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‘Michelin stars’ make a meal out of regulation

The inspection process is about ensuring a safe minimum standard, not rating pharmacies against each other, says Numark MD John D'Arcy

On the back of 170 years of self-regulation, the transition to a new independent regulatory process was bound to require a period of adjustment. That said, while there are teething problems in general terms, pharmacists seem to be coping well with the new regime.

The inspection process is about assuring consumers that pharmacies are meeting standards that create and maintain the right environment for the safe and effective practice of pharmacy.

From a consumer's perspective the key question is, ‘Is this pharmacy safe?'. As such, the most straightforward approach would be to define post-inspection judgments as either ‘pass' or ‘fail'. A fail could be qualified according to whether the shortcomings are considered minor or major.

This is the approach adopted by the Care Quality Commission in its inspection of GP practices: those that meet essential standards are defined as ‘met this standard'; those that do not are labelled ‘action needed' or ‘enforcement action taken'.

By contrast, the GPhC has one definition for shortcomings – ‘poor' – and three for passes – ‘satisfactory', ‘good' and ‘excellent'. As such, it sets itself up as more than a regulator of minimum standards. By grading the extent to which pharmacies exceed its standards, it adopts the status of pharmacy's ‘Michelin star' awarder.

The role of the regulator should be to create an assurance and assessment of minimum standards. The competition in the market will do the rest

As it stands, no pharmacy can achieve the excellent status, since the criteria have yet to be defined. In reality, most pharmacies are graded satisfactory. At present, this is not a big issue, as the information is not in the consumer domain. When it is, however, the grading will become significant in terms of its ability to influence consumer behaviour, especially in the case of ‘satisfactory' pharmacies. While ‘satisfactory' is an adequate descriptor of a position where minimum standards are met, it carries the connotation of ‘could do more', which can be interpreted as ‘not particularly good'. This is hardly the message we want to convey, and may be indicative of an assessment process that has set the bar too high.

There can be no argument against the need to drive up standards in pharmacy and there is evidence of this happening in recent years, thanks to an enhanced regulatory framework and an improvement in choice and competition within community pharmacy associated with increased pharmacy openings. The role of the regulator should be to create an assurance and assessment of minimum standards. The competition in the market will do the rest.

John D'Arcy is managing director of Numark

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