GSK can only produce 40% of the quantity of Clamoxyl I.V.-I.M. required each year because of a shortage of raw materials. The Federal Agency for Medicines and Health Products (FAMHP) and the National Institute for Health and Disability Insurance (RIZIV) are issuing recommendations for hospital pharmacists and hospital-based specialists.
Clamoxyl I.V.-I.M. (manufactured by GSK) has had limited availability in Belgium since March 2019. This will continue to be the case until 2019. The Unavailabilities Working Group has set up an Expert Task Force to find a solution in the short term. The Task Force has made recommendations to address the situation as competently as possible:
Sparing use
Use Clamoxyl I.V.-I.M. as sparingly as possible. Only use Clamoxyl IV if there are no suitable alternatives:
- for endocarditis or serious Enterococcus faecalis infections;
- for meningitis or serious Listeria infections;
- for the empirical treatment of sepsis in children under 3 months.
Alternatives
Where possible, use the following alternatives:
- for severe infections involving amoxicillin-sensitive streptococci:
- Ceftriaxone
- Penicillin G
- for serious pneumococcal infections:
- Ceftriaxone
- Penicillin G
- for respiratory infections:
- Amoxicillin – clavulanic acid
- Cefuroxime
Despite using Clamoxyl I.V.-I.M. as sparingly as possible, it is possible supplies will not suffice to treat conditions for which no suitable alternative is available. In those cases the Task Force recommends using these, less suitable, alternatives:
- for the empirical treatment of sepsis in children under 3 months:
- Amoxicillin – clavulanic acid
- for meningitis or serious Listeria infections
- Co-trimoxazole (contraindicated in pregnancy)
- Penicillin G
- for endocarditis or serious Enterococcus faecalis infections:
- No suitable alternatives are available. Vancomycin is an alternative, but it is less effective.
Kela, which manufactures the alternative drug Penicillin G, will not be unable to meet increased demand. The FAMHP expects a temporary Penicillin G unavailability and is closely monitoring the availability of the various alternatives.
If restricting use is not sufficient to offset the shortage, the only option is to introduce parenteral amoxicillin in accordance with Article 105 of the Royal Decree of 14 December 2006. This always requires a prescription and a medical certificate. Compulsory health insurance does not reimburse the cost of the imported medicine. The FAMHP and RIZIV are aware that this is not an ideal solution because of the high cost. A reimbursement requires a legislative amendment. One is being prepared, but no change in the law can be expected in the short term.
For other farmaceutical forms of Clamoxyl or other medicines with amoxicillin and clavulanic acid there are no problems. For the three medicines that are currenctly unavailable there are alternatives available.
The FAMHP is closely following the situation and is working with RIZIV and the policy department of the competent ministry to find additional solutions.