FDA AIMS TO REDUCE MEDICATION MISTAKES
In June, the Food and Drug Administration (FDA) teamed up with the nonprofit Institute for Safe Medication Practices (ISMP) to launch a campaign aimed at educating health professionals about medication mix-ups caused by unclear medical abbreviations.
These errors are common in all medical specialties, including neurology, said AAN Practice and Patient Safety Manager Steve Rush.
The campaign will focus on correcting mistake-prone abbreviations in handwritten prescriptions; computer-generated labels; medication administration records; pharmacy or prescriber computer order entry screens; and commercial medication labeling, packaging, and advertising. It highlights these among other common errors:
- The abbreviation U is often mistaken for zero, the number four, or CC. It should be written as “unit.”
- The abbreviation IU is often mistaken for IV or the number ten. It should be written as “international unit.”
- The abbreviations MSO4 (morphine sulfate) and MgSO4 (magnesium sulfate) are often confused with each other and should be spelled out.
- Decimal points are sometimes missed, so five milligrams should be written as 5 mg, not 5.0 mg. For the same reason, zeros should be placed before decimal points: 0.5 mg should be written rather than .5 mg.
Rush pointed out that the AAN Patient Safety Subcommittee launched a project in April that allows neurologists to download tips on how to improve patient safety as well as tools to help them do just that. The downloads are available at www.aan.com/patientsafetytips. The program currently has 48 tips and includes an option to enable physicians to submit their own tips via the Web site.
For more information on the FDA/ISMP campaign, visit www.fda.gov/cder/drug/MedErrors and www.ismp.org/tools/abbreviations.
FDA APPROVES NEW FORM OF SELEGILINE
In June, the Food and Drug Administration (FDA) approved a new formulation of an old drug for the treatment of Parkinson disease (PD). The dopamine agonist, selegiline (Zelapar), has been prepared as a once-daily dissolvable tablet for adjunct use with levodopa and carbidopa. The drug manufacturer is Valeant, Inc.
As a monoamine oxidase B inhibitor, selegiline prevents the rapid breakdown of dopamine, and is a levodopa extender, Curt R. Freed, MD, Director of the Neurotransplantation Program for Parkinson Disease at the University of Colorado School of Medicine, told Neurology Today.
Dr. Freed and several other experts, who were not involved in the company-sponsored study that led to its approval, said the newly approved compound is a reformulation of an older drug that has been available in generic form.
“Physicians and patients have known for years that taking selegiline can reduce the dose of levodopa needed to treat PD symptoms and can also extend the time that levodopa is effective, leading to reduced ‘off’ time,” Dr. Freed added.
Lawrence I. Golbe, MD, Professor of Neurology at Robert Wood Johnson Medical School in New Brunswick, NJ, agreed, adding that he saw little or no need for an orally absorbed, rapidly dissolving form of selegiline and a more rapid onset of action.
According to the study led by Cheryl Waters, MD, Albert B. and Judith L. Glickman Professor in the Department of Neurology at Columbia University, the dissolvable tablet reduced “off-time” for Parkinson patients by an average of 2.2 hours per day compared with 0.6 hours per day in patients given a placebo in a 12-week multicenter, double-blind, placebo controlled study (Mov Disorders 2004: 19(4):426–432).The reduction in treatment time between the two treatment groups was statistically significant (p < 0.001).
Caroline M. Tanner, MD, PhD, Director of Clinical Research at the Parkinson's Institute in Sunnyvale, CA, told Neurology Today that the new formulation of selegiline is “mildly effective as an adjunct to levodopa, with similar efficacy to the conventional selegiline 5 mg BID tablet.” She suggested, however, that advantages of the dissolvable tablet could include a “lower risk of MAOA inhibition and consequent hypertensive crisis, greater ease of use, especially for patients with problems swallowing, and perhaps fewer dopaminergic side effects.”
J. Timothy Greenamyre, MD, PhD, Professor of Neurology and Director of the Pittsburgh Institute for Neurodegenerative Diseases, said he would prescribe the new formulation “only for those rare patients who have severe problems with gastrointestinal absorption – or, in the unlikely event it were less expensive.”
AMA BACKS WAITING PERIOD FOR DTC ADS
The American Medical Association (AMA) announced in June that it would support a waiting period on direct-to-consumer ads that would give physicians time to study the products before they are advertised. One expert said the controversy surrounding drugs such as natalizumab (Tysabri) suggests a waiting period would help physicians to decide on a drug before patients ask for it.
Natalizumab had received fast-track approval for multiple sclerosis in November 2004, but the manufacturer, Biogen, pulled it from the market three months later after three patients taking it developed progressive multifocal leukoencephalopathy (PML); two of whom died. In June, the FDA approved the resumed marketing of natalizumab with these requirements: that Biogen establish a mandatory patient registration program and physicians conduct periodic evaluations to check for any new cases of PML.
The AMA's new position is in line with voluntary guidelines adopted by the pharmaceutical industry last year that recommend that companies educate physicians before beginning consumer-ad campaigns. At previous AMA meetings, the group considered supporting a ban on all direct-to-consumer ads, arguing that they influence patients to demand drugs and medical devices that their physicians may not deem appropriate.
AAN Education Committee Chair Ralph F. Jozefowicz, MD, said a waiting period would give physicians time to see if their patients have any adverse clinical reactions to a certain drug or device before prescribing it more widely. He said since most new neurology drugs have complicated statistics on efficacy, “It is confusing enough for physicians to understand, let alone patients.”
