing for Year 2000. If you have questions or concerns related to our Y2K efforts, please contact the Unisys Y2K Hotline at (225) 237-3210, and your call will be returned as quickly as possible.
�Experienced HIV/AIDS Provider� Defined
The Journal of the American Medical Association indicates that the care provided to Medicaid-eligible persons with HIV disease improved during the period from January 1996 to December 1998. The Health Care Financing Administration REMAINS COMMITTED TO CONTINUOUSLY IMPROVING THE QUALITY OF CARE PROVIDED TO ALL Medicaid recipients living with HIV/AIDS. There remains a substantial and disturbing gap in the receipt of antiretroviral therapy between Medicaid recipients and those receiving care covered by private third-party payers. A number of studies have indicated that treatment by an experienced HIV provider is critical to receipt of quality care. The fact sheet below also provides a definition of an "experienced HIV/AIDS provider" and other references that can be used to guide your efforts to improve the access to and use of experienced providers by Medicaid recipients who are living with
HIV/AIDS.
Fact Sheet on Experienced HIV/AIDS Providers
Definition of an Experienced HIV/AIDS Provider:
An experienced HIV/AIDS provider is a licensed physician, nurse practitioner, or physician assistant who has maintained an active HIV/AIDS medical practice by providing continuous and direct medical care to a minimum number of individuals and has completed a minimum number of hours of continuing medical education on topics related to the care and management of individuals with HIV/AIDS.
Experts recommend an active ongoing caseload of at least 25 individuals with HIV/AIDS over the preceding 24 months, either in regular practice or as part of a supervised post-graduate training program. In urban areas with high incidence this should be a minimum of 50 patients over the preceding 24 months. Experts in the HIV/AIDS field further suggest 12 as the minimum number over a 1-year period.
Note: For managed care purchasers, Sample Purchasing Specifications for HIV Infection, AIDS, and HIV-Related Conditions, which include a definition of HIV/AIDS experienced providers, have been prepared by the Center for Health Services Research and Policy at the George Washington University School of Public Health and Health Services with support from the Centers for Disease Control and Prevention and the Health Resources and Services Administration. These sample specifications may be found at
http://www.gwu.edu/chsrp.
HIV/AIDS Treatment Guidelines:
The HCFA-supported AIDS Treatment Information Service (ATIS) maintains current versions of all Department of Health and Human Services endorsed HIV-related treatment guidelines on its website, http://www.hivatis.org. You may access and print the guidelines free of charge from the ATIS
site.
References:
Data from the HIV Cost and Services Utilization Study showed that the percentage of Medicaid beneficiaries who were not receiving antiretroviral treatment (but should have been according to treatment guidelines) decreased from 38 percent in December 1996 to 19 percent January 1998. However, Medicaid beneficiaries were more than twice as likely not to receive antiretroviral therapy as those with private insurance. M. Shapiro, et al., "Variations in the Care of HIV-Infected Adults in the United States," JAMA. 1999;281:2305-2305.
One study has shown that, after adjusting for CD4 count and severity of illness, the risk of death was 43 percent lower for patients with the most experienced physicians than for patients of the least experienced. (M.M. Kitihata, et al. "Physicians' Experience with the Acquired Immunodeficiency Syndrome as a Factor in Patients' Survival." NEJM March 14, 1996; 334(11):701-706.
Another study in Canada showed that patients with inexperienced providers were nearly seven times less likely to receive antiretherapy as those with experienced providers. S. Strathdee et al. "HIV+IDUs eligible for Antiretrovirals: What are the Barriers to Receiving Therapy Despite Universal Access?," Fifth Conference on Retro viruses and Opportunistic Infections 1998, Abstract 132.
A US-based study showed that women receiving care in high-experience clinics survived longer after an AIDS diagnosis than those in low-experience clinics, showing a 50 percent reduction in likelihood of death. C. Laine, et al. "The Relationship of Clinic Experience with Advanced HIV and Survival of Women," AIDS, March 5, 1998 12(4):417-424.
A study of New York State Medicaid patients showed that patients in clinics with expert providers of HIV care were half as likely to use emergency departments for care. L.E. Markson, et al., "Repeated Emergency Department Use by HIV-Infected persons: Effect of Clinic Accessibility and Expertise in HIV Care." Journal of Acquired Immune Deficiency Syndromes & Human Retrovirology 17(1):35-41, 1998.
