Vigilance is derived from the Latin “vigilare”, to stay awake or to care for and is the process of paying close and continuous attention. Surveillance is defined as the systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary (1) Vigilance and surveillance (V&S) are used in association to underline that the attitude of vigilance needs to be associated with the methods of surveillance.
In practice a number of terms have been developed to describe V&S for specific types of products:
Pharmacovigilance: is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU. The WHO Program for International Drug Monitoring came into effect in 1968, in response to the thalidomide disaster in the 1960s.
Haemovigilance: is a set of surveillance procedures covering the entire transfusion chain (from the donation of blood and its components to the follow-up of recipients of transfusions), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent the occurrence or recurrence of such incidents (2).
Haemovigilance systems have been implemented in many developed countries to monitor the adverse occurrences associated with the transfusion of blood and blood products. In the early stages of haemovigilance, the concept was little more than collation of existing data. Over the years, analysis and process improvement have led to enhanced patient safety. Haemovigilance systems arose as a response to the threat of emerging infections, such as HIV, to the safety of the blood supply. The recognition of the AIDS epidemic, which resulted in the deaths of thousands of recipients of blood and plasma products, led to public debates, commissions of inquiry, and legal prosecution stemming from management of the nascent HIV risk of the 1980’s. The epidemic also provided an additional stimulus to assess the safety of transfusion services through ongoing risk assessment measures. Haemovigilance was developed first in Japan and then in France in 1993, which featured mandatory reporting. The UK developed the first voluntary system in 1996. Since this time, countries around the world have established Haemovigilance systems and have formed the International Haemovigilance Network to share common definitions and data (3).
Since 1995, the Committee of the Ministers the Council of Europe adopted the Recommendation No. R (95) 14 of the Committee of Ministers to member states on the protection of health of donors and recipients in the area of blood transfusion. Its Article 29 says “The patient's need for a transfusion should be assessed by pre-transfusion testing; post-transfusion tests are recommended in order to monitor and keep on record the effectiveness of the transfusion on the recipient. Haemovigilance systems should be implemented in order to detect possible adverse effects on the recipient”. Then the “Recommendation No. R (2002) 11 of the Committee of Ministers to member states on the hospital’s and clinician’s role in the optimal use of blood and blood products” suggests that a policy for clinical transfusion medicine should be developed at the country level. One of the key elements is the local application of existing guidelines for clinical use of blood and blood products, including implementing comprehensive quality procedures (covering pre-transfusion, transfusion and clinical surveillance), haemovigilance at all stages of blood transfusion. WHO has published an aide-memoire and a guidance document on the development of a national haemovigilance system.
Biovigilance: was incorporated into French law on 21 December 2003 with the publication of Decree n° 2003-1206. Its scope ranged from human organs, human tissues and cells to human cellular therapy preparations and ancillary products. It was then first incorporated into European legislation in the tissue and cell European Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 and in Directive 2010/53/EU of the European Parliament and of the council of 7 July 2010 for organs. In the United States, biovigilance has been extended to incorporate all MPHO including blood, tissues, cornea, cells, gamets and organs.
The basic elements of MPHO vigilance (haemovigilance and biovigilance) include:
• Identification and reporting of adverse occurrences involving harm to donors, recipients or children born following assisted reproduction with donated gamets or embryos;
• Monitoring and reporting of adverse occurrences that imply a risk of harm to donors or recipients;
• Product quality assurance (including processing controls and error management);
• Emerging threat assessment using epidemiologic and laboratory data (e.g., TTI bioinformatics, repositories).
The WHO guideline on adverse events and reactions reporting emphasizes that the effectiveness of the systems should be measured, not only by data reporting and analysis, but also by the use of such systems to improve patient safety. WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation, Guiding Principle 10, states “the level of safety, efficacy and quality of human cells, tissues and organs for transplantation, as health products of an exceptional nature, must be maintained and optimized on an ongoing basis”. This requires implementation of quality systems including traceability and vigilance, with adverse events and reactions reported both nationally and for exported human products (4).
The guideline outlined the following core concepts on MPHO vigilance:
• The fundamental role of patient safety reporting systems is to enhance patient safety by learning from failures of the healthcare system.
• Reporting must be safe. Individuals who report adverse occurrence must not be punished or suffer other ill-effects from reporting.
• Reporting is only of value if it leads to a constructive response. At a minimum, this entails feedback of findings from data analysis. Ideally, it also includes recommendations for changes in procedures and systems of healthcare.
• Meaningful analysis, learning, and dissemination of lessons learned require expertise and other human and financial resources. The agency that receives reports must be capable of disseminating information, making recommendations for changes, and informing the development of solutions.