PHARMACY

Report: HPV vaccination rates remain too low to achieve cancer prevention potential

BY Sandra Levy

Although the human papillomavirus, or HPV, vaccine uptake has improved in recent years, underuse of the HPV vaccine remains a serious threat to progress against cancer in the United States, according to a report released Thursday by the President’s Cancer Panel Chair.

The report, “HPV Vaccination for Cancer Prevention: Progress, Opportunities, and a Renewed Call to Action,” finds that while there has been demonstrated progress in HPV vaccine uptake in the United States over the past five years, vaccination rates remain unacceptably low and well below the government’s Healthy People 2020 goal of 80% of age-eligible adolescents.

The panel chair concludes that recent, notable strides must be amplified and expanded, and recommends several steps to increase HPV vaccination both in the United State, as well as globally.

“We have a safe, effective vaccine that protects against a cancer-causing virus, and we applaud the efforts of cancer and immunization leaders joining forces and rising to the challenge of accelerating HPV vaccine uptake,” chair of the President’s Cancer Panel Barbara Rimer said in a statement. “Yet, the fact remains, that this vaccine remains seriously underutilized — we are still missing opportunities to prevent cancer and save lives.”

In its 2012-2013 report, “Accelerating HPV Vaccine Uptake: Urgency for Action to Prevent Cancer,” the President’s Cancer Panel issued a call for action that was later echoed in other high-profile reports, including 2015 and 2018 reports from the National Vaccine Advisory Committee and 2016 reports from the Cancer Moonshot Blue Ribbon Panel and Cancer Moonshot Task Force.

On average, the percentage of adolescents who started the HPV vaccine series increased five percentage points each year between 2013 and 2017. Yet, as of 2017, less than half of U.S. adolescents were fully vaccinated. In addition, HPV vaccines are not included in the national vaccine programs of many low- and middle-income countries, where the vast majority of cervical cancer cases and deaths occur.

The Panel Chair concluded that that provider- and system-level changes have the greatest potential to increase U.S. HPV vaccination rates, and that partnerships and collaborations among key stakeholders are essential for sustaining momentum and expanding the reach of this urgent call to action.

The Panel Chair also urges renewed action around the following goals: reduce missed clinical opportunities to recommend and administer the HPV vaccine; increase parents’ acceptance of HPV vaccination; maximize access to HPV vaccination services; and promote global HPV vaccine uptake.

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Survey: Pharmacists want to counsel patients, build provider relationships

BY Sandra Levy

Patients visit their pharmacists 30 times per year, and that number is increasing as pharmacists’ roles within healthcare delivery evolve and expand, but pharmacists are only able to spend 10% of their time counseling patients, according to a recent survey conducted by Maru/Matchbox for AmerisourceBergen’s inaugural “Pharmacy Check-Up: Activity & Barriers to Care Analysis.”

The survey, conducted among more than 250 pharmacists working in chain, health system, independent and specialty settings also found that 62% of independents and 58% of specialty pharmacists reported being bogged down by contracting with manufacturers and payers.

All pharmacists agreed that building relationships with prescribers is a top way to overcome some of these barriers, and that inventory management tools can help to better solve daily obstacles.

The study also found the following:

  • Chain pharmacists spend the largest proportion of their time filling prescriptions compared with pharmacists within alternative sites of care (38% versus 24% independent, 19% hospital, 16% specialty);
  • On average, pharmacists across all sites of care also stated they’re only able to spend 10% of their time counseling patients, primarily focused on providing education around how to safely and effectively take medication, potential side effects and compliance. However, this is the same task that pharmacists feel like they should spend more time devoted to, along with medication therapy management, which was most strongly felt by chain pharmacists;
  • Across all sites of care, counseling patients was an area that all pharmacists believe they will spend more time on in the future, with chain being the most pronounced (counseling: 75% versus 57%
    independent and 55% specialty; MTM: 85% versus 68%/62%/63% respectively);
  • They also feel they will spend more time caring for patients via preventive care screening,
    administering immunizations and urgent care/on-site clinic. This is particularly true for chain. Hospital and specialty pharmacists feel they will spend more time on data reporting in the future (47% hospital, 65% specialty versus 24% chain, 24% independent);
  • On the flip side, pharmacists feel they should be spending less time on insurance/reimbursement related activities. Chain pharmacists are more likely to think they should be spending less time on this activity compared with hospital and specialty pharmacists (70% versus 44%/40%);
  • Hospital and specialty pharmacists spend the most time on insurance and reimbursement
    activities relative to their counterparts;
  • Specialty pharmacists also expect to be spending more time on insurance/reimbursement related
    activities as compared with chain and independent pharmacists (53%versus 25% and 31%);
  • All pharmacists agree reimbursement issues are a significant barrier to good care. For chain, they are stymied by staff resources (73% significant barrier versus 29% independent, 49% hospital, 40% specialty), while independent and specialty are particularly bogged down by contracting with payers and manufacturers;
  • The majority also agree that building relationships with prescribers is a top way to overcome some of these barriers (76% for chain, 72% for independent, 71% for hospital and 65% for specialty), and that inventory management tools can help to better solve daily obstacles (62% for chain, 47% for independent, 52% for hospital and 50% for specialty);
  • When it comes to barriers to running a successful business, pharmacists agree that fair reimbursements and staff management/training are the largest barriers;
  • However, chain and hospital pharmacists are more likely than independent and specialty to cite staff
    management/training as a barrier (73% for chain and 63% for hospital versus 46% for independent and
    40% for specialty); and
  • Finally, when looking ahead, all pharmacists outside of the hospital setting rank being able to play a greater role in patient care as what they are most excited about as the field of pharmacy evolves.

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23andMe to offer direct-to-consumer pharmacogenetics reports

BY Sandra Levy

The Food and Drug Administration has granted consumer genetics and research company 23andMe de novo authorization to offer reports on pharmacogenetics, indicating how customers’ genetics may influence the way they metabolize certain medications.

This is the first authorization of a direct-to-consumer report on pharmacogenetics and came through the FDA’s de novo classification process. The FDA has classified these direct-to-consumer pharmacogenetic reports as moderate risk that have special controls to ensure safety, effectiveness and accuracy. This authorization enables 23andMe to report on numerous variants associated with pharmacogenetic response.

“We’ve continued to innovate through the FDA and pioneer safe, effective pathways for consumers to directly access genetic health information,” 23andMe co-founder and CEO Anne Wojcicki said in a statement. “Pharmacogenetic reports are an important category of information for consumers to get access to and I believe this authorization opens the door for consumers to work with their health providers to better manage their medications.”

23andMe had to demonstrate the accuracy of its testing and consumer comprehension of the testing information, including “treatment adherence” and whether or not a customer would continue their prescribed treatment of a medication, or change or stop treatment. Studies showed that more than 97% of users understood that they should not use the report to make any changes to treatment without consulting their doctor, the company said.

The authorization allows for the reporting of variants in multiple genes that impact how well an individual metabolizes certain medications, for example clopidogrel, which is commonly prescribed to prevent heart attacks and strokes. These genes are associated with response to more than 50 other commonly prescribed and over-the-counter medications. The authorization allows 23andMe to provide customers with information on whether they are predicted to be fast or slow metabolizers based on their genetics, and when supported by appropriate clinical evidence, whether they may experience reduced efficacy or have an increased chance of side effects from certain medications.

Finally, the company said that the decision continues the commitment made by 23andMe to return all the types of genetic health information to customers that it offered prior to an FDA warning letter in 2013. However, 23andMe has not determined when it will be able to make these new reports available to its customers.

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