DUE was one of practical restricted drug use policies that all hospitals in this study have operated in order to promote RDU. The objectives of performing DUE were to control and monitor the medicine prescribing of these exceptional items to ensure the proper use regarding efficacy and safety for individual patient. Of all 5 hospitals, different committees ran this function. In two hospitals, other committees in their hospitals were responsible for performing this function. Conversely, the PTCs of 3 hospitals were responsible for conducting DUE. The PTCs delegated the DUE activities and implement the policies through sub-committees reports. After the sub-committees determined cost-effective drug items regarding to the hospital formulary lists, the secretary of the PTC, the head of the pharmacy department, distributed the general drug policies to other medical practitioners trough the hospital intranet system, notification letters, the formal meeting minutes, regulatory documents and official announcements, as well as face to face communications. The pharmacists from these three hospitals carried out DUE using a retrospective method rather than a concurrent method due to limiting of human resources in data collection process. In some special cases, some high-cost items were allowed to use by specialist physicians. These PTCs conducted DUE on several drugs. The most frequent antibiotic items which were conducted DUE show in Table 3. In addition, the other items that more than one hospital conducted DUE was celecoxcib. The medications that need to perform DUE were defined by several criteria including the drugs which were in the index of the essential national list, high cost, or risky to cause ADRs or MEs, or irrational drug use. There were 3 PTCs had interventions after DUE activities, for example, developing the form to restrict the use and defining the criteria for prescribing some medications.
In terms of developing or adapting standard treatment guidelines (STGs) there were two hospitals whose PTCs were responsible for this function. One hospital gave the example showed that they had developed a protocol guiding rational drug prescribing for patients who needed chemotherapy. Another hospital had developed a STG for antibiotic use. The success of the STG implementations was not investigated in this study. Moreover, the PTC role as an advisory committee to medical staffs, the hospital administration department orthe pharmacy department was almost none existent in any of the enrolled hospitals.
According to the overall satisfaction to the PTC, three of five participants were satisfied on their PTCs operations. On the other hand, the other two participants were not satisfied with their PTC because they thought that their PTCs did not perform activities as they should and the policies were not completely implemented. Some practitioners might not update and/or adhere to the policies. As a result, the policies may not be successfully adhered. To resolve these issues, the respondents suggested that the PTC should contribute the various routes of communications and provide availability of materials for education on rational clinical practice and evidence-based medicine information.
In terms of strengths, the respondents stated that their PTCs had ability to manage budget for medication expenditure. The chairperson of the PTC used a compromising method to reduce conflictions among the committee members. In addition, the committee members usually shared ideas, opinions, and suggestions during the PTC meetings. On the other hand, the respondents were also mentioned to the weaknesses of their PTCs. The important issue was that the policies were not completely implemented. The compromising method in meeting might cause leniency in process of policy implementation. Moreover, the meeting were often postponed because of the conflicts of the PTC member works schedules. Particularly, the chairperson was the main key person who led the directions of the committee.. But the chairperson usually had a lot of works, so they could not delegate the time to directthe PTC policies.
This study surveyed the current activities and practical policies of the PTCs in the hospitals under the jurisdiction of MoPH in lower northern part of Thailand. Several RDU policies had been utilized. To promote RDU policies, PTC is believed to be a key in order to balance between the cost and quality of care. Over two decades ago, Thai MoPH regulated and accomplished setting up a PTC in all levels of hospitals under the jurisdiction of MoPH to manage effective inventory control, improve rational drug use and warrant patient safety10
The structures of the PTCs in this study was comparable to the guidelines of Thai drug management manual, WHO, previous studies in Thailand, and other countries.5-6,11-15Even though, the roles of the PTC in each hospital are mostly the same, the strengths of the PTC in each hospital mainly depends on the support of the administration. In the other words, the PTC could function effectively if the director and the administration team give full supports to the committee. However, when the new director or the new administration team has been appointed, the direction of the PTC may be changed. Therefore, the role of the leader is the most important factor to determine the success of the PTC in each hospital. The direction of the PTC should be pointed by the system not a person. How to stabilize the function and strengthen the PTC are truly needed to discuss seriously in the national level.
The previous study in Thailand by Sripairojet al. demonstrated that, the term of PTC membership was not defined.6 It was noted that, this situation was the same as the international PTCs which the membership and structures had not been changed overtime. The dominate membership of drug and therapeutic committee (DTC) were medical, nursing, and pharmacy representatives. Moreover, some DTC members included consumers, general physicians, and community pharmacists.15 But the PTC members in this study did not include the consumers, general physicians, and community pharmacists. The results showed that mostly PTC members usually were the head of each medical department and the representatives from pharmacy department. With their overloads of daily activities, therefore, they might not have enough time to contribute in the PTC meetings and activities. This characteristic of the positions of the PTC assembly as in a study by Sripairoj et al.6In Lao, most of PTC members held the position of head of departments or a hospital director and they had been recruited to the permanent PTC tasks.14
In terms of numbers of frequency of the meetings, the frequency of the meeting in the PTCs was1-4 times and duration of not more than 3 hours/time. Therefore, all issues could not be completely discussed in the limited time. The meeting of these PTCs was irregular due to the directors of the hospitals and the members had over workload which was similar to the previous study.6Therefore, unsurprisingly, the committee had focused mostly on drug selection during the limited time in the meeting which related to the main budget of the hospital. If they had times, other issues would be considered. Therefore, the availability of the members is crucial in order to advocate the PTC performances. Because of over workload of PTC members in both Thailand6and Lao14, the PTCs could not perform PTC tasks appropriately. In Lao, poor PTC performances also were due to have irregular meeting, have many positions held by PTC members, lack of interest in PTCs responsibility, have insufficient knowledge about PTC functions and responsibilities, and loss of training PTC members. Besides, formula list control, the ideal PTC should play roles in developing policies on the use of drugs, monitoring patients safety, establishing and developing guidelines for medical management, and planning on the overall budget framework by considering both patients safety and cost effectiveness. According to PTC functions defined in the appointment orders, in these settings, the functions of these PTCs were different in details. They had been struggling on performing the ideal functions mentioned previously and tried to develop their performances as their capacity and ability. However, some gaps were still remained. To improve PTC performance and overcome the barriers during discussion, there has been suggested that, assigning priority to PTC decision15, training PTC members in PTC activities, recruiting more dynamic PTC leaders and improving reporting system and meeting techniques14were needed.
