Li Ran (李然)

Department of Pharmacy, Beijing First Hospital of Integrated Chinese and Western Medicine, Beijing 100029, China

ABSTRACT OBJECTIVE: To interfere with the improper prescriptions of Chinese herbal pieces issued by the outpatient doctors so as to reduce the doctor's prescription error rate and ensure the safety of medication for patients. METHODS:Based on Prescription Administrative Policy, Management Standard of Chinese Herbal Pieces in Hospital, and Beijing Chinese Herbal Pieces Dispensing Regulation, 2000 prescriptions were collected and analyzed according to the different intervention, and solutions were put forward for a variety of reasons. RESULTS: In 2000 prescriptions, there were 932 prescriptions containing toxic drug overdose without double signature, 577 prescriptions of dose error, 282 prescriptions of ingredients error, 85 prescriptions with wrong route of administration, 73 prescriptions of herb incompatibility without double signature, and 51 prescriptions with repeat herbs, accounting for 46.5%, 28.85%, 14.1%, 4.25%, 3.65% and 2.55% of the total number of prescriptions respectively. After the intervention of pharmacists, 2000 prescriptions were all successfully intervened to protect the safety of medication. CONCLUSIONS: TCM pharmacist should double check prescriptions with errors issued by doctors, so as to reduce the prescription error rate, and ensure the safety of medication and rehabilitation of patients, and then improve values of pharmacists.

KEY WORDS: Intervention of Chinese herbal pieces prescription; TCM doctors; TCM pharmacist

Chinese herbal pieces is an important embodiment of syndrome differentiation and treatment of traditional Chinese medicine (TCM) in clinical practice according to TCM theory and processing methods of Chinese herbal medicine, which can be used directly in the clinical application. The prescription of Chinese herbal pieces is the essence of TCM medication, and the rationality of ingredients and dose is an important factor to guarantee the efficacy1. Prescription of Chinese herbal medicine is a written document identifying patients' general information,clinical diagnosis, the name, quantity, usage and dosage of Chinese herbal pieces, doctor's signature and date of prescription, price, total weight of each ingredient, check,dispensing, review and pharmacist's signature, which is a record and evidence of syndrome differentiation and treatment by doctors, reflecting doctor's syndrome differentiation principles and methods, as well as medication requirement. It is a written notice to pharmacist from the doctor, and the basis of Chinese herbal pieces dispensing with legal significance2. Prescription Administrative Policy stipulates that establishing a prescription review system to intervene in the unqualified prescription timely. Article 35 stipulates that pharmacist shall examine the suitability of prescription. Article 36 stipulates that after examining the prescription, the pharmacist should inform the doctor when inappropriate prescription is found, and asks the doctor for confirmation or reissue the prescription. If the pharmacist finds any serious unreasonable use or errors in medication,he or she could refuse to dispense the prescription, and inform the doctor in time. The details should be recorded and reported. Due to the variety of Chinese herbal medicine, with many factors influencing the type and dosage of medication, some mistakes can be made. As a TCM pharmacist who reviews the prescriptions, the author may come across prescriptions with error in reviewing the prescriptions. In this article, 2000 error prescriptions were involved in the intervention and analyzed as follows:

MATERIALS AND METHODS

General data

A total of 2000 error prescriptions of Chinese herbal pieces needed intervention from 2008～2016 were collected as the subjects of study. The prescriptions were from department of endocrinology, department coronary heart disease, cardiovascular department, department of spleen and stomach disease, department of pulmonary disease, department of nephrology, etc. Among all the Chinese herbal prescriptions, there were 284 cases in 2008, 262 cases in 2009, 249 cases in 2010, 233 cases in 2011, 227 cases in 2012, 208 cases in 2013, 183 cases in 2014, 179 cases in 2015 and 175 cases in 2016. The prescriptions above were analyzed and the unreasonable ones were identified to conduct the statistical analysis.

Methods

According to Prescription Administrative Policy,Regulation of Dispensing Chinese Herbal Pieces in Beijing, Management Standard of Chinese Herbal Pieces in Hospital (on trial), the unreasonable Chinese herbal prescriptions were classified and generally divided into three categories, including non-standard prescriptions,prescriptions with inappropriate ingredients and beyond routine prescriptions. The specific reasons of prescription in each category were analyzed. In the first category,the reasons of non-standard prescription included (1)prescriptions with inappropriate ingredients, (2) beyond routine prescriptions, (3) non-standard writing of clinical diagnosis, and (4) illegible writing of the dosages of ingredients. In the second category, the reasons for prescriptions with inappropriate ingredients were: (1)repeated medication, (2) indications, (3) usage and dosage, and (4) ingredient types. In the third category, the specific reasons for beyond routine prescriptions included:(1) no indications, and unconformity of symptoms and prescriptions. The 2000 prescriptions collected by the author for prescription intervention were analyzed for different reasons, and solutions were proposed accordingly.

