Hello,
we publish the text of the ORDINANCE for amendment of Ordinance № 3 from 5 March 2020 G.
for the adoption of a pharmaco-therapeutic guide for the treatment of infectious diseases, published in issue 71 of SG of 27.08.2021 G. – Friday.
The Ministry of Health has prepared a regulatory change, approving the establishment of an outpatient procedure, paid by the NHIF. It includes diagnostic and treatment activities and services, which will be provided in outpatient care and which will be provided to patients with COVID-19 disease. These diagnostic and treatment activities also include prescribing the necessary drugs for home treatment of the patient, which will be paid 100% from the NHIF.
At the end of the text is indicated drug therapy. ORDINANCE for amendment of Ordinance № 3 from 5 March 2020 G. for the adoption of a pharmaco-therapeutic guide for the treatment of infectious diseases (prom., DV, no. 30 from 2020 G.; add., no. 105 from 2020 G.)
Obn., DV, no. 71 from 27.08.2021 G.
§ 1. In the appendix to Article only the text of item. 7. “Coronavirus” is amended as follows:
“7. Coronavirus
Coronaviruses are RNA viruses of the Coronaviridae family, with four genera - ?, ?, ? and ?. Their name derives from their characteristic shape when viewed under an electron microscope. They have a surface S (spikes) protein, responsible for attachment to target cells, E (envelope) protein, membrane M protein and N (nucleocapsid). Some CoVs have hemagglutinin-esterase (HE) protein, suitable for S protein.
They cause GDP infections, DDP and GIT in mammals and birds. Affecting the respiratory system, lead to the development of fever, throatache, lymphadenopathy, but also to severe bronchitis and pneumonia in children and adults. Some CoVs can cause SARS with a serious prognosis and death.
In humans, the main representatives are Human CoV 229E, Human CoV OC43, SARS-CoV, Human CoV-NL63, Human CoV HKU1, MERS-CoV.
The circulation of MERS-CoV has been registered for the last six years, originally in Middle Eastern countries. The virus causes severe respiratory diseases in adult patients and those with underlying diseases, leading to high mortality among patients (about 36 %). Subsequently, it spread to Central and East Asia thanks to the developed air transport, causing epidemic outbreaks, the largest of which in 2015 G. in South Korea.
There is currently no effective antiviral treatment. At the end of December 2019 G. in Central China, Hubei Province, cases of pneumonia have been reported, caused by a new type of SARS coronavirus. The International Committee on Taxonomy of Viruses gives it the name SARS-CoV-2, and the disease, which he causes, was named COVID-19 by the World Health Organization and was declared a pandemic in early March 2020 G. The anthroponotic transmission (R0 = 1,8 – 3,6) occurs primarily through respiratory drops (when sneezing and coughing). After an incubation period of 2 to 14 days (average ~ 5 days) COVID-19 usually presents with fever and symptoms of upper airway inflammation, namely dry cough and dyspnea. Asymptomatic course is common, as well as the appearance of some other complaints (anosmia, abdominal pain, diarrhea). The clinical course of the disease varies from very mild to severe pneumonia and even critical, life-threatening complications, such as: acute respiratory distress syndrome (ORDS), shock and multiple organ dysfunction. Recommendations for infection control and preventive measures usually include: personal hygiene (hand washing), avoiding public places and contact with infected people (> 15 minutes / 24 hours in case confirmed), quarantine / isolation and wearing appropriate personal protective equipment (LPS). The diagnosis was confirmed by RT-qPCR of SARS-CoV-2 RNA, isolated from patient samples, preferably from the nasopharynx.
The first contact with the health system of persons suspected of being infected with a coronavirus infection shall be made in accordance with the established procedure.:
- in medical establishments for outpatient medical care - GPs, specialist doctors- you in individual practice, medical centers, DCC and laboratories;
- by emergency mobile teams of CSMP and during outpatient examinations in their branches;
- in the emergency departments - the diagnostic-consultative blocks of medical establishments for hospital care;
- from RHI - by phone or during an epidemiological study.
In outpatient care, the screening of patients suspected of being infected with a coronavirus infection is performed on the basis of a history of epidemiological focus for possible contact with an infected and, if possible, clinical examination., as at the discretion of the physician, in the presence of reasonable doubt, additional consultations and studies may be appointed and carried out, including. PCR or other test confirming coronavirus infection.
The fact must be taken into account, that as the number of cases increases, the possibility of additional consultation with an infectious disease specialist may be difficult. For patients with a proven coronavirus infection, outpatient facilities also perform an initial health assessment and determination of treatment needs..
