ordering techniques and opening prescriptions for midwives

AGAINSTas announced at the end of August 2023 (see. our article dated September 5, 2023), the first campaign to prevent lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants with or without risk factors began on September 15, 2023 in France.

This campaign is based on a single injection of the monoclonal antibody BEYFORTUS (nirsevimab). see. Box 1).

The prescription also applies to midwives

Decree published in Official newspaper from September 15, 2023 [1] includes nirsevimab (BEYFORTUS) in the list of drugs that midwives can prescribe to newborns when first prescribed.

Consequently, a doctor or midwife can now prescribe BEYFORTUS to infants who are targeted by a prevention campaign (Wed Box 2).

Midwives, as well as doctors and nurses, are also authorized to administer this monoclonal antibody. [2].

Note: The same decree allows midwives to prescribe specific anti-HBs immunoglobulins in combination with hepatitis B vaccine to newborns whose mothers are carriers of the HBs antigen.

Order conditions and delivery schedule

Detailed information on ordering methods and availability schedule was provided by the General Directorate of Health (DGS) in two DGS-Urgents published on September 15, 2023. [3, 4].

Community Pharmacy: Direct Order from Sanofi

For community pharmacists in mainland France, requests for supplies of BEYFORTUS have been open since 15 September. Delivery time is from 3 to 6 working days after order.

Orders must be placed directly with Sanofi Laboratory. by using online form (connection by using prosantéconnect with e-CPS card):

• up to a maximum of 5 doses per order;
• only with a registered doctor’s prescription. Placement of orders for the purpose of replenishing stock at the pharmacy is not permitted.

The prescription must be intended for a patient covered by French health insurance (including patients awaiting eligibility).
It is not possible to order and dispense BEYFORTUS to a cross-border patient.

BEYFORTUS is provided by the state without billing families. [5].

According to information provided by pharmacists’ unions [6]The pharmacist receives a remuneration of 6.55 euros excluding tax (mainland tariff) for ordering and delivering BEYFORTUS:

• 3.50 euros excl. tax per order
• + 1 euro excluding tax for delivery of packaging
• + 0.50 euros excl. VAT, prescription fee
• + 1.55 euros excluding taxes related to the patient’s age

Provision in healthcare institutions

The first batch of BEYFORTUS 50 mg was delivered by the laboratory to all medical institutions with maternity hospitals that requested it.

Restocking requests will begin September 25 and will be made via direct laboratory order for the 100 mg dosage.

Methods for monitoring Dispostock stocks and administrations by using The Medicalization of Information Systems (PMIS) program is intended for healthcare institutions by using a rapid health report (MARS) followed by an information note.

Available in DROM

For overseas departments and regions (DROM) BEYFORTUS is available exclusively by using healthcare institutions.

Help with use: quick answers from HAS

In parallel with the launch of BEYFORTUS, the Higher Health Authority (HAS) published the first episode online Quick answers support healthcare workers in this unique campaign and remind you about the conditions for using nirsevimab. [7, 8].

There are 8 quick answers in total:

• Two answers regarding the mode of action and proper use of nirsevimab (BEYFORTUS):
  • Quick answer 1 : Nirsevimab is a monoclonal antibody drug administered as a single intramuscular injection (anterolateral thigh) indicated for the prevention of lower respiratory tract infections caused by RSV in neonates and infants during the first year of exposure to the virus.
  • Quick Reply 2 : BEYFORTUS is not a vaccine(see. our article dated September 14, 2023). The duration of protection provided by nirsevimab is at least 5 months.
• Three answers about the prevention campaign and the target population:
  • Quick Reply 3 : Immunization campaign 2023–2024 will begin on mainland France from September 15, 2023 until the end of the epidemic, usually at the end of January.
  • Quick Reply 4 : Nirsevimab should be given as a pre-epidemic priority to neonates and infants born after 6 February 2023, as they are not considered to have been exposed to RSV during the previous epidemic season. This date was determined by the French Public Health Authority based on epidemiological data for the past year (the end of the epidemic was observed on January 22 in mainland France + time since infection).
  • Quick reply 5 : Nirsevimab should be administered preferentially prior to discharge from the neonatal delivery unit from September 15, 2023.
• Quick measures for children at high risk of RSV infection:
• Two quick answers regarding co-injection with other vaccines or specific situations:
  • Quick reply 7 : Nirsevimab can be given on the same day as your child’s vaccination, but at separate injection sites.
  • Quick reply 8 : Nirsevimab injection is not recommended in the case of fever or an ongoing moderate to severe acute infectious episode, or after an episode of confirmed RSV infection.

Hypersensitivity to one of the components of the drug is a contraindication.

HAS also reminds you of the precautions you should take before any injection:

• provide clear information to parents and obtain their consent;
• exercise special caution when prescribing to children with thrombocytopenia, bleeding disorders, and those being treated with anticoagulants;
• Check the appearance of the product with the naked eye, which should not have any anomalies.