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| CLINICAL NEWS FOR OUR PARTICIPATING HEALTH CARE PRACTITIONERS |
Best Practice: Area Facilities Assess Cardiac Care Quality
New and Emerging Technologies
Recent Literature on: Cardiovascular Disease, Diabetes and Cancer
New Disease Management Programs
Cholesterol Management After Acute Cardiovascular Events
Prescription Protection Program
Dual Oral Antiplatelet Therapy
COX-2 Selective Inhibitors- A Clinical Update
AAP Recommendation Change for Synagis
Our QI Program: Setting Goals for Improved Care and Service
Best Practice: Area Facilities Assess Cardiac Care Quality
The following is presented in an effort to highlight hospital “best practice” around the region. CareFirst BlueCross BlueShield (CareFirst) and CareFirst BlueChoice, Inc. (CareFirst BlueChoice) want to share with you the innovative ways in which Maryland, Virginia and Washington, D.C. hospitals are improving quality of care while controlling the rising cost of health care. Look for additional “best practice” features in future issues of InFocus.
Some facilities in CareFirst and CareFirst BlueChoice’s service area participate in the American College of Cardiology Foundation's National Cardiovascular Data RegistryTM (ACC-NCDR), which helps them assess the quality of care for patients who undergo percutaneous coronary intervention (PCI), such as cardiac catheterization, angioplasty and stent procedures.
National Cardiovascular Data Registry
The ACC nationally compares participating facilities’ cardiac patterns and outcomes, allowing them to learn where improvements can be made. The national program:
- is voluntary, outcome-oriented, patient-based, secure and confidential;
- allows longitudinal analysis; and
- uses standardized data elements and definitions.
Participants receive:
- Quarterly benchmark reports— based on data submitted quarterly from active participants. Data reflect all adult patients who have undergone PCI or cardiac catheterization.
- Annual report— includes a year’s worth of data comprising 142 evidence-based elements that correspond to current ACC/AHA clinical guidelines. Helps identify areas where quality improvements can be made.
- Data quality reports— make it easy to ensure that submitted data are complete and consistent. Participants can log on to www.acc.org to access the reports on the Web.
- Quarterly newsletters— contain subscriber profiles and detail how some subscribers use NCDR programs to improve care.
- ACC-NCDR pocket guide— consists of patient demographics, hospital admission dates, procedures and discharge information.
The Leapfrog Group
Comprised of more than 150 public and private organizations that provide health care benefits, The Leapfrog Group (Leapfrog) works with medical experts to initiate improvements in health care safety and provides consumers with information to make more informed hospital choices.
Leapfrog recently revised its voluntary hospital-patient safety survey so that it partially relies on the ACC-NCDR’s outcomes-based measurement system, assessing quality of procedures rather than quantity. The survey will ask hospitals if they participate in the ACC-NCDR and, if so, how they ranked against the national average on a risk-adjusted mortality rate.
Many large national employers and benefit consultants base their health plan selection on those plans that design and manage provider networks in a way that is consistent with Leapfrog’s principles.
Participating Area Facilities
The following area facilities actively participate in the ACC program by submitting quarterly data:
- Union Memorial Hospital
- Peninsula Regional Medical Center
- Washington Adventist Hospital
- Virginia Hospital Center
- Inova Hospital System
- Western Maryland Health System
Most member facilities in the area review the quarterly data to identify specific areas that need improvement in patient care. Then, the staff develops a plan of action to strengthen the hospital’s approach and monitors progress.
For more information on becoming a participant, click here or call 800-253-4636, extension 451.
Union Memorial Hospital
Union Memorial currently collects cardiac catheterization data and has an active cardiac Performance Improvement (PI) program, which discusses results on a monthly basis. When issues are identified, the committee creates and institutes action plans. The next logical step was to participate in the ACC-NCDR to build on the current PI program. Union Memorial submitted data for the first time during third quarter 2003 and is awaiting its first report.
The ACC-NCDR’s standardized data definitions will allow Union Memorial to benchmark its PI program against the national membership every quarter and, as a result, provide patients with the best possible outcomes. The outcome reports will help Union Memorial stay current and change practice patterns when appropriate.
Peninsula Regional Medical Center
Peninsula Regional exceeds the ACC’s standards in many areas. After reviewing the ACC’s outcomes, hospital officials decided to evaluate allergic reactions to contrast media inserted into catheters to assess left ventricular function. They developed a plan of action in October 2002 and instituted the use of contrast warmers to decrease:
- vasospasms in the vessels
- reactions (e.g., rashes)
- severe allergic reactions (e.g., respiratory or cardiac arrest)
- rhythm abnormalities (e.g., v-tach, transient heart block)
Peninsula Regional is currently examining data to determine the impact.
Washington Adventist Hospital
Washington Adventist Hospital compares its aggregated data of cardiology procedures with the ACC’s standards, recommendations and outcomes reports. Specific tracked outcomes include average length of stay and mortality, which are compared to previous performance and the ACC’s national data.
