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Pharmacovigilance requirements in China

 

 

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Adverse Drug Reaction Reporting and Monitoring Management Measures
Release Date: 2017-02-21
Chapter One: General Rules

 

"Article 1" In order to strengthen post-marketing supervision of drugs, standardize adverse drug reaction reports and monitoring, timely and effectively control drug risks, and ensure the safety of drug use by the public, these measures are formulated in accordance with the "Drug Administration Law of the People's Republic of China" and other relevant laws and regulations.

Article 2   The reporting, monitoring and supervision of adverse drug reactions within the territory of the People's Republic of China shall be subject to these Measures.

Article 3 The country implements an adverse drug reaction reporting system. Pharmaceutical production enterprises (including overseas pharmaceutical manufacturers that import pharmaceuticals), pharmaceutical distributors, and medical institutions shall report discovered adverse drug reactions in accordance with regulations.

Article 4  The State Food and Drug Administration is in charge of the national adverse drug reaction reporting and monitoring work, and the local drug regulatory authorities at all levels are in charge of the adverse drug reaction reporting and monitoring work within the administrative area. Health administrative departments at all levels are responsible for the management work related to the implementation of the adverse drug reaction reporting system in medical institutions within their respective administrative regions.

The local drug supervision and administration departments at all levels shall establish and improve the adverse drug reaction monitoring agency, and be responsible for the technical work of the adverse drug reaction report and monitoring within the administrative area.

Article 5 The state encourages citizens, legal persons and other organizations to report adverse drug reactions.

 

Chapter Two: Jobs and Responsibilities

 

Article 6 The State Food and Drug Administration is responsible for the management of national adverse drug reaction reports and monitoring, and performs the following main responsibilities:

(1) Jointly formulate management regulations and policies for adverse drug reaction reporting and monitoring with the Ministry of Health, and supervise their implementation;

(2) Jointly organize with the Ministry of Health to conduct nationwide investigation and treatment of adverse drug group adverse events that have a greater impact and cause serious consequences, and release relevant information;

(3) Take emergency control measures in accordance with the law for drugs that have been confirmed to have had serious adverse drug reactions or drug group adverse events, make administrative decisions, and make them public;

(4) Announce the national adverse drug reaction report and monitoring situation;

(5) Organizing and inspecting the development of adverse drug reaction reports and monitoring work of drug production and trading enterprises, and jointly organizing inspections of the development of adverse drug reaction reports and monitoring work of medical institutions with the Ministry of Health.

Article 7 The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the management of adverse drug reaction reports and monitoring within their administrative regions, and perform the following main duties:

(1) In accordance with these Measures, jointly with the health administrative department at the same level formulate the management regulations for the reporting and monitoring of adverse drug reactions in the administrative area, and supervise the implementation;

(2) Jointly organize with the health administrative department at the same level to carry out the investigation and handling of the adverse drug group adverse events that have occurred in the administrative area, and release relevant information;

(3) Take emergency control measures in accordance with the law for drugs that have been confirmed to have had serious adverse drug reactions or drug group adverse events, make administrative decisions, and announce them to the public;

(4) Announce the reports and monitoring of adverse drug reactions in the administrative area;

(5) Organizing and inspecting the development of adverse drug reaction reports and monitoring work of drug production and trading enterprises in the administrative area, and jointly organizing inspections of the adverse drug reaction reports and monitoring work of medical institutions in the administrative area with the health administrative department at the same level Development status;

(6) Organize the publicity and training of adverse drug reaction reports and monitoring in the administrative area.

Article 8. The drug supervision and administration departments at the city and county levels divided into districts shall be responsible for the management of adverse drug reaction reports and monitoring within their respective administrative regions; jointly organize with the health administrative departments at the same level to carry out drug group adverse events in their respective administrative regions Investigate and take necessary control measures; organize and carry out publicity and training of adverse drug reaction reports and monitoring in the administrative area.

Article 9   The health administrative department at or above the county level shall strengthen the supervision and management of clinical drug use in medical institutions, and take relevant emergency control measures for confirmed serious adverse drug reactions or drug group adverse events within the scope of their duties.

