NPA: GDPR could be a ‘main’ cause of 64% increase in error reports
The number of errors reported to the National Pharmacy Association (NPA) increased by more than 60% in the three months which saw EU data regulations implemented.
There was a 64% increase in patient safety incidents reported between March and June, compared with the first three months of the year, and “reports almost doubled in June compared to April and May”, the NPA said in its latest Medication Safety Officer (MSO) report.
NPA director of pharmacy Leyla Hannbeck told C+D that the General Data Protection Regulation – which came into force on May 25 – could have been “one of the main contributing factors for pharmacy contractors to report all types of incidents”.
The GDPR is a set of regulations designed to protect EU citizens from privacy and data breaches. It has made pharmacy owners into data “controllers” and carries data infringement fines of up to €10 million.
“Pharmacy teams have more knowledge around GDPR through webinars, resources and workshops,” Ms Hannbeck said. “This could have prompted more frequent usage of our [error reporting] platform.”
“Panic” after serious incident
In her letter to all pharmacy superintendents, Ms Hannbeck said the NPA received “a number of serious patient incident reports” between April and June, including a patient self-administering the wrong insulin after it was dispensed in error.
An ambulance was sent to the patient’s home to treat them for hypoglycaemia, it explained.
“A number of cases” also led to patients being hospitalised, according to the NPA, including a patient receiving a double dose of sodium valproate modified-release tablets in their monthly blister packs, instead of ranolazine hydrochloride modified-release tablets.
The patient was hospitalised two weeks later with ventricular tachycardia storm, it said.
“Chaos” over missing CD keys
Other “interesting examples” noted by the NPA included a responsible pharmacist taking the keys to the controlled drugs (CD) cabinet home, which resulted in “extreme chaos” in the pharmacy when the second pharmacist could not find them.
The NPA recommended CD keys be placed in an envelope at the end of the day that is signed, sealed and handed to a “relevant member of staff”, then stored in “a suitable place”, as per Home Office guidance.
The NPA also noted that 33% of the total errors reported involved “a pharmacist self-checking their own work”.
While self-checking is sometimes “unavoidable due to practical reasons”, the NPA stressed that “robust procedures” must be put in place, with “additional steps” taken to avoid patient safety incidents (see below for more tips on self-checking).
“Work and environment factors” continued to be the main contributors to patient safety incidents in the three months to June, accounting for 45% of errors, the NPA pointed out.
Ms Hannbeck said: “There does seem to be a correlation between ‘work and environment factors’ and incidents involving self-checking.”
“However, I also believe that there are other pressures that pharmacy contractors are having to face, such as funding cuts, price concessions, [the] category M clawback – so reducing staffing levels may only be an option.”
The majority of all incident reports – 57% – continue to involve no harm to the patient, and 29% were reported as “near misses” to the NPA, it added.
Read a full copy of the NPA’s report for April-June 2018 here.