ZHAO Yang, WANG Shu-ling, TANG Xiao-mei, KONG Ling-yu

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

Hospital Outpatient Drug Repercussion: Risks and Countermeasures

ZHAO Yang, WANG Shu-ling, TANG Xiao-mei, KONG Ling-yu

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

Objective To raise measures for reducing hospital outpatient drug repercussion in order to prevent the risks. Methods Typical case analysis and statistical analysis were conducted. Results and Conclusion Drug repercussion phenomenon is caused many factors, such as imperfect hospital facilities, irrational prescriptions, patients’ weak awareness of rational drug use, etc. Therefore, it is suggested some measures should be taken to reduce the risks of outpatient drug repercussion, for example, setting up related rules for drug repercussion, regulating medical practice of doctors, strengthening the publicity, etc.

hospital pharmacy; outpatient drug repercussion; risk

Ministry of Health of the PRC issued No.11 [2011]“Pharmacy Administration regulations of Medical Institutions”, in which Chapter V, Article 28 clearly states:“In order to ensure medication safety of patients, drugs which have been sold cannot be returned, except for drug quality reasons”[1]. Nevertheless, most hospitals now allow drug returns, and individual hospitals also have specialized drug return treatment windows. Although this can reduce patient disputes to some extent, it inevitably produces some new, hidden risks of drug returns, and thus cannot guarantee the medication safety of patients.

1 The situation of drug return in certain hospitals

1.1 Meaning of drug return risks

The risk is the uncertainty of the degree of changes of various results that may occur under certain conditions and in a period of time, the uncertainty is caused by incomplete recognition to the objective regular pattern, and the process is out of control. On the other hand, the result of the case is uncertain, people can’t get the desired outcome that they designed and hoped, and unnecessary or unexpected loss often appears[2]. As a special commodity, drug’s twosided nature of “treating illness” and “being pathogenic”determines its risks. The management of drug risks is accomplished through a variety of effective measures to detect, assess, prevent, and control drug risks, which measures can be used for the dynamic management of“benefit maximization, risk minimization of patients[3].”

Drug return means that patients return drugs which had been sold back to the hospital pharmacy. According to the procedure, drugs are sent from the pharmacy to patients or clinical departments, and then returned to the pharmacy. Drug return can be divided into internal and external returns. Internal return means that a drug is returned because of medical officer’s fault; External drug return is because of patient’s reasons, such as ADR, death.

In this situation, the drug return risk is unnecessary or unexpected loss due to various causes in the drug return process. Therefore, drug management and risk control is crucial in each link of drug circulation, such as research and development, production, marketing, and distribution. As one link in drug circulation, intervention and control of drug return is necessary. The thesis mainly focuses on studying drug return situation of certain hospital outpatients.

1.2 Analysis of the number of drug returns in the hospital

The thesis is based on the data of 330 drug returns from hospital outpatients during the period of March, 2007 to August, 2013. Figure 1 shows drug return times and numbers. From Figure 1, we know drug return was on the rise from March, 2007 to August, 2013, which rise is themost obvious in 2008, 2011 and 2013. It shows a modest downward trend in 2009 and 2012. The quantity of drug returns grows significantly in 2013, about double from previous years. The reasons are varied, such as people’s enhanced awareness of drug safety, patients less trustful of their doctors’ diagnosis, and hospital records being more complete.

Figure 1 Distribution map of hospital outpatient drug return times and numbers

Figure 2 shows that the percentage of various drugs returned is quite different in this hospital. The most drugs returned were hepatopancreas drugs, which accounted for 42.73% of all returned drugs. Second were antibacterial and cardiovascular drugs, which accounted for 20.30% and 15.15%, respectively. The least returned drugs were immunomodulatory drugs, antineopastic drugs, and urinary system drugs, which accounted for 0.61%, 1.21% and 1.21%, respectively. Other drugs were returned are more evenly.

