Minnesota Board of Pharmacy Annual Report

Transcription

1 Minnesota Board of Pharmacy 2014 Annual Report

2 Acknowledgements Technical Data Contact: Dr. Katrina Howard, Pharmacist Consultant Program Contacts: Barbara Carter, Program Manager Melissa Winger, Program Coordinator Contact Information: Minnesota Board of Pharmacy Prescription Monitoring Program 2829 University Ave SE, Suite 530 Minneapolis, MN Minnesota Board of Pharmacy Phone: Website: Prescription Monitoring Program Phone: Website: Date of Publication: March 20, 2015 Updated May 13,

3 Table of Contents Acknowledgements... 1 List of Tables and Figures... 3 Executive Summary... 4 Introduction... 6 Operations... 7 Prescription Data... 8 Dispensed by County... 9 Opioids Common Pain Medications Partial Opiate Agonists Stimulants Sedatives Benzodiazepines Muscle Relaxants Antitussives Prescriber and Recipient Data Analysis Database Access Accounts Database Utilization Delegate Accounts Other Permissible Use of PMP Data Multiple State Data Exchange Program Objectives for Key to Abbreviations Bibliography

4 List of Tables and Figures Table 1. Total Reported Controlled Substance Prescriptions Dispensed ( )... 8 Table 2. Top Ten Reported Controlled Substance Prescriptions Dispensed (Generic) Table 3. Controlled Substance Prescriptions Reported as Dispensed (By Count 2014) - All Counties (1) Table 4. Opioids Reported as Dispensed (2014) Table 5. Common Pain Medications Reported as Dispensed (Monthly 2014) Table 6. Hydrocodone- and Oxycodone-Containing Products Reported as Dispensed (Monthly 2014) Table 7. Partial Opiate Agonists Reported as Dispensed (2014) Table 8. Stimulants Reported as Dispensed (2014) Table 9. Sedatives Reported as Dispensed (2014) Table 10. Benzodiazepines Reported as Dispensed (2014) Table 11. Muscle Relaxants Reported as Dispensed (2014) Table 12. Antitussives Reported as Dispensed (2014) Table 13. Average Number of New Account Requests per Day Table 14. Approved Prescriber and Pharmacist Accounts by County (2014) Table 15. States Actively Exchanging PMP Data with MN Figure 1. Controlled Substance Prescriptions Reported as Dispensed... 9 Figure 2. Common Pain Medications Dispensed Monthly in Figure 3. Account Holders vs. Total Licensed Professionals by Health-Related Licensing Boards Figure 4. Total Users and Queries ( ) Figure 5. Total Accounts, Usage, and Queries by Quarters (2014) Figure 6a. Queries by Discipline ( ) Figure 6b. Queries by Discipline ( ) cont Figure 7. System Accounts by User Type (2014) Figure 8. Delegate Usage ( ) Figure 9. Delegate Usage by Quarter (2014) Figure 10. Law Enforcement and Recipient s Requests (2014) Figure 11. Law Enforcement Request and Figure 12 Recipient Requests Figure 13. Multiple State Queries-Monthly (2014) Figure 14. Volume of Records Exchanged via PMP InterConnect (7/ /2014)

5 Executive Summary 2014 marked the 5th year that the Minnesota Prescription Monitoring Program (PMP) has been in operation. In 2009, MN Stats required the Board of Pharmacy (Board) to develop and maintain a database of controlled substance prescriptions for the purpose of promoting public health and welfare by detecting abuse, misuse, and diversion of controlled substance prescriptions. The goal of the PMP is to improve patient care and reduce the misuse of controlled substances. Additionally, the Board was mandated to appoint an advisory task force, made up of representatives from health related licensing boards, other state agencies, professional associations and members of the public. The Task Force counsels the Board on the development and operation of the PMP. Meetings have been convened at various times throughout the year depending on need, but beginning in 2015 meetings will be held quarterly. In 2014, the MN Legislature passed House File 2402 amending the PMP legislation. The bill authorized the PMP to collect prescription information for additional drugs of concern, expanded prescriber s permissible use to include accessing the database when providing emergency services and with patient consent for any other valid medical purpose, and permitted the PMP staff to access the data to identify recipients who meet a set criteria which may indicate doctor shopping behavior. Effective 7/1/2014, the PMP was also permitted to participate in interstate data sharing, using a secure method of transmission. Operational Findings In 2014, almost 100 percent of the pharmacies required to report controlled substance prescription data uploaded information into the PMP database, most within 1 day of dispensing. The total number of controlled substance prescriptions dispensed was approximately 800,000 more than in 2013, but the quantity dispensed (units) was roughly one-half as compared to The most commonly dispensed controlled substance prescriptions were for hydrocodone/acetaminophen followed by dextroamphetamine/amphetamine and oxycodone/acetaminophen. Between January 2013 and December 2014, there was a steady increase in new system user account applications received, with an average of 14.1 applications per day. The overall number of approved accounts in 2014 reached 15,707, an increase of 3,891, of which 929 were for delegate accounts for health care providers and pharmacist staff. With the almost 3-fold increase in the number of delegate accounts, there was also a 50% increase in their system utilization. At the end of 2014, there were 14,189 MN licensed prescribers and pharmacists approved for system accounts, an increase of approximately 23% from In 2014, 68.5% of the controlled substance prescription records in the PMP were prescribed by 4,000 health care providers; of these 4,000 most frequent prescribers, 69.5% had PMP accounts. 4

6 From 2013 to 2014, the total number of patient queries conducted by permissible data users, including health care providers and pharmacists, increased by 29 percent from 562,214 to 786,734. In 2014, the average number of patient queries conducted annually by health care providers and pharmacists increased for most provider groups as compared to The most noticeable was a 3- fold increase in use by dentists. In 2014, patient-requested reports rose to 247, an increase of 185 from These reports would have been mailed directly to the patient or to a third-party provider at the patients request. In 2014, the program was served, by law enforcement, with 469 search warrants requesting data on an individual s prescription history, pharmacy s dispensing history, and prescriber s prescribing history. July of 2014 was the first month the MN PMP officially participated in a system that enabled sharing PMP data across state lines. MN PMP account holders conducted more than 157,000 queries to other participating states and more than 98,000 queries were received from other participating states. 5

