Xiao Yao,Sun Lihua

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

Abstract Objective To analyze the causes of drug shortages in China and put forward some countermeasures and suggestions accordingly.Methods Based on the relevant data of 14 provinces that issued the lists of drug shortages from 2018 to 2020,377 kinds of drugs were sorted out first,and then the features of shortage were analyzed descriptively.Finally,the degree and causes of shortage were studied based on field investigation and literature summary.Results and Conclusion Among the drugs in short supply across the country,69.2% of them were listed in the National Medical Insurance Catalogue,37.1% were essential drugs and 26.5% were low-price drugs.They were used for different diseases,and most were for treating nervous system and blood system.There were many reasons for drug shortages.For instance,any problems in supply chain (production,circulation,use)could lead to drug shortages,of which the production accounted for the largest proportion.This paper puts forward targeted measures to solve drug shortages from the aspects of unwillingness and inability of manufacturing enterprises in their production.

Keywords:drug shortage;status quo;cause;countermeasure

Drugs are taken as special commodities in the world with the notable features of timeliness and specificity,which means drugs are made for certain patients in time,but not patients are waiting for any drugs to be produced.Therefore,ensuring the supply of drugs and promoting rational use of them have been valued by WHO and governments of all countries.However,due to various causes,there are drug shortages in many countries or regions to a certain degree.Drug shortage means drugs approved by the drug administration for listing,which are irreplaceable or cannot be completely replaced,are insufficient or unstable in supply in a certain period of time or a certain area[1].In recent years,drug shortage in China has become more serious,which not only affects the safety and health of the public,but also brings heavy economic burden to patients,even causing social panic and unrest.Therefore,the causes of drug shortages are analyzed,and then some measures or suggestions are put forward to solve or alleviate this problem effectively.

1 Status quo of drug shortages in China

Based on the relevant data of 14 provinces that issued the lists of drug shortage from 2018 to 2020,377 kinds of drugs in shortage were summarized,and then the features of shortage were analyzed.

1.1 Policy attributes

Referring to the List of Low-cost Drugs within the Pricing Scope of National Development and Reform Commission,the 2018 edition of the National Essential Drugs Catalogue (hereinafter referred to as the National Essential Drugs Catalogue),and the 2019 edition of the National Catalogue of Drugs for Essential Medical Insurance,Industrial Injury Insurance and Maternity Insurance (hereinafter referred to as the National Medical Insurance Catalogue),we found that among the 377 drugs in shortage,100 of them were lowcost drugs,accounting for 26.5%.140 were essential drugs,accounting for 37.1%,and 261 were listed in the National Medical Insurance Catalogue,accounting for 69.2%.

1.2 Distribution of drug shortages

Based on the classification criteria of the 2018 edition of the National Essential Drugs Catalogue and the 2019 edition of the National Medical Insurance Catalogue,377 drugs in shortage were summarized(Table 1).The results showed that among the drugs in shortage,323 of them were chemicals,35 were Chinese patent drugs and 19 were biological agents.The shortage of chemicals for treating both nervous system and blood system is the most severe,each accounting for 9%,and the following were anti-tumor and anti-infective drugs,taking 8.5% and 8.5%,respectively.

Table 1 Top 13 severe chemicals shortage

1.3 Classification of dosages in short

The degree in drugs shortage was different,and the injection shortages were more severe.Among the 377 drugs in short,52.3% were injections and 20.4% were tablets.The remaining 27.3% were capsules,and oral tincture paste,etc.Because of its fast absorption and rapid action,injections were more used for patients with severe illness or critical illness.

2 Causes of drug shortages

In this paper,four 3A medical institutions in Shenyang of Liaoning Province were investigated.In view of the limited number of samples,the existing research results of literature and the causes for drug shortages in 2019 published in Liaoning Province were analyzed and summarized,and the reasons for drug shortages are as follows[2-13].

As to production,manufacturing enterprises were unwilling to produce these drugs due to the unreasonable price increase of raw materials caused by the monopoly.Meanwhile,the increase of management and environmental protection costs resulted in the production costs.Besides,the small profit margin of low-priced drugs made the enterprises unable to bear the price increase of raw materials.The government’s bidding and procurement policy for its limitation to the high but not to the low made the bid price of drugs low.Some drugs,such as drugs for rare disease,for women and children specialty,or emergency were small varieties of drugs,which had low clinical demand.Therefore,manufacturing enterprises had low production enthusiasm.In view of exclusive production of drugs,if enterprises upgraded more advanced equipment,expanding the supply capacity of other products,part of the original line would be replaced,resulting in a phased shortage of some drugs.Enterprises could not produce some drugs due to the influence of the external environment.For example,the government rectified drug manufacturing enterprises,modified drug quality standards.In addition,enterprises failed to pass the dynamic inspection because enterprises were not in accordance with the Good Manufacturing Practice (hereinafter referred to as GMP),resulting in the shortages of drugs within a certain period of time.Lastly,the expiration of import drug registration certificates could also cause drug shortages.

