Our Journey to Addressing the PA PDMP Program. Dean Parry, RPh AVP Clinical Informatics, Care Support Services Geisinger Health System
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1 Our Journey to Addressing the PA PDMP Program Dean Parry, RPh AVP Clinical Informatics, Care Support Services Geisinger Health System 1
2
3 Geisinger Health System Geisinger Health System is an integrated health services organization widely recognized for its innovative use of the electronic health record and the development of innovative care delivery models such as ProvenHealth Navigator, ProvenCare and ProvenExperience. As one of the nation s largest health service organizations, Geisinger serves more than 3 million residents throughout 45 counties in central, southcentral and northeast Pennsylvania, and also in southern New Jersey at AtlantiCare, a Malcolm Baldrige National Quality Award recipient. In 2017, the Geisinger Commonwealth School of Medicine became the newest member of the Geisinger Family. The physician-led system is comprised of approximately 30,000 employees, including nearly 1,600 employed physicians, 12 hospital campuses, two research centers, and a 551,000- member health plan, 3
4 The Pennsylvania Law 4
5 Key Dates Legislative Act Effective: June 30, 2015 (Achieving Better Care by Monitoring All Prescriptions Program) Pharmacy Reporting Began: June 24, 2016 Provider Registration Began: August 8, 2016 Provider Requirement to Utilize Database: August 25, 2016 Regulatory Update: January 6,
6 Key Focus of the Program Collect data on ALL Controlled substances dispensed in PA (Classes II through V) Require all providers to access the database prior to dispensing a new controlled substance prescription and if there is any reason to suspect abuse or diversion Allow providers to view a complete record of their controlled substance prescriptions that have been filled Allow patients to view their own controlled substance record for prescriptions that have been filled 6
7 Provider Expectations Enroll in the PA PDMP Program Review database information prior to issuing a new controlled substance prescription Review database any time there is any reason to suspect diversion or abuse of a controlled substance Document in EHR that the database has been reviewed Document in EHR if the information in the Database alters their decision to issue a controlled substance prescription. If the prescribing decision is altered the information should be reviewed with the patient or caregiver as to the reason the decision was made 7
8 Risk of Non-Compliance There is a risk of the DOH taking action which could be any or all of the following: Provider Warning letters for non-compliance Block the ability to renew a providers DEA License Block the ability to renew a providers State Medical License Require the revocation of the Provides State Medical License Criminal penalties including fines and/or prison 8
9 Remember Why this Program is in Place
10 Key Issues to Be Addressed Education about the program and need to sign-up Create a standard documentation point For documenting checking the database For documenting an concerns identified Simplify access to the State Database PMP Aware Clarify the regulatory questions Consult legal to insure interpretation and key compliance issues Explore direct connect through EHR Single sign-on 10
11 Geisinger Tools Initial Phase EPIC Smart Text and Smart phrases are built to streamline the documentation process: Smarttext #35929 GHS Prescription Drug Monitoring Program Smartphrase.pdmp ID# I have checked the PA PDMP databased and no issues were identified Link to the PA PDMP Program Placed under weblinks function in EPIC PA PDMP program information placed on our internal website (Infoweb) under Provider Links on the pharmacy webpage 11
12 EPIC Web Link Link to PA program including sign-up info and other supporting documentation Link to PA patient database
13 Link on Infoweb
14 Posters Must be Displayed in Patient Areas to identify that we are using the PA PDMP process Can only use official poster format from State Must be displayed in English and Spanish Posters outline patient s rights and also how they can access their own data. 14
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16 Geisinger IT Governance Process Problem submission Outline current state Problem Potential Solutions Review by appropriate governance team (inpatient, outpatient or administration) Approval for Investigation Phase Investigation presentation to governance team Approval for Project Charter Charter Presentation to governance team Approval Assignment of IT resources and implementation 16
17 PA PDMP and Governance Problem submission: September 2016 Investigation approve: October 2016 Investigation Completed: November 2016 Investigation moved to Charter: November 2016 Charter Completed: December 2016 Charter Approved: December phase project: Phase 1: Internal changes and decision support approved Phase 2: Direct connection to State database through EPIC 17
18 Phase I Key Elements Ease identification of Controlled substances for prescribing providers Facilitate access (in workflow) to PMP Aware (PA State Database) Standardize documentation of check of PA PDMP Database Educate Providers on Changes 18
