Disclosures. Adding New Pieces to the Illinois Pharmacy Law Puzzle. The New Illinois Controlled Substance Act. Learning Objectives.

Transcription

1 Disclosures Adding New Pieces to the Illinois Pharmacy Law Puzzle I have no relevant financial disclosure to announce. Sometimes I wish I did! Scott A. Meyers, RPh, MS, FASHP Executive Vice President, ICHP Learning Objectives Describe changes to the Illinois Controlled Substance Act passed in Discuss current pharmacy related issues before the Illinois General Assembly. Explain current Board of Pharmacy action relating lti to USP Chapter 797. Describe the use of the Illinois Prescription Monitoring Program in reducing prescription drug abuse. Describe progressive areas within the Illinois Pharmacy Practice Act that have other states seeking to copy it. The New Illinois Controlled Substance Act Last year s HB2917 has most of the changes to the Controlled Substance Act and B2255 has the rest! The rules have not yet been drafted but are expected by the end of the summer. This was a major revision. (d 10) "Compounding" means the preparation and mixing of components, excluding flavorings, (1) as the result of a prescriber's prescription drug order or initiative based on the prescriber patient pharmacist relationship in the course of professional practice or (2) for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. "Compounding" includes the preparation of drugs or devices in anticipation of receiving prescription drug orders based on routine, regularly observed dispensing patterns. Commercially available products may be compounded for dispensing to individual patients only if both of the following conditions are met: (i) the commercial product is not reasonably available from normal distribution channels in a timely manner to meet the patient's needs and (ii) the prescribing practitioner has requested that the drug be compounded. (f) "Controlled Substance" means (i) a drug, substance, or immediate precursor in the Schedules of Article II of this Act or (ii) a drug or other substance, or immediate precursor, designated as a controlled substance by the Department through administrative rule. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in the Liquor Control Act and the Tobacco Products Tax Act. 1

2 Good Faith now allows for recognizing that there may be clinical circumstances where more or less than the usual dose may be used legitimately. (u 0.5) "Hallucinogen" means a drug that causes markedly altered sensory perception leading to hallucinations of any type. Medication Shopping and Pharmacy Shopping added to this section but are more clearly explained in later sections (z 10) "Mid level practitioner" means (i) a physician assistant who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches, in accordance with Section 7.5 of the Physician Assistant Practice Act of 1987, (ii) an advanced practice nurse who hasbeen delegated authoritytoto prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches or by a podiatrist, in accordance with Section of the Nurse Practice Act, or (iii) an animal euthanasia agency (ee 5) "Oral dosage" means a tablet, capsule, elixir, or solution or other liquid form of medication intended for administration by mouth, but the term does not include a form of medication intended for buccal, sublingual, or transmucosal administration. SB2255 on APN prescribing of C IIs They may now prescribe any oral, topical or transdermal C II as long as it is under a written collaborative agreement with a physician in the outpatient setting. They are not limited to only five oral C IIs. PAs still have the 5 oral C II limitation. This was changed in another bill last session. What medication is not available to an APN in the outpatient setting? 1. Oxycodone po 2. Fentanyl patch 3. Fentanyl lollipop 4. Morphine po Additional Revised Pre printed prescription Prescription Information Library Prescription Monitoring Program Stimulant Newly Scheduled Drugs Schedule II Tapentadol (Nucynta ), Lisdexamfetamine (Vyvanse ) Schedule III Apobarbital ( Oramon ),Butabarbital (secbutabarbital, Butisol ) B t lbit l (Fi i t ) B t b bit l(b t th l) Butalbital (Fioricet ), Butobarbital (butethal) Thiopental (Pentothal ), Buprenorphine (Suboxone ) Schedule IV Carisoprodol (Soma ), Dichloralphenazone (Midrin ) Fospropofol (Lusedra ), Tramadol (Ultram ) Schedule V Lacosamide (Vimpat ), Pregabalin (Lyrica ) 2

