PowerPoint Presentation

To Fill or Not to Fill,That Is the QuestionPresenters:Karen M. Ryle, RPh, MS, Associate Chief of Pharmacy for Ambulatory Care, Massachusetts General HospitalMike Menkhaus, RPh, EPRN Project Manager, KrogerEdward McGinley, MBA, RPh, DPh, President, National Association of Boards of PharmacyPharmacy TrackModerator: Chad C. Corum, PharmD, Co-Owner and Pharmacist, Corum Family Pharmacy, and Member, Operation UNITE Board of Directors

DisclosuresEdward McGinley, MBA, RPh, DPh; Mike Menkhaus, RPh; Karen M. Ryle, RPh, MS; and Chad C. Corum, PharmD, have disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

DisclosuresAll planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.The following planners/managers have the following to disclose:John J. Dreyzehner, MD, MPH, FACOEM Ownership interest: Starfish Health (spouse)Robert DuPont Employment: Bensinger, DuPont & Associates-Prescription Drug Research Center

Learning ObjectivesIdentify warning signs that a Rx will be abused or diverted.Explain a project that integrates PDMP data into the workflow of a pharmacy system.Compare in-workflow access to PDMP data with traditional website access to PDMP data.Provide accurate and appropriate counsel as part of the treatment team.

To Fill or Not to Fill: That is the QuestionKaren M Ryle, MS.,RPh

DisclosureKaren Ryle, MS, RPh has disclosed no relevant, real or apparent personal or professional financial relationships with propriety entities that produce healthcare goods and services.

Learning ObjectivesIdentify warning signs that a Rx will be abused or diverted.Explain a project that integrates PDMP data into the workflow of a pharmacy system.Compare in-workflow access to PDMP data with traditional website access to PDMP data.Provide accurate and appropriate counsel as part of the treatment team.

Pharmacists Corresponding ResponsibilityCFR, Title 21 sec 1306.04,Purpose of Issue of PrescriptionA prescription for a controlled substance to be effective must be issues for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practiceThe responsibility for the proper prescribing and dispensing of controlled substances shall be upon the prescribing practitioner, but a corresponding responsibility shall rest with the pharmacist who fills the prescription

USA v Holiday CVS2011-Pill Mill law prohibits Doctors from dispensing Schedule II and III substances.More Oxycodone 30mg was distributed to Florida than all states combined.2 CVS pharmacies located in Sanford, FloridaPurchased large amounts of controlled substances without effective controls against diversion1000Rx/day-mostly controlled substancesOxycodone 30mg Rxs coming from 4 DoctorsRxs coming from South Florida located 200 miles awayPatients coming from Kentucky and TennesseeMany patients with the same diagnosis

USA v Holiday CVSFilling controlled substances for 6 months from one Doctor, whose licensed expired.Filled a total of 55 prescriptions for Oxycodone 30mg from another physician whose license expired.Customers started lining up at the pharmacy before it opened.Pharmacist put limits on the amount of Oxycodone given per day. Prescriptions were filled on a first come first serve basis and would often run out by 12 noon.Pharmacist tells the DEA: We needed to save some for our legitimate patients.Pharmacy also put limits on cocktail prescriptions for Oxycodone, Carisprodol and Alprazolam. Prescriptions were called and verified.Large amount of patients paying cashMultiple patients getting the same prescriptionsOxycodone 30mg and Oxycodone 15mg

USA vs. East Main Street Pharmacy

When a pharmacist either knows or has a reason to know that the prescription is not written for a legitimate medical purpose.A pharmacist may not intentionally close his eyes and thereby avoid knowledge of the real purpose of the prescription.Red flags should have given the pharmacist a reason to know.Dispensed cocktail prescriptions.No individualization of dosing.Multiple prescriptions for the strongest formulationEarly refills..etc

