Federal Bureau of Prisons Health Services National Formulary Part I Approved: Jeffery D. Allen, MD, MEDICAL DIRECTOR Page 1 of 52 Table of Contents Summary of Formulary Changes Winter 2020 Meeting .............................................................................................................. 3 National BOP Formulary Mission / Procedural Statement ................................................................................................................... 5 Definitions/Rules ......................................................................................................................................................................... 7 FDA Medication Guides and Side Effects Statement .................................................................................................................. 8 Over The Counter Medications ................................................................................................................................................... 8 Directly Observed Therapy (Formerly “Pill Line”) Only ............................................................................................................... 8 Non-Substitutable Products ........................................................................................................................................................ 9 Look Alike/Sound Alike Medications ........................................................................................................................................... 9 Risk Evaluation and Mitigation Strategies (REMS) .................................................................................................................... 10 Keep On Person (KOP), I.E. Self-Carry Medications................................................................................................................... 10 Non-Controlled Substances Restricted to Directly Observed Therapy ..................................................................................... 11 Non-Formulary Clinical Criteria/Justification Requirements, Algorithms, and Treatments ..................................................... 12 Worksheet for Use of Nutritional Supplement ......................................................................................................................... 31 Non-Sterile Compounding Worksheet ...................................................................................................................................... 32 Urgent Care Cart and Kit Content.............................................................................................................................................. 35 Formulary OTC Prescribing Criteria Matrix 2020 ...................................................................................................................... 36 Hypertensive Emergency & Urgency Guidance ......................................................................................................................... 42 High priority Medical Conditions/Diagnoses ............................................................................................................................. 44 Guidance on Therapeutic Substitution on Intake ..................................................................................................................... 45 Naloxone Protocol and Standing Order .................................................................................................................................... 49 Cautions and Contraindications: ................................................................................................................................................ 51 PART II ......................................................................................................................................................................................... 52 Bureau Of Prisons Medical Services Request For Addition To Formulary …………………………………………………….….Sallyport Forms Items Restricted to Directly Observed Therapy………………………………………………………………………………………….…BEMR RX Report Page 2 of 52 Summary of Formulary Changes Winter 2020 Meeting *** The prescribing of medications against the restrictions, without an approved non-formulary request, is considered an unauthorized use of government funds. The procurement of non-formulary medications or the procurement of formulary medications used outside of formulary restrictions is considered an unauthorized procurement. The prescriber is responsible for justifying the non-formulary request. *** The following is a summary of the major changes as a result of the Winter 2020 BOP Formulary meeting; please refer to the Winter 2020 National P&T minutes for additional information and detailed discussion regarding all of the changes. Revisions or changes from the previous year are highlighted in Yellow throughout the document. Topic Final Action Antimicrobial Stewardship Reviewed Anti-obesity Agents DEFERRED Apixiban Utilization Monitoring Reviewed Aripiprazole ER (Abilify Maintena®) DELETE Aripiprazole lauroxil ER (Aristada® and Aristada Initio®) ADD Asenapine (Saphris®) ADD non-formulary use criteria Azithromycin (Zithromax®) ADD inclusionary diagnostic criteria Bevacizumab (Avastin®) DELETE Bevacizumab-awwb (Mvasi®) ADD Biosimilars ADD restrictions, non-formulary use criteria Buprenorphine extended release injection (Sublocade™) ADD Central Fill and Distribution Procedures (CFAD) APPROVED Clopidogrel Utilization Monitoring Reviewed Colchicine (Colcrys®) UPDATE restriction Epoetin alfa (Epogen®) DELETE UPDATE non-formulary use criteria Epoetin alfa (Procrit®) DELETE UPDATE non-formulary use criteria Epoetin alfa-epbx (Retacrit®) ADD ADD non-formulary use criteria Famotidine (Pepcid®) ADD Fenofibrate (Tricor®) ADD with inclusionary diagnostic criteria Gemfibrozil (Lopid®) DELETE ADD non-formulary use criteria Icosapent ethyl (Vascepa ®) ADD non-formulary use criteria Infliximab (Remicade®) UPDATE non-formulary use criteria Infliximab-abda (Renflexis®) UPDATE non-formulary use criteria Lorcaserin (Belviq®) DEFERRED Lurasidone (Latuda®) ADD non-formulary use criteria Naltrexone/bupropion ER (Contrave®) DEFFERRED Naloxone Nasal Spray (Narcan®) Standing Order ADD standing order Olanzapine pamoate (Zyprexa® Relprevv™) DO NOT ADD ADD non-formulary use criteria Omega-3 fatty acid (Lovaza®) ADD non-formulary use criteria Ondansetron tablet (Zofran) tablets DELETE restriction Orlistat (Xenical®, Alli® OTC) DEFERRED OTC Prescribing Criteria Matrix See famotidine (Pepcid®) Paliperidone palmitate (Invega Sustenna®) ADD Paliperidone palmitate ER (Invega Trinza®) DO NOT ADD ADD non-formulary use criteria Pegfilgrastim (Neulasta®) DELETE DELETE inclusionary diagnostic criteria ADD non-formulary use criteria Page 3 of 52 Pegfilgrastim-bmez (Ziextenzo®) ADD ADD restriction, inclusionary diagnostic criteria and non-formulary use criteria Pegfilgrastim-cbqv (Udenyca®) DO NOT ADD ADD non-formulary use criteria Pegfilgrastim-jmdb (Fulphila®) DO NOT ADD ADD non-formulary use criteria Pharmacovigilance, Patient Safety, and Controlled Reviewed Substance Monitoring Phentermine/topiramate (Qsymia®) DEFERRED Ranitidine (Zantac®) DELETE Rituximab (Rituxan®) DELETE Rituximab-abbs (Truxima®) ADD Therapeutic Substitution Monitoring Review Reviewed Trastuzumab (Herceptin®) DELETE Trastuzumab-anns (Kajinti®) ADD Page 4 of 52 National BOP Formulary Mission / Procedural Statement Purpose: The formulary system, as defined in the "ASHP Statement on the Formulary System", is a method for evaluating and selecting suitable drug products for the formulary of an organized health-care setting. The BOP formulary is a list of medications that are considered by the organization’s professional staff to ensure high quality, cost-effective drug therapy for the population served. Participants of the Pharmacy, Therapeutics and Formulary Meeting are responsible for the development, maintenance and approval recommendations of the formulary to the BOP Medical Director. Periodically, medications are reassessed and extensively reviewed for inclusion, exclusion, or restrictions in the formulary as applicable per current evidence-based practices and security concerns. Regular maintenance of the BOP formulary ensures optimal treatment options are uniformly consistent and readily available. The primary goals of BOP Formulary Management are to optimize therapeutic outcomes, optimize cost effectiveness of medications, and to ensure drug usage is conducive within the correctional environment. Expectations: 1. ALL BOP institutions, including Medical Centers, are expected to abide by the formulary as outlined in the BOP Pharmacy Services Program Statement. It is expected that persons in the review process will NOT be circumvented in the event of a short term absence for non-urgent requests. 2. ALL comments made on the request are expected to be medically appropriate and of a nature conducive to being placed in the medical record. 3. It is expected that non-urgent non-formulary medications will not be initiated until AFTER authorization is received, even if the medication is on the shelf from a previous request. Doing so can be deemed an unauthorized procurement. 4. Prescribers (BOP Physician / MLP / Dentist/ Clinical Pharmacist) are expected to thoroughly justify the request including why the formulary agent cannot be used, and provide pertinent laboratory information. It is expected that non- formulary use criteria will be thoroughly addressed point by point and that all