VHA FORMULARY MANAGEMENT - Veterans Affairs



DEPARTMENT OF VETERANS AFFAIRSVETERANS HEALTH ADMINISTRATIONSouth Central VA Health Care NetworkDATE: January 17, 2014Policy Memorandum No. 16-PB-47TABLE OF CONTENTSFORMULARY MANAGEMENT PROCESS PAGE(S)Purpose, Background, Definitions1-5Scope & Responsibilities5-7Procedures8-12Compassionate Use of Nutriceuticals12-14 Cosmetic and Enhancement Drugs14Tablet Splitting14-16Inventory Management16-17Compounding Of Non Sterile Pharmaceutical Preparations18-20PBM Safety Bulletin Preparation and Distribution Policy.20Processes for Reporting Adverse Drug Events20-21Processing Non-VA Prescriptions21-22References & Attachments22-23DEPARTMENT OF VETERANS AFFAIRSVETERANS HEALTH ADMINISTRATIONSouth Central VA Health Care NetworkDATE: January 17, 2014Policy Memorandum No. 16-PB-47Formulary Management Process1. PurposeTo establish responsibility, policy and guidance for the VISN management of the VA National Formulary (VANF) and Pharmacy Benefits Management processes and for monitoring drug use in the network.2. BACKGROUNDDrug formularies in the Department of Veterans Affairs (VA) date back to the mid-1950s. Beginning in 1996, an evolutionary process began to move from a system using more than 170 individual drug formularies to assist in the management of pharmacotherapy, to a formulary process that would result in a single VA National Formulary. This process involved overlaying VISN Formularies to the existing facility formularies, then overlaying a VA National Formulary to the facility and VISN formularies. In 2001, VA abolished medical center formularies, leaving only VISN Formularies and the VA National Formulary to guide management of drug therapy. The migration to VISN and national formularies has allowed VA to rely more uniformly on evidence-based drug evaluations and provide more consistency across VA. The formulary process enables VA to focus on the goals of improved Veteran safety, appropriate drug use, improved access to pharmaceuticals, promotion of a uniform pharmacy benefit, and reduction in the acquisition cost of drugs when feasible.3. DEFINITIONSa. Adverse Drug Event (ADE): An adverse drug event is an injury resulting from the use of a drug. The term ADE includes harm caused by the drug (adverse drug reactions and overdoses) and harm from the use of the drug (including dose reductions and discontinuations of drug therapy).b. Biological Product. Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man.c. DESI Drug. Any drug approved by the FDA prior to 1962 solely on the basis of safety. Thereafter, Congress required all drugs to exhibit efficacy as well. The FDA initiated a Drug Efficacy Study Implementation (DESI) to evaluate the effectiveness of those drugs and any drug related, and similar to them. These drugs may continue to be marketed until the administrative proceedings evaluating their effectiveness have been concluded, at which time continued marketing is only permitted if a New Drug Application (NDA) is approved.d. Do Not Substitute. A listing of drugs for which another manufactured drug may not be substituted. The determination of which product will be used is based on clinical or contractual considerations. The VA “Do Not Substitute” listing will be posted on the VA PBM internet web site ().e. Inservice. Instructional programs that are designed to increase knowledge, and eventually competency, by assisting staff in acquiring, maintaining, improving, and increasing skills and knowledge relevant to fulfilling the requirements of the position for which the individual has been hired.f. Meal. Any time food is served and eaten during or in lieu of breakfast, lunch, or dinner.g. No Buy. The term utilized to identify when the purchase of a specific drug or supply is prohibited, due to law or such designation by the Medical Advisory Panel and VISN Pharmacy Executives.h. Non-Formulary. Drugs or supplies that are defined as commercially available products, but are not included on the VA National Formulary.i. VISN Pharmacy Benefits Management (PBM). A program office aligned under the VISN Chief Medical Officer which is comprised of pharmacy and physician leaders from each site in VISN 16 with expertise in clinical pharmacy practice, prescription benefits management, VA regulations and federal law related to pharmacy operations. This program office works with the National PBM, Medical Advisory Panel (MAP) and the VISN Pharmacy Executives (VPE) to facilitate and coordinate the VA National Formulary process and implement national and VISN medication management processes within VISN 16.j. Pharmaceutical Company Representative. This term refers to anyone acting on behalf of a manufacturer (i.e., pharmaceutical, supply, etc) or its business partners for the expressed purpose of promoting the use of its products. These products primarily include drugs and to a lesser extent medical supplies, nutritional supplements, and similar commodities managed under the VA formulary process.k. Placebo. An inert or innocuous substance without pharmacologic properties.l. Reorder Point (ROP). This is the minimum level at which time additional inventory is to be ordered.m. Reorder Quantity (ROQ). This is the quantity of a given product that is ordered when stock levels reach the reorder point.n. Restriction. The establishment of criteria to guide the use of drugs or supplies that require close monitoring to ensure appropriate use. Restrictions are evidence-based and allow prescribing by authorized providers with recognized expertise when clinical conditions warrant drug use. o. Therapeutic Class. A grouping of individual drugs with similar therapeutic uses, but not necessarily similar pharmacologic activity (e.g., an Antilipemic Therapeutic Class could contain HMG-CoA RIs, Bile Acid Sequestrants as well as Fibric Acid Derivatives and Nicotinic Acid).p. Therapeutic Interchange. The authorized exchange of a therapeutic (drug) alternative that is available on the National Formulary, in accordance with established, written guidelines.q. Therapeutic Subclass. A grouping of drugs with similar pharmacologic activity (e.g., the therapeutic class of Antihyperlipidemics would include the therapeutic subclass