Prof. Dr. Hasan Abbas Zaheer Project Director Safe Blood Transfusion Services Programme Pakistan

Country Introduction BT Sector of Pakistan: Indicators, Facts & Figures System Architecture Key Stakeholders Current State of Development Future Vision and Strategies

Pakistan Founded as an independent state in 1947 Location: Southeast Asia Borders Afghanistan (NW), China (N), India (SE), Iran (SW) and Arabian Sea (S) Area: 796,096 sq Km Population 180 M _ sixth largest in the world Median age 21.6 years High population density areas Urban Population: 35% Literacy rate: 49.5% Life expectancy: 65 Yrs Language: Urdu (National), English (Official)

Number of whole blood donations collected by type of donations Voluntary non-remunerated donations 165,822 15.4% Family/replacement donations 910,167 84.6% Paid donations 0 0 Others 0 0 Total number of donations 1,075,989 Annual blood collection approx. 3 M units About 800 Blood Banks (not all registered) Estimated blood collection/1000 pop: 16.6 * Data collected from 324 blood establishment (321HBB and 3 Blood Centers), 2011

Pakistan Developing Countries Transitional Countries Developed Countries 16.6 3.6 10.1 45.4 Relatively high figure compared to those of other developing and transitional countries High consumption of blood by thalassemia patients (estimated two-thirds of blood produced are utilized by thalassemia patients). Excluding thalassaemia patients, the annual blood collection for other conditions is approximately 5/1000, still higher than the average of developing countries.

Replacement donations culturally ingrained due to their linkage with the biradari system in Pakistan Criteria for voluntary donations still variable Current strategy Blood donor policy developed (soon to be implemented) Nation-wide KAP survey conducted Conditions for potential of replacement to voluntary donors to be explored Approximate figures for types of donors (estimates): Replacement/directed-85% Voluntary-10% Paid-5% Replacement and paid donations Pakistan Developing Countries Transitional Countries 90% 37% 26% 2% Developed Countries

Number of blood centers that perform screening of blood donations for TTIs=324/324 Number of donations that were screened for the TTIs Total Percent HIV 1,052,584 97.82% Hepatitis B 1,075,979 99.99% Hepatitis C 1,075,979 99.99% Syphilis 688,064 63.95% Malaria 688,034 63.94% Number and % of infections in blood donations for the following TTIs marker Total Percent HIV 93 0.01% Hepatitis B 23,296 2.2% Hepatitis C 42,301 3.9% Syphilis 4,030 0.6% Malaria 681 0.1% * Data collected from 324 blood establishment (321HBB and 3 Blood Centers), 2011

Public Sector (including Armed Forces) Approximately 15% contribution in terms of blood supply Mostly Hospital Blood Banks Private Sector Approximately 85 % contribution in total, predominant sector esp. in the provinces of Punjab and Sindh Hospital based blood banks and stand-alone blood banks NGOs (mostly not for profit) Diverse in terms of functions and capacities from donor mobilization only to the entire v2v transfusion chain Major contributors to management of thalassaemia patients BDOs Mostly university based organizations Major contributors to the voluntary blood donor pool in Pakistan

More than 60 BDOs/NGOs are working independently and have variable functions NGOs (mostly not for profit) Diverse in terms of functions and capacities from donor mobilization only to the entire v2v transfusion chain Major contributors to management of thalassaemia patients (regular blood transfusions) BDOs Mostly university based organizations Major contributors to the voluntary blood donor pool in Pakistan through their donor motivation and mobilization programmes

System Reform envisaged by the Safe Blood Transfusion Programme, Pakistan Based on a centralized model Functional separation between RBCs (collecting, processing, testing, storing and distributing blood) and HBBs (storing and issuing blood) In the current phase of the SBT project (->2014), 12 RBCs and 78 affiliated HBBs would be constructed/refurbished In the first phase, the model will contribute approximately 15% to the sector in terms of blood supply

RBC-50,000 donations/year RBC-20,000 donations/year

Ministry of Health exercised key steering function till the devolution of health to the provinces (June 2011) (based on 18 th amendment to the constitution in June 2010) Provincial Departments of Health have now assumed the stewardship in each of the provinces (legislation, policy, standards and guidelines) Blood Transfusion Authorities, established under the Provincial Health Departments, are the key regulatory bodies

Medical Universities Basic education and training to doctors and medical technologists Other Teaching and Training Institutes Diverse range of laboratory related diplomas Pakistan Society of Haematology Country-wide platform for all haematology and blood banking related professionals Forum for information exchange and teaching (annual conferences, workshops, newsletters, other publications) Potential importance as accrediting body for blood banks

