Pharmacy Law Disclosure Statement. Objectives 6/11/2016. I have no conflicts of interest to disclose related to this presentation.

Transcription

1 Pharmacy Law 2016 Ronda H. Lacey, J.D., M.S. Pharm Disclosure Statement I have no conflicts of interest to disclose related to this presentation. Objectives At the conclusion of this continuing education program, each pharmacist and pharmacist consultant will be able to: Identify and explain the changes contained in the ALBOP amendment to the Institutional Pharmacy Rule, 680-X Explain Alabama law(s) dealing with emergency Schedule-II prescriptions; and analyze a case from the Department of Justice dealing with the inappropriate dispensing of Schedule-II medications. Explain Alabama law(s) dealing with emergency prescription refills. Define and discuss the professional legal responsibilities of a pharmacist in dispensing the opioid an antagonist, naloxone hydrochloride, pursuant to ALA. Code

2 Institutional Pharmacies The Alabama State Board of Pharmacy, ALBOP, has amended 680-X-2.18 to allow for the use and operation of automated dispensing systems in skilled nursing facilities under certain conditions. May 5, 2016 was the last day for comments on the rule. Listed as680-x-2.18 (6) Automated Dispensing Systems in Skilled Nursing Facilities. Today we will review some of the major provisions dealing with institutional pharmacies. Institutional Pharmacies Automated Dispensing system: an electromechanical system that performs operations or activities related to the storage and dispensing of medications and which is capable of collecting, controlling and maintaining all required transaction information and records. Institutional Pharmacies Emergency Medication: any medication, including controlled substances, ordered by a licensed prescriber in response to a critical patient need. STAT Medication: any medication, excluding controlled substances, ordered and added to the drug regimen of a newly admitted patient or an existing patient that is not available from the Managing Pharmacy in sufficient time to prevent risk of harm to the patient and that might result from a delay in obtaining such medication. 2

3 Institutional Pharmacies The Board will meet to consider approval for the automated system. The request must be submitted at least 30 days prior to the Board meeting where the request is considered. There must be a managing pharmacy physically located in Alabama responsible for supplying the medication and safe operation of the system. Institutional Pharmacies Must provide a document containing written policies and procedures. Important to note that the automated dispensing system shall be considered an extension of the Managing Pharmacy. Confirm that positive identification will be used to access the medication and information contained in the automated dispensing system. Institutional Pharmacies Restocking Licensed pharmacist Registered pharmacy technician of managing pharmacy Licensed nurse of the facility or Other licensed healthcare personnel approved by ALBOP. On-site physical inventory of contents at least quarterly. 3

4 Review Questions Is a long term care facility required to use an automated dispensing system to improve compliance and minimize diversion? Can the automated dispensing machine be restocked by a LPN if approved by ALBOP? PharMerica Corp. May 2015 the Department of Justice announced a settlement in the amount of $31.5 million dollars against PharMerica Corporation. The lawsuit alleged that PharMerica had dispensed Schedule II controlled drugs without a valid prescription; and that they had violated the False Claims Act by submitting false claims to Medicare for the improperly dispensed drugs. PharMerica Corp. The lawsuit was a whistleblower case under the False Claims Act. The suit was settled and resolved without determination of or admission of liability. U.S. ex rel. Denk v. PharMerica Corp., No. 09-cv-720 (E.D. Wis). 4

5 PharMerica Corp. Allegations included: Dispensing C-II controlled drugs in nonemergency situations without first obtaining a written prescription from a treating physician. Failing to confirm with a physician whether the narcotics were necessary. Enabling nursing home staff to order narcotics and pharmacists to dispense them. Emergency C-II Prescriptions (g) Code of Alabama: In an emergency situation, a pharmacist may dispense a Schedule II controlled substance for a resident of a longterm care facility, a patient receiving hospice services, or a patient receiving home health care services pursuant to an emergency oral prescription transmitted by the practitioner to the dispensing pharmacy. The quantity dispensed pursuant to an emergency oral prescription shall be limited to the amount adequate to treat the patient during the emergency period not to exceed 72 hours. The practitioner, within seven days of the emergency oral prescription, shall provide the dispensing pharmacy with a written prescription for the quantity prescribed. (Acts 1971, No. 1407, p. 2378, 308; Act 1995, No , p. 1565, 1; Act , p. 1358, 1, Act , p. 256, 1.) Emergency C-II There must be: 1. An emergency situation. 2. Oral prescription/order/communication from the prescriber. 3. Amount of medication is limited to the amount necessary to treat the emergency and cannot exceed a 72 hour supply of medication. 4. Federal law required the oral communication must be reduced to writing although not listed in Title 20, please remember to do this! 5. Prescriber must provide a written copy within 7 days. 5

6 Written Prescription A prescription written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may be transmitted by the practitioner or the agent of the practitioner to the home infusion pharmacy by facsimile. The facsimile shall serve as the original written prescription (b) Written Prescription A prescription written for Schedule II substances for a resident of a long-term care facility may be transmitted by the practitioner or the agent of the practitioner to the dispensing pharmacy by facsimile. The facsimile shall serve as the original written prescription (c) Written Prescription Prescriber may also send an electronic prescription to serve as the written prescription. 6