3 Which of these drugs did not change controlled schedule? 1. Butalbital 2. Tramadol 3. Carbisoprodol 4. Propofol Mid level Practitioners APN s may prescribe any oral C II medication in the outpatient setting. Must be part of a written collaborative agreement PA s are still limited to 5 different oral C IIs. Physicians are now required to enter each collaborative agreement into the PMP. APN s within a hospital may prescribe any C II for which they have been credentialed by the medical staff. Oral, IM, IV, SubQ, topical. Electronic Prescribing Sec Electronic prescriptions for controlled substances. Notwithstanding any other Section in this Act, a prescriber who is otherwise authorized to prescribe controlled substances in Illinois may issue an electronic prescription for Schedule II, III, IV, and V controlled substances if done in accordance with the federal rules for electronic prescriptions for controlled substances, as set forth in 21 C.F.R. Parts 1300, 1304, 1306, and 1311, as amended. Sec 312 (i 5) A prescriber may use a machine or electronic device to individually generate a printed prescription, but the prescriber is still required to affix his or her manual signature. C II Sequential 30 day Prescriptions C II prescriptions may not be written for more than a 30 day supply and may be valid for up to 90 days after the date of issuance. (a 5) Physicians may issue multiple prescriptions (3 sequential 30 day supplies) for the same Schedule II controlled substance, authorizing up to a 90 day supply. Before authorizing a 90 day supply of a Schedule II controlled substance, the physician must meet both of the following conditions: Each separate prescription must be issued for a legitimate medical purpose by an individual physician acting in the usual course of professional practice. The individual physician must provide written instructions on each prescription (other than the first prescription, if the prescribing physician intends for the prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill that prescription. What was an unexpected consequence of the three 30 day sequential prescription change? 1. Extended dating on the 2 nd and 3 rd Rx s 2. Maximum 30 day supply for all C IIs 3. Prescriber can t write for two 30 day supplies 4. There aren t unexpected consequenses Mailing of Controlled Substances Controlled substances may be mailed if all of the following conditions are met: The controlled substances are not outwardly dangerous and are not likely to cause injury to a person's life or health. The inner container of a parcel containing controlled substances must be marked and sealed and be placed in a plain outer container or securely wrapped in plain paper. If the controlled substances consist of prescription medicines, the inner container must be labeled to show the name and address of the pharmacy or practitioner dispensing the prescription. The outside wrapper or container must be free of markings that would indicate the nature of the contents. 3

4 Current Pharmacy Legislation HB0030 Medical Marijuana Creates the Compassionate Use of Medical Cannabis Pilot Program Act. Allows for legal possession of up to 2.5 oz of medical cannabis by a registered qualifying patient. Allows registered nonprofit medical cannabis organizations to acquire, possess, cultivate, manufacture, deliver, transfer, transport, sell, supply or dispense cannabis, paraphenalia, or related educational materials to registered qualifying patients. One Nonprofit medical cannabis organization per Senate District! HB3882 Life Saving Drug Shortage Act Sponsor Jack Franks, D, Woodstock Creates the Life Saving Drug Shortage Act Requires manufacturers to notify the Director of IDPH when a drug is discontinued, production is interrupted or adjustment of the manfacture would like result in a shortage. Notification must be 6 months in advance of discontinuation or planned interruption or adjustment. HB3896 Prescription Drug Repository Act Sponsor Patricia Bellock, R, Westmont, IL Creates the Prescription Drug Repository Act Requires IDPH to establish a repository program under which a healthcare facility may donate prescription drugs or supplies to an individual who meets eligibility ibilit requirements. No drugs or supplies donated may be resold. Pharmacists and pharmacy are not required to participate. Amends the PPA and the CSA to allow. HB4454 Amends Pharmacy Practice Act Rep. Angelo Skip Saviano, R, Elmwood Amends multiple practice acts including pharmacy Provides that a disciplinary i hearing may take place without a Board member present. A Department sponsored bill HB5293 Unemployed Protected Status Rep. Mary Flowers, D, Chicago Apply to unemployed collecting benefits or whose benefits have been exhausted. Amends the Public Utilities Act No public utility can cut off gas or electric Amends the Illinois i Marriage and Dissolution i of Marriage Act, Non Support Punishment Act and the Income Withholding for Support Act. May not be imprisoned for non payment of child support Amends the Pharmacy Practice Act Pharmacies must fill prescriptions if the pharmacy receives State or federal funds. 4

