Risk Management Alerts & Advisories

Let the Risk Managers of The Neurologists' Program keep you up to date with the latest in professional liability news.

OCR Issues Guidance on HIPAA Privacy Rule, Talking to Patient's Family Members
September 16, 2008: Today the Office for Civil Rights, the agency responsible for enforcing HIPAA, issued guidance for both patients and providers about when a provider may - under the federal Privacy Rule - communicate with a patient's family, friends, and other persons involved in care. The guidance for providers explains how the rule operates in several scenarios, and gives examples of things providers can and cannot do in those scenarios. To download a copy of the guidance document, click here. It is important to remember that this guidance only addresses the requirements of HIPAA. Your state's law, and your ethical obligations, may be more protective of patient information

HIPAA Enforcement By HHS
September 9, 2008: The two HHS agencies responsible for enforcement of HIPAA’s Privacy Rule and Security Rule have made detailed enforcement information available online. HHS’ Office for Civil Rights (OCR) has made Privacy Rule enforcement information available at http://www.hhs.gov/ocr/privacy/enforcement/ including the following:

• Enforcement process
• Enforcement statistics
• Enforcement case examples

HHS’ Center for Medicare and Medicaid Services (CMS) has made Security Rule enforcement information available at http://www.cms.hhs.gov/Enforcement/ including the following:

• Compliant examples Compliance review information and examples
• Enforcement statistics

FDA Now Posts Quarterly Listings of Medications Being Investigated for Potential Problems
Sept 5, 2008:  FDA today posted the first of what will be quarterly listings of medications being investigated for potential problems.  The listings indicate that potential signals of serious risks have been identified for the medication using the Adverse Event Reporting System data, but do not indicate that the FDA believes the drug actually has the risk.  Medications listed will be investigated further by the FDA to determine whether the signals identified correspond to any actual risk or not.  FDA is required to post this list by law, and states that "the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication."  Instead, the lists are intended to promote communication between patients and physicians about prescription drug safety.  To view the list, click here.  To read FDA's explanation of the list, click here.

Information Available About Adverse Events Involving Methodone
August, 2008: Information about serious adverse events and deaths involving methadone prescribed for chronic pain is becoming more widely available.  Such events have been reported even when medication abuse is not present.  It is essential that physicians who prescribe methadone and other opioids for pain management understand the risks associated with these medications.  The US Substance Abuse and Mental Health Services Administration ("SAMHSA"), in conjunction with local medical boards, schools, hospitals and societies sponsors CME classes on prescribing opioids for pain management.  For more information about these ACCME-accredited courses, click here.

Guidelines Issued for Use of Medication Samples
June 24, 2008: The National Coordinating Council for Medication Error Reporting and Prevention today issued guidelines for dispensing medication samples, designed to highlight risks involved with the use of samples and to help prevent errors. The guidelines are available on NCCMERP's website. Click here to view the guidelines.

Preventing Pediatric Medication Errors
April 11, 2008: The Joint Commission has issued a Sentinel Event Alert which includes specific strategies for reducing pediatric medication errors. Click here to view the Alert

CDC’s MMWR Report Addresses School-Associated Student Homicides
View January 18, 2008 Report

Final Rule - Multiple Prescriptions for Schedule II Drugs
11-7-07: The DEA has issued a final rule - "Issuance of Multiple Prescriptions for Schedule II Controlled Substances". The rule, codified at 21 CFR Part 1306, is effective December 19, 2007.

DEA regulations have been amended "to allow [under certain specified conditions] practitioners to provide individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90-day supply of that controlled substance". Click here to read the rule. [NOTE: The actual modifications to the rule appear at the very end of the document.]

HHS Issues Security Guidance on Use of Laptops and Other Portable Devices
CMS, the HHS agency responsible for enforcement of HIPAA's Security Rule, has issued a guidance document related to the security of laptops and other portable devices. The document provides specific strategies that CMS may consider reasonable and appropriate for offsite access to electronic protected health information (EPHI). View guidance document.

Final Rule Issued on Restraints and Seclusion
12-8-06: The Centers for Medicare and Medicaid Services published a final rule on patients' rights for facilities participating in the Medicare and Medicaid programs. Among other things, the rule:

• has stricter standards for restraint and seclusion training,
• allows additional types of practitioners to conduct the required face-to-face evaluation within one hour of the use of
• restraint or seclusion,
• and increases the obligation to report deaths associated with restraints or seclusion.

To view the rule, please click here.

HHS Releases Regulations Creating Exceptions to the Stark and Anti-Kickback Laws for Electronic Prescribing and Electronic Health Records Technology

• View HHS News Release
• View CMS Fact Sheet

Agency for Healthcare Research and Quality online patient safety resource and journal - Web M&M.
Agency for Healthcare Research and Quality is an online patient safety resource and journal -- Web M&M: http://www.webmm.ahrq.gov. The site features:

• Analysis of medical errors reported anonymously
• interactive CME
• links to other patient safety and medical errors resources

Joint Commission's Speak Up Campaign
The Speak Up Program to prevent medical errors develops patient brochure to prevent medication mistakes. View website.

Joint Commission's International Center for Patient Safety
This site provides numerous patient safety resources. The Joint Commission's International Center for Patient Safety's mission is "To continuously improve patient safety in all health care settings."

"The Joint Commission and Joint Commission Resources (JCR) established the Joint Commission International Center for Patient Safety in March 2005. The Center is a natural extension of the well-established patient safety activities for which the Joint Commission and JCR are recognized. The Center leverages the expertise, resources and knowledge from both the Joint Commission and JCR." View website.

FDA Warns of Serious or Even Fatal Skin Reactions
FDA warns of serious of even fatal skin reactions for some patients treated with medications containing carbamazepine.

"FDA informed healthcare professionals that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B*1502 is present should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine."

More information is available on the FDA website.