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FDA’s New Campaign: Safe Drug Use

Drug Benefit TrendsDrug Benefit Trends Vol 21 No 11
Volume 21
Issue 11

In early November, the FDA announced the launch of the Safe Use Initiative, a program to protect patients from injury and death caused by improper use of over-the-counter and prescription medications.

In early November, the FDA announced the launch of the Safe Use Initiative, a program to protect patients from injury and death caused by improper use of over-the-counter and prescription medications. As a result of this effort, pharmaceutical manufacturers may be asked to find ways to make proper dosing more evident. But the main focus of the program will be getting patients to follow directions for medication use, said Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research.1

The Safe Use Initiative will include the creation of programs to increase awareness about the risk of acetaminophen misuse as well as misuse of other medications, to safeguard against fires in surgical settings that result from the use of alcohol-based surgical swabs, and to avoid contamination of vials of injectable medications that may be used multiple times. But these programs are currently in the design stages. Margaret A. Hamburg, the FDA commissioner, said the agency will also be reaching out to insurers, drugmakers, physicians, pharmacists, state regulators, and others to identify and discuss specific problems and develop ways to address them.

Also on the table is the issue of whether the United States should move to the practice, common in other industrialized countries, of having a single standardized leaflet of consumer information about each drug. Current materials include FDA-approved labeling supplemented by largely unregulated information sheets developed by drugmakers, pharmacies, individual practitioners, and pharmacy benefit managers.

1. Food and Drug Administration. FDA Unveils Safe Use Initiative That Targets Preventable Harm From Medication Use. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189081.htm. Published November 4, 2009. Accessed November 16, 2009.

Wealthier Patients More Likely to Benefit From Electronic Health Records
Despite widespread agreements that electronic health records (EHRs) significantly reduce prescription errors, adoption of the technology has been spotty. Hospitals that serve large populations with low incomes were less likely to have implemented health information technology systems, even though EHRs may increase quality of care, according to a study led by Ashish Jha, MD, MPH,1 associate professor of health policy and management at the Harvard School of Public Health, Boston.

Survey results from 2368 acute care hospitals showed that those less likely to adopt EHRs served a higher than average number of indigent Medicare and Medicaid patients. They were also more likely to be large, nonprofit teaching institutions and to be located in the South. Of note, these hospitals were less likely to have an electronic formulary available, which might lead to a lower use of preferred medications.

Of those hospitals that had not adopted EHRs, cost was cited as the most significant barrier to implementation. In addition, the authors reported that these hospitals may be unable to maintain costs necessary to continue supporting advanced information technology once it is implemented.

1. Jha AK, DesRoches C, Shields AE, et al. Evidence of an emerging digital divide among hospitals that care for the poor. Health Aff (Millwood). 2009;28:w1160-w1170.

Should Pharmacies Pay for Injuries Caused by Rx Drug Abusers?
Thirty-three states operate prescription-tracking programs in an attempt to spot improper medication use. But a serious legal question is emerging-just what is the liability of a pharmacist who has received notification that a patient may be using medications inappropriately? The National Association of Boards of Pharmacy has just put together a task force to look into the issue and is weighing whether it must develop guidelines on the subject.

The concern has come to the fore because of a case pending in the Nevada Supreme Court, Sanchez v Wal-Mart. In 2004, Gregory Sanchez Jr was killed and Robert Martinez was injured in a highway accident caused by 35-year-old Patricia Copening, a patient taking prescription painkillers, when she swerved off the highway and careened into their vehicle. Copening has pleaded guilty of reckless driving.

But can the pharmacies that supplied her with these prescription painkillers-157 hydrocodone and other pills were found in her car-be ordered to pay damages to the accident victims and their families? The Nevada drug-tracking system had identified Copening as an abuser, and the state’s Prescription Controlled Substance Abuse Prevention Task Force had sent warning letters to 14 pharmacies in the Las Vegas area.

The trial court that initially heard the Nevada case held that the pharmacies had no liability to the accident victims, and the Nevada Supreme Court is reviewing that ruling. An opinion by the court is expected by the end of the year.

Seven chain pharmacies are defendants in the case. A brief filed by one of the defendants, Walgreens, warned that if pharmacies are responsible for the misdeeds of customers, they might simply stop stocking those regulated painkillers most subject to abuse. This could make it difficult for patients to get painkillers for legitimate use.

Protests Mount Over DEA Controls on Prescribing Narcotics
Although the US Department of Justice has scaled back enforcement of marijuana distribution regulations, it has intensified its scrutiny of the distribution of narcotics, making it hard for some legitimate patients to get such drugs as oxycodone and morphine. Now advocates for those patients who need these medications are pressuring Attorney General Eric H. Holder Jr to get the Drug Enforcement Administration (DEA) to ease up its campaign.

The DEA rules require a written prescription from a physician before nursing home patients can be given pain medication. Recently, this requirement has been intensively enforced in a pilot program covering Virginia, Ohio, Michigan, and Wisconsin. Facilities that allow a nurse to administer such drugs on a verbal order from a doctor-a common practice at night, when few nursing homes have a physician on duty-face steep fines.

Under the rules, the signed order can be sent by fax, but that may still lead to delays that can be dangerous. A letter to Holder from senators Herb Kohl (D, Wis) and Sheldon Whitehouse (D, RI) warned that by not making drug control rules congruent with actual practices at long-term–care facilities, the DEA crackdown produces “adverse health outcomes and unnecessary rehospitalizations, not to mention needless suffering.”1

1. Johnson C. DEA crackdown hurts nursing home residents who need pain drugs. Washington Post. October 29, 2009: A07.

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