Article 10 The National Adverse Drug Reaction Monitoring Center is responsible for the technical work of the national adverse drug reaction report and monitoring, and performs the following main duties:

(1) To undertake the collection, evaluation, feedback and reporting of national adverse drug reaction reports and monitoring data, as well as the construction and maintenance of the national adverse drug reaction monitoring information network;

(2) Formulate technical standards and specifications for adverse drug reaction reporting and monitoring, and provide technical guidance to local adverse drug reaction monitoring institutions at all levels;

(3) Organize the investigation and evaluation of serious adverse drug reactions, and assist relevant departments in the investigation of adverse drug group events;

(4) Issue warnings about adverse drug reactions;

(5) To undertake the publicity, training, research and international exchanges of adverse drug reaction reports and monitoring.

Article 11  The provincial-level adverse drug reaction monitoring agency is responsible for the technical work of the adverse drug reaction report and monitoring within its administrative area, and performs the following main duties:

(1) To undertake the collection, evaluation, feedback and reporting of adverse drug reaction reports and monitoring data in the administrative area, as well as the maintenance and management of the adverse drug reaction monitoring information network;

(2) Provide technical guidance to the city-level and county-level drug adverse reaction monitoring institutions divided into districts;

(3) Organize the investigation and evaluation of serious adverse drug reactions within the administrative area, and assist relevant departments in the investigation of adverse drug group adverse events;

(4) Organize and carry out the publicity and training of adverse drug reaction reports and monitoring in the administrative area.

Article 12. Adverse drug reaction monitoring institutions at the city and county levels divided into districts shall be responsible for the collection, verification, evaluation, feedback and reporting of adverse drug reaction reports and monitoring data within their administrative areas; carrying out severe adverse drug reactions within their administrative areas Investigation and evaluation; assisting relevant departments in the investigation of adverse drug group events; undertaking the publicity and training of adverse drug reaction reports and monitoring.

Article 13   Drug production and operation enterprises and medical institutions shall establish adverse drug reaction reports and monitoring management systems. Pharmaceutical production enterprises shall set up specialized agencies and be equipped with full-time personnel, and drug trading enterprises and medical institutions shall set up or designate agencies and be equipped with full-time (part-time) personnel to undertake the reporting and monitoring of adverse drug reactions of their own units.

Article 14   The staff engaged in the reporting and monitoring of adverse drug reactions shall have relevant professional knowledge in medicine, pharmacy, epidemiology or statistics, and shall have the ability to scientifically analyze and evaluate adverse drug reactions.

 

Chapter III Reporting and Disposal

 

Section 1   Basic Requirements

 

Article 15 Pharmaceutical production and trading enterprises and medical institutions shall report adverse reactions that may be related to drug use through the national adverse drug reaction monitoring information network; if they do not meet the online reporting requirements, they shall report the local adverse drug reactions through paper reports. The reaction monitoring agency shall report online on behalf of the local adverse drug reaction monitoring agency.

The content of the report should be true, complete and accurate.

Article 16   Adverse drug reaction monitoring institutions at all levels shall evaluate and manage the adverse drug reaction reports and monitoring data within their administrative regions.

Article 17   Drug production and trading enterprises and medical institutions shall cooperate with drug regulatory authorities, health administrative departments, and drug adverse drug reaction monitoring institutions in the investigation of adverse drug reactions or group adverse events, and provide the materials required for the investigation.

Article 18   Drug production and operation enterprises and medical institutions shall establish and keep records of adverse drug reaction reports and monitoring files.

 

Section 2   Cases of Adverse Drug Reactions

 

Article 19 Pharmaceutical production and trading enterprises and medical institutions shall actively collect adverse drug reactions, and shall record, analyze and deal with them in detail after learning or discovering adverse drug reactions, and fill in the "Adverse Drug Reaction/Event Reporting Form" (see Attachment 1) And report.

Article 20   Domestic drugs during the new drug monitoring period shall report all adverse reactions of the drug; other domestic drugs shall report new and serious adverse reactions.

Imported drugs shall report all adverse reactions of the imported drugs within 5 years from the date when they are first approved for import; for 5 years, report new and serious adverse reactions.

Article 21   Drug production, business enterprises and medical institutions shall report new and serious adverse drug reactions within 15 days when they discover or learn about them. Death cases must be reported immediately; other adverse drug reactions shall be reported within 30 days. If there is follow-up information, it should be reported in time.