DEA ResponseNovember 13, 2012 , DEA revoked their licenseAdministrative Law Judge rulingViolated their corresponding responsibility by dispensing prescriptions not for a legitimate medical purpose.Failure to maintain effective controls in place for ordering large quantities of narcoticsFilling prescriptions for controlled substances from physicians whose license is expired is against the law.Simply calling a doctors office to verify that a he/she wrote a prescription does not meet the requirement of legitimate.Failing to resolve red flags.Calling the prescriber will not resolve red flags because the red flags indicate the prescriber is collaborating with the patient.Revoked both DEA licenses

Red Flags for Pharmacist1. Repeatedly dispensing cocktailed prescriptions2. No individualization of dosing by the Prescriber3. Filling multiple prescriptions for the strongest formulations4. Request for early refills5. Doctors located 100 miles away from pharmacy

Red Flags for Pharmacist6. A large proportion (75%) of prescriptions filled by the pharmacy were controlled substances written by one particular physician7. Pharmacist doesnt reach out to other Pharmacists to see why they arent filling the particular doctors prescription8. Patients travel in groups to the pharmacy9. Filling a large percentage of cash prescriptions10. verification of a prescription as legitimate was not satisfied simply because the practitioner said so.

NABP Red Flag Videohttps://www.youtube.com/watch?v=WY9BDgcdxaM&feature=youtu.be

Opiate Nave PatientOpioid tolerant patient is a patient that has been on the equivalent of 60mg of oral Morphine daily, 30 mg of oral Oxycodone daily, 8 mg of Hydromorphone daily or equianalgesic dose of another opioid for over 1 week.32 year old patient having back pain, prescribed Tramadol 50mg q6 hours for pain, Methocarbamol 750mg, Carisoprodol 350mg and Alprazolam 2mg for a few months.Pharmacy dispensed Fentanyl 75mcg patches to the patient.Pharmacist received alert from 3rd party DUR asking to confirm that the patient is opiate tolerant.Pharmacist thinks it is Ok because she was taking Tramadol, a mild synthetic opioid.Patient expires within 48 hours.

DiscussionPharmacist overrides the DUR alertPatient does not meet the definition of opioid tolerantPharmacist doesnt know exactly what it means to be opioid tolerant or nave.She did not consult with the Doctor despite what she indicated in the override. (consulted with prescriber-filled as is)Can you convert someone from Tramadol to Fentanyl?What is the morphine equivalent dose?Did the pharmacist meet the standard of care?Fentanyl 75mcg=180mg MorphineTramadol 200mg= 20mg Morphine

Morphine Equivalent DoseMED is a system to equate different opioids and their varying potencies into a standard morphine equivalent value.Conversion chart created by Centers of Disease Control (CDC).Patients odds of overdosing or abuse increases dramatically when a patient reaches a daily level of 120 (CMS).Prescriber and/or pharmacist should press pause to reevaluate the effectiveness and safety of the patients pain management plan.MassHealth-prior approval for patients over 120 MEDNYC MME calculator app on iphone

MethadoneNationally, Methadone accounts for 2% of opioid pain prescriptions but 30% of opioid related overdoses.Very tricky to convert from other opioidsRule of thumb: Go LOW and SLOWCross toleranceFull analgesic effect may not be obtained for 3-5 daysUnique pharmacokinetic properties, analgesic action is shorter than plasma elimination lifeMethadone treatment for addiction is not reported to the PMPDeath of 22 year old-fell off horse, Methadone 10mg QIDCounsel patient

NaloxoneNaloxone reverses opioid related sedation and respiratory depression= pure opioid antagonist.Fast acting, inexpensive and non-addictive with minimal side effects.May be administered IM, IV, SC, INActs within 2-8 minutes.Lasts 30-90 minutes-overdose may return.Second dose may be necessary.

Nasal NaloxoneStanding orderCollaborative Drug Therapy AgreementPharmacist only dispensingOver-the-counterList states and different activity

NaloxoneNew Mexico allows the dispensing without a prescription.Idaho allows for Pharmacist prescribing.Rhode Island provided a waiver to pharmacies trained in nasal naloxone to dispense under a collaborative drug therapy agreement.Massachusetts can provide naloxone through a standing order.14 states now allow naloxone to be sold without a prescriptionFDA already denied an OTC applicationStates are looking at removing barriers for pharmacist dispensing

Naloxone Kits

Includes 2 Naloxone syringesIncludes 2 atomizersInstructions for use

How to Give Nasal Naloxone1. Pop off two yellowcaps and one red cap.2. Screw medicinegently into deliverydevice.

