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PBM-MAP Ez-Minutes Newsletter is an on-line quarterly newsletter. The newsletter is rich in information that will assist you in your clinical practice at the VA. Information such as updates to the National Formulary, availability of new Criteria for Use, and recent medication safety issues are included in the newsletter. The goal is to keep front line clinicians/providers and supporting staff informed while serving our Nation’s Veterans. The Ez-Minutes Newsletter serves as our means to communicate the information to the field. In order for you to receive notification in your InBox that the next issue is available, you need to subscribe to it. It’s Ez to subscribe, the newsletter is Ez to read, and it’s FREE. Here is how you can subscribe...
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, (note, I didn't write OLD subscriber) please forward this newsletter to your staff, fellow colleagues, incoming new residents, P&T committee members so they may take this opportunity to subscribe.
Editor's Note: You “old” subscribers might have noticed a technical glitch in the electronic reminder for the last issue. Everything is now resolved and the system is a GO! We apologize for any inconvenience. As a reminder, please note that the newsletter is in a HTML format. A printer-friendly document throughout the system is more likely to occur with a HTML format compared to a word document. Users should select print preview and review the document, then make any necessary changes to the document before printing to ensure the document will print fine for their hardware configuration. We welcome all constructive feedback and comments. Please send comments directly to Janet.Dailey@va.gov with Ez-Minutes in the subject line. Look for the next issue of Ez-Minutes on November 8, 2011 |
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INSIDE THIS ISSUE · National PBM Documents Posted: May-July 2011 · VAMedSAFE Documents Posted (May-July 2011) · Tis’ the Season: LDL and Hemoglobin A1C Fluctuations · Avoid Using Opioid Analgesics with Buprenorphine SL for Acute Pain · Pharmacy-Prosthetics-Logistics Acquisitions ( PPLA) Workgroup Recommendations |
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National Safety Bulletins |
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· Colistimethate for Injection and Dosing Confusion [July, 2011] · Marcaine® (Bupivacaine HCL) Potential Look-Alike Confusion [May, 2011] · Simvastatin: updated Restrictions, Contraindications and Dose Limitations [June, 2011] National PBM Communication · Churchill Medical Skin-Prep Wipes Recall Due to Bacterial Contamination [June, 2011] · Dronedarone (Multaq®) and Risk of Death and Serious CV Events in Patients with Permanent AF [July, 2011] · Recall of Butalbital, APAP, and Caffeine Tablets and Hydrocodone Bitartrate and APAP Tablets-Mislabeling [June, 2011] · Simply Thick Thickening Gel Products Recall and Possible Presence of Bacteria [June, 2011] · Smith and Nephew Various Adhesive Remover Wipes and Potential Contamination and Addendum Recall [May, 2011] · Warfarin and High Potency Recall, Expanded [May, 2011, June 2011] |
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On June 8, 2011, the U.S. Food and Drug Administration (FDA) recommended limiting the use of simvastatin 80mg because of increased risk of muscle damage. In addition, the FDA is requiring changes to the simvastatin label to add new contraindications and dose limitations when used with certain medicines. In response to the announcement, the PBM MAP-VPEs developed guidance for VA providers. The guidance (summary and detailed) were reviewed and unanimously approved by the MAP and VPEs and were shared with the field on Monday, June 26th and posted on July 6th. The statin criteria are in the process of being modified to incorporate the recent restrictions and dose limitations for simvastatin. The guidance documents can be accessed using the following links: Simvastatin 80 mg Summary Guidance for Providers Simvastatin 80 mg Detailed Guidance for Providers Seasonal Effects of LDL and Hemoglobin A1C Did you know “tis the season” really does make a difference when monitoring lipids and HgbA1c? Research has shown that the LDL varies according to season (higher in winter and lower in summer). So, in previously stable patients, not only questions regarding adherence, alcohol, diet etc. should be evaluated, but also, remember to also check the season when the labs were drawn. Perhaps, repeating lipid levels prior to changing or intensifying the dose of statins especially if the patient is close to desired target (after encouraging better adherence to diet and medication) would be an appropriate approach. So, not to complicate the matter more, one study in a small group of patients showed LDL-C fluctuated by as much as 20% in 95% of patients tested weekly for four weeks. In this same study, 40% of patients moved in or out of a risk category and 10% of patients moved two risk categories from desirable to high risk or vice versa. http://archinte.ama-assn.org/cgi/content/abstract/150/8/1645. So even within the same season of testing, there may be significant differences that are normal. This is very important since a patient may have a certain LDL level, a lipid panel is repeated 4-6 weeks later and different value is noted (higher or lower). The concern is a change may be initiated based upon the difference in values when it is simply normal intra patient fluctuation. Providers are encouraged to factor in specific patient risk as well as factors such as seasonal and laboratory variation when making decisions on changing lipid lowering therapy. The current VA LDL control measure is being revised to reflect emerging evidence that, for many patients, use of an appropriate dose of a statin, rather than treatment to a target LDL below 100 mg/dl, can lower cardiovascular risk and avoid muscle damage from inappropriate dose escalation. Seasonal variability is also associated with Hgb A1c values (higher in winter and lower in summer). Read more details: Am J Cardiol 2009; 103:1056 –1060; Am J Epidemiol 2005; 161:565-74. Avoid Using Opioid Analgesics for Acute Pain in Patients Taking Sublingual Buprenorphine As more patients receive sublingual buprenorphine/naloxone (Suboxone®) or buprenorphine (Subutex®) (collectively called buprenorphine) for the treatment of opioid addiction, complications resulting from concomitant treatment with other opioid analgesics may increase. Complications may include the following: · Inadequate pain relief. Buprenorphine has high affinity for opioid receptors and may block the full mu-receptor agonist. · Opioid withdrawal symptoms. This may occur if the buprenorphine-maintained patient stops buprenorphine to take the opioid analgesic and then restarts buprenorphine. · Relapse of opioid addiction or opioid overdose. If patients do not receive adequate pain relief from health care providers (see first bullet point), they may use additional or illicit opioids to control this pain.
