January 2006 • www.ecardiologynews.com Practice Trends 33 CMS ‘E-Prescribing’ Rule Presents Big Challenges BY JENNIFER LUBELL the projected cuts in Medicare physician 1, according to the Federal Register. drug program,” said Mike Leavitt, secre- Associate Editor, Practice Trends payments of 4.4% in 2006 and a cumula- CMS also plans to pilot test initial e-pre- tary of the Department of Health and Hu- tive 26% reduction from 2006 to 2011,” scribing standards, which may be includ- man Services. ithout the proper technology, Neil Kirschner, Ph.D., senior associate ed in a final rule to be issued by April 2008. For the most part, medical organiza- physician practices may find it for regulatory and insurer affairs with the “These standards will allow Medicare, tions expressed support for the agency’s e- Wdifficult to participate in American College of Physicians, said in physicians, hospitals, group practices, oth- prescribing initiative. “Having standards is Medicare’s new “e-prescribing” standards an interview. er health providers, and prescription drug good. It will provide a common language under the Part D drug benefit, physician The Centers for Medicare and Medicaid plan sponsors and Medicare Advantage or- for anyone using this method,” Dr. Mary groups claim. Services in a final rule established the set of ganizations to take advantage of e-pre- Frank, board chair of the American Acad- “Most primary care physicians will be standards for electronic prescribing, or e- scribing technology to improve medica- emy of Family Physicians, said in an in- unable to afford to implement this tech- prescribing, of drugs covered by Medicare’s tion prescribing for Medicare beneficiaries terview. E-prescribing would also reduce nology on their own, particularly with prescription drug benefit that started Jan. that participate in the new prescription errors, increase patient safety, and when it is fully interoperable, increase quality in health care as well, she said. BIDIL® (isosorbide dinitrate/hydralazine HCl) adverse experiences compared to 12% who discontinued placebo. Overall, adverse events were more common in BiDil- INDICATIONS AND USAGE treated than in placebo-treated patients. Table 1 lists adverse events reported with an incidence of ≥2% in patients treat- Unfortunately, few practices are using BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to ed with BiDil in A-HeFT, and, after rounding to the nearest 1%, occurring more frequently than in the placebo group, improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. regardless of causality. Headache and dizziness were the two most frequent adverse events and were more than twice as this technology, Dr. Kirshner said. “Sur- There is little experience in patients with NYHA class IV heart failure. Most patients in the clinical trial supporting effec- frequent in the BiDil group. The most common reasons for discontinuing BiDil in the A-HeFT trial were headache (7%) and tiveness (A-HeFT) received a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor block- dizziness (4%). veys vary, but the percentage of practices er, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist. Table 1. Adverse Events Occurring in the A-HeFT Study in ≥2% of using it ranges somewhere from 5% to CONTRAINDICATIONS Patients Treated with BiDil. BiDil is contraindicated in patients who are allergic to organic nitrates. BiDil Placebo 18%.” The number is even lower for the WARNINGS (N=517) (N=527) typical small practice, he added. Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors such as sildenafil, varde- (% of patients) (% of patients) nafil, or tadalafil could result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Reasonable supportive care should consist of those measures used to treat a nitrate overdose with eleva- Headache 50 21 Only 25%-30% of the AAFP’s members tion of the extremities and central volume expansion. Dizziness 32 14 have electronic health records, Dr. Frank PRECAUTIONS Chest pain 16 15 General Asthenia 14 11 said. “They are, at present, the only ones The precautions that need to be taken when using BiDil are those appropriate to each of its components. Nausea 10 6 Treatment with hydralazine hydrochloride may produce a clinical picture simulating systemic lupus erythematosus includ- Bronchitis 8 7 who might be able to immediately adopt ing glomerulonephritis. If systemic lupus erythematosus-like symptoms occur in patients treated with BiDil, discontinua- Hypotension 8 4 tion of BiDil should be considered only after a thorough