|Year : 2022 | Volume
| Issue : 1 | Page : 104
Blood is a drug and drug controller is the right regulatory authority for licensing and monitoring blood transfusion services - Contrary view
Shabneez Hussain, Manzoor Ahmed
Regional Blood Center, Karachi (Managed by Fatimid Foundation), Karachi, Pakistan
|Date of Submission||16-Mar-2022|
|Date of Decision||21-Mar-2022|
|Date of Acceptance||26-Mar-2022|
|Date of Web Publication||29-Apr-2022|
Dr. Shabneez Hussain
Regional Blood Center, Karachi (Managed by Fatimid Foundation), Karachi
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Hussain S, Ahmed M. Blood is a drug and drug controller is the right regulatory authority for licensing and monitoring blood transfusion services - Contrary view. Glob J Transfus Med 2022;7:104
|How to cite this URL:|
Hussain S, Ahmed M. Blood is a drug and drug controller is the right regulatory authority for licensing and monitoring blood transfusion services - Contrary view. Glob J Transfus Med [serial online] 2022 [cited 2022 May 20];7:104. Available from: https://www.gjtmonline.com/text.asp?2022/7/1/104/344333
By definition, medicines or drugs are products of chemical or biological origin that acts medically on the humans to treat illnesses, injuries, and handicaps. Blood component, though biological in origin, cannot be manufactured nor it can be used to cure illness. Although therapeutic and life-saving, blood component therapy is more of substitution as it compensates the missing factor at a point in time. Blood rarely cures or treats disease, and viewed in this context, labeling blood components as a drug would be incorrect.
There is a significant difference between blood component therapy and treatment with plasma-derived drugs from other medicines since blood's availability is strictly dependent on donor mobilization. These ethical concerns of blood centers relate to donor confidentiality and transmission of infections which differ significantly from those faced by pharmaceutical industries. Hence, labeling blood component as a “drug” would be contradictory.
Blood components are of two types; labile fresh products (red cells, platelets, fresh frozen plasma, cryoprecipitate, and cryosupernatant) and plasma-derived medicinal products (albumin, immunoglobulins, and coagulation factor concentrates). Immunoglobulins and coagulation factors are chemically purified, but raw materials for these products are blood donors; therefore, it is contradictory to label them as “drugs.” In countries like Switzerland, blood and blood products are considered as medicines, while in Europe, there are two directives – “medicine” directive encompasses plasma from fractionation and “blood” directive deals with labile blood products.
Another issue with labeling blood product as a “drug” is the lack of maintenance of the voluntary blood donor pool due to the “commercialization” of the final product. If blood component is labeled as a drug, the blood donor will be treated as a raw material for the final product, giving the rights of distribution to the “company” manufacturing it. Furthermore, no two donors are alike, and hence, blood collected from them cannot be standardized like other pharmaceutical products. When the raw material (donor's blood) itself lacks standardization, the products prepared from them cannot be designated as drugs and expected to heal the sick.
Every donor is a batch by himself/herself, and hence, batch testing to assess quality is not possible unlike with other drugs. The resulting product being different from donor to donor (variations in raw material) gives rise to differences in therapeutic response and adverse events. Red cells cannot be compared to paracetamol or aspirin. They are neither prepared from the same raw material nor do they contain the same number of red cells or produce the same therapeutic responses in patients. Adverse events due to transfusion of fresh frozen plasma, for instance, may vary from a simple allergic to an anaphylactic reaction.
Monitoring transfusion services requires adequate knowledge of transfusion medicine as the components, and the dose may need to be adjusted for different patients to achieve the same benefit. Hence, monitoring blood and blood products can be done only by an expert who has an in-depth understanding of all the nuances of medicine and not by a pharmacologist who is only trained in good manufacturing practices. Besides this, advances in transfusion medicine and its applications like therapeutic apheresis have delinked it from pharmacology completely.
In conclusion, blood is not a drug, and therefore, it cannot be regulated by a drug regulatory authority. Every country must have a separate national blood authority managed by experts in the field of transfusion medicine. Blood may be labeled as a drug with a price associated with it, but its real value is immeasurable.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Confederation TFAotS. Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA); January 01, 2022. Available from: https://www.fedlex.admin.ch/eli/cc/2001/422/en
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Garraud O, Tissot JD. Blood components: Are they drugs or special medicines? Transfus Clin Biol 2016;23:127-31.
Van Der Poel CL, Seifried E, Schaasberg WP. Paying for blood donations: Still a risk? Vox Sang 2002;83:285-93.