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News New Mexico Board of Pharmacy December 2018 News New Mexico Board of Pharmacy Published to promote compliance of pharmacy and drug law 5500 San Antonio Dr NE, Suite C • Albuquerque, NM 87109 • Tel: 505/222-9830 • Fax: 505/222-9845 In-State Only Toll Free: 1-800/565-9102 • www.rld.state.nm.us/boards/Pharmacy.aspx New Board Member Nick H. Brown John A. Heaton Joe Anderson, PharmD, PhC, BCPS, served two com- Grace Colvin John Huffmyer plete terms as a New Mexico Board of Pharmacy member Kenneth L. Corazza Lowell M. Irby and served as the Central District representative. As a George E. Downs Dale L. Kemper Board member, Joe served on the Board’s pharmacy prac- tice committee. He was a staunch advocate for pharmacy George Elgrably William J. Long students and pharmacy education in the state of New Lawrence N. Etherton Joseph Mengoni Mexico. Joe will continue to serve the public as a cardio- J. Ronald Ewing Edward A. Osborne vascular pharmacotherapy clinician. Majed T. Faruki Philip A. Parkhurst Replacing Joe as the Central District representative is Arturo Figueroa Robert T. Shmaeff Lewis Dale McCleskey, RPh. Lewis brings to the Board Kenneth L. Fourcher Raymond C. Sierks more than 40 years of pharmacy experience across mul- John (Chris) C. Gallegos Larry W. Sparks tiple pharmaceutical platforms. The Board would like to Robert Ghattas Paul F. Tunell welcome Lewis and the vast practical experience he brings Ronald Jack Glenn Johnny S. Volpato to the Board. Richard Gomez The current makeup of the Board is: ♦ Richard Mazzoni, RPh, Northeast District, Board Significant Adverse Drug Events Chaiman 1. A 72-year-old male patient was prescribed thyroid ♦ Chris Woodul, RPh, Southwest District,Vice Chair- (pork) 90 mg, but was given levothyroxine/liothyronine man 90 mg at the point of sale. The dispensing error was not ♦ William “Bill” Lord, RPh, Hospital Representative noticed until the subsequent fill. After taking the medi- ♦ Lewis Dale McCleskey, RPh, Central District cation for approximately one month, the patient com- ♦ Neal Dungan, RPh, Southeast District, Secretary plained of indigestion and drowsiness. The pharmacist ♦ Teri Rolan, RPh, Northwest District attributes the error to a lack of focus and recommends ♦ Michael Garringer, Public Member familiarizing staff with all the different forms of thyroid ♦ Cathleen Wingert, Public Member medications stocked in the pharmacy. ® ♦ Gwen Griscom, Public Member 2. A 30-year-old female patient was prescribed Xarelto Fifty-Year Pharmacists for deep vein thrombosis prophylaxis. A pharmacy technician sold the patient a prescription for Remeron® The following is the current list of pharmacists who have intended for a patient with the same first and last name. been licensed by the state of New Mexico for at least 50 After taking one dose, the patient was admitted to the years and who also maintain an active license. The Board hospital for treatment of moodiness and suicidal ide- thanks you for your service and dedication to the profession ation. The pharmacist attributes the error to inattention of pharmacy and the citizens of New Mexico. on the part of the technician due to a death in the family. This year there are four newcomers to this distinguished The pharmacist recommends adding a middle initial to list. They are: George Elgrably, Majed T. Faruki, Dale L. all duplicate names as company policy so that techni- Kemper, and Paul F. Tunell. Thank you for all you do. continued on page 4 NM Vol. 20, No. 4 Page 1 National Pharmacy Compliance News December 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. SAMHSA Publishes Guidance for ♦ respond to stakeholder feedback requesting guid- Treating OUD ance on the meaning of “facility” under section 503B. To help broaden health care professionals’ un- derstanding of medications that can be used to treat In the guidance, FDA explains that a section 503A Americans with opioid use disorder (OUD), the establishment compounding drugs pursuant to pa- Substance Abuse and Mental Health Services Ad- tient-specific prescriptions may be located near or in ministration (SAMHSA) offers guidance on clinical the same building as the outsourcing facility provided best practices in the February 2018 publication titled that they are completely separate. As explained in the Treatment Improvement Protocol 63, Medications for guidance, the boundaries between the section 503A Opioid Use Disorder. The publication reviews the use establishment and outsourcing facility should be clear of the three Food and Drug Administration (FDA)- and may include permanent physical barriers, such as approved medications used to treat OUD – metha- walls or locked doors, and the two