Article 22 The drug manufacturing enterprise shall investigate the death cases it learns, learn in detail the basic information of the death case, drug use, occurrence of adverse reactions, diagnosis and treatment, etc., and complete the investigation report within 15 days and report to the location of the drug manufacturing enterprise The provincial-level adverse drug reaction monitoring agency.

Article 23   When an individual discovers a new or serious adverse drug reaction, he may report it to the treating physician, or to the drug manufacturer or distributor or the local adverse drug reaction monitoring agency, and provide relevant medical records when necessary.

Article 24 The city-level and county-level adverse drug reaction monitoring institutions divided into districts shall review the authenticity, completeness and accuracy of the received adverse drug reaction reports. The review and evaluation of the severe adverse drug reaction report shall be completed within 3 working days from the date of receipt of the report, and the review and evaluation of other reports shall be completed within 15 working days.

Adverse drug reaction monitoring agencies at the city and county levels divided into districts shall investigate the death cases and learn in detail the basic information of the death cases, the use of drugs, the occurrence of adverse reactions, diagnosis and treatment, etc., and 15 work from the date of receipt of the report Complete the investigation report within days and submit it to the drug supervision and administration department and the health administration department at the same level, as well as the higher-level drug adverse reaction monitoring agency.

Article 25   The provincial-level adverse drug reaction monitoring agency shall complete the evaluation within 7 working days from the date of receiving the serious adverse drug reaction evaluation opinion submitted by the next-level adverse drug reaction monitoring agency.

For fatal cases, the provincial-level adverse drug reaction monitoring institutions in the place where the incident occurred and where the drug manufacturing company is located shall promptly analyze and evaluate based on the investigation report, conduct on-site investigations when necessary, and report the evaluation results to the provincial drug regulatory authority and health The administrative department, and the National Adverse Drug Reaction Monitoring Center.

Article 26 The National Adverse Drug Reaction Monitoring Center shall analyze and evaluate the death cases in a timely manner, and report the evaluation results to the State Food and Drug Administration and the Ministry of Health.

 

Section III: Adverse Events of Drug Groups

 

Article 27: After drug production and trading enterprises and medical institutions are notified of or discover adverse drug group adverse events, they shall immediately report it to the local county-level drug supervision and administration department, health administrative department and adverse drug reaction monitoring agency by telephone or fax. Reports can be skipped if necessary; at the same time, fill in the "Basic Information Form of Drug Group Adverse Events" (see Appendix 2), and fill in the "Adverse Drug Reaction/Event Report Form" for each case in time, and pass the National Adverse Drug Reaction Monitoring Information Network report.

Article 28: After being informed of adverse drug group adverse events, the districted city-level and county-level drug supervision and administration departments shall immediately jointly organize on-site investigations with the health administrative departments at the same level and report the investigation results to the level of the provincial drug by level. Supervision and management departments and health administration departments.

The provincial drug supervision and management department and the health administrative department at the same level jointly supervise and guide the investigations at the districted city and county levels, analyze and evaluate the adverse events of the drug group, and have a greater impact on the drugs that occur in the administrative area For group adverse events, an on-site investigation should also be organized, and the evaluation and investigation results should be reported to the State Food and Drug Administration and the Ministry of Health in a timely manner.

For adverse drug group adverse events that have a large impact and cause serious consequences across the country, the State Food and Drug Administration should jointly carry out relevant investigations with the Ministry of Health.

Article 29: Pharmaceutical manufacturers should immediately conduct investigations upon learning of adverse drug group adverse events, and learn more about the occurrence of adverse drug group adverse events, drug use, patient diagnosis and treatment, drug production, storage, circulation, and previous similar adverse events. Complete the investigation report within days and submit it to the local provincial drug regulatory authority and adverse drug reaction monitoring agency; at the same time, quickly conduct self-examination to analyze the cause of the incident, and if necessary, suspend the production, sales, use and recall of related drugs, and report to the local province Level drug supervision and management department.

Article 30   Drug distributors should immediately notify the drug manufacturer when discovering adverse events in the drug group, and at the same time quickly conduct self-examination, suspend drug sales when necessary, and assist the drug manufacturer to take relevant control measures.