Figure 2 Scale map of different kinds of drugs return in the hospital

2 Analysis of the formation of hospital drug return risks

2.1 The increasing workload of medical staff leads to the rise of error rate

In order to guarantee the quality of returned drugs, each large hospital has certain rules about medicine return principles and a program that needs physicians, pharmacists, nurses, financial personnel, and a number of medical staffs. Hence, it not only costs much time, but also increases the workload of medical staffs which, in turn, increases the probability of medical staffs making errors. This kind of work errors is mainly manifested in two aspects: the medical staffs’ errors and the errors in the process of returning medicine. The survey of DU Shu-zhang[4]and others shows a medicine return order on average takes the nurse 15.30 minutes, and takes the pharmacist 2.30 minutes, which increases the medical staff’s workload, and then leads to the exhaustion of body and mind. These situationsmay bring about some unnecessary errors, and these errors probably result in more unnecessary disputes in the process of returning medicine.

2.2 No guarantee of the quality of returned drugs because of a difficult test

(1) The quality of returned drugs. Drugs are a commodity which needs careful custody. For example, some special drugs must be stored in airtight, micro thermal, or refrigerated condition, but patients store them under normal condition for some time because the patients have no or little knowledge of proper storage conditions. In this situation, the effectiveness of returned drugs has changed, however, the pharmacist just can check drug manufacturers and batch number. They cannot check purchase channels and quality. For some scattered drug and injection, they cannot even implement qualitative detection and determine if the medicine has been polluted. So such returned drugs may have hidden trouble.

(2) The management of returned drugs. The management of pharmacy drugs is very ordered, convenient, and efficient on the basis of batch number. But returned drugs may no longer be reliably associated with their original batch number, which makes it difficult to manage and even harder to collect adverse reactions. Pharmacy staff cannot find the source of a returned drug, and cannot track the quality of the returned drug, and therefore cannot guarantee the quality of the returned drug.

(3) People get benefits from stealthily substitute. Because of the implementation of drug return is imperfect in many hospitals, criminals make use of different excuses to return used and fake drugs to such hospitals to get benefits through the way of stealthily substitute. In September 1982, someone returned Tylenol brand cold capsules, maliciously tainted with potassium cyanide, to a drugstore in Chicago. Unaware that the capsules were tainted, the drugstore kept selling the tainted, returned drugs which lead to the death of seven people. This shocking Tylenol cold capsules event set off alarm bells about the potential danger of drug return[5]. It can be seen that this kind of illegal behavior raises a hidden trouble of drug return and directly threatens people’s life safety.

2.3 The returned drugs will increase the disputes between doctors and patients

High drug price has created tension between doctors and their patients. Drug returns will intensify this tension. In particular, a elaborate, program of drug return because of doctors’ making wrong prescription or pharmacists dispensing the wrong drug makes patients anxious, doubtful, and even negative, which reduces the trust in hospitals and causes unnecessary disputes. In addition, the drug return is a kind of worthless work, which bores some medical staff, leading to disputes. The medical negligence caused by continuing to sell those changed returned drugs also results in disputes, even if hospitals could find the patients who returned the drugs.

2.4 The drug return enlarges the chance of conspiracy

Some people involved with drug return conspire together to abuse the drug return program for their personal benefit, most often patients and pharmacists or pharmacists and nurses. For example, in order to get benefits, patients use fake drugs instead of real ones. Pharmacists allow the fake drugs to be returned on purpose, and then split what they get with the patient. The conspiracy of pharmacists and nurses is more serious, especially because some hospitals connect infusion fees with drug return. Related medical staffs skimp on drugs by all means and then they transform“drug return” to “infusion fees” to pay. Now in some hospitals, we can often see nurses having free access to the pharmacy or being interposed in the drug return matching process. It is enough to make us wonder whether this way of working would have provided a conspiracy platform and create hidden risks even if pharmacists and nurses have no conspiracy. In addition, hospitals must dispose of parts of returned drugs in order to ensure the patients’ safety because they cannot conduct a comprehensive inspection of the quality of returned drugs. It is inevitable to cause economic loss for hospitals by receiving a large amount of returned drugs, and then to improve the financial risk greatly, when we see the drug return is coming frequently.