benefit-to-risk assessment. Symptoms and signs of systemic Sinusitis 4 2 this approach. I say ‘might’ because not all lupus erythematosus usually regress when hydralazine hydrochloride is discontinued but residua have been detected Ventricular tachycardia 4 2 EHR systems have the e-prescribing com- many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests.) Palpitations 4 3 Symptomatic hypotension, particularly with upright posture, may occur with even small doses of BiDil. Therefore, BiDil Hyperglycemia 4 3 ponent.” Until there is some financial sup- should be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Rhinitis 4 3 Hydralazine hydrochloride can cause tachycardia potentially leading to myocardial ischemia and anginal attacks. Paresthesia 4 2 port to help doctors implement this tech- Careful clinical and hemodynamic monitoring is recommended when BiDil is administered to patients with acute myocar- dial infarction to avoid the hazards of hypotension and tachycardia. Vomiting 4 2 nology, it will not be used widely, she said. Hydralazine hydrochloride has been associated with peripheral neuritis, evidenced by paresthesia, numbness, and tingling, Amblyopia 3 1 which may be related to an antipyridoxine effect. Pyridoxine should be added to BiDil therapy if such symptoms develop. Hyperlipidemia 3 2 Even if a physician does have the mon- Isosorbide dinitrate therapy may aggravate angina associated with hypertrophic cardiomyopathy. Tachycardia 2 1 ey to adopt e-prescribing, “he or she is at Information for Patients Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed. The following adverse events were reported in A-HeFT in at least 1% but less than 2% of patients treated with BiDil, and risk of purchasing a system that might not also occurred in at least 0.5% more patients than in placebo-treated patients; all such events are included unless they are Patients should be told that headaches often accompany treatment with BiDil, especially during initiation of treatment. too non-specific to be meaningful or appear to reflect underlying disease. Headaches tend to subside even with continued dosing. Patients should be instructed to consult a physician to adjust the integrate” with a future electronic health dose of BiDil if headache continues with repeated dosing. Treatment of emerging headache was managed with aceta- Body as a Whole: Allergic reaction, malaise. minophen in some clinical trial patients. Central nervous system: Somnolence. record system, she said. Treatment with BiDil may be associated with lightheadedness on standing, especially after rising from a recumbent or Gastrointestinal: Cholecystitis. Dr. Kirschner noted that the recent re- seated position. Metabolic: Hypercholesteremia. Patients should be cautioned that inadequate fluid intake or excessive fluid loss from perspiration, diarrhea or vomiting Musculoskeletal: Arthralgia, myalgia, tendon disorder. lease of safe harbor antikickback and Stark may lead to an excessive fall in blood pressure and cause lightheadedness or even syncope. If syncope does occur, BiDil Skin: Alopecia, angioedema, sweating. should be discontinued, and the prescribing physician should be notified as soon as possible. In the V-HeFT I and II studies, a total of 587 patients with heart failure were treated with the combination of isosorbide exception rules allowing hospitals, group Patients should be cautioned about the increased risk of hypotension especially if they are taking antihypertensive drugs dinitrate and hydralazine hydrochloride. The type, pattern, frequency and severity of adverse experiences reported in concomitantly. these studies were similar to those reported in A-HeFT, and no unusual adverse experiences were reported. practices, and Medicare Part D drug plan Patients should be cautioned against concomitant use of BiDil with phosphodiesterase-5 inhibitor drugs used for the Prior experience with BiDil components sponsors to provide necessary e-prescrib- treatment for erectile dysfunction or pulmonary hypertension such as sildenafil citrate (Viagra®; RevatioTM), vardenafil The following additional adverse events have been reported with hydralazine hydrochloride or isosorbide dinitrate but not (Levitra®) or tadalafil (Cialis®). Use of BiDil may produce an extreme drop in blood pressure that may result in fainting or necessarily with BiDil: ing technology to physicians may help fa- may provoke chest pain or a heart attack. Digestive: paralytic ileus. Laboratory Tests Cardiovascular: paradoxical pressor response, crescendo angina. cilitate