Article 31   Medical institutions shall actively treat patients after discovering adverse drug incidents, quickly conduct clinical investigations, analyze the cause of the incident, and take emergency measures such as suspending the use of drugs when necessary.

Article 32 The drug supervision and administration department may take control measures such as suspension of production, sales, use or recall of drugs. The health administrative department shall take measures to actively organize the treatment of patients.

 

Section 4  Foreign Serious adverse drug reactions 

 

Article 33 For serious adverse drug reactions of imported drugs and domestic drugs that occur overseas (including those collected by the spontaneous reporting system, found in post-marketing clinical studies, and reported in the literature), the drug manufacturer should fill in the "Adverse Drug Reactions Occurring Overseas" / Incident Report Form” (see attached table 3), submitted to the National Adverse Drug Reaction Monitoring Center within 30 days from the date of notification. If the National Adverse Drug Reaction Monitoring Center requires the original report and related information, the drug manufacturer shall submit it within 5 days.

Article 34 The National Adverse Drug Reaction Monitoring Center shall analyze and evaluate the adverse drug reaction reports received, and report to the State Food and Drug Administration and the Ministry of Health every six months. It shall promptly find information that suggests potential safety hazards of drugs. report.

Article 35. If the sales, use or withdrawal of imported drugs and domestic drugs overseas due to adverse drug reactions are suspended, the drug manufacturer shall report to the State Food and Drug Administration and the State Adverse Drug Reaction Monitoring in writing within 24 hours of being notified. center.

 

Section 5: Periodic Safety Update Report

 

Article 36  Drug manufacturing enterprises shall conduct periodic analysis on the adverse reaction reports and monitoring data of the drugs produced by the enterprise, aggregate domestic and foreign safety information, conduct risk and benefit assessments, and write regular safety update reports. The rules for writing regular safety update reports are formulated by the National Adverse Drug Reaction Monitoring Center.

Article 37 For domestic drugs that have established a new drug monitoring period, a regular safety update report shall be submitted every 1 year from the date of obtaining the approval documents, until the first re-registration, and then every 5 years thereafter; for other domestic drugs, Report every 5 years.

For the first imported drug, since the date of obtaining the import drug approval document

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Guidelines for the collection and reporting of individual Case Safety Reports (ICSRs) 