of HMG- Coenzyme A [CoA] Reductase Inhibitors [RI]).r. VA National Formulary (VANF). A listing of products (drugs and supplies) that must be available for prescription at all VA facilities, and cannot be made non-formulary by the VISN or an individual medical center. Regarding chemical or biological entities that by law must be submitted to the U.S. Food and Drug Administration (FDA) for pre-marketing approval, only those entities that actually have been approved by FDA, via a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or biologics license, may be added to the VANF or recommended for addition by the VISN 16 PBM Committee.s. VA Provider. A VA Provider is a health care professional who performs specific professional medical services. For the purpose of this policy a VA Provider refers to a licensed individual practitioner (e.g., Physician, dentist, pharmacist, nurse practitioner, physician’s assistant etc.), with prescriptive authority within VHA.t. VISN Restriction. In the absence of national guidelines, reasonable restrictions may be imposed at the VISN level. Facility specific restrictions for antibiotic stewardship is permissible; however, local site restrictions may not supersede national guidelines. Restrictions will not be based solely on economic issues and should not be so limited as to prevent Veterans with legitimate medical needs from receiving needed medications.u. VISN Pharmacy Executive (VPE) – The VISN Pharmacy Executive is charged by the VISN Director and VISN Chief Medical Officer with the task of chairing or co-chairing the VISN PBM Committee and serving as the VISN 16 representative to the national VISN Pharmacy Executive Committee.v. VISN Pharmacy Executive Committee. A group comprised of pharmacists and physicians who represent each of the 21 VISNs. They provide clinical, strategic and operational input to the PBM on VA National Formulary management issues.w. VISN Clinical Pharmacy Workgroup. A group comprised of clinical coordinators and clinical pharmacists from each site in VISN 16. Their function is to provide input to the VISN PBM Committee regarding emerging pharmacotherapy, cost initiatives, medication use evaluations, CPRS tools / templates, and safety alerts. 4. SCOPEFormulary management is an integral part of VA’s comprehensive health care delivery process. The VANF is the only drug formulary authorized for use in the Veterans Health Administration (VHA). The use of VISN formularies or local drug formularies at individual medical care facilities is prohibited. The formulary management process must provide pharmaceutical and supply products of the highest quality and best value, while assuring the portability and standardization of this benefit to all eligible Veterans.5. RESPONSIBILITIESa. The VISN PBM Committee will be chaired by the VISN Pharmacy Executive and will be composed of the Chief, Pharmacy Service, and Chair of the P&T Committee from each Medical Center. Additional members may be added with the approval and guidance of the VISN Chief Medical Officer (CMO). Supporting staff who serve as ex-officio members will include, but not be limited to, the VISN Clinical Pharmacist (Pharmacoeconomics); VISN Data Warehouse Clinical Manager and/or Data Warehouse specialist and others as approved by the VISN CMO. VISN PBM Committee members will name alternates or representatives to attend meetings in their absence. The VISN PBM Committee is responsible for:(1) Identifying and requesting drugs for listing to or removal from the VANF;(2) Widely disseminating draft and final Drug Monographs, Criteria-for-Use Statements, Pharmacologic Management Guidelines, and other material necessary to manage the formulary process;(3) Effectively communicating VANF decisions to facility Pharmacy and Therapeutics Committees and all clinical staff;(4) Reviewing PBM reports and data on non-formulary utilization or access to VANF products and taking appropriate action when necessary;(5) Developing VISN tablet splitting policy (if tablet splitting is utilized) to assure appropriate procedures are in place, listing drugs that are candidates for tablet splitting and reviewing that list on an annual basis;(6) Monitoring split medications for adverse events, tracking those events and submitting an annual report to the PBM;(7) Assessing clinical outcomes related to medications being split (i.e., via labs and vital signs);(8) Providing a copy of the VISN Therapeutic Interchange plan to the National PBM as requested, when required by a VANF initiative;(9) Reviewing data provided to the National PBM on the formulary status designation of drugs within the VISN and assuring their accuracy with the VANF designation; and(10) Monitoring and trending of adverse drug events throughout the network.(11) Monitoring the use of treatment guidelines, criteria for use, and measuring Veteran outcomes for drugs as decided by the Committee, its workgroups, or VISN leadership;NOTE: VISN PBM Committee and workgroup discussions and other work of the groups are considered confidential and restricted to VA use. Names and phone numbers of members, agendas, minutes and processes of these groups will not be released to pharmaceutical representatives. Committee and workgroup decisions will be made by consensus when possible. Issues requiring formal votes will be decided by a majority of the voting members present. A quorum will consist of a simple majority of all members. The VISN Pharmacy Executive will cast a vote only in the event of a tie. To assure appropriate representation for all facilities, members are responsible for sending alternates to the meetings or conference calls in their absence. For national recalls that require a response, the VPE shall compile the responses from all VISN 16 sites and send to national as one response. b. The VISN Clinical Pharmacy Workgroup is comprised of clinical coordinators and clinical pharmacists from each site in VISN 16. The VISN Clinical Pharmacy Workgroup is responsible for: (1) Evaluating and recommending emerging pharmacotherapy to the VISN PBM. This data includes monographs, clinical guidelines, therapeutic interchange programs, and criteria for use published by the national PBM.