3. Hold spray device andscrew it onto the top ofthe delivery device.4. Spray half of themedicine up one sideof the nose and half upthe other side.

Naloxone RescueOver 2000 overdoses were reversed in Massachusetts in 2013 due to naloxone initiative.Massachusetts leading the country in reversal of overdoses.Quincy police Department takes the leadGood Samaritan law protects those that seek help for someone overdosing from being charged or prosecuted for drug possession or minor drug crimes.Gloucester police department taking drug seizure money to fund naloxone.

Story of Robby

Drug DisposalMail Back ProgramsTake Back EventsDrug Disposal

To Fill or Not to Fill: The Role of the PharmacistMike Menkhaus, R.Ph.Kroger Company

Edward G. McGinley, MBA, RPh, DPhPresident, National Association of Boards of Pharmacy

29

Disclosure StatementMike Menkhaus has disclosed no relevant, real, or apparent personal or professional financial relationship with proprietary entities that produce health care goods and services.Edward G. McGinley has disclosed no relevant, real, or apparent personal or professional financial relationship with proprietary entities that produce health care goods and services.

30

Learning ObjectivesIdentify warning signs that a Rx will be abused or diverted.Explain a project that integrates PDMP data into the workflow of a pharmacy system.Compare in-workflow access to PDMP data with traditional website access to PDMP data.Provide accurate and appropriate counsel as part of the treatment team.

31

Notes:PMP and PDMP can be used interchangeably.CS = controlled substances, as reportable to PDMPs

Limited Use of PDMP DataMost states have developed excellent PDMP databases over the past half decade BUT, they have remained significantly underutilized due to the difficulty of providing efficient access

A quick, efficient means to access the PDMP data is crucial to provide clinical details the prescriber and pharmacist need to ascertain if a true clinical need exists for the CS therapy under consideration

SAMHSA grants have been offered to states that are willing to engage business partners to develop more user friendly methods for access to the PDMP data

33

Kroger SystemKroger participated in a pilot with the Ohio PDMP (OARRS) to move PDMP access into workflowPilot was partially funded by a SAMHSA grantPartnership with Appriss, Inc., the host for NABPs PMP InterConnect programProvides access to PDMP Data from multiple states in secondsProvides data analysis via NARxCHECK

34

PDMP Data AccessIn Krogers system, at the DUR step in workflow, CS Rxs have a PDMP button, labeled in RedClicking that button will retrieve and display the patients PDMP records from one or more statesSharing of PDMP data across state lines is still hindered by privacy concerns, legislation and technical details (mostly capacity)

35

Data PresentationThe data is presented from most to least currentIt includes Rx attributes - the quantity dispensed, the days supply and, for opioids, the Morphine MgEq dose/dayThe report also includes the prescribers & the dispensing pharmacies

36

Data Analytics - example

Initially, there is little reason for concernOne concurrent prescriberRefills are on time with no/few overlapping daysSometimes even a late refill

Screen prints from NARxCHECK

37

Data Analytics (Cont. .)No therapy gapsAppearance of early refillsPrescriber changeWas it clinically driven? (Specialist to general practitioner)

Screen prints from NARxCHECK

38

Data Analytics (Cont. .)Concurrent prescribers! Suspicion should rise significantlyWhy concurrent prescribers (accidental or intentional)No gaps in therapyScreen prints from NARxCHECK

39

Data Analytics (Cont. .)Prescriber stopped prescribingSuggestive of awareness of problemAnother new prescriber is addedVery significant therapy duplicationNeed for intervention is very evidentScreen prints from NARxCHECK