7 Introduction There is growing evidence that prescription drug monitoring programs (PDMP/PMP) play an important role in the fight against prescription drug abuse. PDMP/PMPs have proven to be effective in reducing prescription drug abuse, misuse, and diversion, assisting in identifying inappropriate prescribing or dispensing, and aiding in drug investigations, amongst other efforts. To begin addressing prescription drug abuse in the State, on May 25, 2007, the Governor signed into law MN Stats , which required the Minnesota Board of Pharmacy (Board) to establish an electronic system for the reporting of controlled substance prescriptions that are dispensed to residents of the state. The Board subsequently implemented the Minnesota Prescription Monitoring Program (PMP). Collection of data from dispensers of controlled substances began on January 4, 2010 with authorized access to the data commencing on April 15, MN Stats also required the Board to appoint an advisory task force consisting of at least one representative of the Department of Health and Department of Human Services; each healthrelated licensing board that licenses prescribers; professional associations representing the medical community, pharmacy community, nurses, and dentists; a consumer privacy or security advocate; a consumer or patient rights organization; and an association of medical examiners and coroners. The advisory task force advises the Board on the development and operation of the prescription monitoring program including technical standards for reporting and proper analysis and interpretation of PMP data. This annual report serves as an overview of the utilization of the database by prescribers, pharmacists and other permitted users; controlled substance prescription dispensing activities in this state; and as a comparison of annual PMP statistics from previous years. The report is intended to educate individuals regarding the controlled substance prescription dispensing landscape in Minnesota as well as PMP database usage by prescribers, pharmacists and their delegates. Throughout this report controlled substance is defined as all controlled substance schedules II-V and butalbital per MN Stats , Subd. 1(c). Data presented are based on prescription records in the database as of 1/8/2015. Future queries of the database may result in differing output due to dispenser s submission of previously overlooked or amended prescription records and the removal of duplicated records. In the interest of patient privacy, if less than ten of a particular medication was dispensed, it is reported as <10 throughout the report as opposed to the actual number dispensed. 6

8 Operations In 2014, the PMP completed its fifth year of operation. Currently the PMP is staffed by 3 FTE; Program Manager, Program Coordinator and Pharmacist Consultant. The Board receives an annual appropriation, for operation of the PMP, from the state government special revenue fund. The health-related licensing boards apportion between the Board of Medical Practice, Board of Nursing, Board of Dentistry, Board of Podiatric Medicine, Board of Optometry, Board of Veterinary Medicine and the Board of Pharmacy an amount to be paid through fees by each respective board. Each board s apportioned share is based on the number of prescribers and pharmacists licensed collectively by these boards. The Board is currently administering a 2011 Harold Rogers Prescription Drug Monitoring Program grant, from the U.S. Department of Justice, Office of Justice Programs, and Bureau of Justice Assistance, to enhance the current electronic system, provide funding for participating in outreach/education events, and to develop and implement a mechanism to allow for interstate sharing of data. Prescription data are submitted to the PMP by dispensing prescribers and pharmacies. All entities dispensing controlled substances in or into the State of Minnesota are required to report data daily, and dispensers who do not dispense a controlled substance on a given business day are required to submit a zero report each day. PMP staff and a contracted vendor audit the submission of data as well as the data itself to ensure compliance in reports and data integrity. Pharmacies that are noncompliant in reporting data are communicated with by various means and a lack of response to the request to comply are referred to the Board s Complaint Review Panel for further action. At the end of 2014, 2047 pharmacies were licensed by the Board. However, only 1631 are required to report data to the PMP. Current law allows an exemption from reporting when; 1. The pharmacy is an Opioid Treatment Program pharmacy or facility and therefore is prohibited from reporting according to federal regulations CFR 42; 2. The pharmacy is a licensed hospital pharmacy that distributes controlled substances for inpatient hospital care only; 3. The pharmacy or facility solely distributes controlled substances to individuals through the use of an automated drug distribution system in accordance with Minnesota Statutes ; 4. The pharmacy or facility never dispenses controlled substances in or into the State of Minnesota; or 5. The pharmacy or a facility never dispenses controlled substances. 7

9 Prescription Data Since the PMP s implementation in 2010, the number of controlled substance prescriptions dispensed in Minnesota has been on the rise. However, the number of metric units (tablets, capsules, grams, milliliters) dispensed annually significantly decreased from 2013 to It can be speculated that although the number of prescriptions dispensed increased in 2014, the quantities dispensed decreased. Table 1. Total Reported Controlled Substance Prescriptions Dispensed ( ) Year Number of Reported Prescriptions Quantity Dispensed (units) Dispensed ,607, ,130, ,686, ,829, ,007, ,077, ,158, ,946, ,994, ,066,362 In 2014, the most commonly dispensed controlled substance prescription was hydrocodone/acetaminophen, with over 1.4 million prescriptions and 74 million units sold. This exceeded the second most commonly dispensed prescription by roughly 780,000 prescriptions. Below in Table 2, data is presented to show the number of reported prescriptions and quantities dispensed of the top ten generic controlled substance prescriptions in Table 2. Top Ten Reported Controlled Substance Prescriptions Dispensed (Generic) 2014 Generic Name Number of Reported Prescriptions Dispensed Quantity Dispensed (units) Hydrocodone/Acetaminophen 1,461,195 74,146,435 Dextroamphetamine/Amphetamine 679,499 31,899,813 Oxycodone/Acetaminophen 635,110 36,426,204 Oxycodone 628,755 45,749,640 Zolpidem Tartrate 557,527 18,910,202 Lorazepam 550,284 25,944,842 Clonazepam 441,828 27,869,020 Methylphenidate HCl 411,118 20,941,942 Alprazolam 379,849 21,027,266 8