Pakistan Medical & Dental Council Regulatory body for medical professional has the mandate to develop and revise medical curricula Higher Education Commission of Pakistan Has the mandate to develop/revise curricula for M.Sc and B.Sc programmes (including of Medical Technologists) College of Physicians and Surgeons of Pakistan Key fellowship training and the highest degree awarding institute of Pakistan for medical doctors. Standardized training, curriculum and examinations throughout the country l

Diversity in the system NGOs, BDOs, Private Sector System Reform (functional separation) 15 years since the first BT law enacted(during the period 1997-2004 all provinces have passed their respective legislations on blood safety) Advancements in Transfusion Medicine More emphasis is required on Traceability Haemovigilance Blood transfusion regulatory authority (their role and responsibility) Consensus on a New Template of BT Law The enactment process has started at DOH

Used to develop the key guiding tool (roadmap) for the implementation of the SBT project (German Technical & Financial Cooperation, Safe Blood Transfusion Project) Revision in the first half of 2013 to incorporate several key unaddressed issues (gender, publicprivate partnership, BDOs, disaster management, post-devolution scenario)

Blood Transfusion Authorities Notified in all provinces Not fully functional except in the province of Sindh Current strategy-capacity development Material resources provided, functional brief under development Programme Managers Representatives of DOH Focal persons for the BT programmes National Steering Committee Formed to implement the National Blood Policy and Strategic Framework Task Forces & Working Groups Include all stakeholders Formed to undertake specific tasks (development of National Standards and Guidelines, CUB guidelines, SOPs)

The first edition approved and published by the MOH in 1999 mainly adopted from an international document widely disseminated, but not fully implemented Current strategy revision untaken by a Task Force comprising local experts with the objective of creating an applicable document the revised document caters to the sector diversity and defines only the minimum standards SOPs have been drafted for blood banks by the working groups including local experts in the relevant field

Wide diversity Existence of ISO certified institutions on the one hand Lack of even basic quality control measures on the other hand Local external quality assurance (EQA) programmes existing (e.g. Armed Forces Institute of Pathology) Potential importance of Pakistan Society of Haematology as an accrediting body (analogous to College of American Pathologists)

Most blood transfused as Whole Blood till the widespread occurrence of the dengue epidemic Component production and storage facilities increasingly becoming available Diversity in the methods and techniques for transfusion transmittable infectious disease testing Gold standard methods (e.g NAT testing) available in some centres Intermittent supply of screening kits compromises blood safety at the other end of the spectrum

First CUB guidelines Published and disseminated in 1999 Not utilized by clinicians for several reasons (developed only by a small group of haematologists, did not include whole blood which comprised the predominant blood product at that time, HTCs non-existent) Clinical governance-hospital Transfusion Committees existing and functional in a few centres Current strategy Revision of CUB guidelines by a Task Force comprising all stakeholders (clinicians, haematologists, CPSP, PMDC, PSH etc.) Establishment of Hospital Transfusion Committees for clinical governance: Terms of Reference developed, information sharing about existing HTCs through workshops and monthly SPTP newsletter, plan for their actual institution to be developed

Concept relatively new in Pakistan Centralized haemovigilance does not exist Current strategy Blood Transfusion Authorities would also be given the mandate to elaborate haemovigilance rules and to coordinate haemovigilance Hospital Transfusion Committees would be responsible for transmitting Haemovigilance related information to BTAs 'Pakistan Haemovigilance Network (PNH) (to be supported by the INH): national baseline survey, reporting system PNH would encourage and assist in the formation of HTCs all over the country. The HTC will collect haemovigilance data from their respective centers and report to PHN. PHN would compile Annual Reports, which would help in policy making, planning and blood safety improvement.

The concept of coherent, reliable data recording and management only beginning to be understood and implemented The recently introduced DHIS comprises the first centralized management information system in the Health Sector In most cases, some data recorded manually but not utilized for management decisions Well-functioning MIS in some hospitals Current strategy: introduction of nation-wide BT MIS, functional brief for MIS developed

Bringing all stakeholders on board (Task Forces, Working Groups) Networking and information sharing Defining minimum essential regulations and standards applicable to all, allowing for diversity in a sector of on-going transformations Avoiding over-regulation and policing Utilizing pertinent expertise in Pakistan for situation specific solutions

NGOs Application of thalassemia prevention strategies through family screening of index cases 1 BDOs Change agents for the paradigm shift from the replacement to voluntary blood donations 1 Ahmed S, Saleem M, Modell B, Petrou M. Screening extended families for genetic hemoglobin disorders in Pakistan. N Engl J Med 2002 Oct 10;347(15):1162-8.

Development of standardized blood bank curricula for all cadres of blood bank and clinical staff Doctors Collaboration with PMDC and CPSP Medical Technologists Collaboration with the Higher Education Commission of Pakistan Development of Business Plans for the future centralized systems Public-private partnerships A code of ethics for laboratory practice is envisaged to generate additional motivation and allegiance to blood safety