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Risk Management Alerts and Advisories
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.
Industry Consortium Releases Guidelines for Preventing Hospital-Acquired Infections
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.
The American College of Obstetricians and Gynecologists (ACOG) has updated and reissued its Practice Bulletin No. 92: "Use of Psychiatric Medications During Pregnancy and Lactation."
Members of ACOG can access the Practice Bulletin on the ACOG website (www.acog.org) under "Publications," then "Practice Bulletins." The study was also published in Obstetrics & Gynecology (Apr, 2008; 111:1001-1020) and may be purchased from the journal website at www.greenjournal.org. A summary of the information can be found at Medscape.
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.
American Heart Association Issues Sstatement: "Cardiovascular Monitoring of Children and Adolescents With Heart Disease Receiving Stimulant Drugs"
The American Heart Association and American Academy of Pediatrics have issued a joint statement clarifying recommendations about obtaining ECGs prior to pharmacological treatment of children and adolescents with ADHD. To resolve confusion regarding AHA's 4/21/08 statement entitled "Cardiovascular Monitoring of Children and Adolescents with Heart Disease Receiving Stimulant Drugs," the AAP and AHA released this joint statement clarifying the strength of various recommendations regarding obtaining a focused cardiac history and obtaining an ECG prior to initiating pharmacological therapies for ADHD. Obtaining the history is strongly recommended; obtaining the ECG is considered reasonable, but is not expected for all patients.
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
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
Antidepressant
Use
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
FDAs 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
CDCs
MMWR Report Addresses Suicide
View
June 11, 2004 Report: http://www.cdc.gov/mmwr/weekcvol.html
JCAHOs
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 HIPAAs 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
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