Use care when regulating biosimilars
Wednesday, February 6, 2013
Biologic medications and biosimilar substitutes have the potential to greatly improve the quality of life of patients suffering from debilitating illnesses, including cancer and HIV-AIDS. These are highly powerful medicines, engineered from biotechnology and are far more complex than traditional chemical drugs like Tylenol. However, given the inability of biosimilars to precisely replicate the composition of biologics, careful monitoring, information flow and recordkeeping are of critical importance to effective treatment and patient safety.
Speaking for many physicians in Virginia, I believe that House Bill 1422, recently introduced in the Virginia legislature by a practicing Richmond neurologist, Del. John M. O’Bannon III, is important to protect patients and must be supported.
HB 1422 would allow greater oversight to physicians when prescribing biologics and biosimilars. Virginia law currently governs drug substitution for chemical drugs, but has not yet addressed substitution standards for this class of drugs.
However, I remain concerned that the Senate version, Senate Bill 1285, may omit an important provision regarding physician notification when biosimilars are substituted for biologics.
Here’s why: As a pediatrician who cares for children with special health care needs, I have seen the incredible benefits these medications have brought to my patients. They have changed the lives of my young patients, allowing them to live pain-free, attend school, play sports and develop typically. But, as with any powerful intervention, these medications have significant potential adverse effects. Due to the complex nature of the composition of biologic medications, they are difficult to replicate with precision. As such, substitutable biosimilars are prone to vary from their biologic reference product if not made by the same manufacturer, which can lead to unintended and adverse patient consequences.
Due to subtle differences between a biologic and its biosimilars, physicians and pharmacists need to work collaboratively to ensure that the treating physician is aware of the exact biologic or biosimilar given to a patient. This data facilitates patient care and assists in identifying whether a problem is from the change in medication, the underlying disease or another cause.
Patient notification of product substitution and careful record-keeping are important provisions that must be included in final legislation. If physicians know about product substitutions and there is an established information trail, then they possess a critical piece of information that will enable them to alter the course of treatment should an issue arise.
It is important to note that patient notification and record-keeping is not dissimilar to other activities performed by pharmacists every day; hence, this sensible measure will not saddle pharmacists and will serve to reduce negative patient outcomes.
The discrepancy with regard to patient notification of product substitution and record-keeping between House Bill No. 1422 and Senate Bill No. 1285 is significant and must be reconciled before passing and enacting final legislation.
The goal of our state’s health regulations and medicine in general must always be to provide the best care possible for patients in Virginia.
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