Institute of Medicine workshop: advising the FDA, improving drug safety

There's currently a two-day workshop convening at the Institute of Medicine (IOM) to gather experts' advice for the Food and Drug Administration (FDA). Highlights of an expert panel on the first day include:

• "Toning down" drug advertisements to temper patient expectations


• Providing simpler display strategies (e.g. graphics, charts, tables) for comparing risks and benefits of different therapeutic options to aid patients and clinicians with the decision-making process


• Continuing efforts to simplify drug labels

(More on this workshop via Reuters, "Less ads, more data urged for drug safety", May 30, 2006)

There is also a pending Institute of Medicine report, expected to be released in July 2006, examining the FDA's practices for assessment of drug safety, focusing particularly on improving the national system for post-marketing surveillance of potential additional adverse effects. The IOM site contains meeting agendas, transcripts, and audio files of open meetings related to this project to date.

United States DHHS report: suboptimal critical care and looming shortage of intensivists

The Department of Health and Human Services released a report to Congress today entitled Critical Care Workforce: A Study of the Supply and Demand for Critical Care -- it discusses critical care broadly and notes a potential coming shortage of intensivists (through 2020). The report details the history of the intensivist role and examines data on supply and demand related to this role in the US.

The report draws from recent studies of the intensivist workforce in the US and infers that the proportion of patients receiving intensivist-managed care should increase from the current level (one-third of patients) for improved patient outcomes; the report also notes the lack of availability of intensivist care management in many settings.

(Additional press release highlights available via Medscape)


Supporting data from the Committee on Manpower for the Pulmonary and Critical Care Societies (COMPACCS) study:

Critical care delivery in the United States: distribution of services and compliance with Leapfrog recommendations. Crit Care Med. 2006 Apr;34(4):1016-24.

Caring for the critically ill patient. Current and projected workforce requirements for care of the critically ill and patients with pulmonary disease: can we meet the requirements of an aging population? JAMA. 2000 Dec 6;284(21):2762-70.

Journal impact factors

Earlier this year, Eugene Garfield published a JAMA article (2006 Jan 4;295(1):90-3) providing historical background and discussion of the significance of the journal impact factor (Garfield was a co-founder of Science Citation Index from which the impact factors are derived).

There has been considerable controversy about the role of journal impact factors in scientific publishing, including critiques of its utility/validity in the faculty tenure review process and possibly "shady" activities of some journal editors in prompting authors to increase the number of citations to their journal before accepting a given article for publication (i.e. attempting to "boost" the journal's impact factor by mandating citation of its articles).

A quick PubMed search yields a number of articles describing these and other issues, as well as how these factors are being used in some areas of biomedical research (such as exploring how impact factors change once a journal becomes available online).

Update:
Science journals artfully try to boost their rankings, Wall Street Journal, June 5, 2006

Alerts to reduce prescribing errors

Two recent interrupted time-series analyses in May 2006 issues of the Archives of Internal Medicine highlight the potential signification contribution of electronic decision support systems to reducing inappropriate or contraindicated prescriptions.

A study by Smith et al focused on reducing contraindicated prescriptions in an elderly outpatient population by introducing alerts in the electronic medical record system; these alerts appeared at the time of prescription entry and were associated with a 22% relative decrease in "nonpreferred" medication orders, particularly with regard to tertiary tricyclic prescriptions.

A study by Feldstein et al examined the utility of EMR-based alerts with or without group academic detailing to reduce the coprescription of selected interacting agents (acetaminophen, nonsteroidal anti-inflammatory medications, fluconazole, metronidazole, and sulfamethoxazole) with warfarin in 15 primary care clinics. The analysis revealed an approximately 15% decrease in coprescription of these agents at 12 months after implementation of the alerts. Authors note that the addition of detailing practices did not affect alert effectiveness.

Though not a medical example, this brief definition of time series analysis from the North Central Regional Educational Laboratory may be useful: "Interrupted time series design: One limitation of pre-post design is that it does not take into account that students were on a particular learning trajectory before the treatment. One way researchers may try to improve on pre-test/post-test design is to determine pre-intervention trends in performance. Researchers may collect information on student or school performance for the several semesters or years prior to the arrival of the intervention. These pre-intervention trends are then compared to the trends in outcomes following the introduction of the technology program. Any differences observed in the trends may be associated with the effectiveness of the intervention." Source

National Medical Error Disclosure and Compensation (MEDiC) Bill

In this week's New England Journal of Medicine, Hillary Clinton and Barack Obama have a perspective piece describing the latest US effort in patient safety reform, the National Medical Error Disclosure and Compension Bill (S.1784).

This proposed legislation (currently in committee in the Senate, which will decide if the bill is sent to the Senate floor) would amend the Public Health Service Act and lead to the creation of an office in the DHHS dedicated to patient safety and healthcare quality, including funding the creation of a nationl patient safety database, grant projects, and additional research with a patient safety focus.

The legislation is also intended to address physician liability issues and rising insurance costs by implementing model programs for error disclosure and compensation negotiation. Clinton and Obama also note, "Participating insurance companies and health care providers would be required to apply a percentage of the savings they achieve from lowered administrative and legal costs to the reduction of premiums for physicians and toward initiatives to improve patient safety and reduce medical errors."

The story is accompanied by an audio interview with Richard Boothman, chief risk officer managing a model program at the University of Michigan Health System mentioned in the Clinton and Obama article.

Update: A recent related overview article from Critical Care Medicine discussing the disclosure of medical errors in the intensive care unit setting, including an example scenario describing a positive interaction associated with frank and open communication between a physician and a patient after a medical error.

Erin Brockovich takes role as plaintiff in Medicare suits, Los Angeles Times, June 7, 2006: 7 lawsuits filed alleging that Medicare has been inappropriately billed for procedures and other care resulting from medical errors. The article reports, "Her seven lawsuits, filed Friday in Los Angeles County Superior Court, allege that healthcare companies are charging Medicare, the federally funded health plan for seniors, to treat illnesses they helped cause by medical error or neglect. The lawsuits do not involve specific allegations of wrongdoing but seek instead to find evidence of such treatments, arguing that Medicare should be reimbursed."

Searching the clinical adverse effects literature

Golder SP, McIntosh HM, Loke YK. Identifying systematic reviews of the adverse effects of health care interventions. BMC Med Res Methodol 2006 May 8;6(1):22

This recent study published in BMC Medical Research Methodology explores the challenges of constructing one catch-all search strategy for identifying systematic reviews of adverse effects of healthcare interventions.

Interesting that even in these relatively small databases, with a topic that seems fairly well-defined, it was difficult to construct strategies that were precise and sensitive;

The authors conclude that hand searching DARE and Cochrane, the 2 resources that were the focus of this work, is the only way to be certain that you've identified all relevant items.