3 Analysis of the causes of drug return in hospital

Drug return has many participants, including doctors, pharmacists, patients, and pharmacy personnel, so a variety of reasons may cause drug return. But the main reasons are the doctor’s prescription errors, adverse reactions in patients, and patient refused treatment. Table 1 shows an analysis of outpatient drug return in a hospital, the outpatient’s drug return accounts for 69 percent of all drug returns.

Table 1 Class table of the reasons for hospital outpatient drug return

Table 1 shows that: adverse reactions to drugs is the main reason that drugs are returned, accounting for 42.54 percent, and a low proportion of drugs are returned because of facilities (personnel) failures and because patients give the wrong drug information, representing 2.63 percent and 4.39 percent, respectively. Although the above data records the basic situation of drug return, for these cases a number of drawbacks in the hospital program were also found in the finishing process of drug return.

First, records are incomplete. When looking for relevant records, comprehensive records from May to August in 2012 are missing, and the other months are less, only 5 in 2013 accounted for 13%.

Second, records are not standard. There is no consistent record system, only handwritten records, so there are many difficulty and other issues when dealing with it.

Third, when those who handwrite records are not careful, the reason for drug return is not clear. For example, a doctor writes each patient’s drug return with the same reason. The doctor may not have accurate records, so drug name and manufacturer records are incomplete. Therefore, not only can drug return not guarantee the returned drug’s quality, but also the quality cannot be tracked.

Based on the above reasons for drug return, the analysis was made in three parts: the hospital, the patients, and the drugs.

3.1 Hospital factors

3.1.1 Hardware and software for drug return not being standardized

Software: many hospitals do not have a sound, complete and efficient system of drug return nor a clear drug return principle, so such hospitals blindly accept any drug return behavior. Meanwhile, the process of drug return is unreasonable. In order to save time and effort, some hospitals often allow patients to return drugs to the pharmacy and make corresponding records, without involving multiple parties associated with doctors, pharmacists, and financial. Such a simple way to return drugs cannot guarantee the safety of drugs, but it will reduce the integrity of the hospital, resulting in patient disputes and other issues.

Hardware: an imperfect hospital information system is another cause of drug return. The information management system of some hospitals is imperfect, and when the patient may go to a different clinic for treatment, or there is a lack of drugs in the pharmacy. If the drug information system does not set up to remind the project, there will be phenomena of repeat prescription or open the wrong prescription that lead to drug return. In addition, some hospitals don’t have perfect drug return information management system, so they cannot effectively preserve the long-term data, instead storing up problems for future patient disputes.

3.1.2 Unreasonable prescriptions

Doctors play an important role in the drug return behavior. Drug returns caused by doctors include four aspects:

(1) The wrong prescription. When the patient’s condition changes, the doctor’s advice will change, or doctors prescribe the wrong drug due to similar specifications and names of drugs. These all will lead to drug return.

(2) Excessive prescription drugs. Under the lure of money, doctors will put aside ethics and prescribe excessive amounts of drugs, including unnecessarily high dosage, frequency of administration, or quantities, resulting in wasted medicines. Or there is a combination of thephenomenon of adverse reactions or reduced efficacy, etc.

(3) Doctors do not communicate effectively with patients, reducing patient compliance with medication regimens.

(4) Doctors do not give the appropriate reminders for special populations, such as the elderly, children and pregnant women. At the same time, there is no special attention for special drugs, for example, high-risk drug under the safety scope of digoxin, methotrexate, etc, did not do a limited amount of drug, nor do mycophenolate mofetil capsules and other immunosuppressants which are used for special disease of medicare patients who need special limited edition after organ transplantation[6].

