The Health Ministry will purchase almost 40 000 vaccines for a total amount of BGN 4.27 million without a tender, through direct negotiation procedure. The aim is to control the crisis with the 6-valent immunizations.
The crisis started as the only company that participated in the summer tender and won it failed to deliver the vaccine. This is about one of the two included in the Positive list 6-valent vaccines, which is in the form of injection. The company, however, offered to provide quantities in vials. But this form does not appear in the Paid list.
The Minister suspended the execution of the contract, because otherwise he would have committed legal offence. But on the last day for appeal – 8th of October this year, the supplier filed a complaint with the Commission for Protection of Competition against the decision of Dr. Nenkov. While the case is considered, the Ministry of Health can not buy the vaccines and thousands of newborns can not be vaccinated.
“I decided to refer to art. 90 of the Public Procurement Act, which allows in extreme situation to proceed to direct negotiations, despite the appeal of the producer,” explained Dr. Nenkov.
Thus on the website of the Ministry of Health (again on the 8th of October) appeared the direct negotiation procedure, where, however, only one invitation is given – to the second producer. “Only he qualifies as the first producer is appealing and said that before the summer he can not deliver the 6-valent vaccine, so there is no one else to invite” (in the Paid list there are only two vaccines from two producers), explained from the Ministry of Health..
If again there is an appeal and if Nenkov is convicted, the sanction will be a personal fine of BGN 15 000. “I figured that I can take a consumer loan and pay it, but I can not let anyone put me and the Ministry of Health on our knees,” the Minister said. His deputies and a patient organization promised to give money if it comes to conviction. “To solve the casus, we will address the World Health Organization and UNESCO,” said Nenkov.
His team predicts a new crisis with vaccines and in the beginning of 2015, as the vaccination calendar for next year is not ready yet. “Against the vaccination calendar there is resistance in the Ministry of Health on the grounds that the changes we offer do not exist anywhere else in the world no. And it is not so.” snapped Nenkov. He wants the immunization calendar to describe diseases against which immunization of children in Bulgaria will be compulsory, not to indicate the type of vaccines protecting against these diseases. In this way, even if a vaccine is missing, there will be a way for public procurement and the Bulgarian children will not remain unprotected.
Currently in the Regional Health Inspections there are enough 4-valent vaccines to immunize the newborn. And the vaccination against hepatitis B can be made additionally, until a new delivery for the 6-valent vaccine is secured. “Revaccination of 6-year-olds will be delayed, but this will in no way affect the health of the children,” assured Dr. Nenkov.
Among them are some of the best-selling medications for pain, flu and allergies.
The result of the imposed antimarket one year moratorium on the increase of prices of the over-the-counter medicines is that at the end of the moratorium some of them logically have increased. A total of 112 medicines had price increases in the short window between April and early August this year, when the moratorium was not in effect, became evident from the statement of the National Council on prices and reimbursement of medicines.
The previous caretaker government froze the prices of the over-the-counter medicines as a social measure – till April 2014. At the end of her mandate Tanya Andreeva, however, decided to prolongate the moratorium – from 8th of August till the end of the year.
Anticipated
As the experts in the sector warned a year ago, immediately after the suspension of the moratorium in April the prices of some of the medicines increased because during this period their production costs increased or because the manufacturers begun to equalize the prices of the medicines with those in other European countries. Until last year, the government had not intervened on the market of over-the-counter medicines – medications for headache, pain, flu, cold, cough or rash, vitamins, because it is not covering with funds from health insurance fund any part of them. This market is worth BGN 356 million at BGN 2.3 billion total market of medicines and their sales do not affect public spending on prescription medicines of chronically ill of BGN 1.5 million. And there are the high costs of medicines that can not be rolled over, as prices here are the lowest in the EU and the public funds for the sick poor are insufficient. Thus the moratorium was perceived as a populist measure which will not be felt particularly by the users. The reason is that the market of over-the-counter drugs is extremely competitive and the producers usually sell them well below the maximum registered price, as in group compete at least 10-15 medicines of the same group. As anticipated after the suspension followed rise in prices.
