Improving the safety of vaccine delivery

ABSTRACT

Vaccines save millions of lives per annum as an integral part of community primary care provision worldwide. Adverse events due to the vaccine delivery process outnumber those arising from the pharmacological properties of the vaccines themselves. Whilst one in three patients receiving a vaccine will encounter some form of error, little is known about their underlying causes and how to mitigate them in practice. Patient safety incident reporting systems and adverse drug event surveillance offer a rich opportunity for understanding the underlying causes of those errors. Reducing harm relies on the identification and implementation of changes to improve vaccine safety at multiple levels: from patient interventions through to organizational actions at local, national and international levels. Here we highlight the potential for maximizing learning from patient safety incident reports to improve the quality and safety of vaccine delivery.

KEYWORDS:

• adverse event monitoring
• data linkage
• incident reporting
• vaccine safety
• vaccine errors

Vaccinations save millions of lives globally per annum, yet 18.7 million children do not receive basic vaccines.¹ Public health interventions are seeking more complete population coverage.² Laboratory advances in disease prevention can contribute to more complex vaccination schedules. The World Health Organization (WHO) points to a larger number of adverse events (defined as “an incident that results in harm to a patient”³) from vaccine delivery outnumbering adverse events from the pharmacological properties of the vaccine.⁴ Little research and development has been devoted to the safety of the vaccine delivery process.⁵

As vaccines become more effective in reducing the burden of disease, vaccination itself could create a greater harm from adverse events.⁵ Research and improvement efforts may now mitigate harm occurring during the vaccination process, which commonly include: giving the wrong vaccine; giving vaccines at the wrong time in a schedule; giving extra (unnecessary) vaccines; administering vaccines via the wrong route; and prescribing or administering the wrong dose.^2,6,7 Several studies have shown that approximately one-third of patients experience at least 1 vaccine error.^8,9 Feikema and colleagues estimated the United States wastes $26.5 million per annum on unnecessary vaccines given to infants between 19 and 35 months.¹⁰ The international savings could be valuably redirected to address low vaccine uptake in target population groups.

Valuable insights in the common failure of vaccine delivery processes have come from the MedMARx reporting system in the United States and the England and Wales National Reporting and Learning System.^5,7 Surveillance systems primarily capturing data about adverse drug reactions, such as the Vaccine Adverse Event Reporting System, can also contain reports about the vaccine delivery process.¹¹ Whilst safety incident reporting systems cannot accurately measure the frequency of vaccination errors, they can support the identification of priorities for improvement.¹² Research led by the PISA Group at Cardiff University into vaccine-related safety incidents reported from primary care in England and Wales mirror issues reported in other healthcare systems across the world.^2,7 Although these concerns are not new,⁹ we recognize a systems improvement approach is essential.

A multifaceted systems improvement approach will require patient and practitioners to work together to design / redesign care delivery in organizations that are committed to national and international learning about vaccine safety.¹³ Enabling patients to maintain an accurate immunization history could be supported by a shared health record. Encouraging patients to self-report their experiences of error will contribute to system learning.¹⁴ With the expanding options to have seasonal vaccinations in pharmacies, workplaces, and numerous other transient clinics, a secure, linked, up-to-date immunization record serves to ensure the safe delivery of vaccines.

Organizations must support their staff to develop awareness and confidence to identify and report report patient safety incidents, defined as “an event or circumstance that could have resulted, or did result, in unnecessary harm to a patient” and near misses which are defined as “an incident which did not reach the patient”.^4,15 Busy healthcare staff may not feel the urgency to report incidents that do not lead to harm. High performing organizations demonstrate their ability to learn from those situations where an error was prevented from occurring.^16,17 It is imperative to “close the loop” of incident reporting by using the data provided to drive improvement efforts, engage staff in analyzing the data they have provided, and demonstrate how patient and staff's concerns have been acted upon. Open and transparent data will support this.¹⁵

Nationally and internationally, data-linking initiatives can support safer vaccine delivery processes.¹² Collating essential information about patients from potentially multiple electronic sources, into one electronic medical care record is needed,¹⁸ and should include information about immunization scheduling (which vaccines are still needed and when, and a history of vaccines received to date), patient characteristics like age and co-morbidities that mean patients should receive extra vaccines, and known allergies. Such access to data would enable the practitioner to delivery vaccines safely, timely and reliably. A shift in practice from passive incident reporting systems to active incident surveillance would enable more timely investigation of incidents and coordinating for systems improvement.¹⁸ For example, from our analysis of safety incidents in children, administering the wrong number of doses was the most frequent administration error. How easy it would be to detect and prevent such error with a simple computer algorithm, should all vaccine-related data be centralized.⁷

Uniting safety report data systematically, nationally, and internationally will enable the identification of signals that are too small to be seen on a local level. Working internationally will garner the greatest benefits, by prioritizing efforts together and sharing context-specific solutions between countries. Vaccine safety serves as an ideal candidate to realize the potential of patient safety incident reporting by sharing data to maximize learning between countries, minimizing wasted resources, and reducing risk of healthcare-related harm.

Disclosure of potential conflicts of interest

AC-S is a co-chief investigator of a NIHR HS&DR grant to characterize patient safety incident reports in primary care.