The health reform law will require drug makers to disclose the amounts of free samples they distribute, a requirement which promises to shed light on a practice whose scope could previously only be estimated. The Wall Street Journal‘s Jared Favole has found some preliminary disclosures; the resulting numbers can be found in the graph below. The numbers should only be treated as the roughest of estimates, as some companies disclosed the market value of the drugs while others gave wholesale numbers. Likewise, some measured the number of samples based on the number of doses, while others counted larger units. Samples, Favole writes, are a key weapon in pharma’s war against generics as they can be a gateway to brand-name medicines.
A 2008 study in the Southern Medical Journal found that doctors in a clinic were more than three times more likely to prescribe generic medications to uninsured patients after drug samples were removed from that clinic. “Free drug samples may lead to higher costs for uninsured patients by encouraging physicians to write prescriptions for brand-name drugs only,” the study said.
The group’s state chapters – except for Alabama, Arizona, Connecticut and Hawaii – reported their own donations to Grassley, he wrote in a letter to NAMI’s executive director and president of the board of directors. According to the letter, the California chapter received $632,000 in contributions between January 2005 and October 2009, the most of any state. Ohio NAMI received $623,000 and New York NAMI $448,000. The top ten states received a total of $3.84 million.
Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.
The network is designed to alert pharmacists of dangerous and life-threatening errors as well as to educate them on how to prevent those specific errors from also occurring in their own respective practices. The system is intended to help the same errors from being repeated time after time across the country.
Landro wrote that “Medication errors cause at least one death every day and injure approximately 1.3 million people annually in the United States,” and added that there are some indications that the weakening economy has had a negative impact on medication safety.
Here’s Landro explaining the new network:
The non-profit Institute for Safe Medication Practices, which is certified by the federal government to collect error reports and other information about quality breaches, and the American Society of Health-System Pharmacists are launching a new National Alert Network for Serious Medication Errors. The network, which was unveiled last month, will be used to send email alerts to 35,000 pharmacists working in hospitals and health systems, as well as physicians and nurses, when a dangerous or life-threatening error is reported to ISMP. The two organizations are also in discussions to extend the network to as many as 26 other organizations that promote safe medication use. The hope is that widely spreading the word about such errors will cause doctors and pharmacists to be more cautious—and ultimately prevent future mix-ups. Relevant alerts will also be sent to 20,000 drugstore pharmacists.
On the Wall Street Journal‘s Op-Ed page, Jerome Groopman and Pamela Hartzband cite the shortcomings of a quality metric-based system in Massachusetts and describe various misguided quality metrics. Groopman and Hartzband are both on the staff of Beth Israel Deaconess Medical Center in Boston and on the faculty of Harvard Medical School.
Initially, the quality improvement initiatives focused on patient safety and public-health measures. The hospital was seen as a large factory where systems needed to be standardized to prevent avoidable errors. A shocking degree of sloppiness existed with respect to hand washing, for example, and this largely has been remedied with implementation of standardized protocols. Similarly, the risk of infection when inserting an intravenous catheter has fallen sharply since doctors and nurses now abide by guidelines. Buoyed by these successes, governmental and private insurance regulators now have overreached. They’ve turned clinical guidelines for complex diseases into iron-clad rules, to deleterious effect.
Groopman and Hartzband cite several examples of regulations later proven questionable or even harmful, including the monitoring of ICU patients’ blood-sugar levels, the provision of statins to patients with kidney failure, and the monitoring of blood sugar in certain diabetics.
These and other recent examples show why rigid and punitive rules to broadly standardize care for all patients often break down. Human beings are not uniform in their biology. A disease with many effects on multiple organs, like diabetes, acts differently in different people. Medicine is an imperfect science, and its study is also imperfect. Information evolves and changes. Rather than rigidity, flexibility is appropriate in applying evidence from clinical trials. To that end, a good doctor exercises sound clinical judgment by consulting expert guidelines and assessing ongoing research, but then decides what is quality care for the individual patient. And what is best sometimes deviates from the norms.
Groopman and Hartzband cite studies showing that quality metrics had “had no relationship to the actual complications or clinical outcomes” of hip and knee replacement patients at 260 hospitals in 38 states and that, in 5,000 patients in 91 hospitals “the application of most federal quality process measures did not change mortality from heart failure.”