Inclusion of Antihistimine/Decongestant Products
Effective for services beginning October 26, 1999, the Bureau of Health Services Financing will begin reimbursing for the following antihistamine/decongestant products for the medically approved indication of allergic rhinitis (seasonal or perennial). Please be reminded that in accordance with Section 1927 (d) (2) of the Social Security Act, the Medicaid agency is allowed to exclude coverage of drugs or classes of drugs containing cough and cold agents when those products are prescribed for the treatment of coughs and colds. In addition, the Department will commence Drug Utilization Reviews on a retrospective basis as well as develop prospective drug utilization criteria to reduce therapeutic duplication of antihistamine products and/or concurrent therapy with other antihistamine/decongestant
products.�
Generic Description
ACRIVASTINE AND PSEUDOEPHEDRINE
AZATADINE AND PSEUDOEPHEDRINE
BROMPHENIRAMINE AND PHENYLEPHRINE
BROMPHENIRAMINE, PHENYLEPHRINE, AND PHENYLPROPANOLAMINE BROMPHENIRAMINE AND PSEUDOEPHEDRINE
CARBINOXAMINE AND PSEUDOEPHEDRINE
CHLORPHENIRAMINE, PHENINDAMINE, AND PHENYLPROPANOLAMINE CHLORPHENIRAMINE AND PHENYLEPHRINE
CHLORPHENIRAMINE, PHENYLEPHRINE, AND PHENYLPROPANOLAMINE CHLORPHENIRAMINE AND PHENYLPROPANOLAMINE
CHLORPHENIRAMINE, PHENYLTOLOXAMINE, AND PHENYLEPHRINE CHLORPHENIRAMINE, PHENYLTOLOXAMINE, PHENYLEPHRINE, AND
PHENYLPROPANOLAMINE
CHLORPHENIRAMINE AND PSEUDOEPHEDRINE CHLORPHENIRAMINE, PYRILAMINE, PHENYLEPHRINE, AND PHENYLPROPANOLAMINE
CLEMASTINE AND PHENYLPROPANOLAMINE
DEXBROMPHENIRAMINE AND PSEUDOEPHEDRINE
DIPHENHYDRAMINE AND PSEUDOEPHEDRINE
FEXOFENADINE AND PSEUDOEPHEDRINE
LORATADINE AND PSEUDOEPHEDRINE
PHENIRAMINE AND PHENYLEPHRINE
PHENIRAMINE, PHENYLTOLXAMINE, PYRILAMINE, AND PHENYLPROPANOLAMINE PHENIRAMINE, PYRILAMINE, AND PHENYLPROPANOLAMINE
PROMETHAZINE AND PHENYLEPHRINE
TRIPROLIDINE AND PSEUDOEPHEDRINE
CHLORPHENIRAMINE, PHENYLEPHRINE, AND METHSCOPOLAMINE CHLORPHENIRAMINE, PHENYLEPHRINE, PHENYLPROPANOLAMINE, ATROPHYOSCY,
SCOPOLAM
CHLORPHENIRAMINE, PHENYLPROPANOLAMINE, AND METHSCOPOLAMINE CHLORPHENIRAMINE,PSEUDOEPHEDRINE AND METHSCOPOLAMINE
CPT Code 99282
FIMS #5829
(RA Message on 11/9/1999)
CPT code 99282 has been added to the list payable to Certified Nurse Practitioners with an effective date of service August 1, 1999.
Additional Report Needed for Transplant Claims
Due to some problems with conflicting surgical dates for transplant claims, the Medical Review Department will need a dated operative report in addition to the BHSF letter of authorization in order to review and approve claims for payment of transplant procedures. This will include claims from the surgeon, assistant, co-surgeon, anesthesiologist, and hospital providers
Requirement for Access Clause in Contracts
Providers participating in the Louisiana Medicaid Program must comply with the provisions contained in 42 CFR � 420.32 which requires that a contract between a provider (e.g., pharmacy, doctor, hospital, etc.) and a subcontractor (e.g., management company) must include a clause that allows federal and state regulatory agencies access to the subcontractor�s records if the contract is for services that either cost or are valued at $10,000 or more over a twelve (12) month period. This includes contracts for both goods and services in which the service component is worth $10,000 or more over a twelve (12) month period.
Access to the subcontractor�s records must be available to federal and state regulatory agencies for four(4) years after the services are furnished under the contract or subcontract. Access to records shall also be allowed for any contract between the subcontractor and organizations related to the subcontractor.
