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Volume 13. Issue 3. Fall 2007

pharmacist di est The News that Matters to Pharmacists

A Procter & Gamble Health Care Publication

Understanding the Cold Infection Process Procter & Gamble Research & Development, 2007

Tear Ducts

Nostrils

Virus particles usually enter through the nostrils or the tear ducts.

system, these conditions do not cause the infection or the symptoms. Virus particles usually enter the respiratory system through the nostrils or the tear ducts and are then transported through the nasal cavity in the mucociliary flow to the nasopharynx. In the case of rhinovirus, it binds to adhesion molecule (ICAM-1) receptors on host epithelial cells. The nasopharynx is usually the first point of infection, and the entire nasal epithelium is not usually infected during peak symptoms. The nasal secretions that form a coating on the nasal mucosa have an important role in defense against infection. The mucus traps viruses and bacteria, which are then removed by the sweeping action of mucociliary clearance. It also contains various antibacterial and antiviral substances such as immunoglobulins. The mucus is transported to the throat where it is swallowed. Any bacteria or viruses trapped in the mucus are destroyed by the acidity of the stomach. There is normally only a thin layer of mucus overlying the nasal mucosa, but physical or chemical irritation of sensory nerves in the nose triggers a nasal reflex with profuse watery secretion from glands deep in the mucosa. This reflex action is protective as it washes away irritants and infective agents such as viruses. The infection route can be direct transfer from hands or by inhalation of airborne droplets. Decades of research have shown that the person-to-person transmission of bacterial as well as viral agents is facilitated by the hands. In fact, it has been shown that the transmission of the cold virus is more a function of hand transmission versus airborne droplets from the sneeze of an infected individual. (continued on page 7)

Pharmacy Practice

n Medicare Part D Coverage

n Pharmacist Supply Projections n Pandemic Preparedness

Treatment & Prevention

n Reanalysis of Rosiglitazone Data n Arthritis Pain Relief

n Updated Asthma Guidelines

n Omeprazole/Esomeprazole Safety

This Season

n Influenza Vaccine and Diabetes

n Medication Reminders for Parents n Dark Chocolate and Blood Pressure

New Vicks Early Defense

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Patient questions in the pharmacy often probe myths and facts about the contracting and resolution of colds. Procter & Gamble researchers recently aggregated data from extensive sources to create this overview of the cold infection process. Common colds are upper respiratory tract infections caused by viruses. A series of viruses are responsible for cold infections, including rhinovirus, coronavirus, respiratory syncytial virus and adenovirus. The rhinovirus group is the most frequent cause of colds, being responsible for 30% to 50% of reported infections. Colds are not a result of “getting wet hair” or “not wrapping up warm in the winter.” In the Southern Hemisphere, people catch colds as often as the Northern Hemisphere despite the vast difference in temperatures. While environmental conditions such as crowding, dampness and low temperatures, as well as poor nutrition and stress, may make subjects more susceptible to virus infection by compromising the immune

Inside This Issue:

Vicks provides patients with two lines of defense: n New Vicks Early Defense Foaming Hand Sanitizer kills 99.9% of germs on contact. It helps protect hands from new germs for up to three hours.* n New Vicks Early Defense Nasal Decongestant Spray fights cold congestion at the first signs of a cold. Thermal-activated gelling polymer helps keep the product in the nasal cavity, where cold symptoms begin. For more information, visit www.vicks.com. *Under laboratory conditions


Pharmacy Practice

Free Guide to Pandemic Preparedness http://tinyurl.com/ywo4yw

A new publication titled A Pharmacist’s Guide to Pandemic Preparedness provides key elements to consider in planning for pandemic influenza. The guide includes a “Pandemic Flu Pharmacy Checklist” that outlines needed supplies and medications, as well as a list of the top non-influenza medications dispensed by a major pharmacy chain to meet patient needs during Hurricane Katrina. The guide was created through a collaborative effort of the American Pharmacists Association (APhA), American Society of Health-System Pharmacists (ASHP), and National Association of Chain Drug Stores (NACDS) Foundation. It is available from the Web sites of all three organizations or at the address shown above.

