Risk Management Alerts and Advisories

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

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: http://www.cdc.gov/mmwR/preview/mmwrhtml/mm5702a1.htm

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).

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
  

SAMHSA Releases Roadmap to Seclusion and Restraint Free Mental Health Services

View Report.

Medicare Prescription Drug Benefit - Medicare Part D

View article.

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

View Press Release.

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

View Press Release.

FDA Issues Public Health Advisory for Adderall

• View FDA's Adderall and Adderall XR Information Page, which includes links to Patient Information Sheet, Healthcare Professional Sheet, etc.
• View FDA's Public Health Advisory
• View FDA's Statement on Adderall
  

Antidepressant Use

• NEW: APA and AACAP issue guides for parents and for physicians prescribing antidepressants to children and adolescents
  www.parentsmedguide.com
• View FDA’s current information on “Antidepressant Use in Children, Adolescents, and Adults”
  www.fda.gov/cder/drug/antidepressants/default.htm
• View FDA’s Public Health Advisory “Suicidality in Children and Adolescents Being Treated with Antidepressant Medications” (10/15/04)
  www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm
• View FDA’s “Statement on Recommendations of the Psychopharmacologic Drugs and Pediatric Advisory Committees” (9/16/04)
  www.fda.gov/bbs/topics/news/2004/NEW01116.html
• View FDA's information from March 22, 2004, including Public Health Advisory, FDA Talk Paper, and Questions and Answers on Antidepressant Use in Children, Adolescents and Adults
  www.fda.gov/cder/drug/antidepressants/default.htm
• View FDA's Questions and Answers on Paxil from June 19, 2003
  www.fda.gov/cder/drug/infopage/paxil/paxilQ&A.htm

Speak Up Program

JCAHO's Speak Up Program to Prevent Medical Errors Develops Patient Brochure to Prevent Medication Mistakes
www.jcaho.org/news+room/press+kits/medication_mistakes/index1.htm

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

View FDA’s MEDWATCH
www.fda.gov/medwatch/safety.htm

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

View AHRQ's summary of the background report:
http://www.ahrq.gov/clinic/epcsums/adolvisum.htm

View NIH's State-of-the-Science Conference Statement:
http://consensus.nih.gov/ta/023/youthviolenceDRAFTstatement101504.pdf

CDC’s MMWR Report Addresses Suicide

View June 11, 2004 Report: http://www.cdc.gov/mmwr/weekcvol.html

JCAHO’s Joint Commission Resources Launches Patient Safety Web Page

View the information: http://jcrinc.co.mansellgroup.net/UM/T.asp?A2557.25634.800.1.46848

GlaxoSmithKline Releases Pediatric Clinical Trials Data

View the information: www.gsk.com/media/paroxetine.htm

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

View Report: http://www.hipaa.samhsa.gov/Part2ComparisonClearedTOC.htm

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

View May 12, 2004 Press Release
www.hhs.gov/news/press/2004pres/20040512.html
View the Guidance
http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finalguid.pdf

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

View the OIG Alert:
www.oig.hhs.gov/fraud/docs/alertsandbulletins/
2004/FA033104AssignViolationI.pdf

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

View the information
www.ftc.gov/opa/2004/04/cybersecure.htm

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

View the information
www.samhsa.gov/news/newsreleases/040108nr_cooc_ta.htm

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.

You can also view the APA's Practice Guideline online by clicking here.

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.

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

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

http://www.webmm.ahrq.gov