These potential complications make acute pain management in buprenorphine-treated patients challenging. Typical doses of full mu-receptor agonists may not be sufficient to relieve severe pain, and most providers and nurses will probably be unfamiliar with the management of patients who require high opioid doses. If buprenorphine is stopped, its effects will slowly diminish as it dissociates from the receptors, but patients may be on very high doses of opioids that increase the risk of overdose. Patient-controlled analgesia may be preferable in certain cases to allow patients to self-titrate the opioid dose according to their pain intensity and to prevent withdrawal as the effects of buprenorphine wear off.
Recommendations:1-3 1. Providers who prescribe opioids for acute pain management, such as dentists, surgeons, and emergency medicine physicians, should · Check for buprenorphine when evaluating patients’ medications. · Avoid, if possible, prescribing concomitant opioids to the buprenorphine maintained patient. · Consider other pharmacologic treatments for pain. · Consult the buprenorphine prescriber to discuss the appropriate treatment plan for pain. 2. Anticipated Pain (e.g., elective surgery, tooth extraction): · For mild pain, do not prescribe additional opioids. Inform the buprenorphine prescriber beforehand of the surgery. For pain management, consider using nonopioid analgesics such as acetaminophen or NSAIDs. Continue the buprenorphine at the same dosing regimen. Sublingual buprenorphine is not recommended solely for pain management in VA.2 · For moderate to severe pain, the patient should be referred to their buprenorphine prescriber, taken off of buprenorphine, and transitioned to short-acting opioids for 1 or more days, and preferably 5 or more days, before surgery. Expect opioid requirements to be higher in patients who have received SL buprenorphine for less than 5 days before surgery because of physical opioid dependence and receptor-blocking effects of residual buprenorphine. Send the patient to their buprenorphine prescriber after surgery to stop the postoperative opioid analgesic and re-initiate buprenorphine. 3. Unanticipated Pain (e.g., emergency surgery, major trauma, renal colic, bone fracture): · For mild pain, use the same approach as for anticipated pain. Another option is to attempt to improve the analgesic effects of sublingual buprenorphine by giving the same or higher daily dose divided every 6 to 8 hours. However, if this option is considered for pain management, consult the buprenorphine prescriber. · For moderate to severe pain, discontinue buprenorphine. Start the patient on patient-controlled analgesia preferably using fentanyl (because of its high receptor affinity and short duration). Avoid high-dose continuous opioid infusions. Place the patient in a closely monitored setting (e.g., ICU). Expect opioid requirements to decrease as buprenorphine levels decrease (half-life averages 37 h but varies from about 24 to 60 h). Consider other analgesic options such as regional anesthesia. Optimize non-opioid, adjunctive analgesic therapy. Consider consulting anesthesiologists or pain specialists. 4. Do not give buprenorphine when the patient is already taking opioids. It may precipitate severe opioid withdrawal. 5. If the patient has been off of buprenorphine for 5 or more days, the usual postoperative opioid agents may be used; however, anticipate that dosage requirements may be higher due to opioid tolerance. Refer the patient to their buprenorphine prescriber after surgery to taper opioids and reinstitute buprenorphine therapy.
References: 1. Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2004, page 74-76. Available at: http://buprenorphine.samhsa.gov/Bup_Guidelines.pdf 2. Fiellin D. PCSS-B Training Guidance: Treatment of acute pain in patients receiving buprenorphine/naloxone. Last updated 11/10/05. Available at: http://pcssb.org/wp-content/uploads/2010/09/PCSS-B-Treatment-of-acute-pain-in-patients-receiving-buprenorphine-naloxone.pdf 3. Alford DP, Compton P, Samet JH. Acute pain management for patients receiving maintenance methadone or buprenorphine therapy. Ann Intern Med. 2006 January 17; 144(2): 127–134.
