Chapter 16 Risk Management for Drugs and Biologics in the United States Chapter 16RISK MAnAgEMEnT FOR DRugS AnD bIOLOgICS In THE unITED STATES Arcoxia, Vioxx, Acomplia, Zelnorm, and Tysabri; Aranesp, Procrit, Avandia, and Lucentis —all of these prominent drugs, and others, have been in the news often over the past year.1 The concerns raised about them illustrate the unprecedented combined focus on both drug safety and costs, not only by the Food and Drug Administration (FDA), but also by Congress and the Centers for Medicare and Medicaid Services (CMS).
LayoutVolume 2 Spring 2007 REAP THE BENEFITS OF LOWERING LDL CHOLESTEROL BELOW 70 Over 50 percent of the U.S. population have cholesterol levels that are considered New patient enrollment to be too high. High blood cholesterol, also called hypercholesterolemia, is known tosignificantly lead to heart disease and stroke. Sometimes, no matter how much a person controls their diet, weight, exercise and medical conditions, it just isn'tenough. There are numerous medications on the market that help you to lower cholesterol 388-1889, 388-1083 levels. We have the ability to prevent or slow down cholesterol buildup in arteries, but 388-1871, 388-1084 what's even more amazing is that new studies have shown that drug therapy canactually reduce buildup. Finally, doctors can tell their patients about the unclogging 388-1846, 388-1082 of arteries – a doctor's version of Drano! The Executive Evaluation Center Typical Drug Therapy: The Traditional Way Early studies showed that the use of "statin" drugs slowed down the progression of plaque build up in the arteries. In the past, standard drug therapy was anoption limited to high-risk patients with LDL (bad) cholesterol 229 West Bute Street levels above 130 mg/dL. In 2003, it was reported that more than 76 million American adults had Wainwright Building LDL levels at 130 mg/dL or higher. Less Suites 700 and 910 than half of those who qualified fortreatment actually received it. Evenworse, less than half of those who Visit us on the web at
qualified and had the highest risk received treatment. Of those who did receive treatment, only about one-thirdachieved their LDL goal. In 2004, theNational Heart, Lung and BloodInstitute (NHLBI) updated theirrecommendations to include high-risk What's Inside.
patients with LDL levels from 100 andhigher. Today, the typical medical practice closely A Guide To Taking follows NHLBI standards for detection, evaluation and Cholesterol Medication treatment of high cholesterol levels. For patients with high cholesterol,physicians loosely aim for LDL levels of 100. But does this have enough punch The Benefits Of Carotid when it comes to fighting heart disease and preventing heart attacks and strokes caused by high LDL cholesterol? Meet The Nurses Of The continued on next page Dedicated Care Center Aggressive Drug Therapy: Our Way INSIGHT TO YOUR
A new study, called ASTEROID (A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden), shows that the use ofintensive "statin" drug therapy not only slows down the progression of plaque, butalso strips away the "bad" cholesterol. Doctors at the Dedicated Care Center believe that a more aggressive approach will help patients prevent heart attacks, congestive heart failure, crippling strokes and lossof cognitive function. Our medical practice uses intensive drug therapy aiming forcholesterol levels that are 30 points lower than NHLBI recommendations. A LDLcholesterol level of 70 is a typical goal for our patients. This is an aggressive approachto lipid management, but we know it provides the best chance of preventing heartdisease, heart attack and stroke.
The Dedicated Care Center and The Executive Evaluation Center provide cutting- edge screening and treatment strategies designed to give you the best possible careavailable today. Tips to start losing weight.
Utilizing screening tools such as carotid artery PVL's (see accompanying article on stroke prevention) and CAT scan coronary calcium scoring, we can assess for Set an obtainable goal early blockages long before they produce dangerous symptoms. We encourage you (10% of current weight).
to take advantage of the latest technology and medications to optimize your health No matter which way you care experience.
look at it, 3,500 calories cut is one pound lost. Whether you take in 500 fewer or burn500 more calories a day, by the end of the week you'll A GUIDE TO TAKING be one pound lighter! You won't stick to a diet that CHOLESTEROL MEDICATION is comprised of foods you • Starting doses can typically lower cholesterol 25-35%, depending on the medication and on individual factors. Higher doses can achieve 50% reductions or greater. You need to plan alternative • Cholesterol medication must be taken on a regular basis to work well.
strategies to cope with • A low fat diet should be continued.
emotional eating. • Lipitor and Crestor can be taken at any time of day. Most of the others should be Your weight will fluctuate from day to day. Resist the • Generic versions of Mevacor, Zocor, urge to weigh yourself on a and Pravachol are available.
daily basis, as doing so will discourage you. Side effects
• Most side effects are mild
• The most common side effects are BON VOYAGE!
muscle aches (about 3%). The muscle aches can vary from mild to Please join us in severe and should be brought to our congratulating Dr. Bethea on attention. If they are mild, stop the setting sail toward some much medication for 1 week and then restart it. If the muscle aches continue needed rest and relaxation! with the medication, then we need to Dr. Bethea has decided to take change to a different one or lower the a leave of absence and we are dose. For severe muscle aches, STOP THE MEDICATION and come in looking forward to seeing him for an appointment.
back to work at the • A blood test called CPK can be ordered to check for muscle breakdown. It is not Dedicated Care Center. done routinely, but can be added to your lab tests if you have concerns.
