NACDS urges simple, single med document for patients
ALEXANDRIA, Va. — Simplify, simplify.
That’s the message chain pharmacy lobbyists conveyed to the Food and Drug Administration in November, as the National Association of Chain Drug Stores urged federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients. The message — conveyed in a letter from NACDS VP government affairs and public policy Kevin Nicholson to FDA commissioner Margaret Hamburg — came as the agency mulls new federal guidelines on patient package inserts and other prescription drug information.
Nicholson also asked the FDA to step up its efforts to clear the way for an approval pathway for generic versions of biologically engineered drugs.
NACDS, Nicholson told Hamburg, strongly endorses federal efforts to adopt a simpler, single medication information document for patients. The goal, he said, should be clear: easy-to-understand instructions and warnings about possible side effects of prescription medicines.
Such a document, Nicholson asserted, provides the “final link in the prescription supply chain,” and should be “standardized with respect to format and content.”
“Today, patients receive several different types of written medication information, developed by different sources that may be duplicative, incomplete or difficult to read and understand,” Nicholson pointed out. “This current system is not adequate to ensure that patients receive essential medication information.”
NACDS, he reminded Hamburg, was part of a coalition of pharmacy groups that urged the agency in 2008 to require drug suppliers to provide “a concise, plain-language document for patients” when they fill a prescription.
Among the group’s other priorities with the agency: adoption of “an abbreviated approval pathway for biogenerics.” Nicholson also applauded recent efforts by the FDA’s Center for Drug Evaluation and Research and its director, Janet Woodcock, to address lingering skepticism among “certain sectors of the public” about the therapeutic equivalence of generic drugs.
“We applaud Dr. Woodcock for acknowledging this skepticism and for making its resolution a high priority,” he added.
Adults want control of their private health data
AUSTIN, Texas — An overwhelming majority of respondents to a recent poll want to choose which companies and government agencies can view and use their health information.
An online survey of more than 2,000 adults conducted in November by the advocacy group Patient Privacy Rights and Zogby International — with a margin of error of plus or minus 2.2% — found that nearly all respondents favored personal control over health information, including information stored electronically. “No matter how you look at it, Americans want to control their own private health information,” Patient Privacy Rights founder Deborah Peel said. “We asked the question, ‘If you have health records in electronic systems, do you want to decide which companies and government agencies can see and use your sensitive data?’ Ninety-three percent said ‘Yes.’”
Nearly all respondents shared these sentiments; 97% said they thought doctors, hospitals, labs and health technology systems should not be allowed to share or sell health information without their consent, while 98% said insurance companies should not. Ninety-one percent of respondents said they wanted the ability to decide which individuals could see and use their information. “Americans overwhelmingly believe that they are the only people in the right position to make decisions about how their information can be used,” Peel said. “Researchers do not get a free pass.”
The results are significant considering the country’s move toward electronic health records and electronic prescribing, provisions for which were a prominent component of the American Recovery and Reinvestment Act of 2009. While supporters said the move to EHRs could save billions of dollars by reducing the risk of errors and eliminating waste, concerns about fraud and misuse of patients’ personal information have arisen as well.
Another poll, conducted online in February by Harris Interactive on behalf of Xerox — which provides a number of healthcare IT and documentation products and services — found that nearly half of the 2,180 adults surveyed were ready to give up paper medical records in favor of electronic ones and thought EHRs would lead to more efficient health care, despite many not knowing what to expect when the transition took place. A majority of respondents to the Harris poll still expressed concerns, including 79% who feared theft of records, 69% who were concerned about misuse of information and 68% who were afraid of lost or damaged records.
“Providers can ease this fear by discussing the security precautions taken to safeguard against data breaches,” Xerox VP healthcare providers John Jones said. “By arming Americans with information on EHR basics, we can prevent some of the influence of the media hype cycle around potential security risks.”
Sun seeks to acquire Caraco
DETROIT — An India-based drug maker is looking to acquire all outstanding shares of another generic drug manufacturer based in the United States.
Caraco said it received and will discuss the proposal from Sun Pharma, by which Sun would acquire all outstanding shares of common stock it doesn’t already own.
The $4.75-per-share cash transaction represents a 5% premium over the closing price of Caraco common stock on Dec. 2, Caraco said.