(2) Developing cost effective strategies to follow recommendations from the national lost opportunity cost report (LOC) and other cost-saving initiatives developed at the national or VISN level. (3) Implement VISN medication use evaluations to evaluate clinical outcomes and Veteran safety data.(4) Expand the use of CPRS tools / templates into clinical pharmacy practice to better utilize the time and efforts put forth by clinical pharmacy staff.c. The Pharmacy and Therapeutics (P&T) Committee at VA medical centers or similar authorized body is responsible for:(1) Performing all functions required in the most current applicable Joint Commission (JC) accreditation manuals and the American Society of Health-System Pharmacists (ASHP) Statement on the P&T Committee. (2) Implementing, supporting and monitoring compliance with VANF initiatives;(3) Monitoring non-formulary use (rate of approvals/disapprovals)and providing the information to the VISN PBM Committee;(4) Providing input to the VISN PBM Committee regarding the impact of VANF decisions on medical center operations;(5) Assuring compliance with access to VANF items in closed therapeutic classes and sub-classes or select therapeutic classes and sub-classes; (6) Assuring that the VISN PBM Committee is properly informed of any problems or concerns;(7) Assuring compliance with the VISN Therapeutic Interchange plan when required by a VANF initiative;(8) Complying with the FDA’s MedWatch process, trending Adverse Drug Events (ADE) to identify opportunities for future avoidance and providing relevant and timely information to support the FDA’s MedWatch program (see );(9) Evaluating all protocols concerned with the use of investigational drugs on human subjects; (NOTE: Refer to the VHA Handbook 1108.04 for guidance regarding Investigational Drugs and Supplies.) (10) Reviewing and approving requests for addition to the VANF from providers and forwarding any approved requests to the VISN PBM Committee.(11) Meet as defined in the local medical center policy, but at least six times each calendar year.6. PROCEDURESa. Effective January 15, 2009, the VA National Formulary is the sole drug formulary used in VA.b. VISNs are not permitted to modify PBM-MAP Criteria-for-Use documents. A review of all local Criteria-for-Use documents should be completed annually by the local P&T Committee to ensure compliance with National PBM-MAP Criteria-for-Use documents. c. The VANF Drug Listing will be grouped according to the VA Classification System or other nationally developed/licensed classification system adopted by the PBM and will be updated when changes are required.d. Individual VA medical centers are prohibited from marking VANF drugs and supplies as non-formulary in their local drug file as a means to enforce restrictions or control utilization. e. VANF recommendations will be based on the review of only those drug products approved by the Food and Drug Administration (FDA).f. All reviews of New Molecular Entities will emphasize safety and efficacy of the drugs in patient populations similar to the Veteran population.g. Drugs and supplies will not be added or recommended for addition to the VANF solely for the purpose of performing a clinical trial; however, the VANF is not intended to impede the use of any pharmaceutical agent in legitimate scientific studies.NOTE: Requests for drug or drug class reviews may be submitted to the National PBM by the VISN PBM Committee, the VISN Pharmacy Executive Committee, the Medical Advisory Panel (MAP), VHA Chief Medical Consultants or VHA Chief Medical Officers. Similarly, requests for change in VANF status may be submitted to the National PBM by the VISN PBM Committee, the VISN Pharmacy Executive Committee (VPE), the Medical Advisory Panel (MAP), a VHA Chief Medical Consultant or VHA Chief Medical Officer. An individual or group of physicians or group of physicians may submit a request for VANF addition through their VISN Formulary Committee(s). All requests for change in VANF status will come through the VISN PBM Committee and must contain confirmation that the request has been approved through the local Medical Center P&T Committee process. The following elements, which must be included the VISN request for National PBM action, must be included in the Medical Center request to the VISN PBM Committee: (1) Confirmation of the local Medical Center committee in which action was taken on the product (if applicable); and(2) Literature citations that support the recommendation.(3) Criteria for drug use that addresses indications, monitoring, and any efficacy or safety outcomes specific to the Veteran population, cost effectiveness, safety/risk issues (including propensity for medication errors, abuse potential, etc.);(4) Completion of the Request for Formulary Review form (Appendix A-1);(5) Completion of the Conflict of Interest Form by the parties presenting the drug for formulary addition (Appendix B-1); and NOTE: If approved by the VISN PBM Committee the subsequent referral to the National PBM will contain the signature of the VISN Pharmacy Executive or Chief Medical Officer. These requests will be forwarded to: Pharmacy Benefits Management Service (119D), P.O. Box 126, Hines, IL 60141.h. Requests for the change of VANF status, with regard to pharmacy dispensed medical and surgical supplies, may be initiated by the Medical Center’s Commodity Standards Committee but must be submitted to the VISN PBM Committee for review prior to forwarding to the National PBM for consideration by the MAP and VPEs committees.NOTE: The PBM will send acknowledgement of receipt of the request to the submitting committee or individual within 30 days of receipt of a request for change in formulary status or review of a drug class. This response will be in writing and if a national review is to be conducted, will identify the target date for completion. The National PBM will notify the VISN Pharmacy Executives of requests received and seek evidence-based feedback from the VISN PBM Committee before any decision regarding VANF addition or deletion is made. If a review is conducted, a draft will be distributed to VISN Formulary Committees for wide dissemination and comment.i. Products with