Controversy over generic substitution

We read with interest the paper discussing the English Department of
Health’s decision to introduce generic substitution in primary care (1).

Generic substitution has been permitted for several years in Australia but
continues to cause considerable problems for health consumers, some of
which are briefly discussed in this paper. We have recently completed a
multi-stage qualitative study involving 104 Western Australian (WA)
seniors with at least one chronic disease exploring their views and
experiences of taking medicines safely. The most important and consistent
theme that arose related to generic substitution and associated problems
with drug packaging and labelling.

Considerable doubt was expressed about the equivalence of generic
medicines partly because of a broader mistrust of pharmaceutical companies
and the increasing geographic dispersal of medicine production. The
problem of inconsistent appearance and taste of different generic forms of
a drug were also frequently described. More importantly though was the
associated problem of inconsistent packaging and labelling, not described
in the paper by Ferner et al. Figure 1 provides just one example where
different forms of perindopril were dispensed to the same patient. Three
core issues exist: the larger font size, and therefore more prominent
brand name, the entirely different packaging, and the apparent change in
dose due to change from one salt to another of perindopril. This patient
was taking both drugs concurrently until adverse effects were identified
by the pharmacist. The WA study revealed that generic substitution was
rarely discussed in detail with patients either by their general
practitioner or pharmacist, other than to discuss the potential cost
saving. For most consumers however, the reduced price of a generic
substitute was insufficient to change their preference for a specific
brand.

While this issue is well recognised by health consumers and practitioners,
it appears to be largely ignored by policy makers seeking to generate
financial savings from generic substitution. Tighter regulatory frameworks
are required to ensure not only clinical equivalence, but also consistency
of drug packaging and labelling to minimise confusion caused by generic
substitution, particularly in those taking multiple medicines. Strict
adherence to generic substitution could have important unintended
consequences for the safe and effective use of medicines without such
regulations in place.

Competing interests:
None declared