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.
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?
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?
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.
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?
There are many different specialized pharmacies but this is a new unique specialization. A new website has launched to list and direct patients to 850 pharmacies that specialize in mental health pharmacy services. These pharmacies meet certain criteria to be listed and the website allows the patient to search for a pharmacy by address. This appears to be a nice way to help patients. Now the challenge is to get providers and patients to know about the website and use it! Would you recommend a patient use this website if the patient would transfer to another pharmacy? Will payers see the value in specialized services for certain populations? We welcome your thoughts through the comments section below or sending us a message.
This summer, Highmark announced that the vaccine administration fee paid to pharmacies would be cut from $25 to $3. The Pennsylvania Pharmacists Association (PPA) acted swiftly to address this 88% reduction in payment that could severely impact pharmacies throughout the Commonwealth. PPA members and staff held a discussion with Highmark to highlight the concerns with such a drastic reduction in payment. Highmark listened to their concerns, conducted research, and effective September 12, 2016, increased the administration fee they pay to pharmacies for all vaccines to $10. While still a reduction compared to the earlier payment rate, the increase to $10 helps to account for the time and resources that pharmacies spend to provide vaccines to their patients. Was Highmark’s response appropriate? What is a fair administration fee to a pharmacy for providing an immunization?
What is precision medicine?
Precision medicine is a practice of individualizing medical treatment based on a variety of patient-specific characteristics, moving away from treatments based on the “average” patient. Medical decisions are based on a patient’s genetics, disease characteristics, environment, and lifestyle.
Precision medicine vs. patient-centered medicine
Patient-centered medicine is the practice of individualizing medical care focused on involving the patient in treatment decisions. Using patient-centered medicine, the healthcare professional will make a plan involving the patient’s needs, concerns, and preferences. Precision medicine builds upon the patient centered foundation of behavioral and lifestyle aspects, but also incorporates physical, genetic, and environmental characteristics outside of the patient’s control to optimize treatment.
Precision Medicine Initiative
For precision medicine to be widely adopted and effective, the relationships between each patient characteristic (genetics, lifestyle, biological markers, activity, physiological measures, etc.) and their effects on a patient’s health needs to be understood. The Precision Medicine Initiative, announced in the 2015 State of the Union Address, is a nationwide research effort to study a cohort of 1 million U.S. patients. The initiative is still in its beginning stages and patient recruitment is ongoing. In July 2016, Walgreens announced its patient enrollment efforts through in-person, online, and mobile app outreach.
The goals of the cohort program are:
The Future of Precision Medicine
The future of healthcare is expected to be driven by precision medicine; elements of precision medicine, such as records in EHR and point-of-care testing, may impact future quality measures and provider reimbursement. Pharmacists are expected to play a major role in patient monitoring, most obviously on medication adherence, outcomes, and adverse effects but could include genetics, lifestyle, and other health markers.
The DEA plans to reduce the total opioid production in 2017. Could this be part of the strategy to squeeze the supply of opioid medications in the marketplace? The decrease may vary by product but the overall decline is about 25%. This change seems large until learning that previous production levels included a 25% buffer to avoid drug shortages. What are your thoughts about this reduction? Will this have any affect on each of the different stakeholders? Is this part of the DEA’s strategy to combat opioid addiction in the country? Will this situation drive more patients to seek illicit drugs?
The following linked article provides viewpoints from many different stakeholders regarding drug pricing. One of the good discussion points includes that if a manufacturer brings a product to market, Medicaid will pay for it. Americans drive innovation but just because something is available, does that mean the expectation is that it is covered by health insurance? What are your thoughts on the societal issues around drug pricing? Will society continue to pay for drug innovation?