PHARMACY

Catalina Health finds near-total interest in simplified medication information

BY Alaric DeArment

ST. PETERSBURG, Fla. — Results of a survey indicate a positive response among patients to redesigned patient medication information distributed to patients at retail pharmacy chains in two states as part of an eight-week program.

Catalina Health said it launched the eight-week quality improvement initiative in August 2012 to disseminate the information focusing on three medications dispensed in stores in an unnamed "leading pharmacy chain" in California and Michigan.

Results of the initiative showed that 90% of patients recalled receiving the new information and considered it useful. The purpose of the QI initiative was to provide patients with clearer medication information when they pick up prescriptions at the pharmacy.

"This eight-week project demonstrates that patients want, read and keep a single page of information about their prescriptions that is written in an easy-to-understand format rather than multiple pages of complex medical text," Catalina Health president Renee Selman said. "Catalina Health is committed to providing patients clearer information, and we are proud to have led this pharmacy pilot with our healthcare partners."

Results, collected in a telephone survey of patients, showed equal recall rates among men and women and among all age groups. In addition, new patients were more likely to read and to keep the patient medication information, and those aged 18 to 40 said they would prefer to have it delivered electronically in addition to receiving a single-page information sheet in the pharmacy and would like having a pharmacist explain it.

In addition to Catalina Health, the initiative included experts at Duke University, Emory University, Northwestern University, Purdue University, the Regenstrief Center for Healthcare Effectiveness Research, the Food and Drug Administration, GlaxoSmithKline, Pfizer and Johnson & Johnson. 

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Hearing focuses on FDA response to meningitis outbreak

BY Alaric DeArment

WASHINGTON — Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.

"This outbreak is one of the worst public health disasters in our country’s history and is a terrible tragedy and an epic failure," the committee’s chairman, Rep. Tim Murphy, R-Pa., said in his opening remarks at the hearing, titled "A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented." "Sadly, the [FDA], which is supposed to protect the public, has spent its time passing blame and hiding behind judicial robes rather than taking any responsibility."

To date, the outbreak has sickened 733 and resulted in 53 deaths, according to the Centers for Disease Control and Prevention. Those sickened in the outbreak were chronic pain patients who received doses of the injected steroid drug methylprednisolone acetate compounded at the Framingham, Mass.-based New England Compounding Center that was contaminated with Exserohilum rostrum, a type of mold that attacks muscle and nerve tissue, causing severe pain and, if or when it reaches the brain, death.

A subsequent investigation uncovered widespread contamination and disregard for sanitation at the NECC. The pharmacy was involved with sterile compounding, which differs from the traditional compounding used to mix medicines such as cough syrups and ointments in that it requires strict adherence to sterilization protocols and must be done in clean rooms by trained staff who wear special protective clothing. Most sterile compounded drugs are injectables, including injectable steroids like the one from the NECC, chemotherapy drugs and biotech drugs repackaged for administration in smaller doses.

"We should have more aggressively applied existing authority in spite of an ambiguous statute, a changing legal landscape and continuous challenges by industry to our authorities," Hamburg said at the hearing. "We are being more aggressive now."

Hamburg said that in the last several months, the FDA has inspected more than 50 compounding pharmacies, uncovering many practices and conditions that create the risk of contamination. Most recently, the agency investigated 31 compounding pharmacies, finding problems that warranted warnings from the agency in all but one. Still, Hamburg said, many of the pharmacies have tried to hinder the FDA’s investigations, forcing the agency in some cases to obtain federal warrants and have U.S. marshals accompany investigators.

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Sandoz launches generic cardiovascular disease drug

BY Alaric DeArment

PRINCETON, N.J. — Generic drug maker Sandoz has launched a generic version of a drug used to treat high blood pressure and angina.

The company, a subsidiary of Swiss drug maker Novartis, announced the launch of diltiazem hydrochloride extended-release capsules, a generic version of Forest Labs’ Tiazac. Sandoz is launching the drug in the 120-mg, 180-mg, 240-mg, 300-mg, 360-mg and 420-mg strengths.

Various versions of the drug had sales of about $174 million in 2012, according to IMS Health.

 

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