The Ministry of Health has approved new rules for the use of antibiotics and antimicrobial drugs
The Ministry of Health of Ukraine has approved two new standards for the rational use of antimicrobial drugs. These standards apply to antibiotics as well as systemic antiviral, antifungal, and antiparasitic drugs.
The new documents were developed in accordance with the State Strategy for Combating Antimicrobial Resistance through 2030.
The new rules will apply at two levels of healthcare:
- for primary care facilities;
- for specialized healthcare facilities.
The main goal of the changes is to establish uniform approaches to prescribing, adjusting, and discontinuing antimicrobial therapy to make the treatment of infectious diseases more effective and safer while curbing the spread of antimicrobial resistance.
Antimicrobial resistance (AMR) occurs when microorganisms stop responding to drugs designed to combat them. As a result, infections become more difficult to treat, and the risks of severe disease progression and complications increase.
The new standards apply to systemic antibacterial, antifungal, antiviral, and antiparasitic medications.
The fundamental principle is that an antimicrobial drug should be prescribed only for clear medical indications, at the necessary dose, and for the optimal duration.
Each prescription must be supported by a written justification in the medical records or the electronic health care system.
“The physician must specify the diagnosis or a reasonable suspicion of infection, the name of the active ingredient, the dose, the route of administration, the duration of treatment, and the date of its review,” the Ministry of Health explained.
Antibiotics may only be prescribed in the presence of a confirmed or reasonably suspected bacterial infection.
To select a medication, the WHO AWaRe classification will be used, which divides antibiotics into three groups: access, observation, and reserve.
At the same time, prescribing antimicrobial drugs solely at the patient’s request, without medical indications, is prohibited.
In certain cases, a bacteriological test will be performed before starting antibiotic therapy, and once the results are available, treatment will be adjusted according to the sensitivity of the identified pathogen.
In addition, the effectiveness of antibiotic therapy should be assessed 48–72 hours after the start of treatment.
“If a bacterial infection is not confirmed or a different diagnosis is established, antibiotic use must be discontinued,” the Ministry of Health explained.
The new standards require that patients be informed in plain language.
The doctor must explain:
- why the medication was prescribed;
- what dosage is required;
- how long the treatment will last;
- what possible side effects there are;
- what to do if the condition worsens.
The primary care standard includes recommendations for treating common bacterial infections in adults and children.
It also allows the doctor to issue a delayed prescription.
In this case, the patient begins taking the antibiotic only after the onset of symptoms identified by the doctor, a worsening of the condition, or confirmation of the bacterial nature of the illness.
A separate standard regulates the use of antimicrobial drugs in outpatient and inpatient settings.
It provides for:
- the use of laboratory test results and local antibiotic susceptibility testing;
- monitoring of prescriptions by clinical pharmacists;
- prior approval for the use of reserve antibiotics;
- switching from intravenous to oral administration of the drug as soon as the patient’s condition permits.
The Ministry of Health emphasized that the newly implemented rules should not hinder the prompt provision of emergency care.
“In particular, in cases of reasonable suspicion of septic shock, antibiotic therapy must be initiated within the first hour—immediately after collecting samples for bacteriological testing,” the ministry clarified.
Compliance with the new requirements will be assessed based on specific quality indicators.
At the primary care level, it is desirable that at least 90% of prescribed antibiotics belong to the “access” group, and that the proportion of “reserve” drugs be 0%.
For specialized medical care, the indicators will vary depending on treatment conditions.
Specifically, the desired proportion of reserve-class antibiotics should be:
- 0%—in outpatient settings;
- less than 2% – in inpatient settings.
This was reported by the press service of the Ministry of Health (MOH) of Ukraine.
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