Pharmacies’ data on drugs often varies

Suddenly flushed, sweating and agitated, Jan Lefler of Roswell re-read the drug information pamphlet Walgreens sent home with her prescription for a new osteoporosis drug.

The pamphlet made no mention of the symptoms as a potential side effect of the drug —- although they are. Had she picked up her prescription from Rite Aid instead, that store’s pamphlet would have at least alerted her that the drug could cause “flushing of the face.”

Whether consumers get critical information about the medications they take varies greatly depending on the pharmacy they use, according to research commissioned by the U.S. Food and Drug Administration.

An Atlanta Journal-Constitution review of pamphlet information used by Atlanta-area pharmacies for some widely prescribed drugs found serious risks downplayed or omitted entirely.

On Thursday, an FDA advisory committee will begin examining how the pharmacy pamphlets can be improved and whether their content should be regulated.

“The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said recently.

Walgreens, CVS and other pharmacy industry officials contacted by the AJC said the pamphlets are appropriate and strive to provide accurate and concise information written at a sixth- to eighth-grade comprehension level. Still, industry associations representing the nation’s drug companies and chain pharmacies said they support the review.

“Our goal all along is to make sure that patients have as thorough an understanding as possible of the medications that they take so that they can maximize the benefit and minimize the risk,” said Alan Goldhammer, vice president of science and regulatory affairs for the Pharmaceutical Research and Manufacturers of America.

The National Association of Chain Drug Stores, which represents 39,000 pharmacies that fill 2.5 billion prescriptions annually, has told the FDA it recognizes “current programs are not meeting their objectives and are in need of reform.”

Medication reactions cause more than 700,000 emergency room visits a year and nearly 120,000 patients require hospitalization, according to the Atlanta-based Centers for Disease Control and Prevention.

The Institute of Medicine, part of the prestigious National Academies, concluded in a 2006 report that patients must play an active role in their use of medications to avoid problems.

But to do that, patients need good information. In 1995, the FDA proposed regulations for patient prescription information —- but Congress stopped them from taking effect under the assumption the private sector would meet voluntary quality goals.

Over time, when serious safety concerns arose about individual drugs, the FDA mandated that patients taking certain drugs be given an agency-approved “medication guide.” Manufacturers of some other drugs, such as birth control pills and medicines with estrogen, attach a detailed, FDA-approved “patient package insert.”

But most drugs don’t come with these kinds of FDA-reviewed instructions, and consumers are instead given pharmacy-issued pamphlets.

“There are enough studies showing that a large proportion of patients do not get the full, or even the basic, fundamental information about how to use a drug safely from their doctor or pharmacist,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, which has for years advocated for better consumer information.

An evaluation of the pharmacy pamphlets, released by the FDA in December, found many were lacking important information —- especially directions for monitoring medications and actions to take when side effects occur.

Researchers sent secret shoppers to about 365 pharmacies in 41 states last year to fill prescriptions for two common drugs: lisinopril (a blood pressure drug) and metformin (a diabetes drug).

Some leaflets failed to fully detail reasons a drug might be contraindicated for the patient, such as medical conditions or allergies. Some neglected to mention drug interactions, others didn’t alert patients of the need for periodic medical tests while taking the drug.

And even pamphlets written by the same vendor varied depending on how the dispensing pharmacy edited them. At 6 percent of the pharmacies, no written information was provided beyond the few words written on the pill vials.

“I think there just needs to be some standards that have some teeth in them so patients can count on the crucial information being in there and have it formatted and at a reading level they can understand,” said Carole Kimberlin of the University of Florida’s College of Pharmacy, a study author.

Like many consumers, Lefler —- a retired nurse —- said she assumed the drug pamphlets stapled to pharmacy bags already were regulated by the FDA.

“If it were in the printout, you could at least make an informed choice to decide whether you want to take the medication or not. That’s what makes me angry: We’re not really given an informed choice,” she said.

Lefler, 71, no longer takes the osteoporosis drug Miacalcin nasal spray, which she started taking last May —- a few days before she started having flushing, agitation and tremors. The symptoms were so severe her daughter took her to an emergency room. Lefler said a neurologist told her the drug likely caused the problems, which she said went away after she stopped taking it.

Lefler said she always looks at the Walgreens pamphlets sent with medicines but often tosses any “fine print” drug company materials sometimes inserted inside packages. She was surprised later to see flushing and agitation listed in Miacalcin’s dense FDA-approved prescribing information —- after getting beyond a diagram of the drug’s chemical structure and wading through highly technical writing about clinical pharmacology.

However, the Walgreens pamphlet didn’t list flushing or agitation. Walgreens spokeswoman Tiffani Washington said the pamphlets stores distribute, which are written by an outside vendor, provide good information.

PROTECT YOURSELF

> Take notes: When your doctor prescribes a new drug, ask about side effects, any special instructions for taking the medication (such as times of day, with or without food, etc.), how you will know if it is or is not working, and whether any tests are needed to monitor the drug’s safety or effectiveness.

> Think side effects: Assume any new symptom may be caused by a medication and ask your doctor or pharmacist for advice. Be aware that some side effects can occur weeks after you stop taking the drug.

> Use your pharmacist: Because of their in-depth training on medications, pharmacists are a great resource for information about potential side effects, drug interactions and ways to use drugs most effectively.

> Be very careful with three drugs: Insulin (for diabetes), warfarin (a blood thinner) and digoxin (a heart medicine). These three drugs are responsible for one-third of the emergency room visits caused by adverse drug events among people 65 and older, said Dr. Dan Budnitz, a medical officer in the CDC’s Division of Healthcare Quality and Promotion. Patients taking them, and their doctors, need to be especially vigilant.

READ UP ON DRUGS

In addition to the pharmacy pamphlet, here are some other places to check out your medicines.

> Public Citizen’s Health Research Group: www.worstpills.org, some information requires a $15 annual registration fee.

> National Library of Medicine: www.nlm.nih.gov/medlineplus/druginformation.html

> Food and Drug Administration: www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm

> FDA-approved drug labels: If you are willing to dig through medical jargon, a drug’s official prescribing information, which is written for doctors, can be a great resource. Many drug labels are posted on this government Web site: http://dailymed.nlm.nih.gov.

VOICE YOUR OPINION

The FDA is accepting public comments on ways to ensure consumers receive useful information about their medications. Tell them what you think about the drug information leaflets you get from your pharmacy.

Write to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments can be submitted at www.regulations.gov (reference Docket No. FDA-2008-N-0038).

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