Washington Adventist Hospital reports outcomes to internal boards and standing committees to support and enhance quality and performance initiatives. If these outcomes significantly vary from previous performance or the ACC’s standards, then a focused investigation of practice patterns, treatment modalities or internal processes will be initiated. Washington Adventist Hospital has not had any significant variances that have prompted any investigations to date.
Virginia Hospital Center
In 2003, after reviewing the ACC’s national comparison and presenting the results to physicians at their monthly Cardiac Catheterization Conference, Virginia Hospital Center found that, according to the ACC, they were at the benchmark level or better.
“One of the primary reasons to participate [in the ACC-NCDR] is to be able to receive the national benchmark information provided quarterly by the ACC-NCDR so that we can ensure that we are providing the best possible care to our patients,” said Virginia Hospital Center’s Quality Assessment Outcomes Database Administrator Shawn Palmiter.
At the conference, Virginia Hospital Center found it could decrease the time it took to get patients with ST elevation myocardial infarction (MI) from the Emergency Department to the Cardiac Catheterization Lab. National guidelines recommend a time of less than two hours from diagnosis of ST Elevation MI to the cardiac catheterization lab for interventional procedure. The guidelines indicate that decreasing the time from diagnosis to intervention can make a significant difference in patient outcomes. Consequently, the Virginia Hospital Center staff was motivated to pull together a team of physicians, emergency department, cardiac catheterization lab and administrative personnel to analyze and improve the process. As a result, the time was brought down to the ACC’s national benchmark.
Virginia Hospital Center also sends reports upon request to individual physicians and physician groups that perform procedures in the cardiac catheterization lab so that they can see how they compare with the ACC’s benchmarks.
Inova
Inova currently uses the ACC’s data to confirm its success in meeting or exceeding the ACC’s standards. “We can compare ourselves to like institutions and see where we stand as an organization. I am proud to say that Inova Fairfax Hospital is above the ACC standards for complications and mortality,” said clinical practice specialist of invasive cardiology at Inova Fairfax Hospital Maggie Perih.
Inova still continues to analyze the data closely for areas that need improvement.
Western Maryland Health System
Western Maryland Health System is above the ACC’s standards for all measures. “In a community hospital... it is important to know that we are providing quality outcomes that measure up against established programs,” said Director of Cardiovascular Services at Western Maryland Health System Karen Stair.
Western Maryland Health System is currently examining the prevalence, contributing factors and ways to minimize the impact of cardiac disease in the area. Its goal is to help citizens change their habits to help prevent adverse effects of cardiovascular disease.
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Educate Parents of Cardiac Risks in Children
It is easy for busy doctors to overlook the need to inform parents how to create healthy habits in their children now to prevent development of chronic diseases in the future.These Web sites offer some practice pointers, regardless of your specialty.
- www.aap.org Click on You & Your Family for useful information, especially about childhood obesity and diabetes.
- www.americanheart.org/ Click on Children: Heart Disease & Health, for information on children and cholesterol, nutrition, blood pressure, exercise and weight control.
- www.cdc.gov/nccdphp/dash/index.htm The CDC’s Adolescent & School Health home page.
- http://www.cdc.gov/healthyyouth/ The CDC’s Chronic Disease Prevention site, featuring Healthy Youth: Investing in Our Nation’s Future .
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New and Emerging Technologies
CareFirst’s Technology Assessment Committee-- which includes CareFirst physicians, CareFirst nurses and consulting physicians outside of CareFirst-- reviews new and developing technologies. The committee relies on current medical literature, local expert consultants and physicians to determine whether those technologies meet CareFirst’s criteria for coverage. Coverage policies applicable to national Blue Cross Blue Shield accounts and Federal Employees benefits programs may differ from those at the local account level. Click here to find the review criteria by clicking on Medical Policies . The Technology Assessment Committee recently made the following determinations.
| New Technology |
Description |
CareFirst Determination |
Endovenous laser treatment
(EVLT) of varicose
vein disease/ saphenofemoral
reflux |
Minimally invasive procedure that uses a laser-tipped catheter to close refluxing vessels. May be performed in the physician’s office.
EVLT is less traumatic and generally better than the older ligation and stripping procedure. Long-term follow-up data for EVLT indicate a low rate of complications and durable relief of painful symptoms of varicose vein disease.
|
Considered medically necessary for symptomatic venous disease that demonstrates reflux at the saphenofemoral junction. Providers who perform this procedure in their offices are reimbursed based on the allowed benefit for both the acquisition cost of obtaining the special laser catheters and the professional fee for the procedure.
|
Staple hemorrhoidectomy
(PPH hemorrhoidectomy,
Longo hemorrhoidectomy) |
Uses a specially designed surgical tool that excises complex hemorrhoidal tissue and corrects prolapse in a single step procedure.
The staple hemorrhoidectomy technique involves a shorter
recovery time than conventional
surgical hemorrhoidectomy and
a reduced level of postoperative discomfort. Long-term data indicate the procedure is durable and well-tolerated by most patients. Complications have been reported with this procedure, but it is generally felt to be safe.
|
When patients with Grade III or IV hemorrhoidal disease are unresponsive to more conservative approaches, this procedure is considered medically necessary as an alternative to conventional surgical hemorrhoidectomy. Most patients with symptomatic hemorrhoids can be managed conservatively or with office-based interventions, such as sclerosing or rubber band ligation. Surgery is offered to patients with severe disease and prolapse.