FDA approval in a category that is not regulated by the FDA will be preferentially selected for addition to the VANF over Non-FDA approved products.j. In therapeutic classes or therapeutic sub-classes where national standardization contracts have been awarded, additional items from the same class or sub-class may not be added to the VANF, but will be made available through the non-formulary process when medically necessary. k. A non-formulary request process must exist at each VA medical center. The process should assure that decisions are evidence-based and timely. Routine requests for non-formulary agents will be reviewed and the requestor notified of the decision within 96 hours of receipt of a complete non-formulary request. Emergency requests for non-formulary agents will be immediately addressed by individual/s identified in local VA medical center policy. NOTE: If the degree of urgency/emergency is in question, the drug should be provided immediately and the nature of the urgency/emergency reviewed afterwards.l. Non-formulary drugs that have received FDA approval should only be approved when:(1) A documented contraindication exists to the formulary agent(s);(2) A documented adverse reaction occurred to the formulary agent(s);(3) A documented therapeutic failure to formulary therapeutic alternatives exists;(4) No formulary alternative exists;(5) The patient has previously responded to a non-formulary agent and serious risk is associated with a change to a formulary agent; or(6) Other circumstances having compelling evidence-based clinical reasons.m. All physician-initiated appeals of a non-formulary drug request will be received and adjudicated by the Chief of Staff, or designee(s), at the respective medical center.n. There will be no administrative action taken to discontinue pharmacotherapy initiated by an authorized provider at one VA medical center, when a patient transfers their care to a second VA medical center or when care is transferred back to the primary facility. However, VA providers should exercise good clinical judgment to discontinue a medication started at a different VA medical center when they have determined that it is not the best agent for a given clinical situation.o. A new non-formulary request will not be required for patients who have had pharmacotherapy initiated on a non-formulary agent at one VA facility, if their care has been transferred to another VA facility, or when care is transferred back to the primary facility. All documentation for the initiation of therapy should be justified in the patient’s record through a non-formulary consult to pharmacy. The process used by each local facility to track non-formulary requests may be used to facilitate communication between requesting providers and pharmacy.p. For selected non-formulary approvals, the VISN PBM Committee or local P&T Committees should require a reevaluation of the approval based upon clinical response, new clinical findings or after a pre-determined period of time has elapsed.q. The VISN PBM Committee will analyze, trend and report non-formulary utilization data at the VISN and local facility levels. Reported information will include: the number of non-formulary requests received; the number of non-formulary requests approved and denied; and the average time taken to approve completed requests (reported in hours). This information will be sent to the National PBM on a monthly basis.r. VHA policy is to always dispense generically equivalent drugs when they are available. The National PBM/MAP will maintain a list of pharmaceutical products for which substitution is not permitted. Such products will be published as the “VA Do Not Substitute” list. (NOTE: The listing is available on the PBM web site, .)s. CMOP brand of diapers will be utilized with exemptions considered on a case-by-case basis via non-formulary request. Patients in long-term care facilities and under contract will not be supplied diapers as those items should be included in the contract services. t. Therapeutic Interchange (TI) of drugs is permissible when required as a result of a VANF initiative. The National PBM will provide guidance to VISNs regarding essential conversion process elements and such conversions will be reviewed and additional guidance will be provided by the VISN PBM Committee as needed.u. The TI Plan will include examples of patient and provider communication instruments and education materials and a general description of how TI will be accomplished. If required by the National PBM, reporting to the PBM will be completed within 90 days of implementation of the VANF initiative.v. Restrictions to prescribing can be established for VANF items that require close monitoring to ensure appropriate use. For example, in the case of anti-infectives, facility level restrictions intended to prevent resistance are permissible. Restrictions may include evidence-based guidelines and/or prescribing privileges for providers with specific expertise. Restrictions shall not be based solely on economics nor shall they be so limiting as to prevent patients with legitimate medical needs from receiving these medications and supplies.w. The outpatient use of nutritional supplements will be restricted to patients who are tube-fed or who have mechanical eating problems. Use is also permitted for spinal cord injury (SCI) wound care patients. Close periodic monitoring will be assured in all patients to assess the need for ongoing supplementation. Products used for outpatient use (oral or tube feeding) will be limited to items on the VA’s National Formulary. Other items will require approval through the non-formulary approval process.x. All Blanket Purchase Agreements (BPA) will be negotiated at a national level by the National PBM. BPAs that require national participation will be approved by the VISN Pharmacy Executive Committee. VISN participation in a BPA that does not require national participation, will be determined by the VISN PBM Manager in consultation with their VISN PBM Committee.y. A patient must meet one or more of the following medical criteria for issuance of a blood glucose monitoring device (BGMD) as per National PBM Guidelines and adopted from the VA/DOD