News Bulletin Summer 2020 Bureau of Narcotics & Dangerous Drugs Missouri Department of Health and Senior Services health.mo.gov/safety/bndd/index.php Reminder of initial dispensing pharmacy is closed and unable to dispense the medication. The pharmacies/pharmacist Emergency Waivers: may dispense up to a 14-day supply of emergency medication during the State of Emergency. The pharmacy providing the emergency dispensing must BNDD reminds registrants that the waivers set in place notify the prescribing practitioner in writing of the by DHSS are in place for BNDD issues and will last until emergency dispensing within seven (7) days of the the end of the state of emergency. As the Governor dispensing. extends our response, the waivers will continue. Annual Inventory by Missouri Controlled • • • • • • • • • Substances Registrant 19 CSR 30-1.042(3) shall be waived to the extent necessary to allow annual inventories, which are due Waivers Relating to the to be taken during the State of Emergency, to have their due dates extended to no later than 120 days Bureau of Narcotics & after Executive Order 20-02 is terminated. Providing Written Prescriptions After Dangerous Drugs Emergency Telephone Authorization The Missouri BNDD is following the DEA waiver to Temporary Health Care Facilities Operation allow 14-days instead of seven (7) days. Section 195.030.6 shall be waived to the extent necessary to allow temporary hospitals or other On Your Mark...Get Set... temporary health care facilities to be set up and operated during the State of Emergency, without first BNDD Resuming Inspection Visits obtaining a registration. BNDD has resumed inspection visits to registrants. Pharmacies Dispensing Emergency Supply The bureau is mindful of the risks to practitioners and of Controlled Substances patients and will be taking precautions on planning Section 195.060.1 shall be waived to the extent and performing tasks at selected locations. BNDD staff necessary to allow pharmacies to dispense an have been equipped with PPE such as hand sanitizer, emergency supply of controlled substances to a gloves, and masks. Investigators may provide a list of patient if the pharmacy that originally filled the records to be seen and the records may be brought to prescription is closed or unable to fill the prescription them in one place, in lieu of the investigator roaming due to the State of Emergency. Pharmacists must around the practice setting. Inspections will be make a good faith effort to verify the medication to be performed on a tablet and there will not be a dispensed and the authorized prescriber and dosage requirement for the registrant to sign a form. Copies of form (e.g., as listed on the patient’s prescription vial). the inspection materials will be scanned and emailed Pharmacies/pharmacists must attempt to verify the to the registrants. 1 Regulation Updates in Progress... BNDD is in the process of updating some regulations to match the DEA and recent changes in statutes. Once approved, the rules will be filed in the Missouri Register where a thirty (30) day comment period will begin. The bureau is working on: • 19 CSR 30-1.002—Updating the list of controlled substances to match the DEA. • 19 CSR 30-1.015 & 1.017—Updating the process for applying online for registrations. • 19 CSR 30-1.026—Changing EMS registrations so that only one registration is required at a headquarters location and not at all secondary satellite locations. • 19 CSR 30-1.064—Updating the Schedule II partial dispensing rule to match the DEA so that partial dispensing can occur for 60 days. • 19 CSR 30-1.066—Amending the rule of dispensing by practitioners in their office setting. The rule is amended so that if the DEA authorizes a pharmacy to deliver a prescribed drug back to the physician for administration, the rule is updated to remind practitioners of the record keeping and security laws. This is in response to HB1682 just signed into law in July 2020 that amended Section 195.070.4, RSMo. • 19 CSR 30-1.072—Amending the rule for pharmacies dispensing without a prescription. The rule is amended in response to HB1682 signed into law in July 2020 that changes the way pharmacies may dispense methamphetamine precursor products such as pseudoephedrine. Pharmacies and local jurisdictions may no longer require a mandatory prescription so dispensing pharmacies will need to use the NPLEx database. Pharmacies Joining NPLEx pharmacies can ask about joining the system. The Pseudoephedrine Tracking Database existing contract provides for technical support, a toll free 800 number for calls and online tutorial videos to train staff. NPLEx stands for the National Precursor Log Exchange. This is the statewide database that tracks the sales Reporting Losses, Thefts, and of methamphetamine precursor products. There are currently approximately 1,369 retail pharmacies in Diversions to BNDD Missouri. Available information at this time shows At this time, the mandatory reporting of losses, that 1,288 are available to use the NPLEx database. A thefts and diversion is a paper process. The form review has shown that there are 49 local jurisdictions is available on the bureau’s website. Registrants that have passed a local ordinance to require a complete a paper form and it is sent to the bureau. mandatory prescription. This impacts approximately To make reporting easier and faster and to make the 81 pharmacies. Governor Parson signed HB1682 in July handling of data more efficient, the bureau is in the 2020 that changes the amounts of dispensing to only process of developing an online reporting system 7.2 grams per month and no more than 43.2 grams so that paper will not be required in the future. The in a 12-month period. The new law also abolishes bureau is using a federal grant and hiring a computer all local ordinances that require a prescription so project specialist. In the future, the goal will be to that a prescription is not mandatory. This means the have a link on the BNDD website where the data is pharmacies in those locations will have to start using submitted electronically and submitted. The data can the NPLEx database. The new law goes into effect on be sent immediately without paper and it will stored August 28, 2020. To join the database, pharmacies electronically. The bureau will provide additional may visit the website of Appriss, Inc. at https:// information, updates and instructions when the system apprisshealth.com or they may Google “NPLEx”. There is developed, tested and operational. is a link on the page for contact information and the Missouri Department of Health and Senior Services, Bureau of Narcotics and Dangerous Drugs, 3418 Knipp Drive, PO Box 570, Jefferson City, MO 65102; (573) 751-6321; (573) 751-2569 fax; [email protected] health.mo.gov/safety/bndd/index.php Alternate forms of this publication for persons with disabilities may be obtained by contacting the Missouri Department of Health and Senior Services, BNDD, P.O. Box 570, Jefferson City, MO, 65102, (573) 751-6321. An EO/AA employer: Services provided on a nondiscriminatory basis. Individuals who are deaf, hard-of-hearing, or have a speech disability can dial 711 or 1-800-735-2966.