Prescription Drug Monitoring Program

Virginia Herold

Executive Officer

California State Board of Pharmacy

Disclosure

I have no conflicts of interest to disclose.

Learning Objectives

Increase pharmacists’ knowledge and desire to access and use California’s prescription drug monitoring program --CURES. Understand new law regarding the duty to check CURES. Describe the various features of a CURES report. Identify Red Flags to identify possible efforts by patients to obtain controlled substances

Protection of the public shall be the highest priority for the California State Board of Pharmacy in exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.

California Business and Professions Code section 4001.1

Statutory Mandate of Board

2,390 Pearl Harbor Deaths

2,973 9/11 Deaths

http://www.cbsnews.com/2100-224_162-2035427.html

Establishing some statistics

22,767 CY 2013 Prescription Painkiller Overdose Deaths

Every day in the United States, 44 people dies as a result of prescription opioid overdose.

Centers for Disease Control and Prevention. National Vital Statistics System mortality data. (2015)

http://www.cdc.gov/drugoverdose/data/overdose.html

More Data

Drug overdose was the leading cause of injury death in 2013.

Among people 25 to 64 years old, drug overdose caused more deaths than motor vehicle traffic crashes.*

There were 43,982 drug overdose deaths in the United States in 2013. Of these, 22,767 (51.8%) were related to prescription drugs.**

*Centers for Disease Control and Prevention. Web-based Injury Statistics Queryand Reporting System (WISQARS) [online]. (2014)

**Centers for Disease Control and Prevention. National Vital Statistics System mortality data (2015)

http://www.cec.gov/drugoverdose/data/overdose.html

More Data

Duplicate this slide for remainder of content

http://www.cdc.gov/drugoverdose/data/index.html

Rates of Prescription Painkiller Sales, Deaths and Substance Abuse Treatment Admissions (1999-2010)

Sources: National Vital Statistics System, 1999-2008; Automation of Reports and Consolidated Order System (ARCOS) of the Drug Enforcement Administration (DEA) 1999-2010; Treatment Episode Data Set, 1999-2009

http://www.cdc.gov/vitalsigns/PainkillerOverdose/index.html

Most prescription painkillers are prescribed by primary care and internal medicine doctors and dentists, not specialists.

Roughly 20 percent of prescribers prescribe 80 percent of all prescription painkillers

Policy Impact: Prescription Painkiller Overdoses, National Center for Injury Preventionand Control, Centers for Disease Control and Prevention, Page 7, November 2011

Additional facts

The economic burden of prescription opioid overdose, abuse and dependence in U.S. 2013 was $78.5 billion.

One-third of this cost was due to increased health care and substance abuse treatment costs

One-quarter was paid by the public sector in health care, substance abuse treatment and criminal Justice costs.

This was an increase from an estimated $55.7 billion in 2007.

Florence CS, Zhou C, Luo F, Xu, L The Economic Burden of Prescription Opioid Overdose, Abuse and Dependence in the United States, 2013 Medical Care (Official Journal of the Medical Care Section, American Public Health Association) October 2016, Volume 54, Issue 10 – P 901-906

Financial Costs of Prescription Drug Misuse

A Los Angeles County Department of Public Health article, dated April 1, 2014, stated 24.5% of LA County’s prescribers prescribed 90.9% of all opioids in that county.

Rx for Prevention – Controlled Substance Utilization Review and Evaluation System,A Tool for Judicious Prescribing; Page 2, Volume 4, Number 4; April 1, 2014;

Los Angeles, County Department of Public Health, Tina Kim, PhD,Mike Small, Catherine Hwand, Shantel Muldrew, MPH

More Numbers

In the past year, approximately 44.5 percent of the US Population used one of the following:

Prescription pain reliever use: 119 million Americans aged 12 or older -- 97.5 million or 36.4%,

Tranquilizers (39.3 million or 14.7%),

Stimulants (17.2 million or 6.4%) and

Sedatives (18.6 million or 6.9%)

Hughes A, Williams MR, Lipari RN, Bose J, Copello EAP, Kroutil LA NSDUH Data Review Substance Abuse and Mental Health Services Administration (SAMHSA)/RTI International; September 2016

“The opioid medications are often referenced to as “powerful painkillers.” In fact, the evidence shows that they are mild to moderate painkillers and less effective than over-the-counter ibuprofen. They have, however, powerful side effects that harm hundreds of thousands of individuals every year in the U.S.”