If the contract between the provider and the subcontractor does not contain the required clause, the costs for the services furnished under the contract or subsequent subcontract will not be considered allowable costs by the Louisiana Medicaid Program.
DHH Hosts Medicaid Conference
The Department of Health and Hospitals is hosting a one-day Medicaid Conference to solicit ideas on improving the delivery of Medicaid services. The conference will be held in the Wade O. Martin, Jr. Auditorium on Friday, December 17 from 9 a.m. to 3:30 p.m. at the State Archives Building, 3851 Essen Lane, Baton Rouge, LA 70809.
DHH is soliciting conceptual presentations on improving current Medicaid services while assuring access to quality care delivered in more efficient and effective ways. Persons interested in making a presentation should provide key components of their idea including the new method of delivering services and the advantages over the existing system of
care.
Participants will be limited to a ten-minute presentation and are asked to submit written summaries of no more than three pages at the time of presentation. Presentation times will be reserved on a first-call, first-scheduled basis. Participants may call (225)342-3807 to reserve a presentation time.
Persons who are not able to participate in the conference may submit a written summary of no more than three pages to DHH, Madeline McAndrew, Executive Director, Division of Research and Development, P.O. Box 2870, Baton Rouge, LA 70821-2870.
Addition of Codes for Crossover Claims
FIMS # 5798
(RA Message on 10/12/1999 and 10/19/1999)
The following codes have been made payable for crossovers claims effective with date of service
given:
G0125
PET Lung
Effective with date of service 4/01/1998
G0126 PET Lung
Effective with date of service 4/01/1998
G0163 PET Colorectal
Effective with date of service 7/01/1999
G0164 PET Lymphoma
Effective with date of service 7/01/1999
G0165 PET Melanoma
Effective with date of service 7/01/1999
Unisys Holiday Schedule for Calendar Year 2000
(RA Message on 1/11/2000 and 1/18/2000
New Year�s Day - December 31, 1999
Good Friday - April 21, 2000
Memorial Day - May 29, 2000
Independence Day - July 4, 2000
Labor Day - September 4, 2000
Thanksgiving- November 23, 2000
Day After Thanksgiving-Nov. 24, 2000
Christmas - December 25, 2000
LADUR Education Article
Appropriate Use of H2-Antagonists and Proton Pump Inhibitors for Managing Gastrointestinal Disorders
Shatha A. AL-Samarrai, Pharm.D. and W. Greg Leader, Pharm.D.
Issues
� H2RAs and PPIs continue to play an important role in the treatment of common gastrointestinal
disorders.
� These agents have significant differences in efficacy, drug interaction, and adverse
effects.
� The use of combined H2RA and PPI therapy is irrational and adds to the cost of therapy.
Introduction
It is estimated that 20% to 40% of the adult population report heartburn on a monthly basis. Common gastrointestinal disorders such as peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD) affects a large percentage of the American population. Over 30, 000 prescriptions for histamine2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) are adjudicated through the Louisiana Medicaid program each month. Clearly, the cost of treating these illnesses is substantial.
Despite advances in the understanding of the pathophysiology of PUD and GERD and the non-acid mechanisms that contribute to the development and maintenance of these disease states,
H2RAs and PPIs continue to play an important role in the treatment of these disorders. Agents from both classes, by different mechanisms, substantially reduce the production of gastric acid; however, there are significant differences in efficacy, drug interactions and adverse effects that may translate into differences in clinical outcome, patient quality of life, and the cost of therapy. Therefore, the purpose of this paper is to address the appropriate use of these agents in the treatment of common acid-related gastrointestinal disorders and thus why they should not be used concomitantly.
Pharmacology
Histamine2-Receptor Antagonist
The class of agents commonly referred to as the H2RAs reduce gastric secretion by competitively and selectively inhibiting the binding of histamine to the histamine-2 receptor located on the basolateral surface of the parietal cell (Figure 1).
Figure 1: Schematic of acid secretion in the Gut. PPI = Proton Pump Inhibitor, H2RA = Histamine2-Receptor Antagonist
This competitive inhibition decreases cyclic AMP production in the parietal cell resulting in decreased hydrogen ion secretion. H2RAs cause a decrease in both basal and food stimulated acid secretion. Currently four
H2RAs are marketed, cimetidine (Tagamets), famotidine (Pepcid), nizatadine (Axid) and ranitidine (Zantac). All four agents are equally effective when used in equipotent doses (Table 1).
