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Track-and-Trace: Staggered Deadlines May Lead to Workflow Disruption

The Track-and-Trace law, also known as the Drug Supply Chain Security Act (DSCSA) was signed into law November 27, 2013.  The DSCSA outlines the steps and deadlines the pharmaceutical supply chain participants and pharmacy industry must take to build a system that identifies and traces pharmaceuticals.  By November 27, 2023, DSCSA expects the system to facilitate the exchange of information at the individual package level by showing where a drug has been in the supply chain.[1]

Other staggered deadlines occur throughout the ten-year implementation period with one occurring on November 27, 2017.  At that time, pharmaceutical manufacturers are required to place unique product identifiers on their packages.  This identifier is composed of the product’s NDC, a serial number, lot number, and the expiration date, all of which are recorded in a 2D bar code.  Repackagers are required to comply by November 27, 2018.  Wholesalers are required to use the 2D bar code by November 27, 2019, and pharmacies are required to do so by November 27, 2020.

As manufacturers prepare for their 2D bar code deadline, some are including the 2D bar code and the current linear UPC bar code.  Other manufacturers are replacing the linear UPC bar code with the 2D bar code. This is a cause for great concern for some pharmacies.

Although the law and its provisions have been public knowledge for almost 3½ years, those industry segments with later deadlines may not have completed upgrades to use 2D bar codes in their workflow processes.  It is unknown as to the extent how much of the current technology used in pharmacies cannot utilize a 2D barcode.  Packages with only a 2D bar code cannot be scanned by pharmacies without 2D scanning capability to verify the correct product has been selected for dispensing.  This situation may require manual system overrides and increase the potential for dispensing errors.

Entities downstream in the supply chain are evaluating steps needed to minimize disruption in workflow caused by the removal of a linear UPC bar code.  These steps may include installing new 2D bar code readers and associated software.  However, if this technology is not implemented in time, others may need to develop procedural “workarounds.”

In an effort to ensure a smooth transition and compliance with the law, NCPDP work groups proposed working with manufacturers to determine when their packages will be changing to comply with DSCSA requirements and which products will have their linear UPC bar codes replaced with 2D barcodes.

PHSI encourages pharmacies to talk with their software vendors or pharmacy IT support to determine how this issue may affect their organization.

PHSI has written about Track-and-Trace since President Obama signed this Act in 2013. Please see the below publications for more information:

http://phsirx.com/news-events/publications/computertalk-januaryfebruary-2015

http://phsirx.com/news-events/publications/computertalk-marchapril-2014

 

[1] https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ Accessed May 18, 2017

Micromedex Mobile Drug Information Collection Application Updates

PHSI re-reviewed the Micromedex App after learning that Micromedex has recently updated their mobile drug information collection to include the Micromedex Drug Reference App and the Micromedex Drug Reference Essentials App. These two new additions replaced the previous Drug Information App in March 2017. Users with internet-based subscriptions through an employer or school will be able to log in to that subscription through the Drug Reference App. Pharmacists and other healthcare professionals are still able to access evidence-based drug information without a subscription with the Essentials App. Both apps provide information on over 4,500 drug products. The chart below contains details on what is offered.

Micromedex

Micromedex reports being the world’s most complete and carefully researched clinical decision support system, utilizing a team of more than 90 specialized clinicians who perform in-depth reviews of published medical literature. Micromedex is a product of Truven Health Analytics, Inc., whose goal is to deliver unbiased information, analytic tools, benchmarks, and services to the healthcare industry.

The information is easy to navigate, and products can be searched by name or therapeutic class. There is also a “What’s New” section which identifies recently added and removed drug products and drug information documents. Limitations include the apps do not enable the user to view common searches or save specific products as favorites.

Subscription users are able to log into the app for free with a password. Non-subscription users are able to purchase the Essentials app for $2.99/year. The apps are compatible with iPhone, iPod touch, iPad, and Android. iOS 3.0 or later is necessary for Apple products, and Android 2.2 or later is necessary for Android products. Updated versions of the apps are continuously released. To ensure that users utilize the most current information, the apps cannot be opened unless all updates have been downloaded. In addition to drug information, Micromedex offers apps specifically covering drug interactions, IV compatibility, pediatrics, and neonates for a fee.

For more information, visit http://truvenhealth.com/products/micromedex/quick-reference/mobile.

 

Medication Disposal Service for Allegheny County Residents

There has been an increase in programs designed to help address the opioid crisis. PHSI has supported initiatives such as the distribution of opioid pouches to discard opioid medications and changes in pain management procedures to limit opioid prescribing and incorporate non-opioid treatment as alternative pain therapy. DEA Drug Take Back Days provide a safe and proper disposal method of unused or unwanted medications.

