11/11/2015. MVAs Suicide Firearms Homicide. Where Can I Find A Copy of the PDMP Law? Why Was the Law Established? Why Was the Law Established?

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1 Where Can I Find A Copy of the PDMP Law? Alabama Uniform Controlled Substances Act Code of Alabama (Article 10) -210 through 220 and Rules through.13 1 Why Was the Law Established? Hydrocodone is the most frequently prescribed opioid in the US and is associated with more abuse than any other licit or illicit opioid An unintentional drug overdose death occurs every minutes in the US (41,340 in 2011) Of these 41,340 unintentional deaths, 22,810 (55.2%) were attributed to prescription drugs Of the 22,810 deaths attributed to prescription drugs, 16,917 (76.3%) were due to opioids Prescription drug abuse is the fastest growing drug problem in the US 2 Why Was the Law Established? In 2009, for the first time, drug induced deaths exceeded deaths due to MVAs Suicide Firearms Homicide 3 1

2 Number of Deaths in Thousands /11/2015 Why Was the Law Established? Alabama has the highest number of painkiller prescriptions per year in the US at 143 Rxs per 100 people (tied with TN) (Hawaii = 52) 4 Why Was the Law Established? The US accounts for 5 % of the world s population The US accounts for 99.3% of the world s hydrocodone use at 79,700kg/yr (Next closest is the UK at 200kg/yr) 5 Drug-Poisoning Deaths Involving Opioid Analgesics or Heroin in the US, Heroin Opiods '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 U.S. Drug Enforcement Administration 6 Date Prepared/Source: 01/28/15, CDC/NCHS, National Vital Statistics System, Mortality File Year Office of Diversion Control 2

3 When Was the Law Established? The Act became effective August 1, 2004 It authorized the Alabama Department of Public Health to establish a controlled substance database for the collection of controlled substances prescription data All information in the database is declared privileged and confidential Information in the database is not subject to subpoena or discovery in civil proceedings It is to be used only for investigatory or evidentiary purposes. 7 How Many Other States Use PDMP? As of 7/29/ States had operational PDMPs 2 States/District had enacted legislation, but not yet operational (NH, DC) 1 State had no legislation pending (MO) 8 What are the goals of the PDMP? To provide a source of information for practitioners and pharmacists regarding the controlled substance usage of a patient To reduce prescription drug abuse by providers and patients To reduce time and effort to explore leads as assess the merits of possible drug diversion cases, and To educate physicians, pharmacists, policy makers, law enforcement, and the public regarding diversion, abuse, and misuse of controlled substances 9 3

4 What Does the PDMP Law Require? All dispensers of controlled substances in Alabama are required to report to the PDMP except methadone clinics (exempted by federal law) and federal facilities. Dispensers include pharmacies, veterinarians, physicians, other practitioners licensed by an Alabama regulatory board. The definition of dispensing is going out the door with or to the patient. Does not include a controlled substance administered to a patient while in the practitioner s office or in a hospital. 10 What Does the PDMP Law Require? The law requires dispensers of controlled substances to report at least daily when the dispensing facility is open. Exception: Veterinarians must report at least monthly. Must report according to ASAP standards. If the dispenser does not have dispensing software, reporting can be done via an on-line account (contact PDMP Help Desk at ). If no controlled substances are dispensed a Zero report must be submitted daily (business days). The Board of Pharmacy and Board of Medical Examiners receive a list of their licensees who are not reporting or under reporting. 11 Daily Reporting Is Required As of November 2014, dispensers have been required to report daily (business days) (Exception: Veterinarians may report monthly) 12 4

5 Daily Reporting Why is Daily Reporting Better Than Weekly? The information is available sooner to be used by pharmacists and physicians as they access the information! 13 What Is Expected by The Board of Pharmacy? The responsibility for the proper prescribing and dispensing of controlled substances is upon the practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. 21 CFR (a) U.S. v. Hayes 595 F.2d 258 (5 th Cir 1979) U.S. v. Leal 75 F. 3d 219 (6 th Cir 1996) U.S. v. Birbragher 603 F. 3d 478 (8 th Cir 2010) East Main Street Pharmacy 75 Fed. Reg (Oct. 27, 2010) 14 What Is Expected by The Board of Pharmacy? Keep your controlled substance certificate information up-to-date with the Board Accurately report controlled substance dispensing information to the database on a daily basis Use your DEA number, not your NABP or NPI number, for reporting! You must send the report, even if your volume is zero Interact as needed with prescribers 15 5

6 How Can I utilize the Information In The Database? Physicians: When you have a patient encounter and you suspect that abuse is likely, you should access the database. Pharmacists: When you are presented with a prescription and you suspect that abuse is likely, you should access the database. You must have a legitimate reason to access the database! 16 Is there Anything I Should Not Do with the Data? If you intentionally make an unauthorized disclosure of information contained in the database, you shall be guilty of a Class A misdemeanor. If you intentionally obtain unauthorized access to or you alter or destroy information contained in the database, you shall be guilty of a Class C felony. (Act , p. 781, 7.) Reports generated from the database contain confidential information, including patient identifiers, and are not public records. The information should not be provided to any other persons or entity. The information can be discussed with other healthcare professionals on a patient-specific basis when needed 17 Who May Access the Database For Cause? Certifying boards. State licensed practitioners. State licensed pharmacists. State licensed physician assistants. State, local, and federal law enforcement authorities (employed in the state). State licensed certified nurse practitioners. State licensed nurse midwives. Medicaid Agency (for Medicaid recipients only). Physician delegates. 18 6

7 Report Disclaimer No Warrant Is Made As To the Accuracy of the Information The information is based on data provided by the dispensing entities. For questions or for more information about any prescription, please contact the dispenser or the prescriber. The report contains confidential information, including patient identifiers, and is not a public record. The information should not be provided to any other persons or entity, including the patient. 19 What Happens with the Reports? A list of pharmacies not reporting or under-reporting to the database is given to the Board of Pharmacy at least every 6 months. A list of dispensing physicians who do not report is given to the Board of Medical examiners at least every 6 months. Drug Utilization Review letters to prescribers and dispensers whose patient has visited 6 or more prescribers or dispensers in one month. 20 Why Is It Important to Enter the Correct Prescriber's DEA Number and Patient Demographics? Information entered into the database is used downstream for many purposes Physicians access it Pharmacists access it Law Enforcement accesses it Incorrect information leads to confusion, duplication, and loss of confidence in the Program to accomplish its goals! 21 7

8 For additional help, call the PDMP Technical Support Desk at