recommendations for preserving stocks

recommendations for preserving stocks
recommendations for preserving stocks

Résumé

Oral clarithromycin specialties (tablet and drinkable form) are subject to supply constraints worldwide.

In , available stocks are limited and distribution is limited in town and in hospitals.

In this disrupted context, the ANSM has made available a document summarizing the main recommendations for the attention of prescribers, dispensers and patients.

For prescribers, the ANSM reminds the different situations for which clarithromycin is indicated, and the action to take in the event of unavailability of this antibiotic. In particular, in the treatment of whooping cough, it invites prescribers to anticipate unavailability by indicating on the prescription the mention “if clarithromycin is unavailable, treatment with azithromycin may be provided”to the attention of the dispensing pharmacist.

As part of prophylaxis in a contact subject with a confirmed case of whooping cough, the prescription of antibiotic treatment is not systematic. It should be reserved for certain patients in accordance with recommendations.

At the pharmacy, the ANSM reminds the possibility of implementing single delivery in order to preserve stocks and only deliver the quantity corresponding to the prescription.

DSignificant supply tensions for oral clarithromycin are reported internationally. This situation is caused by an increase in the consumption of this antibiotic linked to the current whooping cough epidemic, an increase to which industrial production capacities cannot fully respond.

In France, this situation affects the city and the hospital. All oral forms are concerned: in film-coated tablets at 250 mg and 500 mg and in granules for oral suspension at 25 mg/mL and 50 mg/mL [1, 2].

Concerning the drinkable forms at 25 mg/mL and 50 mg/mL, according to the latest information communicated as part of the winter plan to combat shortages of winter medicines, the state of coverage of needs among wholesalers- dispatchers is currently “unsatisfactory” [3].

In this context, the following logistical measures are applicable:

  • distribution is quantitatively limited in all markets (city and hospital);
  • laboratories must prioritize supplying pharmacies with clarithromycin via wholesalers-distributors to enable the fairest possible distribution of boxes/stocks across the territory (in accordance with the commitment charter for players in the pharmaceutical chain).

To date, no normal release date has been announced.

Recommendations for proper prescription and use

In order to ensure that needs are met and preserve available stocks, the National Agency for the Safety of Medicines and Health Products (ANSM) asks prescribers to prescribe and use this antibiotic wisely, in only situations indicated [45].

General recommendations relating to the proper use of antibiotics must be respected (cf. Boxed).

Clarithromycin and whooping cough

Clarithromycin is a first-line antibiotic in the curative treatment and prophylaxis of whooping cough (cf. our article of June 27, 2024).

Concerning antibiotic prophylaxis around a confirmed case of whooping cough, the ANSM reminds that this strategy should not be systematically implemented in people in contact with a case of whooping cough. The prescription of antibiotic prophylaxis is reserved strictly for defined populations (cf. our article of August 29, 2024):

  • Subjects at high risk of severe form of whooping cough and those in their close contact (sharing the same home or caring for them, etc.). People at high risk are infants:
    • less than 6 months regardless of the vaccinations of the mother or child;
    • from 6 to 11 months with less than 2 doses or whose second dose is less than 2 weeks old,
  • Subjects at risk of severe form of whooping cough. These are people over 80 years old and/or with chronic respiratory disease, obesity or immunodeficiency.

Whooping cough: anticipate unavailability on the prescription

In the context of whooping cough, in order to allow patients to have immediate treatment, it is recommended that doctors anticipate the unavailability of clarithromycin on the prescription by indicating the following statement, for the attention of the pharmacist : “if clarithromycin is unavailable, treatment with azithromycin may be provided”.

In this case, taking into account the differences in administration schedules between the two antibiotics, the prescription will clearly state:

  • The dosage and duration of treatment of clarithromycin: 7 days;
  • The dosage and duration of treatment of azithromycin: 3 days.

The ANSM reminds that extending the duration of treatment for whooping cough provides no benefit and may pose risks.

Clarithromycin and infections Mycoplasma pneumoniae

Macrolides, including clarithromycin, are the standard outpatient treatment for pneumonia. Mycoplasma pneumoniae may show signs of seriousness (cf. Rapid response from the HAS: atypical pneumonia Mycoplasma pneumoniae) ; clarithromycin or azithromycin are indicated as first-line treatment.

The ANSM recalls, however, that “in the vast majority of cases, Mycoplasma pneumoniae infections are benign, resolve spontaneously and do not justify prescribing antibiotics ».

In the event of supply difficulties, alternative options are:

Clarithromycin and bacterial angina

In cases of acute strep throat confirmed by TROD, amoxicillin is the first-line antibiotic.

Clarithromycin is recommended uniquely in exceptional cases of contraindication to beta-lactams.

Clarithromycin and non-tuberculous mycobacteria infections

In the case of non-tuberculous mycobacterial infections, long-term treatment is prescribed. The ANSM emphasizes the need to have a sufficient quantity of clarithromycin available for the entire duration of treatment, and to ensure this before initiating treatment.

In the current context of strong supply tensions, treatment with azithromycin may be considered for patients with non-tuberculous mycobacteria infection, except for those included in a clinical trial conducted with clarithromycin, for whom it is important that the research protocol can be respected.

Recommendations to Providers

In addition to the quota applicable to distribution, the following measures can be implemented at the pharmacy, during dispensing [45] :

  • provide packaging adapted to the duration of treatment;
  • in the event of difficulty in having packaging suitable for the prescription, the single dispensation specialties based on clarithromycin can be used;
  • deliver another antibiotic:
    • issue the replacement antibiotic indicated on the prescription, if the doctor anticipated the unavailability of clarithromycin,
    • for indications relating to long-term treatment: contact the doctor to consider the possibility of replacing it with azithromycin.
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