In order to standardize the collection and reporting of individual adverse reactions after the drug is marketed, and to guide marketing license holders to carry out work related to adverse drug reaction reports, in accordance with the "Regarding Deepening the Reform of the Review and Approval System of the Central Committee of the Communist Party of China and the State Council" "Opinions" (Ting Zi [2017] No. 42), "Administrative Measures for Adverse Drug Reaction Reporting and Monitoring" (Ministry of Health Order No. 81), "Announcement on Direct Reporting of Adverse Reactions by Drug Marketing Authorization Holders" (National Drug Administration Announcement No. 66 of 2018), with reference to the International Human Drug Registration Technical Coordination Committee "Post-marketing Safety Data Management: Definitions and Standards for Rapid Reporting" (ICH E2D) to formulate these guidelines.
This guideline applies to marketing authorization holders (including manufacturers holding drug approval documents, hereinafter referred to as holders) to collect and report individual adverse drug reactions.
If the health administration department and the drug supervision and administration department of the State Council have other provisions on the collection and reporting of adverse vaccine reactions, such provisions shall prevail.
The individual adverse drug reactions in this guideline refer to the adverse reactions of a single patient using drugs.
Collection of 1 case of adverse drug reaction
The collection and reporting of individual adverse drug reactions is the basis of the monitoring of adverse drug reactions and the basic legal responsibility that the holder should perform.
Holders should establish effective information channels for doctors, pharmacists, patients, etc., and actively collect information on adverse reactions involved in clinical use, clinical research, market projects, academic literature, and relevant websites or forums of holders.
The holder shall not interfere with the spontaneous reporting behavior of the reporter for any reason or means.
1.1 Medical institutions
Holders can use daily visits, e-mails, telephones, faxes, etc., to regularly collect information on clinical adverse drug reactions from medical staff, make detailed records, and establish and save adverse drug reaction information files.
When the holder or its distributor signs a drug purchase and sale contract with a medical institution, the medical institution should be fully aware of the holder’s adverse reaction reporting responsibilities, and medical personnel are encouraged to report adverse reactions to the holder.
1.2 Pharmaceutical operating companies
Pharmaceutical business enterprises shall directly report adverse reaction information to the holder, and the holder shall establish a smooth channel for reporting information.
The holder collects information on individual adverse reactions through the drug distributor, and the two parties shall agree on the distributor’s responsibilities in the entrustment agreement and clarify the requirements for information collection and transmission. The holder shall regularly evaluate the dealer’s ability to perform the information collection responsibilities and take necessary measures to ensure the quantity and quality of the information collected.
Holders or their distributors should ensure that pharmaceutical retail companies know effective ways to report adverse reactions to them, develop an information collection plan, and train resident pharmacists or other personnel to understand the goals, methods, methods, and methods of information collection. Content, preservation and record requirements, etc., to improve the accuracy, completeness and traceability of adverse reaction information.
1.3 Calls and complaints
The drug insert sheet, label, and contact number published on the holder’s portal are important ways for patients to report adverse reactions, make complaints or consult. The holder should designate a person to answer the phone, collect and record adverse reaction information reported by patients and other individuals (such as doctors, pharmacists, and lawyers). The holder should ensure that the phone is open, someone should answer it during working hours, and a voice message should be set up during non-working hours. If the phone number is changed, it should be updated in the manual, label and portal in time. Holders should inform consumers of adverse reaction reports in an effective way.
The holder should report the adverse reaction learned through legal proceedings, regardless of whether the report has been submitted to the supervisory authority by other reporters.
1.4 Academic literature
Academic literature is one of the high-quality sources of information on adverse drug reactions. Holders should regularly search the literature and report individual adverse reactions in the literature. Holders should formulate document retrieval procedures, and stipulate the frequency, time range, document source, document type, retrieval strategy, etc. of document retrieval.
For new drugs that are on the market for the first time or imported for the first time within five years, a literature search shall be conducted at least once every two weeks, and other drugs shall be conducted once a month in principle, and can also be determined according to the risk of the variety. The search time range must be continuous and uninterrupted.
Holders should search widely used literature databases, such as domestic literature databases such as China Knowledge Network (CNKI), VIP.com (VIP), Wanfang database, and foreign literature databases such as PubMed, Embase, and Ovid. Domestic and foreign documents require at least two databases to be searched at the same time.
The types of literature related to adverse reactions mainly include: case reports, case series, adverse reaction reviews, etc. In addition, clinical effectiveness and safety studies, meta-analysis, etc. may also involve adverse drug reactions. Individual adverse reactions from literature sources are mainly searched for adverse reaction case reports (description and discussion of the adverse reactions of a single patient, such as "a case of liver failure caused by XX drug") and adverse reaction case series (for multiple patients with the same nature of adverse reactions) The reaction is described and discussed, such as "Four cases of anaphylactic shock caused by XX drug"). Adverse reactions in other types of literature reports (such as clinical observational studies with the main purpose of observing curative effects) are generally not reported as individual cases.
