A Procter & Gamble Health Care Publication

The News that Matters to Pharmacists

Volume 13. Issue 3. Fall 2007

Inside This Issue:Pharmacy Practicen Medicare Part D Coverage

n Pharmacist Supply Projections

n Pandemic Preparedness

Treatment & Preventionn Reanalysis of Rosiglitazone Data

n Arthritis Pain Relief

n Updated Asthma Guidelines

n Omeprazole/Esomeprazole Safety

This Seasonn Influenza Vaccine and Diabetes

n Medication Reminders for Parents

n Dark Chocolate and Blood Pressure

New Vicks Early Defense

Vicks providespatients with twolines of defense:

n New VicksEarly DefenseFoaming HandSanitizer kills99.9% of germson contact. Ithelps protecthands from newgerms for up tothree hours.*

n New Vicks Early Defense NasalDecongestant Spray fights cold congestion at the first signs of a cold.Thermal-activated gelling polymerhelps keep the product in the nasalcavity, where cold symptoms begin.

For more information, visit www.vicks.com.

pharmacist di estUnderstanding the Cold Infection ProcessProcter & Gamble Research & Development, 2007

Patient questions in the pharmacy oftenprobe myths and facts about the contractingand resolution of colds. Procter & Gambleresearchers recently aggregated data fromextensive sources to create this overview ofthe cold infection process.

Common colds are upper respiratorytract infections caused by viruses. Aseries of viruses are responsible for coldinfections, including rhinovirus, corona-virus, respiratory syncytial virus and adenovirus. The rhinovirus group is the most frequent cause of colds, beingresponsible for 30% to 50% of reportedinfections. Colds are not a result of “getting wet hair” or “not wrapping upwarm in the winter.” In the SouthernHemisphere, people catch colds as often as the Northern Hemisphere despite thevast difference in temperatures. Whileenvironmental conditions such as crowding, dampness and low temperatures,as well as poor nutrition and stress, maymake subjects more susceptible to virusinfection by compromising the immune

system, these conditions do not cause theinfection or the symptoms.

Virus particles usually enter the respiratory system through the nostrils or the tear ducts and are then transportedthrough the nasal cavity in the mucociliaryflow to the nasopharynx. In the case ofrhinovirus, it binds to adhesion molecule(ICAM-1) receptors on host epithelialcells. The nasopharynx is usually the firstpoint of infection, and the entire nasalepithelium is not usually infected duringpeak symptoms.

The nasal secretions that form a coatingon the nasal mucosa have an importantrole in defense against infection. Themucus traps viruses and bacteria, whichare then removed by the sweeping action of mucociliary clearance. It alsocontains various antibacterial and antiviralsubstances such as immunoglobulins. Themucus is transported to the throat where it is swallowed. Any bacteria or virusestrapped in the mucus are destroyed by theacidity of the stomach. There is normallyonly a thin layer of mucus overlying thenasal mucosa, but physical or chemicalirritation of sensory nerves in the nosetriggers a nasal reflex with profuse waterysecretion from glands deep in the mucosa.This reflex action is protective as it washes away irritants and infective agentssuch as viruses.

The infection route can be direct transfer from hands or by inhalation ofairborne droplets. Decades of researchhave shown that the person-to-persontransmission of bacterial as well as viralagents is facilitated by the hands. In fact,it has been shown that the transmission ofthe cold virus is more a function of handtransmission versus airborne dropletsfrom the sneeze of an infected individual. (continued on page 7)

P&GNews

*Under laboratory conditions

Tear Ducts

Virus particles usually enter

through the nostrils or the tear ducts.

Nostrils

Pharmacy Practice

Medicare Part D Secured Drug Coverage for Most SeniorsHealth Aff 2007;26:w630-43; http://tinyurl.com/yw9oq2

Medicare Part D secured prescription drug coverage for most seniors who lacked it in2005, according to the results of a surveypublished as a “Web Exclusive” article byHealth Affairs. More than 16,000 community-dwelling seniors participated in the survey,which was conducted from October toDecember 2006 by the Kaiser FamilyFoundation, Commonwealth Fund, and Tufts-New England Medical Center.

Only 8.5% of the seniors surveyed reportedhaving no prescription drug coverage in 2006.These seniors generally were either in relativelygood health or potentially difficult to reachbecause of sociodemographic characteristics(e.g., older, lower income, less education).