In the present study, the respondents stated that the PTC members knew their responsibilities but not realized their individual tasks. This may be one of the most important weaknesses of the PTC in order to improve their performances. Defining job descriptions may facilitate and motivate the PTC members to comprehend their co-operations. Moreover, some hospitals included only physicians and pharmacists in the committee; this might be a crucial barrier for policy distribution and implementation to all stakeholders.
Unsurprisingly, all PTCs from these hospitals mainly focused on managing inventory supply. Although most of the participants stated that their PTCs carefully considered evidence-based medicine information and drug profiles from the manufacturers, there was no standard or practical criterion for selecting and evaluating the formulary lists published in any setting. Therefore bias data may be considerably concerned on quality of drug information and might affect the PTCs judgments. This showed that the development of PTCs to promote RDU in Thailand have not been moved from the past.
In Australia, the PTCs is called the Drug and Therapeutics Committee (DTC). A study determined how DTC decisions should be prioritized.15They found that DTC decisions should be prioritized for implementation which may use the domains of importance as the basis for priority assignment. The survey reported that patient safety, ensuring the practice of evidence based medicine within their institution, cost, and ensure practice according to legislative requirements were the domains of importance from the most to less, respectively. However, they still had no idea how this could be done. In the settings of the present study, the cost of medicine and number of the formulary list seem to be important among other issues.
In order to promote RDU, all of these PTCs involved in management of medication errors (MEs) and adverse drug reactions (ADRs) as well as utilization of drug use evaluation (DUE) reports both direct and indirect ways. The pharmacists were the persons who carried these issues on hands. Supported by a qualitative study16, the results suggested that the DTC decisions and policies are currently implemented by pharmacists. In addition, these activities concurred to the WHO practical guideline11 which stated that PTC has a role in ensuring that all medicines are prescribed, dispensed and administered to patients safely and adequately. PTC should monitor and address medication errors, monitor and ensure drug quality, as well asmonitor and manage ADRs.
In Nepal, the PTC had a vital role in ensuring drug safety in the hospital. The PTC had started pharmacovigilance service by reporting ADRs and had planned to utilize several strategies to reduce medication errors in their hospitals.17 In Lao, one of the PTCs tasks was also to stimulate reporting ADRs to the PTC.14
Moreover, in these enrolled settings of our study, the PTCs also had to manage MEs in their hospitals. The working groups took actions and fed back data to the PTCs to improve their hospital drug systems. Most pharmacists played the important roles in collecting and writing reports. Then the information had been reported directly to the PTCs during the meeting. However, the frequency of MEs report of these hospitals was not certain.
The PTC practical guideline defined by WHO11 mentioned that the pharmacists should play a dominant role in DUE process because the pharmacists are the experts in the area of medication treatment. The six steps of a DUE are establishing responsibility, developing the scope of activities and defining the objective, establish criteria for review of the medicine, collecting data (the data may be collected retrospectively, from patient charts and other records, or prospectively, at the time a medicine is prepared or dispensed. Retrospective DUE may be quicker and is the best accomplished way when considering the patient care areas and distractions, compared with other methods. The advantage of a prospective review is that the reviewer can intervene at the time the medicine is dispensed to prevent errors in dosage, indications, interactions or other mistakes. According to our findings, all of these hospitals utilized a retrospective method rather than a concurrent method because of limitation in human resources. The process of DUE from five hospitals were different in details, but concurrence to the steps recommended by WHO.11The secretary of the PTC, the head of the pharmacy department, usually distributed the drug policies to other medical practitioners trough many routes for helping them to disseminate the information. It is noted that, the steps of DUE in all of these hospitals were similar as stated in the guideline. However, one step that these PTCs did not performed was to follow up outcomes after they feedback DUE information to prescribers and the PTCs.
There were some limitations of the present study. Data was collected only from pharmacists. There foresome opinions on several aspects may be different if we conducted the interview with other professionals. The data from five hospitals might not be good representatives of all PTCs in Thailand because each hospital has differences in context. We did not evaluate the outcomes of the policies implementation. Further study in evaluating formulary management criteria and outcomes of these policies and PTCs performances are warranted.
This study found that the PTCs mainly operated on managing an effective and efficient medicine inventory supplies. The PTCs utilized several strategies to promote RDU policy in their hospitals. However, they had been struggling to establish the effective formulary systems and implemented RDU policies. With unbalances between human resources and workloads, they mostly focused on drug inventory. To improve performances of the PTCs, clarify job descriptions of PTC committee, conduct effective human resources, develop leadership skill, increase frequency of official meetings, and promote efficient communication and distribution of in-house policies may be warranted.
The authors would like to thank all respondents from the hospitals in the lower northern Thailand for their contribution on data collections for the study. The study was funded by the National Health Security Office Region 3, Nakornsawan, Thailand.
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