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How to Survive a DEA Inspection Series NEW YORK CITY PHARMACISTS SOCIETY How To Survive A VOLUME 29, ISSUE 9 PSSNY HELPLINE 1-800-632-8822 DECEMBER 2020 - YEAR END DEA Inspection Series: The Voice of Pharmacy in the Big Apple www.NYCPS.org $15,080 Per Civil Fine© PRESIDENT’S MESSAGE Well, here it is as we I want to wish pharmacists, get recognized as an approach 2021 and everyone a Happy essential healthcare partner in the we wish you, your and a Healthy New community setting. family, and your staff Year!!! We also had a very big win late lots of health, happi- Instead of recapping last year with the Supreme Court’s ness, and wealth in 2020 I want to talk unanimous decision overturning 2021! We also wish your pharmacy about what we can the Eighth Circuit’s decision that a checkbook, lots of health! anticipate this coming year. There 2015 law banning pharmacy benefit My article is about your pharmacy are so many things to look forward managers from swindling local and your inventory of controlled sub- to like Covid-19 testing that pharma- pharmacies defying the Employee stances. If you do not want to keep a cies already started, COVID-19 vac- Retirement Income Security Act perpetual inventory of your controlled cines that we will be providing and (ERISA). If you remember that the substances because you trust your a lot more opportunities that will be Governor Cuomo’s veto was partly pharmacists and staff, I can sell you coming our way as we, community based on the ERISA ruling and now continued on page 20 continued on page 20 ATTENTION PHARMACISTS: IF YOU ARE A PHARMACIST AND HAVE BEEN IN CONTACT WITH A COVID-19 PATIENT, YOU CAN OBTAIN PRIORITY TESTING BY CALLING THE NYS DEPARTMENT OF HEALTH COVID-19 HOTLINE AT 888-364-3065 AND TELL THEM YOU ARE A PHARMACIST - AND SINCE YOU ARE A HEALTH CARE WORKER WHO HAS BEEN EXPOSED TO AN ACTIVE COVID-19 PATIENT, YOU WILL BE GIVEN A CALL BACK FOR PRIORITY TESTING WITHIN 24-48 HOURS. MODERN COMPOUNDING PSSNY an OPen Letter tO PERSPECTIVES President’s Message gOv. andrew CuOMO P AGE 3 P AGE 7 P AGE 1 9 CARE OF YOUR DUES, WE NEED YOU AND YOU NEED PSSNY/NYCPS. NEED YOU AND YOU NEED WE DUES, YOUR OF CARE OFFICERS Ilana Aminov, President 212-737-8800 IN THIS ISSUE TAKE AND 8822 632 800 AT PSSNY CONTACT PLEASE NAME. YOUR ABOVE Bill Scheer, Treasurer 917-805-4207 President’s Message ......................1 Jim Schiffer, Secretary 212-616-7069 RIGHT SO, STATING MESSAGE A SEE WILL YOU DELINQUENT ARE YOU IF Mohammed Taher, President Elect 718-827-7528 How To Survive A DEA BOARD OF DIRECTORS Inspection Series............................1 Aneidi Etuk, Chairwoman 212-222-3652 Danny Dang 212-246-8169 Modern Compounding Imran Kazmi 917-449-0086 Vinnie Mazzamuto 718-543-3116 Perspectives ..................................3 Joseph P. Navarra 516-249-7436 Treasurer’s Corner .........................4 Roger J. Paganelli 718-364-6100 Marina Plotkin 212-313-5409 A Message & Greetings from Rathna Veeramachanani 201-780-7210 PSSNY Executive Director ...............4 PAST PRESIDENT BOARD MEMBERS Mike Agovino 718-543-3116 PSSNY President’s Message .......... 7 Charles Catalano 718-358-1300 Ron DelGaudio 718-230-3535 Reminder on Medicaid Managed Care Jim DeTura 718-292-1856 Patients Conversion Back to Medicaid Russell Gellis 212-877-3480 Ray Macioci 914-439-2781 Fee for Service Billing .....................7 Boris Mantell 347-276-5566 Secretary’s Report ..........................8 John Navarra 516-650-1870 Alex Perchuk 718-835-2000 Chairwoman’s Report Parthiv Shah 718-292-4244 News from Around the World ........12 PSSNY REGIONAL REPS Yes, I Got the Vaccine! ..................15 REQUESTED SERVICE ADDRESS Danny Dang Bronx Imran Kazmi Manhattan NCPA Message ............................17 Rathna Veeramachanani Brooklyn, Staten Island Ilana Aminov Queens ISMP ...........................................18 10006 NY York, New 2002, Suite Broadway, 111 RECORDING SECRETARY CPESN ........................................18 Joseph P. Navarra 516-249-7436 An Open Letter to Society Pharmacists City York New The NEWSLETTER Jim Schiffer, Senior Editor 212-616-7069 Governor Andrew Cuomo ..............19 Designed, Printed & Mailed by: GBV Printing Services 631-231-7300 PAAS...........................................21 PAGE 2 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER Keeping you Independently Healthy Helping pharmacies adapt through changing times You’re never just another account. As a family-oriented wholesaler, Kinray provides the speedy, flexible, and nimble service needed to help independent pharmacies adapt for a changing environment. Through a myriad of solutions and as the #1 provider in front-end health solutions, pharmacies are set up for a healthy future and a healthy community. Each pharmacy is part of the Kinray family. LeaderNet • RCS • Reconciliation Our solutions can help you implement retail best practices and prepare you to meet ever-changing healthcare challenges with confidence. Learn how independently healthy you can be by reaching out to your Kinray Sales Consultant today. © 2019 Cardinal Health. All Rights Reserved. KINRAY and the Kinray LOGO are