Holders should formulate reasonable search strategies to ensure comprehensive search results and reduce missed inspections. For example, keywords can be searched using the international non-proprietary name (INN)/active ingredient of the drug, or the generic name of the drug approved by the drug regulatory authority , Product name and alias combination to search.
1.5 Internet and Social Media
Holders should regularly browse the websites initiated or managed by them to collect possible adverse reaction cases. The principle does not require the holder to search external websites, but if the holder learns of the adverse reaction in the external website, he should evaluate whether to report it.
Holders should use the company’s portal website to collect information on adverse reactions, such as establishing a special route for adverse drug reaction reports on the website, providing report methods, report forms and report content guidance, and publishing complete and up-to-date product instructions.
Print media, digital media, and social media/platforms initiated or managed by the holder are also one of the sources of cases of adverse drug reactions, such as the use of corporate WeChat official accounts, microblogs, and forums.
1.6 Post-market research and projects
Individual adverse reactions found in post-marketing studies initiated by companies (including studies carried out overseas) or organized data collection projects should be reported as required, such as clinical trials, non-interventional epidemiological studies, and key drug monitoring , Patient support projects, market research or other marketing projects, etc.
Adverse reactions discovered in post-marketing research or projects should in principle be reported by the holder to the regulatory authority, but the holder shall not interfere with the reporting behavior of the research or project partner for any reason or means.
1.7 Sources of regulatory authorities
The adverse drug reaction report reported by the domestic regulatory authority to the holder is mainly used for the holder’s safety analysis and evaluation of the product. The holder shall deal with the feedback reports, such as terminology regularization, evaluation of severity and expectation, and evaluation of relevance, etc., and report according to the scope and time limit of individual adverse drug reactions (see 3.2 and 5.2).
If the adverse drug reaction report reported by the overseas regulatory authority to the holder meets the requirements of overseas reporting, it shall be submitted to the regulatory authority of my country in accordance with the overseas report processing procedure.
2 records, transmission and verification of adverse drug reactions
2.1 Record
The first person of the holder or the entrusting party who is aware of the adverse reaction of an individual case is called the first recipient. The first recipient should obtain as much information as possible about adverse reactions, including patient conditions, reporter conditions, suspected and concurrent drugs, and adverse reactions. If it is difficult to obtain information comprehensively, try to obtain the four elements of information first (see 3.1).
There should be original records of adverse reaction information received through various channels, such as emails, letters, telephone calls, and doctor interviews. In addition to the reporter, the information of other relevant personnel who provided case report information should also be recorded to ensure that the information provider is identifiable (see 3.1). Records should be true, accurate and objective, and should be properly kept. The original records can be paper records, electronic documents, audio recordings, or website screenshots. Routine collection methods such as telephone records and doctor interviews should develop original record forms.
All original records should clearly indicate the date when the holder or its entrusting party obtained the adverse drug reaction this time, as well as the name and contact information of the first recipient. Document retrieval should record the retrieval date, personnel, retrieval strategy, etc., and save the relevant original documents obtained from the retrieval; if the relevant information is not retrieved, it should also be recorded.
For the data fed back by the supervisory authority, the holder shall ensure that the feedback data is downloaded in a timely manner, and record the download time, quantity, operating personnel and other information.
2.2 Delivery
When the original records of individual adverse drug reactions are transmitted from the first recipient to the pharmacovigilance department, the authenticity and integrity of the records shall be maintained, and no deletion or omission shall be allowed. To ensure the timeliness of the report, the delivery time limit should be required. All changes to the original data should be noted. The holder should formulate rules for handling missing information to ensure the consistency of handling. The pharmacovigilance department shall number all the individual adverse reaction reports received, and the numbering shall be continuous and traceable to the original record according to the number.
2.3 Verification
The holder shall evaluate the authenticity and accuracy of the information on individual adverse reactions. When the authenticity of the patient or reporter is doubted, or the accuracy of the information content is doubted, the information should be verified as much as possible. The report reported by the regulatory authority is authentic and accurate by default, but if the holder believes that the report may affect the overall safety assessment of the drug, it should be verified as much as possible.
If the adverse drug reaction comes from a partner other than the holder, such as an information collection unit entrusted by an enterprise, an institution entrusting a literature search, a research cooperation unit, etc., the agreement between the two parties should have binding provisions to ensure that the information collected by the partner is true and accurate. The holder is responsible for reviewing the adverse reaction information provided by the partner and is responsible for the report submitted to the regulatory authority.
Confirmation of 3 cases of adverse drug reaction reports