Observation standards

The improper use of Chinese herbal pieces can be divided into extraordinary prescription, repeated medication,herbal compatibility, abnormal usage and dosage,contraindication in drug-using, unconformity diagnosis and medication. Extraordinary prescription: the number of ingredients was large and the price was high; Repeated medication: the same function of herbal medicine was used in one prescription (For example, use Radix Astragali 40g and Radix Hedysari 20g in the same prescription).Herbal compatibility: the prescription contained eighteen incompatible medicaments, and nineteen medicaments of mutual restraint. Abnormal usage and dosage: Too large or too small dosage of ingredients will lead to side effects or being ineffective. Contraindication in drug-using: The prescription was administered without following the regulations for patient of the elderly, children or pregnant woman. Unconformity of diagnosis and medication: The ingredients prescribed were not in conformity with the patient's syndrome. Details of medical disputes caused by unreasonable use of ingredients should be recorded.

RESULTS

In 2000 prescriptions, there were 932 prescriptions containing toxic drug overdose without double signature, 577 prescriptions of dose error, 282 prescriptions of ingredients error, 85 prescriptions with wrong route of administration,73 prescriptions of herb incompatibility without double signature, and 51 prescriptions with repeat herbs, accounting for 46.5%, 28.85%, 14.1%, 4.25%, 3.65% and 2.55% of total number of prescriptions respectively. After the intervention of pharmacists, 2000 prescriptions were all successfully intervened to protect the safety of medication. The specific results were shown in Table 1.

Table 1. Analysis of 2000 error prescriptions of Chinese herbal decoction

DISCUSSION

In recent years, the variety and specifications of Chinese herbal pieces have been continuously increased.The application of Chinese herbal pieces is given high attention in clinical study. Inevitably, western medicine doctors issued prescriptions of Chinese herbal medicine in clinical practice. Due to the different degree of mastery of medication knowledge and understanding of medications,there are many irrational prescriptions of Chinese herbal pieces, such as repeated medication, excessive dosage,and even unconformity of diagnosis and prescriptions.For example, patient who was diagnosed with externallycontracted wind cold was treated with Yinqiao Powder,which not only reduced the effects of clinical treatment,but also to some extent, aggravated the contradiction between doctors and patients. Repeated medication refers to the use of two or more ingredients with the same efficacy in the same prescription, which on one hand increases the medication burden and on the other hand causes medication risks, such as bleeding3.

In addition, the common irrational prescriptions of Chinese herbal pieces also include extraordinary prescriptions and incompatibility. Therefore, the review of the prescription of Chinese herbal pieces must be implemented by developing an effective system of Chinese herbal prescription review, so as to strengthen the management of prescription of Chinese herbal pieces and enhance rationality of clinical application of Chinese herbal pieces. In this study, prescriptions of overdose ingredients without double signature occupied 46.5% of the total number of prescriptions. For example, Fructus Tribuli 15g was prescribed while the maximum dose of oral administration should be 10g. The maximum dose of oral administration of Radix Aconiti and Radix Aconiti Kusnezoffii was 3g while they were prescribed in 10g.There were 73 pieces of prescriptions with incompatibility without double signature, accounting for 3.65% of the total number of prescriptions, such as Rhizoma Pinelliae and Radix Aconiti Lateralis Praeparata, Flos Caryophylli and Radix Curcumae. The prescriptions with impropriate dosage accounted for 28.85% of the total prescriptions.

The main problems lied in the quantity, such as Rhizoma Cyperi 123g, Inula Japonica Thunb 100 g, Radix Rehmanniae Praeparata 1g. Prescriptions with the wrong route of administration accounted for 4.25%. For example, external application was mistakenly issued as oral administration, or oral administration was mistaken for external application.Repeated medication accounted for 2.55% of the total prescription, such as raw Radix Astragali seu Hedysari 40g,Radix Hedysari 40g; clam powder and Indigo Naturalis.Prescription with wrong ingredients accounted for 14.1% of the total prescriptions. The reasons lied in western medicine doctors' lacking of knowledge of Chinese herbal medicine because they were not familiar with the name of Chinese herbal pieces, and mistakenly wrote ingredients. For example,Radix Aconiti Lateralis Praeparata was written as Rhizoma Typhonii, Fructus Corni was written as Fructus Evodiae.

Manifestation of prescription problem

Inappropriate medication based on syndrome differentiation

For example, the patient was diagnosed as stomach cold, and was prescribed with raw Fructus Gardeniae,which was bitter and cold and easily hurt the stomach. It was not suitable for medication.