trademarks of Cardinal Health and may be registered in the US and/or in other countries. (2/19) NYCPS NEWSLETTER DECEMBER 2020 YEAR END EDITON PAGE 3 Modern Compounding Perspectives: Assuring the Compliance of Your Compounding Operation – Temperatures and Drug Storage - Items to Consider Assuring Regulatory Compliance. As the pandemic continues to spread, we finally with the requirements and guidance of the USP/NF for have some good news--- several vaccine candidates the materials in your possession. In New York State, this have obtained emergency use authorizations from FDAi. begins with the regulations of the Board of Pharmacy. Pharmacists continue to work as an integral part of the Since most of this regulation deals only with refrigerated healthcare team, we are looking forward to being a large storage (2 to 8 degrees C or 36 to 48 degrees F) you part of the distribution mechanism for these promising must look to National compendia for clear standards in vaccines. No doubt pharmacists will be in the thick of the other areas that are part of your pharmacy operations. the vaccination and distribution efforts to turn the tide of pandemic. As the vaccine stocks begin to be distributed, HOW DO I PUT THIS INTO DAILY PRACTICE? we can do well to focus on what we can control, especially As you access your entire pharmacy operation, you in terms of our service to our patients. need to remember to include all areas where drugs Much has been written about the “cold chain” (both prescription and non-prescription medications) requirements of the Pfizer vaccine candidateii and the are stored. Where the pharmacy department extends to Moderna candidate although less complicated, has the selling floor in retail operations, having the general its own transport and storage challenges as welliii. For ability to monitor this temperature is essential to assure any healthcare professional directly involved in the that you have control over this inventory. If you are using procurement, distribution, and administration of these a storeroom or basement area away from the retail or vaccine you should be thoroughly familiar with all of these general pharmacy areas to hold over-stock or inventory, requirements and processes to protect the drug and the you must be able to monitor those areas. It is ideal for you patients we all serve. to create a standard method to monitor these all these With all that has been published recently on the areas daily and have a way to record these temperatures handling if these vital drug candidates, many health to document the control of this drug inventory. facilities began to review and access their capabilities A small investment in a basic continuous monitoring for the storage of medications in general. This is a system for all these areas (not just the refrigerators prime opportunity for all of us to review our drug storage & freezers) in your pharmacy will make this daily task conditions, processes and the documentation we use simpler. Please remember that the Centers for Medicare to be able to assure that all the active pharmaceutical & Medicaid Services (CMS)iv require that all vaccines ingredients (API), medications (both prescription and be monitored, and those temperatures recorded twice non-prescription) as well as other legend supplies in our daily. These temperature monitoring devices can be charge are appropriate. wired, wireless, or have Blue-tooth™ conductivity. The What follows is an overview of the methods, regulation, equipment you choose will depend upon the number of and general practices to assist you in assessing your areas or devices (i.e., refrigerators) you need to monitor, current situation and to assist you in improving your your budget, as well as the level of for reporting which methods where possible. the accompanying software can deliver. Please refrain The pandemic and the resulting interruptions of our from buying and installing “home-type” systems which normal supply channels have served to underline how are easily found on the web, as these systems are not fragile our pharmaceutical supply pathways can be, so intended for medical or pharmacy applications, and even why not do all you can do to protect and preserve these if they can be “calibrated” they cannot be calibrated to vital materials? the standards of the National Institute of Standards and Technology (NIST)v which is a required annual activity for SO, WHERE SHOULD I BEGIN? any measuring devices in your Pharmacy. It is the responsibility under both Slate and Federal So, what are my targets for temperature monitoring law to assure that all the drugs, components (both active to be compliant to the many overlapping regulations that & inactive) and other medications be of the highest must be satisfied for the storage of my medications and quality and conform to the storage conditions consistent supplies? The USP/NF in General Chapter <659> lays continued on page 25 PAGE 4 DECEMBER 2020 YEAR END EDITON NYCPS NEWSLETTER Our healthcare cost for the United States is $3.5 trillion TREASURER’S a year, increasing each year almost 5%, and consuming 17% of our Gross Domestic Product (GDP).
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