Patients Make Risky Choices to Avoid Drug CostsAmerican Society of Health System Pharmacists, http://tinyurl.com/fvk5h

A Procter & Gamble Family Health Publication

The News that Matters to Pharmacists

pharmacist di estVolume 11. Issue 1. Spring 2006

FDAUpdate

Inside this Issue:

Treatment & PreventionDandruff Treatments;Statin Therapy for Cardiac Patients;Bisphosphonates for Steroid Patients;Diabetes Control and Memory

Pharmacy PracticeLow-Literacy Patients

Same Name,Different DrugFood and Drug Administration,http://tinyurl.com/puz4b

The FDA is warning health care professionals and patients that although a drug may have the identical brandname in the U.S. and in a foreign country,or on a foreign internet drug site, theactive ingredients may be unrelated.For example, in the U.S., Flomax is thebrand name for tamsulosin, used to treatan enlarged prostate. However, in Italy,the active ingredient in the brand namedrug called Flomax is morniflumate, an anti-inflammatory.

The FDA has also found 105 U.S.brand name drugs with foreign namesthat look or sound familiar but containa different active ingredient. For example,the name Ambien, a U.S. sleeping pill,is similar to Amyben, a foreign drugused to regulate heart rhythms. A full listof drugs that may cause confusion canbe found at www.fda.gov/oc/opacom/reports/confusingnames.html.

A new survey conducted by the AmericanSociety of Health System Pharmacists(ASHP) found that the rising cost of drugsis pushing many Americans to chooserisky behaviors when it comes to theirprescription medications. Patient coping

strategies include skipping doses, takingless than the prescribed dose, or stoppingmedications altogether.

The recent survey of 1,006 peoplefound that nearly one third of Americanfamilies spend at least $100 per month onprescription drugs. The average amountspent monthly is highest in householdswith one or more senior citizen (age 65or older), at $156.

The survey also found that nearly 73% of American households have at leastone family member who currently takesa prescription medicine, and that theaverage number of medicines taken inhomes with a senior citizen is almost six.

In its conclusions on the survey, ASHPreminds Americans that they can rely ontheir pharmacist for help in streamliningmedication regimens and managing med-ication costs.

This SeasonHelp for Travelers

nApproximately one out of 10 Americans(10.8%) say that they or a familymember has been sick for a prolongedtime or became sicker as a result ofnot being able to afford the cost offilling their prescription medications.

n Nearly three-fourths of Americanhouseholds (72.8%) have at least onemember currently taking a prescriptionmedication, and three or more med-ications are being taken in nearly halfof all American households (47.6%).

nAmerican households spend an averageof $103.50 monthly for out of pocket

prescription costs, and 10 million households (12.8%) spend $200 or more.

To cope with rising drug prices,Americans have:

n Bought generic drugs (90.5%)

n Requested free medication samplesfrom their doctor (27.1%)

n Not filled a prescription medication(13.7%)

n Skipped doses or taken less than theprescribed dose (11.5%)

n Stopped taking prescription medica-tions altogether (7.3%)

How Medication Costs Affect Families

1

Thanks to your recommendation,he’s enjoying another day

free from frequent heartburn.*

© 2005 P&G PJAN05171 8/05

It’s possible withPrilosec OTC.* Heartburn 2 or more days a week.

Use as directed for 14 days for treating frequent heartburn.Reference: 1. ACNielsen all outlet data, weighted average pill price, January 2004 –April 2005. Prilosec OTC is a registered trademark of the AstraZeneca group of companies.

For the first time in more than 25 years,the Food and Drug Administration hasrevised the format of the drug label, alsoknown as the package insert, that isincluded with all prescription medications.

Significant changes to the drug labelinclude:

nA new “Highlights” section to allowimmediate access to the most importantinformation about the drug includingBoxed Warning, Indications and Usage,and Dosage and Administration

nAddition of a table of contents forquicker location of safety and efficacyinformation

n Toll-free telephone and Internet accessinformation to make it easier for healthcare professionals to report adverse events

nA new “Patient Counseling” sectiondesigned as a discussion guide on themedication’s uses, limitations and risks.

Within the “Highlights” section, drugmanufacturers will be required to identifyall significant changes made within theyear. This will ensure that health careprofessionals have the most up-to-dateinformation on each drug they prescribe.

According to the FDA, the new labelformat will initially apply to newly andrecently approved drugs and drugs that

are approved for new uses. The formatwill gradually be expanded to include alldrugs approved within the past five years.