guidelines. (1)Type I diabetics and Type II diabetics treated with insulin;(2)Diabetic who is initiating insulin treatment;(3)Gestational diabetes mellitus;(4)Patient receiving hyperalimentation therapy, or(5)Non-Insulin Dependent Diabetics (NIDDM) when provider determines use will alter clinical outcome and patient/provider establish measurable clinical contract for use.NOTE: For stable type II DM, no more than 50 strips per 150 days. z.The patient and/or caregiver must be physically and mentally capable of operating the BGMD and agree to utilize the BGMD. The patient's provider will determine this capacity before the device is issued. The patient must be willing to comply with all home BGMD policies and procedures. Compliance will be evaluated at the time of equipment issuance and at appropriate clinic follow-up visits.7. Compassionate Use of Nutriceuticalsa. The National MAP and VPEs have determined that only those dietary supplements, where an FDA approved pharmaceutical that has been proven to be safe and/or effective does not exist, may be considered for the VANF and for use in VA patients. The dietary supplements meeting this criterion are referred to as “nutriceuticals.” If a dietary supplement meets this definition, it must also meet other rigorous criteria to be considered for use in the VA that include:(1) Possessing scientific evidence supporting its safe and effective use in a particular disease state; (NOTE: The evidence must come from well-designed, randomized controlled trials, providing level 1A evidence and published in recognizable peer-reviewed journals.)(2) Meeting compendium standards for the particular nutriceutical (if standards exist for the product); (NOTE: The National PBM will review the manufacturing standards to ensure the product’s consistency of formulation. If compendium standards do not exist for a nutriceutical, the National PBM will review all available manufacturing information to satisfy the concern.)(3) Utilizing Good Manufacturing Practice (GMP) standards as recommended by the FDA to ensure a product’s purity; and(4) The prohibition of any product considered to be a food or beverage.b. Products meeting all of the above criteria for a nutriceutical, may then be reviewed by the National MAP and VPE committees, who can recommend formulary status and develop Criteria-for-Use. To determine if the product meets these criteria the MAP and VPEs will:(1) Review all clinical evidence collected by the PBM clinical staff;(2) Make a determination of whether or not the supplement meets the VA definition of a nutriceutical; (3) Recommend the need to develop Criteria-for-Use for the nutriceutical;(4) List the factors or advantages, in which they are interested (e.g. fish oils: product with a lower number of capsules needed to meet required intake), to assist in product selection; and(5) Recommend VANF Status.c. Once VANF status has been recommended, the assigned national contracting officer will:(1) Develop a solicitation to request bids from manufacturers of the specific nutriceutical;(2) Provide a projected number of users of the product;(3) Review manufacturer documentation pertaining to consistency regarding the quantity of ingredients contained in a product; and (4) Review all manufacturer documentation of GMP standards and evidence that they are practicing them.d. The contracting agent will review all available product information to determine:(1) The best price available;(2) How the needs of VA, with regard to product supply, will be met;(3) Product consistency related to the quantity of ingredients contained in a product; and (4) The manufacturer’s GMP standards.e. The following procedures must be followed in all instances when a product is being considered:(1) Nutriceuticals may be submitted for review by the MAP and VPE Committee as a Dietary Supplement or based on a perceived need for VA patients.(2) As with pharmaceuticals, the National PBM will assign a clinician to review the particular dietary supplement.(3) The clinician will determine if the supplement meets the VA definition for a nutriceutical. When a supplement does not meet the definition, the requestor will be informed.(4) If the supplement meets the VA definition of a nutriceutical, the clinician will review the peer-reviewed, published literature to develop a review or monograph. This review will be similar to that performed for any FDA approved pharmaceutical.(5) If the nutriceutical is covered in the U.S. Pharmacopeia, Homeopathic Pharmacopeia of the U.S., or the National Formulary, the manufacturer must provide proof that the manufacturing process ensures that the product consistently meets the compendia standard.(6) If the product is not covered by a compendia standard, the manufacturer must be able to demonstrate that their nutriceutical product contains a consistent quantity of the ingredients. However, if the manufacturer is unable to prove product consistency with regard to the ingredients, it cannot be considered for addition to the VANF or for non-formulary approval.(7) Manufacturers must be able to demonstrate or provide adequate documentation regarding their current GMP standards. If they are unable to do so and VA is not assured that the product is free from contaminants or impurities, introduced during the manufacturing process, the product cannot be considered for addition to the VANF or for non-formulary approval.8. COSMETIC AND ENHANCEMENT DRUGSRefer to VHA Handbook 1008.08. 9. Tablet Splittinga. Medical centers are permitted to establish tablet splitting programs for both inpatients and outpatients. However, tablets should be split for inpatients only when the required dosage is not available in a commercial package. b. Determination of patient suitability for a tablet splitting program will be individualized according to a patient's unique capabilities. Patients who express a desire to not participate in a tablet splitting program must be permitted to receive full tablets.c. All patients in a tablet splitting program will be provided a tablet splitter and will be educated regarding its use.d. Tablets will not be split into more than two pieces unless specifically designed for that purpose.e. To assure appropriateness, all medical center tablet splitting programs will be approved by the VISN’s Formulary/PBM Committee. (App C-1)f. Tablets may be split outside of a formal tablet splitting program to achieve an intermediate dose not available with marketed strengths, or at the request of an individual provider.g. The following requirements must be followed whenever tablet splitting is instituted.