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Drug Diversion and Reportable Events Stefanie Mozgai Assistant Commissioner. What is Drug Diversion?. Transfer of controlled dangerous substances from a lawful to an unlawful channel of distribution or use (Uniform Controlled Substances Act 1994)
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Drug Diversion and Reportable Events Stefanie Mozgai Assistant Commissioner
What is Drug Diversion? • Transfer of controlled dangerous substances from a lawful to an unlawful channel of distribution or use (Uniform Controlled Substances Act 1994) • Illegally obtaining, possessing or distributing drugs for personal or other use
Drug Diversion Methods • Drug Tampering • Improper wasting • Stealing Controlled Substances from patients • Removing excessive amount of Controlled Substances from AD machines
Drug Diversion How many tablets of Alprazolam and Hydrocodone will a 44 ounce soda cup hold?
What is Drug Tampering? • The inappropriate or illegal alteration of a drug formulated under specified conditions • Harm to patients • Risk of infections
Opportunities for Improvement 8:43A 9.3 (b)(7) • The facility’s P&Ps for the administration, control, and storage of medications shall include: • The control of drugs subject to the CDS Act including: provision for a verifiable record system for controlled drugs; P&P to be followed in the event that inventories of controlled drugs cannot be verified or drugs are lost, contaminated, unintentionally wasted, or destroyed; procedures for the intentional wasting of controlled drugs including signature of a second person who shall witness the disposition.
Opportunities for Improvement 8:43A 9.5(d) • A declining inventory of all drugs in Schedules I through V of the CDS Acts and amendments thereto shall be made at the termination of each shift and shall be retained wherever these drugs are maintained.
Opportunities for Improvement • PREVENT Education Signs of Impairment • DETECT Policy Development Adequate Surveillance • RESPOND Proper Reporting Multidisciplinary Approach
Licensed Facilities in New Jersey • All licensed healthcare facilities must be in compliance with N.J.A.C. 8:43 E
Reportable Events Reporting of Drug Diversions: • In accordance with 8:43E 10.11 (a) criminal acts or potentially criminal acts, such as drug diversion, that occurs within a facility and poses a danger to the life or safety of patients shall immediately be reported to the appropriate police authorities
Reportable Events Reporting of Drug Diversions: • In accordance with 8:43E 10.11 (b) and (d) criminal acts or potentially criminal acts are to be reported to the Department immediately • Reporting to the Professional Boards or The Health Care Professional Information Clearinghouse does not satisfy this regulatory requirement
Reportable Events • HOW TO REPORT: • All facilities not accessing Hippocrates to submit reportable events use the Department’s 24 hour hotline • Please call (800) 792-9770 • Select Option 1 for Long Term Care facilities • Select Option 2 for Acute Care facilities
Reportable Events • REPORTING THROUGH HIPPOCRATES: • Hippocrates is a web-based application suite used to capture, manage, display, and disseminate critical information about New Jersey’s health infrastructure status • Information submitted using the reportable events online form is managed and tracked in Hippocrates by the Division of Health Facilities Survey & Field Operations • A Hippocrates account is NOT needed to use the online form
HCPRREA • All health care entities must be in compliance with 8:30 The Rules for Implementing the Health Care Professional Responsibility and Reporting Enhancement Act
HCPRREA Health care entities must: • Notify the Clearinghouse Coordinator • Use the required form to notify the Coordinator • Cooperate with requests for information by the Division, a board, or the Medical Review Panel • Execute a joint report to the Coordinator with a healthcare professional
HCPRREA Health care entities must: • Provide a copy of the report filed with the Coordinator to the health care professional who is subject to the report • Provide a copy of the notice submitted to the Coordinator to a staffing agency or healthcare services firm when the subject of the report is providing services to the health care entity pursuant to a contract with a staffing agency
HCPRREA A facility inquiring about a healthcare professional must: • Use the CN-9 which is available on the Department’s website • Use the CN-9 for making inquiries to health care entities other than facilities (ie agencies)
HCPRREA A facility receiving an inquiry about a healthcare professional must: • A facility that received a validly executed inquiry form shall complete and return the form and any other information to the inquiring health care entity within 8 business days of receipt of the inquiry form. • A facility that received a validly executed written inquiry that was not on the CN-9, shall complete and return the required form within 8 business days of receipt of the inquiry and attach the written request to the response.
HCPRREA A health care entity must: • Maintain records of all complaints of events related to patient care provided by, and disciplinary proceedings or actions against, a health care professional who the entity employs/employed or has/had an affiliation for a period of 7 years from the date of the occurrence that triggered the creation of the record.
HCPRREA A health care entity must: • Maintain all records and source data relating to the entity’s mortality, morbidity, complication, infection, and readmission rates that relate to a specific health care professional for a period of 4 years from the date of the occurrence that triggered the creation of the record.
HCPRREA CIVIL MONETARY PENALTIES • $500 per violation may be assessed per day for not reporting to the Clearinghouse Coordinator • $250 per violation for failing to cooperate with a request for information • $1000 per violation for an entity failing to execute a joint report with a healthcare professional
HCPRREA CIVIL MONETARY PENALTIES • $250 per violation may be assessed per day for failing to respond in a timely and/or truthful manner to an inquiry • $500 per violation may be assessed per day for failing to comply with a request for records • $1000 per violation for failing to maintain records
Drug Diversion and Reportable Events THANK YOU