Main problems of the National Essential Medicines List and the lists of supplemented medicines implemented in each province
Overall, the National Essential Medicines List is scientific and reasonable. Despite a few problems, it has played a positive role in guaranteeing the availability of essential medicines, regulating medical services, and promoting rational medication. One study from Peking University showed that the available rate of a commonly used drug does not exceed 40% before the system is implemented; however, after the initial implementation at 20 provinces, they found that the availability rate increased to about 60% after conducting a survey between February-March 2010 . Statistical data from State Council Medical Reform Office indicated that the average price at primary health care institutions dropped by 16.9%. Expense of single prescription and the prescription rate of antibiotics decreased by 9.0% and 1.38% after the reform in township hospitals, respectively.
The provincial lists of supplemented medicines have problems in terms of number, structure, and category of medicine. First, the selection is excessive and does not follow strict selection principles. The average number of supplemented medicines in each province equals to 67% of the entire List; such excessiveness weakens the function of the National Essential Medicines List. Second, some categories of supplemented medicines are not selected scientifically; thus, these lists of supplemented medicines show characteristics of “excessiveness, dispersion, and disorder.” Many clinically non-preferred medicines with serious side effects are introduced into primary care health institutions due to the unscientific selection approach. For example, somiton is the only medicine listed by all 29 provinces. The aminopyrine found in somiton causes hypoleukocytosis, which resulted in 1,981 deaths in the U.S. from 1931 to 1934, prompting the U.S. government to eliminate it from the legal medicines list in 1938. Another ingredient of somiton is phenacetin, which has been proven to be one of the causes of renal failure and is already restricted in many countries [18, 19]. Meanwhile, cimitidine is listed by 24 provinces and ranks second in supplementing frequency; this has complicated pharmacological effects and multiple side effects. It can also accentuate the pharmacological activity or toxicity of other medicines through drug-drug interactions. Therefore, cimitidine is usually replaced with ranitidine [20, 21]. Diethylstilbestrol is listed by 18 provinces as a supplemented medicine for estrogen supplement. However, it can cause serious adverse events, including carcinoma of the vagina in young girls. Such major adverse events have made diethylstilbestrol an uncommon choice in large hospitals both at home and abroad .
Form the literature and interview date, almost all of the 29 provinces based their selections on various experts’ opinions in producing their respective lists of supplemented medicines, and a majority of experts are from the prime health care institutions. In comparison, the selection of the WHO Lists of Essential Medicines is mainly based on evidence-based medicine and pharmaceutical economics – opinions of experts are only considered as references. Currently, only a few provinces (e.g., Sichuan) apply the method of evidence-based medicine selection and consider the disease status in common patients.
The function of the provincial lists of supplemented medicines and their actual effects
Under the regulation of the essential medicines policy in China, and due to the concern that the National Essential Medicines List may not meet all the needs of primary health care institutions, the policy now allows province to add to the List those drugs that are associated with current use at the first stage of the reform. Provincial supplemented medicines should be limited to local use for special diseases, and their usage must coincide with the functions and positions of primary health care institutions. Aims of the provincial supplementing policy are include meeting the rational needs of prime health care institutions, and cutting the financial ties between doctors and drug manufacturers, gradually changing the medication practices of doctors, promoting the rational use of medicine, that same to essential medicines system.
However, the goal of this policy has not yet been achieved. On one hand, even with regulation and revisions of the principles and methods of supplementation, the provincial supplemented lists are still unreasonable and random. This is because the provinces have been creating their own lists based on the existing medication practices of their respective health care institutions and doctors. Moreover, most provinces do not have a guideline on the proportion of the supplemented medicines. These greatly have reduced the effectiveness of the essential medicines system in promoting the rational use of medicine and changing the medication practices of doctors. The fact that doctors still use the same medicines makes it impossible to cut the financial ties between doctors and drug manufacturers. In turn, this makes it more difficult to meet the goal of the essential medicines system.
On the other hand, even after the provinces added essential drugs, the primary health care sector still cannot meet the actual needs of doctors and patients [23, 24]. The total number of medicines available is still high despite the fact that the List lacks some commonly used drugs that vary in diverse regions, at various institutions, and with some doctors.
Although provincial lists of supplemented medicines are unable to reach their original targets, revising the National Essential Medicines List should be based on the supplementing experience of each province; furthermore, frequently supplemented medicines with clear pharmacological benefits should be added. After revising, the List should meet the most basic medication needs of primary health care institutions in terms of both the category and the number of the medicines.
Recommendations on usage policy of essential medicines
The usage policy of essential medicines is one of the key measures of the essential medicine system in China. The provincial supplementing policy is based on usage policy, which is related to the selection and function of National Essential Medicine List and the provincial lists of supplemented medicines. Thus, it is necessary to discuss the current usage policy, despite the fact that it does not directly follow from the data in research results. The usage policy of essential medicines should also be adjusted. Doctors in primary health care institutions should not be limited to prescribing only the essential medicines and should enjoy some autonomous rights within a certain range.
A country that controls the prescription practices of doctors with an essential medicines list covering a few medicine categories, in order to reduce medicine cost and promote rational medication is rare. This rarity is due to the specificity of the medical industry and the individual variations within it. The existence of a reasonable enough list that suggests the best treatment therapy for every patient is impossible because of the limitation of categories and the number of essential medicines. Apart from the fact that medication needs in different areas are not the same, the limitation resulting from the essential medicines list is in conflict with the current medical insurance system in China, given that the list just covers less than 1/7 of the Basic Medical Insurance Directory. Limiting the medication of all health care institutions and doctors to the same list of medicines can be a short-term measure, but such a policy is inappropriate for the situation in China and incompatible with the law of medicine as a whole. This practice can also cause conflicts between the prescription practice of doctors and the medical needs of patients, resulting in great decrease of doctors’ enthusiasm and patients’ satisfaction. In fact, these events have happened in some areas in China.
Analyzing the issue from another angle, the aim of designing the usage policy is improving rational use and cutting the profit link between health institutions, doctors, and medicine. However, there are many factors in China that cause irrational drug use. These factors mainly include the following: (1) medical personnel do not have the required level of knowledge and capability and may even have poor prescription habits; (2) financial interests among pharmaceutical firms, hospitals and doctors (i.e., hospitals profit by reselling drugs); (3) patients demand inappropriate use of medicines due to their limited medical knowledge and long-term doctor-induced habits. When many patients do not obtain the desirable outcomes, they often demand the use of antibiotics and parenteral. Current usage policy may not improve rational use.
As for the issue of cutting the financial ties between doctors and drug manufacturers and then solving the problem of the health care system, simply depending on the essential medicines system is not enough–more comprehensive efforts are needed. First, the management mechanism, compensation model, and income distribution mechanism in health institutions should be transformed. Second, relevant departments should strengthen the supervision on the diagnosis and treatment behavior of health institutions and health workers. Third, the production and circulation of medicines should be regulated, including the restriction of medicine approval, control of medicine prices, and circulation cost. Finally, the mode of medical insurance payment should be turned from post payment to the imprest system. The current usage policy cannot obtain its goal and would only be able to do so with the above combined efforts.