Availability of medicines in town and in hospital

EBetween October 9 and 10, 2024, the National Agency for the Safety of Medicines and Health Products (ANSM) reported new disruptions or updated the availability data of several specialties marketed in France [1, 2] distributed on the dual city/hospital channel.

PEGASYS: evolution of the emergency repair request procedure

PEGASYS 90 micrograms, 135 micrograms and 180 micrograms solution for injection in pre-filled syringe (peginterferon alfa-2a)

Availability status according to ANSM

Situation in the city and at the hospital: Persistent tension due to the supplier’s halt in raw material production coupled with an increase in global demand
the qualitative quota is maintained. In order to best preserve available units and maintain patient treatments, it is recommended:
- to adapt the dosage whenever possible;
- to postpone treatment initiations whenever possible and during renewals to favor alternatives when they exist.
Expected delivery date: during March 2025
Also consult the repository of good clinical practices, with proposed alternatives for each of the known uses of PEGASYS.
Only for treatment initiations of polycythemia vera without symptomatic splenomegaly that cannot be deferred: the ANSM has authorized the exceptional and transitory importation of BESREMI 250 µg/0.5 mL solution for injection in a pre-filled pen (ropeginterferon alfa-2b) . This medication has been dispensed by pharmacies for indoor use (PUI) in health establishments since the end of 2024 (cf. our articles of August 6, 2024 and September 3, 2024).

Additional information from the laboratory: new emergency repair request procedure

Letter from the laboratory to healthcare professionals, prescribers and pharmacists (October 8, 2024): in the event of unavailability of PEGASYS in the patient’s pharmacy, exceptional assistance may be granted according to the following two criteria:

the prescriber is a specialist in hepato/gastroenterology, infectious diseases, internal medicine, hematology or a doctor competent in blood diseases
in the event of an indication in onco-hematology, the indication is mentioned in the INCa recommendations above as being without alternative.

If both criteria are met, troubleshooting can be organized according to the following steps:

outpatient patient:
- at the request of the community pharmacist who is unable to obtain PEGASYS via its wholesalers, the prescriber sends an email to the address [email protected] mentioning that no alternative is possible for the patient and specifying the indication, date of birth, gender and initials of the patient as well as the contact details of the pharmacy for receiving the assistance.
- upon receipt of the email, the laboratory will contact the pharmacy to organize repairs.
hospitalized patient:
- at the request of the PUI pharmacist who was unable to obtain PEGASYS, the prescriber sends an email to the address [email protected], mentioning that no alternative is possible for the patient and specifying the indication, date of birth, gender and initials of the patient as well as the contact details of the PUI.
- upon receipt of the email, the laboratory will organize troubleshooting to the designated PUI.

REPEVAX: supply tension until the end of 2024

TcaP vaccine (diphtheria, tetanus, pertussis and poliomyelitis) REPEVAX suspension for injection in pre-filled syringe

Availability status according to ANSM

City supply voltage
Establishment of a quantitative quota in the city.
Hospitals and DROMs are not impacted by this quota
Normal delivery planned for the end of 2024

As a reminder, the other dTcaP vaccine BOOSTRIXTETRA suspension for injection in pre-filled syringe is also subject to a supply shortage until the end of the year (cf. our article of October 8, 2024).