No 46 - 2014

Patient safety incidents in the childhood vaccination programme

The press has recently focused on patient safety incidents (PSI) in connection with mix-up of vaccines in the childhood vaccination programme, and Statens Serum Institut (SSI) has received a specific enquiry from the Pharmaceutical Committee Region Zealand, which has registered that approx. 10% of the registered events from primary healthcare concern childhood vaccinations. The registered PSIs include the following, among others:

• Mix-up of childhood vaccines, i.e. cases in which the child has been given another vaccine than the one that is appropriate for the child's age
• Lacking administration of vaccine in cases in which the child needs two injections
• Administration of solvent that had not been mixed with powder.

The vaccines used in the Danish childhood vaccination programme are all approved and registered vaccines. Therefore, the vaccines as well as any associated utensils such as syringes and needles, information material and packaging have been approved by the medicine authorities. Furthermore, any healthcare professional has a duty to ensure unambiguous identification of both the patient and the medicine before administering a vaccine.

The SSI has contacted the National Agency for Patients' Rights and Complaints who are responsible for registration of PSIs in the Danish Patient Safety Database (DPSD). The National Agency for Patients' Rights and Complaints responded that in the 1-year period from 13 October 2013 to 13 October 2014, a total of 150,000 PSI cases were registered in the DPSD. Of these, a total of 4,170 cases reportedly occurred at a general practitioner.

The National Agency for Patients' Rights and Complaints has extracted PSIs for the above-mentioned 1-year period and has identified a total of 156 events, of which approx. 80 are associated with the childhood vaccination programme. The general practitioners were not comprised by the PSI system until 2010, and the National Agency for Patients' Rights and Complaints assesses that some under-reporting of PSIs from general practice remains, that the extent of this is unknown, and that it is not certain if all vaccine-related AEs were identified for the extraction as the database has no unequivocal variable for vaccinations.

Below we provide some examples of PSIs that were identified as part of the data extraction from the DPSD:

• DTaP-IPV primary vaccine given without first mixing it with the Hib vaccine (provided as powder in the package)
• During the temporary vaccination programme, Infanrix hexa was given along with the DTaP-IPV/Hib vaccine. 
• During the temporary vaccination programme, the MMR vaccine was given instead of Infanrix hexa.
• During the temporary vaccination programme, the meningococcal vaccine Nimenrix was given instead of Infanrix hexa (provided by the same manufacturer).
• During the temporary vaccination programme, the dTap booster was mixed with IPV vaccine and injected in the same syringe.
• The MMR vaccine was confused with Gardasil (from the same manufacturer).

The National Agency for Patients' Rights and Complaints informs that DPSD cannot generally be used as a tool for statistics as it was only designed for identification of risk areas to which healthcare professionals and managements should pay particular attention and from which they should learn. The aim of the database is to underpin patient safety through the collection, analysis and dissemination of knowledge about unintended events and thereby induce systematic learning.

The SSI encourages everyone who gives vaccinations, to children as well as to adults, to ensure that vaccines are stored and handled expediently and correctly, to minimise the risk of any mix-up to the extent possible, and to always ensure unambiguous identification of both the vaccine and the patient before injection. Furthermore, if a PSI occurs you are encouraged to report it to the DPSD via this link: https://dpsd.csc-scandihealth.com/Form/PublicSubmission.aspx?form=DPSD_Public 
(P.H. Andersen, Department of Infectious Disease Epidemiology)

European Antibiotic Awareness Day 2014 and national Danish antibiotic campaign

18 November 2014 will see the celebration of the 7th European Antibiotic Awareness Day; a joint European initiative which counts the participation of 43 countries (www.ecdc.europa.eu).

The European Antibiotic Awareness Day is an annual event designed to increase awareness of the appropriate use of antibiotics. This year, in connection with the Awareness Day, a national Danish antibiotic campaign will be launched to increase awareness of the correct treatment of airway infections in children.

The campaign contains material in the form of the poster and folder "Does my child need antibiotics?" The messages are also presented in banners on netdoktor.dk and apoteket.dk and in video clips that are shown on flat screen monitors in pharmacies. Additionally, a dialogue sheet will be published for general practitioners that may be used for the conversation with the parents to small children about antibiotics. The campaign will also be shown on the website www.antibiotikaellerej.dk. (In Danish)

"Does my child need antibiotics?" is funded by means from the Danish Antibiotics Council and implemented as a cooperative initiative counting the Danish Ministry of Health, the Danish Medical Association, the Danish Health and Medicines Authority, Danish Regions , Danish Association of Danish Pharmacies and Statens Serum Institut.
(L. Skjøt-Rasmussen, R. Skov, Microbiology and Infection Control, B. Jørgensen, Digital Communication)

Link to previous issues of EPI-NEWS

12 November 2014