PBM MAP

 

Pharmacy Benefits Management-

Medical Advisory Panel

Ez-Minutes

Volume 7, Issue 1   January 2009 – April 2009

 

Mission of Ez-Minutes

 

The mission of the Ez-Minutes is to communicate with the field on items that will impact clinical practice in the VHA...whether it would be additions/deletions to the National Formulary, the availability of new Criteria for Use, or new safety information. Bottom line is that many critical issues are included in the newsletter to assist providers in caring for our veterans. Without a doubt, “timely” communication is key. Delivering the information is not only important but also ensuring that the information is received/reviewed by providers in the front line is imperative. Successfully accomplishing this in a large system is challenging. To assist, the following action items will occur:

• The release dates for Ez-Minutes will be altered and posted to the PBM website three weeks following key decision-making VPE-MAP (VISN Pharmacist Executives-Medical Advisory Panel) meetings.  At the time of press, dates of FY10 meetings are being confirmed, so please check the InTRAnet PBM website when future Ez-Minutes will be released;

• Secondly, PBM-MAP encourages sites/individuals to inform providers when the newsletter is posted but to also subscribe to the newsletter. The mechanism to ensure all providers receive the newsletter automatically is currently being discussed, so in the meantime, below is how new subscribers can get on board.:

 

For NEW subscribers only; click on stxcollage@va.gov with "PBM subscribe" in the subject line to subscribe to the newsletter. If you are already a subscriber, please forward this newsletter to your staff, fellow colleagues, P&T committee members so they may take this opportunity to subscribe.

We welcome any feedback and/or suggestions on how to improve the process. Send comments directly to Janet.Dailey@va.gov with Ez-Minutes in the subject line.

 

New Name: Did you catch the new name above? Due to the vast array of duties given to the VISN Formulary Leaders and to better describe their function, VISN Formulary Leaders name has been changed to VISN Pharmacist Executives.

 

New PBM Member:  We would like to welcome Bernadette Heron, Pharm.D., BCOP to the Pharmacy Benefits Management Services.

 

INSIDE THIS ISSUE

·       Posting of National PBM Documents-Jan-April 09

·       Posting of VAMedSAFE Documents Jan-April 09

·       Adult Vaccination Update

·       Oral Sodium Phosphate Products (OSP) for Bowel Cleansing

·         Generic formulation of lamotrigine and topiramate

·         VA Mobile Pharmacy

·         VHA Formulary Management Handbook

·         Procedure to request VA National Formulary Change

·         Call for Publications by VA Pharmacists

·         Ask PBM Clinical E-mail

·         Pharmacy and Prosthetics

·         Pharmacy Residency Director’s Conference-August 09

·         SAVE THE DATES:CE PROGRAMS Anticoagulation and VADERS

·         Chronic Opioid Guidelines

Posting of National PBM Documents: January-April  09

VA National Formulary (VANF) Decisions

Added to the VA National Formulary

Not added to the National Formulary

Removed from the National Formulary

·         bovine thrombin-maintained on VANF; recombinant human thrombin added

·         darunavir (PrezistaTM)—(updated) restricted to ”ID practitioners or providers that provide care to HIV patients”

·         lanthanum carbonate-restricted to

criteria

·         meningococcal conjugate vaccine (MCV4)

·         nutritional osmolite

·         ofloxacin otic solution

·         regadenoson (LexiscanTM)

·         sevelamer carbonate- restricted to criteria

·         tizanidine (Zanaflex®)–VANF restrictions changed to “spinal cord injury, neurology, rehabilitation, pain management specialist, and traumatic brain injury clinics”

·         zanamivir (Relenza®)-restricted to criteria

·         alvimopan (Entereg®)

·         amlodipine/olmesartan (AzorTM)

·         ciprodex-(ciprofloxacine 0.3% and dexamthasone 9.1% otic suspension-maintain VANF status

·         human thrombin (EvithromTM)

·         levocetirizine (Xyzal®)

·         quetiapine (Seroquel XR®)

·         rivastigmine transdermal patch (Exelon®)

·         AK-Rinse

·         bisacodyl/phospho soda kit

·         benzocaine/cetylpyridinium CL (OTC) and

cetylpyridinium CL/menthol (OTC)-- renamed as “Throat Lozenge, lozenge”

·         griseofulvin suspension and tablet

·         itraconazole, injection

·         metaproterenol inhaler

·         mumps virus vaccine

·         nutren products

·         papain products

·         rubella virus vaccine

·         sevelamer HCL-product will be unavailable after 9/30/09

·         tetanus toxoid

·         GFR and CrCl (Estimated) in Kidney Dysfunction

·         Protease Inhibitors in Treatment-naїve HIV-infected Veterans

·         Vardenafil (PDE5 Inhibitor) Quantity Limits

Drug Class Review

·         Pharmacologic Management of Pulmonary Arterial Hypertension

Frequently Asked Questions:

·         How is an AB Generic Rating Approved?