Medicare Part D Secured Drug Coverage for Most Seniors Health Aff 2007;26:w630-43; http://tinyurl.com/yw9oq2 Medicare Part D secured prescription drug coverage for most seniors who lacked it in 2005, according to the results of a survey published as a “Web Exclusive” article by Health Affairs. More than 16,000 communitydwelling seniors participated in the survey, which was conducted from October to December 2006 by the Kaiser Family Foundation, Commonwealth Fund, and Tufts-New England Medical Center. Only 8.5% of the seniors surveyed reported having no prescription drug coverage in 2006. These seniors generally were either in relatively good health or potentially difficult to reach because of sociodemographic characteristics (e.g., older, lower income, less education). The primary sources of prescription drug coverage were Medicare Part D (50.2% of the seniors surveyed), employer plans (30.8%), and the Department of Veterans Affairs (VA; 3.1%). Compared with seniors covered by employers or the VA, Part D enrollees were more likely to have higher

out-of-pocket costs and to spend more than $300 per month on medications. They also were more likely to skip or delay filling or refilling prescriptions because of cost considerations. Awareness of the Part D Limited Income Subsidy (LIS) was low, particularly among African American and Hispanic seniors. Only half of surveyed seniors in the LIS target population (income less than or equal to 150% of poverty and no LIS benefits) were aware of the LIS program. The Centers for Medicare & Medicaid Services (CMS) provide a number of resources for helping beneficiaries learn about and apply for the LIS. The 2007 LIS Outreach Toolkit — available on the CMS Web site at http://tinyurl.com/2zn53b —

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includes downloadable materials and links to

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patient-directed publications.

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DON’T LET PAINFUL ARTHRITIS FLARE-UPS CHANGE THE WAY YOU SEE THINGS. 2

pharmacist digest Fall 2007


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New Pharmacist Supply Projections Higher Than Expected

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18 in

17 in

Pharmacy Practice

Order Free Samples Online

J Am Pharm Assoc 2007;47:463-70

Data from the 2007 Bureau of Health Professions Pharmacist Supply Model published in the July/August issue of Journal of the American Pharmacists Association show an unexpected increase in the number of active pharmacists. Compared with estimates from the 2000 supply model, the latest projected supply of active pharmacists is 14% higher for the year 2010, 20% higher for 2015, and 27% higher for 2020. The authors attribute these substantial increases primarily to pharmacists remaining in the workforce longer (59.5% of the increase) and larger numbers of pharmacy graduates (34.7% of the increase). Pharmacists from other countries who become licensed to practice in the United States represent less than 6% of the increased supply. Other key projections include the following:

n Pharmacy will continue to be the third

largest health profession in the United States, behind nursing and medicine.

n Because of a trend toward part-time

work, the estimated number of full-timeequivalent pharmacists will be about 15% less than the estimated total number of active pharmacists through 2020.

n Women will account for more than

60% of pharmacists by 2020.

n The mean age of pharmacists will

decrease from 47 to 43 by 2020.

n Although the ratio of pharmacists to

the general population will increase through 2020, the ratio of pharmacists to the over-65 population will decrease beginning in 2011 and continue past 2020 as the baby boomers move through retirement age.

We know that providing exceptional patient care creates exceptionally busy days in the pharmacy. So, for your convenience, free Prilosec OTC samples for your frequent heartburn patients and Medicare Part D Coverage Gap brochures can now be ordered online. Just visit www.prilosecotc-hcp.com to request what you need. We’ll be honored to partner with you in this way to support your pharmacy’s commitment to patient care.

INTRODUCING THERMACARE ARTHRITIS HEATWRAPS. You shouldn’t have to pay a price for doing the things you love. Use new ThermaCare Arthritis HeatWraps at the first sign of a flare-up and you’ll get 12 hours of heat for relief that lasts all day. It’s going to make you see things in a whole new light. Available in hand, neck/shoulder, and knee.

KEEP FLARE-UPS FROM KEEPING YOU DOWN.

