Arizona has become the first U.S. state to allow pharmacists to change the medicine prescribed on a doctor’s prescription for a similar drug product. The law requires the patient to be informed.
Phoenix – In essence, the new law means that if a medical doctor prescribes a drug product branded X, a pharmacist may substitute this for a product branded Y, provided that the product is designed to do the same thing.
The law is called the “Substitution of Interchangeable Biologic Medicines” and it was passed this month by Governor Doug Ducey as House Bill 2310. Substituted medicines are sometimes referred to a “biosimilars.”
The law was passed because although the issue of whether one biologic medicine is similar to another is decided by the U.S. Food and Drug Administration (FDA), whether this is enacted comes down to each state. States can decide if one product may be substituted in place of a doctor’s prescription and also if a pharmacist must inform patients and doctors of the change.
The law has been welcomed by the trade association Biotechnology Innovation Organization. A spokesperson for the body, Jim Greenwood, told Pharmaceutical Processing magazine: “House Bill 2310 enjoys the support of physicians across Arizona and the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record.”
Greenwood added: “By signing this bill into law, Governor Ducey has added Arizona to the list of states that allow retail pharmacies to substitute interchangeable biologic medicines.”
However, the issue is controversial with those who fear that biologics are not exactly the same and some products, while having the same active ingredient, will carry different side effects. Importantly, the substituted products are not generic medicines (medicines made by one manufacturer to be identical to another — they are simply similar.) With this, the counter argument is that only a person’s doctor will understand the full medical history of a person. A second argument is that the law unravels the rights of a doctor to prescribe what is in the best interests of their patients.
Those in favour of the legislation say that such measures maintain incentives for innovation in the pharmaceutical sector and also promote a competitive market for biologic medicines. Another argument in favour, made by the Arthritis Foundation’s Advocacy & Access program, is that the measures potentially give patients access to new and novel medications, although these would come at a higher price. (Source: Digital Journal)