It feels like much more
According to the Council on prices the average increase in the prices of these medicines was 26%, but in most cases we are talking about pennies. Moreover, because of the huge competition these products are not sold at the maximum possible price. The Council on prices comments that the medicines with increased prices are only 7.4% of all over-the-counter medicines – a total of 1544 total products. Thus the price increase for the noted period relative to all over-the-counter medicines is only 2%. For example, the Chairman of the Bulgarian Pharmaceutical Union prof. Ilko Getov estimated some days ago that it comes to an average increase of 3-4%. The 112 medicines with new prices are among the best-selling and obviously the feeling is for a more wide scale rise. Among the medicines with increased prices are some popular preparations against influenza.
Why are they with new prices?
A year ago, the manufacturers were allowed to register a new price twice a year. Now this opportunity is once a year and with the rate of inflation. Since this is a free market, the companies can take into account the increase in production and marketing costs, electricity prices and other. In this way the companies explain the increase, adding that in addition to the increased production costs, the marketing costs for the country have also increased.
All staff working in hospital pharmacies must have an employment contract with the recpective medical facility which opened the pharmacy. This is provided in the draft amendment to the Ordinance No.28 of the Ministry of Health on the work of pharmacies. The text includes also the pharmacies of the psychiatric, skin and cancer dispensaries, and inpatient hospices.
The document also provides that for every two assistant pharmacists there must be one master of pharmacy in the hospital pharmacies. If the medical facility has over 400 beds, or has at least ten wards, the pharmacy has to have at least one master of pharmacy with specialty “Clinical Pharmacy” or with such specialization. The same goes for the oncology centers.
The draft amendments also provide the working hours in hospital pharmacies to be determined by the medical facilities and impose the obligations on the Master pharmacists to attend to the patients during non-office hours in emergencies.
The hospital pharmacies are also obliged to maintain a five days reserve of drugs, medical devices and other consumables.
The period within which the health facilities must bring their work in accordance with the new requirements is three years.
All draft amendments to the Ordinance and the motives for them are uploaded on the website of the Ministry of Health.
Community-acquired pneumonia (CAP) is a common infectious disease of the lungs that occurs with significant morbidity and mortality.
In Europe and America about 4 million cases of CAP lead to 1 million hospitalizations annually. Incidence of pneumonia is variable and depends on patient’s age, increasing in the age group over 60 years. All modern studies show that mortality in patients with CAP depends on the severity of the inflammatory process. The highest mortality occurs in patients with severe pneumonia treated in intensive care and requiring mechanical ventilation.
Pneumonia is defined as an acute infection of the lung parenchyma, which occurs with:
1.at least two of the following symptoms: fever, chills, severe coughing (with orwithout expectoration) or chronic cough with change in the color of the sputum, pleural pain, shortness of breath;
2.auscultatory evidence of pneumonia (crepitation or late inspiratory crackles on restricted area, bronchial breathing);
3.new infiltrative changes in the X-ray of the chest, for which there is no other explanation (pulmonary edema or infarction).
Depending on the causative bacteria, pneumonias are divided into typical and atypical. The most common agents are bacteria which grow outside the host cell. Extracellular bacteria are Pnevmokokokite, Haemophilus and Moraxella and the more rare – Klebsiella, Coli. They cause the typical pneumonia, which in our country accounts for about 75% of cases.
The most common cause of pneumonia in our country is Streptococcus pneumoniae. In our country, this microorganism is characterized by a not very high level of penicillin resistance and a tendency towards a reduction in recent years. This fact is due largely to the improvement of the antibiotic strategy for the treatment of CAP in our country.
Haemophilus influenzae is the second most common cause of typical pneumonia, but is the most common cause of acute exacerbation of chronic bronchitis. In infants and elderly patients substantial part of pneumonia is caused by S. aureus. In recent years, a reduction of methicillin resistance of staphylococci is observed.
Atypical community-acquired pneumonias represent a diagnostic and therapeutic challenge. They are about 15 to 25% of the community-acquired infections in the lower respiratory tract. Agents of atypical CAP are microorganisms that are difficult to cultivate.