These agents are rapidly absorbed, and with the exception of nizatidine, all undergo extensive first pass metabolism in the liver. All four agents are metabolized by the liver to some extent and are also eliminated renally via both glomerular filtration and tubular secretion. Dosages need to be adjusted in hepatic failure and renal insufficiency. Cimetidine has been associated with increases in serum creatinine concentrations due to its ability to block the tubular secretion of creatinine; however, this increase in serum creatinine does not appear to be clinically relevant.
In general, the H2RAs are well tolerated and severe adverse effects are uncommon. Headache, lethargy, thrombocytopenia, confusion, depression and hallucinations have been reported. CNS effects such as confusion are more common with larger doses, when the dosage of the drug is not decreased in patients with renal insufficiency, and in elderly patients. Cimetidine has antiandrogenic effects and may cause impotence and gynecomastia.
Because it binds to and inhibits several isozymes of the cytochrome P-450 enzyme system, cimetidine is associated with a number of drug-drug interactions. Most notably, cimetidine inhibits the metabolism of theophylline, warfarin, phenytoin, and drugs such as cisapride that are metabolized by CYP 3A4. The other
H2RAs do not appear to cause clinically significant metabolic drug interactions, however, the resultant reduction in acid secretion may decrease the bioavailability of drugs that need an acidic environment for absorption (e.g., ketaconazole, itraconazole, ampicillin, iron salts, and
digoxin).
Proton Pump Inhibitors
The PPIs supress acid reduction by binding reversibly or irreversibly to the hydrogen potassium adenosine triphosphatase enzyme system (H+K+ ATPase or Proton Pump) that serves as the final mechanism for pumping hydrogen ions from the parietal cell into the lumen of the gut. (Figure 1) This results in potent and dose dependent inhibition of acid secretion stimulated by acetylcholine, histamine, and gastrin. (Figure 1) Currently, there are three PPIs available in the United States, omeprazole (Prilosec), lansoprazole (Prevacid), and rabeprazole (Aciphex). All three agents are basic compounds that must be protonated and metabolized to an active form. Omeprazole and lansoprazole bind irreversibly to the proton pump. Rabeprazole binding appears to be partially reversible.
Absorption of the three available PPIs ranges from approximately 30% for rabeprazole to more than 80% for lansoprazole. All three agents are metabolized hepatically through the cytochrome P-450 system with little or no parent drug eliminated renally. Thus, patients with renal impairment require no dosage adjustment; however, a dosage reduction should be considered for lansoprazole in patients with severe hepatic disease.
As with the H2RAs, the PPIs are well tolerated and have minimal adverse effects. Adverse effects for the three available agents are similar with headache, diarrhea, nausea and abdominal pain being most common. In a small number of patients, skin rashes and eruptions have been reported. A potential complication of long-term use of these agents is prolonged hypergastrinemia and its potential consequences. The degree of hypergastrinemia appears to be related to the extent of acid suppression. Hypergastrinemia has been associated with the development of gastric enterochromaffin-like cell (ECL) carcinoid tumors and ECL dysplasia in rats; however, no ECL dysplasia or tumors have been reported in humans receiving long-term PPIs. Nonetheless, some clinicians suggest the serum gastrin concentrations be obtained yearly in patients receiving continuous long-term PPI therapy.
Because these agents are metabolized through the cytochrome P-450 system, the potential for drug-drug interactions exists. Omeprazole may increase serum concentrations of clarithromycin, phenytoin, and some of the benzodiazepines including diazepam. Lansoprazole and rabeprazole do not appear to cause any clinically significant drug interactions involving drug metabolism. Because of the effect of these agents on gastric acidity, drugs requiring an acidic environment for absorption (e.g., ketaconazole, itraconazole, ampicillin, iron salts, and digoxin) may have decreased bioavailability when given concurrently with
PPIs.
Role of Antisecretory Agents in the Treatment of Acid-Related Disorders
Numerous studies have demonstrated the efficacy of these classes of agents in the treatment of PUD, GERD and Zollinger Ellison Syndrome (ZES). Despite a more in-depth understanding of the importance of non-acid related factors in the development and maintenance of these disease states,
H2RAs and PPIs remain an important part of therapy; however, a renewed understanding exists of the appropriate role of these agents in
therapy.
Peptic Ulcer Disease
In recent years we have come to understand that PUD has three primary etiologies, helicobacter pylori infection, non-steroidal anti-inflammatory (NSAID) use, and hypersecretory states such as ZES. The vast majority of patients that develop PUD not associated with NSAID use are positive for H. pylori. Based on this knowledge, the focus of treatment has shifted from the long-term control of acid-related symptoms to ulcer healing, H. Pylori eradication and prevention of relapse.