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| Thoracic electrical bioimpedance for assessment of cardiac output |
A form of plethysmography used as a non-invasive assessment of cardiac output in selected patients. |
Considered medically necessary as an alternative to insertion of a thermodilution catheter in instances where the physician needs to determine cardiac output for diagnosis or medical decision making. Literature fails to clearly define patient-selection criteria for bioimpedance cardiography. However, because of good correlation, bioimpedance cardiography could easily be supported in patients who may require cardiac output measurement, but conventional measurement by thermodilution would be contraindicated or is unavailable. Bioimpedance is not indicated for patients who have had cardiac surgery within 20 hours or those with fluid in the cavity or distortion of the vessels, such as extensive pulmonary edema, pleural effusion, hemothorax, aortic dilatation or severe mitral regurgitation. In these cases studies show that cardiac outputs measured using bioimpedance are not acceptably accurate.
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| Botulinum toxin A (i.e., Botox® injections for chronic headache disorders) |
Uses botulinum toxin injections off-label to reduce frequency and/ or severity of chronic migraine, tension headache or other chronic headache disorder.
Over the past several years, a number of published uncontrolled case series suggest botulinum toxin is worthy of study as a remedy for chronic headache disorder. Anecdotal evidence is abundant because the use of botulinum as a remedy for headache disorders has become widespread. As with any chronic, painful condition, studies should be of a rigorous design with adequate placebo controls, knowing that such illnesses are highly subject to the placebo effect. The few randomized placebo controlled studies that are published lack statistical power to draw any definite conclusions related to patient outcomes. One study shows no significant treatment effect over placebo; another shows a remarkably lower treatment effect with a higher injected dose of toxin.
|
CareFirst considers this use of botulinum toxin A as experimental/ investigational. At the present time, FDAapproved label of Botulinum toxin A does not list headache disorders as an indication, and, therefore, is an off-label use of an FDA approved pharmaceutical. The most widely recognized reference sources of pharmacology, namely the United States Pharmacopeia Drug Information and the American Hospital Formulary Service Drug Information, do not list headache disorders as an accepted indication for treatment using Botulinum A injections.
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Recent Literature on: Cardiovascular Disease, Diabetes and Cancer
By T.A. Dadisman, MD, Medical Director, Preventive Medicine and Health Promotion
This article is intended to call your attention to recent information you may have missed on issues concerning cardiovascular disease, diabetes and cancer.
| Cardiovascular Disease |
| What's Available |
Where to Find It |
| Cardiovascular Disease Resulting from a Diet and Lifestyle at Odds with Our Paleolithic Genome: How to Become a 21st Century Hunter-Gatherer is a readable and informative article that contrasts our modern, highly processed, synthetic diet and sedentary lifestyle with Paleolithic genome that evolved when people consumed wild, unprocessed food foraged and hunted from the environment. Given that there has been little change in the human genome in the past 10,000 years, this mismatch lies at the center of our current epidemics of obesity and the metabolic syndrome, which includes hypertension, diabetes and cardiovascular disease. The authors outline this heritage and find that the hunter-gatherer diet has more in common with the traditional Mediterranean diet than with the currently popular low-carbohydrate and traditional low-fat diets. The authors suggest no extreme diet or activity changes; rather, they advocate physical activity and specific elements of a more ideal diet. |
Mayo Clinic Proceedings 2004; 79 (Jan):101-108 |
| Antiplatelet Therapy for Ischemic Heart Disease is an excellent and useful review largely for the primary care physician treating patients with recent percutaneous coronary intervention. The authors state, “Since platelets have a pivotal role in the pathogenesis of thrombosis after plaque rupture, it is not surprising that various antiplatelet agents (aspirin, the thienopyridines [i.e., clopidogrel], and the glycoprotein IIb/IIIa inhibitors) have proved to be effective in reducing the incidence of adverse events that are associated with plaque rupture. The antiplatelet agents differ in their modes of action, antiplatelet potency, onsets of action, costs, and the specific circumstances and temporal framework in which they should be used.” |
New England Journal of Medicine 2004; 350 (No. 3, Jan 15): 277-280 |
| The authors of Statin-Related Muscle Toxicity indicate the Adult Treatment Panel III’s (ATP III) lower cut points for treating patients with high total cholesterol levels - and the new indications for statin therapy - have led to an unprecedented increase in the number of patients who could benefit from taking these drugs. While the myotoxicity of statins is well documented, physicians should not be overly dependent on CK testing as an indicator of problems. “Perhaps even more important than CK monitoring is counseling the patient about symptoms of myopathy [such as weakness or pain] and when these symptoms warrant contacting the physician.” Note: CME credit hours are available in Advanced Studies in Medicine. |
Advanced Studies in Medicine 2003; 3 (No.10, Nov/Dec): 554-560 |