Submitted by: Francine Goodman, PharmD, BCPS, Clinical Pharmacy Specialist, Pharmacy Benefits Management Services (10P4P) Pharmacy-Prosthetics- Logistics and Acquisitions (PPLA)* Workgroup Recommendations The table below depicts the various products reviewed at the April-June 2011 meetings. The X marks which service(s) is responsible for managing the respective products. Please CLICK HERE for further details and explanation of the decision process including decisions made from earlier meetings.
*The Pharmacy, Prosthetics, Logistic-Acquisitions (PPLA) workgroup was created to help clarify the responsibility for management (e.g. ordering, storing, purchasing, AND/OR dispensing) of those products in which it is not clear which service should provide. The workgroup is not responsible for determining formulary status, clinical merit or appropriate use of the products reviewed. Implementation of these recommendations should be coordinated between services at local sites to ensure a smooth transition if recommendations lead to a change in responsible service. If you have any questions related to this announcement, please contact the responsible local service (Pharmacy, Prosthetics, and Logistics-Acquisitions) for more detailed information. If you’ve been eager to know the status of a new drug as it moves through the formulary approval process, check it out on the New Molecular Entity Review List. http://vaww.national.cmop.va.gov/PBM/New%20Molecular%20Entity/Forms/AllItems.aspx If you have a question about criteria for use, medication management guidance/monitoring etc., 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. PBM-MAP-VPE and VAMedSAFE Educational Programs
VA Adverse Drug Event Reporting System (VA ADERS): DATE: August 25, 2011 at 12 PM (NOON) EST and 2 PM EST VANTS Number: 1-800-767-1750 code 76421 This one-hour training will cover ADR Report Entry (ADRs) including definitions, entry tips, user tools, Vaccine Adverse Event Reports (VAERs) and submission to the FDA MedWatch program. Target audience: Anyone that reports ADRs, especially pharmacy staff (pharmacists, technicians, residents, students) and any staff involved with patient care. Please share this information with anyone interested in or responsible for reporting ADRs in your facility. Contact Anthony Au (anthony.au@va.gov ) and/or Von Moore (von.moore@va.gov) with questions. Please note, there will not be any accreditation for this program.
August/September 2011 Webinar: Hepatitis C Therapy and New oral HCV Protease Inhibitors Series Part I: (August 24, 2011 at 1 PM EST) VANTs Number: 1-800-767-1750; Access Code 49792# Accreditation: ACPE Part II: (September 28, 2011 at 2 PM EST) VANTs Number: 1-800-767-1750; Access Code 49792# Accreditation: ACPE
October Webinar: Celebrate National Pharmacy Month: Speaker Dr. Jesse, Principle Deputy Under Secretary of Health October 13, 2011 at 12PM (NOON), EST
Taped Dabigatran Webinar Series Part I (June, 2011): Dabigatran: What do I Need to Know? Click Here Part II (July, 2011): Dabigatran What Do I Need to Know in the VA? Click Here
Please see PBM Website under Distance Learning Broadcast tab for program slides, Live Meeting Link and additional information. The Veteran’s Health Administration (VHA) and FDA’s Drug Safety Oversight Board (DSB) The FDA Drug Safety Oversight Board (DSB) discussed 3 topics at the May 2011 meeting, 4 topics at the June 2011 meeting, and 3 topics at the July 2011 meeting. The April 2011 meeting had been cancelled. A link to the Public Summary of each meeting is included. DSB members representing the VHA include Drs. C. Bernie Good (VA Pittsburgh Healthcare System), Peter Glassman (VA Greater Los Angeles Healthcare System), Walid F. Gellad (VA Pittsburgh Healthcare System), Mark Enderle (VA Arkansas Healthcare System), and William Duncan (VA Washington DC Healthcare System). The Board also discusses recently released and proposed Drug Safety Communications at each of its meetings. FDA Drug Safety Communications can be accessed through the following webpage: http://www.fda.gov/Drugs/DrugSafety/ucm199082.htm
Update on Recent Board Topics: October 2010: Glass syringes and Risk of Adverse Events due to Incompatibility with Needleless IV Connectors, second Drug Safety Communication on May 6, 2011. http://www.fda.gov/Drugs/DrugSafety/ucm254215.htm
May 2011: Bad Ad Program: The Pink Sheet (July 22, 2011) interviewed guest speaker Michael Steinman who presented at this meeting, Article caption “Can Bad Ad Program’s Light Penetrate Murky CME Clinical Trial Practices?” Dr. Steinman is an Associate Professor of Medicine in the Division of Geriatrics at the University of California San Francisco (UCSF) School of Medicine and a staff physician at the San Francisco VA Medical Center.
Editor’s Note: As mentioned previously, a new feature to the newsletter will be including recent updates discussed by the DSB. We hope that it will provide greater awareness among VA healthcare professionals about the DSB. If you have any feedback to the DSB, please contact Georgiann Ienzi, Project Manager of the Drug Safety Oversight Board. Publications by VA Pharmacists: Hold on to your submissions for now. More details will be posted soon on the PBM website.
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