Use as directed. TPAD07058 ©2007 P&G

thermacare.com

pharmacist digest Fall 2007

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Treatment & Prevention Local Treatments Preferred for Hand Osteoarthritis Ann Rheumatic Dis 2007;66;377-88

Topical agents such as capsaicin are preferred over systemic therapy for mild to moderate pain associated with osteoarthritis of the hand, according to evidence-based recommendations developed by the European League Against Rheumatism (EULAR) Osteoarthritis Task Force. These are the first recommendations for the management of hand osteoarthritis developed by an international multidisciplinary group. The guideline development group included 21 experts representing 15 European countries. They used a combination of published literature and expert consensus to create 11 key recommendations. Some of the recommendations include the following:

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New ThermaCare Arthritis Provides All-Day Pain Relief

New ThermaCare Arthritis® is an air-activated heat wrap designed for patients who suffer from minor osteoarthritis pain or occasional arthritis flare-ups. It provides 12 hours of heat for all-day arthritis pain relief, allowing patients to stay active. Heat therapy is clinically proven to provide greater pain relief than acetaminophen and greater flexibility than ibuprofen in patients with osteoarthritis of the knee1. Available in three versions, ThermaCare Arthritis is specifically designed for a comfortable fit on common arthritis pain sites: the hand & wrist, knee & elbow, and neck & shoulders. To learn more, visit www.thermacare.com. 1

Data on file, P&G

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n The

optimal management of hand osteoarthritis combines nonpharmacologic modalities and drug therapy. n Local application of heat is beneficial, especially before exercise. n When systemic treatment is needed, acetaminophen is the oral analgesic of first choice. The total daily dose should not exceed 4 g. n If oral therapy with nonsteroidal antiinflammatory drugs (NSAIDs) is needed, the lowest effective dose should be used for the shortest possible duration to reduce the risk of serious gastrointestinal toxicity. n Patients at increased risk of gastrointestinal adverse effects should be treated with either (1) a nonselective NSAID plus a

gastroprotective agent or (2) a selective COX-2 inhibitor. n COX-2 inhibitors should not be used in patients with increased cardiovascular risk. These patients should be treated cautiously with nonselective NSAIDs. The authors acknowledged both the lack of research evidence specific to hand osteoarthritis and the need for further clinical trials. New guidelines reflect the consensus of international experts

Reanalysis of Rosiglitazone Data Questions Increased Cardiovascular Risk N Engl J Med 2007;356:2457-71; Ann Intern Med 2007;147:8

A widely publicized meta-analysis of 42 trials concluded that rosiglitazone (Avandia) was associated with an approximately 43% greater risk for myocardial infarction (odds ratio 1.43; 95% CI, 1.03-1.98; p=0.03) and an approximately 64% greater risk for cardiovascular death (odds ratio 1.64; 95% CI, 0.98-2.74; p=0.06) than placebo or other antidiabetic regimens. The metaanalysis appeared in the June 14 issue of New England Journal of Medicine. The authors noted a number of important limitations, including the following: n The trials were not designed to explore cardiovascular outcomes. n Many of the trials were short-term and small. n The authors did not have access to original source data for any of the trials. In an article published in the October 16 issue of Annals of Internal Medicine, Diamond and colleagues discussed two additional limitations to the original metaanalysis. First, studies were combined on the basis of a lack of statistical heterogeneity, despite substantial variability in study designs and populations. Second, zero total event trials (i.e., trials in which no cardiovascular events were seen in either the

pharmacist digest Fall 2007

treatment or comparator groups) were excluded from the analysis, which may have affected estimations of risk.

Diamond and colleagues reanalyzed the 42 trials using various modeling and weighting methods. Based on the lower odds ratios that resulted—ranging from 1.26 to 1.43 for myocardial infarction and 1.17 to 1.64 for cardiovascular death—the authors concluded that the risk for myocardial infarction and death from cardiovascular disease with rosiglitazone is uncertain. They also stated that only prospective clinical trials designed for the specific purpose of establishing the cardiovascular benefit or risk of rosiglitazone will resolve the controversy about its safety.