Drug Monographs

Formulary Criteria For Use

·         alvimopan (Entereg®)

·         aprepitant (Emend®)

·         hyaluronidase: bovine preparations AmphadaseTM, HydaseTM; ovine preparation: VitraseTM; human recombinant preparation: HylenexTM

·         levocetirizine (Xyzal®)

·         regadenoson (LexiscanTM)

·         topical thrombin products: (bovine-Thrombin JMI®, pooled human plasma-Evithrom®, recombinant human-Recothrom®)

 

·         antiviral agents for influenza (updated)

·         phosphate binder (lanthanum carbonate, sevelamer carbonate)

·         alvimopan (Entereg®)

·         meropenem (Merrem®)

·         oral disintegrating tablets

 

Posting of VAMedSAFE Documents: January-April 09

National PBM Alerts:

      National PBM Communication

·         Digoxin and tablet size variability recall-April, 09

·         Infed (Iron Dextra) and precipitate formation recall-April, 09

·         Rapitiva (efalizumab) and Progressive Multifocal Leukoencephalopathy (PML), March, 09

·         Clopidogrel and alteration of effectiveness due to inhibition-Jan, 09


Adult Vaccination Update: Focus on Meningococcal and Tetanus Containing Vaccines

 

The updated Centers for Disease Control (CDC) Adult Immunization Schedule was published in January 2009 http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm

 

Addition of Meningococcal Conjugate Vaccine to VA National Formulary

There are two types of vaccines against Neisseria meningitides; the original meningococcal polysaccharide vaccine (MPSV4) was licensed in the 1970’s and the newer meningococcal conjugate vaccine (MCV4) was licensed in 2005. Both vaccines are effective in preventing approximately 90% of immunized individuals against four types of meningococcal disease.  Immunization is recommended for at risk adults including: college freshmen living in dormitories, microbiologists routinely exposed to N. meningitides, military recruits, travelers to or residents of countries in which N. meningitidis is hyperendemic or epidemic (particularly with prolonged contact with the local population), individuals with anatomic or functional asplenia or terminal complement component deficiencies, and individuals receiving eculizumab. The meningococcal polysaccharide vaccine (MPSV4) is administered to those greater than 55 years of age, while the MCV4 is designated to those 19-55 years of age.

Click to read more about the differences between meningococcal polysaccharide vaccine (MPSV4) and meningococcal conjugate vaccine (MCV4) formulations and recommendations for use in adults.

 

Since there are differences between the polysaccharide and conjugate vaccine in terms of recommended age group to administer, duration of immunity and need for booster doses, providers are requested to specify which vaccine (polysaccharide or conjugate) is to be administered to individual patients and that information should be documented in the patient’s medical record.

 

Tetanus Containing Vaccines

There are currently three different tetanus containing vaccines available for use in adults:  tetanus and diphtheria (Td), tetanus, diphtheria, and pertussis (Tdap) and tetanus toxoid (TT).

Click here to read the complete article including the CDC recommendations for routine vaccination, prophylaxis with this vaccine, and what the PBM-MAP did to reduce confusion with the tetanus containing vaccines on VA National Formulary.                                                                                                                                                        Return to the Top


Oral Sodium Phosphate Products (OSP) for Bowel Cleansing

On 12/11/2008, the FDA issued an Alert which warned of acute phosphate nephropathy being associated with oral sodium phosphate (OSP) products used for bowel cleansing prior to a procedure.  Acute phosphate nephropathy describes deposition of calcium-phosphate crystals in the distal tubules and collecting ducts and may result in acute kidney injury and permanent impairment of kidney function.  In March 2006, an FDA Alert reported cases of acute phosphate nephropathy associated with the OSP solution and prescription tablets for bowel cleansing; some of these cases resulted in renal failure.

