District of Columbia Prescription Drug Monitoring Program

Transcription

1 District of Columbia Prescription Drug Monitoring Program What Our Users Need to Know Health Regulation and Licensing Administration Pharmaceutical Control Division February 28, Mission Statement To promote and protect the health, safety and quality of life of residents, visitors and those doing business in the District of Columbia. 2 1

2 Opioid Drug Epidemic 3 Opioid Drug Epidemic Opioids including prescription painkillers and heroin killed more than 28,000 people in ,000 deaths were linked to prescription opioids 4 2

3 Objective Describe how Prescription Drug Monitoring Programs (PDMPs) benefit health practitioners, policy makers and law enforcement Explain the process of reporting information Explain the process of registering and obtaining information from the database Describe the purpose and ideal use cases for using PDMP Discuss the limitations of PDMPs Answer questions pertaining to the PDMP 5 Definitions Covered Substance 1 All drug products containing Cyclobenzaprine or Butalbital All controlled substances included in schedules II, III, IV and V Administer The direct application of a controlled substance, whether by injection, inhalation, inhalation, ingestion, or any other means, to the body of a patient or research subject by a practitioner (or in the practitioner s presence, by the practitioner s authorized agent) or the patient or research subject at the direction of and in the presence of the practitioner Dispense To distribute a drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery Reporting Period The 24 hour time period immediately following the dispensing of a covered substance 6 3

4 Definition Continued Prescriber A practitioner or other authorized person who prescribes a controlled substance or other covered substance in the course of his or her professional practice Dispenser A practitioner who dispenses a covered substance to the ultimate user PDMP Advisory Committee The multi-discipline committee established pursuant to section 3 of the Act, which functions under the Department to advise the Director on the implementation and evaluation of the District s prescription drug monitoring program Interoperability The ability of that program to share electronically reported prescription information with another state, district, or territory of the United States prescription drug monitoring program or a third party, approved by the Director, which operates interstates prescription drug monitoring exchanges 7 What are PDMPs? PDMPs are electronic databases used to monitor prescription trends within a jurisdiction by reporting the dispensation of targeted controlled drugs 2 Information is collected from dispensers to monitor controlled substance dispensations Prescriber s and dispensers are encouraged to use PDMP data to make informed patient care decisions This information may be used to monitor matters of substance abuse, fraud or diversion PMP AWARxE (developed by Appriss) is the software vendor for the DC PDMP 8 4

5 System Overview Dispenser PDMP Dispenser Law Enforcement Regulatory Prescriber 9 Interoperability Below are state PDMPs that can exchange information from one another 3 : Active connections: Massachusetts, West Virginia, and Connecticut 10 5

6 Timeline Listed below is the timeline for the enacting program 4 : Events Dates Stakeholder Meeting on Draft Legislation February 2012 Legislation Introduced in City Council September 2012 Committee on Health Hearing July 2013 Legislation Passed February 2014 Draft regulations Ready Fall 2014 Stakeholder Meeting on Draft Regulations November 2014 Regulation Effective December 11 th Day Notice Sent 5 May 15 th 2016 Program Registration July 1 st 2016 Reporting Begins August 15 th 2016 Database Access Launched October 19 th 2016 PDMP Project Transitioned to Program November 30, Individuals Who May Access Database Records Prescriber Dispenser Delegate Authorized Agent Patient 12 6

7 Registration 13 Registration 14 7

8 Registration 15 Access 16 8

9 Prescriber Role Support avoidance of prescribing duplicate therapies Detection of patients at risk of drug abuse Prescriber s have access to self-reports illustrating their prescribing activity Must provide notice at their practice stating the use of the PDMP 6 Any covered substance being dispensed including one s dispensed at their practice must be reported 7 17 Unsolicited Reports Reports sent proactively to providers Highlights morphine milliequivalents Serve as a critical tool to proactively reduce drug diversion activity Promote safer patient care by way of evidence-based medicine 18 9

