Malfunctions in Apotti System in 2022

The Safety Investigation Authority assessed incidents in the Apotti information system that had threatened customer and patient safety and studied the malfunction related to prescriptions reported during 15–19 August 2022. 

Apotti is a shared information and ERP system¹ for healthcare and social welfare, and it has a total of 47,000 users working in healthcare and social welfare. Apotti is used by the Hospital District of Helsinki and Uusimaa (HUS) as well as Helsinki, Vantaa, Kerava and Kauniainen. 77% of the healthcare and social welfare professionals in Uusimaa use Apotti. There are approximately 14,000 simultaneous users in the system every day.

In the study, the Safety Investigation Authority used reports of malfunctions in Apotti as well as the material included in them. In addition, information related to the patient safety incidents that was received from HUS and Oy Apotti Ab as well as discussions with the National Supervisory Authority for Welfare and Health (VALVIRA) were also used.

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1. COURSE EVENTS

Starting from 1 January 2018 until 24 August 2022, a total of 106,786 HaiPro reports were submitted at HUS. HaiPro is a tool that has been developed for reporting incidents that threaten patient and customer safety. A total of 53 cases involving serious harm were reported. During the current year, a total of seven incidents classified as serious have been reported. One of them was caused by a problem in the wireless network connection and six were caused by problems related to the characteristics of the information system. No incidents leading to the death of a patient related to the functionalities of Apotti were reported during the period in question. 

The number of HaiPro requests for information that arrived at Oy Apotti Ab by September 2022 was 66% lower than in the previous year. During 2022, Oy Apotti Ab submitted four incident reports to the National Supervisory Authority for Welfare and Health, and Epic Helsinki Oy, the manufacturer of the system, submitted one incident report. 

The malfunction related to the prescriptions of patients during 15–19 August 2022 affected Apotti's functionalities, such as prescription centre query and verifying the compatibility of medications, issuing bar codes for medications and prescription renewal requests. The internal communications related to the malfunction were felt to be deficient. 

During the malfunction, a wrong medication was transferred to the patient's medication information. However, the wrong medication was not administered to the patient during care at the ward, and no attempts were made to create a prescription with the wrong medication. A total of eight error reports were submitted about the malfunction in situations, in which the professionals noticed the error while verifying the compatibility of the prescription. Concerning ten patients, a professional had rejected or removed the requested prescription due to incorrect medication information. As far as is known, no patients received the wrong medication in any of these cases, but in some cases the doctor had already approved the medication for the list of medications. The negative impact of the malfunction on patients was that the renewal of the requested prescription was delayed.

2. FACTORS BEHIND THE EVENTS

 
Serious patient safety incidents are processed in a multi-professional cooperation meeting, in which development measures are also planned. In order to investigate the incidents and learn from them, processes have been developed between Ab Apotti Oy and the operators that use the information system.

The Apotti information system requires regular updates. The medication database is updated twice per month. In connection with the update, the medication records of the Pharmaceutical Information Centre, the Social Insurance Institution of Finland (KELA) and HUS Pharmacy are updated in the Apotti system. During the update, the Pharmaceutical Information Centre sends information about the Nordic Article Numbers (VNR) of the medications that have been removed from the market. The removal information also removes the VNR in question from the Apotti system. Packages of medications that can still be used even though they have been removed from the market may nevertheless be stored in hospitals. For this reason, the system is also updated manually in connection with the update. In the malfunction related to prescriptions, a human error occurred in the manual processing of the update, which caused the malfunction.

In the malfunction related to prescriptions, the communications started immediately, but they remained on a general level, because the exact cause and impact of the incident were not immediately available for the communications.

3. SAFETY OBSERVATIONS

The problems related to the Apotti ERP system have been discovered relatively quickly in clinical operations. Serious risks to customer and patient safety are reduced by the round-the-clock ability of Oy Apotti Ab to react to system failures.

HUS, Helsinki, Vantaa and Kerava can request reports on incidents that have threatened patient and customer safety from Oy Apotti Ab, and they can submit development requests. Oy Apotti Ab processes the development measures according to its own management and assessment process and implements them, if necessary.

Oy Apotti Ab has the projects "Apotti 2.0 Käyttäjäkokemuksen ja tyytyväisyyden parantaminen" (Apotti 2.0 Improving user experience and satisfaction) as well as "Tieto- ja kyberturvallisuuden kehitysohjelma" (Information and cyber security development programme) in progress as development projects to promote customer and patient safety.

The National Supervisory Authority for Welfare and Health monitors the compliance of healthcare and social welfare information systems with requirements, and it processes malfunctions found in the information system as incident reports in accordance with the Act on the Electronic Processing of Client Data in Healthcare and Social Welfare (784/2021).

Among other things, problems related to the introduction to the use of Apotti and training in its use have come up in the investigation of the Safety Investigation Authority. The serious patient safety incidents due to Apotti should be investigated systematically, and the ERP system should be developed in a goal-oriented manner to be increasingly safer. Sufficient and clear internal communications in case of incidents should be ensured.

In the study that was carried out, it was not found that the Apotti system would have caused an immediate incident with very serious consequences.

Based on the study carried out, SIA will not initiate a safety investigation into the malfunctions of the Apotti system. If necessary, initiating the investigation will be reassessed.