  

FDA recommendations to manufacturers

·         Add a Boxed Warning to prescription OSP tablets (OsmoPrep®, Visicol®)

·         Use medication guides

·         Develop a risk evaluation and mitigation system (REMS)

·         Conduct a post-marketing clinical trial 

FDA recommendations to providers

·         OTC (over-the-counter) OSP laxative products should not be used for bowel cleansing

·         OTC OSP laxative products may continue to be used as laxatives for relief of constipation

·         OSP products should only be used by prescription for bowel cleansing

Because of recent voluntary recalls of many OTC OSP bowel cleansing solutions (as a result of the FDA recommendation that OTC products not be used for bowel preparation), PBM Services discussed ways to ensure the safe use of OSP preparations with the Renal and Gastrointestinal (GI) Field Advisory Committees, PBM Medical Advisory Panel, and VISN Pharmacist Executives, with additional input from local gastroenterologists.  Since adequate colon cleansing is essential for optimal visualization during colonoscopy and will often depend on the patient’s ability to complete the bowel preparation, our advisors felt that OSP products should be available for patients who cannot tolerate PEG solutions, and that a variety of options should be available to the provider when selecting a preparation for an individual patient taking into consideration efficacy, safety, and tolerability.  Therefore, the PBM-MAP and VPEs agreed that OSP products should be available on the VA National Formulary to provide another option for patients requiring bowel preparation.   

 

As a result, the following changes will be made to the VA National Formulary:

 

Add: Sodium Phosphate, Tab; Restricted to GI 

Two prescription OSP tablets (OsmoPrep® and Visicol®) are marketed, with each tablet containing the same amount of sodium phosphate monobasic/dibasic (total 1.5 grams).

OsmoPrep is the preferred product because of a lower sodium phosphate load, lower risk of transient electrolyte shifts, as well as lower risk of GI adverse events compared to Visicol, without compromising efficacy. Unlike Visicol, OsmoPrep does not contain the inert ingredient microcrystalline cellulose that may interfere with visualization of the intestinal lumen or require removal. 

 

Remove: Sodium Biphosphate/Sodium Phosphate (OTC) Liquid, Oral (no longer available)

Remove: Bisacodyl/Phospho Soda Kit (Tab/Supp/Liquid)

 

Look for additional information in the provider information sheet “Formulary Updates: Oral Sodium Phosphate Products (OSP) for Bowel Cleansing” to be posted to the PBM INTRAnet site in the near future.


Generic formulation of lamotrigine and topiramate has begun to be dispensed in VA facilities and CMOPs. To ensure a safe and efficacious transition, the following guidance should be implemented;

For non-epilepsy patients

·         generic conversion can begin when patients are identified and prescriptions are matched appropriately

·         brand and generic entries are listed in the National Drug File

·         CMOP will be ready to dispense generic for this patient group when notified by the Medical Center

·         Patients and providers should be notified of the conversion.

 

For epilepsy patients

·         The patient lists are available on Share Point

·         Conversion cannot be done in an epilepsy patient until the provider has been contacted and a return message allowing the switch to generic is made by the provider. This may be coupled with education regarding AB rated generics. A review of this can be found at http://vaww.national.cmop.va.gov/PBM/Clinical%20Guidance/FAQ%20SHEETS/generic%20statement%20AB%20rating%20final%2004%2015%2009.doc

·         Patients who will not be converted should be mapped to brand name entries

·         Patients should be notified of any changers to their prescriptions as well, this would include but not limited to names of medication on label, different tablet size and appearance

·         PBM is currently working on obtaining a sole source product.  Effective date TBD

·         As part of a national MUE, PBM VAMedSAFE will use administrative databases to screen converted patients for specific triggers (e.g. dose adjustment, ER visit, etc) on a monthly basis for 4 months following conversion.  Lists of patients that were picked up in the trigger screening will be posted on the SharePoint site for completion of a case report form.  This form will also be posted on the SharePoint site.

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VA Mobile Pharmacy

The Department of Veterans Affairs, Emergency Pharmacy Service (EPS) displayed its second mobile pharmacy (MP) at the American Pharmacist Association Annual Meeting. The vehicle is a fully functioning pharmacy, capable of delivering life-saving pharmaceuticals to veterans during times of natural disaster or other emergency situations.  Medications to treat acute illnesses as well as chronic medical conditions are on board.