Individual adverse drug reactions collected through various channels should be confirmed. The content to be confirmed mainly includes: whether it is a valid report, whether it is within the scope of the report, whether it is a repeated report, etc. If it is confirmed that there is no need to submit an adverse drug reaction to the regulatory authority, the reason for non-submission shall be recorded and the original record shall be kept.
3.1 Effective report
First, confirm whether it is a valid report. An effective report should include the following four elements (four elements for short): identifiable patients, identifiable reporters, suspected drugs, and adverse reactions. If the four elements are incomplete, the report is deemed invalid and should be supplemented before reporting.
"Identifiable" refers to the ability to confirm the presence of the patient and reporter. The patient is considered identifiable when one or more of the following items are available: name or initials, gender, age (or age group, such as adolescent, adult, and elderly), date of birth, and other identification codes of the patient. The initial reporter who provided the case information or the relevant person contacted for obtaining the case information should be identifiable. For case reports from the Internet, the recognizability of the reporter depends on whether the existence of the patient and the reporter can be verified, such as providing a valid e-mail address or other contact information.
3.2 Report scope
When a patient uses a drug with a harmful reaction that is not related to the purpose of the drug, when the correlation between the reaction and the drug cannot be ruled out, it should be reported in accordance with the principle of "report if suspicious". The scope of the report includes the adverse reactions that occur under the normal usage and dosage of the drugs, as well as the harmful reactions that occur in the case of off-label use, such as over-indication medication, over-dose medication, contraindication medication, etc., and suspected drug quality problems caused Harmful reactions etc.
Information on drug overdose should be collected and analyzed in regular safety reports. Overdose of drugs that cause adverse reactions should be reported on a case-by-case basis.
Drugs exported overseas (including Hong Kong, Macau, and Taiwan) and serious adverse reactions of imported drugs overseas, regardless of the patient's ethnicity, fall within the scope of individual case reports. Non-serious adverse reactions do not need to be submitted on a case-by-case basis, and should be summarized in the regular safety update report.
For adverse reactions from post-marketing research or organized data collection projects, if the reporter or holder judges that there is a possible causal relationship with the drug, it should be reported to the regulatory authority. Adverse reactions from other sources, including reports reported by the regulatory authorities, should be reported to the regulatory authorities regardless of whether the holder believes that there is a causal relationship.
For adverse reactions reported in the literature, if the suspicious drug is determined to be the holder’s product, it should be reported regardless of whether the holder believes that there is a causal relationship; if it is determined that it is not the holder’s product, there is no need to report it. If it is uncertain whether it is the holder's product, it should be discussed in the regular safety update report, and it may not be used as an individual adverse reaction report.
If multiple drugs are mentioned in the literature, the suspected drug should be reported and the holder of the suspected drug should report. Suspected drugs are determined by the authors of the literature, and the authors usually mention the causal relationship between suspected drugs and adverse reactions in the title or conclusion. If the reporter believes that the suspected drug is different from the suspected drug determined by the author of the literature, it can be stated in the remarks of the report.
3.3 Duplicate reports
In order to avoid duplicate reports due to different collection methods, the holder should check the duplicate reports and submit them after removing duplicate reports. Reports that cannot be determined whether they are repeated should be reported in time.
Evaluation of 4 cases of adverse drug reactions
After receiving an individual adverse drug reaction report (including the report fed back by the regulatory authority), the staff of the pharmacovigilance department should evaluate the report, including the determination of new adverse reactions and serious adverse reactions, and the development of the association between drugs and adverse reactions Sexual evaluation.
4.1 Determination of new adverse drug reactions
When the nature, severity, characteristics or results of an adverse reaction are inconsistent with the terms or descriptions in the owner's instructions, it shall be considered as a new adverse reaction (or unanticipated adverse reaction). The holder cannot be sure that the adverse reaction is new or known, and should be treated as new.
An adverse reaction leading to death should be considered a new adverse reaction, unless it is clear in the instructions that the adverse reaction may cause death.
The same type of drugs may have some or some of the same adverse reactions, which are called "like reactions." Class reactions can only be considered as known adverse reactions when they are clearly described in the instructions, for example: "Like other drugs of the same kind, drug XX will also have the following adverse reactions." or "Similar drugs, including drug XX will Cause..." If the drug XX has no record of the adverse reaction so far, the following description may appear in the instructions: "It has been reported that other drugs of the same kind will cause..." or "There have been reports that similar drugs will cause..., but no drug has been received so far. XX’s report.” In this case, it should not be considered that the adverse reaction is a known adverse reaction to drug XX.
4.2 Judgment of serious adverse drug reactions
One of the following adverse reactions should be judged as serious adverse drug reactions: (1) cause death; (2) life-threatening; (3) cause hospitalization or prolonged hospitalization; (4) cause permanent or significant disability/ Loss of function; (5) Congenital abnormalities/birth defects; (6) Causes other important medical events, such as those listed above may occur without treatment.
For adverse reactions, "severity" and "severity"

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