A new option for disposal of unwanted medications is now available in Allegheny County, PA.  The Sheriff’s Office has provided a convenient option for their residents to dispose their medications through Project D.U.M.P (Disposal of Unused Medications Properly).  Residents contact a Sheriff’s Office Evidence Custodian, who will come to your residence to remove unused, unwanted, and expired medications. Residents can schedule an appointment for medication pick-up by contacting the Project D.UM.P Hotline at 412-459-5000. The process is simple and beneficial in addressing a public health safety issue with a goal of reducing preventable harm from drug abuse or misuse. What do you think about Project D.U.M.P? Can this service be expanded to have a greater impact? How would you measure and ROI for the program?

Prescription Transfer Incentives Eliminated

How many patients do you know that regularly transfer prescriptions between stores to take advantage of gift cards or other incentives offered by the pharmacy?  For over 25 years, patients have been maximizing their benefit of these offers by transferring prescriptions between pharmacies.  The Tennessee Board of Pharmacy has created a rule to eliminate these offers and is now in effect as of March 2017.

This rule will help to avoid polypharmacy and offer more opportunities for pharmacists to fully screen the patient’s entire drug therapy regimen for potential issues.  Transfers between pharmacies can still occur as usual, there is just no up-front inducement permitted.  The rule does not mention incentives for new prescriptions.  What do you think of this rule in Tennessee?  Will you advocate for this rule in your state?

http://www.knoxnews.com/story/news/2017/03/09/no-more-cash-incentives-rx-transfer-after-tn-board-pharmacy-ruling/98949662/

PHSI Intern Matches for Residency

The entire PHSI team would like to congratulate PHSI Intern Kaysee Gruss who matched for the Managed Care Program (PGY1) pharmacy residency at Kaiser Permanente Mid-Atlantic States!  Kaysee worked with PHSI for one year and gained valuable knowledge and insights that augmented her clinical skills, making her the best candidate for this Kaiser residency.  Way to go Kaysee!

Pipeline and New Product Support with Respective Drug Compendia Providers

PHSI subject matter experts evaluate and interpret compendia information during the review of pipeline product draft labels.  This assessment helps to forecast therapeutic categorization and to support product descriptions that adequately fit the limited character spaces in EHRs, pharmacy systems, and payer adjudication systems. While proper compendia listing for client drug products may seem straightforward, the impact of these listings on e-prescribing product selection, payer formulary and coverage, and pharmacy dispensing, is often underestimated. Moreover, many health systems/IDNs are requiring physicians to e-prescribe products by their chemical/generic name. The compendia listing of a new product’s chemical name affects this process.  The importance of proper product listing in the compendia is becoming critical, especially with new product launches.  PHSI supports pharmaceutical manufacturer at any point in the product development process, from clinical trial stages to FDA approval.

Contact PHSI to discuss compendia support for pipeline and new products.

 

Additional Resources:

Product Analogs Help Manufacturer Strategy

Manufacturer Sought Insight on Package Size Compendia Listing Issue

Research Updates Brand Designation in Drug Databases

Post-Launch Drug Compendia Review

Emergency Room Changes to Opioid Administration

The strategies developed to combat the opioid epidemic have been diverse. PHSI previously reported on Prescription Drug Monitoring Programs, Naloxone availability, and opioid deactivation pouches. These are just a few of the many programs being piloted across the country and new ones are being introduced.

St. Joseph’s Regional Medical Center in Paterson, New Jersey has an initiative to decrease opioid prescribing in its emergency room. Last year the ER changed its’ protocol to include ultrasound guided nerve blocks, laughing gas, non-narcotic injections, and nontraditional strategies such as music therapy and energy healing. By incorporating these non-opioid treatments, the hospital hopes to change both patient and physician perception of narcotics. Many healthcare providers and patients believe that narcotics are the fastest and surest way to alleviate pain, which may not be true for all conditions. St. Joseph’s has reported great success with their new pain management protocol.

Rhode Island and Alabama are two states taking steps to stop over prescribing of opioids. Both states have joined with the American Medical Association to develop ‘toolkits’ for prescribers. The toolkits contain opioid abuse data, practice guidelines, and various resources to help improve prescribing practices. It is too early to see if prescribing practices have changed, however providing education to providers is certainly helpful.