The primary sources of prescription drugcoverage were Medicare Part D (50.2% ofthe seniors surveyed), employer plans(30.8%), and the Department of VeteransAffairs (VA; 3.1%). Compared with seniorscovered by employers or the VA, Part Denrollees 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 IncomeSubsidy (LIS) was low, particularly amongAfrican American and Hispanic seniors.Only half of surveyed seniors in the LIS target population (income less than or equalto 150% of poverty and no LIS benefits)were aware of the LIS program.

2 pharmacist digest Fall 2007

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DON’T LETPAINFULARTHRITISFLARE-UPSCHANGE THEWAY YOUSEE THINGS.

You shouldn’t have to pay a price fordoing the things you love. Use newThermaCare Arthritis HeatWraps atthe first sign of a flare-up and you’llget 12 hours of heat for relief thatlasts all day. It’s going to make you seethings in a whole new light.Availablein hand, neck/shoulder, and knee.

INTRODUCINGTHERMACARE ARTHRITISHEATWRAPS.

thermacare.com

KEEP FLARE-UPSFROM KEEPINGYOU DOWN.

Use as directed.TPAD07058©2007 P&G

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A new publication titled A Pharmacist’sGuide to Pandemic Preparednessprovides key elements to consider inplanning for pandemic influenza. The guide includes a “Pandemic FluPharmacy Checklist” that outlinesneeded supplies and medications, aswell as a list of the top non-influenzamedications dispensed by a majorpharmacy chain to meet patient needsduring Hurricane Katrina.

The guide was created through a collaborative effort of the AmericanPharmacists Association (APhA),American Society of Health-SystemPharmacists (ASHP), and NationalAssociation of Chain Drug Stores(NACDS) Foundation. It is available from the Web sites of all three organi-zations or at the address shown above.

Free Guide to Pandemic Preparednesshttp://tinyurl.com/ywo4yw

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 —

includes downloadable materials and links to

patient-directed publications.

pharmacist digest Fall 2007 3

Pharmacy Practice

DOC Path:Procter_Gamble:Volumes:Procter_Gamble:Thermacare:Mechanicals:301-PGB484:Documents:PGB484 C.indd 100%Laser

Printed @:

Agenc Job #: 301-PGB484C

SETU

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Studio Artist

Copy Writer

Traffi c

Production

Account Mgr.

Project Mgr.

Job Desc

Bleed

Trim

Safety

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Mech. Scale

Colors

Pub Date

Publication

18 in x 5.375 in

17 in x 4.875 in

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None

100%

4C

9/21/07

Matt L

James Du

-

Kristan Gabriel

Kristan Gabriel

Guy Shipp

None

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CappsJob#: Notes:

None

Last Modified: 9/20/07 10:02 AM

ITC Franklin Gothic (Demi Extra Compressed, Book Condensed; Type 1)Times (Roman; Type 1)

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Document Name: PGB484 C.indd Creation Date: 9/20/07 9:14 AM

Pharmacist Digest

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Capps NY127795_1_v1

DON’T LETPAINFULARTHRITISFLARE-UPSCHANGE THEWAY YOUSEE THINGS.

You shouldn’t have to pay a price fordoing the things you love. Use newThermaCare Arthritis HeatWraps atthe first sign of a flare-up and you’llget 12 hours of heat for relief thatlasts all day. It’s going to make you seethings in a whole new light.Availablein hand, neck/shoulder, and knee.

INTRODUCINGTHERMACARE ARTHRITISHEATWRAPS.

thermacare.com

KEEP FLARE-UPSFROM KEEPINGYOU DOWN.

Use as directed.TPAD07058©2007 P&G

S: 16 in

S: 4.375 in

T: 17 in

T: 4.875 in

B: 18 in

B: 5.375 in

127795_1_v1 1 9/20/07 9:04:07 PM

P&GNews

Order Free Samples Online

We know that providing exceptionalpatient care creates exceptionally busy days in the pharmacy. So, for yourconvenience, free Prilosec OTC samplesfor your frequent heartburn patients and Medicare Part D Coverage Gapbrochures can now be ordered online.Just visit www.prilosecotc-hcp.comto request what you need. We’ll be honored to partner with you in this way to support your pharmacy’scommitment to patient care.