7 Emergency C-II Can a physician s employee call in an Emergency C-II prescription for a patient in a LTCF? How many days does the prescriber have to provide a written prescription after a verbal Emergency C-II? Emergency Prescription Refills Practitioners may confuse the laws dealing with Emergency Prescription Refills with the laws dealing with Emergency C-II Prescription. Emergency Dispensing Refills Prior existing rx Unable to obtain refill authorization Necessary for pt Dispense a 1 time emergency refill Max: 72 hour supply Not a C-II or C-III Create a written rx Notify prescriber Obtain written rx within 72 hours Schedule II No existing rx Remember no C-II refills (in the event patient had prior rx) Must be an emergency Must be communicated by prescriber May dispense up to 72 hour supply Create a written rx/order Prescriber must provided written rx within 7 days. 7

8 Emergency Dispensing Questions? Naloxone ALA. Code Opioid Antagonist Prescriptions; Administration; Liability. Opioid antagonist ( ) means naloxone hydrochloride or other similarly acting drug that is approved by the federal Food and Drug Administration for the treatment of opioid overdose. Opioids Prescription opioids are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among others, and have both benefits as well as potentially serious risks. These medications can help manage pain when prescribed for the right condition and when used properly. But when misused or abused, they can cause serious harm, including addiction, overdose and death. FDA.gov: Opioid Medications. 8

9 Opioid Overdose Due to their (opioids) effect on the part of the brain which regulates breathing, opioids in high doses can cause respiratory depression and death. An opioid overdose can be identified by a combination of three signs and symptoms referred to as the opioid overdose triad. The symptoms of the triad are: pinpoint pupils Unconsciousness respiratory depression. Opioid Overdose This is a medical emergency call 911. Seventy-eight (78) people in the U.S. die every day from an opioid overdose, according to the Centers for Disease Control and Prevention (CDC). June 6, 2016 U.S. News & World Report Prince On June 2, 2016, the Midwest Medical Examiner s Office in Ramsey, MN, reported that Prince, age 57, died from accidental fentanyl toxicity (opioid overdose). U.S. News & World report used the following statement to describe the drug fentanyl: Fentanyl, a prescription opioid drug used to treat severe pain, carries a high risk for addiction and dependence; Prince was reportedly taking it for hip pain. 9

10 Opioid Overdose/Naloxone A physician or dentist acting in good faith may directly or by standing order prescribe and a pharmacist may dispense an opioid antagonist to either of the following: Individual at risk Family member, friend or other individual (police officer) in position to assist Opioid Overdose/Naloxone The physician or dentist (prior to dispensing) may require: Written communication providing a factual basis for a reasonable conclusion to either of: Individual seeking help is at risk The individual other than the individual at risk of experiencing the overdose and who is seeking the opioid antagonist is in relation to the individual at risk as a family member, friend or otherwise in a position to assist. In other words, the physician or dentist wants to make sure the reason falls within Opioid Overdose/Naloxone If the individual that administers the naloxone has a good faith belief that the individual is experiencing an opioid overdose they may administer the naloxone. They are immune from any civil or criminal liability. They must receive basic instructions and information on how to administer the opioid antagonist. 10

11 Opioid Overdose/Naloxone Keep in mind that if you do this you may be dispensing a drug for use in an individual that is NOT your patient. You are providing instructions to someone that will need to use the naloxone in an emergency situation where they may NOT be thinking clearly. Make sure you conduct proper education and maintain appropriate documentation. Liability Concerns? Make sure you are dispense the naloxone pursuant to a protocol/standing order or prescription. Have a solid education program don t just give the purchaser a handout. Consider video training or one on one training to supplement the handouts. Document, document, document Naloxone Does naloxone have side effects? What warnings should you give to the purchaser. Yes, we want to prevent an overdose but do patients have potential adverse reactions when they do not have access to drug? 11

12 Possible Agitation? Make Sure The purchaser knows that this is a medical emergency and that they should call 911! Even if you don t believe they will call 911 advise them to call 911! The family or patient knows that naloxone is not a cure all. The underlying problem of addiction still exists. Opioid Withdrawal Early symptoms of withdrawal include: Agitation Anxiety Muscle aches Increased tearing Insomnia Runny nose Sweating Yawning 12

13 Opioid Withdrawal Late symptoms of withdrawal include: Abdominal cramping Diarrhea Dilated pupils Goose bumps Nausea Vomiting y/article/ htm. June 3, Questions Are you required to dispense naloxone? Which of the following is true regarding the dispensing of naloxone? You must follow the protocol or standing order of a physician, dentist or mid-level practitioner? You can only dispense to an individual that is using an opioid or is addicted to opioids? THANK YOU! 13

14 Thank You APA Ronda H. Lacey, J.D., M.S. Pharm. 14