What steps is your organization taking to combat prescription misuse? What impact have you seen in the results?

http://www.acepnow.com/article/st-josephs-regional-medical-center-aims-avoid-opioid-use-emergency-department/?singlepage=1

Morphine Equivalency Calculator

West Virginia is making it easier for physicians and pharmacists to determine a patient’s morphine equivalent doses when taking multiple opioids.  By creating a calculator tool that will automatically pull records of all prescribed opioid medications for a patient from the Controlled Substance Monitoring Program (administered by the Board of Pharmacy) and calculate a dosage amount by each specific opioid the patient fills. The dosage amount will be converted to a morphine milligram equivalent score using formulas and conversion equations provided by the Centers for Disease Control and Prevention (CDC). The score will be a standard, comparable measurement that will provide the potency of the combined medications the patient is taking. The score will be present at the top of the patient’s profile on the state’s database. The goal of this tool is to provide useful information for the prescriber and pharmacist to quickly see the total opioid usage by the patient.

The tool prevents patients from being overprescribed opioids by going to different pharmacies and prescribers, which should prevent some cases of addiction and abuse. West Virginia Attorney General Patrick Morrisey’s office has paid out $40,000 from its consumer protection fund to build the calculator and The Board of Pharmacy will cover the ongoing costs of the project. PHSI believes this is a positive step using the WV Prescription Drug Monitoring Program to present the current morphine milligram equivalents to prescribers to provide a complete picture of the patient’s opioid therapy.  Do you think this will impact the prescribing of opioids in West Virginia?

http://wvrecord.com/stories/510974499-ag-board-of-pharmacy-create-launch-tool-to-help-reduce-opioid-use

http://www.wsaz.com/content/news/Morphine-calculator-launches-to-reduce-opioid-abuse-388598962.html

http://www.washingtontimes.com/news/2016/jul/28/west-virginia-offering-potency-calculator-for-opio/

Brief Overview of Non-Alcoholic Steatohepatitis (NASH) and Potential Future Treatments

Non-alcoholic steatohepatitis (NASH) is liver inflammation and damage caused by a buildup of fat. It is a more severe and progressive form of nonalcoholic fatty liver disease (NAFLD). While NAFLD has a relatively benign prognosis, NASH has a risk of progression to fibrosis, cirrhosis, and rarely liver cancer. About a quarter of patients with NAFLD progress to NASH. The major risk factors for NASH are obesity, type 2 diabetes mellitus, dyslipidemia, and metabolic syndrome. The prevalence of NASH is estimated at 1-5% of the population.  NASH is typically a silent disease in the early stages. It can take years or even decades for NASH to become serious enough to cause symptoms such as fatigue, weight loss, weakness, and right upper quadrant discomfort.

The gold standard for diagnosing NASH is liver biopsy, as this is the only test that can distinguish NASH from NAFLD. Considering the invasive nature of liver biopsy and the sheer number of NASH patients, routine use of biopsy will be financially challenging. Manufacturers and researchers are studying the accuracy and clinical utility of non-invasive diagnostic tools to more easily diagnose patients.

The treatment of NASH involves non-pharmacologic therapy including weight loss through exercise and dietary changes and a restriction in alcohol consumption. Currently, there are no FDA approved medications for NASH. However, efficacy has been demonstrated with pioglitazone and vitamin E, which are now used off-label.

With no medications approved for NASH, the pipeline is filled with potential agents exploring different mechanisms.  It is clear that manufacturers are in an exploratory phase of treating this condition.

For example, one of the early medications is obeticholic acid (OCA), a farnesoid X receptor inhibitor. This medication decreases liver bile acid build up, inflammation, and fibrosis of the liver. OCA is already approved for the orphan disease primary biliary colangitis (PBC), making NASH the second potential indication for OCA.

As new medications have been tested for NASH, defining the population that will benefit most from pharmacologic therapy has become increasingly important. Some clinical trials have a population consisting of all patients with NASH, while others have a population of patients with NASH and severe fibrosis. The FDA held a liver conference in 2013 and determined that the best patient population for NASH medications is those with NASH and a high fibrosis score. These patients are most at risk for cirrhosis and liver failure.

Treatments for NASH are expected to be a major focus once FDA approved products are on the market.  Start planning now for managing the expected new treatments for NASH.

Different Actions Targeting Opioid Abuse and Misuse

There are many different actions taking place to target opioid abuse and misuse.  PHSI regularly posts about the DEA Drug Take Back Days.  Prescription Drug Monitoring Programs enable healthcare providers to monitor patient use of opioids with the goal to reduce deaths due to opioid use.  Changes are being made to make naloxone available without a prescription through standing orders.  Physicians can now treat an increased number of patients with buprenorphine.  Another new solution on the horizon is an opioid deactivation pouch.  This product deactivates opioids by adding the tablets/capsules/liquid/patch, etc. to the pouch and adding water then disposing of the combination in the trash.  This simple process will enable patients and caregivers to safely dispose of opioid medications and provide another option beyond the drug take back programs. What do you think of the deactivation pouch?  In what situation would you think that the pouch would be helpful?

http://www.startribune.com/30-000-opioid-deactivation-pouches-being-distributed-in-state/394659601/