(1) Tablets that must not be split are:(a) Sustained release preparations (unless scored and designed to allow tablet splitting);(b) Enteric coated tablets;(c) Tablets that crumble easily;(d) Tablets that cannot be split consistently into equal parts unless small fluctuations in the delivered dose do not alter clinical effect (i.e., some HMG-CoA reductase inhibitors);(e) Tablets with a narrow therapeutic, index unless required for therapeutic reasons or titration or where the required dose is not commercially available; and (f) Products in which tablet splitting would result in destruction of the release mechanism of the individual drug.(2) Any patient who is otherwise able, but is unwilling to participate in a tablet splitting program, must be provided whole tablets if they are commercially available. Patients with caregivers with similar reservations should also be provided whole tablets.(3) The patient or caregiver should be able to demonstrate:(a) An understanding of the purpose for splitting medication;(b) An understanding the intended dose and treatment regimen; and (c) The physical ability to easily and accurately split the tablet. (4) Medications eligible for tablet-splitting will have an associated message tagged in the master drug file that alerts the provider that the dose will be provided as a split tablet unless otherwise ordered. This message will appear on the screen in CPRS when one of the tagged medications is selected for prescription.(5) Tablet splitting will be considered only when it is clinically appropriate and after determination of patient suitability and willingness to participate. (6) If the patient is not willing or is unable to split tablets utilizing the intended device, the provider will notify pharmacy of the need to dispense whole tablets. (7) Patients will be provided tablet splitting devices, free of charge, as often as necessary. Written instructions on their use will be provided with each splitter. (8) The dosage strength of the whole tablet should be printed on the label as part of the product name.(9) Directions on the prescription label must reflect the exact product and dosing instructions. To avoid misunderstanding providers should prescribe the medication strength and dose in milligrams (e.g., simvastatin 40 mg. tablet. Take 20mg [one-half tablet] daily). One-half should be spelled out on the label to avoid misreading “1/2” as 1-2 tablets.h. If tablets are to be split for inpatients: (1) The pharmacy will split the tablet to be dispensed in the most ready to administer dose for the nurse, doctor, pharmacist or other healthcare team member approved to administer the medication.(2) Split tablets for inpatient use will be bar coded so that they will be recognized as the appropriate final dose in the Barcode Medication Administration (BCMA) system. 10. INVENTORY MANAGEMENTa. Inventory control is an integral part of formulary management. VISN 16 medical centers are required to follow VHA Handbook 1761.2, Section 9, published by the VHA Office of Clinical Logistics (10F). Pharmacy inventory managers, purchasing agents and their supervisors must be fully acquainted with VHA Handbook 1761.2 and follow all requirements. The following are items of particular importance:(1) The pharmaceutical prime vendor will be used as the primary source of all pharmaceutical purchases whenever possible;(2) When needed, inventory management staff may request training manuals and on-site training from the pharmaceutical prime vendor; (3) Demand Forecasting, in which weighting factors are applied to past purchases, will be utilized to factor trends into the calculation of both the Reorder Point (ROP) and Reorder Quantity (ROQ) for more accurate inventory management;(4) Bar Code shelf labels containing the product name, item number, reorder point (ROP) and reorder quantity (ROQ) will be affixed to all stock locations;(5) A hand held barcode reader, provided by the prime vendor, will be used for scanning the shelf label for items whose schedule dictates reorder;(6) All received invoices will be uploaded into the VistA drug accountability software;(7) End of year purchases make pharmaceutical inventories increasingly difficult to manage and should be avoided;(8) An annual wall-to-wall inventory of all items will be sent by individual facilities to the National PBM Service by February 28th of each calendar year. b. There must be a clear separation of duties to minimize the risk of fraud or loss of property. Assignment of duties, such as: authorizing, approving, and recording transactions; receiving assets; approving cardholder statements; making payments; certification of funding; and reviewing or auditing, need to be assigned to separate individuals to the greatest extent possible. For clarification, one person cannot be the cardholder and approving official for the same transaction.c. “Specialty Distributed” drugs are not available through the prime vendor's normal process.? They have an ordering process specific to the manufacturer and are distributed through a Specialty Distribution Company or a third party distributor.? Reasons for specialty distribution include patient safety, limited manufacturing capacity and need for educating providers and pharmacies to assure appropriate use.? (NOTE: The National PBM maintains a website with a list of specialty distribution drugs and the process for ordering.) . The ABC inventory analysis method will be utilized to manage pharmacy medications and supplies. The “A” items (approximately 70% of the inventory dollars and 10% of the products) are to be monitored closely to reduce total inventory carrying cost. The “B” items (approximately 20% of the inventory dollars and 20% of products) can be managed less aggressively. The “C” items (approximately 10% of the inventory dollars