10 Dispenser Role Dispensers are required to report all covered substances dispensed unless exempt May access database to analyze patient history of covered substance If a correction to the information is needed it must be corrected by the dispenser within 72 hours 8 Must give notice at their facility stating that patient information will be sent to the PDMP 6 Based on data review, the dispenser can discuss concerns with prescriber and patient 19 Items Needed for Reporting Prescriber Information Prescriber s DEA number, NPI number or other mutually acceptable identification number 9 Full name Date prescription was issued Dispenser Information Dispenser s DEA number, NPI number or other mutually acceptable identification number Facility Address Telephone number Date prescription was dispensed Medication Processing Information Prescription number Prescription type (new or refill) Number of refill being dispensed(if applicable) NDC code of the drug dispensed Quantity dispensed Day s supply dispensed Number of refills ordered Patient Information Full name Address Telephone number Date of Birth Gender Payment Method 20 10

11 Zero Report Zero report forms must be completed when covered substances are not dispensed during the reporting period 10 Due 24 hours after last report Permanent zero status may be requested if covered substances will not be dispensed for a prolonged period of time Permanent zero reports are null upon dispensation of a covered substance 21 Reporting Exemptions Exemptions may be granted to the following categories: Administering covered substances 9 Covered substances dispensed in an appropriately licensed narcotic maintenance program Covered substances dispensed in a hospital or nursing facilities for inpatient use Covered substances dispensed in licensed hospices for inpatient use For substantial hardship created by a natural disaster or other emergency beyond the control of the dispenser 11 For dispensing in a controlled research project approved by a regionally accredited institution of higher education or under the supervision of a governmental agency Exempted parties must have an approval from the program 22 11

12 23 Consequences for Failing to Report Covered Substances Revocation, suspension, or denial of a District controlled substances registration 9 Disciplinary action by your health occupations board Civil fines 24 12

13 Delegate Role Delegates are employee s who work with prescribers or dispensers and will have access to the PDMP 7 May include licensed pharmacy technicians and nurses et al Prescribers and dispensers are responsible for ensuring compliance of delegates with following the protocols of the PDMP Supervising prescribers or dispensers may have up to two delegates 25 Applying to be a Delegate Registration Requirements Must be licensed, registered or certified by a health occupations board Must be employed at the same location and under the direct supervision of the prescriber or dispenser Separate applications for delegate registration Registration Process Application must include individual license, registration or certification number and a copy of another government issued identification Application must be co-signed by supervising prescriber or dispenser Expiration of Registration Registration for delegates expire June 30 th of every even numbered year If the delegate becomes ineligible the program must be notified in writing within 24 hours 26 13

14 Delegate Registration 27 Law Enforcement and Regulatory Agency Database Access Law Enforcement and regulatory agencies must register as an authorized agent in order to obtain access to records 12 Applicant s employer must confirm the identity and eligibility to receive reports before registering Authorized agent registration expires June 30 th for every even numbered year 28 14

15 Information Request from Law Enforcement Valid Reason for Release of Information Related to a specific criminal investigation Agency case number or other identifier needed to identify an individual investigation Specified time period to be covered Specific patient, prescriber or dispenser for whom the report is for Name, title and original signature of the official under whose authority the request is made The information requested may not be used for the following: Discovery Subpoena Other means of legal compulsion in civil litigation 29 Law Enforcement and Regulatory Data Request Form 30 15

16 Law Enforcement and Regulatory Registration 31 Patient Request Patients may request data Must have a copy of a government photo identification upon request 13 Must have notarized signature of requesting party Patient s under 18 years old Information may only be released to parent or legal guardian Identification and signature are still needed 32 16

17 Research Use Information from the program may be used for research purposes upon request Data elements that identify a specific patient, prescriber or dispenser will be removed before disclosing Request must contain the researcher s credentials, written proposal or abstract explaining the purpose and scope, analysis, education or study plan to ensure validity of request Must have signed agreement between requestor and the program 33 Discretionary Disclosures The program may also disclose information to the following parties: Department of Health Care Finance Medicaid Fraud Control Unit Office of the Inspector General Office of the Chief Medical Examiner Disclosure request must be submitted on a Regulatory Prescription Report form Reports are specific to an investigation or regulatory proceeding for a specific dispenser or prescriber 34 17