3.1.3 Pharmacists are not serious

As the last one in the chain of drug safety supervision, pharmacists’ attitudes directly determine the hospital’s drug return cases. These are the reasons caused by pharmacists that lead to drug return:

(1) Dispensing errors, including wrong drug name, size, dosage form, quantity, and other reasons which led to the wrong drugs. Drugs are wrong, such as: adalat sent rather than acarbose. The quantity of drugs is less or more that prescribed. Dosage mistake, or injections made into tablets. Specification errors, such as Novolin, 30R and 50R, refills and injections. Because of the similar packaging sent the wrong drugs.

(2) The wrong patients. Patients are generally accompanied to the hospital by more than one family member. While patients are suffering from diseases, dispensary payment tends to fall on the families of patients. Dispensaries often mistake family members for patients, because the pharmacist misread a scribbled patient name on the prescription, the patient got it wrong, and drugs are given to the wrong patient when the pharmacist calls the patient’s name.

3.2 Patient factors

3.2.1 Limit of own conditions

Their own conditions refer to the nature of patients’own constitution and wishes, and are internal properties. These include three aspects:

First, changes in condition. When the patient’s condition improves or gets worse, patients think the drug is useless so that they return the drug.

Second, patients refuse treatment. Because doctorpatient communication is inappropriate, instructions on adverse reactions would generate fear, so that patients refuse drugs.

Third, patients expect too much about drug efficacy. Some drugs are long-acting drugs, but some patients stop before the drug takes effect.

3.2.2 Impact of the external environment

Another factor is the external environment, such as drug prices. Patients cannot afford to buy drugs at hospital pharmacies where drug prices are higher than at retail pharmacies[7]. In addition, patients who are influenced by the remarks of relatives and friends, choose drug return.

3.3 Drug factors

There are the causes that as the result of drug factors leading to drug return:

First, drug quality problems. Reasons that patients return drugs are the quality of drugs, including expired drugs and drugs within the validity period but the package is damaged, color is changed, solution is precipitated and other situations where physical and chemical changes can be observed visually.

Second, drug adverse reactions. Reasons for the occurrence of adverse drug reactions are extremely complex. There is the influence of drugs, body and the effect of treatment method，including drug allergies, gastrointestinal reasons, nervous system response, And other adverse reactions are exist and individual differences[8].

Differences in the physical characteristics of among patients will produce adverse effects of drugs. For this reason, drug return is acceptable.

Through the adverse reactions the appropriate information can be fed back to the doctor to further improve the quality of drugs and improve the health level of the development of medical and pharmaceutical industry.

4 Drug return risk prevention measures and recommendations

4.1 Institutional strengthening at all levels

4.1.1 The adjustment of government return provisions

According to the investigation of the reality, the Ministry of health “institutional pharmacy management Interim Provisions” “drug has been issued, shall not return”needs to be revised, because of the phenomenon of drug return is varied, only to emphasize the “return”, although this can prevent the risks arising from back drug, but will intensify the contradiction between doctors and patients. In addition, if information about a patient’s adverse reaction to a drug is provided to the physician, the physician can make timely adjustments to the medication plan, effectively reducing medical accidents, and raising the cure rate. Therefore, the relevant provisions of the government should take patients as the center, combined with the reality in the premise of safety, formulate reasonable requirements, reasonable division of return drugs phenomenon according to the different risk to put forward specific provisions. In addition to amending the relevant regulations, the hospital should establish a complete set of return principles and processes to make the patients have something to according to, see Figure 3.

Figure 3 Flow chart of drug withdrawal

In addition, the Medicare drug return is separately, but due to the particularity of adverse reaction of drug return may require the prescribing physician to fill in the adverse drug reaction reports. The survey suggests that[9], when the return mechanism of hospital is properly built, the instances of drug return will be greatly reduced. When the return amount is reduced to when hospital can bear the range, the returned drug should reimburse bad debt and not use any more.