New Pharmacist Supply Projections Higher Than ExpectedJ Am Pharm Assoc 2007;47:463-70

Data from the 2007 Bureau of HealthProfessions Pharmacist Supply Model published in the July/August issue ofJournal of the American PharmacistsAssociation show an unexpected increasein the number of active pharmacists.Compared with estimates from the 2000supply model, the latest projected supplyof active pharmacists is 14% higher forthe year 2010, 20% higher for 2015, and27% higher for 2020. The authors attributethese substantial increases primarily topharmacists remaining in the workforcelonger (59.5% of the increase) and largernumbers of pharmacy graduates (34.7% of the increase). Pharmacists from othercountries who become licensed to practicein the United States represent less than 6%of the increased supply.

Other key projections include the following:

n

Pharmacy will continue to be the thirdlargest health profession in the UnitedStates, behind nursing and medicine.

n

Because of a trend toward part-timework, the estimated number of full-time-equivalent pharmacists will be about15% less than the estimated total numberof active pharmacists through 2020.

n

Women will account for more than 60% of pharmacists by 2020.

n

The mean age of pharmacists willdecrease from 47 to 43 by 2020.

n

Although the ratio of pharmacists to the general population will increasethrough 2020, the ratio of pharmacists to the over-65 population will decreasebeginning in 2011 and continue past2020 as the baby boomers move throughretirement age.

Reanalysis of RosiglitazoneData Questions Increased Cardiovascular RiskN Engl J Med 2007;356:2457-71; Ann Intern Med 2007;147:8

Local Treatments Preferred for Hand OsteoarthritisAnn Rheumatic Dis 2007;66;377-88

A widely publicized meta-analysis of 42trials 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 placeboor other antidiabetic regimens. The meta-analysis appeared in the June 14 issue of New England Journal of Medicine.The authors noted a number of importantlimitations, including the following:

n

The trials were not designed to explore cardiovascular outcomes.

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Many of the trials were short-term and small.

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The authors did not have access to original source data for any of the trials.

In an article published in the October 16issue of Annals of Internal Medicine,Diamond and colleagues discussed twoadditional limitations to the original meta-analysis. First, studies were combined onthe basis of a lack of statistical heterogeneity,despite substantial variability in studydesigns and populations. Second, zero totalevent trials (i.e., trials in which no cardio-vascular events were seen in either the

treatment or comparator groups) wereexcluded from the analysis, which mayhave affected estimations of risk.

Diamond and colleagues reanalyzed the 42 trials using various modeling andweighting methods. Based on the lowerodds ratios that resulted—ranging from1.26 to 1.43 for myocardial infarction and1.17 to 1.64 for cardiovascular death—theauthors concluded that the risk for myocardialinfarction and death from cardiovasculardisease with rosiglitazone is uncertain. Theyalso stated that only prospective clinicaltrials designed for the specific purpose of establishing the cardiovascular benefitor risk of rosiglitazone will resolve thecontroversy about its safety.

Topical agents such as capsaicin are preferred over systemic therapy for mild to moderate pain associated withosteoarthritis of the hand, according to evidence-based recommendations develo-ped by the European League AgainstRheumatism (EULAR) Osteoarthritis Task Force. These are the first recommen-dations for the management of handosteoarthritis developed by an internationalmultidisciplinary group.

The guideline development groupincluded 21 experts representing 15European countries. They used a combinationof published literature and expert consensus to create 11 key recommendations.Some of the recommendations include the following:

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The optimal management of handosteoarthritis combines nonpharmacologicmodalities and drug therapy.

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Local application of heat is beneficial,especially before exercise.

n

When systemic treatment is needed, acet-aminophen is the oral analgesic of firstchoice. The total daily dose should notexceed 4 g.

n

If oral therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) is needed,the lowest effective dose should be usedfor the shortest possible duration to reducethe risk of serious gastrointestinal toxicity.

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Patients at increased risk of gastrointestinaladverse effects should be treated witheither (1) a nonselective NSAID plus a

gastroprotective agent or (2) a selectiveCOX-2 inhibitor.

n

COX-2 inhibitors should not be used in patients with increased cardiovascularrisk. These patients should be treatedcautiously with nonselective NSAIDs.

The authors acknowledged both the lack of research evidence specific to handosteoarthritis and the need for further clinical trials.