Legionellosis is evidenced by microbiological detection of the antigen in the urine of the patient, or by genetic, culture and serologic methods
Treatment of CAP
Even in hospital settings, using all diagnostic methods, the etiologic pathogen is evidenced in no more than 40-50 % of pneumonia. For this reason, the initial treatment is almost always empirical. The empirical approach to the prescription of antibiotic is based on the probability of a particular pathogen to cause disease in a particular patient. The decision on the selection of antimicrobial agent depends on many factors such as patient age, severity of condition, concomitant diseases, immune suppression, venue of treatment (outpatient or inpatient), characterization of the sensitivity of microorganisms in the geographical area and others. The conditions to be met by an empirical antibiotic treatment are the widest possible spectrum of activity, rapid and high concentration in the bronchial tree and lungs, less adverse events and convenient administration.
During the last decades professional organizations and associations in various countries around the world have established guidelines for the treatment of CAP in adults, in order to facilitate the physicians in the choice of strategy. The Bulgarian guidelines for the treatment of CAP are based on previously existing consensus, but are consistent with the characteristics of epidemiology, etiology and risk factors in our
Place | Severity | Treatment | |
Subgroup | Recommended | Alternative | |
Outpatient | All | Beta – lactam and/or macrolide | Levofloxacin |
Hospital | Mild/moderate | Penicillin ± macrolide, Beta – lactam ± macrolide, cephalosporin ІІ – ІІІ ± macrolide | Levofloxacin |
Hospital | Severe | cephalosporin ± macrolide | ІІІ generation cephalosporin ± levofloxacin |
Hospital | Severe and risk for P. aeruginosa | Anti-pseudomonal cephalosporin + ciprofloxacin | Acyl Ureido penicillin beta-lactamase inhibitor + ciprofloxacin or with carbapenem + ciprofloxacin |
For inpatients it is recommended to begin the antibiotic therapy immediately after the confirmation of the CAP diagnosis.
The usual duration of antimicrobial therapy is 7-10 days. For intracellular pathogens such as Legionella spp., the treatment should be at least 14 days.
The sequential antibiotic therapy is an important component of the antibacterial treatment of pulmonary diseases. It reduces the cost of treatment, shortens the hospitalization. When the intravenous antibiotic infusion may be replaced with an oral medicament depends on the assessment of the clinical response and the evaluation of the symptoms – cough, sputum expectoration, dyspnea, fever, and leukocytosis. Most often this term is three days from the initiation of treatment, after improvement of cough and shortness of breath, normalization of body temperature, reduction of leukocytosis, and in the presence of well-functioning gastrointestinal tract. When the causative pathogen is not identified, the antibiotic must be similar to the venous.
Tchaikapharma High Quality Medicines provides on the Bulgarian market antibiotics with the following trade names:
JF 491 Climox (Amoxicillin/Clavulanic acid ) 875mg/125mg x 14 tabl.
JF 509 Lifurox (Cefuroxime) 500 mg x 10 tabl.
JF 499 Levor (Levofloxacin) 500 mg x 10 tabl.
JF 400 Klacar (Clarithromycin) 500 mg x 14 tabl.
JF 515 Klacar XL (Clarithromycin) 500 mg x 7 tabl.
The price of all these antibiotics is BGN 14.99.
The elderly people in our country are satisfied with the General Practitioners and pharmacists, because they in details and clearly explain them the diseases and drug therapies and are considerate and kind to them. This shows a study of the problems of the elderly in Bulgaria conducted by the newly created think-tank “Solidarity with elders”. The study is based on in-depth interviews of elderly living alone in the capital, it is combined with the country representative data on the problems of people over 70 years of age.
Part of the problems of the elderly in Bulgaria and the base for their possible solution were presented on the occasion of the International Day of the Elderly people on the 1st of October.
The survey data shows that only a quarter of the elderly people are able to visit alone their General Practitioner because of reduced mobility. Nearly 80% of people who regularly visit a doctor and pharmacy have more than one disease and take many medications.
Among the problems of the elderly are such as lack of circle of friends, difficulties associated with the lack of recreation areas in institutions, hospitals and commercial buildings. It is clear from the survey that leaving the home is also a problem for people over 70 years, because of fears of the state of urban infrastructure and the dynamics of the urban environment.