EMEA Draft Guideline on Epidemiological Data on Blood Transmissible Infections

The drug development regulators, the EMEA, has published a draft guidelines GUIDELINE ON EPIDEMIOLOGICAL DATA ON BLOOD TRANSMISSIBLE INFECTIONS (EMEA/CPMP/BWP/125/04. Rev 1) for consideration.

Executive Summary

In the light of experience gained with the application of the Guideline on Epidemiological data (published in Jan. 2005) a group of experts was assigned to critically look at the:

• 2006 epidemiological data submitted in the Plasma Master File (PMF) annual update, in conjunction with the CHMP Epidemiological guideline,
• 2006 and 2007 PMF evaluation reports for the relevant PMF

Feedback on this work was provided to the PMF Drafting Group and to BWP/CHMP and a revision of the guideline was recommended.

Main Guidance Text

Purpose

The requirement to collect epidemiological data on blood transmissible infections is intended to obtain information on the infection risk in a specific donor population and is thus an essential part of the measures taken to ensure an adequate selection of donors of blood and plasma.The purpose of collecting these data is to characterise the donor population with respect to infection risk, to allow trend analyses to be undertaken over periods of time, and to allow comparison of risks between donor populations of individual collection centres. Continuous epidemiological evaluation at individual blood/plasma collection centres together with an annual update of the assessment are therefore required.

Infectious Disease Markers

Epidemiological data should be collected on those blood-borne infectious agents for which a potential transmission by blood products is well recognised and routine testing of blood and plasma donations is mandatory. These infectious agents currently include human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).

Only confirmed infections should be reported.

Donor Classifications

The Council Recommendation on the suitability of blood and plasma donors and the screening of donated blood in the European Community (98/463/EC) provides the following definitions of types of donors:

• Prospective donor: Someone who presents himself/herself at a blood or plasma collection establishment and states his/her wish to give blood or plasma.
• First time donor: Someone who has never donated either blood or plasma.
• Repeat donor: Someone who has donated before but not within the last two years in the same donation centre.
• Regular donor: Someone who routinely donates their blood or plasma (i.e. within the last two years), in accordance with minimum time intervals, in the same donation centre.

Prevalence and Incidence

This section first describes the general concepts of incidence and prevalence for infectious diseases and then the application of these concepts in the study of blood and plasma donors.
Prevalence and incidence can be defined as follows:

• Prevalence: Frequency of infection identified (including both past and recent infections) at a specified point in time or over a specified time period in a defined population.
• Incidence: Rate of newly acquired infection identified over a specified time period in a defined population.

Prevalence and incidence are complementary in that they provide information on past and current risk of infection in the population. High prevalence and incidence is indicative of established infection with continuing transmission. High prevalence and low incidence is indicative of established infection but with intervention measures (e.g. education on risk of infection, effective therapy) having been introduced. Low prevalence and high incidence indicates infection which is probably recently introduced into the population.

Recommendations for reporting of data on infectious disease markers

In reporting epidemiological data it is important to clearly describe the testing result definition and the classification of the donor as this will affect the results obtained and the comparability of data. The potential risk for plasma-derived products arises from undetected infectious donations entering the plasma pool. A viraemic donor may donate once or several times during the “window period”, i.e. the period of infection when the infected (and viraemic) donor is tested negative by screening tests. Therefore, in order to facilitate the risk assessment (see section 7 below), collection centres should report the number of donations collected as well.

Epidemiological Assessment of Donor Populations, and Trends Over Time

The criteria used by the PMF Holder to establish acceptable ranges for epidemiological data, and to identify any individual blood/plasma collection centres reporting data above the acceptable range, should be described. The results of the analysis should be provided and information given on any collection centres outside of the acceptable range and the corrective actions taken.

Estimation of the Risk of Infectious Donations Passing Undetected Through Routine Donation Screening.

The method used by the PMF Holder to estimate the risk of infectious donations passing undetected through routine testing at the time of donation collection should be fully described. Citing a reference describing the method is not sufficient.

If donations from first time tested donors are used this should be included in the overall estimation of the risk, as well as being presented separately.

There is a risk of infectious donations passing undetected through routine testing due to inabilities or failures of the testing systems to detect established (prevalent) infections. For each individual virus and test system reported the risk of releasing a truly positive donation is a function of:

• the sensitivity of the tests, and
• the risk of errors in the testing system, and
• the prevalence of the infection amongst donors.

Results should be reported using the tabular format.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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