4 pharmacist digest Fall 2007

Treatment & Prevention

New ThermaCare Arthritis® is an air-activated heat wrap designed forpatients who suffer from minorosteoarthritis pain or occasional arthritisflare-ups. It provides 12 hours of heatfor all-day arthritis pain relief, allowingpatients to stay active. Heat therapy isclinically proven to provide greaterpain relief than acetaminophen andgreater flexibility than ibuprofen inpatients with osteoarthritis of the knee1.Available in three versions, ThermaCareArthritis is specifically designed for acomfortable fit on common arthritispain sites: the hand & wrist, knee &elbow, and neck & shoulders. To learnmore, visit www.thermacare.com.

pharmacist digest Fall 2007

P&GNews

New ThermaCare Arthritis Provides All-Day Pain Relief

1Data on file, P&G

New guidelines reflect the consensus of international experts

The National Asthma Education andPrevention Program (NAEPP) has issuedExpert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma.“EPR-3” represents the first comprehensiverevision of the guidelines since 1997.

The EPR-3 guidelines address fouressential components of asthma care:assessment and monitoring, patient education, control of factors contributingto asthma severity, and pharmacologictreatment. EPR-3 incorporates a number of key differences from previous guidelines,including a stronger distinction betweenclassifying asthma severity and assessingasthma control. Of special note to pharmacistsis a specific recommendation regardingeducational interventions provided bypharmacists: EPR-3 states that the use ofsuch interventions “is feasible, may helpimprove self-management skills and asthmaoutcomes, and merits more clinical studies.”

Recent data demonstrate a need forimproved asthma care. In a survey publishedin the June issue of the Journal of Allergyand Clinical Immunology, 55% of therespondents (1812 adult patients with

moderate-to-severe asthma receiving standardasthma medications) reported havinguncontrolled disease. More than half (56.6%)of patients with uncontrolled asthma andabout one third (29.6%) of patients withcontrolled asthma admitted using theirasthma medications more frequently thanprescribed. Also, only 35% of patientswith uncontrolled asthma and 26% ofpatients with controlled asthma had everreceived a personalized asthma action plan.

pharmacist digest Spring 2007 5

National Asthma Guidelines Updatedhttp://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htmJ Allergy Clin Immunol 2007;119:1454-61

Bifidobacterium infantis 35624 Improves Symptoms of IBSAm 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 infantis35624 was found to have demonstratedefficacy for improvement in IBS symptoms.Inadequate data were available to commenton the efficacy of other probiotics.

Of the 13 trials identified by the investi-gators, 11 were deemed to have suboptimalstudy design with inadequate blinding,inadequate trial length, inadequate samplesize, and lack of intention to treat analysis.Only three studies provided any quantifiabledata about tolerability and adverse events.

The efficacy of B. infantis 35624was demonstrated in two appropriatelydesigned studies. In the first study, B.infantis 35624 resulted in significantimprovement in the primary compositeoutcome measure (abdominal pain/dis-comfort, bloating/distention, and bowelmovement difficulty) compared withplacebo for the entire treatment period. In the second study, B. infantis 35624demonstrated superior efficacy to placeboat 4 weeks for the primary outcome measureof abdominal pain/discomfort, as well as for a number of secondary measures(bloating/distention, incomplete evacuation,straining, passage of gas, and a compositescore of abdominal pain/discomfort, bloating/distention, and bowelmovement satisfaction).

The results of the systematic reviewwere presented in a poster session at theAmerican College of Gastroenterology2007 Annual Scientific Meeting andPostgraduate Course, held October 12-17 in Philadelphia, Pennsylvania.

Treatment & Prevention

A preliminary review of safety data foromeprazole (Prilosec) and esomeprazole(Nexium) suggested no increased risk of myocardial infarction or other cardiacevents, according to an August 9 early communication from the Food and DrugAdministration (FDA). Therefore, theFDA did not believe that health careproviders or patients needed to changeeither their prescribing practices or theiruse of these products at that time. TheFDA planned to complete its review within 3 months.

Data from two small long-term clinicalstudies comparing anti-reflux surgery with drug therapy in patients with severe gastroesophageal reflux disease (GERD)raised concerns that the long-term use ofomeprazole or esomeprazole may increasethe risk of heart attacks, heart failure, and

heart-related sudden death. The earlycommunication from the FDA pointed outthat while both of these studies collectedsafety data, the protocols did not specifyhow cardiovascular events were to bedefined or documented. Also, patients whounderwent surgery tended to be youngerand less likely to have a history of, or riskfactors for, cardiovascular events. The FDAstated that these differences could havebiased and significantly influenced thesafety data from these studies.

