American Academy of Dermatology releases position statement on substitution

November 8, 2012 12:31 PM

Although biosimilar pathway is still not clear in the United States, the discussions about biosimilars, interchangeability and substitution are still ongoing without a break. 

The American Academy of Dermatology (AAD) updated their position paper on substitution and published it on their website yesterday. Here below you can find the whole statement of AAD:

Generic therapeutic substitution is the replacement at dispensation of an alternative, therapeutically equivalent drug than what was originally prescribed by a physician. Drugs are considered to be therapeutically equivalent even if they are chemically different, but hold the same pharmacokinetic properties.

Biologics are large, complex molecules derived from living cells using recombinant DNA technology. Due to their inherent variability, biologics can never be exactly replicated. Because of these differences in biosimilars, it cannot be assumed that they will be equally effective and, have the same side effects and safety profile.

Therefore, biosimilars must be carefully evaluated by a patient’s physician and health care team to determine the benefits and risks of a biosimilar substitution. It is imperative that data be collected regarding efficacy and safety, and that these products have different names so that medical records can fully reflect the exact medication prescribed and taken.

Therefore, in order to ensure patient safety, the American Academy of Dermatology Association supports a prohibition on generic therapeutic and biosimilar substitution unless all of the following minimal thresholds are met:

(1) in the case of biosimilars, the biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic in a patient’s permanent record, and to allow for the collection of adverse event information;

(2) in the case of biosimilars, the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;

(3) the prescribing physician provides explicit permission to the pharmacist that a generic therapeutic or biosimilar may be used as a substitute to the original therapeutic or biologic medication;

(4) the patient (or patient’s authorized representative) must be informed and educated about a generic therapeutic or biosimilar substitution at the point of sale;

(5) the pharmacist notifies the prescriber in writing or electronic communication within 24 hours prior to the substitution; and

(6) upon notification of a substitution, the pharmacy and the prescribing physician are encouraged to retain a permanent record in the patient’s medical record of the generic therapeutic or biosimilar substitution.


Source: AAD position paper

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