| The One-Pill Theory: Can This Strategy Change the World of CVD? is a good summary of the papers and editorial in the June 28, 2003 issue of the British Medical Journal (BMJ 2003; 326 1407-1408; 1419-1423; 1423-1427; 1427-1434), in which the authors present the concept of a mechanism that administers well-known interventions to prevent cardiovascular disease (CVD) to the general population. This single pill, the Polypill, could contain a statin, a thiazide diuretic, an ACE inhibitor, a calcium channel blocker, folic acid and low-dose aspirin. Considerable discussion has ensued. The editor of the BMJ said in a comment separate from these papers, “…keep this issue… It’s perhaps more than 50 years since we’ve published anything as important as [this] cluster of papers…” Note: All issues of LipidManagement from the National Lipid Education Council (NLEC) are useful because they include excellent synopses of pertinent articles and each issue is now certified for CME credit. This issue is particularly valuable because it contains a good Patient’s Guide to Prevention of CVD, which may be reproduced and distributed. |
LipidManagement 2003/2004; 8
(No. 4, winter): 1-8
|
| Diabetes |
| What's Available |
Where to Find It |
|
The summary of revisions in American Diabetes Association Clinical Practice Recommendations, 2004 contain:
- “Glycemic Control: Updated recommendations, including ‘more stringent goals (i.e., a normal A1C, <6%)… in individual patients’
- Blood pressure control: Updated recommendations for based on recent studies (including ALLHAT). [A target of <130/<80 is reasonable if it can be safely achieved. Two or more agents in proper doses are generally required to achieve goal. The regimen of treatment should include either an ACE inhibitor or an ARB]
- Lipid management: Updated recommendations based on recent studies (including the Heart Protection Study) to include the recommendation that in people with diabetes over the age of 40 with a total cholesterol =135 mg/dl, statin therapy to achieve an LDL reduction of approximately 30% regardless of baseline LDL levels may be appropriate.
- Anti-platelet agents: Clarified recommendation regarding aspirin use as primary prevention in type 1 and type 2 diabetes.
- Retinopathy: Updated recommendations, including consideration of less frequent exams in low-risk patients with advice from an eye care professional.
- Footcare: Updated recommendations on screening for peripheral arterial disease (PAD).
- Care of older adults: Incorporated language from recent guidelines by the American Geriatric Society on this topic.”
Unchanged recommendations include: cessation of smoking; screening for nephropathy with microalbuminuria determination; screening for coronary artery disease; and immunizations with influenza and pneumococcal vaccines. Strategies for improving diabetes care are outlined, including utilization of nurse education and case management services, which are available from Certified Diabetes Educators (CDEs). Local availability of CDEs can be found on the American Association of Diabetes Educators Web site.
|
Diabetes Care 2004; 27
(Jan): S1-S150 |
| Cancer |
| What's Available |
Where to Find It |
| “Public health officials, physicians and disease advocacy groups have worked hard to educate individuals living in the United States about the importance of cancer screening.” The authors of Enthusiasm for Cancer Screening in the United States found that,“Most adults (87%) believe routine cancer screening is almost always a good idea and that finding cancer early saves lives (74% said most or all the time). Less than one third believe that there will be a time when they will stop undergoing routine screening. A substantial proportion believe that an 80-year-old who chose not to be tested was irresponsible: ranging from 41% with regard to mammography to 32% for colonoscopy. Thirty-eight percent of respondents had experienced at least 1 false-positive screening test; more than 40% of these individuals characterized that experience as ‘very scary’ or the ‘scariest time of my life.’ Yet, looking back, 98% of adults were glad they had the initial screening test. Most had a strong desire to know about the presence of cancer regardless of its implications: two thirds said they would want to be tested for cancer even if nothing could be done; and 56% said they would want to be tested for pseudodisease (cancers growing so slowly that they would never cause problems during the persons lifetime even if untreated). Seventy-three percent of respondents would prefer to receive a total-body computed tomographic scan instead of receiving $1000 in cash.” |
Journal of the American Medical Association 2004;
291 (No. 1, 7 Jan): 71-78 |
| The authors of Family Perspectives on End-of-Life Care at the Last Place of Care looked at the adequacy and quality of end-of life care in institutions compared to deaths at home.They found,“Many people dying in institutions have unmet needs for symptom amelioration, physician communication, emotional support and being treated with respect. Family members of decedents who received care at home with hospice services were more likely to report a favorable dying experience.” |
Journal of the American Medical Association 2004;
291 (No.1, 7 Jan): 88-93
|
| Other Topics of Interest |
| What's Available |
Where to Find It |
| Steven Woolf states in the provocative article, Patient Safety Is Not Enough: Targeting Quality Improvements to Optimize the Health of the Population, that “Patient safety, in context, is a subset of health problems affecting Americans. Safety is a subcategory of medical errors, which also includes mistakes in health promotion and chronic disease management that cost lives but do not affect ‘safety.’ These errors are a subset of lapses in quality, which result not only from errors but also from systemic problems, such as lack of access, inequity and flawed system designs. Lapses in quality are a subset of deficient caring, which encompasses gaps in therapeutics, respect, and compassion that are undetected by normative quality indicators. These larger problems arguably cost hundreds of thousands more lives than do lapses in safety, and the system redesigns to correct them should receive proportionately greater emphasis. Ensuring such rational prioritization requires policy and medical leaders to eschew parochialism and take a global perspective in gauging health problems. The public’s well-being requires policymakers to view the system as a whole and consider the potential effect on overall population health when prioritizing care improvements and system redesigns.” |