 

A satellite dish is mounted on the vehicle’s roof to provide connectivity to the VA wide area network and to transmit prescriptions to VA’s Consolidated Mail Outpatient Pharmacy for remote filling of non-urgent prescriptions.  These transmitted prescriptions can be mailed to veterans at a temporary address if one is available, or they can be shipped to a central location near the disaster site for in person pick-up by the veteran.  VA EPS staff will receive training on the new MP in late April, and the vehicle will then be delivered to its permanent location where it will undergo final preparation for deployment.

Click here to see a picture of the vehicle


VHA Formulary Management Process—Handbook 1108.08 is Now Available

Have you heard? VISN Formularies no longer exist; VA has only a National Formulary.  Patients on a VISN Formulary drug that is not on the National Formulary can be grandfathered on that drug but any new patients for a VISN Formulary drug that is not on the National Formulary will have to use the non-formulary process.

 

Internet http://www1.va.gov/vhapublications/

Intranet http://vaww1.va.gov/vhapublications/

 

Procedure to Request a VA National Formulary  (VANF) Change

Requests for change in VANF status may be submitted to the PBM by a VISN Formulary Committee, the VISN Pharmacist Executives (VPE), the Medical Advisory Panel (MAP), a VHA Chief Medical Consultant or VHA Chief Medical Officer.    Click here to read complete document                 


Call for Publications/Abstracts by VA Pharmacists

The VA PBM Research Steering Committee would like to house publications of articles and/or abstracts by VA pharmacists published for national meetings. Please submit your citations and/or abstracts starting from calendar year 2008 to Janet.Dailey@va.gov . Citations will be posted to the PBM website. Your research is much appreciated and will assist other sites in making better informed decisions.


ASK PBM Clinical E-Mail

Eager to know the status of a new drug as it moves through the formulary approval process or have a question about criteria for use etc?; then send an e-mail to VHAPBH Ask PBM Clinical (AskPBMClinical@va.gov).

Please note this address should only be used by VA employees; requests from e-mail addresses outside the VA may not receive a response.


Pharmacy and Prosthetics: The VA Pharmacy Benefits Management and VA Prosthetics Services have recently convened a group to help clarify the responsibility for managing (ordering, purchasing, and dispensing) certain products. Over the past few months, it has become evident that there are inconsistencies between VISNs and facilities and the goal is to provide guidance and reduce some of the inconsistencies. The group is not responsible for determining formulary status or appropriate use of such products, only to determine which department (pharmacy or prosthetics) will manage (order, purchase, and dispense) a particular product.

 

If you have a question about whether pharmacy or prosthetics is responsible for managing a product, please e-mail your VISN Pharmacist Executive or your local Prosthetics Department. They will forward the question to the VA Pharmacy-Prosthetics Subgroup for consideration.

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Attention Pharmacy Residency Program Directors

The PBM and Pharmacy Residency Advisory Board would like to announce the FIRST National Residency Program Directors Conference in Nashville, Tennessee on August 10-12th.  The theme for our first meeting is “Preceptor Development. The conference will begin Monday August 10th (travel August 9th) and end at noon on Wednesday August 12th.  All invitees are expected to attend the conference in its entirety to be eligible for ACPE C.E.U.  If you have specific questions regarding the agenda or contents of the conference, you may contact Lori Golterman  lori.golterman@va.gov


SAVE THE DATES for the Following CE Programs:

“Minimizing Anticoagulants Bleeding” Broadcast CE Program Coming July 09. Click here for details in the near future.

VANTs call post airing on these dates only: July 8th @ 1 PM ET; August 5th @ 1 PM ET; and August 11th @ 4 PM ET Dial in Number: 1-800-767-1750; Access Code: 86460

“VA Adverse Event Reporting System (VA ADERS):  ADE Report Entry and Building Reports”

 August 4, 2009 (1-3PM EST), August 6, 2009 (1-3PM EST) and August 12, 2009 (1-3PM EST). More details will be posted soon.


The National Directory of Anticoagulation Services http://vaww.national.cmop.va.gov/HighAlertMedications/Anticoagulants/Forms/AllItems.aspx.

In order to facilitate the provision of care for traveling veterans, the High-Alert Anticoagulant Workgroup has created a National Directory of Anticoagulation Services which will be readily accessible to all providers within the VA system. The main goal of this directory is to provide contact information for one site to communicate with the other to assist continuity of care for our traveling veterans.


Chronic Opioid Therapy Guidelines

The American Pain Society and American Association of Pain Management recently published evidence-based guidelines on chronic opioid therapy. Full text can be accessed at:

http://www.jpain.org/article/S1526-5900(08)00831-6/abstract .