The Wall Street Journal Health Blog, April 28, 2011, By Laura Landro


New efforts are underway to help patients to take their prescription drugs correctly, amid a rise in emergency room visits and hospitalizations related to adverse outcomes from taking medications, today’s Informed Patient column reports.

The FDA, through its Safe Use Initiative, is working with the Brookings Institution to evaluate a new single-page standard medication-information document — to be known as PMI, for Patient Medical Information. It would replace the plethora of material now handed out to patients with their prescriptions, including the FDA-approved package inserts from drug companies.

In February, Brookings’ Engelberg Center for Health Reform convened a workshop to discuss pilot programs testing the distribution to patients of prototypes of the one-page format. But it won’t be an easy undertaking: federal funds for the project are yet to be approved, and some in the industry believe more work needs to be done to test the effectiveness of the PMI concept, especially the scaled-down format.

While FDA officials acknowledge that there is no evidence regarding optimal page length, the agency says a single-sided page of information would provide essential information; for more detailed resources, patients could be referred online. “We think we can get the paper document down to one page [if] you take out [what] we feel is repetitive information, or information that a typical patient wouldn’t want or need to know,” FDA senior program manager Denise Hinton tells the Health Blog.

She says the FDA doesn’t plan to have a review or approval process for the PMI documents, which would cover thousands of drugs, and instead will develop standards for drug manufacturers to comply with.

That also worries some, including third party independent drug information publishers. Gerald McEvoy, assistant vice president of the American Society of Health-System Pharmacists, which provides the medication information on the National Library of Medicine’s MedlinePlus website, says he is concerned that one page may not be enough for more complex or risky drugs. He also questions the ability of manufacturers to provide “objective, balanced information about their drugs in an unregulated setting.”

In a  presentation at an FDA hearing last year, McEvoy warned that consumers don’t trust manufacturers’ information and called on the FDA to ensure that new proposed content standards provide all information that is essential for patients and that they not be inferior to existing materials about safe and effective medication use.

Dorothy Smith, founder and president of Consumer Health Information Corp., which develops patient medication instructions and patient education programs, agrees the one-page format is too constricting. But she says all the consumer medical information in the world won’t ensure that patients take their medications correctly unless they’ve been verbally counseled by health professionals such as doctors and pharmacists.

What about consumers who are embarrassed about asking a pharmacist about their medications in front of others? Smith suggests asking to be counseled in a private room or area behind the counter. “Don’t leave the pharmacy or doctor’s office until you understand what the drug is for and how you should be taking it,” she tells the Health Blog.

It could take years before a final rule on the PMI goes into effect, and in the meantime, other efforts are underway to provide consumers with easy-to-understand information at the pharmacy. The Institute for Safe Medication Practices has designed more than a dozen eye-catching, colorful single sheets — printed on both sides — for so-called high-alert medications (such as Fentanyl pain patches and the long-acting insulin Levemir) that pose the greatest risks if used incorrectly. ( Here’s an example.)

ISMP President Michael Cohen tells the Health Blog the sheets, which will be tested with pharmacists and patients, were designed to educate patients about side effects and the avoidance of the serious medication errors that are common with those drugs.

“Our hypothesis is that a more attractive, bulleted, easier-to-read document will be more helpful in communicating safety information to patients than what you get at the drugstore,” Cohen says.





Suggestions for Making Prescription-Drug Labels More Clear


The Wall Street Journal Health Blog, By Katherine Hobson



A  report by the Institute of Medicine estimates that 90 million Americans can’t fully understand and act upon health information. The U.S. Pharmacopeial Convention, which sets drug standards, today proposed changes to chip away at some of that confusion, at least when it comes to the labels that pharmacists put on prescriptions they fill.

The USP is offering standards that it says will make label information and instructions more comprehensible. For example, instructions to “Take two tablets twice daily” can raise confusion; saying “Take 2 tablets in the morning and 2 tablets in the evening” makes the numbers more explicit and also specifies exactly when to take the medications.

The recommendations also suggest that if it’s okay with the patient, labels should include the purpose of the drug, and in plain language, i.e. “for high blood pressure” rather than “for hypertension.”

And, the proposed standards recommend formatting that can make labels easier to read, including using regular sentence structure, and laying out labels so users don’t have to rotate the container to read them.

Here are the details (click on the link below) of the USP’s proposed standards.  If they are finalized, they could be adopted by state pharmacy boards or other authorities.



Confusion Over Sound-Alike Drug Names Can Harm Patients



Wall Street Journal Health Blog, By Jacob Goldstein

A doctor means to prescribe primidone, an anti-seizure drug. But because of a miscommunication somewhere along the line, the patient gets prednisone, a steroid that affects the immune system and reduces inflammation — a potentially deadly mistake, according to a report from the U.S. Pharmacopeia, a group that sets drug standards.