Follow-up of asymptomatic individuals and the treatment and monitoring of mild and uncomplicated forms of coronavirus infection are performed at home under the supervision and supervision of general practitioners.. Home treatment is performed according to the individual experience of the doctor, the recommended and currently used protocols for diagnosis and treatment, the individual health condition of the patient, the presence of concomitant diseases, etc.. Home treatment and monitoring of patients with mild forms is organized as follows, to provide an opportunity for rapid reassessment of behavior in case of deterioration and indications for subsequent hospital treatment. Patients are informed in detail under what circumstances and to whom they can turn in these cases (CSMP, PLL). Using the accumulated experience and the registered symptoms of the disease and its clinical course, general practitioners monitor (including remote, on the phone) the condition of the infected persons, as well as home treatment patients.
Therapeutic behavior:
- Asymptomatic or presymptomatic form - isolation and monitoring of the main indicators;
- Light form - insulation, clinical monitoring and maintenance therapy - adequate hydration, vitamins, antipyretic, antitussives;
- Mild to moderate form of the disease - isolation, adequate hydration, balanced diet, pulmonary physiotherapy and respiratory gymnastics, antipyretic, NSPVS, bromhexine or other antitussive agent, corticosteroid and AB only at the discretion of a physician and empirically in case of suspicion of secondary bacterial superinfection and / or microbiological verification of a bacterial causative agent, LMWH - conventional or prophylactic dose - at the discretion of a physician. Daily clinical evaluation for hospitalization.
The choice of laboratory parameters is at the discretion of the attending physician.
Therapy is the exclusive choice of the supervising / treating physician, as AB therapy is strictly indicated in certain cases - severity, concomitant diseases, laboratory and clinical empirical correlation for secondary bacterial superinfection, but not requiring hospitalization, image data, suspected of secondary bacterial superinfection, but not requiring hospitalization and others. Drug therapy includes:
• Cefuroxime - oral suspension 125 mg / 5 ml and 250 mg / 5 ml; on 125 mg twice daily, the dose should not exceed 250 mg for 24 o'clock (children under 2 years) or 250 mg by mouth 12 o'clock, the dose should not exceed 500 mg for 24 o'clock (this dosage is for children over 2 years); duration 7 – 10 days. In adult patients - tablets of 250 mg i 500 mg - twice as much 250 or 2 times more 500 mg for 7 days. It is administered parenterally in doses 100 – 150 – 250 mg / kg weight / for 24 hours depending on age, distributed in 3 – 4 taken intramuscularly or intravenously for 5 – 10 days.
Note: Doses, the intake and duration are specified by a doctor depending on the nature of the infection as an organ involvement.
• Azithromycin - oral suspension 100 mg / 5 ml and 200 mg / 5 ml, reception - 10 mg / kg body weight - once daily for 3 days. In adults: capsules from 250 and 500 mg - the first day 500 mg, followed in the following days by 250 mg for 2 to 5 days. Parenterally - 500 mg intravenously - once daily, at least two days, then you can continue through the mouth for 7 days. Duration and dosage: depending on age and organ localization. Antibiotic, recommended in most manuals for coronavirus infection.
• Levofloxacin – табл. from 250, 500, 750 mg; oral suspension 25 mg / ml; intravenously 250 mg solution for infusion (50 ml) and 500 mg solution for infusion (100 ml). Application: 250 mg or 500 mg orally or intravenously for 24 hours for 7 – 10 days; maximum dose 750 mg / 24 hours, 5 – 7 days.
• Enoxaparin - solution for injection in pre-filled syringes: 20 mg / 0.2 ml; 30 mg / 0.3 ml; 40 mg / 0.4 ml; 60 mg / 0.6 ml. Application: 30 mg each 12 hours subcutaneously; 40 mg once daily subcutaneously or 60 mg once daily once daily; the dose depends on the indications in the respective patient; as prevention of venous thromboembolism 40 mg for 24 hours for 7 – 10 days.
• Nadroparin - Prophylactic dose: 3800 IU, ie. 0,4 ml of 45 to 70 Kg; 5700 IU, ie. 0,6 ml of 71 to 110 Kg.
• Dabigatran etexilate - capsules from 75 mg, 110 mg, 150 mg; as a prophylaxis of thrombosis one capsule of 150 mg twice daily, the duration depends on the patient's age and renal function, 28 – 30 days.
• Bromhexine - tab. from 8 mg; adults and children over 14 years - 3 times two tablets for 5 – 7 days.
• Budesonide - powder for inhalation 200 or 400 microgram dose twice daily for 3 days.
• Dexamethasone orally or intravenously 6 mg / for 24 hours to 10 days.
• Clopidogrel - tablets from 75 mg; 7 – 10 days.
Infected persons, in which hospital treatment is required, are accommodated in a medical institution for hospital care.”
FINAL PROVISION
§ 2. The ordinance was adopted by a Decision of the National Council on Prices and Reimbursement of Medicinal Products, adopted in accordance with Protocol № 452 from 24.08.2021 G.