10 Dispensed by County The database was queried by Minnesota County based on the address of the recipient of the prescription. Unsurprisingly, Hennepin County, with the largest population, had the greatest volume of reported prescriptions dispensed in In fact, there was a correlation between population of county and quantity of prescriptions dispensed for the top four counties. According to population estimates collected by the U.S. Census Bureau, the top ten counties in Minnesota as of July 2013, by population are: Hennepin (1,198,778), Ramsey (526,714), Dakota (408,509), Anoka (339,534), Washington (246,603), St. Louis (200,540), Stearns (152,092), Olmsted (149,226), Scott (137,232), and Wright (128,470). Below, Figure 1 shows the top ten counties based on number of reported prescriptions dispensed. Table 3 shows the total number of controlled substance prescriptions dispensed and reported by county in 2014 as well as their corresponding population. In 2014, 1,444 controlled substance prescriptions were dispensed per 1,000 persons to recipients that reside in the state of Minnesota, where data was reported. The county with the highest rate of prescriptions dispensed per 1,000 persons was Mahnomen County (2,551), and the lowest rate dispensed was Houston County (807). Figure 1. Controlled Substance Prescriptions Reported as Dispensed (Top 10 Counties 2014) 1,676,838 Number of Prescriptions Dispensed by Top 10 Counties # Rx 709, , , , , , , , ,788 9

11 Table 3. Controlled Substance Prescriptions Reported as Dispensed (By Count 2014) - All Counties (1) County (Population) Number of RX County (Population) Number of RX County (Population) Number of RX County (Population) Number of RX Aitkin (15,742) 32,414 Fillmore Martin 20,364 (20,835) (20,422) 32,414 Rock (9,520) 11,958 Anoka Freeborn Mcleod Roseau 513,167 40,558 52,905 (339,534) (30,948) (35,918) (15,520) 21,097 Becker (33,231) 56,610 Goodhue Meeker Scott 66,209 31,002 (46,464) (23,119) (137,232) 167,538 Beltrami Mille Lacs Sherburne 70,753 Grant (5,989) 11,741 54,428 (45,670) (25,833) (90,158) 133,554 Benton Hennepin Morrison Sibley 57,162 1,676,838 52,996 (39,214) (1,198,778) (32,872) (15,072) 18,968 Big Stone (5,122) Blue Earth (65,528) 8,848 80,746 Houston (18,799) Hubbard (20,658) 15,176 32,759 Brown (25,332) 34,726 Isanti (38,204) 63,697 Carlton (35,460) Carver (95,562) 127,085 Cass (28,555) 70,391 Chippewa (12,093) Chisago (53,761) 62,254 Itasca (45,564) 86,218 17,181 Clay (60,661) 102,084 Clearwater (8,838) Jackson (10,260) Kanabec (15,996) Kandiyohi (42,410) 11,099 28,262 55,911 80,316 Kittson (4,503) 6,485 18,146 Koochiching (13,206) Lac qui Parle (7,027) Mower (39,327) Murray (8,533) Nicollet (33,032) Nobles (21,617) Norman (6,631) Olmsted (149,226) Otter Tail (57,581) Pennington (14,118) 54,906 11,448 39,893 21,529 St. Louis (200,540) Stearns (152,092) Steele (36,465) Stevens (9,735) 364, ,404 55,600 11,517 12,495 Swift (9,546) 12, ,788 92,378 25,032 25,066 Pine (29,104) 48,926 10,659 Pipestone (9,270) 16,723 Cook (5,200) 10,013 Lake (10,777) 17,299 Polk (31,569) 59,938 Cottonwood (11,616) Crow Wing (63,208) Dakota (408,509) Lake of the 17,587 5,007 Pope (10,932) 17,119 Woods (3,929) Le Sueur 34,559 Ramsey 105, ,098 (27,810) (526,714) Red Lake 586,269 Lincoln (5,830) 7,978 5,985 (4,057) Dodge (20,349) 18,075 Lyon (25,487) 31,556 Douglas (36,545) Faribault (14,191) 72,518 20,425 Mahnomen (5,532) Marshall (9,425) 14,110 Redwood (15,744) Renville (15,166) 20,347 24,939 13,178 Rice (65,049) 83,737 Todd (24,382) Traverse (3,445) Wabasha (21,443) Wadena (13,804) Waseca (19,098) Washington (246,603) Watonwan (11,137) Wilkin (6,557) Winona (51,232) Wright (128,470) Yellow Medicine (10,143) 39,091 6,557 28,545 27,751 24, ,466 13,582 10,536 68, ,700 13,040 10

12 Opioids In Minnesota, more than 3.6 million opioid prescriptions were reported as being dispensed in Hydrocodone/acetaminophen, oxycodone/acetaminophen and oxycodone ranked as the top three opioids reported as being dispensed. Recipients aged 50 to 59 received the most opiate prescriptions (201,979 recipients), followed by those aged (159,541) and then (157,793). Table 4 provides an overview of opioids reported as being dispensed in Table 4. Opioids Reported as Dispensed (2014) Drug Code Rx Count HYDROCODONE/ACETAMINOPHEN 1,461,195 OXYCODONE HCL/ACETAMINOPHEN 635,110 OXYCODONE HCL 628,755 TRAMADOL HCL 363,582 ACETAMINOPHEN WITH CODEINE 177,756 MORPHINE SULFATE 149,391 FENTANYL 93,375 HYDROMORPHONE HCL 83,475 METHADONE HCL 50,056 HYDROCODONE/IBUPROFEN 8,925 TRAMADOL HCL/ACETAMINOPHEN 6,112 CODEINE/BUTALBITAL/ASA/CAFFEIN 5,537 BUTALBIT/ACETAMIN/CAFF/CODEINE 4,633 CODEINE SULFATE 3,619 TAPENTADOL HCL 2,675 OXYMORPHONE HCL 1,952 MEPERIDINE HCL 1,114 HYDROMORPHONE HCL/PF 974 FENTANYL CITRATE 821 OPIUM/BELLADONNA ALKALOIDS 812 OXYCODONE HCL/ASPIRIN 747 FENTANYL CITRATE/PF 437 MEPERIDINE HCL/PF 421 HYDROCODONE BITARTRATE 296 MORPHINE SULFATE/PF 57 IBUPROFEN/OXYCODONE HCL 24 LEVORPHANOL TARTRATE 12 CODEINE PHOSPHATE <10 DHCODEINE BT/ACETAMINOPHN/CAFF <10 SUFENTANIL CITRATE <10 TOTAL 3,681,883 11

