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NPA: GDPR could be a ‘main’ cause of 64% increase in error reports

Leyla Hannbeck: GDPR could have prompted more frequent use of NPA's error reporting platform
Leyla Hannbeck: GDPR could have prompted more frequent use of NPA's error reporting platform

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.

Self-checking concerns

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).

Contributing factors

“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.

NPA’s tips for additional steps to take when self-checking

If self-checking is required, additional steps should be undertaken, such as:

  • Pick each item against the prescription – do not read from the label
  • Read the prescription out loud (ensuring patient confidentiality) each time while picking the item, labelling and checking
  • Ask another member of the pharmacy team to undertake at least one step of the dispensing process, such as picking items from the shelves
  • Take a break between each step (picking the items, labelling the items and accuracy checking).

Source: NPA patient safety quarterly report, April-June 2018

What is the main cause of dispensing errors in your pharmacy?

Greg Lawton, Community pharmacist

Were any of the incidents reported to the ICO? If so, it would be interesting to hear the experiences of notifying them.

For example, handout or delivery errors to the wrong patient, which will involve a patient having access to another's health data (a "special category" of data under the GDPR), are such incidents being reported?

The GDPR article 29 working party has issued some guidelines on data breach notification, including examples of breaches that should be reported to the ICO and those that don't need to be. It gives the example of "An individual phones a bank’s call centre to report a data breach. The individual has received a monthly statement for someone else" and identifies that this should be reported.

None of these examples have anything to do with GDPR. The error rate is a refelction of the state of the industry. The whole of community pharmacy is on it's knees. The margin for error has increased because there is not sufficient funding to operate in any other manner. 

We are still great at doing our job but there is no slack in the system. Triple lock safety checks are no more.

Paul doherty, Pharmacist Director

Barry you are spot on! We are expected to do more for less and are relying on increasing services to maintain income thus putting further pressure on the pharmacist or accuracy checker.  At no point do any of the above incidents mention breach of confidentiality so how did this inference come about.  PSNC and PDA need to assess what is causing the increase in errors reported and use this to improve the current contract remuneration.  Also, maybe all contractors were so busy attempting to scrape some money back by attaining QP points that their checking time was reduced thus increased risk of error.  Pressure to complete QP targets by area managers who hold conference calls to chase figures and services etc but never ask .... how many near misses have there been this week and how has this happened.  Work place pressure is the reason why incidents are increasing, due to increased stress from governing and contractual bodies and public expectation and decreasing remuneration and staff levels. Spiraling locum costs may also be causing pharmacist owners running small concerns to work more hours further adding fuel to the fire. 

Things need to change!!

Benjamin DeCostas, Administration & Support

Pharmacy was at breaking point years ago, and still they want us to do more for less. If you've got kids at school and a mortgage to pay, then you're in trouble. But for anyone else, run a mile and find something else to do with your life!

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