Evidence for the Efficacy of Pain

Medications, Donald Teater, M.D.,

Medical Advisor, National Safety Council,

October 2014

“We need to change the paradigm of how we treat pain in the county. In the process, we will reduce the suffering from pain, save money, and save lives.”

The Psychological and Physical Side Effects

of Pain Medications, Donald Teater, M.D.,

Medical Advisor, National Safety

Council, March 2015

1939 The California Triplicate Prescription Program (TPP) was created in 1939, capturing Schedule II prescription information.

1997 CURES was initiated, operating in parallel with the TTP’s Automated Triplicate Prescription System (ATPS) to evaluate the comparative efficiencies between the two systems.

1999 CURES replaced the TTP/ATPS and began capturing Scheduled II through IV prescription information.

2005 TPP/ATPS decommissioned after Senate Bill 151 eliminated the triplicate prescription requirement for Schedule II controlled substances, making CURES permanent.

2009 PDMP introduced as a searchable, client-facing component of CURES

2015

History of CURES

CURES stores and reports Schedule II, III and IV prescription dispensation data reported by dispensers to DOJ.

Pharmacies and Direct Dispensers are required to report dispensations of Schedules II through IV controlled substances at least weekly.

CURES receives about one million prescription reports per week.

CURES data reflects dispensing information exactly as it is reported to DOJ.

CURES/PDMP Program

Number of prescriptions filled in US annually: 4 B

Number of prescriptions filled in CA annually: 650 M

Number of controlled substances filled in CA: 50 M◦ 10 M Schedule II prescriptions

◦ 20 M Schedule III prescriptions

◦ 20 M Schedule IV prescriptions

More Numbers

DOJ does not add, modify, or delete prescription data reported to CURES.

DOJ does not validate the accuracy or truthfulness of the data.

The pharmacy or direct dispenser creates and owns the prescription record submitted to DOJ. DOJ is a custodian (and not editor) of these aggregated prescription records.

CURES/PDMP Program

CURES provides registered prescribers and dispensers with a Patient Activity Report (PAR) up to one year patient prescription history to assist health practitioners prescribe safely and to identify patients at risk of addiction.

All California licensed pharmacists and all California licensed prescribers who are authorized to prescribe scheduled drugs are required to register with CURES by July 1, 2016.

CURES/PDMP Program

From SB 482 (Lara)

A health care practitioner may provide a patient with a copy of the patient’s CURES patient activity report as long as no additional CURES data is provided and keep a copy of the report in the patient’s medical record

Recent Law Changes Involving CURES

A health care practitioner, pharmacist, and any person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from any false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for any resulting failure of the CURES database to accurately or timely report that information.

More New Law (also SB 482)

A health care shall consult the CURES database to review a patient’s controlled substance history before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every four months thereafter if the substance remains part of the treatment of the patient.

New Law: Checking CURES before Prescribing Controlled Substances

--A health care practitioner shall obtain a patient’s history from the CURES database no earlier than 24 hours or the previous business day, before prescribing, ordering, administering, or furnishing a Schedule II -IV controlled substance to the patient.

The duty to consult before dispensing or prescribing every four months does not apply to veterinarians or pharmacists.

More CURES Checking

When a patient is being administered medication or being transferred to a◦Clinic, health setting (section 1250)

◦Outpatient setting

◦County Medical Setting

◦Practice setting

◦Hospice care

Annotate non-checking in patient’s file why not accessed

Exemptions to Prechecking CURES before Prescribing

Not reasonably possible to check CURES

No other health care provider or delegate around

Not more than a 5-day supply is ordered and no refill is ordered

There are technology failures

Exceptions to Checking CURES

The Value of CURESFrom a Board Investigation

In about a four-year period:◦ One patient obtained 636 prescriptions for various controlled

substances (over 25 different drugs)

The Prescribers

The patient saw a total of 116 prescribers (including dentists, physician assistants, and physicians)

The patient saw 58 prescribers and obtained only a single prescription from each that was filled

The DispensersThe patient used 76 pharmacies to fill the prescriptions for controlled substances ◦17 pharmacies filled more than 15 prescriptions (22.4%)

◦15 pharmacies filled between 5 and 10 prescriptions (19.3%)

◦44 pharmacies filled 4 or fewer (57.9%)

636 prescriptions, 25 controlled drugs, 116 prescribers

The Controlled Substances

44,423 doses obtained by the patient, including:◦11,850 hydrocodone dose (26.7%)◦6,520 morphine sulfate (14.7%)◦6,473 hydromorphone (14.6%) ◦3,025 oxycodone (6.8 %)◦2,574 alprazolam (5.8%)◦1,440 zolpidem (3.2%)

Another No-CURES Check Incident A patient obtained 303 prescriptions from same prescriber

The prescriptions were filled at 28 pharmacies in 22 cities, However, 41 percent were filled at one pharmacy

The patient obtained 30,479 doses of Oxy #4 and Oxy IR

Plus additional controlled substances

Health Insurance Portability and Accountability Act (HIPAA)

& Attendant Regulations

42 U.S.C. §§ 1320d to 1320d-8, and 45 CFR 164, et seq.

California Confidentiality of Medical Information Act

CA Civil Code §§ 56 to 56.16

California Information Practices Act

CA Civil Code § 1798, et seq.

