Trumm Drug

January 2009 Drug News

Pharmacy Meets With Obama Transition Team
NCPA and other pharmacy groups last week met with the President-elect Obama’s health care policy transition team, presenting three broad pharmacy reform principles that the groups had agreed upon. They are:

Improve quality and safety of medication use.
Assure patient access to needed medications and pharmacy services.
Promote pharmacy and health information technology and interoperability.

“The devil is in the details naturally, but the Obama representative was very appreciative that 10 associations and three companies could agree on so much,” said Bruce T. Roberts, RPh, National Commnity Pharmacist Association executive vice president & CEO. “Basically we said pharmacists are highly trained, under utilized, and can be an enormous help.” The Coalition met with President-elect Obama’s Transition Team about the critical role pharmacists can play in health care reform. The meeting was very successful stressing the importance of pharmacist-provided patient care services in improving patient outcomes and reducing health care costs.

FDA Releases Study on Consumer Medication Information On December 16, the Food and Drug Administration (FDA) released a study on the usefulness of printed consumer medication information (CMI) that is voluntarily provided by pharmacies. In 1996, Congress set a goal that 95% of patients, when receiving their prescriptions, also receive written information that meets specific criteria for usefulness. FDA’s study showed that 94% of patients were receiving written information when receiving their prescriptions but only 75% of these CMIs met the usefulness criteria. The Study also found that CMIs lacked consistency, making the information less comprehensible for patients. In response, FDA intends to initiate a new plan to meet the goals mandated by Congress, such as further discussions with stakeholders, a new public comment period, and the launch of a new CMI Web site.

Pharmacists Highly Ranked in Media Polls. In a recent USA Today/Gallup poll rating the honesty and ethics of workers in 21 different professions, pharmacists were again ranked among the most ethical. Pharmacists rank second only to nurses at 84% among 21 professions, based on a USA Today/Gallup poll of 1,010 adults. High school teachers are in third place (65%). At the bottom of the list, in the 5%-7% range, are car salesmen, telemarketers, and lobbyists.US News & World Report also compiled its annual list of 30 Best Careers and pharmacists made the list.

Pharmacist’s Visits Help the Medicine Go Down: The Minnesota Visiting Nurse Agency is Finding and Fixing Drug Interaction Problems That Plague Older Patients — and Add Costs.
Dec. 19—For an hour Wednesday afternoon, pharmacist Shannon Reidt knelt at the feet of June Mendoza in her south Minneapolis apartment and listened as Mendoza talked about living in constant pain and exhaustion.
By the time her patient finished speaking, Reidt had reached a diagnosis: Some of Mendoza’s 22 prescription drugs aren’t working.
It’s a problem Reidt finds repeatedly as she makes her way from home to home across the Twin Cities on behalf of the Minnesota Visiting Nurse Agency, seeing clients who are mostly poor and older. In her first 93 home visits over the last 18 months, Reidt found — and fixed — 306 drug-interaction problems.
Making those fixes is keeping people healthier — and saving the health care system thousands of dollars by cutting hospital and emergency room visits.
“If you’re sick, drug-therapy problems make you sicker and weaker, make your life miserable — maybe even kill you,” Reidt said as she traveled between patients. “It happens more often than not when you have multiple meds, multiple doctors or multiple pharmacies.”
The pilot project of the nonprofit home health agency, best known for giving flu shots, and the University of Minnesota began a year ago. It has been so successful that the agency made it permanent and hired Reidt, an assistant professor at the university.
It is believed to be the only such program in the nation, and it could have huge consequences. The number of Minnesotans 65 and older is expected to grow from about 650,000 now to more than 1 million in a decade, “so the issue of drug interactions is only going to grow,” said Mary Ann Blade, CEO of the Visiting Nurse Agency. “As more older people want to stay in their homes, it should be a major focus area for home care.”
Nationally, people over 65 account for about one-eighth of the population but one-third of the 3 million or so drug-interaction problems each year.
More drugs, more trouble
The average nursing home resident takes eight medications. Reidt’s patients average 18 drugs and eight health conditions — creating an average of 3.4 drug-therapy problems per patient.
“I get confused,” admitted Thomas Tribble, 67, as Reidt sat beside his pile of 20 medications during a visit earlier Wednesday and went through them one by one. “There’s so much. I depend on Nadine [his personal care attendant] to keep that stuff straight.”
Reidt finds problems during nearly every visit. She gives her patients suggestions — perhaps taking pills fewer times a day or using a calendar to keep track of medication schedules. She also recommends drug changes to doctors and makes suggestion to the agency’s nurses and family caregivers.
“Sometimes they take the drug wrong or have bad side effects,” she said. “And sometimes they just get the wrong drug for their condition.”
As a graduate student two years ago, Reidt began a residency with the visiting nurses and developed the visiting pharmacist program. She works one day a week at the university and four days at the agency, the program’s $100,000 annual cost split between them.
She developed protocols on how to work with doctors and home health nurses and how to choose among the agency’s 300 patients for home visits — essentially, anyone with nine or more medications. She’s designing a program outline that other agencies can use.
So far, Reidt’s research shows that of 70 patients on whom she had complete records, hospitalizations were cut from 32 to 16 and emergency room visits from 16 to eight.
“Some days I just want to sit and not move, not even think,” said Mendoza 58, who has kidney, heart, liver and breathing problems, diabetes, depression and some forgetfulness. She lives with her husband and daughter and has custody of another daughter’s two children.
She also has a persistent stomach infection that kills her appetite. But she’s had trouble sticking with a 14-day antibiotic treatment — the reason a nurse referred her to Reidt.
“In her home, where she feels safe, a patient will tell me about symptoms and problems she may not tell the doctor,” Reidt said later. “I can work with her doctor and home-health nurse, and together we can catch problems before they lead to a health crisis.”
Among her solutions this day: Alert Mendoza’s doctor that her inhaler prescription has expired and that one pain drug may be ineffective; create a big calendar to track the most important of Mendoza’s medications; and return next week for a follow-up visit.
“Oh, yes, come back,” Mendoza said. “This is so hard, but you’re helping.”
“That,” said Reidt as she left the apartment, “is why I love this work. I can help somebody feel better today.”
Source: Star Tribune, Minneapolis
Publication date: 2008-12-19