operations should done, naltrexone, and buprenorphine – and other not share rooms, equipment, supplies, or pass-through strategies and services needed to support recovery openings (eg, they may not subdivide a room with for people with OUD. temporary barriers such as curtains). The guidance further explains that the labeling should clearly iden- Additionally, in February 2018, SAMHSA released tify the compounder who produced the drug. Lastly, the publication Clinical Guidance for Treating Preg- the guidance reminds industry and stakeholders that nant and Parenting Women with Opioid Use Disorder all drug products compounded in an outsourcing facil- and Their Infants, which offers standard approaches ity are regulated under section 503B and are subject for health care professionals. This publication pro- to current good manufacturing practice requirements, vides evidence-based treatment options, including even if those drug products are compounded pursuant pharmacotherapy with methadone, buprenorphine, to patient-specific prescriptions. Additional infor- and buprenorphine/naloxone, for pregnant women mation can be located at www.fda.gov/newsevents/ with OUD. The clinical guidance also helps health newsroom/fdainbrief/ucm607339.htm. care professionals and patients determine the most clinically appropriate action for a particular situation EU-US Mutual Recognition Agreement and informs individualized treatment decisions. Both Now Operational Between FDA and 12 publications can be found in the Publications section Member States of SAMHSA’s website at www.samhsa.gov. In January 2018, FDA confirmed the capability FDA Issues Final Guidance Policy on of four more European Union (EU) member states – Outsourcing Facilities Czech Republic, Greece, Hungary, and Romania – to In May 2018, FDA issued a new policy designed carry out good manufacturing practice inspections at to address any ambiguity around how to define the a level equivalent to the United States. With the addi- physical features and operations of outsourcing facili- tion of the four EU member states, FDA can now rely ties. According to FDA Commissioner Scott Gottlieb, on inspection results from 12 EU member states. The MD, the policy in the final guidance, Facility Defini- mutual recognition agreement between the EU and US tion Under Section 503B of the Federal Food, Drug, to recognize inspections of manufacturing sites for hu- and Cosmetic Act, will help to: man medicines conducted in their respective territories is progressing as planned, with plans for the agreement ♦ ensure that compounded drugs are made under to be operational in all EU member states by July 15, appropriate quality standards; 2019, indicates a European Medicines Agency (EMA) ♦ provide transparency to patients and health care press release. In 2017, FDA determined the agency will providers about the standards under which the recognize eight European drug regulatory authorities in compounded drugs that they purchase are made; Austria, Croatia, France, Italy, Malta, Spain, Sweden, and and the United Kingdom as capable of conducting Page 2 National Pharmacy Compliance News December 2018 inspections of manufacturing facilities that meet FDA Pharmacists Are Critical to Drug requirements. The EMA news release, “Four more EU Supply Chain Integrity, States FIP Member States benefit from EU-US mutual recognition Medicines are specialized commodities and, if they agreement for inspections,” can be found in the News are not managed rationally or appropriately, they are and Events section at www.ema.europa.eu. equivalent to a dangerous substance, indicates the US Surgeon General Advisory Urges International Pharmaceutical Federation (FIP). In a More Individuals to Carry Naloxone May 2018 report, Pharmacists in the supply chain: In an April 2018 advisory, US Surgeon General Jerome The role of the medicines expert in ensuring quality M. Adams, MD, MPH, emphasizes the importance of and availability, FIP provides a global picture of the more individuals knowing how to use naloxone and keep- role of pharmacists in supply chains, the tasks cur- ing it within reach. Surgeon General Adams recommends rently undertaken by pharmacists in different coun- that family, friends, and those who are personally at risk tries, and pharmacists’ unique competencies. Based for an opioid overdose keep the drug on hand. As stated on reviews of literature, survey data, and case studies in the advisory, expanding the awareness and availability from nine countries, pharmacists were identified as of naloxone is a key part of the public health response having expertise that is critical to supply chain integ- to the opioid epidemic. The Surgeon General
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