40

Data Analytics (Cont. .)Poly-pharmacy & prescriber are clearly evidentPrescriber out of pharmacy typical service areaConcurrent patronage with Rx overlap & early fills demonstrates abuse or diversionary intentAgain, intervention need is obvious

41

What Now?Once evidence indicates that the patient is inappropriately seeking CS Rxs, the clinician must ACTTo date, the heavy emphasis on the benefits of PDMP data review is to STOP the prescribing or dispensing of CS RxsIndeed, there is even a program call I-STOPWith IMMEDIATE access to PDMP data, a new I Program is possible I-DONT START!By use of the PDMP data and the knowledge of red flags, prescribers can avoid prescribing and pharmacies can decline to fill CS Rxs when no legitimate need existsBut this isnt the end..

42

Clinical Use of PDMP DataOnce its determined a patient is attempting to procure a CS Rx for reasons other than the clinical indications for the CS drug, we cant STOP there.We need yet another I program:I STARTI START identifying the underlying drug/alcohol problemI START engaging the patient in an intervention processI START identifying the path away from the downward spiral of addiction to a drug and alcohol free life . the path to recoveryAnd, when needed, I START engaging law enforcement

43

Advantages of In-workflow AccessWeb portal use typically requires multiple steps:Open web browserLog through internal firewallNavigate to state PDMP site & log inEnter patient criteria and searchView/analyze PDMP dataRepeat steps independently for additional statesAn in-workflow process Eliminates all login stepsCan provide concatenated multi-state dataCan perform analytics to facilitate review

44

BarriersNot Plug-N-PlayMajor impediments to complete access to patients PDMP history include:Privacy laws and regulationsTechnology problemsDevelopment PrioritizationIncomplete National NetworkCapacity concerns many state PDMPs would not have the band width to process PDMP report requests from all states or even neighboring statesLegal requirements Signing of MOUs for many statesNotarized registration (at least one state)

45

What To DoIn addition to supporting a national network of PDMPs:E-D-U-C-A-T-E particularly representatives and regulators at the state and federal levels about SHARINGIf a pharmacy dispenses a CS Rx to a patient, unaware that the patient has already received a sufficient supply in another state, and the patient overdoses, it will be little consolation to tell loved ones that we protected the patients privacyWork through organizations, such as the National Council for Prescription Drug Programs (NCPDP) and NABPEngage your software vender or development team

46

What To Do (Cont. .)In addition to supporting a national network of PDMP, continued:Press for in-workflow access to PDMP data based upon the utility of PDMP data as a clinical decision making tool to help ensure patient safety concernsContact your state representativesPDMP access, in workflow, needs fundingA national network of PDMPs requires state collaboration and sharing of data that may require legislative changes

47

Rx Alternative OptionsThere are alternative treatment modalities for most of the indications for which CS Rxs are usedFor example: Americans consume 80% of the global supply of opioid pain killer while representing but 4.6% of the worlds population DO WE REALLY SUFFER 80% OF THE PAIN?Other treatment options exist we need to change the current paradigm that looks first and foremost to an CS solution

48

Additional Alternative TherapiesOpioids are not the only over-consumed CSSedativesSleeping pillsMuscle relaxantsStimulants (ADHD, weight loss, narcolepsy)Common feature CS drugs are the easiest option. But, for each of these CS treatments, there are alternatives treatments that can be used alone or in conjunction with CS to eliminate or reduce CS need.

49

Alternative Pain Therapies

Examples of pain treatment options with proven efficacy include:Alternative medicationsNSAIDSGlucosamine with ChondroitinHerbal remediesPhysical Treatments, includingPhysical TherapyAcupunctureYogaHypnosisMassageDiet

50

Alternative Pain Therapies, ContinuedAdvantages of alternative pain treatments:Alternative pain treatments can be used in conjunction with each otherConcurrent use may reduce the dose of medications, particularly opioidsMost alternative pain treatments have very limited and far less dangerous side effectsThere are no addiction concerns In many cases, they provide complete or partial resolution of the underlying cause of painDiet and some physical therapy may require no additional expense

51

SummaryWe have a long way to go. Take-aways:Money spent at the front end (preventing addiction) is far more effective than spent at the back endIn workflow design can include tools to facilitate the data analysisIncreased PDMP access = fewer CS Rxs, more timely interventions for recovery, less potential for abuseMinimizing CS usage = fewer addictions, less abuseChange the treatment paradigm!Consider alternative treatments FIRSTIntervene when appropriate

52

Thank you.

