International Pharmaceutical Federation (FIP) Adds Biosimilars To Policy On Pharmacists’ Right To Substitute One Medicine For Another
Pharmacists’
authority to use their expertise to substitute one medicine for another
should also apply to biological medicines, the International
Pharmaceutical Federation (FIP) made clear today. 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.
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. 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.
Notes for editors
Links: The full FIP Statement of Policy “Pharmacist’s authority in pharmaceutical product selection: Therapeutic interchange and substitution” can be found here.
About FIP The International Pharmaceutical Federation (FIP) is the global federation of national associations of pharmacists and pharmaceutical scientists, and is in official relations with the World Health Organization. Through its 144 member organisations, it represents over four million practitioners and scientists around the world. www.fip.org
PRESS CONTACT
Lin-Nam Wang, communications manager
Email linnam@fip.org
Tel +31 6 316 29160