Treatment & Prevention Bifidobacterium infantis 35624 Improves Symptoms of IBS

National Asthma Guidelines Updated http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm J Allergy Clin Immunol 2007;119:1454-61

The National Asthma Education and Prevention Program (NAEPP) has issued Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. “EPR-3” represents the first comprehensive revision of the guidelines since 1997. The EPR-3 guidelines address four essential components of asthma care: assessment and monitoring, patient education, control of factors contributing to asthma severity, and pharmacologic treatment. EPR-3 incorporates a number of key differences from previous guidelines, including a stronger distinction between classifying asthma severity and assessing asthma control. Of special note to pharmacists is a specific recommendation regarding educational interventions provided by pharmacists: EPR-3 states that the use of such interventions “is feasible, may help improve self-management skills and asthma outcomes, and merits more clinical studies.” Recent data demonstrate a need for improved asthma care. In a survey published in the June issue of the Journal of Allergy and Clinical Immunology, 55% of the respondents (1812 adult patients with

moderate-to-severe asthma receiving standard asthma medications) reported having uncontrolled disease. More than half (56.6%) of patients with uncontrolled asthma and about one third (29.6%) of patients with controlled asthma admitted using their asthma medications more frequently than prescribed. Also, only 35% of patients with uncontrolled asthma and 26% of patients with controlled asthma had ever received a personalized asthma action plan. 26% have personalized action plan

45% controlled asthma 29.6% use medications more frequently than prescribed

35% have personalized action plan

55% uncontrolled asthma 56.6% use medications more frequently than prescribed

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FDA First Report: No Increased Cardiovascular Risk with Omeprazole or Esomeprazole http://www.fda.gov/cder/drug/early_comm/omeprazole_esomeprazole.htm

A preliminary review of safety data for omeprazole (Prilosec) and esomeprazole (Nexium) suggested no increased risk of myocardial infarction or other cardiac events, according to an August 9 early communication from the Food and Drug Administration (FDA). Therefore, the FDA did not believe that health care providers or patients needed to change either their prescribing practices or their use of these products at that time. The FDA planned to complete its review within 3 months. Data from two small long-term clinical studies comparing anti-reflux surgery with drug therapy in patients with severe gastroesophageal reflux disease (GERD) raised concerns that the long-term use of omeprazole or esomeprazole may increase the risk of heart attacks, heart failure, and

heart-related sudden death. The early communication from the FDA pointed out that while both of these studies collected safety data, the protocols did not specify how cardiovascular events were to be defined or documented. Also, patients who underwent surgery tended to be younger and less likely to have a history of, or risk factors for, cardiovascular events. The FDA stated that these differences could have biased and significantly influenced the safety data from these studies. As part of its analysis, the FDA reviewed pooled analyses of 14 other comparative studies of omeprazole (including 4 placebo-controlled trials) in which patients were treated for up to 2 years. In these studies, patients treated with omeprazole had fewer cardiovascular events than patients who received placebo.

pharmacist digest Fall 2007 pharmacist digest Spring 2007

Am J Gastroenterol 2007;102(suppl 2): S500, Abstract 1040

In a systematic review of randomized controlled trials evaluating the efficacy, safety, and tolerability of probiotics in the treatment of irritable bowel syndrome (IBS), only Bifidobacterium infantis 35624 was found to have demonstrated efficacy for improvement in IBS symptoms. Inadequate data were available to comment on the efficacy of other probiotics. Of the 13 trials identified by the investigators, 11 were deemed to have suboptimal study design with inadequate blinding, inadequate trial length, inadequate sample size, and lack of intention to treat analysis. Only three studies provided any quantifiable data about tolerability and adverse events. The efficacy of B. infantis 35624 was demonstrated in two appropriately designed studies. In the first study, B. infantis 35624 resulted in significant improvement in the primary composite outcome measure (abdominal pain/discomfort, bloating/distention, and bowel movement difficulty) compared with placebo for the entire treatment period. In the second study, B. infantis 35624 demonstrated superior efficacy to placebo at 4 weeks for the primary outcome measure of abdominal pain/discomfort, as well as for a number of secondary measures (bloating/distention, incomplete evacuation, straining, passage of gas, and a composite score of abdominal pain/discomfort, bloating/distention, and bowel movement satisfaction). The results of the systematic review were presented in a poster session at the American College of Gastroenterology 2007 Annual Scientific Meeting and Postgraduate Course, held October 12-17 in Philadelphia, Pennsylvania. B. infantis 35624 is the only probiotic with demonstrated efficacy for improvement in IBS symptoms