In patients who test positive for H. Pylori, it is imperative to treat with appropriate antibiotics; however, the addition of an anti-secretory agent enhances ulcer healing. In comparative trials, PPIs have been shown to be as good or better than
H2RAs with respect to ulcer healing after four or eight weeks of therapy. Because of this, a triple drug regimen (two antibiotics and an antisecretory drug) that includes a PPI is considered the gold standard for the treatment of H. pylori associated PUD. The addition of the PPI to the two antibiotics significantly increases eradication rates. Although the infection is usually eradicated after 10 to 14 days of therapy, ulcer healing is slower. Therefore, it is recommended that PPIs be continued for a total of 4 weeks of therapy and
H2RAs be continued for a total of 6 to 8 weeks of therapy. Longer durations of therapy are unnecessary unless ulcer symptoms reoccur. If ulcer symptoms reoccur, the patient should be reevaluated for resistant or inappropriately treated H. pylori infection.
The treatment and prevention of NSAID induced ulcers is somewhat more problematic than those caused by H. Pylori infection. Either a PPI or an
H2RA (but not a combination of both) may be used to promote ulcer healing. Continuation of the NSAID during the ulcer treatment phase will delay healing. If the NSAID must be continued, PPIs may be more effective than
H2RAs in promoting healing. If H2RA therapy is selected, a higher daily dose or a longer treatment period (12 weeks instead of 8) may be necessary. Gastric ulcers may require higher doses of anti-secretory agents and a longer duration of therapy. The most effective method of preventing recurrent NSAID induced PUD is the discontinuation of the NSAID; however, this course of action is often not feasible. Misoprostol (Cytotec) is the only agent that is approved by the FDA for preventing NSAID induced ulcers, but clinical trials with both
H2RAs and PPIs have shown them to be effective in preventing ulcers in patients on chronic NSAID therapy. More recent studies have shown that PPIs may be superior to
H2RAs at standard doses in patients with NSAID ulcers.
The combination of a PPI and H2RA for the treatment of PUD has never been shown to be more effective than either agent alone. Based on the pharmacologic profile of these two classes of agents, this combination is irrational and may put the patient at higher risk for adverse effects or drug interactions than if an appropriate trial of a single agent is used.
Based on the available data and standards of practice, antisecretory maintenance therapy is not indicated in most patients with PUD. A single treatment regimen with 4 weeks of a PPI or 8 weeks of a
H2RA is usually sufficient to treat most patients. Higher doses of a PPI (e.g., omeprazole 40mg/day) are often effective in treating ulcers unresponsive to standard therapy. In patients with refractory ulcers, other factors such as patient compliance, NSAID use, heavy smoking, or gastrin secreting tumors should be
examined.
Gastroesophageal Reflux Disease
A number of factors contribute to the development and continuance of GERD. The disease itself can vary from intermittent heartburn to debilitating esophagitis. Unlike PUD, GERD can be a chronic disease that requires prolonged therapy. Recent guidelines from the American College of Gastroenterology present a step plan for its treatment. Initial and chronic therapy should always involve lifestyle modifications. The use of patient directed therapy with over-the-counter (OTC) antacids and
H2RAs is appropriate in most patients. OTC H2RAs appear to be particularly effective when used prior to activities that precipitate reflux. Patients should be reminded to let their pharmacist and physician know that they are taking these agents.
For patients with more severe GERD or those who have symptoms despite patient directed therapy, acid suppression therapy with either a PPI or H2RA (but not both) is usually effective in relieving symptoms and healing esophagitis. Therapy may be initiated with low dosages of
H2RAs (OTC doses, ranitidine 75mg BID) and escalated until symptoms are controlled. Alternatively therapy may be initiated with once or twice daily PPI therapy (omeprazole 20mg QD or BID) and then decreased to the lowest effective dose. High doses of
H2RAs (e.g., ranitidine 300mg BID) may often be necessary to control GERD symptoms. Although promotility agents (e.g., cisapride [Propulsid]) may provide some benefit to patients with esophageal motility disorders, PPIs appear to be more effective. Divided daily doses of
H2RAs appear to be more effective than single daily doses in the treatment of GERD.