• Liver test abnormalities are also possible (about 3%). We need to monitor your liver If you are a patient of tests every 3 months for the first year and then every 3-6 months thereafter. If your Dr. Bethea's, please continue liver tests elevate to a significant degree, we will stop or reduce the medication and to call 757-388-1851 and a watch them return to normal. Sometimes we need to switch brands to find a Patient Services Coordinator will medication that does not cause significant liver enzyme elevation.
be happy to direct your care • Some medications interact poorly with "statin" medications. These include protease inhibitors (used in treating HIV), erythromycin, itraconazole (anti-fungal), to one of our other immunosuppressants, clarithromycin, diltiazem, verapamil, and large amounts of Dedicated Care Physicians.
grapefruit juice. Lescol, Pravachol, and Crestor do not have the interaction with grapefruit juice.
A story of a stroke prevented: THE EXERCISE
CAROTID ARTERY IMAGING Mrs. Smith felt fine. She played tennis on a regular basis and stayed active chasing Look at what diet and exercise the grandchildren around. At 58 years old, she enjoyed her life and with her earlyretirement, she looked forward to spending more time with her family. She had no did for Mr. John B. He was recently clue that her ability to walk, talk, and feed herself was threatened with every diagnosed with high cholesterol passing moment.
Mrs. Smith had over a 90% blockage in her carotid artery, the main blood supply with a total cholesterol of 220 line to the brain. Had a significant piece of that blockage broken off before it wasdetected, it would have traveled into the brain and caused a massive stroke.
mg/dl, his HDL's were 35, LDL's Fortunately, she decided to take a were 151, and triglycerides were closer look at her arteries with apainless non-invasive test BEFORE measured at 170. We told him she developed any warning that exercise and changing his symptoms or suffered a devastatingstroke. A special ultrasound study diet would help him with the (called a carotid PVL) done in the preventable component of his office identified the blockage andwe immediately arranged for an intervention that completelycleared the problem away.
Working with our colleagues at Could this blockage have been Fitness Together, a one-on-one found by any other means? Mrs.
Smith had a routine examination 5 personal training studio, he began months before the blockage was exercising 3 times a week with a found that included an examination of the neck arteries with a stethoscope. The blockage was not detected, but this is trainer and once on his own. not an unusual occurrence! Over one third of high-grade blockages CANNOT be After 8 weeks of training and diet detected by routine stethoscope exam. The stethoscope is a tool that is nearly 200years old and certainly is not capable of bringing the best we have to offer for this it was time for a re-evaluation. In the world of insurance, if you don't have symptoms of the disease you don't He lost 5 pounds and his total need to worry about it. That clearly doesn't always work. Suffering a stroke cholesterol dropped to 195 mg/dl, certainly is a steep price to pay for blissful ignorance. This relatively inexpensivetest is available now to our members of the Dedicated Care Center. Ask your doctor his HDL's were measured at 43, or any member of our staff if this test is right for you.
his LDL's were now 122, and his triglycerides were 150. Later with medication , Mr. John B. reached EET THE NURSES OF THE DEDICATED CARE CENTER John's changes were a good start and show the potential that The Dedicated Care Center nursing staff is an intricate part of the care team for our patients. Our nurses provide our patients with the highest level of care and attention. They a dedicated diet and exercise strive to promptly answer medical questions, coordinate ancillary care, and educate our plan can bring to help combat patients on preventativemeasures concerning health problems. their general health andwell being. Our nursingstaff is comprised ofeducated, experienced,caring professionals thatare happy to help youmeet your goals of living a healthier life.
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PHARMACOLOGICAL PRINCIPLESPsychopharmacology, one of the most active and developing areas of psychiatric research, is the use of psychotropic medication to treat psychiatric disorders. Psychiatric–mental health nurse practitioners (PMHNPs) must have a thorough understanding of the science and art of prescribing—of the pharmacokinetic and pharmacodynamic actions of a given drug, as well as the client's motivation to take the drug. The basic pharmacological principles are discussed in this chapter.