CURES Legislation

CA Health and Safety Code § 11165, et seq.

Relevant Provisions of Law

Delegation Authority◦ Prescribers and dispensers can easily assign delegates who can initiate CURES 2.0

patient inquiries on their behalf.

Compact Flagging◦ Prescribers can easily notate their patients with treatment exclusivity compacts,

forewarning other providers that additional prescribing to these patients can be potentially counter-productive to their existing treatment regimen.

CURES 2.0 User Features

Peer-to-Peer Communication◦ Prescribers and dispensers can instigate alert messages to fellow doctors and

pharmacists about mutual patients of concern.

Patient Safety Alerts/Messaging◦ Prescribers are alerted daily with information regarding their patients who reach

various prescribing thresholds.

CURES 2.0 User Features

PDMP patient data lacks positive identifiers.

John Doe, Johnnie Doe, John J. Doe, Jack Doe

06/19/1953, 06/19/1935, 06/19/1963

2101 Columbus Avenue, Sacramento, CA 95814

2101 Columbus Street, Sacramento, CA 95814

1201 Columbus Boulevard, San Diego, CA 95828

De-Duplication

Every day approximately 145K new Rx records are added to the CURES 2.0 data base. With this new data, the analytics engine must re-resolve patient, prescriber and dispenser entities across the 1TB database every night.

Person entities are resolved by:

Name and DOB and Zip(5)

OR

Name and Street Address and City

The de-duplicated data also contributes to the quarterly and annual systematic production of 58 county and one statewide de-identified data sets for use by public health officers and researchers.

De-Duplication

Once the data is de-duplicated nightly, the analytics engine identifies the resolved person entity’s current prescriptions based on date filled and number of days supply.

The resolved person entity’s current prescription medicinal therapy levels are calculated and compared against pre-established thresholds. Therapy levels exceeding those thresholds trigger Patient Safety Alerts to current prescribers.

Medicinal Computations

1. Rx Recipients Who are Currently Prescribed More than 100 Morphine Milligram Equivalency Per Day

2. Rx Recipients Who Have Obtained Prescriptions from 6 or More Prescribers or 6 or More Pharmacies During Last 6 Months

3. Rx Recipients Who Are Currently Prescribed More than 40 Milligrams Methadone Daily

4. Rx Recipients Who Are Currently Prescribed Opioids More Than 90

Consecutive Days

5. Rx Recipients Who Are Currently Prescribed Both Benzodiazepines

and Opioids

Patient Safety Alerts

Pharmacist’s Dashboard

Delegate Function

CURES 2.0 allows prescribers and dispensers to register delegates.

Prescribers and dispensers assume responsibility for delegates’ use of CURES 2.0.

Delegates may initiate PAR searches on behalf of their “Parent” prescriber or dispenser. Delegates do not view results.

Prescribes and dispensers may have several delegates. Delegates can support several prescribers and dispensers.

Delegates are deleted when they have not been associated with any CURES users for 30 days or if the delegate has not logged into CURES for 12 months.

Manage Delegates

From the Navigation Menu, select “User Account.”

From the drop down, select “Manage Delegates.”

User will be navigated to the Manage Delegates screen.

Adding a Delegate

1. Enter the required fields:

• Delegate First Name

• Delegate Last Name

• Delegate Email Address

• Re-enter Delegate Email Address

2. Accept the Terms and Conditions.

3. Click “Add.”

Delegate

The added delegate will appear on the Parent-Dispenser’s Manage Delegates screen.

Centers for Disease Control and Prevention. National Vital Statistics System mortality data (2015)

Delegate will receive three emails:

1. Status Notification

2. User ID

3. Temporary Password

From the Temporary Password email, the delegate must select the “Verify” link to login for the first time.

Delegate

Delegate First-time Login

1. Enter User ID.

2. Enter Temporary Password.

3. Click “Login.”

4. The system will prompt user to:

• Create unique password.

