News Utah Board of Pharmacy
Total Page：16
File Type：pdf, Size：1020Kb
May 2018 News Utah Board of Pharmacy Published to promote compliance of pharmacy and drug law PO Box 146741 • Salt Lake City, UT 84114-6741 www.dopl.utah.gov/licensing/pharmacy.html Legislative Update for Utah 2018 General SB 208 4 Sub: Pharmacy Benefits Manager or Session Coordinator Amendments (Senator Evan Vickers – District 28). This bill requires a pharmacy benefits manager By Drew Favero, 2018 PharmD Candidate (PBM) or coordinator that uses direct or indirect remuneration The following are summaries of bills passed by the Utah fees to report related information to the contracted pharmacy or State Legislature in the 2018 General Session. pharmacy services administration organization, and prohibits Pharmacy a PBM from preventing a pharmacist from disclosing cost Senate Bill (SB) 184 2 Sub: Pharmacist Dispensing information to a patient. Specifically, this bill: Authority Amendments (Senator Todd Weiler – District ♦ Requires that a pharmacy is provided with a reimburse- 23). This bill permits a pharmacist to dispense a self- ment report that: administered hormonal contraceptive under a standing ◊ Explains the reason for any adjusted compensation; and prescription drug order established under a licensed physician. ◊ Is provided in an easily accessible format within 120 Specifically, this bill: days of the request. ♦ Allows a pharmacist or pharmacy intern to dispense a ♦ Prohibits a PBM from preventing a pharmacist from: self-administered hormonal contraceptive when: ◊ Disclosing the cash price of a medication; and/or ◊ The patient is 18 years of age or older; ◊ Charging a patient the retail price of the medication ◊ The patient has completed a self-screening risk assess- without prescription drug coverage. ment questionnaire that has been approved by the Utah Cannabis Products Board of Pharmacy and the Utah Physicians Licensing Board and the results indicate it is safe; and SB 130 2 Sub: Cannabidiol Product Act (Senator Vickers). This bill enacts and amends provisions related ◊ The duration of pharmacist or pharmacy intern dispens- to cannabidiol products and gives the Utah Department of ing does not exceed 24 months without the patient hav- Agriculture related rulemaking authority. Specifically, this ing consulted with a primary care or women’s health bill: care practitioner. ♦ Grants the Department of Agriculture rulemaking ♦ Requires the patient to be provided written information authority to: with: ◊ Apply for a federal waiver from the Controlled ◊ The importance of seeing a primary care or women’s Substances Act; health practitioner; ◊ Authorize the cultivation, production, possession, and ◊ The effectiveness and availability of long-acting use of cannabidiol oil under certain circumstances; reversible contraceptives; ◊ Set a fee to register cannabidiol products; ◊ The patient’s completed self-assessment tool; and ◊ Set requirements for a cannabidiol producer license; ◊ A description of the contraceptive dispensed; or ◊ Establish a cannabidiol product tax; ◊ The basis for not dispensing a contraceptive. ◊ Test cannabidiol products for safety; and ♦ Does not create a duty or standard of care for a person to prescribe or dispense self-administered hormonal ◊ Ensure that products have accurate labeling and any- contraceptives. thing else deemed necessary. ♦ Restricts the liability of a physician who issues the stand- House Bill (HB) 195 3 Sub: Medical Cannabis Policy ing prescription drug order. (Representative Brad Daw – R). This bill is a “right to try” bill that allows cannabis-based treatment for terminally ill patients. Specifically, this bill: continued on page 4 UT Vol. 2, No. 2 Page 1 National Pharmacy Compliance News May 2018 NABPF National Association of Boards of Pharmacy Foundation The applicability of articles in the National Pharmacy Compliance News to a FOUNDATION particular state or jurisdiction can only be ascertained by examining the law of such state or jurisdiction. FDA Requires Labeling Update on drugs or press it into counterfeit prescription pills, often Opioid-Containing Cough and Cold without users’ awareness, which leads to overdose inci- dents, notes the 2017 NDTA. To access the 2017 NDTA, Medicines visit www.dea.gov/divisions/hq/2017/hq102317.shtml. In January 2018, Food and Drug Administration (FDA) announced that the agency is requiring safety labeling FDA Recognizes Eight European Drug changes to limit the use of prescription opioid cough Regulatory Authorities Capable of and cold medicines containing codeine or hydrocodone Conducting Inspections in children younger than 18 years old because the seri- FDA has determined it will recognize eight European ous risks of these medicines outweigh their potential drug regulatory authorities as capable