Priority list of off-patent antibiotic products at risk for lack of availability in Sweden
In order to identify antibiotic products that are particularly valuable for the Swedish healthcare, the Public Health Authority, in collaboration with PLATINEA and an external reference group, has carried out a clinical evaluation of antibiotic products based on their substance, formulation and strength.
The Public Health Agency has published a new priority list within the framework of the government's mission To strengthen access to off-patent antibiotics, in collaboration with PLATINEA and an advisory reference group. In contrast to previous corresponding priority lists from 2017 and 2021, antibiotic products that are not marketed in Sweden but are often prescribed under license, or are widely used in Europe have also been valued and prioritized.
The analysis includes all drugs (ATC codes) that contain an antibacterial substance and are used to treat or prevent bacterial infection, including systemic (infusion fluids and oral) and topical drugs (ointments, creams, gels, drops, vaginal, suppositories and oral non-absorbable).
Selection criteria used to identify antibiotic products for the clinical evaluation
Off-patent antibiotic products marketed in Sweden 2021:
- Total sales in 2021: ≤ SEK 3,000,000, or
- Repeated shortage situations (2017–2021; only non-exchangeable, no parallel imports):, concluded as well as ongoing, for at least 60 days in total
Antibiotic products not marketed in Sweden in 2021:
- All deregistered in 2020–2021
- Prescribed on license: ≥ 30 times in 2021
The experts in the reference group scored all products on a scale of 0–2. The individual scores were compiled and categorized by the Public Health Authority. Categories A–C mean the following valuation:
- A. Very valuable to have access to in Sweden. Considerable clinical consequences if the product is not available.
- B. Valuable to have access to in Sweden. Clinical and/or logistical (resource-wise) consequences if the product is not available.
- C. There is usually a relatively equal alternative.
A total of 128 antibiotic products were assessed, of which 108 are marketed in Sweden. Of 32 marketed products in category A, 22 were not interchangeable according to the Medical Product Agency's definition. Twenty-one products are on the priority list, due to repeated shortages, regardless of sales value. Of these, three were categorized as A. Twenty products that are not marketed in Sweden, of which six due to extensive use in Europe, were evaluated clinically.
The evaluation showed, among other things, that preparation forms adapted to children were highly prioritized.
ATC | Substance | Formulation | Strength | Category |
---|---|---|---|---|
J01GB03 | Gentamicin | Intravenous | 40 mg/ml | A |
J01XB01 | Colistin | Intravenous | 1 million IE | A |
J01DD02 | Ceftazidime | Intravenous | 2 g | A |
P01AB01 | Metronidazole | Oral suspension | 40 mg/ml | A |
J01CR02 | Amoxicillin-clavulanic acid | Tablets/Capsules | 500 mg/125 mg | A |
J01DB05 | Cefadroxil | Oral suspension | 100 mg/ml | A |
J04AB02 | Rifampicin | Oral suspension | 20 mg/ml | A |
J01CA04 | Amoxicillin | Oral suspension | 100 mg/ml | A |
J01EE01 | Trimethoprim-sulfametoxazol | Oral suspension | 40 mg/ml + 8 mg/ml | A |
J01CF05 | Flucloxacillin | Oral suspension | 50 mg/ml | A |
J01CE02 | Phenoxymethylpenicillin | Tablets/Capsules | 250 mg | A |
