12 September 2023
Ombudsman Diana Kovacheva sent an opinion to the Minister of Health Prof. Dr. Hristo Hinkov, in which she recommends that an alternative option for prescribing and dispensing antibiotics and medicinal products for the treatment of diabetes be adopted. According to a draft decree of the Ministry of Health of 1 October this year, these two groups of medicines will be prescribed only by electronic prescription. This means that sick people will not be served in any pharmacy in the country if they have a white prescription, i.e. a paper prescription. The Ministry of Health’s argument for switching to e-prescription for these drugs is to prevent a shortage of diabetes medicines and to limit the overuse of antibiotics that leads to resistance.
“Uncontrolled prescribing and, in particular, dispensing of medicinal products for the treatment of diabetes mellitus and their use by patients outside the indications in the summary product characteristics (e. g. for weight reduction in case of overweight by non-diabetic individuals) is one of the main reasons why medicinal products for the treatment of diabetes mellitus are lacking and in short supply, and why prevention measures are necessary and even overdue. In addition, the indiscriminate use of antibiotics and their dispensing without a prescription leads both to a lack and shortage of antibiotics in pharmacies, especially during the winter season and in epidemic conditions, and to development of antimicrobial resistance, with resulting ineffectiveness of treatment and a threat to both individual patient health and public health, writes the Ombudsman.
However, Prof. Kovacheva draws attention to the fact that currently dispensing of medicinal products for diabetes treatment and antibiotics is to be carried out only after prescribing them on a paper prescription form and in this regard much more effective and stringent control is needed.
“Understanding the need to adopt measures to address these issues, as a public defender I am concerned about the possibility of providing for only electronic prescription of certain groups of medicines could result in infringement of patients' rights by limiting and delaying their access to treatment. This is particularly undesirable for vulnerable groups, the elderly, people with disabilities and, above all, children, for whom timely application of antibiotic treatment is often crucial to control the disease and prevent serious complications”, states the Ombudsman.
Diana Kovacheva draws attention to the fact that citizens’ unsecured access to medical care outside the work schedule of general practitioners on weekdays and 24 hours a day on weekends and holidays is also a serious problem to which a comprehensive solution has not yet been found. Often in small and remote settlements, where there are no on-call offices and general practitioners have announced that they will provide round-the-clock care for patients themselves, but in practice they do not, citizens are forced to seek medical help from other doctors and paramedics they trust, and from emergency teams.
It should also be borne in mind that there are competent and practising medical doctors and dentists who do not have a contract with the National Health Insurance Fund (NHIF) and/or do not have the necessary equipment and technical knowledge to use the electronic system, and the need to prescribe antibiotics only electronically will violate their rights and especially the rights of their patients, including children. Lack of infrastructure and guaranteed internet connectivity across the country are also among the possible reasons for non-prescription or delayed prescription of antibiotics.
The provision of dental care by dental doctors who do not work under a contract with the NHIF and/or do not have the necessary hardware and software for prescribing electronic prescriptions is also among the possible reasons for the infringement of patients' right to timely access to antibacterial medicinal products for systemic use.
The Ombudsman also draws attention to the fact that the lack of pharmacies in small and remote areas is also a cause for concern and a reason for breaches of citizens' rights of access to treatment.
“At the same time, there are still small pharmacies that may encounter serious difficulties in providing a technical possibility to dispense medicinal products prescribed with electronic prescriptions”, writes Prof. Kovacheva.
She also notes as a problem the current lack of interest in the mobile application for issuing electronic prescriptions by doctors who are members of the Bulgarian Medical Union, the registration for which requires from a doctor to have an electronic signature, and in order to use it the doctor needs to have a stable Internet connection. Prescribing medicines via the app would also be impossible in the above cases, including for doctors from emergency teams visiting patients at their homes.
“As Ombudsman, I believe that non-prescribing or delaying the prescription of antibiotic therapy, for whatever reason, will infringe the rights of patients and their timely access to this group of medicines, which often, especially for children, is crucial for the successful treatment”, warns Diana Kovacheva.
In conclusion, in her opinion to the Minister for Health, the Ombudsman recommends that the problems described be thoroughly examined and that measures be considered to address them, for example to provide for exceptions and an alternative option for prescribing and dispensing medicinal products in the above cases, while ensuring effective control.
“I would like to hope that the right of citizens across the country, including especially children, to timely and guaranteed access to systemic antibacterial medicinal products on prescription will be guaranteed and that no delay in treatment will be allowed, with resulting infringement of patients' rights and risks to their health”, the Ombudsman concludes.