13 Common Pain Medications Figure 2 illustrates the number of common pain medication prescriptions dispensed and reported each month in For a complete list of the prescription quantities view Table 5 below. When the total quantities of each controlled substance were assessed, hydrocodone-acetaminophen prescriptions far outweighed all other prescriptions. On average, 6,178,870 metric units of hydrocodone-acetaminophen were dispensed each month in The next most common pain medication dispensed per metric unit, per month on average, was oxycodone (3,812,470) followed by oxycodone-acetaminophen (3,035,517), tramadol (2,405,926), and morphine (865,698). From July to December, 25,882,835 units of tramadol were reported to the PMP. While this is a large number, it doesn t compare to the total quantity of hydrocodone-acetaminophen that was dispensed in 2014 (74,146,435 units). As a reminder, metric units refer to the number of units dispensed in each prescription (tablets, capsules, milliliters, grams). In 2014, the U.S. Drug Enforcement Agency (DEA) published two final rules that impacted the prescribing and dispensing of two commonly prescribed drugs; tramadol-containing and hydrocodone-containing products (2). On July 2 nd, 2014, tramadol was added to the Federal Controlled Substance Schedule IV (2). Prior to July, dispensers were not required to report tramadol to the PMP (3), and therefore, a dramatic increase of tramadol dispensed is noticed in Figure 2 from July onward i. On October 6 th, 2014, hydrocodone was rescheduled from a Schedule III controlled substance to a Schedule II controlled substance (4). When hydrocodone-containing products became a schedule II they became more regulated and for some individuals, harder to obtain. Although the final rule allowed prescriptions for hydrocodone-containing products that were issued prior to October 6 th, 2014 to be refilled prior to April 8 th, 2015, many pharmacies chose not to honor remaining refills and required a new prescription once the rule went into effect. In Figure 2, a dramatic decrease of hydrocodone-acetaminophen prescriptions is noticed from August to December. A possible reason for the increase in hydrocodone-acetaminophen seen in the month of August could be due to a change in MN Stats which removed an exemption from reporting prescriptions for individuals in long-term care facilities 12

14 Number of Prescriptions Dispensed Figure 2. Common Pain Medications Dispensed Monthly in , ,000 Utilization of Common Pain Medications Dispensed Monthly 146, , , , ,000 80,000 60,000 40, , , , , ,427 28,550 60, ,810 65, , ,539 60,773 Hydrocodone/APAP Oxycodone/APAP Oxycodone APAP/Codeine Morphine Methadone Fentanyl 20,000 Tramadol 0 Hydromorphone Table 5. Common Pain Medications Reported as Dispensed (Monthly 2014) Utilization of Common Pain Medications by Number of RX Monthly Month Oxycodone Hydro/ APAP Oxy/ APAP APAP/ Cod Morphine Methadone Fentanyl Tramadol Hydromorphone JA 121,233 51,178 44,483 14,699 11,283 3,991 7,401 n/a 6,045 FE 107,710 45,090 40,399 13,235 10,132 3,547 6,851 n/a 5,441 MR 116,088 49,648 44,038 14,154 11,175 3,885 7,234 n/a 5,970 AP 117,520 49,355 44,532 14,412 10,884 3,877 7,271 n/a 6,040 MY 146,888 61,485 56,349 17,553 13,905 4,744 9,079 n/a 7,503 JN 117,427 48,475 44,164 13,682 10,723 3,699 7,265 n/a 5,904 JL 126,777 52,330 49,143 14,531 11,661 4,118 7,778 28,550 6,649 AU 152,434 63,075 66,619 17,771 16,887 5,614 10,226 60,350 9,330 SE 119,113 50,461 55,630 14,709 13,740 4,567 8,365 61,803 7,783 OC 120,810 57,512 63,352 17,548 15,471 4,975 9,041 65,355 8,991 NV 101,539 50,798 57,127 15,196 13,713 4,213 7,923 55,732 8,216 DE 113,656 55,703 62,919 16,828 15,562 4,716 8,585 60,773 8,637 13

15 In 2014 hydrocodone-acetaminophen and oxycodone-acetaminophen were preferred over the ibuprofen and aspirin containing products. Table 6 lists the number of prescriptions dispensed and reported each month that contain hydrocodone or oxycodone. In 2014, hydrocodone combination products were preferred over the single-entity formulation. Zohydro ER was the first single-entity, extended release, hydrocodone product (5). It was released into the market on October 25 th, 2013 and has gradually been dispensed in or into Minnesota as seen in Table 6. A total of 177 Zohydro ER prescriptions were dispensed in 2014 to 64 recipients. The majority of the recipients that received Zohydro ER ranged in age from 40 to 59 years old. Table 6. Hydrocodone- and Oxycodone-Containing Products Reported as Dispensed (Monthly 2014) Month Hydrocodone Bitartrate* Hydrocodone- Acetaminophen Hydocodone- Ibuprofen Oxycodone HCL Oxycodone- Acetaminophen Oxycodone- Ibuprofen Oxycodone- Aspirin JA , ,483 51,178 <10 58 FE , ,399 45,090 <10 72 MR , ,038 49,678 <10 70 AP , ,532 49,355 <10 62 MY , ,349 61,485 <10 78 JN , ,164 48,475 <10 62 JL , ,143 52,330 <10 70 AU , ,619 63,075 <10 58 SE , ,630 50,461 <10 61 OC , ,352 57,512 <10 72 NV , ,127 50,798 <10 57 DE , ,919 55,703 <10 56 * Of note, hydrocodone bitartrate consists of Zohydro ER products as well as hydrocodone bitartrate powder used in compounded analgesics. 14