J01CA01 | Ampicillin | Intravenous | 2 g | A |
J01XA01 | Vancomycin | Intravenous | 500 mg | A |
J01CF05 | Flucloxacillin | Tablets/Capsules | 125 mg | A |
J01MA02 | Ciprofloxacin | Oral suspension | 100 mg/ml | A |
J01CF02 | Cloxacillin | Intravenous | 1 g | A |
J01GB06 | Amikacin | Intravenous | 250 mg/ml | A |
J01MA02 | Ciprofloxacin | Intravenous | 2 mg/ml | A |
J01CA04 | Amoxicillin | Tablets/Capsules | 500 mg | A |
J01EA01 | Trimethoprim | Oral suspension | 10 mg/ml | A |
J01FA01 | Erythromycin | Oral suspension | 100 mg/ml | A |
J01FF01 | Clindamycin | Oral suspension | 15 mg/ml | A |
J04AB04 | Rifabutin | Tablets/Capsules | 150 mg | A |
J01FA10 | Azithromycin | Tablets/Capsules | 250 mg | A |
J01CE02 | Phenoxymethylpenicillin | Oral suspension | 50 mg/ml | A |
J01XX08 | Linezolid | Oral suspension | 20 mg/ml | A |
G01AA10 | Clindamycin | Vaginal | 100 mg | A |
D06AX09 | Mupirocin | Ointment | 2% | A |
J01CR02 | Amoxicillin-clavulanic acid | Oral suspension | 50 mg/ml + 13 mg/ml | A |
J01EA01 | Trimethoprim | Tablets/Capsules | 160 mg | A |
J01CA04 | Amoxicillin | Oral suspension | 50 mg/ml | A |
J01EE01 | Trimethoprim-sulfametoxazol | Tablets/Capsules | 800 mg/160 mg | A |
J01CE02 | Phenoxymethylpenicillin | Tablets/Capsules | 500 mg | B |
J01EA01 | Trimethoprim | Tablets/Capsules | 100 mg | B |
J01DD02 | Ceftazidime | Intravenous | 1 g | B |
J01DD02 | Ceftazidime | Intravenous | 500 mg | B |
J01FF01 | Clindamycin | Intravenous | 600 mg | B |
J01FA10 | Azitromycin | Oral suspension | 40 mg/ml | B |
J01CE02 | Phenoxymethylpenicillin | Oral suspension | 250 mg/ml | B |
G01AF01 | Metronidazole | Vaginal | 500 mg | B |
J01CA01 | Ampicillin | Intravenous | 1 g | B |
J01CA08 | Pivmecillinam | Tablets/Capsules | 400 mg | B |
J01CA04 | Amoxicillin | Tablets/Capsules | 750 mg | B |
J01MA14 | Moxifloxacin | Tablets/Capsules | 400 mg | B |
P01AB01 | Metronidazole | Tablets/Capsules | 200 mg | B |
J01FA01 | Erythromycin | Tablets/Capsules | 250 mg | B |
J01XE01 | Nitrofurantoin | Tablets/Capsules | 5 mg | B |
S01AA01 | Chloramphenicol | Eye ointment/-gel | 10 mg/g | B |
J04AB02 | Rifampicin | Tablets/Capsules | 150 mg | B |
J01EE01 | Trimethoprim-sulfametoxazol | Tablets/Capsules | 400 mg/80 mg | B |
J01CR02 | Amoxicillin-clavulanic acid | Tablets/Capsules | 875 mg/125 mg | B |
J01CR05 | Piperacillin-tazobactam | Intravenous | 2 g/0,25 g | B |
J01GB01 | Tobramycin | Inhalation | 300 mg/5 ml | B |
J01DB05 | Cefadroxil | Tablets/Capsules | 500 mg | B |
J01FF01 | Clindamycin | Tablets/Capsules | 150 mg | B |
G01AA10 | Clindamycin | Vaginal creme | 2% | B |
J01FA10 | Azithromycin | Tablets/Capsules | 500 mg | B |
D06AX01 | Fucidin | Ointment | 2 % | B |
S02CA05 | Fluocinolonacetonid and antiinfectives | Ear drops | 3 mg/ml + 0,25 mg/ml | B |
J01CA04 | Amoxicillin | Tablets/Capsules | 1 g | B |
J01CA04 | Amoxicillin | Tablets/Capsules | 375 mg | B |
J01FA01 | Erythromycin | Tablets/Capsules | 500 mg | B |
J01MA12 | Levofloxacin | Tablets/Capsules | 500 mg | B |
J04AB02 | Rifampicin | Intravenous | 600 mg | B |
S01AA01 | Chloramphenicol | Eye drops | 5 mg/ml | B |
S02AA15 | Ciprofloxacin | Eye drops | 2 mg/ml | B |
S02AA15 | Ciprofloxacin | Eye drops | 3 mg/ml | B |
S02CA02 | Flumetason and antiinfectives | Eye drops | 0.2% + 1% | B |
J01MA02 | Ciprofloxacin | Tablets/Capsules | 750 mg | B |
J01MA12 | Levofloxacin | Tablets/Capsules | 250 mg | B |
