The Medicines Agency has decided to include certain vaccines on List I of poisonous substances since September 2023. Why? Is this worrying? Answers from the ANSM.
Since September 14, 2023, all vaccines, with the exception of flu and Covid-19 vaccinesis classified on list I of poisonous substancesannounced the general director of theMedicines Agency (ANSM). As a result, the pharmacistsnurses or midwives will be able to establish a prescription medical in order to deliver the vaccine, and no longer just general practitioners. According to Public health codethere list I of poisonous substances understand :
► Medicines for human use likely to present directly or indirectly a danger to health
► Medicinal products for human use containing substances whose activity or side effects require monitoring medical
► Any other product or substance presenting direct or indirect health risks
► Substances or preparations, and medicines for human use and products presenting the highest health risks.
Which vaccines are covered by this list?
Are classified on list I of poisonous substancesmedicinal products for human use containing all or parts of the following bacteria or viruses in all their forms and whatever their group, strain or variant :
- Bordetella pertussis (Whooping cough), virus poliomyelitis And Haemophilus influenzae, hepatitis B: REVAXIS, INFANRIXTETRA, ACELLULAR TETRAVAC, BOOSTRIXTETRA, REPEVAX, INFANRIX QUINTAPENTAVAC, INFANRIX HEXA, HEXYON, VAXELIS
- Haemophilus influenzae alone (Hib): ACT-HIB
- Leptospira icterohaemorrhagiae (Leptospirosis): SPIROLEPT
- Neisseria meningitidis (Meningococcus): NIMENRIX, MENVEO, BEXSERO, TRUMENBA
- Salmonella typhi (Fever typhoid): TYPHIM VI, VIVOTIF
- Streptococcus pneumoniae (Pneumococcus): PREVENAR 13, PNEUMOVAX
- Japanese encephalitis virus: IXIARO
- Yellow fever virus: STAMARIL
- Hepatitis B virus: ENGERIX B10 and B20, HBVAXPRO 5 and 10, TWINRIX ADULTE
- Mumps, measles, rubella viruses: MMR-VAXPRO, PRIORIX
- Vaccinia virus (cowpox): IMVANEX, JYNNEOS
“For pharmacists to be able to prescribe these vaccines, they had to be placed on this list”
According to the definition of Laroussethe word “poisonous” is said in a substance that contains poison. Enough to arouse concern and fear among the general public. “The term “poisonous” can certainly worry or scare the general public a little, but in this legislative and regulatory context, the word “poisonous” is not at all related to a notion of danger or toxicity. It is simply a matter ofa legal decisionwith the simple aim is to harmonize the conditions of prescription and delivery of these vaccines on a regulatory level. So that pharmacists, nurses and midwives could prescribe the delivery of these vaccines, they had to be placed in the list of poisonous substances.“, reassures the ANSM press service that we contacted for the occasion. In other words, in this context, The term “poisonous” is a legal and regulatory term that determines how a substance is prescribed, distributed, and monitored. It is also a good way to ensure that the general public is fully informed of the possible risks and side effects of a vaccine. This update aims to standardize and unify the procedures for prescribing and distributing vaccines, in accordance with the new skills pharmacists, nurses and midwives to prescribe certain vaccines, as stipulated in thearticle 33 of the social security financing law for 2023.
“For the general public, it won’t change much”
“For the general public, it won’t change much. That is to say, they will be able to have these vaccines prescribed, no longer only by their general practitioner, but also by other health professionals such as pharmacists, nurses or midwives.“, the ANSM press service tells us. Concretely, the vaccines on list I can only be delivered in pharmacies in exchange for a medical prescription and only for the duration mentioned on the prescription. On the vaccine box, we will find a red box (see right). The ANSM specified that the labeling of the packaging of the vaccines concerned would gradually be updated in the coming months. Previously manufactured packaging (thus without a red box) will not be recalled so as not to create supply tensions on the French market. As for flu vaccines and Covid-19 vaccines, they remain accessible without change in the specific context of future vaccination campaigns.
Thanks to the press and communications department of the Medicines Agency (ANSM)