• Enter the CAPTCHA.

• Select questions and enter answers.

5. Click “Submit.”

Delegate First-time Login (continued)

When logging into CURES 2.0 for the first time, Delegates must:

• Review their profile for accuracy.

• Complete required fields.

• Check the box to accept Terms and Conditions.

• Click “Save.”

User Profile update is mandatory and will be required annually.

Delegate Dashboard

Upon login, the CURES 2.0 Dashboard is the first page presented to Delegates.

To initiate a Patient Activity Report, select PAR on the Navigation Menu.

Patient Activity Report (PAR) Search

1. Enter search criteria: • Last Name* • First Name*• DOB*• Gender • Address, City, State, Zip Code

2. Set search mode to:

• Partial Match/Exact Match

3. Search by:

• Time Period • Date Range (Start/End) (mm/dd/yyyy)

4. From the Generate PAR On Behalf Of drop down, select “Parent.”

5. Click “Submit.”

Message indicates successful submission to Parent-Dispenser.

Patient Activity Report (PAR) Search (continued)

The patient’s name will appear on the Parent-Dispenser’s Dashboard in the Favorites section.

The Parent-Dispenser must run the PAR and select “Search” to view results.

Patient Activity Report (PAR) Search (continued)

Deleting a Delete

A Parent-Dispenser may remove a Delegate at any time. Once removed, a Delegate will no longer be able to generate a PAR search on behalf of the Parent.

Delegate User accounts are automatically deleted from CURES 2.0 when:

• Delegate has not been associated with any prescriber or dispenser for 30 days

• Delegate has not logged into CURES 2.0 for 12 months

To Delete a Delegate:

1. Select User Profile from Navigation Menu.

2. Click “Manage Delegates.”

3. Select “Delete.”

4. Parent-Dispenser will receive a confirmation message to delete user.

5. Select “OK” to confirm delete.

Parent-Dispenser will receive an email notification when the delegate is removed.

Delegate will receive an email notification when removed as a CURES delegate.

Deleting a Delegate (continued)

Applicants complete the following:

Select “User Role”

License Issued by:•CA DCA

•Agency outside of CA

Enter email address (twice)

Enter CAPTCHA

A confirmation message is displayed once the email address is submitted.

An email is sent to applicant with further registration instructions and a link to the registration page.

The Registration Page

Registration Page (Continued)

The application completes “Applicant” information…

Registration Page (Continued)

…and selects and answers Security Questions, and completes the CAPTCHA.

The approved applicant selects the link and enters his/her USER ID…

Then answers the security questions…

The approved applicant logs into CURES 2.0 with the Temporary Password and User ID.

• Irregularities on the face of the prescription itself;

• Nervous patient demeanor;

• Age or presentation of patient (e.g., youthful patients seeking chronic pain medications);

• Multiple patients at the same address(es);

• Cash payments;

• Requests for early refills of prescriptions;

Red Flags: that should give a pharmacist an inkling of a potential problem with prescriptions and invoke inquiry

• Prescriptions written for an unusually large quantity of drugs;

• Prescriptions written for potentially duplicative drugs;

• The same combinations of drugs prescribed for multiple patients;

• Initial prescriptions written for stronger opiates (e.g., OxyContin 80mg);

• Long distances traveled from the patient’s home to the prescriber’s office or pharmacy;

• Irregularities in the prescriber’s qualifications in relation to the medication(s) prescribed;

• Prescriptions that are written outside of the prescriber’s medical specialty; and

• Prescriptions for medications with no logical connection to diagnosis or treatment;

More Red Flags

1. A pharmacist is required to check CURES for the history of a patient:◦ a. The first time the patient is dispensed a Schedule II controlled substance.

◦ b. When the patient or prescriber’s office is more than 30 miles from the pharmacy

◦ c. Whenever the pharmacist’s professional judgment indicates a check is necessary

◦ d. There is no requirement to check CURES◦ Correct answer: d

Test Questions

2. Dispenser data submitted into CURES data is reviewed by an outside vendor for accuracy

before it can be accessed.◦ a. True

◦ b. False

◦ Correct answer: false

Test Questions

3. A delegate may print out the patient activity reports for a prescriber or◦ dispenser.

◦ a. True

◦ b. False

◦ Correct answer: b

Test Questions

1. Write down the course code. Space has been provided in the daily program-at-a-glance sections of your program book.

2. To claim credit: Go to www.cshp.org/cpe before December 1, 2016.

Session Code:

The Value of CURES – Herold0126-0000-16-657-L04-P