NY State I-STOP Program

1. NY State I-STOP Program Mandatory on August 27, 2013 and Thereafter

2. WHAT IS I-STOP? I-STOP is also known as the Prescription Monitoring Program (PMP) Registry, formally known as CSI I-STOP was developed through the offices of the New York State Attorney General and was passed by the State Legislature and signed by Governor Cuomo in order to “exponentially enhance the effectiveness of New York’s existing PMP to increase detection of prescription fraud and drug diversion.”

3. WHAT IS THE PURPOSE BEHIND I-STOP? • There were a reported 1,818 drug-related deaths in the U.S. in 2008. • For opioids (prescription pain medication and heroin) there were 9,135 emergency department visits and 21,202 hospital admissions reported for 2008 in the US.

4. SO THE PURPOSE OF I-STOP IS TO PREVENT…? To prevent death, overdose and problems related to the inappropriate use of these opioid type medications! Even the most careful prescribers cannot prevent someone from taking a whole bottle of pills if their girlfriend leaves them, or of having their pills stolen and sold on the street, or even from drinking alcohol while taking them.

5. STREET VALUE! • Many controlled substances are cheap to buy, but command a high street value! • Hydrocodone, Oxycontin and even drugs for ADHD are sold, purchased, used and abused regularly!

6. SAFE PRESCRIBING CANNOT STOP ALL MISUSE But the new rules are meant to help! Some rules went into effect in February of 2013 which required patients to present to the prescribing provider monthly for a new refill on certain pain, muscle relaxant and other type medications – multiple refills cannot be given!

7. THE RULES AND REGULATIONS I-STOP DETAILS

8. WHAT EXACTLY DOES I-STOP DO? • The Internet System for Tracking Over-Prescribing Act, (I-STOP), establishes an on-line, real-time, controlled substance reporting system that requires prescribers to consult the prescription monitoring registry prior to prescribing or dispensing Schedule II,III or IV Controlled Substances. • In addition, pharmacists, who did not previously have access to the registry, as a result of I-STOP will NOWhave access to the registry in order to review the controlled substance history of an individual for whom one or more prescriptions for controlled substances are presented to the pharmacist.

9. THE REQUIREMENTS OF I-STOP • Requires the Department of Health to establish and maintain an on-line, real-time controlled substance reporting system to track the prescription and dispensing of controlled substances; • Requires providers to review a patient’s controlled substance prescription history on the system prior to prescribing; • NOTE: A provider may authorize a support staff member to consult the registry on his or her behalf, provided that the provider takes reasonable steps to ensure that the staff member is sufficiently competent to use the registry, and the provider remains ultimately responsible to ensure that the registry is used for authorized purposes and is used in a manner that protects the confidentiality of the information obtained from the registry;

10. THE I-STOP VERBIAGE IS CONFUSING • CAREFUL… In one area the law says…”A practitioner is not required to consult the registry prior to dispensing a controlled substance, provided that all other requirements pertaining to dispensing controlled substances are followed”; • But the law also says you are required to consult the registry prior to prescribing a controlled substances. THE DIFFERENCE IS IN THE WORDING AS MOST PROVIDERS ARE NOT DISPENSING IN THEIR OFFICES! • There are a number of exceptions whereby the duty to consult the registry does not apply, such as (A) it is not reasonably possible to access the registry in a timely manner; (B) no other practitioner or designee who is authorized to access the registry is reasonably available; and (C) the quantity of the controlled substance prescribed does not exceed a 5 day supply (regulations of the NYS DOH will provide more specific information regarding the exceptions); and • The duty to consult the registry does not apply to Schedule V Controlled Substances.

11. WHAT PROVIDERS NEED TO DO RIGHT NOW! • Providers practicing in NY State are required to comply with I-STOP and that requires that they must first have an active “Health Commerce Account” with The State of New York, Department of Health’s Health Commerce System. • Providers seeking to establish such an account must go to: • https://hcsteamwork1.health.state.ny.us/pub/top.html

12. PENALTIES FOR NOT USING I-STOP • Of significant note, the duty for providers to comply is strict and mandatory, carrying severe potential penalties for any failure to comply, including but not limited to, loss of license, civil penalties and/or criminal charges. • To avoid the possibility of such dire events, plans for compliance with I-STOP must be built, implemented and adhered to immediately, and without fail, by every provider throughout New York.

13. SO THIS IS NY STATE TELLING ME HOW TO PRESCRIBE? • Not really, but few people realize that Hydrocodone has become the most prescribed medication nationwide, even topping blood pressure medications such as lisinopril, and cholesterol lowering medications such as simvastatin, AND; • When one considers the risks of Hydrocodone and similar drugs; it simply makes sense to provide one more tool to providers to insure the drugs are prescribed safely, and that misuse can be tracked and stopped.

14. WHAT ABOUT PATIENTS WITH A REAL NEED TO CONTROLLED SUBSTANCES? • With I-STOP providing: • The ability to track the use of these medicines; • The ability to have providers use their support staff to review the I-Stop site; • With more providers insuring: • The proper use of lower level pain medications first (e.g. high dose Ibuprofen) and therapies such as physical therapy, RICE, etc.; • The amount prescribed is lower and the number given is fewer; • By educating the public… THESE MEDICATIONS WILL STILL BE AVAILABLE WHEN NEEDED

15. THE FEW EXCEPTIONS TO CONSULTING I-STOP • When dispensing methadone • Dispensing and administrationof the controlled substance in the prescriber’s office • For medications administered in a hospital, nursing home or hospice setting • Written in an Emergency Department for a supply no greater than 5 days • When a provider cannot access the system through no fault of his/her own, they can prescribe up to 5 days supply • Instances where consulting the system would result in delay in treating a patient

16. E-PRESCRIBING CONTROLLED SUBSTANCES E-Prescribing of controlled substances will be NOT BE available in N.Y. State UNTILJanuary 2015.