19 Elements to Address Phase I Issues Developed medication order questions embedded in all controlled substance orders. Used cascading questions to facilitate response Have you checked the PDMP Database YES No Issues Identified Prescribing decisions changed Appropriate documentation completed Patient not found NO Patient continuing on therapy Technical issues Database not available 19
20 Elements to Address Phase I Issues Facilitate Access to state database in workflow Placed link to PMP Aware direction within each controlled substance medication file. Able to access external database, check patient information and return to EHR to complete ordering Required Standard Questions facilitate and standardize documentation Only required for first controlled substance ordered in an encounter Report developed to allow visualization of responses within previous prescription orders 20
21 Elements to Address Phase I Issues Educate Providers The most difficult part of the process Key concerns: Impact on workflow What to do with information from PMP Aware Chronic patients Pediatric Patients Identification of drugs that are controlled substances Confusion between Opioids, Controlled substances, CII classified agents Need to participate in the program Surgical patients/short-term use Liability 21
22 Education of Providers Development of education tools FAQ document Powerpoint for presentation at Department/service line meetings Education of Pharmacists as key source of support Interaction with legal and documentation of validation of legal requirements and circulation to providers Infoweb information on PA PDMP Program including links to state program website Frequent EPIC messages and updates in Drug Information Newsletter Address individual concerns via EPIC messages, s and phone calls 22
23 Are Geisinger Providers Registered? Work with State PDMP program in order to vet the Geisinger Providers for registration with the program Send a list of all employed providers to the state sorted by licensure Identify whether providers have registered or not List of all unregistered providers sorted by service line/department and sent to department leadership for follow-up List resent 1 month later to state Update showed significant improvement in registration Updated unregistered list send to Service line/department leadership 23
24 January 2017 Brings Changes State adds additional regulatory requirements Requirement to check the database EVERY TIME an opioid or benzodiazepine is prescribed Requirement to check the database at least once during every hospital admission 24
25 Changes to Address January Update Change in order question for opioids and Benzodiazepines Removed option of No answer Limited possible responses to: No Issues Identified Prescribing decisions changed Appropriate documentation completed Patient not found Technical Issues Database not available 25
26 Changes to Address January Update Checking database for Inpatient admission Added order question to all inpatient controlled substance orders Order question appear the FIRST TIME a controlled substance is ordered Response it NOT mandatory to prevent problems with urgent patient care If order question answered autopopulates any future controlled substance orders during the hospitalization If order questions not answered Best Practice alert developed to remind provider to check the PMP Aware database on complete order questions If order question not answered then will continue to appear on future controlled substance orders until questions are answered 26
27 Reporting Develop report of answers to order questions for all controlled substances Report run monthly and issues identified Issues reported to Service Line/Departmental Leadership Summary report provider to system leadership monthly Report of prescribing is vetted against list of providers who have not enrolled in the PA PDMP Program 27
28 Phase II Process Team assembled to review potential solutions Continuing discussion with PA DOH regarding direct access to PMP Aware database Vetting of external vendors who can provide integrated access to PMP Aware database and potential decision support tools Team to develop potential internal decision support solutions Goal of integrated access available by June 2017 Explore impact of E-prescribing of Controlled Substances (anticipated July 2017) on PDMP workflow 28
29 Moving Target Continued Refining of the state regulations Access to PDMP data from surrounding states Additional state regulations regarding controlled substance or opioid prescribing Limitations on ED prescribing of opioids Limitation on Prescribing of opioids to minors Requirement to include education on opioid prescribing and use in all medical professional education Refining the documentation process Standard location within EHR Potential creation of a standard note type Linking to resources for patients where an issue is identified 29
