Haemovigilance Documents To Ensure Safety Of Blood Products Launched In Accra (PICS)

Haemovigilance Documents To Ensure Safety Of Blood Products Launched In Accra (PICS)

A Haemovigilance documents aimed at ensure safety of blood and blood products has been launched in Accra.

According to the documents, it will enable health workers at all levels to report safety issues to tye FDA for appropriate regulatory action.

Speaking on behalf of the Minister of Health, Dr. Kwaku Agyeman Manu, the Director, Technical Coordination, Dr. Baffler Awuah said "Blood and blood products were essential in the treatment of blood and bone marrow disorders, immune deficiency conditions, bleeding in women associated with pregnancy and childbirth, severe anaemia among others"

"Universal Health Coverage meant that all individuals and communities must have access to affordable and timely supplies of safe and quality-assured blood and blood products"

"To ensure that Ghana achieved Universal Health Coverage, systems and structures have to be put in place to address causes of morbidity and mortality, including timely access to safe blood and blood products and their appropriate use"

The Director stressed that the Haemovigilance Framework will outline all steps involved in the haemovigilance processes, reporting of adverse events and roles and responsibilities of all relevant stakeholders with an action plan.

Taking her turn, the Chief Executive Officer (CEO) of Food and Drugs Authority (FDA), Delese Mimi Darko said "Transfusion of blood and blood products is an essential therapy that saves lives in emergencies, improves quality of life and enables many complex medical and surgical procedures to be undertaken.

"The Food and Drugs Authority is the agency mandated by the Public Health Act 2012, Act 851 to regulate whole blood, Blood components and Blood products as biological products"

The CEO added that Haemovigilance is an integral part of quality management in the blood transfusion chain and is required for the continual improvement of the quality and safety of blood and blood products and the blood transfusion process.

She stressed that the the Haemovigilance systems will provide valuable data on a range of adverse events related to blood donation and clinical blood transfusion, from donor syncopal events to Transfusion-reactions.

"The National Haemovigilance Framework for Ghana is developed with the objective to record all steps involved in the haemovigilance process, reporting of adverse events and the roles and responsibilities of all stakeholders"

"Key stakeholders in the national haemovigilance governance structure including Ministry of Health, FDA, National Blood Service, Blood facilities and transfusing facilities, have been identified at each administrative level, local, regional and national with roles clearly defined to ensure effective coordination of the haemovigilance activities"

"One major action plan outlined in the National Haemovigilance Framework to be completed over the next 3 years is training on the haemovigilance systems for all stakeholders and the development of online reporting to complement data collection at all levels to improve the current national haemovigilance system and ensure timely reporting"

Explaining further, Madam Darko noted that the guidelines for Haemovigilance in Ghana was developed to create a working document for health workers involved at different level of the transfusion chain to follow in order to guide their activities and bring about standardization of the activities within the blood transfusion chain, taking into consideration the country’s systems for managing transfusions.

"The guidelines is targeted at all stakeholders in the haemovigilance system including healthcare professional regulatory agencies, blood donor organizations, patient groups, scientific and professional bodies, development partners, hospitals, blood banks and health facilities where transfusion takes place"

"The guidelines provide important information in detail covering the key activities in haemovigilance including reporting and investigation of adverse reactions and adverse events, haemovigilance data collection, data management and use of haemovigilance data, traceability, haemovigilance methods and haemovigilance rapid alert system"

"The development of these two documents is very timely and would contribute to Ghana’s efforts to become a WHO Listed Authority not only in medicines and vaccines but also blood and blood products. The two documents will serve as good reference and invaluable teaching and learning materials for all stakeholders"

On her part, Dr. Shirley Owusu-Ofori, Acting CEO, National Blood Service said "Hon. Minister, Ladies and Gentlemen, blood transfusion is a necessary medical intervention that saves lives and improves the life expectancy and quality of life of patients with various acute and chronic conditions"

"There are, however, risks of adverse events associated with blood donation and transfusion. These adverse events include reactions, incidents, errors and accidents which occur during blood donation and transfusion"

She noted that the World Health Organisation (WHO) recognises the importance of haemovigilance; the systematic blood safety surveillance, to identify and prevent occurrence or recurrence of transfusion-related adverse events, and to increase the safety, efficacy and efficiency of blood transfusion.

"In spite of the critical role of Haemovigilance in ensuring a comprehensive quality system in blood establishments and hospitals, only 40% of countries in the Africa region had a National Haemovigilance system as compared to 83% of European countries as reported in a 2015 WHO Global Database on Blood Safety.  Even where haemovigilance systems are in place, opportunities exist to further raise the bar in safety and quality by expanding the scope of these systems – for example, by incorporating rapid alert or early warning channels; by including capture of poor transfusion decision-making, under- or unnecessary transfusion, and avoidable blood wastage"

Toiching on the journey, she noted that in August 2016, the Ministry of Health in conjunction with the National Blood Service signed a Minutes of Meeting (MoM) with the Japan International Cooperation Agency (JICA) and Terumo Corporation regarding the routine use of the Terumo BCT Mirasol® Pathogen Reduction Technology System and the implementation of a Haemovigilance program in Ghana.

She explained that a Kick-off meeting was held in May 2017, which initiated a series of capacity-building training programs with audits by Association for the Advancement of Blood and Biotherapies (AABB) Consulting Services to clinical staff and Blood service staff.

This, she said, culminated in the National Blood Service receiving 18-months of technical assistance support from JICA and Terumo BCT to establish a Haemovigilance system in Komfo Anokye Teaching Hospital and Korle-Bu Teaching Hospital.

"The Primary Objective of the programme was to monitor and evaluate the safety of the blood supply while comparing Mirasol-treated Whole blood and conventional Whole Blood in routine use with primary focus on Acute Transfusions Reaction"

"Building on this, in June 2020, the NBS and the FDA welcomed the Paul Erlich Institute ‘Blood Train’ who offered to support Ghana to establish Haemovigilance as a National Programme. A joint technical team was then constituted whose unflinching efforts have resulted in our gathering here today to officially launch the HV Framework and Guidelines for Haemovigilance in Ghana"

The Food and Drugs Authority later in the day organised a blood donation exercise its premises for its staff.

The blood donation exercise saw other institutions such as National Identification Authority (NIA), Ghana Institute of Journalism (GIJ) among others partaking in it.

Below are some pictures:

Story by: Joshua Kwabena Smith