Overview of law enforcement practices for 2020 by Roszdravnadzor

 

Russian federal service for surveillance in healthcare (Roszdravnadzor) presented¹ an overview of its control and supervisory activities for 2020. Below are the main conclusions of the Overview.

 

1. Typical violations of citizens’ rights in the sphere of health protection 

 

• Failure of the medical organization to comply with the established deadlines for providing medical care to citizens;

• Unjustified payment at citizen’s expense for laboratory tests on COVID-19 and computed tomography when there are medical grounds;

• Lack of analysis of the results of patients with COVID-19 treatment, as well as the causes of deaths;

• Late data submission on COVID-19 occurrence to the data processing resource;

• Low provision of medical and other staff with means of individual protection based on the daily requirement calculation.

 

2. Typical violations by manufacturers in the sphere of circulation of medicines

 

• There is no established procedure for informing the authorized authority if actions are taken as a result of possible errors in production or other serious problems related to the product quality;

• There is no documented responsibility of management for ensuring the effectiveness of the pharmaceutical quality system and the availability of the required resources to ensure that employees comply with the Good Practice Rules;

• Decisions and actions made as a result of the claims review are not included in the relevant dossier for the batch;

• There is no approved algorithm of actions in case of the analysis results exceeding the specifications and revealing atypical results of the analysis;

• There are no processes or documentation implemented to manage the activities that are being transferred to another company;

• The sampling procedures do not specify the cleaning and storage arrangements for sampling equipment, as well as the special precautions to be taken when sampling extractives and substances.

 

3. Shortcomings of the submitted reports on the conducted research on the facts of substandard medicines detection

 

• A formal approach to the report preparation (a limited list of activities carried out, etc.);

• Lack of a comprehensive approach to the assessment of the fact of substandard medicine detection (the manufacturer does not check the information accuracy, the lack of comprehensive measures to establish the causes);

• No recall of medicines is initiated, no decisions are made to terminate declarations of conformity (certificates of conformity), no measures are taken to notify the participants of medicines circulation of the return of the products.

 

4. Measures recommended by Roszdravnadzor to ensure the quality of medicines introduced into civil circulation

 

• Comprehensive investigations of the facts of substandard medicines detection, which will prevent the re-release of medicines that do not meet the established quality requirements in the future;

• Revision of the manufacturer’s regulatory documentation to identify its possible shortcomings: typos, inaccuracies in the methodology, non-reproducibility of the methodology, use of standard samples that are not produced, etc.;

• Use of standard methods of analysis in the preparation of regulatory documents for the introduction of new medicines; avoiding techniques that will cause problems when they are reproduced within the state control over civil circulation, as well as avoiding the laboratory equipment not included in the register of measuring instruments and reagents, standards that are not produced for commercial use, etc.;

• An informal approach to the investigation of the causes of quality deviations;

• Development of an effective plan of action, with the definition of deadlines and responsible persons, allowing to exclude the re-release of medicines that do not meet the established quality requirements in the future;

• Personnel training of the algorithm of actions in the detection of substandard medicines and the occurrence of non-standard situations.

 

5. The main reasons for blocking Internet resources containing an offer for the retail sale of medicines for medical use

 

• Retail offer for unregistered medicines;

• Offer for prescription medicines, including antibiotics, psychoactive medicines that cause drug addiction;

• Lack of a license to carry out pharmaceutical activities and a permit for remote trading.

 

Given the main conclusions of the Overview, we recommend that manufacturers, distributors, pharmacies, and medical organizations consider the typical errors identified by Roszdravnadzor and try to avoid them in their activities, as well as adhere to the recommendations provided by Roszdravnadzor.

 

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