FDA adds suicide warning to epilepsy drugs
WASHINGTON – Drugs used by millions of patients to control epileptic seizures must carry warnings about heightened risks of suicide, federal regulators said Tuesday.
The Food and Drug Administration announcement comes almost a year after the agency first said patients taking the drugs have a slightly higher risk for suicide than those taking dummy pills.
According to the new language, only about 1 in 500 patients face an increased risk of suicidal thoughts and behavior while taking the drugs. The new warning emphasizes that the risks are about the same among all antiseizure drugs.
The FDA advised patients to consult their doctor before making any changes to their treatment.
The agency is also requiring manufacturers to distribute pamphlets that describe the risks for patients.
“All patients who are currently taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression,” FDA said in a statement.The new warnings apply to 21 medications, including blockbuster products like GlaxoSmithKline’s Lamictal, Johnson & Johnson’s Topamax and Pfizer’s Lyrica.
The FDA stopped short of adding its sternest warning to the medications, as it had proposed earlier in the year.
In July a panel of outside experts recommended against adding the so-called “black box” warning, the strongest type available. Those experts and other physicians cautioned the agency that a boxed warning about suicide could alarm patients and cause them to stop taking their medications.
Anti-seizure drugs are used for a variety of illnesses besides epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder.
London-based Glaxo said it supports the decision to add information about suicide risks to its medication. However, the company added in a statement that it “remains confident in the overall safety and efficacy profile of Lamictal based on our extensive clinical trial experience and the experience of more than 5 million people worldwide.”
FDA said in January its analysis of nearly 200 studies of 11 different epilepsy drugs showed patients taking the treatments were more likely to have suicidal thoughts and behaviors.
Seizure drugs were the fifth best-selling class of drugs in the U.S. last year, with sales over $10 billion, according to pharmaceutical research firm IMS Health.
GlaxoSmithKline’s Lamictal posted sales of $2.2 billion for 2007, while Pfizer’s Lyrica had sales of $1.8 billion.
Shares of GlaxoSmithKline rose $1.54, or 4.2 percent, to $37.88. Shares of Johnson & Johnson rose $1.79, or 3 percent, to $59.60, while shares of Pfizer rose 73 cents, or 4.4 percent, to $17.36.
Pfizer said it would work with FDA to update labeling on Lyrica and Neurontin, an older drug which is approved to treat both epilepsy and nerve pain.
“Pfizer hopes that the labeling change will further facilitate important dialogue that should always occur between patients and their doctors.”
Physician groups like the American Epilepsy Society pressured FDA in recent months to take a measured approach on the warnings, arguing they could cause more harm than good if patients stop taking the drugs.
Doctors have succeeded in curbing other FDA safety warnings in recent years. In 2004, regulators added a black box warning about suicide to antidepressant drugs. However, FDA scaled back the language last year after psychiatrists said it was causing patients to stop taking their medicines, putting them at even greater risk of suicide.
Source: Associated Press/AP Online
Publication date: 2008-12-16

FDA Panel Rules Against Asthma Drugs
A U.S. Food and Drug Administration panel said the drugs Serevent and Foradil shouldn’t be used for treating asthma.
The panel said Serevent and Foradil are often prescribed inappropriately by doctors and used incorrectly by patients, The New York Times said Thursday. The drugs are longer-acting beta agonists intended to prevent attacks but have been shown to increase the risk of more severe attacks if used without a steroid, the newspaper said.
The panel ruled that Advair and Symbicort should continue to be used as asthma treatments. Advair and Symbicort combine longer-acting beta agonists with steroids in a single inhaler.
The newspaper said some drug safety experts recommended that all four drugs be banned from treating asthma, although others said the drugs’ benefits outweighed their risks.
Source: United Press International
Publication date: 2008-12-12

C.B. Fleet Voluntarily Recalls Its Fleet® Phospho-Soda® Products After FDA Safety Alert
Following the issuance of FDA’s Safety Alert on Thursday stating that oral sodium phosphates bowel cleansing solutions should be available by prescription only, C.B. Fleet Company immediately announced a voluntary recall of their over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System. The voluntary recall is directed to retailers and wholesalers.
The recall decision was made to address FDA’s determination that oral sodium phosphate solutions used for bowel preparation prior to medical procedures such as colonoscopy should only be available by prescription, and consumers should not be using over-the-counter products for bowel cleansing. Since Fleet’s Phospho-soda products are currently labeled and sold as over-the-counter products, Fleet decided voluntarily to remove them from the market as expeditiously as possible to address the FDA’s decision that the products be available by prescription only.
As FDA has recommended that doctors not direct their patients to use these over-the-counter products for bowel cleansing, C.B. Fleet requests that consumers not purchase these products for bowel cleansing and contact their physician for alternatives if their physician has recommended their use for this purpose.
About C.B. Fleet
Founded in 1869 and headquartered in Lynchburg, Virginia, C.B. Fleet is a privately held manufacturer and marketer of personal care and healthcare related products. Well-known for its line of laxative drug products, today C.B. Fleet, doing business under its new Fleet Laboratories name, also markets a diverse range of cosmetic and drug products in 100 countries around the world. Fleet ranks among the top nonprescription drug companies in the U.S.
Source: Business Wire
Publication date: 2008-12-12

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