Annals of Internal Medicine 2004; 140 (No. 1, 6 Jan): 33-36 |
|
In his editorial, Overcome Clinical Inertia to Control Systolic Blood Pressure, Patrick O’Connor writes, “Perhaps the most important action we can take to improve hypertension treatment is this: make a move! Do not waste office visits. Make a move whenever the patient has not yet reached his or her BP control goal. The most common mistake in chronic disease care is not prescribing the wrong drug or forgetting to check a creatinine or potassium level when indicated, it is failure to initiate or titrate medications until important evidence-based clinical goals are reached. One of the major obstacles to better BP control is clinical inertia. Clinical inertia may be simply defined as an office visit at which no therapeutic move was made to lower the BP of a patient with uncontrolled hypertension. At a particular office visit, the likelihood that a patient with uncontrolled BP, blood glucose level, or blood lipid levels will have medications started or titrated upward is generally less than 20%. The average patient with hypertension makes more than 5 office visits a year, yet less than half of those with diagnosed hypertension have reached evidence-based BP goals. Clinical inertia can be a major threat to those with multiple uncontrolled cardiovascular risk factors, such as the estimated 24% of US adults with the metabolic syndrome. When multiple variables, such as SBP, low-density lipoprotein and high density lipoprotein cholesterol levels, glucose level and weight are not at goal, risks multiply. There is clear evidence from many studies that in such patients, SBP control is among the most important clinical risk reduction strategies possible.”
|
Mayo Clinic Proceedings 2003; 78 (No. 4, April). |
| Medical Malpractice: A Health Policy Report is an excellent article on the evolution, goals, research and reform of the medical malpractice system. |
New England Journal of Medicine 2004; 350 No. 3, Jan 15): 283-292 |
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New Disease Management Programs
On March 1, 2004, CareFirst and CareFirst BlueChoice partnered with Health Management Corporation (HMC) to offer an expanded asthma management program to eligible members, and a new Chronic Obstructive Pulmonary Disease (COPD) management program for eligible members with chronic bronchitis and/ or emphysema.
HMC will send routine updates to keep you informed about your patient’s progress and adherence to your plan of care. Each enrolled member is assigned to a registered nurse case manager who supports your plan of care. Members receive:
- Quarterly newsletters with tips for managing the specific condition and other helpful resources, including a weekly “Quit Smoking for Good” journal for both conditions and “Learning to Live with COPD” handbook.
- Access to a registered nurse 24-hours a day, 7-days a week by calling 800-445-7922.
- Telephonic case management.
For more information about the programs, visit HMC’s Web site .
CareFirst and CareFirst BlueChoice follow the COPD guidelines established by National Heart Lung and Blood Institute and World Health Organization. To view these guidelines, click here and then click on GOLD Documents/ Resources. For the asthma guidelines, click here or call 800-323-4472.
CareFirst’s and CareFirst BlueChoice’s Disease Management Programs
In addition to asthma and COPD programs, CareFirst and CareFirst BlueChoice offer free, voluntary and confidential programs for eligible members with diabetes, coronary artery disease, cancer and congestive heart failure. To refer members to our Asthma, COPD, Congestive Heart Failure, Coronary Artery Disease or Diabetes programs, call 800-783-4582. To refer members for cancer management, call 888-264-8648.
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Cholesterol Management After Acute Cardiovascular Events
During the Health Plan Employer Data Information Set (HEDIS) data collection process, the Quality Improvement (QI) department identified an opportunity to improve the coordination of care between CareFirst BlueChoice cardiologists and primary care practitioners (PCP).
As a part of CareFirst BlueChoice’s National Committee for Quality Assurance (NCQA) accreditation, the QI department annually collects HEDIS data, conducts a quantitative and qualitative analysis and identifies opportunities for improvement. HEDIS is a set of standardized performance measures designed to allow reliable comparison of managed health care plans’ performances.
HEDIS measured the frequency of LDL-C screening after acute myocardial infarction, coronary artery bypass graft or percutaneous transluminal coronary angioplasty. NCQA’s expectation for this measure is for patients to have an LDL-C screening between 60 and 365 days after discharge for these conditions.
Review of Data
QI nurses schedule appointments to review patients’medical records in PCPs’ offices for data as specified in the HEDIS requirements. If the data are not found in the PCP’s records, the QI nurse reviews documentation in the cardiologist’s or other specialist’s record.
Of the LDL-C screening reports QI nurses located in medical records, 69 percent were found in PCPs’ records and 31 percent were found in cardiologists’ records. Since PCPs generally manage patients’ care, a greater percentage of LDL-C results should be in PCPs’ office records.