5 SB2505/2518 Appropriation of $2.7M for Diabetes Prevention and Control Sponsor Mattie Hunter, D, Chicago $2.7 M to be used for grants and administrative expenses associated with Diabetes Prevention and Control. Additional $250,000 appropriated from the Diabetes Research Checkoff Fund to IDPH. SB2567 Amends the Mental Health and Developmental Disabilities Confidentiality Act Expands the definition of Therapist to include any pharmacist who dispenses meds to a recipient or is consulted by a recipient for the purpose p of dispensing meds that the pharmacist knows or reasonably should know, are intended for the provision of mental health or developmental disability services. Sponsored by the Illinois State Bar Association Why do you think SB2567 is being held in committee? 1. No support 2. There s no need for the legislation 3. The sponsor is ill 4. Too much opposition SB2945 Amends the Smoke Free Illinois Act and Right of Privacy in the Workplace Act Sen. Dan Duffy, R, Barrington Allows health care facilities that provide care to cancer patients to discriminate against smokers or tobacco users when hiring or discharging employees. More specifically it exempts these institutions from discrimination complaints by individuals who use any lawful product for which they discourage the use. SB3197 Creates e Prescribing Act Sen. Iris Martinez, D, Chicago Requires the establishment of a standardized prior authorization process for electronic prescribing software and systems. Prohibits advertising, i commercial ilmessaging, or pop up advertisements that could influence the prescriber including through economic incentives. Prohibits the same for directing to specific pharmacies. SB3513 Amends PPA Vaccinations Sen. Iris Martinez, D, Chicago Decreases the minimum age of children being vaccinated by pharmacists from 14 to 7 years of age. Retains all other requirements regarding vaccinations Requires a prescription or standing order Physician must be notified upon completion 5

6 Who would be opposed to SB3513? 1. Medical Society 2. ASHP 3. IRMA 4. Trial Attorneys USP 797 in Illinois USP 797 and the Illinois Board of Pharmacy The Board heard results of two surveys relating to implementation of USP Chapter 797 at its March 13 th meeting. The first survey was conducted by Board member Miriam Mobley Smith and Chicago State University asking state boards of pharmacy that already require compliance how it has worked for them. USP 797 and the Illinois Board of Pharmacy The second survey was conducted by ICHP and asked Directors of Pharmacy in Illinois hospitals where they were at with compliance andwhat barriers to implementation they have faced. An update will be provided in the April KeePosted. Why can t the Board/Dept. just default to USP 797 as the standard? 1. USP is a federal agency 2. USP is a non governmental agency 3. Illinois doesn t recognize federal standards 4. A and C The Illinois Prescription MonitoringProgram (PMP) 6

7 How the PMP fight prescription abuse When a patient is found to be medication or pharmacy shopping an unsolicited report will be forwarded to each prescriber. Medication Shopping more than 6 prescribers for a controlled substance within 30 days Pharmacy Shopping more that 6 pharmacies filling controlled substance Rx within 30 days. Now monitoring payment type $100 fine per day for willful failure to report dispensing of CSs Why is payment type important to the PMP? 1. To follow the money 2. To detect counterfeit currency 3. Multiple li l payment types often indicates fraud 4. To detect corrupt pharmacies What do we got that others want? Other States are copying our PPA! Really??? Vaccinations/Immunizations (although we re definitely not the only ones) Telepharmacy Remote Prescription/Medication i i Order Od Processing Centralized Prescription Filling Thanks you ve been a great audience! Questions???? scottm@ichpnet.org 7