The Psychiatrists' Program

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

Ethex Corp Recalls Generic Morphine Sulfate, Dextroamphetamine Sulfate, and Two Other Medications
November 10, 2008: Ethex Corp and the FDA notified healthcare providers of a recall of Propafenone HCL tablets, Isosorbide Mononitrate ER tablets, Morphine Sulfate ER tablets, Morphine Sulfate IR tablets, and Dextroamphetamine Sulfate tablets. These products may contain oversized tablets, and up to twice the expected dose of the active ingredient. For more information, view the FDA MedWatch post here.

Recall of Dextroamphetamine Sulfate tablets
October 16, 2008: Today, FDA and Ethex Corp announced a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. Some tablets in these lots may contain as much as twice the labeled amount of the active ingredient, increasing the risk of side-effects. To read the MedWatch announcement, click here.

October 8, 2008: Today a consortium of industry associations including the Joint Commission, American Hospital Association, Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, and Association for Professionals in Infection Control released guidelines for preventing hospital-acquired infections ("HAIs"). Although previous guidelines have provided evidence-based recommendations for detecting and preventing HAIs, these new guidelines include practical recommendations designed to assist hospitals in implementing and prioritizing HAI prevention efforts. To download a copy of the guidelines and for more information, click here.

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
Aug., 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 Reports A Rise In Unintentional Poisoning Deaths Involving Psychotherapeutic Drugs
"Unintentional drug poisoning mortality rates increased substantially in the United States during 1999--2004. Previous studies, using multiple cause-of-death data, have indicated that the trend described in this report can be attributed to. . . prescription psychotherapeutic drugs (e.g., sedatives), and cannot be attributed to heroin, methamphetamines, or other illegal drugs (3,5)." Read the entire article.

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.]

New ADHD Resource from APA / AACAP
ParentsMedGuide.org, the online resource center for patients, families, and physicians, has made a new ADHD resource available. Developed by the APA and AACAP, this new resource - The Medication Guide for Treating ADHD - is available for download at http://www.parentsmedguide.org/

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).

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:

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

SAMHSA Releases Roadmap to Seclusion and Restraint Free Mental Health Services

JCAHO Announces 2007 National Patient Safety Goals for Behavioral Health Care Organizations

JCAHO Announces 2006 National Patient Safety Goals for Behavioral Health Care Organizations

FDA Continuously Updates Its MEDWATCH – Medical Product Safety Information – Webpage With Safety Alerts and Advisories, Safety-Related Drug Labeling Changes, and More

NIH Sponsors "Preventing Violence and Related Health-Risking Social Behaviors in Adolescents" Conference

HHS’ SAMHSA Provides Educational Document Discussing the Confidentiality of Alcohol and Drug Abuse Treatment Records Regulation (42 CFR Part 2) and HIPAA’s Privacy Rule

HHS Provides Guidance on Financial Relationships and Interests in Research Involving Human Subjects

OIG Posts Special Alert To Physicians About Extra Charges For Medicare Patients

Federal Trade Commission Issues Tips For Businesses To Keep Their Computer Systems Secure

SAMHSA Announces A New Technical Assistance Center Available To Aid In Treatment of Co-Occurring Substance Abuse And Mental Health Disorders

APA Publishes Practice Guideline for the Assessment and Treatment of Patients With Suicidal Behaviors

The APA has published the Practice Guideline for the Assessment and Treatment of Patients With Suicidal Behaviors as a Supplement to the November 30, 2003 issue of The American Journal of Psychiatry.

CMS Issues Interim Guidance on EMTALA Enforcement
The Centers for Medicare & Medicaid Services (CMS) on May 13, 2004 issued Revised Emergency Medical Treatment and Labor Act (EMTALA) Interpretive Guidelines. To access the guidance, visit www.cms.hhs.gov/medicaid/survey-cert/sc0434.pdf

To view our EMTALA article from the Fall 2003 issue of our newsletter: Rx for Risk.

JCAHO Issues Additional Prohibited Abbreviations
2004 National Patient Safety Goals - FAQs: View the information.

Agency for Healthcare Research and Quality launches online patient safety resource and journal - Web M&M.