Traceability of biologicals: present challenges in pharmacovigilance

TY - JOUR

T1 - Traceability of biologicals

T2 - present challenges in pharmacovigilance

AU - Vermeer, Niels S

AU - Spierings, Irina

AU - Mantel-Teeuwisse, Aukje K

AU - Straus, Sabine M J M

AU - Giezen, Thijs J

AU - Leufkens, Hubert G M

AU - Egberts, Toine C G

AU - De Bruin, Marie L

PY - 2015/1/1

Y1 - 2015/1/1

N2 - INTRODUCTION: Traceability is important in the postmarketing surveillance of biologicals, since changes in the manufacturing process may give rise to product- or batch-specific risks. With the expected expansion of the biosimilar market, there have been concerns about the ability to trace individual products within pharmacovigilance databases.AREAS COVERED: The authors discuss the present challenges in the traceability of biologicals in relation to pharmacovigilance, by exploring the processes involved in ensuring traceability. They explore both the existing systems that are in place for the recording of exposure information in clinical practice, as well as the critical steps involved in the transfer of exposure data to various pharmacovigilance databases.EXPERT OPINION: The existing systems ensure the traceability of biologicals down to the manufacturer within pharmacy records, but do not support the routine recording of batch information. Expected changes in supply chain standards provide opportunities to systematically record detailed exposure information. Spontaneous reporting systems are the most vulnerable link in ensuring traceability, due to the manual nature of data transfer. Efforts to improve the traceability should, in the short term, be focused toward encouraging health professionals and patients to systematically record and report detailed exposure information. Long-term solutions lie in expanding the accessibility to, and increasing the electronic exchange of exposure data.

AB - INTRODUCTION: Traceability is important in the postmarketing surveillance of biologicals, since changes in the manufacturing process may give rise to product- or batch-specific risks. With the expected expansion of the biosimilar market, there have been concerns about the ability to trace individual products within pharmacovigilance databases.AREAS COVERED: The authors discuss the present challenges in the traceability of biologicals in relation to pharmacovigilance, by exploring the processes involved in ensuring traceability. They explore both the existing systems that are in place for the recording of exposure information in clinical practice, as well as the critical steps involved in the transfer of exposure data to various pharmacovigilance databases.EXPERT OPINION: The existing systems ensure the traceability of biologicals down to the manufacturer within pharmacy records, but do not support the routine recording of batch information. Expected changes in supply chain standards provide opportunities to systematically record detailed exposure information. Spontaneous reporting systems are the most vulnerable link in ensuring traceability, due to the manual nature of data transfer. Efforts to improve the traceability should, in the short term, be focused toward encouraging health professionals and patients to systematically record and report detailed exposure information. Long-term solutions lie in expanding the accessibility to, and increasing the electronic exchange of exposure data.

KW - Adverse Drug Reaction Reporting Systems

KW - Biological Products

KW - Databases, Pharmaceutical

KW - Drug Labeling

KW - Humans

KW - Pharmacovigilance

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

KW - Review

U2 - 10.1517/14740338.2015.972362

DO - 10.1517/14740338.2015.972362

M3 - Journal article

C2 - 25369769

SN - 1474-0338

VL - 14

SP - 63

EP - 72

JO - Expert Opinion on Drug Safety

JF - Expert Opinion on Drug Safety

IS - 1

ER -