In 2003, the rate of LDL-C screening for this population was 80.58 percent, which is within the 90th percentile nationally and the 75th percentile regionally, but below CareFirst BlueChoice’s performance goal of 83 percent.
Recommendations
The Quality Improvement Advisory Committee, which includes members from the physician community, reviewed these results and would like to remind specialists of the importance of:
- Providing detailed consultation reports and updates to PCPs following each patient visit.
- Communicating LDL-C and other test results to PCPs.
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Prescription Protection Program
As part of their Prescription Protection Program, Purdue Pharma L.P., the distributor of OxyContin Tablets, provides personalized tamper-resistant prescription pads at no cost to prescribers to help reduce the illegal diversion of controlled prescription medications.
The prescription pads help protect physicians, pharmacists and patients from those attempting to illegally obtain controlled medications by altering or copying prescriptions. To prevent further tampering, physicians should write prescriptions with the quantity and strength written in both numbers and letters.
The Prescription Protection Program is part of Purdue Pharma’s plan to reduce drug diversion and help ensure that patients continue to have appropriate access to the medication they need to control chronic pain and other medical conditions. Purdue Pharma conducts medical education for health care professionals, works with law enforcement on drug diversion prevention and education efforts, and is developing a prescription drug awareness and prevention program aimed at teens.
The pads can be obtained from Standard Register, the nation’s leading printer of checks, prescription pads and other documents requiring fraud protection, using Purdue Pharma’s order form. Call Purdue Pharma at 800-745-7445, extension 7235 to request an order form.
Members of the community can request a free action kit containing materials that address prescription drug abuse from Purdue Pharma’s Web site or by calling 203-588-8000.
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Dual Oral Antiplatelet Therapy
By Woodrow Proveaux, PharmD, CareFirst’s Clinical Pharmacy Director
Adjunctive antiplatelet therapy (i.e., the combination of aspirin and clopidogrel, an ADP receptor antagonist) is the standard of care when treating ischemic complications associated with Percutaneous Coronary Intervention (PCI) with or without stent placement. Aspirin is typically given before PCI and continued indefinitely after revascularization. For one month following PCI, adjunctive antiplatelet therapy provides protection from ischemic complications related primarily to stent thrombosis.
After one or more years of undergoing PCI, patients face persistent risk of ischemic events, including myocardial infarction (MI), stroke and death. This long-term risk is largely due to the progression of diffuse atherosclerotic disease past the stented coronary vessel.
CREDO Trial
The Clopidogrel for the Reduction of Events During Observation (CREDO) Trial supports use of clopidogrel post-PCI beyond the traditional four weeks. The results of the trial demonstrate that for one year, continued administration of clopidogrel following PCI with or without stenting, in addition to aspirin (ASA) and other standard therapy, yields a 26.9 percent relative risk reduction (RRR) in irreversible atherothrombotic events (i.e., MI, stroke and death; P=0.02). Although treatment with clopidogrel at least three hours before the procedure did not reduce events after 28 days, subgroup analysis suggests that longer intervals between the loading dose and PCI may reduce events.
Summary of Results
- From day 29 to one year, continued clopidogrel therapy led to a 37.4 percent reduction in the combined endpoints of CV death, MI and urgent target vessel revascularization (P=0.04).
- The benefit of long-term clopidogrel therapy was independent of the background therapy that patients received, including IV GP IIb/IIIa inhibitors, and was consistent in all patient subgroups evaluated.
- Subgroup data suggests that a loading dose of clopidogrel (300 mg), given =6 hours prior to PCI, substantially reduces major adverse cardiac events after 28 days.These results are consistent with the PCI-CURE study, which showed a 30 percent RRR in the combined endpoint of CV death, MI and urgent target vessel revascularization at 30 days; patients received a 300 mg loading dose of clopidogrel and 75 mg per day for a median of 10 days prior to PCI.
- Long-term clopidogrel therapy (i.e., one year) following PCI was not associated with a statistically significant increase in major or minor bleeding events.No fatal bleeds or intracranial hemorrhages were observed.
The results of CREDO are applicable to U.S. practices because U.S. sites were the predominant participants in the study, randomization to intervention was short and standard therapies including stents and IV GP IIb/IIIa antagonists are commonly used.
Reference: Steinhubl, S, Berger, P., Topol, E. et al. Journal of the American Medical Association. 2002: Vol 288, No19: 2411-2420.
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COX-2 Selective Inhibitors – A Clinical Update
Cyclooxygenase-2 (COX-2) selective inhibitors drive increases in overall cost and utilization of non-steroidal antiinflammatory drugs (NSAID). The CLASS and VIGOR trials concluded that the COX-2 selective inhibitors are just as effective as traditional NSAIDs, and overall, are shown to be more GI tolerant.
