PHARM NOTES. Neil Medical Group: The Leading Pharmacy Provider in the Southeast. Neil Medical Group: The Leading

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1 PHARM NOTES Neil Medical Group: The Leading Pharmacy Provider in the Southeast Neil Medical Group: The Leading Volume 12, 14, Issue 25 September/October 2011 Aging of the Baby Boomers Is Long Term Care Ready? Did you know that in 2011 the first wave of baby boomers will be celebrating their 65 th birthday and eligible for Medicare? A baby boomer is defined as someone born in the post World War II era from There are an estimated 77.3 million Americans who were born during this demographic boom in births. Our economy is evidence of our aging population, as many are now retiring and leaving the labor force. Between now and 2050, the population of 65+ adults will grow by leaps and bounds. In 2009, 39.6 million Americans were age 65 or older (12.9% of US population). By 2030, the number of Americans 64 years and older will swell to 71 million (20% of US population). Seniors aged 85+ are the fastest growing segment of the population. The most rapid growth of persons age 85+ will occur between 2030 and The 85+ range will have large numbers of women, especially widowed women and women with no children. The life expectancy projections by 2050 are for men to live an average of 86 years and women to live an average of 92 years. Disability rates are projected to sky-rocket (almost triple) during 2030 and In 1986, 5.1 million Americans were disabled compared to future projections by 2040 that 22.6 million Americans will be disabled. The severely or moderately disabled will more than triple as well. This means that aid for special services will drastically increase in many areas such as transportation, housing, recreation, education, nutrition and health. Drug use in the elderly will rise in phenomenal proportions. Currently, seniors compromise 42% of the medication use in the US and $43 billion of total drug cost. By 2050, this is expected to almost double implying that almost 80% of drug use in the US will be by seniors age 65+. Baby Boomers are expected to change nursing home care in many dynamics. They will have higher expectations and demands, starting with the overall feel and environment of LTC facilities. This age group will expect a Hotel feel vs a institution feel to the facility. Food choices will need to be of a higher quality, more elaborate, detailed and tailored for individual preferences. Seniors will expect more choices for activities and exercise and they will want internet/wireless access. The environment and scenery expectations will involve quiet and serene areas away from noises, paging systems, and alarms. Nursing home use in the next 20 years will drastically increase. Back in 1985, NH use for residents 65+ was 5% and for patients 85+ was 22%. Projections for 2030 indicate the rates for NH care will increase by at least 57% for ages 65+ and increase by 300% for ages 85+. The number of patients with Alzheimer s disease will more than triple. Currently 5.4 million Americans have this disease, with an expected growth to 16 million as baby boomers age into 70s, 80s, 90s. By 2040, 70% of cases will be in patients aged 85+. Between now and 2050, Medicare spending on those with AD will increase nearly 600% and Medicaid spending will increase 400%. Now that we have outlined how the US will see increases in seniors and demands for LTC facilities and rise in prescription medication use, let s now focus on provider shortage predictions and implications on the healthcare industry. There are several factors that come into play when considering the shortage of healthcare providers and workers in the next years: Increased number of aging patients with chronic health care conditions Shortages in health care providers due to retirement Possibility of having 32 million newly insured Americans by 2014 under the new national health care plan Continued on page 3 Inside This Issue: Page 2 Page 3 Page 4 5 Pages 6-7 Page 8 Aging of the Baby Boomers FDA Update: Simvastatin Aging of the Baby Boomers Conclusion Fruit Juice/ Medication Interactions The Impact of Dilution on Intravenous Therapy NMG Contact Information

2 FDA Update: Simvastatin Labeling Changes On June 8, 2011 the FDA released new safety recommendations for simvastatin and simvastatin combination products to warn of the risk of increased muscle damage associated with the highest dose (80mg) particularly within the first 12 months of therapy. The high dose of 80mg should not be prescribed to new patients and use should only continue in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity. Simvastatin, generic for the brand name drug Zocor, is a popular medication used for cholesterol management. It is also sold in combination with niacin as Simcor and in combination with exetimibe as Vytorin. In 2010, about 2.1 million patients in the United States were prescribed a product containing simvastatin 80mg. The 80mg dose of simvastatin lowers LDL levels about 6% more than the 40mg dose. This decision by the FDA to change the safety label information was based on their review of the results of a seven year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, other clinical trial data, and analyses of adverse events submitted to the FDA s Adverse Event Reporting System. All of