of conducting benefits in this population. After safety labeling changes inspections of manufacturing facilities that meet FDA are made, these products will no longer be indicated for requirements. The eight regulatory authorities found to be use to treat cough in any pediatric population and will capable are those located in Austria, Croatia, France, Italy, be labeled for use only in adults aged 18 years and older. Malta, Spain, Sweden, and the United Kingdom. This In addition, labeling for the medications will be updated achievement marks an important milestone to successful with additional safety information for adult use. This up- implementation and operationalization of the amended date will include an expanded Boxed Warning notifying Pharmaceutical Annex to the 1998 US-European Union consumers about the risks of misuse, abuse, addiction, (EU) Mutual Recognition Agreement, which enables US overdose and death, and slowed or difficult breathing and EU regulators to utilize each other’s good manufactur- that can result from exposure to codeine or hydroco- ing practice inspections of pharmaceutical manufacturing done. Additional information is available in FDA’s news facilities. “By partnering with these countries, we can release at www.fda.gov/NewsEvents/Newsroom/Press create greater efficiencies and better fulfill our public Announcements/ucm592109.htm. health goals, relying on the expertise of our colleagues Latest NDTA Shows Opioids Pose and refocusing our resources on inspections in higher risk Significant Impact to Public Health countries,” said FDA Commissioner Scott Gottlieb, MD, in a news release located at www.fda.gov/NewsEvents/ Drug Enforcement Administration (DEA) indicates a Newsroom/PressAnnouncements/ucm583057.htm. significant shift in the overall drug threat reported by law enforcement over the last 10 years with opioids (including Incorrect Use of Insulin Pens at Home controlled prescription drugs, fentanyl and other synthetic Can Cause Severe Hyperglycemia opioids, and heroin) reaching epidemic levels and impact- The National Coordinating Council for Medication ing significant portions of the United States. According Error Reporting and Prevention has issued an alert on to the 2017 National Drug Threat Assessment (NDTA) the incorrect use of insulin pens at home causing severe report, every year since 2001, controlled prescription hyperglycemia in patients, including one reported fatal- drugs, specifically opioid analgesics, have been linked to ity. The Institute for Safe Medication Practices National the largest number of overdose deaths of any illicit drug Medication Errors Reporting Program has received sev- class, outpacing those for cocaine and heroin combined. eral reports of patients who failed to remove the inner From 2007 to 2010, responses to the National Drug cover of standard insulin pen needles prior to admin- Threat Survey indicate cocaine was the greatest national istering insulin. In the latest such event, a patient with drug threat, followed by a significant decline as the her- type 1 diabetes did not know to remove the standard needle oin threat increased between 2010 and 2016, eventually cover and was unaware she was using the pen incorrectly becoming the greatest national drug threat in 2015. and had not been receiving any of the insulin doses; the Illicit fentanyl and other synthetic opioids, primarily patient developed diabetic ketoacidosis as a result and sourced from China and Mexico and shipped directly to died. the US or trafficked overland via Mexico and Canada, Since insulin pens may differ between pens with are contributing factors in the current synthetic opioid automatic needle retraction devices and those with stan- overdose epidemic. Traffickers in the US usually mix dard needle covers that require manual removal before fentanyl into heroin products and sometimes other illicit administering insulin, it is imperative that removal of Page 2 National Pharmacy Compliance News May 2018 needle covers be explained to patients who are issued Prescription Drugs, is located on the GAO website at standard insulin pens during their diabetes education. www.gao.gov/products/GAO-18-25. Pharmacists should verify that a patient understands the One in Five Drivers Uses a Prescription appropriate administration technique whenever pens and insulin needles are dispensed, notes the alert, which Drug That Can Impair Driving Despite can be viewed at www.nccmerp.org/sites/default/files/ Receiving Warnings nan-20171012.pdf. A new study that analyzes data from the National Road- FDA Advises on Opioid Addiction side Survey of Alcohol and Drug Use, 2013-2014, found Medications and Benzodiazepines that one in five drivers has taken prescription drugs that could impair driving despite having been warned about Opioid addiction