18 Limitations Data Entry Errors Low Usage Communication Chasms Unfunded Mandates 35 Confidentiality Any information obtained from the program must be kept confidential 14 If the information becomes compromised the party involved must notify the program within 24 hours after discovery Database information is stored for 3 years 36 18

19 Learning Question Which of the following would be a legitimate reason for a prescriber to access the PDMP database? A) The prescriber would like to see if his mother-in-law is using controlled substances B) A patient comes in with a chief complaint of pain and requests an opioid stating They are the only drugs that have ever worked for me C) The prescriber would like to see if the patient has been picking up his antihypertensive medications from the pharmacy regularly. D) A patient returns to the doctor s office because he could not get his prescription filled 37 Learning Question 2 Determine if the statement below is True or False. 1. Prescribers or dispensers may have up to four (4) delegates each

20 Summary PDMPs are useful tools for monitoring prescription trends and/or diversion PDMPs are electronic databases which collect data on patient usage of covered substances Reports must be submitted every 24 hours All covered substances must be reported upon dispensing unless exempt Request for disclosure of information may be accepted with permission from the program 39 DC PDMP Contact Information For more information on the DC PDMP visit the District of Columbia Department of Health website at (doh.dc.gov/pdmp) Questions about the program may be ed to For free educational programs on the opioids, please visit doh.dc.gov/dcrx For technical assistance please contact Appriss at; (855)

21 Resources Getting Patients Off of Opioids (1.5 Credits) Myths and Facts about Opioids (1.5 Credits) Best Practices FAQs 41 References 1. Board of Pharmacy.DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS FOR THE PRESCRIPTION DRUG MONITORING PROGRAM. District of Columbia: Department of Health, 11 Dec PDF. Sect Prescription Drug Monitoring Program Training and Technical Assistance Center. Prescription Drug Monitoring Program Training and Technical Assistance Center, n.d. Web. 20 May "Programs."NABP PMP InterConnect. N.p., n.d. Web. 30 May Onumah, Kofi.Prescription Drug Monitoring Program Stakeholders Meeting FINAL.pptx. District of Columbia: Department of Health, 14 Nov PPT. Slide Department of Health.90-Day Notice to Data Submitters. N.p.: Health Regulation and Licensing Administration Pharmaceutical Control Division, n.d. PDF. 6. Board of Pharmacy.DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS FOR THE PRESCRIPTION DRUG MONITORING PROGRAM. District of Columbia: Department of Health, 11 Dec PDF. Sect Board of Pharmacy.DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS FOR THE PRESCRIPTION DRUG MONITORING PROGRAM. District of Columbia: Department of Health, 11 Dec PDF. Sect Board of Pharmacy.DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS FOR THE PRESCRIPTION DRUG MONITORING PROGRAM. District of Columbia: Department of Health, 11 Dec PDF. Sect Board of Pharmacy.DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS FOR THE PRESCRIPTION DRUG MONITORING PROGRAM. District of Columbia: Department of Health, 11 Dec PDF. Sect Board of Pharmacy.DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS FOR THE PRESCRIPTION DRUG MONITORING PROGRAM. District of Columbia: Department of Health, 11 Dec PDF. Sect Board of Pharmacy.DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS FOR THE PRESCRIPTION DRUG MONITORING PROGRAM. District of Columbia: Department of Health, 11 Dec PDF. Sect Board of Pharmacy.DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS FOR THE PRESCRIPTION DRUG MONITORING PROGRAM. District of Columbia: Department of Health, 11 Dec PDF. Sect Board of Pharmacy.DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS FOR THE PRESCRIPTION DRUG MONITORING PROGRAM. District of Columbia: Department of Health, 11 Dec PDF. Sect Board of Pharmacy.DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS FOR THE PRESCRIPTION DRUG MONITORING PROGRAM. District of Columbia: Department of Health, 11 Dec PDF. Sect