and 70% of the products) can be managed least aggressively and the ordering process for these items can be streamlined to reduce daily workload requirements for these items.11. COMPOUNDING OF NON STERILE PHARMACEUTICAL PREPARATIONSa. Medical centers must ensure that all non-sterile compounded preparations (NSCP) are prepared and stored in a manner consistent with United States Pharmacopoeia (USP) Chapter <795> (entitled “Pharmaceutical Compounding - Non-Sterile Preparations”), USP Chapter <1075> (entitled “Good Compounding Practices”) and USP Chapter <1160> (entitled “Pharmaceutical Calculations in Prescription Compounding”). The Food and Drug Administration’s (FDA) guidance on pharmacy compounding should be used for guidance. b. Pharmacy services must assess their capability to compound such preparations that are not commercially available based on equipment, resources and expertise to evaluate and prepare the final preparation. c. The requested NSCP must not represent a combination formulation consisting of commercially available FDA-approved products unless there exists evidence from published studies to support the safety, efficacy, stability and, lastly, cost effectiveness of the NSCP formulation. d. The pharmacist or designated pharmacy personnel under the supervision of the pharmacist is responsible for compounding preparations of acceptable strength, quality, and purity with appropriate packaging and labeling in accordance with good pharmacy practices and current scientific principles.e. All requests for NSCP must be pursuant to a valid VA prescriber’s prescription (or medical order) for an identified patient. When the request for a NSCP is made, the pharmacist must first recommend an alternative therapeutic regimen from the VHA drug formulary to be given full consideration. If the recommended alternative drug product is non-formulary, appropriate non-formulary approval procedures should be followed to secure the drug product. The request for a NSCP would be considered if it is not available commercially and there exists a specific medical need which renders NSCP as significantly different (e.g., the patient is allergic to one or more of the excipients, inactive ingredients or dyes in the commercially available product, and there are changes in strength, dosage form or delivery mechanism that would be considered unique for the NSCP). Any NSCP provided to the patient must conform to the requirements as outlined in the USP provisions in paragraph 12.a. f. The pharmacist must ensure that the NSCP, if prepared, is:(1) An article in the USP monograph;(2) FDA approved (if no USP monograph exists); or(3) Has evidence of safety from published studies (supplied by the prescriber for labeled or unlabeled use). g. A pharmacist must determine if each active ingredient in the requested NSCP is identifiable as to its quantity and quality. The active ingredient(s) used in the NSCP must be effectively absorbed, either locally or systemically according to the prescribed purpose, preparation and route of administration. h. The requested NSCP must not present demonstrable difficulties in compounding (e.g. sophisticated drug delivery system, dosage uniformity in bioavailability, complex compounding process, sophisticated facilities or equipment or highly technically trained personnel. If so, the pharmacy, may, with approval from the Chief of Pharmacy Service, make a contractual arrangement with a pharmacy provided:(1) The contract pharmacy has the necessary equipment and qualified personnel with appropriate practice experience to compound the NSCP; and(2) It is a certified member of the Pharmacy Compounding Accreditation Board. (NOTE: the website for the Pharmacy Compounding Accreditation Board is .)i. The requested NSCP’s intended use must be within the scope of practice or specialty of the prescriber to justify its medical necessity. j. The requested NSCP must not be a component in the FDA Negative List or have been withdrawn from the market due to safety concerns k. The pharmacist must ensure that the compounding process of the NSCP is assured to minimize error and maximize the prescriber’s intent for the patient. Specifically, the pharmacist must ensure that;(1) The necessary calculations are performed to establish the amounts of ingredients added; (2) The equipment required to compound the product is available and calibrated; (3) The proper attire and procedures are followed by the pharmacist or technician during compounding; (4) Only one prescription product will be compounded at a time; (5) A log of all compounding is maintained;(6) A pharmacist checks and verifies each NSCP; and (7) All required information and instructions are included on the prescription container. l. Both the prescriber (via the prescription) and the patient (via the label) must be aware that a NSCP is being dispensed. m. The pharmacist is to provide patient counseling about the NSCP as to its beyond-use date, storage, and on any evidence of instability (e.g. visual changes, odor, etc.) that may be observed. 12. PBM SAFETY BULLETIN PREPARATION AND DISTRIBUTION POLICYThe National PBM Service monitors the safety of marketed medications on an ongoing basis. In addition, it is also responsible for the VA Adverse Drug Event Reporting System (VA ADERS). VA ADERS standardizes reporting at the facility level, centralizes data analysis and improves efficiency of ADE report coding that is used to categorize and classify adverse drug events. Included in this process are the review, preparation and distribution of Drug Safety Bulletins that provide guidance on patient safety concerns associated with FDA-approved drugs and over-the-counter medications. The release of these bulletins will be assigned in accordance with their assessed level of priority or alert levels.Medical centers will develop local processes to distribute and respond these alerts consistent with guidance issue by the National PBM and VACO. (Attachment D-1)13. PROCESSES FOR REPORTING ADVERSE DRUG EVENTSThe following description provides processes used by the VA medical centers to report adverse drug events under the VA Adverse Drug Event Reporting System (VA ADERS).a. The following terms have been