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31 Opioid Legislation Update The DEA is decreasing licensing of opioids to pharmaceutical industries by 50% over the next two years. On September 28 the PA General Assembly and Governor Wolf passed four bills addressing this growing epidemic. House Bill 1699 Hospital ED & Urgent Care Centers prescribing limitations This legislation limits the quantity of opioid drug products which may be prescribed to a patient seeking treatment in a hospital emergency department or urgent care center. Health care practitioners may prescribe opioid drug products for no longer than seven days for any patient seeking treatment in an emergency department or urgent care center, unless the health care practitioner s professional medical judgment indicates otherwise. Patients who are in the hospital under observation status also have a seven-day prescription limitation. If, in his/her professional medical judgment, the health care practitioner prescribes more than a seven-day supply of the opioid drug product, the health care practitioner must: Document in the patient s medical record (i) the acute medical condition, (ii) pain associated with a cancer diagnosis, or (iii) palliative care need which is triggering the larger quantity of opioid drug products; and Document that a non-opioid product was not appropriate to treat the medical condition. In addition, a health care practitioner in an emergency department or urgent care center may not write a prescription refill for an opioid drug product. A health care practitioner shall refer an individual for treatment if the individual is believed to be at risk for substance abuse while seeking treatment in an emergency department of urgent care center. A prescribing health care practitioner shall also query the prescription drug monitoring program to determine if the patient is currently being treated with an opioid by another health care practitioner. This does not apply to patients who are admitted to a hospital or undergoing care in an emergency department. 31
32 Opioid Legislation Update Senate Bill 1202 Requires dispensers & prescribers to check Rx monitoring database For Pharmacies: A dispenser shall query the prescription drug monitoring program before dispensing an opioid drug product or a benzodiazepine prescribed to a patient if any of the following apply: The patient is a new patient of the dispenser; The patient pays cash when they have insurance; The patient requests a refill early; or The patient is getting opioid drug products or benzodiazepines from more than one prescriber. For the purposes of this subsection of the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) Act, a new patient does not include an individual going to the same pharmacy, or a different physical location of that pharmacy, if the patient s record is available to the dispenser. The ABC-MAP Act was also updated to require pharmacies to submit all information required under the Act to the system no later 72 hours after dispensing a controlled substance. For Prescribers: A prescriber shall query the system: For each new patient the first time the patient is prescribed a controlled substance by the prescriber for the purposes of establishing a baseline and a thorough medical record; If a prescriber believes or has reason to believe, using sound clinical judgement, that a patient may be abusing or diverting drugs; or Each time a patient is prescribed an opioid drug product or benzodiazepine by the prescriber. A query is NOT required if a patient has been admitted to a licensed health care facility or is in observation status in a licensed health care facility, the prescriber does not need to query the system after the initial query above as long as the patient remains admitted to the licensed health care facility or remains in observation status in a licensed health care facility. 32
33 Opioid Legislation Update Senate Bill 1202 (cont d) Licensing Boards: Licensing boards under the Bureau of Professional and Occupational Affairs in the Department of State with jurisdiction over professional licenses or certificate holders who are dispensers or prescribers are to require education in pain management, addiction and prescribing and dispensing practices for opioids. The general rule, except as otherwise provided for in the law, will require at least two hours of education in pain management or identification of addiction and at least two hours of education in the practices of prescribing or dispensing of opioids within 12 months after obtaining an initial license or certification. For dispensers and prescribers applying for the renewal of a license or certification, they must complete at least two hours of continuing education in the above areas as a portion of the total continuing education required for biennial renewal will take effect next licensure renewal period. 33
34 Opioid Legislation Update Senate Bill 1367 Establishes a doctor s prescription limitations to minors A prescriber may not prescribe to a minor a controlled substance containing an opioid unless the prescriber complies with the procedures outlined below. Additionally, except as outlined below, a prescriber cannot prescribe to a minor more than a seven-day supply of a controlled substance containing an opioid. Exemption: A prescriber may prescribe to a minor more than a seven-day supply of a controlled substance containing an opioid if any of the following apply: 1. In the professional medical judgment of the prescriber, more than a seven-day supply of a controlled substance containing an opioid is required to stabilize the minor s acute medical condition. 