Effect of the Policies to Prevent Drug Shortage and Stabilize Drug Prices in Medical lnstitutions

Li Xiaoqi,Fan Jianing,Huang Jiaxin,Liu Xinying,Raela·Abduhilil,Sun Lihua

(School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China)

Abstract Objective To evaluate the effect of some policies to prevent drug shortage and stabilize drug prices,and to provide reference for improving relevant policies.Methods With a combination of random stratified sampling and quota sampling,532 medical institutions in 20 provinces were selected to carry out questionnaire surveys.Then,a comparative analysis was made to study the changes of drugs on the shortage list and drugs on non-shortage list before and after the release of the policy of ensuring supply and stabilizing prices.Results and Conclusion The policy played an important role in curbing the growth of drug shortage in the medical institutions,but it did not curb the growth of drugs on non-shortage list.Besides,the drugs on non-shortage list showed an overall fluctuation and upward trend.Meanwhile,from the perspective of drug prices,the price stability problem of drugs on the shortage list and on the non-shortage list became more serious,and the average price increase was 256% and 239%,respectively.The implementation of policies related to the supply and price stability of drugs prevents the growth trend of drug shortages in the list of medical institutions,which has been recognized by most medical institutions.However,there is an increasing trend in the number of drugs on non-shortage list.In addition,the price increase of drugs on both the shortage list and non-shortage list is severe.Some medical institutions report that they have difficulties in using the information reporting system of drug shortage and the classification,grading and the alternative use of drug shortages.It is recommended to strengthen the management of price stabilization of drugs on the shortage list.Further attention should be paid to the supply and price stabilization of drugs on nonshortage list.At the same time,trainings in the classification and substitution of drug shortage and information reporting system should be actively organized,thus comprehensively improving the capabilities of medical institutions at all levels to deal with the problem of drug shortage.

Keywords: drug shortage;supply and price stability;policy research;management strategy

The problem of drug shortage has always been an issue to which the government attach great importance.Since 2019,with the release of documents such as the “Opinions on Further Ensuring the Supply and Price Stabilization of Shortage Drugs”[1],the “Notice on the Measures for the Administration of the National Shortage Drug List (Trial Implementation)”[2],the “Notice on Printing and Distributing the National Shortage Drug List”[3](hereinafter referred to as the “Opinions” “Measures” and “List”),China begun to implement the list management system in the supply of shortage drugs.At the same time,the “National Shortage Drug List” and the “National Key Monitoring List of Clinically Necessary Shortage Drug” (hereinafter referred to as the “list of drugs”)were formulated to clarify the definition of shortage drugs,which contained a total of 57 drug varieties.In addition,corresponding protection policies in the production,procurement,use,reserve,and other links were made to prevent drug shortages.The release of the above policies related to the supply and price stability of shortage drugs provides a new mechanism,new model and new ideas for the prevention and response to drug shortages in China.Therefore,this study aims to evaluate the effectiveness of the solution and potential problems of drug shortages after the introduction of the above policies,so as to provide reference for further improving the policy.

1 Research methods

This study focused on the key contents of policy evaluation -the degree of resolution of policy problems,social impact and shocks to design questionnaires.And the final questionnaire was formed through pre-research modification and improvement.According to the list of medical institutions at all levels published on the official website of the National Health Commission,532 medical institutions from 20 provinces were selected by a combination of random stratified sampling and quota sampling to carry out questionnaire research.According to the applicable conditions of the policy evaluation methods[4-10],the “have-not” policy comparison analysis method and the “before-after” comparative analysis method were used to analyze the supply,price stability and policy impact of “list drugs” and “non-list drugs” before and after the release of relevant policies.Among them,the national list of drugs included 57 drug varieties,and the non-list drugs included the drug varieties that had a shortage except for the 57 varieties.Since both classes of drugs contained high-priced and low-priced drugs[1],and both common and rare diseases were treated[1],there was no difference in the basic price of the two by default when comprehensive and detailed price information was not available.