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This Season Eating Small Amounts of Dark Chocolate May Reduce Blood Pressure

Increased Influenza Vaccination Rates Needed Among Patients With Diabetes

JAMA 2007;298:49-60

Because patients with diabetes are at increased risk for complications from influenza, the Centers for Disease Control and Prevention (CDC) and the American Diabetes Association (ADA) recommend annual influenza vaccination for all adults and children (6 months of age or older) with diabetes. Yet only about half of adults with diabetes are immunized each year, according to a recent Call to Action issued by the National Foundation for Infectious Diseases. With the flu season here, immunization

Pharmacists should recommend annual influenza vaccination to diabetes patients

centers should strive to vaccinate more patients with diabetes. All healthcare professionals, including pharmacists, should recommend the vaccine to patients with diabetes and refer patients to vaccine clinics or other providers who vaccinate.

Understanding the Cold Infection Process (continued from page 1)

To trigger a cold infection, the virus must enter the host epithelial cell, replicate, be released into the extracellular environment, and then re-infect new cells. The infective dose of rhinovirus is very low, possibly as low as 30 virus particles. Subsequent viral replication triggers the release of inflammatory mediators and activation of neurogenic pathways, which lead to symptoms. Virus is shed throughout the cold, but tends to peak at 2-3 days. Symptoms first occur 10 to 16 hours after virus entry into the nose, and peak

on days 2-3 of infection, corresponding to highest levels of virus shedding. A cold infection is usually first noticed as a slight soreness in the nasopharyngeal region or as nasal obstruction. From here a wave of infection spreads outwards and other symptoms such as rhinorrhea, sore throat, sneezing, cough, and a feeling of malaise can develop. Colds usually last seven days, but around 25% last two weeks. For a complete list of references, contact shafer.ll@pg.com.

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Medication Safety Reminders for Parents http://www.fda.gov/cder/drug/advisory/cough_cold.htm

What should parents know about using cough and cold products in children? The following points were among those included in a recent Public Health Advisory issued by the Food and Drug Administration (FDA). n Parents should not use cough and cold products in children younger than 2 years of age unless given specific directions to do so by a health care provider. n Parents should not give children medicine that is packaged and made for adults. Products should be marked for use in babies, infants or children. n If other medicines (over-the-counter or

prescription) are being given to a child, the child’s health care provider should review and approve their combined use. n Parents should follow the directions in the “Drug Facts” box and avoid giving medicine more often or in greater amounts than is stated on the package. n For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with each different medicine formulation and that is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children.

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n

If a measuring device is not included with the product, parents should purchase one at the pharmacy. The dropper, dosing cup, or dosing spoon should have markings that match the dosing instructions in the “Drug Facts” box or the dosing recommended by the child’s health care provider.

©2007 P&G MPAD07030

The regular consumption of small amounts of polyphenol-rich dark chocolate may be a promising behavioral approach for lowering blood pressure, according to a study published in the July 4 issue of JAMA. The randomized trial included 24 women and 20 men ranging in age from 56 to 73 years. All participants had untreated upper-range prehypertension (blood pressure between 130/85 and 139/89 mm Hg) or stage 1 hypertension (blood pressure between 140/90 and 160/100 mm Hg) but otherwise were in general good health. For 18 weeks, participants consumed a small square providing approximately 30 kcal of either dark (6.3 g) or white (5.6 g) chocolate two hours after the evening meal. The dark chocolate contained 30 mg of polyphenols; the white chocolate contained none. Small but progressive reductions of both systolic and diastolic blood pressure were observed in the dark chocolate group, culminating in mean decreases of –2.9 mm Hg systolic and –1.9 mm Hg diastolic at 18 weeks. Blood pressure remained unchanged among participants who received white chocolate. The authors suggest further study.

http://tinyurl.com/2c8u73

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P&G Pharmacist Digest - Fall 2007  

The Procter & Gamble Periodical Newsletter for Pharmacists