these resources show that patients taking simvastatin 80mg per day had an increased risk of muscle injury compared to patients taking lower doses of simvastatin or other statin drugs. This risk of injury is highest during the first year of therapy, often a result of interactions with certain other medicines, and is frequently associated with a genetic predisposition for simvastin-muscle related injury. Also, new contraindications and dose limitations were released concerning the use of simvastatin when taken with certain other medications. Medications Contraindicated with Simvastatin: Itraconazole Ketoconazole Posaconazole Erythromycin Clarithromycin Telithromycin HIV protease inhibitors Nefazodone Gemfibrozil (former limit was 10mg) Cyclosporine (former limit was 10mg) Danazol (former limit was 10mg) Please note that simvastatin should NOT be used in combination with other triglyceride lowering drug gemfibrozil (Lopid ). Do not exceed 10mg simvastatin with: Amiodarone (former limit was 20mg) Verapamil (former limit was 20mg) Diltiazem (former limit was 40mg) Do not exceed 20mg simvastatin with Amlodipine (New) Ranaolazine (New) Food Interactions Avoid large quantities of grapefruit juice (>1 quart daily) with simvastatin Page 2

3 Aging of the Baby Boomers Is Long Term Care Ready?...continued from page 1 With the rise in the number of geriatric patients who are sicker with more chronic medical conditions, take more prescription meds, and other healthcare burdens, fewer medical practices will accept new patients and people will face longer waits to see physicians (if at all). This means that the healthcare industry will see a huge push for more mid level providers (FNPs, PAs) and these professionals will provide more front-line care. Not only will the US face a shortage of providers, there will be an even more dramatic shortage of geriatric expertise among health-care professionals, which jeopardizes the health of the nation s seniors and aging baby boomers. Physician shortage stats: By 2030 USA facing 130,000 shortage of MDs Now only 7100 physicians are certified geriatricians nationwide (1 specialist per 2,546 older Americans) Number of geriatricians has dropped by 25% in the past decade By 2030, 36,000 geriatricians will be needed Geriatrics not a popular choice by physicians Medical schools are limited in admissions/class size due to the number of available hospitals and residency/ training programs It is very hard for a university to set up and establish a medical school because it must be affiliated with a teaching hospital and have residencies and training programs in place for the students in the program. Again, this is another push for universities to develop Nurse Practitioner, Physician Assistant and Doctor of Osteopathy programs to help meet this upcoming need. The nursing field will also face huge shortages in the next years. A good portion of nurses will retire and leave the labor force. Nursing schools are already maxed out and not taking any more students. By 2025 the USA will face a shortage of 260,000 RNs. In regards to pharmacy, currently there are 1300 pharmacists nationwide that are Certified Geriatric Pharmacists. These are pharmacists who have more experience and expertise with the geriatric population in regards to disease state monitoring, pharmacology and pharmacotherapy. This number will need to increase drastically to help monitor and ensure safe prescribing and monitoring practices for this growing population. So this means that in order to prepare for the future wave of geriatric patients and residents, we need to start preparations now. Universities need to explore adding schools for nursing, Physician Assistants, Nurse Practitioners and Doctor of Osteopathy. Med aide use with medication pass is probably sure to rise in nursing homes due to the shortage in the nursing field. Facilities will need to adapt to the changing dynamics of their residents needs, wants and expectations. Pharmaceutical industries are going to see a huge rise in the need and demand of highly used senior meds such as meds used to treat dementia, Parkinson s disease, anemia, stroke, heart disease, overactive bladder, and depression just to name a few. Prescription drug use will reach all time highs. Are you ready for the next wave of healthcare?? Article by Bobbie Hall, Pharm D, CGP Page 3

4 Fruit Juice/Medication Interactions The underlying mechanism by which different fruit juices adversely affect a variety of medications involves inhibition of enzymes and drug pumps in the human gut. When an individual consumes fruit juices such as grapefruit or orange juice, substances in these juices called flavonoids can inhibit enzymes in the stomach or drug pumps or both. This inhibition, in turn, can have rather significant effects on the amount of a particular medication that is absorbed. With some medications, it has been discovered that this interaction can increase the amount of drug that is absorbed while with other medications this interaction can serve to decrease the amount of drug that is absorbed. These fluctuations in the amount of drug that is absorbed could potentiate the development of side effects resulting in the drug not have the desired effect. Keep in mind that this effect can vary from patient to patient based on the drug as well as individual disease states. Nevertheless, both