Is your pharmacy ready for an unannounced inspection? Since the General Pharmaceutical Council (GPhC) revamped its guidelines, inspectors could turn up at any time – with their finding published online.
The new policy, due to come into effect between April 2019 and April 2020, marks a shift from the previous system where pharmacies were given four to six weeks’ notice of any inspections.
Inspectors will also no longer rate pharmacies as ‘poor’, ‘satisfactory’, ‘good’, or ‘excellent’, but will instead say whether they have ‘met’ or ‘not met’ the standards.
Even where the standards are met, however, inspectors are likely to find a ‘number of areas for improvement’ and these will be included in the published report, however minor.
In a new practice note, the GPhC acknowledges that the decision about whether a standard has been met will not always be clear-cut.
Inspectors will use the inspection decision-making framework to guide them, as well as their own professional judgement.
They must consider the scale and impact of any weaknesses, and can decide that relatively minor weaknesses have the cumulative potential to mean a standard is ‘not met’.
Of course, the greater the concerns for public safety, the higher the chances of a fail.
Only pharmacies with restricted access, such as those in prisons and airports, will be exempt from the unannounced visits.
Damage to reputation
As regulatory lawyer Andrew Andrews notes in Chemist and Druggist, the expectation is that these types of unannounced inspections will become the norm.
Any negative rating could have huge reputational damage, as it is unlikely that pharmacies will have a lawful basis for challenging the publication of the report.
He adds that the standards are wide-ranging and not always obvious, covering areas such as standard operating procedures, pharmacy records, and controlled drugs cabinets.
“This should not be cause for sleepless nights for those well-versed with the changes,” says Mr Andrews. “However, it is strongly recommended that pharmacy owners should be confident their pharmacy would meet all of the standards, were it to be inspected tomorrow.”
Are your processes and procedures up to date?
We know that safety and efficiency are top priorities for pharmacy managers, whether an inspector is at your counter or not.
That’s why Pharmapod’s Document Management module includes an easy-to-use system for creating and circulating documents relating to the Continuous Quality Improvement process.
Is your pharmacy running as smoothly as it could? Talk to the Pharmapod team today about how our healthcare incident reporting software could help.
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