New Rx Drug Label Improves Format & ContentFood and Drug Administration, http://tinyurl.com/qx9d8

Pharmacists May Neglect to Identify Low-Literacy Patients The Annals of Pharmacotherapy, 2005; 39:1441-5, www.theannals.com

Nearly half of adult Americans lack the literacy skills necessary to function effectivelyin today’s healthcare environment. This canresult in patients having a difficult timeunderstanding consent forms and insurancerequirements as well as basic medicationinstructions. Low patient literacy is associatedwith reduced drug therapy compliance andmedication management, increased hospi-talizations and higher healthcare costs, and poor adherence has been linked toincreased mortality. However, a recent studyof community pharmacies found that only7% of those surveyed reported proactivelyattempting to identify and assist patientswith low literacy skills.

The authors conducted a telephone surveyof community pharmacies representing amix of chains and independents. Whilemost of the pharmacies reported having literacy aids available, of 30 pharmaciessurveyed, only two (7%) reported taking-proactive steps to identify literacy-relatedneeds among their patients.

Limited literacy skills are common acrossall demographics but are higher among theelderly and individuals from racial and ethnic minorities. Many adults hide theirlow literacy skills due to embarrassment orfailure to recognize their own limitations.One study showed that, among adults withlow literacy skills, 91% had never toldtheir supervisor, 68% had not told theirspouse and 19% had never told anyone.

The authors conclude that more research isneeded on ways to improve the recognitionof low-literacy patients and on adherence

tools that are most effective in improvingoutcomes with this audience.

Pharmacists can use simpletechniques like these toassess patient literacy skills:

n Hand the patient a brochure upsidedown and see if they turn it aroundto read it.

nAsk the patient to “tell what it says”in the first few lines of a take-homebrochure, “to make sure the printis large enough/clear enough”(avoid use of the word “read”).

n Observe whether the patient identi-fies drugs by pill color and shaperather than by name.

nAssess the patient’s comprehensionby asking open-ended questions.

Many adults hidetheir difficulty with reading.

FDAUpdate

Low-Literacy PatientsRx Drug Label Improvements

pharmacist digest Spring ’06 3

Pharmacy Practice

A recently published study suggests that haircondition is an important consideration in thetreatment of dandruff, due to compliance.Dandruff is a common, chronic conditionthat results in flaking, itching, hair breakageand other symptoms. While symptoms can becontrolled with frequent use of a medicatedshampoo, the authors say that patient compli-ance is influenced by cosmetic attributes of the treatment product in addition to itsability to control the dandruff.

Forty women with mild to moderate dandruff were enrolled in a double-blindcross-over study. After a one-week washoutwith an unmedicated basic cleansing sham-poo, all the subjects used each of two studyshampoos for one week. The two studyshampoos represented significantly differentformulas. Evaluated were a 2% ketoconazole

shampoo that provided good cleaning butcontained few conditioning ingredients, and a 1% pyrithione zinc shampoo that contained a combination of conditioningingredients (dimethicone, cetyl alcohol,polyquaternium-10) commonly used toimprove hair cosmetic attributes.

Both shampoos produced improvement in dandruff at the end of week one and continued to improve dandruff symptoms at week two, as assessed by a dermatologist.At the end of two weeks, 75% of participantspreferred the 1% pyrithione zinc conditioningshampoo over the 2% ketoconazole shampoosince it not only treated the signs and symp-toms of the dandruff but also improved the appearance and feel of the hair. Thedermatologist confirmed that hair-combingease, hair smoothness and hair frizz/fly-away were significantly better at varioustime points in subjects who used the 1%pyrithione zinc conditioning shampoo.

The researchers say this study emphasizesthe importance of selecting maintenanceshampoos for dandruff patients that deliverefficacy combined with cosmetic benefits,to improve patient compliance.

4 pharmacist digest Spring ’06

Statin Therapy Could Benefit Cardiac Patients with Low LDL American Journal of Cardiology, 2005; 96(11):1491-1493, www.ajconline.org

Dandruff Treatment OptionsNew Osteoporosis Nasal SprayStatin Therapy for Cardiac Patients

Treatment & Prevention

Cosmetic Factors Influence Dandruff TreatmentJournal of Investigative Dermatology Symposium Proceedings, 2005; 10(3):201-204,www.blackwell-synergy.com/loi/jds

Osteoporosis Nasal Spray Treatment BeingDeveloped http://tinyurl.com/pxx3s

Nastech Pharmaceutical Company Inc.and Procter & Gamble Pharmaceuticalsrecently announced a collaboration todevelop and market Nastech's ParathyroidHormone (PTH1-34) nasal spray for thetreatment of osteoporosis. Clinical andnon-clinical studies on PTH1-34 nasalspray are currently being completed inpreparation for Phase III clinicaldevelopment.