defined by the National PBM Services Center for Medication Safety.Adverse Drug Event (ADE): is an injury resulting from the use of a drug. Under this definition, the term ADE includes harm caused by the drug (adverse drug reactions and overdoses) and harm from the use of the drug (including dose reductions and discontinuations of drug therapy). Observed ADE: is defined in the Computerized Patient Record System (CPRS) as a reaction that is “directly observed or occurring while the patient was on the suspected causative agent.” Observed refers to a newly noted adverse outcome, typically within the past 3 months. Although the term implies that the clinician of record made the diagnosis, the fact that a clinician of record made the diagnosis, the fact that a clinician does not visually “observe” an adverse drug reaction does not preclude reporting it as “Observed”.Historical ADE: generally refers to events in the past (i.e., more than 3 months old) or that reportedly occurred in the past at another healthcare setting. It is defined in the CPRS system as “reported by the patient as occurring in the past; no longer requires intervention.”Mild ADE: requires minimal therapeutic intervention such as discontinuation of drug(s).Moderate ADE: requires active treatment of adverse reaction, or further testing or evaluation to assess extent of non-serious outcome.Severe ADE: includes any serious outcome, resulting in life- or organ-threatening situation or death, significant or permanent disability, requiring intervention to prevent permanent impairment or damage, or requiring/prolonging hospitalization.b. Reporting ADEs to the VA Adverse Drug Event Reporting System (VA ADERS):All observed and historical ADEs are recorded in CPRS.All observed ADEs, regardless of severity, are entered into the VA Adverse Drug Event Reporting System (VA ADERS).Reports can be entered into VA ADERS by any VA health care provider at who has the ability to access CPRS.Severe ADEs and ADEs to new drugs within three years of entry into the market are reported to VA ADERS and sent to the FDA MedWatch program by the reporter utilizing the VA ADERS fax server.The sections to be completed on the VA ADERS report form include:Reporter informationPatient demographicsSuspect drug(s)ADE event section 1Outcome (MedWatch reports only)ADE event section 2 (MedWatch reports only)Treatment drug(s)Manufacturer information (MedWatch reports only)ProbabilitySeverityMechanism (i.e. drug-drug interaction)PreventabilityNOTE: See attachment C-1, PBM National Safety Alert Distribution Policy, for the preparation and distribution of PBM Safety Bulletins.14. PROCESSING NON-VA PRESCRIPTIONSThis policy may not apply to Veterans in certain programs such as Aid and Attendance, Fee Basis and Vocational Rehabilitation/Chapter 31. VA Healthcare is available for all eligible Veterans; however, only Veterans who are currently receiving care through VA may receive prescriptions from VA. Prescriptions from non-VA providers will not automatically be rewritten. VA pharmacies may only fill prescriptions from providers who are privileged through Credentialing or a Scope of Practice Board. Veterans are encouraged to obtain all of their care through the SCVAHCN. However, there may be situations in which a Veteran chooses or needs to have some of his/her care provided in the community. Nevertheless, each patient must still be assigned to, followed and managed by a VA provider in order to obtain medication and other prescriptive items from the VA. a. If a Veteran is being seen concurrently by a non-VA provider:(1)It is the Veteran’s responsibility to furnish VA with non-VA healthcare records. Appropriate care requires pertinent information that supports the rationale and need for requested medications, supplies, or diagnostic tests.(2)The name, address, and telephone number of the community providers regularly seen by a patient should be documented in the patient’s VA medical record.(3)Veteran patients using community providers on a regular basis must be informed about this policy and given appropriate educational materials. (Attachment E.)(4)VA health care providers can only prescribe medications and supplies that are listed on VA’s approved list (formulary) unless he/she obtains specific approval from the Chief of Staff/designee. The list includes drugs from all major categories. Although trade (brand) name drugs may not be on the list, VA health care providers can prescribe other closely related medications. VA will not reimburse Veterans for medication purchased at a community pharmacy.(5)If a Veteran uses medications not obtained through the VA, those medications will be entered by the VA provider into the patient’s medication profile using the “Non-VA Medications” software in CPRS. Such medications may include prescriptions drugs, over-the-counter (OTC) medications, herbals and non-traditional medications, nutritional supplements, etc.b.VA providers who prescribe high-risk medications that require special monitoring (e.g. warfarin, lithium, digoxin, immuno-suppressive agents, chemotherapy, etc.) must monitor and document appropriate test results in accordance with VHA clinical prescribing guidelines.NOTE: Refer to VHA National Dual Care Policy//signed//Rica Lewis-Payton, MHA, FACHENetwork DirectorAttachments: 5Attachment - A Request for Formulary ReviewAttachment B - Conflict of Interest FormAttachment C - Tablet Splitting ProgramAttachment D - PBM Safety Bulletin Preparation and Distribution Policy\sAttachment E – Patient Education: Co-Managed Care\sEXPIRATION DATE: January 17, 2017RESCISSIONS: SCVAHCN Policy 16-PB-47 dated August 28, 2014REFERENCES:a. ISMP Medication Safety Alert. Tablet Splitting: Do it if you “Half” to, and Then do it Safely. May 18,2006; 11(10): 2-3.b. United States Pharmacopeia Convention, Inc. USP Pharmacists' Pharmacopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005.c.VHA Handbook 1008.08, VHA Formulary Management Process, February 26, 2009. d. VHA National Dual Care Policy, VHA Directive 2009-038, August 25, 2009. RESPONSIBLE OFFICIAL: VISN 16 Pharmacy Executive DISTRIBUTION: All SCVAHCN Medical Centers ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download