Drug Utilization Programs
W.E. Smalley and M.R. Griffin reported that in any given population of NSAID users, 15-25% develop NSAID related dyspepsia; 2-4% of which develop symptoms of an ulcer; and 0.7-2% of which require hospitalization for a GI bleed or other complication. These findings form the basis of managed care organizations’ drug utilization programs, promoting the use of COX-2 selective inhibitors over NSAIDS
in patients with a GI risk. The intent of these strategies were confirmed by an economic study completed at UCLA, and reported in the Annals of Internal Medicine, concluding that the COX-2 inhibitors are a cost effective alternative only when used in the population at the most risk for GI ulcers and complications. The benefit of the COX-2 inhibitors was recently questioned in a series of articles by A.M. Fendrick et al. in a specific population of patients concurrently taking aspirin.
Chronic Prophylactic Aspirin Therapy
Celecoxib
The cardiovascular benefits of aspirin are well documented in medical literature. If the American Heart Association recommendations on secondary prevention of cardiovascular events are followed, a significant portion of any given population should be on chronic prophylactic aspirin therapy. The CLASS trial indicates that patients taking celecoxib showed less GI intolerance overall compared to
those taking ibuprofen and diclofenac. However, the portion of the population that takes aspirin with celecoxib reported no significant difference in terms of GI intolerance. Therefore, celecoxib may not provide a clinical advantage in patients concurrently taking aspirin.
Rofecoxib
Patients concurrently taking aspirin with rofecoxib were excluded from the VIGOR trial, but the FDA recently approved a labeling change for rofecoxib indicating that concurrent use with aspirin caused patients no more GI intolerance than high dose ibuprofen alone. However, the FDA’s change does not specifically state that the incidence of GI intolerance is lower. While some view this as an advantage of rofecoxib over celecoxib, this labeling may also reinforce the aspirin subset of the CLASS trial, which says there is no clinical GI benefit when celecoxib or rofecoxib are used by patients chronically taking aspirin. Thus, it is generally argued that patients already on gastroprotectant and aspirin therapy should be placed on a traditional NSAID.
NSAID Treatment Strategy
Based upon the aspirin subset analysis of the CLASS trial and the rofecoxib labeling change, A.M. Fendrick and S.M. Garabedian-Riffalo present the following NSAID treatment strategy in the table below.
Fendrick and Garabedian-Riffalo suggest that the only clinical situation that a COX-II agent is appropriately used as monotherapy when a patient has a risk of GI intolerance, but is not concurrently taking aspirin. All other patients should take a gastroprotectant in combination with either a traditional NSAID or a COX-II. This recommendation is based on the equal efficacy of the traditional NSAID and the COX-II inhibitor, which has no GI benefit when concurrently administered with aspirin.
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NSAID Treatment Strategies Based on
Gastrointestinal Injury and Cardiovascular Risk
|
| |
Patients at No or Low Risk |
Patients at GI Risk |
| Patients not receiving aspirin based on cardiovascular risk |
Use a traditional NSAID
If gastrointestinal symptoms develop, add an antacid or an antisecretory agent (e.g., a PPI [proton pump inhibitor] or a histamine H2 receptor agonist) to the regimen.
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Use a COX-2 selective inhibitor
If gastrointestinal symptoms develop, add antisecretory agent (e.g., a PPI or histamine H2 receptor agonist) to the regimen,
or
If patient is already taking a PPI, use a traditional NSAID.
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Patients receiving
aspirin based on
cardiovascular risk |
Use a traditional NSAID plus a PPI or a gastroprotective agent (misoprostol),
or
Use a COX-2 selective NSAID plus a PPI or a gastroprotective agent.
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Use a PPI or a gastroprotective agent plus either a COX-2 selective inhibitor or a traditional NSAID. |
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Those at risk for gastrointestinal injury include patients older than 60 years of age (risk increases with age), those with a past history of ulcer disease and those needing high-dose NSAIDs, multiple NSAIDs (including aspirin) and/ or those who require concomitant use of corticosteroids and/ or warfarin.
Cardiovascular disease risk factors include men older than 40 years of age, postmenopausal women, a family history of coronary heart disease and younger individuals with risk factors for coronary heart disease (e.g., dyslipidemia, hypertension, diabetes/ metabolic syndrome or smoking). Consider prescribing aspirin for these individuals.
Data from Executive Summary of the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III), JAMA 2001; 285:2486 2497.8 and U.S. Preventive Services Task Force. Recommendations and rationale: Aspirin for the primary prevention of cardiovascular events. Annals of Internal Medicine 2002; 136:157-160.
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Drug utilization management programs need to reflect the evidence that COX-2 inhibitors are safer than traditional NSAID therapy only in the absence of aspirin therapy, and that the presence of aspirin will minimize any clinical GI benefit. Patients already on gastroprotectant and aspirin therapy should be placed on a traditional NSAID instead of a COX-2 inhibitor unless the patient falls into the highest risk group for GI complications. Therefore, prior authorization criteria will be modified to identify patients concurrently on aspirin.
Please note that CareFirst requires authorization for all COX-II inhibitors.