Repeated medication

It was due to lacking of understanding of Chinese herbal pieces. For example, Radix Astragali seu Hedysari and Radix Hedysari had the same actions and indications.But some doctors issued Radix Astragali seu Hedysari 40g,and Radix Hedysari 40g, which was repeated medication,which not only increased the incidence of adverse reactions in patients, but also was a waste of TCM resources.

Incompatibility

The combination of the two ingredients can result in severe side effects, and reduce or destroy the efficacy of medicine, such as eighteen incompatible medicaments,Rhizoma Pinelliae was incompatible with Radix Aconiti Lateralis Preparata, nineteen medicaments of mutual restraint, and Flos Caryophylli was mutual restraint with Radix Curcumae. Sometimes, a doctor may deliberately issue a prescription with eighteen incompatible medicaments and nineteen medicaments of mutual restraint to treat a special disease, if the pharmacist could confirm that he or she deliberately did it, the prescriptions could be dispensed by providing double signatures.

Unreasonable usage and dosage and the inappropriate treatment course

It is commonly found that many prescriptions were with too small dosage or inappropriate usage. Too small dosage could lead to the poor treatment efficacy. For improper method of use, Pharmacopoeia of the People's Republic of China stipulates that Pollen Pini is for external application in the treatment of eczema, impetigo. Doctors ask patients to take it after mixing with water to improve immunity, but long-term use will inevitably lead to adverse reactions. Another example is that Fructus Bruceae should be taken by wrapping with longan aril or made into capsules,and it cannot be taken after decocting with water, which will stimulate the gastric mucosa, and lead to adverse reactions.

Analysis of the reasons

Western medicine doctors lack in the knowledge of TCM

By the above statistical analysis, it is found that the inadequate use of syndrome differentiation medication accounted for 28.83% of irrational use of medicine, ranking the 2nd, indicating that a large number of doctors were seriously lacking relevant knowledge of Chinese herbal pieces, and caused ineffective syndrome differentiation when diagnosing the patient's conditions, so as to affect the conventional treatment for patients. For example, abuse of drugs occurs when some doctors issue prescriptions without knowing the actions, indications, administrations and dosage of some Chinese herbal pieces4.

Pharmacists' weak ability to review

For patients, excessive or small doses of the drug may have some impact on patients, even may severely jeopardize the patient's life safety. Therefore, the pharmacist's ability to review should be effectively improved, to help them better understand the appropriate dosage of drugs. In addition, due to doctors' writing error, nearly 20% of the prescriptions were improper dosage and treatment course.

Ignorance of adverse reactions

As many medical staff have little knowledge of the adverse reactions of Chinese herbal pieces, believing that if those ingredients have no toxic side effects, and they could prescribe at their will. For example, oral administration of Folium Sennae tea can relax the bowels and lose weight. As it contains anthraquinone components, long-term administration will lead to adverse reactions of melanosis coli.

Suggestions and measures to solve problems in prescription

To improve the professional quality of medical staff

Doctors should treat each prescription with rigorous scientific attitude. Mistakes are often made, such as drug dosage, errors of route administration, including oral administration was issued as external application, external application as oral administration, repeated ingredients.It is recommended that we should strengthen the doctors'responsibility by reviewing the correctness of the prescription information before printing and handing to the patients. In order to reduce the prescription problem of Chinese herbal pieces, hospital training should be carried out for western medicine doctors, especially the training on the Regulation of Dispensing Chinese Herbal Pieces in Beijing, to help them better understand the dispense of the Chinese herbal pieces in their work, the limited dose of toxic drugs, and footnote of pieces6. In addition, we also need to examine suitability of Chinese herbal prescriptions,to prevent medication errors.

To strengthen publicity and carry out clinical pharmacy services

In order to make medical staff better understand the relevant knowledge of Chinese herbal pieces, the hospital needs to put the rational use of Chinese herbal pieces on the network platform to facilitate medical staff to understand them. Meanwhile, it is also necessary to translate some jerky Chinese language into simple information for better understanding, so that doctors can remember it.Dose standard and limitation of Chinese herbal pieces,contraindications during pregnancy, eighteen incompatible medicaments, and nineteen medicaments of mutual restraint should be comprehensively displayed on information platform in selecting drugs to treat symptoms, and facilitate the doctors' selection, and avoid the misuse of drugs.

