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Every licensed health care facility must report the theft or loss of controlled substances. You must immediately report it to the Drug Control Program (DCP) by telephone. You must then follow it up in writing within 7 days of the incident. Facilities licensed by the Division of Health Care Quality (DHCQ)In January this year, the Department modified its requirements for reporting the theft or loss of controlled substances by licensed health care facilities. Facilities licensed by the DHCQ are no longer required to notify the DHCQ in addition to the Drug Control Program for these thefts or losses. The DCP is the primary agency within the Department charged with investigating cases involving the theft or loss of controlled substances. DCP will notify DHCQ of these reports. Licensees are still mandated to contact DHCQ to report other types of reportable incidents occurring within the facility (e.g. patient harm). Always report, even for one unitThe Department considers the loss of one unit of medication to be significant enough to warrant a report of such loss. Such thefts or losses may be part of a pattern within a facility or among several area institutions. Please consult with the Boston Field Office of the Drug Enforcement Administration for further guidelines on reporting thefts or loss of controlled substances to federal agencies. Long term care settingsPlease note that a DEA Form 106 is not necessary in a long term care setting. However, you must still report the loss must to the Department. Additional Resources forFACT SHEET Legislative References: A fact
sheet summarizes relevant legislation in one place. Registrants are reminded to refer to legislation for full context. Additional References:
Loss or Theft Report Form for Controlled Substances and Precursors (CS-FRM-011) Health Canada E-Services Portal to report loss or theft of controlled substances and precursors BackgroundControlled substances are regulated federally by Health Canada and the Office of Controlled Substances (OCS). The Controlled Drugs and Substances Act (CDSA) provides a legislative framework aimed at controlling access to substances that can alter mental processes and produce harm to the health of an individual and/or society when diverted or misused. Pharmacists and hospitals are required to comply with the Narcotic Control Regulations (NCR), the Benzodiazepines and Other Targeted Substances Regulations (BOTSR) made under the CDSA and Part G of the Food and Drug Regulations (FDR-G) made under the Food and Drugs Act governing controlled substances. DefinitionsControlled substance: A drug named in the federal Controlled Drug and Substances Act (CDSA), Schedules I, II, III, IV, V. These substances are also listed in the schedules to regulations made under the Act as either narcotics, controlled drugs, or benzodiazepines and other targeted substances. (CDSA) Date of Discovery: The date at which the pharmacist first becomes aware that a suspected loss or theft has occurred. (CS-GD-005) Loss: The physical disappearance of controlled substances or precursors that is not the result of a theft, and/or is unexplained at the time of discovery. (CS-GD-005) Reporting Narcotic Control Regulations 42. A pharmacist shall report to the Minister any loss or theft of a narcotic within 10 days of his discovery thereof. 63. A person who is in charge of a hospital shall…(c)…report to the Minister any loss or theft of narcotics within 10 days of his discovery thereof. Food and Drug Regulations G.03.013 A pharmacist shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof. G.05.004 A person who is in charge of a hospital shall (…) report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof. Benzodiazepine and Other Targeted Substances Regulations 72 (1) The following persons must take any measures that are necessary to ensure the security of any targeted substance in their possession: (a) a pharmacist; (…) (c) the person in charge of a hospital; (2) A person referred to in subsection (1) who becomes aware of a theft or loss of a targeted substance must provide a written report to the Minister within 10 days after becoming aware of the occurrence. Pharmacist and hospitals should refer to the Health Canada Guidance Document: Reporting of loss or theft of controlled substances, precursors (CS-GD-005) for detailed information on completing and submitting a Loss or Theft Report.
Published: October 2021 College Contact: Pharmacy Practice Revision History
What is significant loss?Significant Loss means any loss of a Prescription Drug that exceeds a reasonable level established by like persons which requires that loss to be reported to the Board or as required by Drug Enforcement Administration or other state and/or federal agencies for Prescription Drugs and controlled substances.
What information is needed for the drug inventory?Name of the substance. Total quantity of the substance to the nearest metric unit weight or the total number of units of finished form. Reason for the substance being maintained by the registrant/licensee and whether such substance is capable of use in the manufacture of any controlled substance in finished form.
Who regulates pharmacies in Wisconsin?The Pharmacy Examining Board is created under Wis. Stat. § 15.405(9), and has authority as outlined in Wis. Stat.
How long is a Schedule 2 prescription valid Wisconsin?Prescription orders for schedule II controlled substances for patients in an LTCF or patients with a medical diag- nosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless terminated earlier by the discontinuance of medication.
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