PHARMACY

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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PHARMACY

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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Sandoz gets FDA nod for biosimilar Hyrimoz

BY Sandra Levy

Sandoz has received the Food and Drug Administration’s blessing for its Hyrimoz (adalimumab-adaz) — a biosimilar of Humira. The drug is indicated to treat rheumatoid arthritis , juvenile idiopathic arthritis in patients four years old and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis

“Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease,” Sandoz global head of biopharmaceuticals Stefan Hendriks said in a statement. “With the FDA approval of Hyrimoz, Sandoz is one step closer to offering U.S. patients with autoimmune diseases the same critical access already available in Europe.”

Adalimumab, the active ingredient in Hyrimoz, is an inhibitor of tumor necrosis factor, a protein that is overproduced in certain autoimmune conditions, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis-causing inflammation, and tissue destruction in joints, mucosa or skin. In some cases of autoimmune disease, the immune system damages the body’s own tissues. Hyrimoz targets and blocks the protein that contributes to disease symptoms.

On Oct. 11, Sandoz announced a global resolution of all intellectual property-related litigation with AbbVie concerning all indications of the proposed Sandoz biosimilar adalimumab, according to the company.

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