For the varieties of shortage drugs,according to the “Technical Guidelines for the Classification and Grading of Drugs in Medical Institutions and the Substitution of Use”,drugs with different manufacturers and common names,dosage forms and specifications are clinically replaceable,and the same drugs from different manufacturers are all in short can be called the clinical shortage of such drugs.Therefore,the shortage of drugs referred to the clinical shortage of drugs in the medical institutes,and the corresponding manufacturers of such drugs are not counted.At the same time,in this study,the number of drugs in short supply every month is taken as the frequency of shortages,and the drugs with the same generic name and specifications as the same product specifications,and the shortage numbers of all drugs are counted.

2 Research results

2.1 Availability of drugs in short supply

The results show that before the introduction of the measures,the difference between drugs on the shortage list and drugs on the non-shortage list is not obvious,and both possess an increasing trend.After the introduction of the measures,the drugs on the shortage list and non-shortage list are generally unchanged,which means that the policy has not had an impact on the shortage of drugs in medical institutions in a short time.After the introduction of the list,the number of shortages of drugs on the list has an overall slow decline trend,but the number of drugs on the non-shortage list does not decrease but rises.Until October 2021,the number of drugs on the shortage list and non-shortage list began to decline rapidly.It can be seen that the measures and lists have played a role in curbing the growth trend of the shortage of drugs in the list of medical institutions.However,after the list was introduced,the drugs on the shortage list and nonshortage list increased with the decrease of anther.

In addition,the survey results show that at the medical institution end,about 70% of the shortage duration of drugs is less than or equals to 6 months,and the average shortage duration of the resolved drug is 5 months.The number of shortages of injections is significantly higher than that of oral preparations,indicating that injections are more prone to shortages than oral preparations.It may be related to factors such as complex processes,long production cycles and strict transportation conditions of injections.However,the average shortage duration of the two is not much different,6 and 7 months,respectively.

2.2 Stable prices of drugs in short supply

From the perspective of both the supply and demand of the market,in the case of unchanged incidence and diagnosis and treatment plan,the demand for shortage drugs remains unchanged,and policies such as small variety production can optimize the supply.Therefore,the price of drugs should remain unchanged or decline after the introduction of the policy.This study takes the price of the drug (excluding the inflation rate) as the baseline,counting the price changes of drugs on the shortage list and non-shortage list before and after the release of the policy to examine whether the policy has achieved the purpose of stabilizing the price of drugs in shortage.The results show that the average price increase of drugs on the list and non-shortage list in medical institutions is high,which is much higher than the proportion of price decline.It is worth noting that the proportion of drug price increases in medical institutions is particularly obvious,which exceeds the proportion of price decline.This shows that the problem of ensuring the supply of drugs on the shortage list has been alleviated.Meanwhile,the problem of price stability has become more severe.Besides,drugs on non-shortage list may be maliciously increased by manufacturers.

However,due to limited data,it is not possible to rationalize the extent of drug price increases.At the same time,because the price changes for some product specifications in different areas of the medical institutions are different,this part uses the number of price increase specifications,the number of price decline specifications,and the number of price unchanged product specifications to be divided by the overall number of product specifications.Since some product specifications have double calculations,the sum of the price increase of medical institutions,the proportion of price decline specifications,and the proportion of price unchanged product specifications is greater than 1.

In addition,in medical institutions,the average price increase of drugs on the shortage list and nonshortage is 256% and 239%.It can be seen that the price of drugs in short supply has risen significantly,and the drugs on the shortage list is higher than that of non-shortage list,which deserves further study.However,due to the large number of drugs on the shortage listed and non-shortage list which cover different fields,there are large differences in the basic prices between different varieties.Besides,it is difficult to obtain the basic price ranges of drugs on the shortage list and non-shortage list from the existing data,so the impact of the rise in the prices of these drugs on the patient needs to be further studied.