17. ESTABLISHING AND MAINTAINING AN HCS ACCOUNT The Rules of the Road!

18. HOW TO ESTABLISH AN HCS ACCOUNT • If you are a licensed professional, the application to establish an account is available on the following website: https://hcsteamwork1.health.state.ny.us/pub/top.html • If you will be using unlicensed staff as your designee, they will first have to obtain an HCA account with approval of your HCS Coordinator (which may be a lead provider in the practice) • Once the unlicensed professional or administrative staff acting as a designee has an HCS account, the prescribing provider must log into the HCS system: https://commerce.health.state.ny.usclick on Coord Account Tools under My Applications, Under Account Request, Click “User” and follow the process

19. I SUBMITTED FOR AN HCS ACCOUNT, WHAT NOW? New accounts are usually established within two weeks. Once your application is processed you will be emailed documents. They must be printed, notarized and received by the DOH for your user ID to be issued. For account information or help with your HCS Account, please contact Commerce Account Management (CAMU) at 1-866-529-1890, option 1.

20. I CURRENLY HAVE AN HCS ACCOUNT – DO I HAVE TO REGISTER AGAIN? For expired passwords, forgotten user names, lost PIN… call the number below! For account information or to help with your HCS account, please contact CAMU at 1-866-529-1890 NO! But if you have not used the account within the last 30 days, and every 30 days thereafter, you will have to reset your password.

21. I HAVE AN HCS ACCOUNT, HOW DO I CONSULT THE I-STOP (PMP) REGISTRY? • Go the HCS at: https://commerce.health.state.ny.us • Log into the system with your user ID and password • Click on the NYS PMP Registry campaign button on the home page or select “Applications” at the top of the page. Click the letter “P” • If you do the latter, scroll down to “Prescription Monitoring Program Registry” • Click the green plus (+) sign under the Add/Remove column to add this application to your favorites • Click to open program • Enter patient and other required information

22. ARE PRESCRIBERS REQUIRED TO REVIEW THE I-STOP (PMP) FOR ANY CONTROLLED SUBSTANCE PRESCRIBED OR IS THE REVIEW LIMITED TO CERTAIN DRUGS? Effective August 27, 2013, the duty to consult the PMP is required of the practitioner prior to prescribing any controlled substance listed on schedule II, II or IV.

23. CAN I SHARE THE REPORT WITH MY PATIENT? Yes. Release of the information to your patient is allowed but should be based on your professional medical judgment. All state and federal confidentiality laws should be adhered to

24. WHAT TYPE OF INFORMATION DOE STHE I-STOP REPORT PROVIDE? Patient search reports will include all controlled substances that were dispensed and reported by the pharmacy or dispenser for the past 6 months. Pharmacy and prescriber information will be provided as well.

25. ARE REFILLS AND PARTIAL FILL REQUESTS REPORTED AS WELL? Yes. Dispensers are required to report refills and partial-filled prescriptions to the DOH through the PMP system.

26. DO I HAVE TO REPORT TO DOH THAT I HAVE REVIEWED THE PATIENT’S PMP HISTORY? NO! But log-ins are tracked and can be used for or against a provider when necessary Make it your practice protocol to document that you checked the registry (or if your designee checks it, he/she should document that and you reference it), OR, why is wasn’t checked (e.g. the FIOS cable to your practice had been cut) AND WHEN SOMETHING SUSPICIOUS SHOWS UP, OR YOU SUSPECT DIVERSION, DOCTOR SHOPPING, ETC – you will note a link on the bottom of the confidential drug utilization report to report a prescription discrepancy, or to send questions or comments about the report to the Bureau of Narcotic Enforcement office.

27. IF I CHOOSE TO USE A DESIGNEE, HOW DO I KNOW IF THERE IS A CONCERN? We strongly recommend that either you as the provider or your designee note in the medical record that the PMP was checked for any patient currently on controlled substances or for whom you will be prescribing. If the report shows a great deal of controlled substances having been filled on this patient, or a lot of providers prescribing, we suggest that you have your designee print the report and provide it to you as the provider directly, while documenting “PMP reviewed, report printed and to provider”, after which the provider should note what, if any action they took based on the report.

28. MY PATIENT APPEARS ON THE I-STOP PMP, DOES THI SMEAN HE/SHE IS A DOCTOR SHOPPER? • Not necessarily. A PMP registry report indicates that your patient has received controlled substance prescriptions in the last 6 months. • The intent is to provide you with access 24/7 to your patient’s controlled substance history to guide you in making your treatment decisions. • You are still in charge of your prescribing patterns.

29. WHAT IF MY PATIENT REPORTS DRUG OR IDENTITY THEFT? Refer the patient to the local police department in the jurisdiction in which the event occurred. Upon receipt of a police report, use your best judgment in writing with any controlled substance prescriptions, document in the I-STOP PMP is you feel the need to do so, and DEFINITLY document your decision-making rationale regarding prescribing or not prescribing in the Medical Record.

30. WHO DO I CONTACT IF I SEE A PRESCRIPTION APPEARING ON THE I-STOP PMP AS HAVING BEEN WRITTEN BY ME, BUT WHICH I DID NOT WRITE? Use the link on the page to report a prescription error to the Bureau of Narcotic Enforcement. The link is located below your patient’s prescription information.