There will be an opportunity for questions at the end of Eds portion of this presentation.

53

NABP Mission StatementNABP is the independent, international, and impartial Association that assists its member boards and jurisdictions for the purpose of protecting the public health.

50 United States, four US jurisdictions,and 12 international associate members

54

Shortcomings of Prescription Monitoring Programs (PMPs)Patients cross state bordersLow utilization by health careSeparate websiteRegistration and loginData entry patient demographics

55

Background on NABP Involvement With PMPsNABPs mission is to support state boards of pharmacy and assist other regulators to protect the public health.In fall 2010, NABP was approached by several members. They requested a low-cost, easy-to-implement, highly enhanced solution for interstate data sharing.

56

57

NABP PMP InterConnect creates interoperability for individual state PMPs via a hub system.Physicians and pharmacists log into their own state PMP and select other participating states from which they want data.PMP InterConnect routes the requests to the various states and the information back to the home PMP for delivery to the physician or pharmacist in one collated report. Patient data is encrypted.

58

Next Steps to Increase Utilization of PMP DataAutomate requests for PMP data into workflow via Health care systems or electronic health record vendors Pharmacy software systems Health information exchanges Increase efficiency by providing access to analytical tools, eg, NARXCHECK

59

Automated RequestingNo registrationNo usernames/passwordsNo data entryNo added stepsNo delay

60

What it means to be a pharmacistProfessional and social responsibility to be proactive participants in your practice, community, and profession.To lead and to inform.To provide information and service to our patients.

61

Can each person make a difference?NABP Efforts:Presidential initiative: Provide pharmacists with the tools and resources to make a differencewww.awarerx.pharmacy enhanced to provide more pharmacist resourcesPharmacist Pledge: Personal commitment and reminder of their professional obligation, with handy access to the AWARXE Prescription Drug Safety Program tools Each person can make a difference.

62

63

64

65

After You Take the Pledge Ten Things You Can Do1. Share the pledge with colleagues and encourage them to sign it.2. Learn more about prescription drug abuse and misuse.3. Check PMPs regularly when filling prescriptions.4. Learn your pharmacys protocol for assisting a patient who may be abusing prescription drugs, so that you can take action if needed.5. Educate patients on medication safety issues, such as safe use, handling, and storage of medication.

66

After You Take the Pledge Ten Things You Can Do6. Promote proper medication disposal:a. Set up a disposal box on site at your pharmacy; orb. Have a disposal site that you can recommend to patients.7. Remind patients to securely store their medications.8. Download and print AWARXE flyers for patients who would like detailed information about:a. proper disposal;b. secure medication storage;c. buying medicine safely online; andd. statistics about the abuse and misuse of prescription drugs.

67

After You Take the Pledge Ten Things You Can Do9. Hang AWARXE posters (available to download and print) in your pharmacy, office, or other practice settings. a. The striking images can alert patients and colleagues to prescription drug abuse at a glance. b. A proper medication disposal poster is also available.10. Give presentations using AWARXEs PowerPoint slides,which include presenter notes.

68

Take the Pledge.Remember your Pledge.Make a difference!

Thank You!

69

To Fill or Not to Fill,That Is the QuestionPresenters:Karen M. Ryle, RPh, MS, Associate Chief of Pharmacy for Ambulatory Care, Massachusetts General HospitalMike Menkhaus, RPh, EPRN Project Manager, KrogerEdward McGinley, MBA, RPh, DPh, President, National Association of Boards of PharmacyPharmacy TrackModerator: Chad C. Corum, PharmD, Co-Owner and Pharmacist, Corum Family Pharmacy, and Member, Operation UNITE Board of Directors