2. The prescription is for: management of pain associated with cancer; use in palliative or hospice care; or management of chronic pain not associated with cancer. A prescriber must document the acute medical condition in the minor s record and indicate the reason why a nonopioid alternative is not appropriate to address the acute medical condition. Procedure: Before issuing a minor the first prescription in a single course of treatment for a controlled substance containing an opioid, regardless of whether the dosage is modified during that course of treatment, a prescriber shall do all of the following: Assess whether the minor has taken or is currently taking prescription drugs for treatment of a substance use disorder, and Discuss with the minor and the minor s parent, guardian or an authorized adult all of the following: (i) the risks of addiction and overdose associated with the controlled substance containing an opioid; (ii) the increased risk of addiction to controlled substances for those suffering from mental or substance use disorders; (iii) the dangers of taking a controlled substance containing an opioid with benzodiazepines, alcohol or other central nervous system depressants; and (iv) any other information in the patient counseling information section of the labeling for controlled substances containing an opioid required under 21 CFR (c)(18) (relating to specific requirements on content and format of labeling for human prescription drug and biological products described in (b) (1)) deemed necessary by the prescriber. 34
35 Opioid Legislation Update Senate Bill 1367 (cont d) The prescriber must get the written consent of the parent, guardian or other authorized adult prior to issuing the prescription for the minor. The prescriber shall record the consent on the form under section 5202(b)(1). The prescriber may not prescribe more than a single seventy-two (72) hour supply if the individual who signs the consent form is an authorized adult. Exemption: The above procedures do not apply if the minor s treatment with a controlled substance containing an opioid meets any of the following criteria: 1. The treatment is associated with or incident to a medical emergency as documented in the minor s medical record. 2. In the prescriber s professional judgement, complying with the above procedures with respect to the minor s treatment would be detrimental to the minor s health or safety. The prescriber shall document in the minor s medical record the factor or factors which the prescriber believed constituted cause for not fulfilling the requirements of the above procedures. Title 35 Amendment Prescribing curriculum for medical colleges and other training facilities The prescriber must obtain the written consent of the parent, guardian or an authorized adult on the form required by the Act prior to issuing the prescription for the minor. A minor may not receive a prescription for more than 72 hours if the minor is accompanied by an authorized adult and not a parent/guardian. A prescriber may prescribe to a minor more than a 7-day supply of a controlled substance containing an opioid if: 1. In the professional medical judgment of the prescriber, more than a 7-day supply of a controlled substance containing an opioid is required to stabilize the minor s acute medical condition. In order for this paragraph to apply, the prescriber must: a. Document the acute medical condition in the minor s record with the prescriber; and b. Indicate the reason why a non-opioid alternative is not appropriate to address the acute medical condition. OR 2. The prescription is for (a) management of pain associated with cancer, (b) use in palliative or hospice care, or (c) management of chronic pain not associated with cancer. The education required under this chapter shall not be considered to be a mandate of the curriculum necessary for graduation. Nothing in this chapter shall be construed to prohibit a college from requiring such curriculum to be necessary to graduate after August 1,
36 Opioid Legislation Update Prescribers shall query the PDMP system: For each patient, the first time he/she is prescribed a controlled substance by the prescriber If a prescriber believes the patient may be abusing or diverting Shall indicate the information obtained from the system in the patient s record if: New patient It is determined that the drug should not be prescribed based on the information from the system GHS Prescriber Registration Status as of 11/9/16: 1,141 prescribers 605 registered 512 not registered 24 pending registration No prescriber is exempt from registering the PA PDMP website reiterates that prescribers are required by law to register if they hold a current DEA license. Files will be sent to Ron Byerly and Alison Mowery for non-registered advanced practitioners and to the individual physician and the physician s direct report with instructions of how to register. The file will be refreshed every two weeks. Prescribers whom do not comply are subject to disciplinary action to be defined by the relevant State Boards. Patient Education Sue Robel and Denise Venditti will help prepare materials to educate our patients to the new guidelines. 36
37 The following are examples of Schedule II through Schedule V controlled substances: Schedule II - drugs with acceptable medical use, but with a high abuse potential that lead to dependence (morphine, methadone, oxycodone). Schedule III - drugs with less abuse potential and a moderate risk of abuse potential (aspirin/codeine combinations, buprenorphine). Schedule IV - drugs with a lower abuse potential (alprazolam, clonazepam, diazepam). Schedule V - drugs with less abuse potential that other schedule drugs contain limited quantities of a controlled substance (robitussin AC, phenergan with codeine). 37
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