Activity of streptokinase preparations varies between manufacturers
There are wide variations in the activity, purity and composition of streptokinase preparations available worldwide, according to a study published this week.
Peter Hermentin, an employee of Aventis Behring GmbH, Germany, and colleagues
tested 16 streptokinase preparations (21 samples) from 11 manufacturers.
Each preparation is available in Brazil, India, Jordan, China, Pakistan
and Europe.
The researchers found that the samples ranged in activity from 20.8 to
107.4 per cent of that claimed on the label. Only three, Streptase (Aventis
Behring GmbH, Germany), Kabikinase (Pharmacia Upjohn, Sweden) and a distinct
batch of Icikinase (ICI Pharm Ltd, India), conformed with the ‘European
Pharmacopoeia’, which requires a fibrinolytic activity of 90 to
111 per cent of that stated on the label. Streptase is available in the
UK.
The authors note that only one sample from each batch was analysed and
therefore their results cannot be generalised.
An accompanying editorial suggests that aspects of post-marketing surveillance,
aimed at curbing manufacture of substandard or counterfeit drugs, are
largely neglected. A spokeswoman for the Medicines and Healthcare products
Regulatory Agency told The Journal: “This is certainly not the
case in the UK. We have a strict rolling programme, on an annual basis,
on all drugs that we license, including surprise site inspections and
checks on quality and efficacy. All prescription-only drugs will be checked
every two years.” |
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