2.3 Impact of policies on medical institutions

This section analyzes the impact of the policies on ensuring the supply and stable price of shortage drugs in medical institutions,the situation of medical institutions joining the direct reporting system of shortage drugs,and the difficulties in collecting,confirming,disposing,classifying,grading,and alternative use of shortage drug information.

Among the medical institutions that have experienced drug shortages,78% of medical institutions believe that the policy of ensuring the supply and stable price of shortage drugs has a positive impact on their response to drug shortage.On the one hand,the policy has effectively alleviated the supply management problems of clinically necessary emergency rescue drugs and other shortage-prone drugs.On the other hand,it has provided many conveniences for medical institutions to purchase shortage drugs,such as direct network procurement,independent filing procurement,temporary import procurement and not subject to the “two-invoice system”.6% of medical institutions believe that the policy of ensuring the supply and stable price of shortage drugs has a negative impact on related work,although the phenomenon of supply assurance has improved significantly.The phenomenon of price increase is more obvious.16% of medical institutions believe that the promulgation of relevant policies has no significant impact on related work.

87% of medical institutions have joined the direct reporting system of shortage drug,and 13% of medical institutions have not yet joined the direct reporting system.Some medical institutions with the direct reporting system have reported difficulties in using the system,mainly including: (1) Some drug information cannot be searched in the direct reporting system when the shortage of drug information is reported,or cannot be reported;(2) The processing of drug shortage information is not timely,and the feedback is slow,affecting the enthusiasm for reporting;(3) The reporting process of shortage information is complicated;(4) The standard for reporting shortage is not clear,such as the situation of online stock and offline high-priced purchase needs to be reported.

In addition,some medical institutions have difficulties in classifying and grading shortage drugs and the assessment of alternative use,mainly including: (1) Lack of clear classification methods,no relevant guidelines or sufficient evidence,and the insufficient pharmaceutical knowledge;(2) When the generic name or similar varieties are replaced,some patients have a low willingness to accept alternative drugs,and there are also other factors in patients that further lead to difficulties in using alternative drugs;(3) Due to the differences of manufacturers,preparation process,drug price and other factors,the clinical efficacy of some drugs can sometimes not be evaluated,making it difficult to use them clinically.

3 Conclusion and recommendations

As to drug supply assurance,the release and implementation of related policies on the supply and price stabilization of shortage drugs has effectively solve the problem of shortage drugs in medical institutions,but the number of drugs on the nonshortage list has increased with a fluctuating upward trend.In terms of price stabilization,the price increase of shortage drugs in medical institutions is severe,and the price increase of drugs on the shortage list accounts for the largest proportion of product regulations.Meanwhile,the price increase of nonshortage list drugs is also higher.Based on the current issues,the following recommendations are made.

3.1 Strengthening the stable price management of drugs in short supply

At present,the supply of drugs on the shortage list has made great progress,and the work of stabilizing prices is still facing great difficulties.It is recommended to carry out research on price calculation,and the impact of some factors such as increased cost input and product quality improvement should be comprehensively considered.Then,a reasonable price ceiling must be established while implementing price policies such as independent quotation to prevent enterprises from forcing price up due to the lack of drugs.In addition,the increase in the number of shortages and price increases of nonshortage list drugs should not be underestimated,and it is recommended that relevant departments increase supervision to curb unreasonable price increases in a timely manner.

3.2 Organizing and carrying out relevant training

Based on the difficulties faced by medical institutions,it is recommended to organize training in the classification and substitution of shortage drugs,the operation of the direct reporting system for shortage drugs,and the drug reserve.Besides,we should clarify the process of substitution of shortage drugs and the standards for reporting shortage information.When the conditions and processes for the use of reserve drugs are clarified,the shortage of drugs at all levels (especially grass-roots medical institutions) can be comprehensively improved.