J01CR02 | Amoxicillin-clavulanic acid | Oral suspension | 80 mg/ml + 12 mg/ml | B |
J01XA02 | Teikoplanin | Intravenous | 400 mg | B |
P01AB01 | Metronidazole | Tablets/Capsules | 500 mg | B |
J01AA02 | Doxycycline | Oral suspension | 10 mg/ml | B |
J04AM02 | Rifampicin och isoniazid | Tablets/Capsules | 150 mg/75 mg | B |
J04AM06 | Rifampicin, pyrazinamide, ethambutol and isoniazid | Tablets/Capsules | 150 mg/75 mg/400 mg/275 mg | B |
J01MA02 | Ciprofloxacin | Oral suspension | 50 mg/ml | B |
J01AA02 | Doxycycline | Tablets/Capsules | 40 mg | B |
D10AF01 | Clindamycin | Cutaneous emulsion | 10 mg/ml | B |
J01MA02 | Ciprofloxacin | Tablets/Capsules | 250 mg | B |
J01MA12 | Levofloxacin | Inhalation | 240 mg | C |
J01XB01 | Colistin | Inhalation | 2 million IE | C |
J01FA01 | Erythromycin | Oral suspension | 200 mg/ml | C |
J01FA10 | Azithromycin | Intravenous | 500 mg | C |
J01XX01 | Fosfomycin | Intravenous | 40 mg/ml | C |
J01MA14 | Moxifloxacin | Intravenous | 400 mg/250 ml | C |
S01AA26 | Azithromycin | Eye drops | 15 mg/g | C |
G01AF01 | Metronidazole | Vaginal gel | 7,5 mg/g | C |
J01AA12 | Tigecycline | Intravenous | 50mg | C |
J01MA12 | Levofloxacin | Intravenous | 5 mg/ml | C |
P01AB02 | Tinidazole | Tablets/Capsules | 500 mg | C |
J01DC02 | Cefuroxime | Intravenous | 1500 mg | C |
D10AF51 | Clindamycin | Gel | 50mg/g + 10mg/g | C |
J01XA02 | Teikoplanin | Intravenous | 200 mg | C |
J01FA09 | Clarithromycin | Tablets/Capsules | 500 mg | C |
A07AA09 | Vancomycin | Tablets/Capsules | 250 mg | C |
J01FA09 | Clarithromycin | Tablets/Capsules | 250 mg | C |
S01CA01 | Tobramycin + dexamethasone, | Eye drops | 3 mg/ml / 1 mg/ml | C |
J01DF01 | Aztreonam | Inhalation | 75 mg | C |
J01DC02 | Cefuroxime | Intravenous | 750 mg | C |
J01AA07 | Tetracycline | Tablets/Capsules | 250 mg | C |
J01AA02 | Doxycycline | Intravenous | 20 mg/ml | C |
J01DC02 | Cefuroxime | Intravenous | 250 mg | C |
J01DF01 | Aztreonam | Intravenous | C | |
J01DB04 | Cefazolin | Intravenous | 2 g | C |
S01AA12 | Tobramycin | Eye drops | 3 mg/ml | C |
S01AA27 | Cefuroxime | Intravenous | 50 mg | C |
J01GB01 (fass.se) (in Swedish)
ATC | Substance | Formulation | Strength | Category |
---|---|---|---|---|
J04AK02 | Ethambutol | Tablets/Capsules | 400 mg | A |
J01DD14 | Ceftibuten | Oral suspension | 36 mg/ml | A |
J01DD14 | Ceftibuten | Tablets/Capsules | 400 mg | A |
J01DD08 | Cefixime | Oral suspension | 100 mg/5 ml | A |
J01DD08 | Cefixime | Tablets/Capsules | 400 mg | A |
J01GB01 | Tobramycin | Intravenous | 10 mg/ml | B |
J01DB05 | Cefadroxil | Tablets/Capsules | 1 g | B |
J01CE01 | Bensatin bensylpenicillin | Intravenous | 300000 E/ml | B |
J01XX01 | Fosfomycin | Oral suspension | 3 g | B |
J01FA09 | Clarithromycin | Oral suspension | 25 mg/ml | B |
J01XC01 | Fucidinsyra | Tablets/Capsules | 250 mg | C |
J01FG01 | Pristinamycin | Tablets/Capsules | 500 mg | C |
J01FA01 | Erythromycin | Enterocapsules | 250 mg | C |
J01MA06 | Norfloxacin | Tablets/Capsules | 400 mg | C |
ATC | Substance | Formulations | No of countries | Clinical evaluation (0-5) |
---|---|---|---|---|
J01DC02 | Cefuroxime-axetil | fixed, oral suspension | 17 | 1 |
J01DD08 | Cefixime& | fixed, oral suspension | 8 | 5 |
J01DD13 | Cefpodoxime- proxetil | fast, oral suspension | 21 | 0 |
J01MA01 | Ofloxacin | several | 13 | 0 |
J01CR01 | Ampicillin-sulbactam | Intravenous | 4 | 4 |
J01CA17 | Temocillin | Intravenous | 4 | 4 |