“A non-invasive PTH1-34 nasal sprayfor the treatment of osteoporosis wouldbe welcomed by physicians and patients,potentially resulting in wider use andincreased patient acceptance,” saidFelicia Cosman, M.D., Medical Directorof the Clinical Research Center at theHelen Hayes Hospital, and a nationallyrecognized osteoporosis specialist. “Ilook forward to the rapid developmentof this exciting product, which has thepotential to improve the lives ofosteoporosis patients.”

P&GNews

75% of patients preferred the 1%

pyrithione zinc condi-tioning shampoo.

Even patients with very low levels ofLDL cholesterol who suffer a myocardialinfarction or other coronary event maybenefit from taking a statin drug, accordingto a new study published in the AmericanJournal of Cardiology.

Researchers from the University ofMichigan at Ann Arbor reviewed thecharts of 155 patients admitted to thehospital with a diagnosis of acute coronarysyndrome (unstable angina or myocardialinfarction) who had very low LDL levels(80 mg or lower) and were not on statintherapy at the time of admission. The

researchers found that patients who weredischarged on statin therapy had a lowerrisk of death, stroke or heart attack at sixmonths after discharge compared withthose patients who were not discharged on a statin. At six months, 29% of patientsnot discharged on a statin experienceddeath, reinfarction or stroke (compositeendpoint) compared to 9.5% of patientswho had been discharged on a statin(p=0.005).

The researchers say their findings indicate a need for additional studies onthe benefits of statin therapy in patients

who have acute coronary syndromes andhave low LDL levels.

Bisphosphonates Underused for Steroid PatientsArchives of Dermatology, 2006; 142(1):37-41, www.archdermatol.com

A new study published in Diabetes Caresuggests that better metabolic control oftype 2 diabetes can lead to improvementsin cognitive function. The study authorssay the finding is important becauseolder adults with type 2 diabetes are atrisk for cognitive dysfunction, perhapsbecause of chronically elevated bloodglucose levels or diabetes-related hyper-insulinemia. Memory and mental processingspeed are the cognitive domains mostoften compromised.

The researchers enrolled 145 peoplewith type 2 diabetes at 18 medical centers

around the United States. Study participantshad to already be taking metformin tocontrol their diabetes and, as part of thestudy, were given add-on therapy witheither rosiglitazone or glyburide. Cognitivefunction, using standard tests, was checkedat baseline and at week 24. Assessmentscovered three categories of cognitivefunction including working memory,learning ability, and cognitive efficiency.

Analysis revealed that adding eitherrosiglitazone or glyburide resulted insimilar reductions in fasting blood sugarafter 24 weeks, although reductions in

fasting insulin were seen only in patientswho took rosiglitazone. The researchersalso found that working memory—including performance of cognitivelydemanding tasks that engage multiplecortical regions—improved significantly,and to a similar degree, in both treatmentgroups. The researchers say additionalstudy is needed to see if the improve-ments are maintained in patients overtime and if they are evident in patientswith more severe cognitive impairment.

Improving Metabolic Control May Aid Memory in DiabeticsDiabetes Care, 2006; 29(2):345-51, http://care.diabetesjournals.org/

Bisphosphonates for Steroid PatientsDiabetes and Memory

Heartburn During Sleep

Treatment & Prevention

pharmacist digest Spring ’06

Factors Predictive ofNighttime HeartburnMedscape Gastroenterology, 2006:8(1),www.medscape.com/viewarticle/516347

Nighttime gastroesophageal reflux hasbeen proven relative to the developmentof severe gastroesophageal reflux disease(GERD) and other complications whichcan substantially diminish patients’ qualityof life. A new study identified risk factorsfor heartburn during sleep.

Researchers analyzed data from nearly16,000 U.S. patients to determine thedemographic, social and medical factorspredictive of heartburn during sleep. Variousevaluative tools were used, including theSleep Heart Health Study’s Sleep HabitsQuestionnaire (SHQ). Of participants,nearly 25% reported experiencing heart-burn during sleep. Significant risk factorswere identified as increased body massindex (BMI), carbonated soft drink consumption, snoring and daytimesleepiness, insomnia, hypertension,asthma and the use of benzodiazepines.

The authors note that the effect of proton-pump inhibitor therapy on nighttime heart-burn and its implications is a growingarea of interest.

5

A new study has documented that, althoughthe American College of Rheumatology(ACR) now recommends bisphosphonatesfor patients on long-term glucocorticoidtherapy, the bisphosphonate drugs are oftennot prescribed. The ACR’s recommendationwas made to prevent glucocorticoid-inducedosteoporosis (GIOP).

