Pharmacists’ authority to use their expertise to substitute one medicine for another should also apply to biological medicines, the International Pharmaceutical Federation (FIP) has made clear.
The federation has published a revised Statement of Policy on “Pharmacists’ authority in pharmaceutical product selection: Therapeutic interchange and substitution”, which has been updated to account for the emergence of biological medicines and their biosimilars onto the medical landscape.
“To date, no major safety issues with the use of biosimilars as alternatives to the original biological medicine have been reported,” the statement says. However, the new text calls for “adequate pharmacovigilance” to ensure identification of a biological medicine should any product-specific safety (or immunogenicity) concerns arise, as well as for post-marketing safety studies by companies marketing generic medicines or biosimilars, with safety updates to be made publicly accessible.
“Pharmacists are key stakeholders in product selection and evaluation. The purpose of this policy is to guarantee quality and good pharmacy practice in this area of pharmacists’ activities. FIP supports well-regulated processes in product changes where goals of safety, positive patient outcomes and economic benefits can be achieved with a good collaboration of all parties,” said FIP Vice President Eeva Teräsalmi.
The full FIP Statement of Policy “Pharmacist’s authority in pharmaceutical product selection: Therapeutic interchange and substitution” can be found here.