The report mined records from a national database between 2003-2006 and found more than 25,000 “look alike /sound alike” errors. (Reporting is voluntary and doesn’t include all errors.) The vast majority of those errors didn’t cause patients any harm, but several hundred did. Primidone-prednisone was one of a handful of mix-ups that may have contributed to a patient’s death.

When the Health Blog first looked at the report, we assumed that this sort of problem was an artifact of docs’ messy handwriting and other hold-overs from the pre-computer era. But though computers may solve some problems, they can create others: “look-alike drug names in computerized direct order entry systems are a source of confusion for prescribers,” the report says.

The report also lists several ways to minimize the errors. One common-sense step: Doctors should write not only the name of the drug they’re prescribing, but what it’s being used for. And this information should be communicated down the line to patients picking up prescriptions. That would make it significantly less likely that a patient who needed a drug to control seizures, for example, would wind up with pills that reduce inflammation.

Bonus confusion: The report lists drugs that may be especially likely to be confused because their names look or sound like the names of so many other drugs. Topping the list was the antimicrobial cefalozin, a name that looks or sounds like 15 other drugs. That was followed by lisinopril with 13 and enalapril, prednisone, and trazodone with 12 a piece.


Justices’ Debate Turns to Privacy for Doctors

The New York Times, By ADAM LIPTAK
Published: April 27, 2011



WASHINGTON — A somewhat esoteric Supreme Court case on Tuesday about data mining by drug companies turned into a debate over a fundamental First Amendment principle that has much engaged the justices lately: What role may the government play in regulating the marketplace of ideas?

In assessing the Vermont law at issue Tuesday (Sorrell v. IMS Health, No. 10-779), which bars some but not all uses of prescription drug data, several justices indicated that they viewed government efforts to alter the mix of available information as constitutionally problematic.

That principle animated last term’s decision in Citizens United, which struck down part of a federal law regulating speech about politics by corporations and unions. The tenor of Tuesday’s arguments suggested that a majority of the justices had similar concerns about the Vermont law, which regulates the use of information collected about doctors by records kept by pharmacies.

The case is not about patients’ privacy rights, as individual information about them is meant to be stripped from the data. Rather, the Vermont law restricts tailored efforts to market drugs to doctors aided by databases showing what medicines they have been prescribing.

The state law forbids the sale of prescription data to market drugs and bars drug companies from using the data to market drugs, unless the prescribing doctor consents. But other uses of the same data are allowed, including ones by law enforcement, insurance companies and journalists. And drug companies remain free to market their drugs in a more indiscriminate fashion, without knowing the prescribing habits of individual doctors.

Bridget C. Asay, an assistant state attorney general defending the law, tried to frame it as one meant to protect doctors’ privacy. But the argument gained little traction, and several justices noted that the law permitted uses that seemed to invade doctors’ privacy as much as the forbidden ones, and in any event doctors remain free to decline to meet with marketers.

Some of the justices also seemed concerned about what the law meant to achieve, as reflected in legislative findings justifying the law.

There is, the state Legislature said, a “massive imbalance in information presented to doctors” and “the marketplace for ideas on medicine safety and effectiveness is frequently one-sided.” The point of the law, several justices suggested, was therefore to protect doctors from hearing from drug marketers that might suggest more expensive drugs even as the state pushed cheaper generic drugs.

“You want to lower your health care costs, not by direct regulation, but by restricting the flow of information to the doctors,” Chief Justice John G. Roberts Jr. told Ms. Asay. “To use a pejorative word,” he went on, the state is “censoring what they can hear to make sure they don’t have full information.”

The chief justice’s two most senior colleagues, Justices Antonin Scalia and Anthony M. Kennedy, forcefully made similar points. The three justices sit at the center of the Supreme Court bench and at times they seemed a juggernaut bearing down on Ms. Asay.

Other members of the court were also skeptical about the way Vermont had chosen to regulate the distribution of prescription data.

Justice Ruth Bader Ginsburg said the state “is interested in promoting the sale of generic drugs and correspondingly to reduce the sale of brand-name drugs.” But she said that goal ran up against a basic First Amendment problem.

“You can’t lower the decibel level of one speaker,” she said, “so that another speaker, in this case the generics, can be heard better.”

Thomas C. Goldstein, a lawyer for several data mining companies challenging the law, said that sort of government manipulation of information is impermissible.

“The way the First Amendment works in the marketplace of ideas that so upsets Vermont is that both sides get to tell their story,” he said. “The thing that is supposed to be biased here is that the drug companies have too much money. That is not a basis for restricting speech.”

New Hampshire and Maine have laws similar to the one in Vermont, and those have been upheld by the federal appeals court in Boston. The Vermont law at issue in Tuesday’s case was struck down last year by a divided panel of the federal appeals court in New York.



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