Because GERD is a chronic disease, long-term therapy may be necessary. Chronic therapy should be titrated to the lowest effective dose and lifestyle modifications should be stressed. Sufficient data to support the use of the combination of the promotility agents and an anti-secretory agent in the treatment of GERD is not available. The use of high dose PPIs alone is more efficacious and cost effective than a combination of a
H2RA and cisapride (Propulsid). As with the treatment of PUD, the combination of a PPI and a
H2RA is irrational and should not be used. H2RA are the drug of choice for maintenance of mild esophagitis; however, patients with moderate to severe esophagitis should be maintained on a
PPI.
Zollinger Ellison Syndrome (ZES)
ZES is a rare disorder that often presents as recurrent and refractory PUD and/or GERD. This painful syndrome is caused by one or many gastrin producing tumors that cause extreme hypersecretion of acid. In the case of a single tumor, resection is often the treatment of choice; however, even after resection, a large percentage of patients will continue to have acid hypersecretion. PPIs are the anti-secretory agent of choice. High dosages are usually necessary with the average omeprazole treatment dose approaching 60-80mg/day and dosages as high as 160mg/day of omeprazole or lansoprazole may be necessary. The PPI dose should be titrated to a basal hydrogen ion secretion of 10mEq/hr or less.
H2RAs may be effective in some patients but extremely high doses (1.2-6grams/day) may be necessary. Cimetidine should not be used in this population due to its anti-androgenic effects.
Conclusions
Acid-related gastrointestinal disorders are common and the use of H2RAs and PPIs are effective in treating these disorders when used appropriately. However, new understanding of these disease states has altered what is considered the appropriate use of these agents. PPIs, the most potent class of anti-secretory agents, may be the drugs of choice in most patients. Single agent anti-secretory therapy is appropriate in all patients. The combination of conventional anti-secretory agents adds to cost of therapy without enhancing healing.
Selected References
Berardi, R. R. (1999). Peptic Ulcer Disease. In: Pharmacotherapy Self-Assessment Program. Module 8:
Gastroenterology, Nutrition, 3rd ed., Carter BL, Lake KD, Rabel MA. et al., eds. Kansas City,
American College of Pharmacy: 1-28.
Berardi, R. R. (1999). Peptic Ulcer Disease. In: Pharmacotherapy: a pathophysiologic approach. 4th ed., Dipiro JT, Talbert RL, Yee GC, et al., eds Stamford, CT, Appleton & Lange:
548-570.
Chen, B. P. and M. S. S. Chow (1999). "Proton Pump Inhibitors: An assessment of efficacy and Safety."
Formulary 34: 437-51.
DeVault, K. R., Castell, D.O. et al. (1999). "Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease." Am J Gastroenterol 94(6):
1434-42.
Feret, B., R. Quercia, et al. (1999). "Rabeprazole: A proton pump inhibitor for the treatment of acid-related disorders." Formulary 34:
313-23.
Fisher, R. S. and Parkman, H. P. (1998). "Management of nonulcer dyspepsia." N Eng J Med 339:
1376-81.
Garnett, W. R. (1993). "Efficacy, safety, and cost issues in managing patients with gastroesophageal reflux disease." Am J Hosp Pharm 50(suppl 1):
S11-S18.
Garnett, W. R. (1998). "Considerations for long-term use of proton-pump inhibitors." Am J Health-Sys Pharm 55:
2268-79.
Hudson, N., Taha, A. S., et al. (1997). "Famotidine for healing and maintenance in nonsteroidal anti-inflammatory drug-associated gastroduodenal ulceration." Gastroenterology 112:
1817-22.
Killian, A., Danziger, LH (1996). Gastroesophageal reflux disease. In: Pharmacotherapy Self Assessment Program: Module 6. Respiratory, Nephrology, Gastroenterology. 2nd ed. Carter BL, Lake KD, Raebel MA. Kansas City, American College of Clinical Pharmacy:
221-237.
Klinkenberg-Knol, E. C., Festen, H. P. M., et al. (1994). "Long-term treatment with omeprazole for refractory esophagitis: efficacy and safety." Ann Intern Med 121:
161-7.
Lampkin, T. A., Ouellet, D., et al. (1990). "Omeprazole: a novel antisecretory agent for the treatment of acid-peptic disorders." DICP Ann Pharmacother 24:
393-402.
Lanza, F. L. (1998). "A guideline for the treatment and prevention of NSAD-induced ulcers." Am J Gastroenterol 93:
2037-46.
Peterson, W. L. (1997). "The role of antisecretory drugs in the treatment of Helicobacter pylori Infection." Aliment Pharmacol Ther 11(suppl 1):
21-5.
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