4.1.2 Establishment of industry codes of conduct clinics

Because the doctor is in the leading position, establishment of norms of behavior is very important for the treatment of drug return phenomenon. Therefore, the industry should establish a unified industry standard medical behavior that mainly includes the following aspects:

First, establish a regular system of education and training for doctors to improve medical service level. Such training should include the basic information of drugs, including manufacturers, batch number, specifications and other specific conditions to prevent prescription of the wrong drug.

Second, on the doctor’s occupation the moral norms, seek truth from facts, by spraying, to prescription.

Third, the communication behavior of doctors, to strengthen the doctor-patient communication, the use of the duty of disclosure, the usage and dosage of drugs and adverse reaction were tell patients, eliminate fear of fear, especially in special populations should be carefully explained, in order to achieve the compliance of patients.

4.1.3 Strengthen inspection and supervision system for hospital

First, establish regular analysis management system. Set a right time to make return records were quantified with data analysis tool, analysis the various sections of return time, varieties and the reasons for the association, do further improved based on the analysis of the problems, the improved and compared the previous time step, thus clearly let the medical staff to see progress can also play the role of incentives.

Second, the accountability system, for avoiding returned drugs phenomenon causes investigation, if the hospital internal error should increase the punishment. The risk for drug return after the drug return, according to the person in charge of the corresponding records dating back to this investigation, and the most fundamental responsibilities. Also set up crony system, the relevant departments for problems leading given sanctions, thereby improving among the various departments of alertness.

Third, the implementation of the performance appraisal system, the return of high frequency of the prescribing physician punitive measures, and the prescription behavior and year-end appraisal, Title Assessment linked to regulate the doctor.

4.2 An overall improvement, and improve the hospital hardware construction

4.2.1 Establishing pharmacists consultation window

In order to save time and energy and physician to solve difficult problems of patients, hospital pharmacist consultation window, give full play to the role of pharmacists, one of patients to answer questions, and effective communication with patients and tell the relevant information, to complement the forgotten information of doctors, and to have told the information the “two tell”strengthening of the role. At the same time, pharmacists in drug carefully examining, clear the specific requirements of“prescription management method”, strict control of “four out of ten on the”, eliminate unreasonable drug[10].

4.2.2 Improve the medical information system

Medical information system is the tool to improve the medical information support and management efficiency[6]. For convenience, high efficiency, long preserved return recording, must perfect the medical information management platform, which not only can accurately to save the data and efficient analysis, but also in the event of disputes or medical accident back to the people responsible for the corresponding, providing the basis for the relevant management mechanism. At the same time, to remind the project set up in the system, the lack of drugs in prescription to remind United cannot use drug and pharmacy, to reduce the occurrence of the phenomenon of drug return.

4.3 Publicity, increase patients rational drug use of propaganda

4.3.1 Increase the safety awareness of drug

Many patients’ awareness of drug-safety is weak. Provisions on drug return is not able to understand legally which leads to the occurrence of medical dispute. Therefore, we should increase publicity and education. By public lectures, flyers, and the like, the importance of drug safety can be taught to the patients, to let them clearly understand the risks and hazards of the drug return process. Adverse reactions in the treatment process are possible, so to avoid liability risk, the hospital should make its patients understand the risks and make appropriate suggestions[11]. This not only can reduce drug returns to some extent, but it can also greatly reduce the incidence of medical disputes and medical accidents.

4.3.2 Increase medication compliance

Reduced patient compliance with medication regimen is due to the asymmetric information between hospital and patient outcome. Patients not knowing their illness clearly, and doctors not informing patients about the drug related information leads to communication barriers. So when prescribing, doctors must ask patients about related disorders, allergic history, and genetic history. When prescribing, doctors must tell patients about adverse reactions, dosage, the effect of drugs, and contraindications to improve patients’ compliance and rational use of drugs.

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Author’s information: WANG Shu-ling, Associate professor. Major research area: Drug market management. Tel: 13998302138, E-mail: lingyi50@163.com