16 Partial Opiate Agonists Partial opiate agonists are commonly used for pain or opioid dependence. The most frequent opiate agonist reported as being dispensed in 2014 was buprenorphine/naloxone (Suboxone, Bunavail, and Zubsolv ). Recipients receiving partial opiate agonists were commonly aged from 20 to 29 years of age (2,472 recipients), (2,413), or (1,618). Table 7 shows the number of partial opiate agonists reported as being dispensed, by prescription count, in Table 7. Partial Opiate Agonists Reported as Dispensed (2014) Drug Code Rx Count BUPRENORPHINE HCL/NALOXONE HCL 51,283 BUPRENORPHINE HCL 8,810 BUPRENORPHINE 4,699 BUTORPHANOL TARTRATE 2,411 PENTAZOCINE HCL/NALOXONE HCL 405 PENTAZOCINE HCL/ACETAMINOPHEN <10 TOTAL 67,610 15

17 Stimulants Stimulants, as categorized by the American Society of Health-System Pharmacists AHFS classifications, consist of anorexigenic agents and respiratory and central nervous system stimulants (6). In 2014, the most commonly dispensed and reported stimulant was dextroamphetamine/amphetamine (Adderall, Adderall XR ) followed by methylphenidate HCl (Concerta, Ritalin, Metadate, etc.) and lisdexamfetamine (Vyvanse ). The stimulants dispensed and reported in or into the state of Minnesota are shown in Table 8. Recipients aged received the most stimulant prescriptions in 2014 (60,737 recipients), followed by those aged (41,249), and (27,592). Table 8. Stimulants Reported as Dispensed (2014) Drug Code Rx Count DEXTROAMPHETAMINE/AMPHETAMINE 679,499 METHYLPHENIDATE HCL 411,118 LISDEXAMFETAMINE DIMESYLATE 117,655 PHENTERMINE HCL 55,310 DEXTROAMPHETAMINE SULFATE 29,169 DEXMETHYLPHENIDATE HCL 27,488 MODAFINIL 24,150 ARMODAFINIL 16,059 METHYLPHENIDATE 7,735 PHENTERMINE/TOPIRAMATE 2,571 LORCASERIN HCL 2,182 DIETHYLPROPION HCL 659 METHAMPHETAMINE HCL 580 PHENDIMETRAZINE TARTRATE 259 BENZPHETAMINE HCL 65 TOTAL 1,374,499 16

18 Sedatives The medications in this grouping of sedatives consist of anxiolytics, barbiturates, hypnotics, and sedatives. In 2014, the most commonly dispensed and reported sedative was zolpidem tartrate. Of all the sedatives reported, 85% of them were zolpidem tartrate (Ambien, Ambien CR, etc.). Table 9 provides an overview of the number of sedatives dispensed and reported in Recipients that received the most sedatives were aged 50 to 59 years old (34,637 recipients), followed by those aged (26,198), and (24,697). Table 9. Sedatives Reported as Dispensed (2014) Drug Code Rx Count ZOLPIDEM TARTRATE 557,527 ESZOPICLONE 45,860 PHENOBARBITAL 33,919 ZALEPLON 19,467 MEPROBAMATE 534 DICHLORALPHENAZONE 54 PHENOBARBITAL SODIUM 41 CHLORAL HYDRATE 37 BUTABARBITAL SODIUM 27 BUTALBITAL 27 PENTOBARBITAL SODIUM 15 SECOBARBITAL SODIUM <10 TOTAL 657,517 17

19 Benzodiazepines A benzodiazepine is a psychoactive drug that can have sleep inducing, antianxiety, anticonvulsant, and muscle relaxing properties. Over 1.5 million benzodiazepines were dispensed in The top three benzodiazepines that were reported as dispensed were lorazepam, clonazepam, and alprazolam, respectively. Recipients aged 50 to 59 were most likely to receive benzodiazepines (79,674 recipients) in comparison to the other age decades. The second age group to receive the most benzodiazepines was (65,223), followed by recipients aged (60,551). Of note, over 48,000 recipients aged 70 or over received a benzodiazepine. According to the American Geriatrics Society Beers Criteria for potentially inappropriate medication use in older adults; benzodiazepines should be avoided for treatment of agitation, delirium, or insomnia in older adults due to the risk of falls, fractures, cognitive impairment, delirium, or motor vehicle accidents (7). Benzodiazepines, however, may be appropriate if used for end-of-life care, seizure disorders, generalized anxiety disorder, sleep disorders, rapid eye movement, benzodiazepine or ethanol withdrawal, or periprocedural anesthesia. Table 10 provides details on benzodiazepines that were reported as dispensed in Table 10. Benzodiazepines Reported as Dispensed (2014) Drug Code Rx Count LORAZEPAM 550,284 CLONAZEPAM 441,828 ALPRAZOLAM 379,849 DIAZEPAM 174,358 TEMAZEPAM 67,941 TRIAZOLAM 11,122 CLORAZEPATE DIPOTASSIUM 4,139 CLOBAZAM 3,252 CHLORDIAZEPOXIDE HCL 2,993 FLURAZEPAM HCL 2,053 OXAZEPAM 1,731 ESTAZOLAM 1,661 MIDAZOLAM HCL 723 MIDAZOLAM HCL/PF 266 MIDAZOLAM <10 MIDAZOLAM HCL IN 0.9 % NACL <10 QUAZEPAM <10 TOTAL 1,642,207 18