As part of its analysis, the FDAreviewed pooled analyses of 14 othercomparative studies of omeprazole(including 4 placebo-controlled trials) in which patients were treated for up to 2 years. In these studies, patients treatedwith omeprazole had fewer cardiovascularevents than patients who received placebo.

pharmacist digest Fall 2007 5

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

B. infantis 35624 is the only probiotic withdemonstrated efficacy for improvement in IBS symptoms

FDAUpdate

45% controlled asthma

26% have

personalized

action plan

29.6% use

medications more

frequently than

prescribed

56.6% use

medications more

frequently than

prescribed

35% have

personalized

action plan

55% uncontrolled asthma

pharmacist digest Spring 2007 7

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pharmacist digest Fall 2007 7

This Season

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

What should parents know about usingcough 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 coldproducts 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 medicinethat is packaged and made for adults.Products should be marked for use inbabies, infants or children.

n

If other medicines (over-the-counter or

prescription) are being given to a child,the child’s health care provider shouldreview and approve their combined use.

n

Parents should follow the directions inthe “Drug Facts” box and avoid givingmedicine more often or in greateramounts than is stated on the package.

n

For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that ispackaged with each different medicineformulation and that is marked to deliverthe recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children.

n

If a measuring device is not includedwith the product, parents should purchase one at the pharmacy. Thedropper, dosing cup, or dosing spoonshould have markings that match thedosing instructions in the “Drug Facts”box or the dosing recommended by thechild’s health care provider.

Increased Influenza Vaccination Rates Needed Among Patients With Diabeteshttp://tinyurl.com/2c8u73

Eating Small Amounts of Dark Chocolate May Reduce Blood PressureJAMA 2007;298:49-60

Understanding the Cold Infection Process(continued from page 1)

Because patients with diabetes are atincreased risk for complications frominfluenza, the Centers for Disease Controland Prevention (CDC) and the AmericanDiabetes Association (ADA) recommendannual influenza vaccination for all adultsand children (6 months of age or older)with diabetes. Yet only about half of adults with diabetes are immunized eachyear, according to a recent Call to Actionissued by the National Foundation forInfectious Diseases.

With the flu season here, immunization

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

The regular consumption of small amountsof polyphenol-rich dark chocolate may be apromising behavioral approach for loweringblood pressure, according to a study published in the July 4 issue of JAMA.

The randomized trial included 24women and 20 men ranging in age from56 to 73 years. All participants haduntreated upper-range prehypertension(blood pressure between 130/85 and139/89 mm Hg) or stage 1 hypertension(blood pressure between 140/90 and160/100 mm Hg) but otherwise were in general good health. For 18 weeks, participants consumed a small squareproviding approximately 30 kcal of eitherdark (6.3 g) or white (5.6 g) chocolatetwo hours after the evening meal. The darkchocolate contained 30 mg of polyphenols;the white chocolate contained none.

Small but progressive reductions of both systolic and diastolic blood pressurewere observed in the dark chocolategroup, culminating in mean decreases of –2.9 mm Hg systolic and –1.9 mm Hgdiastolic at 18 weeks. Blood pressureremained unchanged among participantswho received white chocolate. The authorssuggest further study.

To trigger a cold infection, the virus mustenter the host epithelial cell, replicate, bereleased into the extracellular environment,and then re-infect new cells. The infectivedose of rhinovirus is very low, possibly as low as 30 virus particles. Subsequentviral replication triggers the release ofinflammatory mediators and activation of neurogenic pathways, which lead to symptoms. Virus is shed throughout thecold, but tends to peak at 2-3 days.

Symptoms first occur 10 to 16 hoursafter virus entry into the nose, and peak

on days 2-3 of infection, corresponding tohighest levels of virus shedding. A coldinfection is usually first noticed as a slight soreness in the nasopharyngeal region or as nasal obstruction. From here a waveof infection spreads outwards and othersymptoms such as rhinorrhea, sore throat,sneezing, cough, and a feeling of malaisecan develop. Colds usually last sevendays, but around 25% last two weeks.

Pharmacists should recommend annualinfluenza vaccination to diabetes patients

For a complete list of references, contactshafer.ll@pg.com.

FDAUpdate