of these occurrences can ultimately serve to decrease the quality of health outcomes. While not all medications are affected by this interaction, there are a significant number of medications that are frequently used in the geriatric population that are susceptible to this interaction. Care should be exercised by all members of the healthcare team to minimize the effects of this interaction as much as possible. When caring for patients, a thorough review of not only their medication list but also any dietary habits should be conducted prior to administering any medications. Establishing the potential for any food-drug interactions ahead of time allows for any necessary adjustments to be made. For example, when Allegra (fexofenadine) is administered within 4 hours of grapefruit, orange or apple juice, the amount of fexofenadine that is absorbed can be decreased by as much as 40%. In order to avoid this interaction, Allegra (fexofenadine) should be separated from any of the aforementioned fruit juices by at least 4 hours. Outside of this 4 hour window, the effect is non-existent. Unfortunately, for many other medications, the resolution to this interaction is not so clear cut. However, there are some steps that can be taken to help avoid these interactions. First and foremost, the easiest way in which to manage a potential interaction between a medication and a fruit juice (specifically grapefruit, orange or apple juice) is to have the patient avoid the fruit juice altogether. This may seem rather simple and certainly in some instances easier said than done, but it is the only way to guarantee that these types of interactions will not surface. Secondly, if a patient insists that they must have grapefruit juice or orange juice throughout the course of the day, switching to a medication not known to interact with fruit juice is a viable option. For instance, lovastatin and simvastatin have been shown to interact with grapefruit juice while pravastatin and rosuvastatin have not. Furthermore, it is worthwhile to address some common misconceptions and point out some things to avoid in an attempt to minimize food-drug interactions. For example, separating grapefruit juice from the interacting medication by a few hours does NOT help. The effects of grapefruit juice, and only grapefruit juice, can last up to 3 days. Eating a grapefruit rather than drinking the juice will NOT avoid the interaction. The flavonoids are just as much in the fruit as in the juice. Attempting to reduce the quantity of juice is not beneficial either. The effects from these fruit juices can be seen with as little as 8 oz. of juice or 1 serving of fruit. Adjusting the dose of the medication to minimize the interaction is not advised as it is difficult to ascertain the extent of the interaction and the severity can vary from one patient to another. Lastly, medications given IV are not likely to be affected as the effects of various fruit juices are only limited to the gut. In conclusion, there are several medications which have been studied for their potential susceptibly to interactions with different juices. To date, the only juices that have been studied for medication interactions include grapefruit juice, orange juice and apple juice. While the following tables are limited to only a few dozen medications, the extent of the effect of this interaction on each medication is made apparent. In order to ensure that these interactions are minimized, we should be mindful not only of a patient s medication regimen but also their dietary habits. In doing so, we can help to maximize health outcomes for our patients. In the instance that a patient requires any of these 3 fruit juices and the interaction cannot be avoided, monitor all pertinent vital signs and labs related to each medication. TABLE 1 Medications Studied for Interactions with Grapefruit, Orange and Apple Juices DRUGS DECREASE IN ABSORPTION Sectral (Acebutolol) 7% Tenormin (Atenolol) * 40% Tekturna (Aliskiren) ~ 60% Cipro (Ciprofloxacin) * ~ 20% Allegra (Fexofenadine) ~ 40% Levaquin (Levofloxacin) * 7% Synthroid, Levothroid (Levothyroxine) 11% Singulair (Montelukast) ** 0 22% * Atenolol, Ciproflaxacin and Levofloxacin not studied with grapefruit juice. Percentages given apply to orange and apple juice only ** Montelukast studied with grapefruit juice and no effect observed Aliskeren is a substrate of OATP2B1 whose serum levels were decreased by orange and apple juice Article by Thomas M. Waters Pharm D Candidate Page 4

5 Table 2 Medications studied for Interactions with Grapefruit Juice only. Drugs Findings Implications Acebutolol (Sectral) Decreased absorption (7%) Not likely significant. Can separate by 4 hours. Aliskiren (Tekturna) Decreased absorption (60%) Separate by 4 hours. Amiodarone (Cordarone) Increased absorption (50%) Prescribing info. advises to avoid grapefruit. Benzodiazepines, oral: Diazepam (Valium),Midazolam (Versed), Quazepam (Doral), Triazolam (Halcion) Increases absorption. Alprazolam does not appear to interact Watch for increased sedation. Some references advise avoiding grapefruit with medications listed. Buspirone (BuSpar) Increases absorption Action of the drug does not appear to be affected. Calcium Channel Blockers:Amlodipine (Norvasc), Diltiazem (Cardizem) Felodipine (Plendil), Nicardipine (Cardene), Nifedipine (Procardia, Adalat), Nisoldipine (Sular), Verapamil (Calan, Verelan) Increases absorption Monitor for signs of toxicity including flushing, headache, tachycardia and hypotension. Carbamazepine (Tegretol) Increases absorption Monitor for signs of toxicity including dizziness, drowsiness, tremor, agitation, nausea/vomiting and ataxia. Carvedilol (Coreg) Increases absorption (16%) Clinical significance is unknown. Cilostazol (Pletal) Increases absorption Clinical significance is unknown. Clarithromycin (Biaxin) Delays absorption Not likely significant. Clomipramine (Anafranil) Increases absorption Monitor for signs of toxicity including dry mouth, somnolence, dizziness and fatigue. Digoxin (Lanoxin) Slight increase in absorption Unlikely significant with occasional consumption. Erythromycin (Ery-Tab) Increases absorption Monitor for QT prolongation and torsades de pointes. Estrogens Increases absorption Effects are unknown. Fexofenadine (Allegra) Decreases absorption (40%) Manufacturer labeling recommends taking with water. If taken with grapefruit juice, separate by 4 hours. Fluvoxamine (Luvox) Increases absorption Monitor for nausea. HMG-CoA Reductase Inhibitors: Atorvastatin (Lipitor),Lovastatin (Mevacor) Simvastatin (Zocor) Increases absorption Levothyroxine (Synthroid) May decrease absorption (11%) Separate by 4 hours. Avoid grapefruit. Monitor for increased toxicity including headache, GI complaints and muscle pain. Consider Pravachol, Crestor or Lescol as alternatives. Losartan (Cozaar) May reduce absorption Monitor for increased side effects including hypotension, dizziness, tachycardia, syncope & hyperkalemia. Methadone (Dolophine) Increases absorption Best to avoid grapefruit. Methylprednisolone, oral Increases absorption May increase adverse effects. Quinidine Delays absorption Clinical significance unknown. Sertraline (Zoloft) Increases absorption Clinical significance unknown. Tacrolimus (Prograf) Increases trough Prescribing info. advises to avoid grapefruit. Monitor for signs of toxicity including hypertension, tremor, headache and insomnia. Theophylline (Theo-Dur) Decreases absorption Monitor blood levels. Avoid if possible. Page 5

6 The Impact of Dilution on Intravenous Therapy In the early 16 th century, the physician Paracelsus wrote, All substances are poison; there is none which is not a poison. The right dose differentiates a poison from a remedy. Dilution of toxicants (or poisons) is a principal method used to minimize damage caused by toxicants. Based on these statements, intravenous medicinal chemicals are toxicants whose adverse reactions are decreased by dilution. An important adverse effect of intravenous therapy is the damage caused by the direct contact of infused chemicals with the inner lining of blood vessels. The degree of toxic insult to the healthy tissue is determined by the concentration of a toxicant in contact with the cells lining the inside of the vessel and by the duration of the exposure. This damage occurs primarily to the cells of the inner lumen (tunica intima) of veins near the tip of intravenous catheters. This location is where the medication tends to be the most concentrated as it enters the body. Toxic damage to the cells of the inner lumen of veins can lead to inflammation of the vein (chemically induced phlebitis) and clot formation within the vein. Toxic insult to the vessels can lead to permanent vessel damage or more serious conditions such as infections of surrounding tissues or bloodstream. Dilution of a toxicant reduces the number of times that individual particles of that toxicant will make contact with susceptible tissue cells. Dilution essentially reduces the dose of toxicant that the average cell will receive. Dilution further reduces damage from toxicants by rinsing toxic particles off tissue cells, thereby minimizing the amount of tissue contact time. Determining how much dilution is required to minimize the effects of toxicants can be challenging, both logistically and intellectually. Scientific theory predicts that dilution of intravenous medications by any one or any combination of three methods of dilution will decrease the incidence of chemically induced phlebitis. These three methods are: increasing the amount of diluting solution in the administration container (while the amount of medication remains unchanged), slowing the rate of the administration of the medication into the blood vessel, and infusing the medication into a vein with a larger volume of blood flow. Article by Ellen Walsh, RN Clinical Nurse Consultant Diluting a chemical in a container prior to administration is the most commonly used method of dilution, and is the most easily quantified. For example, a gram of a particular medication comes in a 20-mL bottle supplied by the manufacturer. The medication is already diluted into a solution of approximately 50 mg/ml. The concentration of the medication can easily be diluted to, for example, 4 mg/ml by simply adding 200 ml of diluent to the initial solution. The second method of dilution used in intravenous therapy is to increase the length of time over which a chemical is administered. This results in mixing with a larger volume of blood. For example, the previously mentioned 4mg/mL concentration may be administered over 90 minutes instead of 30 minutes. In this case, the medication is hypothesized to be diluted by 3 times more intravenous blood volume than when administered over 30 minutes. Page 6