20 Muscle Relaxants Centrally acting skeletal muscle relaxants, as categorized by AHFS, consist of carisoprodol, chlorzoxazone, cyclobenzaprine, metaxalone, methocarbamol, and tizanidine. The only medication in this category that is scheduled as a controlled substance is carisoprodol. Recipients aged received the most prescriptions for a carisoprodol-containing product (1,710 recipients), followed by those aged (744), and (336). Table 11 provides an overview of the centrally acting skeletal muscle relaxants that were reported as dispensed in Table 11. Muscle Relaxants Reported as Dispensed (2014) Drug Code Rx Count CARISOPRODOL 33,946 CODEINE/CARISOPRODOL/ASPIRIN 36 CARISOPRODOL/ASPIRIN <10 TOTAL 33,990 Antitussives AHFS categorizes antitussives (or cough suppressants) as benzonatate, codeine, dextromethorphan, and hydrocodone. The medications in this category which are scheduled as a controlled substance are codeine and hydrocodone. In 2014, guaifenesin with codeine phosphate (commonly known as the brand, Cheratussin AC, Guiatuss AC, Robitussin AC, etc.) was the most frequently dispensed antitussive. Recipients that obtained the most antitussives were aged 50 to 59 years old (28,742 recipients), followed by those aged (23,609) and (21,515). Table 12. Antitussives Reported as Dispensed (2014) Drug Code Rx Count GUAIFENESIN/CODEINE PHOSPHATE 166,362 PROMETHAZINE HCL/CODEINE 13,967 HYDROCODONE/CHLORPHEN P-STIREX 4,166 HYDROCODONE BIT/HOMATROP ME-BR 1,669 PROMETHAZINE/PHENYLEPH/CODEINE 337 P-EPHED HCL/CODEINE/GUAIFEN 73 HYDROCODONE/CHLORPHENIRAMINE <10 P-EPHED HCL/HYDROCODONE <10 TOTAL 186,576 19

21 Prescriber and Recipient Data Analysis Data from the PMP can be manipulated to view statistics throughout the year. Several bullet points of key findings are listed below that have been of interest to the PMP staff, Advisory Task Force, and others. The top 500 prescribers prescribed 21% of all controlled substance prescriptions reported as dispensed and 24% of the total quantity reported as dispensed (in metric units). Of the top 100 prescribers of controlled substances reported as dispensed, 76% have requested and obtained access to the Minnesota PMP. 119 individuals obtained and were dispensed controlled substance prescriptions from 20 or more different prescribers in One individual obtained prescriptions from 50 different prescribers. 49 patients obtained and were dispensed controlled substance prescriptions from 10 or more prescribers AND had their prescriptions filled at 10 or more pharmacies from January to June and 65 patients met this criteria from July to December. Using the criteria of an individual filling a prescription from 10 different prescribers AND at 10 different pharmacies in a 90 day period, 11 individuals met this threshold in Q1-2014, 3 in Q2-2014, 12 in Q and 10 in Q

22 Database Access Accounts The following sections will cover PMP system users and their use of the MN PMP. While viewing this data, it is important to remember that not all licensed prescribers and pharmacists need access to the PMP to perform their job functions. For example, a pharmacist conducting research or working at a Pharmacy Benefit Manager would not need to access the PMP to perform their job. For this reason, it is unlikely that 100% of prescribers and pharmacists licensed and practicing in MN would obtain and utilize access to the MN PMP. It is estimated that 36% of all MN licensed prescribers and 59% of all MN licensed pharmacists have requested and obtained access to the PMP. Since the program began in 2010, there has been a steady increase in the number of authorized system users accessing the PMP database. Table 13 shows the average number of new account requests the PMP has received daily since In 2011 there was an increase of account requests as the program started outreach efforts through exhibiting at various healthcare conferences around the state and offered onsite system demonstration and registration at a PMP exhibit booth. Table 13. Average Number of New Account Requests per Day Year New Account Requests (Average) per day* per day per day per day per day *Accounts requested per day in 2010 are reflective beginning April 1 st, Access to data was not available prior to this date. 21

23 Prescribers and Pharmacists can request an account through the PMP online registration system, and after verifying the individual has an active license to dispense or prescribe controlled substances and in the case of prescribers also has a Drug Enforcement Agency (DEA) registration number, will be granted access to the MN PMP. These accounts are identified as Master accounts, and are permitted to link with delegate accounts. The yellow bar in Figure 3 shows registered accounts in the database arranged by the board that licenses the individual. The green bar shows the number of individuals that are licensed by that particular board. Note: The number of prescribers includes all prescribers licensed by the various boards regardless of where they practice or if they have a DEA registration to prescribe controlled substances, with the exception of the Board of Medical Practice where the number of licensees was calculated from information contained in the DEA registration database. There are licensees within these licensing boards that do not actively prescribe or treat patients (administrative positions, research, education, etc.). There are also individuals included in the total licensed professional column that are licensed in MN but may practice in another state or perhaps still hold an active license but may be retired or not practicing and would therefore not need to access the MN PMP. Licensed professionals included under Dentistry are DMD and DDS, under Pharmacy are Pharmacists, and under Medical Practice are MD, DO, and PA s and Residents. The column representing total licensed professionals by the Board of Nursing represents only APRN s who are eligible to register with the DEA to prescribe controlled substances. Figure 3. Account Holders vs. Total Licensed Professionals by Health-Related Licensing Boards 21,000 Registered Accounts vs Total Licensed Professionals by Board 19,475 18,000 15,000 12,000 9,000 7,013 8,191 6,000 3,251 3,897 4,863 3, ,312 0 Dentistry Medical Practice Podiatric Medicine Nursing # Accounts # Licensees as of 12/31/14 Pharmacy 22