Pharmaceutical companies have a market incentive to develop new drugs regardless of whether they are necessarily more effective than others on the market, and physicians and patients have a responsibility to make sure society does not pay for superfluous drugs, Dr. Jozefowicz said.
NIH SCIENTIST'S ALLEGED ETHICS VIOLATION QUESTIONS AGENCY'S OVERSIGHT
A senior scientist at the NIH may have profited by at least $285,000 for transferring human tissue samples to the pharmaceutical company Pfizer Inc., in an apparent violation of agency ethics rules. The incident brings to light questions about how often such improper transfers might occur and whether the agency has a proper oversight system in place.
Investigators for the House Committee on Energy Commerce issued a 26-page report on June 13 that found that a Branch Chief at the National Institute of Mental Health, Trey Sunderland, MD, had provided Pfizer with more than 3,000 samples of human spinal fluid and plasma from patients with Alzheimer disease and control subjects. The transfer began with a 1998 agreement between Dr. Sunderland and the company. In all, Dr. Sunderland received more than $600,000 in payments from Pfizer from 1998 to 2004 for consulting and speaking engagements, for which he neither received prior approval from the NIH, nor disclosed in his financial report filings, according to House investigators.
According to the report, simply procuring the samples, which chronicled the progression of Alzheimer disease on the same subjects over several years, cost $6.4 million.
While the report states that Pfizer did not know of Dr. Sunderland's “questionable conduct,” it holds the NIH accountable for not having earlier uncovered his alleged violations. A colleague of Dr. Sunderland who became concerned about some of the missing spinal-fluid samples contacted the House committee in April 2005, which led to a year-long investigation.
The report found that the NIH has “no uniform, centralized, and mandatory authority regulating the handling of human tissue samples. Some NIH laboratories kept a written record on the maintenance of these samples, but other NIH laboratories did not.”
The House committee held a hearing on NIH research policies and practices regarding human tissue samples in June. Michael M. Gottesman, MD, Deputy Director for NIH Intramural Research, stressed in his testimony that the ethics rules implemented by the agency last year ban all outside consulting by NIH scientists with pharmaceutical and biotechnology companies. He said that the agency's new policies regarding human tissues samples will include a requirement that all transfers of samples be documented and reviewed by senior leadership at the relevant institute.
CA STEM CELL INSTITUTE ASKS FOR SPEEDY REVIEW OF SUITS
Several months after a landmark decision ruled out two lawsuits against a taxpayer-funded California stem cell institute, research in the state is still inching along.
As expected, attorneys for the plaintiffs appealed the April 21 decision, and lawyers for the California Institute for Regenerative Medicine (CIRM) asked an appeals court for a speedy review. Attorneys for the groups behind the suits – the California Family Bioethics Council and the People's Advocate and National Tax Limitation Foundation – have vowed to take the cases to the California Supreme Court if necessary.
As long as the suits are pending, the CIRM is unable to sell state bonds needed to finance the program. To compensate, CIRM President Zach W. Hall, PhD, said that agency has sold Bond Anticipation Notes (BANs) to philanthropic organizations and private donors, which will be repaid with nominal interest once the lawsuits have been resolved. So far, the CIRM has sold $14 million in BANs, $12 million of which was used to award grants to 16 institutions throughout the state.
“The sooner the appeals process is over, the sooner the $3 billion in voter-approved bond funds can be sold and can fund CIRM research,” Dr. Hall said in an e-mail to Neurology Today. “We estimate that it may be as much as a year before the appeals are exhausted.”
California voters had approved a $3 billion bond to support the statewide stem cell initiative in November 2004. An article in the May 16 issue of Neurology Today (pgs. 10–11) examined how the CIRM is staying afloat despite legal challenges.
FDA PLANS EASIER DRUG SAFETY REPORTING
The Food and Drug Administration (FDA) announced on June 21 that it is developing a single Web-based system for reporting drug safety issues.
Scott Gottlieb, MD, FDA Deputy Commissioner for Scientific and Medical Affairs, announced the plans during a health care conference on Capitol Hill. He said the FDA hopes to have the system up and running over the next two years, which will help the agency more quickly analyze the nearly 500,000 adverse-event reports it receives each year.
“The system will be easy to use, so that the general public is encouraged to report incidents and is not deterred by the nature of the information requested,” he said. “Once collected, the consolidated information will make it easier for us to develop robust tools for screening these reports.”
FDA CONSIDERS MORE STRINGENT CLINICAL TRIALS RULES
The Food and Drug Administration (FDA) is considering toughening its rules on clinical trials, which would include a provision to force drug makers to promptly inform the agency of research fraud.
The FDA plans would also include initiatives to standardize the forms used to collect information in studies, adjust the rules on how patients access experimental treatments, and clarify what adverse events investigators should report to study review boards.
FDA Deputy Commissioner Janet Woodcock, MD, unveiled the plans at an industry conference on June 21, and released a copy of her presentation to Neurology Today. Dr. Woodcock said the FDA needs to re-evaluate its current rules because of the way clinical trial practices have evolved over the last few decades.
Among changes, she said, are new trial methods and designs and new arrangements between study coordinators and researchers. Trials today often involve numerous study sites and participants and are often coordinated by for-profit sponsors and contractors, she said. More oversight is also needed for an increasing number of trials involving children and other vulnerable populations, she said.
The FDA began the process of re-evaluating its clinical trials rules in December 2004. Dr. Woodcock said the agency will spend the rest of the year putting together a group to complete the project.