Guest Blog: Elvin Montanez, Pharm.D., Senior Vice President at BioPlus Specialty Pharmacy
The U.S. Food and Drug Administration (FDA) recently added a boxed warning to some of the newer treatments for hepatitis C, warning patients to stop treatment if a systemic or progressive rash develops. Some media outlets treated this information as if it were completely new; however, this rare but real risk of a life-threatening systemic reaction has been known since the publication of the trials that led to the approval of this treatment several years ago.
The new boxed warning addition to the label is helpful because it gives patients a better understanding that a specific medication must be discontinued if a progressive rash develops. This warning will also raise public awareness overall and bring attention to this potential life-threatening event.
Our patients at BioPlus Specialty Pharmacy are extensively educated so that appropriate actions are taken in the event of a progressive rash. This new warning will, however, enhance awareness in patients of the need to be alert to a progressive rash and report it to their clinician.
The Bigger Risk
Any pharmaceutical treatment plan continually balances the risk-benefit profiles of various treatments (or no treatment) with the goal of providing optimal health outcomes for each patient. The fact is that hepatitis C when it is untreated brings the potential for very real life-threatening risks, including cirrhosis, liver failure, and liver cancer.
At BioPlus, we are proud of our high-touch approach that results in improved outcomes for the patients under our watchful care. With our personalized pharmaceutical care, a higher percentage of our patients complete the first 90 days of their hepatitis C treatment. Our Best in Class compliance accounts, in part, for why BioPlus patients exceed the expected cure rates for hepatitis C.
Additionally, the BioPlus high-touch approach educates patients about the difference between a common rash that often develops with protease inhibitors and the progressive kind that means they need to stop this treatment. BioPlus pharmacists work closely with each patient, providing assessments that are designed to distinguish the small skin rashes from the serious rashes.
We have a high level of communication with our hepatitis C patients, starting with a 30-minute initial consultation with a Pharm.D. and then multiple contacts during the first month. This can add up to two hours of patient interaction per month.
In addition, we have prearranged rash protocols in place – and these were established long before the addition of the boxed warning. With our TAP App (Therapy Access Portal application for smart phones, tablets, and lap tops), we can seamlessly get that important feedback to the prescriber.
While the rare risk of adverse effects from the current hepatitis C protocol does exist, our country faces a much bigger risk from untreated hepatitis C. Consider this shocking statistic: up to 5 million Americans have chronic hepatitis C but an estimated 75 percent of them remain undiagnosed. Patients who know they have hepatitis C require treatment – which includes close monitoring for potential side effects – but more than that, we need to continue to get the word out about the importance of widespread screening for hepatitis C infection, especially in the Baby Boomer population.