24 Table 14 shows the number of prescribers and pharmacists with active accounts, by county (based on the facility address stored in their account profile). The county with the largest number of account holders is Hennepin with 4359 accounts; Ramsey is the second highest with 1762 accounts. The database also has account holders outside of MN, this is because the state they practice or dispense in, is a state we are not currently connected to through PMP InterConnect, (see Table 15) Table 14. Approved Prescriber and Pharmacist Accounts by County (2014) County Number of Accounts Number of Prescribers and Pharmacists with an Active Account by County County Number of Accounts County Number of Accounts County Number of Accounts Aitkin 40 Fillmore 10 Martin 45 Rock 27 Anoka 716 Freeborn 40 McLeod 81 Roseau 21 Becker 122 Goodhue 115 Meeker 32 Scott 174 Beltrami 143 Grant 9 Mille Lacs 93 Sherburne 109 Benton 156 Hennepin 4359 Morrison 63 Sibley 20 Big Stone 13 Houston 16 Mower 59 St. Louis 654 Blue Earth 249 Hubbard 63 Murray 31 Stearns 350 Brown 75 Isanti 109 Nicollet 59 Steele 79 Carlton 94 Itasca 135 Nobles 34 Stevens 21 Carver 181 Jackson 10 Norman 11 Swift 14 Cass 53 Kanabec 59 Olmsted 769 Todd 66 Chippewa 49 Kandiyohi 109 Otter Tail 106 Traverse 6 Chisago 133 Kittson 11 Pennington 33 Wabasha 36 Clay 75 Koochiching 28 Pine 39 Wadena 47 Clearwater 27 Lac qui Parle 12 Pipestone 10 Waseca 28 Cook 11 Lake 16 Polk 61 Washington 367 Cottonwood 22 Lake of the Woods 13 Pope 25 Watonwan 27 Crow Wing 190 Le Sueur 44 Ramsey 1762 Wilkin 10 Dakota 1014 Lincoln 11 Red Lake 1 Winona 80 Dodge 12 Lyon 66 Redwood 26 Wright 194 Douglas 94 Mahnomen 16 Renville 15 Yellow Medicine 6 Faribault 27 Marshall 3 Rice 144 Outside MN

25 Database Utilization Just as the number of users has grown over time, so has the utilization of the database. Figure 4 below shows the total number of queries performed during the past five years of operation. It also depicts the increase in users querying the database over time. Figure 4. Total Users and Queries ( ) Total Queries through Time 10,000 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1, ,000, , ,000 # Queries 562, , , , , ,000 79,479 2,087 3,383 5,390 7,477 8, Total# of Users that Queried Total # of Queries 24

26 Figure 5 represents the quarterly utilization throughout It provides the number of registered users, the number of users that actually queried during the timeframe, as well as the number of queries performed during each quarter. A steady increase in usage is noted throughout Note that a registered user who holds a Master Account may appear to not be querying the database when in reality a delegate is requesting data on his/her behalf. Figure 5. Total Accounts, Usage, and Queries by Quarters (2014) Total Accounts and Queries ,000 16,000 12, , , ,754 # Queries 217, , , ,000 8,000 4, ,053 6,221 6,374 6, (Jan - Mar) 2 (Apr - Jun) 3 (Jul - Sep) 4 (Oct - Dec) 160, , , ,000 Total Number of Users that Queried Total Number of Queries by All Users Total Registered Accounts 25

27 Figures 6a and 6b illustrate the number of queries performed by each discipline throughout time. Each license type has shown increase in usage of the database over the past five years with the most common system users being pharmacists, medical doctors, doctors of osteopathy, physician assistants, and residents. Veterinarians and medical coroners or examiners are two new professions that requested and were granted access to the database in Figure 6a. Queries by Discipline ( ) Queries through Time by User Type , , , , ,227 7,370 6,707 3, ,850 37,519 26,594 16, ,498 54,759 63,550 33, RPH MD/DO/PA/Resident APRN DDS/DMD Figure 6b. Queries by Discipline ( ) cont. Queries through Time by User Type 1,661 4,766 3,990 3,204 2, Medicaid DPM Medical Examiners or Coroners OD 26

28 At the end of 2014 there were 15,707 registered account holders. The user type of the account holders is shown in Figure 7 with the highest percentage of registered accounts being Physicians and Pharmacists. Figure 7. System Accounts by User Type (2014) System Accounts by User Type DPM, <1% Delegates 9% DDS 4% ME/Coroner, <1% APRN 9% DO 3% MD 37% OD <1% MRRP, <1% PA 7% Vet <1% RPH 31% Total = 15,707 27

29 Delegate Accounts MN statutes allow for prescribers and pharmacists (Master Account Holders) to delegate the task of accessing the PMP database to an employee under their direction. Delegates must apply for and be granted an individual account which once linked to a Master Account Holders account, will allow access to the database. Linking a delegate to a master account makes the Master Account Holder accountable for a delegate s access to the database. The number of delegate accounts has almost tripled since Figure 8 shows the number of delegates that registered for an account in 2013 and 2014, as well as the number of queries and how many delegate users ran those queries. Figure 9 shows the increase in use by quarter in Figure 8. Delegate Usage ( ) 1,600 1,400 1,200 1, Delegate Use ,139 # Queries 56, , , ,000 80,000 60,000 40,000 20, Active User Reistered Accounts Queries 0 Figure 9. Delegate Usage by Quarter (2014) Delegate Queries Qtr 1 Qtr 2 Qtr 3 Qtr 4 Users Queries 28

30 Other Permissible Use of PMP Data In addition to prescribers, pharmacists, and their delegates, the law allows for others to obtain data from the PMP. Using a valid search warrant, law enforcement officials can receive a report that contains any or all of the following data; a recipient s controlled substance prescription history, the history of all prescriptions associated with a particular prescriber based on their Federal Drug Enforcement Administration (DEA) registration or the history of all prescriptions reported as dispensed by a particular dispenser. In all cases, the MN Board of Pharmacy staff assigned the duties of administering the PMP, access the database and the resulting report is sent to the requestor. In 2014, law enforcement officials presented the MN PMP with 469 search warrants. The recipients of the controlled substance prescriptions reported to the PMP are also permitted to obtain information regarding their own prescription history. A request for release of the data, which has been signed in the presence of a notary public and sent to the PMP office, is required. As with requests made by law enforcement officials, the PMP staff access the database and the resulting report is sent to the requestor. A provision was put in place that will also allow the recipient to give consent for release of the report to a 3 rd party. This provision has been used by legal counsel, probation officials, MN Health Licensing Boards, and others. In 2014, the PMP staff processed 247 requests from recipients or their designee. Figures 10 through 12 show the number of law enforcement and recipient requests received by the PMP in the past several years. 29

31 Figure 10. Law Enforcement and Recipient s Requests (2014) Law Enforcement and Recipient Requests Jan Feb Mar April May June July Aug Sept Oct Nov Dec Law Enforcement Recipient Figure 11. Law Enforcement Request Law Enforcement Requests Figure 12. Recipient s Request Recipient's Requests Law Enforcement Recipient

