Case-control study: A comparative study is made between a case with a certain disease and a control group without a certain disease, with the aim of finding out the differences in previous drug exposure between the two groups. That is to say, there is a disease in the population that needs to be studied, and the patient group (case group) has a higher proportion than the people without that disease (control group) to study whether the former has hypothetical factors.
In the monitoring of adverse drug reactions, the diseases to be studied are the adverse reactions caused by suspected drugs, and the hypothetical factors are suspected drugs. The exposure rate of suspicious drugs in the case group was compared with that in the control group, and if there was statistical significance, they were related.
2. Group study.
Cohort study is to divide the samples into two groups, one is patients exposed to a drug, and the other is patients not exposed to the drug, and observe and verify the difference of the results, that is, the incidence or efficacy of adverse events. Generally, it can be divided into prospective investigation and retrospective investigation. The former is often used to monitor adverse drug reactions, and the prospective investigation is to observe the fixed population from now on.
3. Evaluation method of spontaneous reporting system
Spontaneous reporting refers to the adverse reactions caused by a drug reported by medical staff in medical practice through medical literature magazines or directly to drug regulatory agencies and drug production enterprises. The basic function of spontaneous reporting is to find ADR signals. Although there is no detailed causal judgment in the reported ADR report, it is based on the assumption that if a drug does produce ADR, it should be reported as long as it is suspicious.
Then the national ADR center or the global ADR center will receive a large number of ADR reports about the drug. When the reports accumulate to a certain extent, it is strongly suggested that drugs will cause ADR, and the one-to-one causal relationship will naturally be clear.
4. Prescription Event Monitoring (PEM)
PEM was first proposed by DavidFinney, a British statistician, in 1965 after thalidomide incident, which emphasized the reporting of adverse drug events (ADE) rather than adverse drug reactions. The "event" in "prescription event monitoring" completely changed the original concept.
That is to say, all the symptoms that were confirmed as adverse reactions, suspected adverse reactions or went to the hospital for treatment due to symptoms were included in the "events", such as "rash", "blood pressure170/10", "anemia tendency" and "yellow pox" recorded by doctors in medical records.
Thus, in "prescription event monitoring", "event monitoring" is to make a report according to the doctor's subjective judgment, and then extract objective "events" from the patient's medical records, so as to review the relevance of medication.
5, hospital centralized monitoring system
Hospital centralized monitoring refers to the detailed record of ADR and drug use in a certain hospital or a certain area within a certain period of time (months or years) to explore the occurrence law of ADR, which can be patient-originated centralized monitoring, drug-originated centralized monitoring or specialized centralized monitoring, so as to calculate the corresponding ADR incidence and explore its risk factors, with detailed information and accurate and reliable data.
Because centralized monitoring is carried out within a certain time and scope, the data obtained are not representative, lack of continuity and high cost, so its application is limited unless it is carried out for special purposes. In the initial stage of ADR monitoring in China, there are many centralized monitoring, but the scale is too small to share data. We made a meta-analysis of this.
Because of the obvious advantages of spontaneous reporting, some scholars suggest that a large-scale hospital centralized monitoring should be carried out every 10 year to conduct a comprehensive pharmacoepidemiological study on the occurrence and drug utilization of ADR.
Baidu Encyclopedia-Adverse Drug Reaction Monitoring