Doctors should strengthen the learning of Prescription Administrative Policy, Management Standard of Chinese Herbal Pieces in Hospital, and Regulation of Dispensing Chinese Herbal Pieces in Beijing. Some doctors do not pay attention to the double signature of overdosage of medicines. Article 29 of Management Standard of Chinese Herbal Pieces in Hospital stipulates dispensers should check prescription and dispense according to Prescription Administrative Policy and regulations on the dispensing of Chinese herbal pieces. For prescriptions with eighteen incompatible medicaments, nineteen medicaments of mutual restraint, and contraindications during pregnancy that could cause medication safety issues, they should dispense after being confirmed by the doctor ("double signature") or represcribed. In response to this problem, the upper limit of toxic Chinese herbal pieces should be set, which is recorded into the hospital information management system, and marked with eye-catching colors, indicating overdose. If the condition requires overdose medication, double signatures are required.7For herbs of incompatibility, highlight annotation should be set. And double signature is required when it is necessary. If the patient's condition really needs overdose medication, pharmacists can dispense. Patients also have rights to be informed and sign it. Due to some objective factors, some doctors use overdose medication.Besides toxic herbal pieces, and many other non-toxic herbal pieces are used in large dosage which is times of that is specified in Chinese Pharmacopoeia. The reason is that some doctors think that there are fewer and fewer geo-authentic crude drugs, and quality of Chinese herbal medicine is generally poor. Therefore, some doctors subjectively increase the dosage of medicines, but they hardly realize that optionally increasing dosage of herbs could cause adverse reactions. For example, excessive use of Semen Sterculiae Lychnophorae with kidney toxicity can cause kidney damage; excessive use of Radix Polygoni Multiflori could lead to toxic hepatitis; excessive use of Cortex Cinnamomi is toxic to the kidney and can cause hematuria; excessive Radix Folium seu Flos Tripterygii Wilfordii could cause pulmonary edema, toxic hepatitis and kidney failure; Cordyceps could lead to allergies, skin rash, itchy skin, menstrual disorders or amenorrhea, atrioventricular block. With nephrotoxicity,long-term use may be toxic to the kidneys. Such adverse reactions are numerous. Clinical practice of TCM focus on syndrome differentiation and treatment, and the dose of Chinese herbal medicine should be moderate. Insufficient amount will affect clinical efficacy, and excessive amount will increase toxic and side effects, which does not mean larger amount leads to better results. As the dose increases,adverse reactions and medical safety risks will also increase,directly affecting harmonicity of syndrome differentiation theory of TCM and Chinese herbal medicine8. In addition,prescribing large doses for patients will also increase the difficulty in decocting Chinese herbal medicine, resulting in the waste of resources9. For some lightweight Chinese herbal pieces of Medulla Junci, Medulla Tetrapanacis, Stigma Maydis, Ramulus Euonymi, and Folium Nelumbinis, large dose use will affect the dissolution of other pharmaceutical ingredients, and also affect the curative effect. Therefore,when the doctor issue a prescription, if the patient's condition does require overdose, especially toxic pieces,double signature is required to confirm the dose, and then pharmacists could dispense.

Ingredients error is mainly due to prescriptions and copies. Due to objective reasons, the names of Chinese herbal medicine in the prescriptions are not standardized.There are problems that same name refers to different ingredients, and different ingredients have same name.Besides, wrongly written characters also exist. Some doctors, especially Western medicine doctors are not familiar with names of Chinese herbal medicine, which is the major reason for ingredients error. For example,some ingredients have similar Chinese names, Fructus Corni (shanzhuyu) and Fructus Evodiae (Wuzhuyu),Radix Aconiti Lateralis Preparata (Fuzi) and Rhizoma Typhonii (Baifuzi), Fructus Gleditsiae (Dazaojiao) and Spina Gleditsiae (Zaojiaoci), Poria Rubra (Chifuling) and Cinnabaris Poria Rubra (Zhufuling). And doctors should also master prescription standards specified in Regulation of Dispensing Chinese Herbal Pieces in Beijing. For example, prescription of Magnetitum dispense calcining Magnetitum; Gypsum Fibrosum dispense crude drug.Rhizoma Atractylodis Macrocephalae dispense fried herb. Therefore, Western medicine doctors should strengthen knowledge learning and treating of TCM. For Chinese medicine, they should master the basic courses of "Western leaning traditional Chinese medicine, and for Chinese herbal medicine, they should also master the standard of prescriptions in Regulation of Dispensing Chinese Herbal Pieces in Beijing. Only after passing examinations can they be engaged in the work of TCM.

Pharmacists should be strict with prescription check, and try to find problems before dispensing and solve it. They unqualified prescriptions should be returned with corrective opinions10. Pharmacists should pay attention to the study of TCM, and constantly improve their professional qualities and abilities. In particular,pharmacists are required to have high demandingness,with professional knowledge structure. They should also have the ability to communicate with doctors and patients,so that they can assist doctors to prescribe Chinese herbal medicine safely, effectively, economically and reasonably.