32 Multiple State Data Exchange The MN PMP has been participating in an interstate data exchange system since July MN Stats , Subd. 6(g) permits the Board to participate in a system, provided that permissible users of the data in other states have access to the MN data only as allowed under MN law. The Board chose to utilize the National Association of Boards of Pharmacy (NABP) PMP InterConnect to facilitate the transfer of prescription monitoring program data across state lines to authorized users. It allows participating state PMPs across the United States to be linked, providing a more effective means of combating drug diversion and drug abuse nationwide. It should be noted that no PMP data is retained by the hub. The PMP InterConnect merely acts as a pass through for transferring data to the requesting state s PMP user. Each participating PMP controls who from partnering states can access their data based on their own laws and regulations. At the end of 2014 there were 28 State PMPs, including MN, participating in the PMP InterConnect with MN actively exchanging data with 21 of those states. In 2014, 8,107,151 records were exchanged throughout the country between participating states. Table 15 shows the states MN is actively exchanging data within the PMP InterConnect. Only approved MN prescribers, pharmacists, and their delegates holding active MN PMP accounts have access to data from participating states. Table 15. States Actively Exchanging PMP Data with MN Arizona* Indiana North Dakota Arkansas* Kansas* Ohio * Colorado Kentucky South Carolina Connecticut* Michigan* South Dakota* Delaware Mississippi Virginia* Idaho Nevada* West Virginia Illinois* New Mexico Wisconsin* *MN delegates are not permitted by state to access their data. 31

33 The total number of queries processed nationally through the PMP InterConnect for 2014 was 8,107,151, an increase of 4,503,499 over Authorized MN PMP account holders made 157,506 data requests to other participating states during the time period 7/ /2014. During that same time period other participating state s authorized PMP account holders made 98,845 data request to the MN PMP database. Figure 13 below is a breakdown of data requests, by month, beginning July Figure 13. Multiple State Queries-Monthly (2014) Multiple State Queries ,100 26,425 30,978 28,347 27,726 16,930 14,326 15,390 12,948 18,475 18,897 18,809 July Aug Sept Oct Nov Dec Out of State Requests MN Requests 32

34 Figure 14 reflects the volume of queries requested by MN account holders to the PDMP s in other states compared to the volume of MN database queries requested by other state s PDMP account holders. States that border MN are exchanging data frequently, with the exception of Iowa who was not participating in PMP InterConnect in This information exchange is important for capturing data on individuals who receive prescriptions dispensed across borders. These numbers are expected to rise as more states are added to the PMP InterConnect and MN establishes connections with other states. Note that state connections occurred at various times since July 2014 and some states were only connected towards the end of Figure 14. Volume of Records Exchanged via PMP InterConnect (7/ /2014) Records Exchanged with MN via PMP InterConnect 0 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 Arizona Arkansas Colorado Conneticut Delaware Idaho Illinois Indiana Kansas Kentucky Michigan Nevada New Mexico North Dakota Ohio South Carolina South Dakota Virginia West Virginia Wisconsin ,951 1,670 1,763 1,973 2,327 6,172 6,280 4,457 6,179 4,109 3,820 5,957 6,765 6,804 6,641 6,319 6,335 9,228 9,931 9,288 10,573 8,818 8,372 7,719 10,064 10,285 11,763 14,057 13,852 16,699 10,555 # Records MN Account Holders Requested from Other State # Records State Requested from MN PMP Database 35,394 33

35 Program Objectives for 2015 Objective 1 To provide unsolicited reports (Controlled Substance Insight Alerts) to pharmacists-in-charge and prescribers, alerting them of individuals with suspicious prescription activity. Measure Track the number of reports sent, analyze trends, assess effectiveness Status Effective January 1 st, 2015 Goal To reduce prescription drug abuse and diversion by identifying potential doctor shoppers or those individuals abusing the healthcare system Objective 2 To implement full redesign of the MN PMP website. Measure Track volume of webpage hits and compare to previous like data. Status Under development, full implementation no later than July 1, Goal To provide updated and pertinent information to the prescribers, dispensers, data providers and the public. Objective 3 To update the MN PMP RxSentry interface used by approved database users. Measure User feedback Status Under development Goal To have a restructured interface available no later than 3 rd quarter of 2015 Objective 4 To audit compliance of daily reporting of data to the PMP by MN licensed dispensers. Measure Identify non-compliant dispensers, notify non-compliance dispensers based on established procedures and refer lack of cooperation to the Board s Complaint Review Committee. Status Ongoing-performed monthly by PMP staff Goal To improve the compliance in reporting data within the established timeframe. Objective 5 To review prescription data for errors and missing information. Measure Notify dispensers that submit erroneous and missing data, required data be corrected and re-submitted within an established timeframe. Status Ongoing-performed monthly by PMP staff Goal To improve the integrity of data being reported to the PMP. 34

36 Key to Abbreviations APAP: Acetaminophen, the generic of Tylenol APRN: Advanced Practice Registered Nurse DDS: Doctor of Dental Surgery DO: Doctor of Osteopathy DMD: Doctor of Medicine in Dentistry DPM: Doctor of Podiatric Medicine MD: Medical Doctor ME/Coroner: Medical Examiner/Coroner MRRP: Minnesota Restricted Recipient Program OD: Doctor of Optometry PA: Physician Assistant RPh: Pharmacist RX: Prescription VET: Veterinarian 35

37 Bibliography 1. US Census Bureau, Population Division. Annual Estimates of the Resident Population : April 1, 2010 to July 1, [Online] Federal Register. Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II. [Online] August [Cited: ] 3. Minnesota Board of Pharmacy. Tramadol Requirement Summary. [Online] [Cited: ] 4. Minnesota Board of Pharmacy. FAQ Document for Hydrocodone Rescheduling. [Online] September Administration., US Food and Drug. FDA Approves Extended-Release, Single-Entity Hydrocodone Product. [Online] [Cited: ] 6. Snow, E., Miller, J., Kester, L. et al. AHFS Drug Information American Society of Health-System Pharmacists. [Online] American Geriatrics Society. AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. [Online]