The researchers evaluated 35 dermatologypatients who had been taking steroid drugs(≥10mg/day of prednisone or equivalent)for chronic skin conditions for a median of six months. They found that only seven(20%) of the patients had been prescribedbisphosphonate drugs. The authors say this finding is consistent with those fromstudies in other medical specialties in whichbisphosphonates were rarely prescribed – afinding that is disappointing since bisphos-phonates are agreed to be the most effectivemeans of preventing GIOP.

The authors reference earlier studiesshowing that bone mineral density declineswith daily oral glucocorticoid use, even inlow doses, and that more than one-fourth of patients on long-term glucocorticoidtherapy sustain osteoporotic fractures.

The largest reductions in bone mass occurduring the first six months of treatment,with a rapid increase in fracture risk withinthe first three months of steroid therapy.

The researchers say the harmful effects ofsteroids on bone have been well documentedand are largely preventable by the use ofbisphosphonates. They note that bisphos-phonates should be used with caution inpremenopausal women because of thepotential risk of fetal skeletal abnormalities.The authors conclude that, absent any contraindication, bisphosphonates should be prescribed in conjunction with thesteroids for patients undergoing long-termglucocorticoid therapy.

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Traveler’s Diarrhea is a common problemthat can interfere with vacation pleasure.Especially prevalent in areas such as SouthAmerica, Mexico and Africa, diarrhea thatoccurs during travel is often caused byintestinal infection of bacteria, virus, or othermicrobes from the water or food supply.

Precautions that may help patientsavoid Traveler’s Diarrhea include:

n Eat hot foods when they’re hot andcold foods when they’re cold. Don’t eat room temperature sauces.

nDrink and eat only pasteurized milkand dairy products. In foreign countries,boil tap water before drinking to elimi-nate bacteria.

nAvoid raw or undercooked meat, fish,or shellfish. Don't eat leafy salads,unpeeled fruit, or fresh vegetables indeveloping countries. Choose boiled,baked, or peeled foods.

Those who get Traveler’s Diarrheashould drink lots of liquids to replace lost fluids and restore energy; and take

soups, bouillon, or broths that have been heated to boiling to help replenishsalt lost from the body during diarrhea.

Patients can be advised to pack diarrhea,upset stomach, or heartburn remedies likePepto-Bismol® and Prilosec OTC®, andregularity remedies like Metamucil®, tohelp provide relief while traveling.

Tips for Healthy Traveling www.pepto.com/healthguide.shtml

Travel Destinations Linked to Specific DiseasesNew England Journal of Medicine, 2006; 354:119-30; www.nejm.org

FDAUpdate

Patients Warned About Avian Flu RemediesFood and Drug Administration,http://tinyurl.com/pefmc

Flu Remedies WarningHelp for Travelers

This Season

pharmacist digest Spring ‘06 7

Data from a new study provides a referencefor likely diagnoses of illness in returnedtravelers based on their recent travel destination. Researchers used data from 30 medical clinics on six continents andmore than 17,000 ill returned travelers toassociate travel destinations with the proba-bility of the diagnosis of certain diseases.

Significant regional differences werefound including disproportionately largenumbers of:

n Systemic Febrile illness in travelersreturning from sub-Saharan Africa orSoutheast Asia.

nAcute diarrhea among travelers to southcentral Asia

nDermatologic problems (most commonlyfrom insect bites) among those returningfrom Central or South America or theCaribbean.

Regional differences were also identifiedin relation to specific diagnoses. For example,

each of the three most common causes offever-related illnesses – malaria, dengue andrickettsial infection (primarily tick-bornespotted fever) – was disproportionatelyassociated with one or more of the geographicregions studied.

Evaluation of diarrheal illnesses showedthat bacterial diarrhea is most prevalentduring travel while, for all regions exceptSoutheast Asia, post-travel diarrhea ismore likely to be parasite-induced.

The authors say the study results can beused to guide diagnosis and empiric treatmentin returned travelers and to influence pre-travel recommendations.

P&GNews

Findings can helpguide pre-travel recommendations for patients.

As cases of avian flu in humans continue to be reported in differentcountries, the Food and Drug Admin-istration (FDA) has issued an advisoryon unapproved and unlicensed avian flu related products because it considers them to be a potentialhealth threat to U.S. consumers.There are currently no vaccinesapproved to prevent avian flu inhumans, nor drugs approved to treatthe specific symptoms of avian flu.

The FDA is reminding consumersthat products advertised as avian fluprevention or treatment options may,in fact, be counterfeit versions ofactual drug or vaccine products. Theyalso could contain too much or too little of active ingredients, or impureingredients that could pose a risk for consumers without conveying any benefit against any type of flu. For the most up-to-date information, visit www.fda.gov/oc/opacom/ hottopics/flu.html.

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© 2006 P&G GPAD06011 2/06