7 The third method of dilution relies on the assumption that blood flow volumes increase the closer to the heart that the infusion occurs. This method involves advancing catheter tips into veins with ever-increasing blood flow volumes. The result is dilution from the same principle as slowing the rate of infusion: that is, there is less medication infused per volume of blood (the diluent). Advanced ultrasound technology can be used to measure the actual blood flow rates in veins commonly used for intravenous therapies. Ultrasound is used to obtain a Doppler sample of vascular blood flow speed in meters per second. That blood flow speed is then multiplied by a measurement of the area of the vein lumen at the same location the Doppler sample is taken. This calculation gives the blood flow rate. Currently, effective tools that prevent chemically induced phlebitis are often contradictory and/or based on relatively weak science. For example, some health care professionals insist that certain drugs (such as vancomycin) must be diluted by the blood flow in the superior vena cava, while some researchers demonstrate that these same drugs can be safely infused via peripheral veins. Some research has shown that neither a higher initial dilution nor slowing the infusion rate resulted in the decreased incidence of phlebitis. It is not surprising, then, that research outcome data, professional opinions, and actual practices pertaining to dilution theory vary widely due to inconsistencies in the controlling factors affecting final dilution. There is no reasonable single method for preventing chemically induced phlebitis. It has been suggested that simply infusing all medications into the central vascular circulation is a cheap and relatively safe method for diluting medications. This is offset by problems specific to central catheter placements: equipment needed to place the catheters, the need for x-rays to confirm correct tip placement, sterile insertion procedure, and increased insertion costs. Furthermore, there is no evidence that simply infusing medication into the central vascular blood flow ensures that the medications are diluted to their NOAEL (Toxicologists refer to the safe concentration level as no observed adverse effect level. In intravenous therapy, the safe concentration would be synonymous with the safe dilution level.) Conversely, an argument could be made that diluting all medications to their NOAEL in their initial containers would be the safest and easiest method of dilution. However, diluting all medications in their initial containers to the NOAEL dilution level has drawbacks as well, such as patient fluid level overload. Even dilution by extending infusion times may interfere with the therapy mechanism of many antibiotics and total parenteral nutrition. It is clear then, that when providing sufficient dilution to avoid chemically induced phlebitis, a more sophisticated and individualized approach is required. With the aid of advanced ultrasound technology and specific blood flow rate calculations, it should be possible to identify the NOAEL for each infused chemical and to prevent chemically induced phlebitis. Logically included would be recommendations for insertion sites, optimal final catheter tip positions, and in collaboration with pharmacists and physicians, suggestions for other aspects of dilution such as pump flow rates and initial container dilution. With advancements in the application of dilution therapy, infusion therapies could truly be considered remedies instead of poisons, as chemically induced phlebitis becomes a phenomenon of the past. Page 7

8 Kinston Pharmacy 2545 Jetport Road Kinston, NC Phone Fax Neil Medical Group Pharmacy Services Mooresville Pharmacy 947 N. Main Street Mooresville, NC Phone Fax a note from the Editor I wanted to share this quote that is the motto for Hyman s, a well known seafood restaurant in Charleston. The quote is from Chuck Swindol and I think is worth thinking about. The longer I live, the more I realize the impact of attitude on life. Attitude, to me, is more important than education, than money, than circumstances, than failures, than successes, than what other people think or say or do. It is more important than appearance, giftedness, or skill. It will make or break a company.a church.a home. The remarkable thing is we have a choice everyday regarding the attitude we embrace for that day. We cannot change our past.we cannot change the fact that people act in a certain way. We cannot change the inevitable. The only thing we can do is play on the one string we have, and that is our attitude..i am convinced that life is 10% what happens to me and 90% how I react to it. And so it is with you..we are in charge of our ATTITUDES. Cathy Fuquay Pharm Notes is a bimonthly publication by Neil Medical Group Pharmacy Services Division. Articles from all health care disciplines pertinent to long-term care are welcome. References for articles in Pharm Notes are available upon request. Your comments and suggestions are appreciated. Contact: Cathy Fuquay (cathyf@neilmedical.com) ext Note: Periodically, we are asked to add a name to our distribution list. At this time, copies of Pharm Notes newsletters are distributed in bulk to Neil Medical Group customers only.