As to circulation,some distribution enterprises were reluctant to deliver the varieties with low profits.Besides,the distribution enterprises had insufficient power to deliver drugs to medical and health institutions located in remote places.When some scarce drugs were not supplied properly and not available in many commercial channels,enterprises with these drugs would increase the price,therefore,other commercial transfers were not profitable or had low profits.In addition,distribution enterprises could not deliver drugs because of the influence of the external environment.For instance,when they failed to pass the dynamic inspection of the Good Supply Practice (hereinafter referred to as GSP),they were not qualified or had to rectify or shut down.Lastly,some specific drugs (such as biological agents) required high circulation conditions,which were prone to shortage due to poor management.

As to drug usage,medical institution was reluctant to store the less used drugs for a long time in order to control the cost of inventory.It was easy for the less used drugs to be ignored by the purchasing department because of the low consumption.Besides,due to the uncertainty of the time and small quantity of use (caused by the uncertain onset of the diseases and the number of people),these drugs are easy to be in short.Some drugs in stock were in short because of the loopholes in the management of hospitals,or they were close to expiration.

In view of the proportion of causes for drug shortages (Table 2),the production took the largest proportion.

Table 2 Causes of drug shortage

(to be continued)

Continued Table 2

3 Countermeasures and suggestions

Drug production is the upstream of the supply chain,and its stability is directly related to the supply of drugs.According to the above analysis,there are two factors affecting drug shortages for manufacturing enterprises.One is enterprises are unwilling to produce the drugs with low profits.The other is enterprises are unable to produce because of the exterior factor.Therefore,some corresponding solutions are put forward for these two causes.

3.1 Measures to address the unwillingness for manufacturing enterprises

3.1.1 Broaden the channels in supply of active pharmaceutical ingredients (APIs) and combate the monopoly of APIs

In view of the monopoly of APIs,the government should supervise and intensify the crackdown on monopoly acts,regulating the behavior of APIs manufacturers strictly,reducing unreasonable production costs,and further cutting the burden on downstream pharmaceutical enterprises.On the other hand,the number of domestic qualified APIs suppliers should be increased according to the industry conditions to solve the shortage and monopoly of APIs fundamentally while APIs industry is upgrading for green production.From the point of view of preparation enterprises,they should make full use of the market resources of raw materials at home and abroad,broadening the supply channels of raw materials to ensure the stable and sufficient supply of raw materials.In recent years,China has issued a number of policies to reduce the import threshold of APIs,more enterprises focus on foreign APIs market.In 2019,7 075 enterprises had APIs import business,an increase of 459 compared with that in 2018[19].

3.1.2 Establish a monitoring and early reporting system for pharmaceutical manufacturing and distribution enterprises with drug shortages

On the basis of the current drug shortage monitoring network in medical institutions,the provincial health committees and medical security bureaus should bring drug manufacturing enterprises and all distribution enterprises into the monitoring and early warning system,and establish a monitoring and early reporting system for drug shortages in enterprises.On the one hand,pharmaceutical manufacturing enterprises should report the shortage of products due to the monopoly or lack of raw materials,the relocation of production lines,the price increase of preparations.On the other hand,they should also report specific information such as the market share of their drugs,possible alternatives,the causes for shortage and the time and span of shortage.Distribution enterprises should report the drugs that they cannot deliver,or fail to deliver on time,or difficult to meet the clinical needs of medical institutions.At the same time,drug shortages in the data in many provinces or for two consecutive years should be given much attention and early warning.At present,four distribution enterprises in Jiangxi Province have been selected as the monitoring and warning posts for drug shortages[20].

3.1.3 Establish an integrated information network platform for drugs in shortage

Due to the asymmetry of information between medical institutions and pharmaceutical manufacturing and distribution enterprises,it is possible that some drugs are insufficient in medical institutions but full stock in manufacturing enterprises.For example,in the data of drug shortages in Liaoning Province in 2019,nikethamil injection,nitroglycerin injection,and coenzyme A for injection were in short supply due to late delivery,which was caused by the information asymmetry between medical and health institutions and pharmaceutical manufacturing (distribution) enterprises.In the past drug supply chain,because there was a lack of network platforms for information exchange among the participants,some drugs were in short supply.Therefore,the government should set up the connections between medical institutions,pharmaceutical manufacturing enterprises,and distribution enterprises to realize the information sharing in the whole province and even in the whole country.It will shorten the feedback time and reduce drug shortages caused by asymmetric information.

3.2 Measures to address non-production for manufacturing enterprises

3.2.1 Provide a reasonable transition period for pharmaceutical manufacturers who are forced to stop production due to higher standards

If there is no substitute for drugs in shortage,the government should give a reasonable transition period to manufacturing enterprises that are forced to stop production because of the improvement of standards.They are allowed to continue their production according to the original standards during the transition period.Meanwhile,enterprises should constantly adjust the production quality to meet the new standards.If there are alternatives for shortage,the government can urge qualified manufacturers of similar/substituted drugs to increase production.

3.2.2 Manufacturing enterprises integrate GMP concept into their management

The cancellation of GMP certification means that the production of drugs has entered an era of dynamic GMP inspection.To pharmaceutical manufacturing enterprises,they should know the relevant knowledge of GMP to implement the norms of GMP,integrating relevant concepts of GMP into their daily management.Besides,while pursuing economic interests,manufacturing enterprises should also establish a corresponding sense of social responsibility,putting quality management into all aspects of the life cycle of drug production,and turning external constraints into their own driving forces.