Analysis On The Application Of Quality Risk Management In Drug Storage

Enterprises should take effective quality control measures in drug storage and other links to ensure drug quality. Enterprises should adopt a forward-looking or retrospective approach to assess, control, communicate and review the quality risks in the drug circulation process [1]. The management of drug storage conditions is an important guarantee to ensure the quality, safety and effectiveness of drugs. The management of drug storage conditions is an important task for warehouse managers to manage and store drugs in the warehouse [2]. The quality of drug management will have a direct impact on patients’ disease treatment, physical health, and life safety. Therefore, we must pay attention to the quality risk management of drug storage, and take effective management measures to reduce the probability of drug safety accidents as much as possible and ensure the drug safety of patients [3]. If the drug quality risk management method is adopted, the occurrence of events such as drug expiration, drug delivery errors, drug deployment errors, and drug deterioration and failure can be effectively controlled and reduced.

Part 1 Implement Drug Storage Risk Management

1 Implementation Method Of Drug Storage Comparison

Select the management data of drug safety accidents in the drug storage process for the two years from January 1, 2020 to December 31, 2020, and from January 1, 2021 to December 31, 2021. Collect and organize the drug storage management data of the selected two years, analyze the causes of possible adverse risk events, and formulate corresponding risk response measures based on the reasons.

2 Risk Management Of Drug Storage

The risk assessment tool failure mode and effect analysis (FMEA) is used to conduct risk assessment on the drug storage process, and the specific content includes three aspects: risk identification, risk analysis and risk evaluation [4].

Risk identification: After analyzing the management data of drug safety accidents in the drug storage process, it is found that the risks in the drug storage process are mainly divided into three categories: drug damage, drug expiration and drug deterioration and failure.

Risk analysis: analyze the identified risks in the storage process of drugs. There are many reasons for each type of risk. See Table 1 for details.

Table 1 Risk Analysis

Risk assessment: In the process of drug storage, the identified risks are evaluated according to the severity of the consequences once they occur and the possibility of such risks occurring. Before carrying out risk assessment, the evaluation criteria for risk severity, risk occurrence possibility, risk coefficient and risk level determination criteria should be determined first.

Once a risk occurs, the evaluation criteria for its severity can be seen in Table 2, and the evaluation criteria for its occurrence possibility can be seen in Table 3.

Table 2 Risk severity evaluation criteria

Table 3 Evaluation criteria for the possibility of risk occurrence

According to the severity of the risk and the possibility of risk occurrence, the risk coefficient can be further obtained, and the specific standards can be seen in Table 4.

Table 4 Risk factor

According to the different risk coefficients, risks can be divided into three categories: low risk, medium risk and high risk. Among them, a risk factor of 1-4 is low risk, 6-9 is medium risk, and 12-16 is high risk.

The identified risks can be evaluated according to the possibility of occurrence of the identified risks, the severity once they occur, the risk coefficient and the risk grading standard, and the results are shown in Table 5.

Table 5 Risk Assessment Results

3 Risk Response

Risk responses can be chosen: avoiding risks, taking risks in search of opportunities, eliminating sources of risks, changing the likelihood or consequences of risks, sharing risks (risk reduction), and retaining risks through informed decision-making (risk acceptance) [7].

Drug damage:

For the situation that “drugs are damaged but not found when they enter the warehouse”, we adopt a risk-avoiding approach to deal with it, that is, establish a drug warehouse inspection management system, and implement it after corresponding training for warehouse managers. When entering the warehouse, the management personnel check the medicines in the warehouse one by one to check whether the medicines are damaged. Once the medicines are found to be damaged, they will be rejected.”

For the situation of “drug damage due to improper operation during the storage of drugs”, take the risk reduction method to deal with it, that is, establish a drug handling and storage management system, and implement it after corresponding training for warehouse management personnel, requiring ” Warehouse managers inspect the medicines in stock every day to prevent damage caused by other factors during the storage process.” At the same time, it is required that “warehousing management personnel handle the medicines with care to avoid damage to the medicines caused by brutal operations.”

Drug Expiration:

For the situation of “during the storage of medicines, the medicines that are about to expire are not disposed of in time, causing the medicines to expire”, and the risk reduction method is adopted to deal with them. First, designate a special person to check and register the expiration date of the drug in the storage process; second, follow the principle of “first out before the expiration date” to release the drug from the warehouse; third, special drugs are required to be stored in accordance with the relevant administrative regulations, and set Corresponding security measures; finally, the expired drugs are placed in the unqualified warehouse to distinguish them from the drugs within the validity period.

Drug Failure:

For the situation that “drugs are not stored in accordance with the storage requirements of the medicines during the storage process, resulting in the failure of the medicines”, the method of risk reduction is adopted to deal with it, that is, to provide places, equipment, storage facilities and hygienic environments suitable for the medicines used. Formulate and implement a drug storage system, and take necessary refrigeration, anti-freezing, moisture-proof, insect-proof, and rodent-proof measures to ensure drug quality [8,9].

For the situation that “the amount of use is small but there must be drugs, which cause drug failure, such as nitroglycerin”, the risk acceptance method is adopted to deal with it, and the failure of such drugs is controlled within a certain amount.

Part 2 Results Of Implementing Risk Management

1 Comparison Of Drug Quality Problems During Drug Storage

After the implementation of quality risk management, the incidence of drug safety problems has been significantly reduced compared with that before the implementation, indicating that drug safety in the drug storage process has been effectively controlled. The specific comparison results can be seen in Table 6.

Table 6 Comparison of drug quality problems during storage before and after implementation of quality risk management

2 Results Of Implementing Risk Management

After the implementation of quality risk management, the number of drug safety accidents found in the drug storage process throughout the year was 3 cases, compared with 13 cases before the implementation, which was reduced by 10 cases, and the reduction rate was as high as 76.92%, indicating that this method has great potential. high practical significance.

3 Conclusion And Discussion

Drug storage is closely related to drug packaging, storage environment and expiration date. It is related to drug quality and compliance issues, and pharmaceutical companies should pay attention to it. Drug storage units should provide corresponding resources according to their own environment and the specific requirements of drugs to ensure the quality of drugs [10].

The implementation of drug quality risk management can effectively reduce the incidence of adverse events during drug storage and ensure the safety, effectiveness and quality controllability of drugs during drug storage. By implementing this method, pharmaceutical companies can obtain not only good social benefits, but also huge economic benefits.