References
1. Schneitman-McIntire O., Farnen T.A., et al.Medication misadventures resulting in emergency department visits at an HMO medical center. American Journal of Health-System Pharmacy. 1996; 53:1416-22
2. Smalley W.E., Griffin M.R. The risks and costs of upper gastrointestinal disease attributable to NSAIDs. Gastroenterology Clinics Of North America 1996; 25(2):373-96.
3. Spiegel B.M.R., Targownik L.E., Dulai G.S., Gralnek I.M. The cost-effectiveness of cyclooxygenase-2 selective inhibitors in the management of chronic arthritis. Annals of Internal Medicine 2003;138:795-806
4. Silverstein F.E., et al. Gastrointestinal Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis. Journal of the American Medical Association, 2000; 284(10):1247-55
5. Bombardier C., et. al. Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis. New England Journal of Medicine, 2000(21);343:1520-1528
6. Fendrick A.M., Garabedian-Ruffalo S.M. A Clinician’s Guide to the Selection of NSAID Therapy. Pharmacy and Therapeutics. 2002;27:579-81.
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AAP Recommendation Change for Synagis®
By James King, M.D., and Charles Medani, M.D.
Every year, many people are afflicted with the common cold, which is generally an upper respiratory tract nuisance that resolves after a few days and is frequently caused by respiratory syncytial virus (RSV). However, RSV can cause a select group of premature and other at-risk infants respiratory distress, lower respiratory tract disease and may even lead to hospitalization.
Synagis® (generic name: palivizumab) is an intramuscularly administered monoclonal antibody designed to prevent RSV infection in selected infants less than two years of age who are at increased risk for severe respiratory disease. The following infants may benefit from prophylaxis with Synagis®:
- Very premature infants with a combination of specific risk factors, defined by the American Academy of Pediatrics (AAP)
- Infants who require medical treatment for chronic lung disease
- Infants with hemodynamically significant congenital heart disease
The AAP Committee on Infectious Diseases published revised recommendations for the use of Synagis® in the 2003 Red Book, 26th edition. Since they were last published in 2000, the recommendations are more restrictive for children of 32-35 weeks gestation due to emerging research that questions the utility of Synagis® for these patients. For Synagis® prophylaxis to be considered for infants in this gestation range, the recommendations require the presence of at least two of the AAP’s major risk factors.
On the other hand, based on recent research, the AAP added the recommendation that children with hemodynamically significant congenital heart disease receive Synagis® prophylaxis. Physicians should refer to the AAP’s detailed recommendations when considering Synagis® prophylaxis for any child.
Synagis® is administered via intramuscular injection, and lasts for 1 month. As a result, monthly injections are indicated for children who, according to AAP recommendations, qualify for treatment. RSV prophylaxis should be initiated at the onset of and terminated at the end of the RSV season, which is generally from early
November through March, shown by surveillance data gathered over the last four years at University of Maryland laboratories.
Since the recommendations are detailed and have recently changed, we suggest that all physicians involved in the care of children review the revised recommendations, regarded as the best scientifically-based approach that we have to prevent RSV infection in these groups of at-risk infants. It is important to identify these patients so that they can benefit from Synagis®. Visit the AAP’s Web site or call 866-THE-AAP1 to buy a copy of the 2003 Red Book, 26th edition.
Dr. King is Board Certified in Pediatric Infectious Diseases, and Professor of Pediatrics and Chief of the Division of General Pediatrics at the University of Maryland. He can be contacted at 410-706-5289.
Dr. Medani is the Pediatric Medical Director at CareFirst BlueCross BlueShield. He can be contacted at 410-528-7851, or via e-mail .
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Please note:
Caremark and Nova Factor, Inc. are the contracted specialty providers for CareFirst BlueCross BlueShield and CareFirst BlueChoice members for Synagis®. Please remember that Synagis® is usually covered under a patient’s medical benefit and is usually billed by the supplier.
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Our QI Program: Setting Goals for Improved Care and Service
CareFirst and CareFirst BlueChoice are committed to providing the highest quality of care and service to its members. The Quality Improvement (QI) Program strives to improve clinical care and administrative services in all areas of the delivery system.
Our QI Council works closely with community physicians to develop and implement the QI Program in a coordinated effort to improve clinical care and service, including patient safety.
Annually, CareFirst and CareFirst BlueChoice implement a QI work plan that outlines specific clinical and service-related improvement activities using the National Committee for Quality Assurance (NCQA) Standards and Guidelines as a framework. Data are collected and analyzed for each activity throughout the year. Work groups then study barriers to improvement and develop targeted interventions to help us achieve our established goals. For example, to improve childhood immunization rates, a series of age-specific letters are mailed to educate parents and remind them about the immunizations due for their child.
Categories of measures included in CareFirst and CareFirst BlueChoice’s quality improvement plan include:
- Use of preventive services
- Compliance with clinical practice guidelines
- Continuity and coordination of care in medical and behavioral health care
- Effectiveness of disease management programs
- Patient safety
- Availability of practitioners and access to care
- Potential over- and under-utilization of care
- Member and provider satisfaction
For more information about the QI Program and how CareFirst and CareFirst BlueChoice meets established goals, call 410-528-7997 or 800-323-4472.
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