Biologics switching is in pharmacists’ scope


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Pharmacists’ authority to use their expertise to substitute one medicine for another should also apply to biological medicines, says FIP

The International Pharmaceutical 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. 

The core principles that were in the original statement remain, and include: that generic substitution is recommended as part of the pharmacist’s dispensing role; that pharmacists should be provided with bioavailability data by regulatory authorities and manufacturers; and that a medicine should only be substituted with a product containing a different active ingredient in agreement with the prescriber.

The use of generic names is still encouraged, but the revised statement gives focus to the use of international non-proprietary names in particular.

The revision also recommends that, to ensure safety, information about excipients should be taken into account when making decisions on substitution.

“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,” said FIP Vice President Eeva Teräsalmi.

“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.”

In Australia, there is evidence of significant reluctance among pharmacists to substitute biologics, while a number of other health stakeholders retain concerns about their doing so.

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