Pockets of resistance

For every action there is an equal and opposite reaction. Just over a year ago, the publication of BS8404 aimed at improving the child-resistance of non-reclosable pharmaceutical packaging - namely strip and blister packs - was greeted with rejoicing by several campaigning organisations. And now that the consultation period has ended, those who will be affected directly by the implementation of the standard are - not unexpectedly - voicing fundamental concerns about the impact of the changes on pharmaceutical manufacturers, contract packers, machinery suppliers, retailers and, ultimately, consumers.

There can be little doubt that some form of conformance to a standard is long overdue where blister packs are concerned. There is little or no evidence to suggest that the number of child poisonings will be slashed by such regulation, but at least there would be no more complaining about uneven playing fields. If blister packs represented a serious risk to children, then the number of poisoning incidents would have increased in line with their proliferation and action would have been taken long before now. But nor can we continue to assume without evidence either way that blister packs are inherently child resistant.

Of course, even the most stringent regulation is no substitute for consumer education. We've all heard about the warning on the packet of peanuts: 'Caution - contains nuts'. But somehow the equally blindingly obvious warning to 'Keep medicines out of reach of children' seems to slip past the first and most effective line of defence: responsible adults.

Although the idea of a standard has been under discussion for at least a decade, its imminent introduction seems to have taken the pharmaceutical sector by surprise. But to be fair, it is hard to make provisions in advance of legislation without knowing just what the requirements are going to be.

Yet this is precisely the position in which makers and users of blister packs now find themselves. Even if they were able to adapt their production lines, and find the cost of the modifications and the additional packaging, storage and transport in a market where margins are already tight, and even if there were facilities in place to undertake the necessary product relicensing, it is possible that proposed EU legislation on the horizon could force them to go through the whole process again to meet a different set of criteria.

There is a real danger that some low-cost, low margin generic products may no longer be viable to produce once the new standard comes into force, thereby reducing the element of choice for the consumer. It would be the supreme irony if the blister pack itself - for all its advantages of ease of access for the elderly, its convenience and its economic benefits - were to be regulated out of the market, a victim of its own success.