Abstract
BACKGROUND:
The prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) adverse reactions should start from the primary health center (PHC), as the first gatekeeper in community health services. However, there is no specific module available for health care professionals (HCPs) in Indonesia for the prevention of adverse drug reactions (ADR) at PHCs. NSAID is commonly used for the elderly treated at PHC in Indonesia, even though the ADR risk is well-known.
OBJECTIVE:
We aimed to develop a module to be used in PHC for preventing NSAID-associated upper gastrointestinal (GI) ADRs in elderly patients treated for musculoskeletal diseases.
METHODS:
The module was developed based on inputs from focus group discussions (FGD) among government health officers, PHC representatives, clinical pharmacologists, internal medicine and community medicine clinicians, pharmacovigilance experts, and professional organizations. A pilot implementation was conducted to test its feasibility and its effect on the HCPs’ knowledge.
RESULTS:
Capacity building of HCPs, development of intra-HCP cooperation, as well as standard operating procedure (SOP) for the prescription of NSAID constituted important components of the module. A pilot study of the module in two PHCs showed that it was applicable with some recommendations for improvement in duration, number of participants, room space, presentation, and use of credit points as compliments. The HCPs’ knowledge was improved after following the module.
CONCLUSIONS:
Our study showed that the module is feasible in PHC in Indonesia and useful in improving knowledge of HPC.
Introduction
Arthritis is ranked second out of ten of the most common elderly health problems in Indonesia, which is why nonsteroidal anti-inflammatory drugs (NSAIDs) have become one of the most prescribed drugs for elderly patients [1]. However, elderly patients have a higher risk of adverse drug reactions (ADR) to NSAIDs, especially upper gastrointestinal (GI) problems [2].
Our preliminary survey found that the mismanagement of musculoskeletal disease with NSAID in Indonesian primary health centers (PHC) was high; the under-prescription of gastroprotective drugs reached 59%, and the use of a combination of NSAIDs and corticosteroids without clinical indication reached 15,3% [3].
Inappropriate prescribing may be caused by factors such as a lack of therapeutic guidance, inadequate drug knowledge and experience, and lack of a standard operating procedure (SOP) [4,5]. In Indonesia, nurses and even midwives have the authority to write prescriptions in PHCs due to the dearth of medical doctors [6]. However this does not include the prescription of NSAIDs for elderly patients [7,8]. According to Indonesian laws, prescribing drugs to elderly patients with musculoskeletal diseases is a clinical decision that is an exclusive preserve of physicians. Thus, the proficiency of nurses and midwives in NSAIDs management is limited. Nurses under a doctor’s delegation can prescribe over-the-counter (OTC) drugs [7].
Prescribing errors and other factors that may contribute to NSAIDs-associated ADRs must be prevented, starting from the PHC as the first gatekeeper of health care services. Currently in Indonesia there is no specific module available for HCPs at PHCs for the prevention of inappropriate prescribing that may result in drug-associated adverse reactions. This study reports the result of our effort to develop the first module for the prevention of ADRs due to inappropriate prescribing. The module is developed to prevent NSAID-associated upper GI ADRs among the elderly patients with musculoskeletal diseases treated in PHCs.
Methods
We conducted a qualitative study which was divided into two phases. The first phase was the focus group discussion (FGD), the second phase was expert reviews. The result of both phases was piloted in PHC.
A FGD is a form of qualitative research that focusses on specific issues with a predetermined group of people participating in an interactive discussion. They are led by a trained moderator. In our study, we use FGDs to uncover a range of perspectives, experiences as well as the expectation of the module. Various sentences and phrases from verbatim transcripts of the FGDs were coded and compiled as the components and sub-components of the module [9].
From the results of the FGD, researchers may develop a detailed structure and content of the draft module based on the components and subcomponents. The draft module was also enriched with relevant published literature found using a desk-review.
All participants were fully informed about the research and signed the informed consent form prior to participation. The study was approved by the ethics committee of the Faculty of Medicine, University of Indonesia with number 0897/UN2.F1/ETIK/2018.
Focus group discussion
Stakeholders of medical services at PHC were invited to attend FGDs. FGD participants were representatives from: (a) the top level of policy makers at the Ministry of Health, (b) local policy makers at the Local Health District Office, (c) the Indonesia National Agency of Drug and Food Control, (d) the Indonesia Medical Association, Indonesian Clinical Pharmacologist Association, Indonesian National Nurses Association, and Indonesian Midwives Association, (e) the HCPs who work in PHCs (doctors, nurses and midwives), and (f) experts in NSAIDs use in musculoskeletal disease and associated ADRs at PHCs (clinical pharmacologists, pharmacovigilance experts, internal medicine, and community medicine physicians).
FGD participants were divided into four groups: the policy regulator, representatives and experts from physicians’ professional organizations, PHC doctors, and PHC nurses and midwives as well as their organizations’ representatives. The participants were grouped in the same institution/occupation to allow them to express their opinions freely.
The questions posed in the discussion are described in Table 1. The questions raised during the FGDs were divided into two sessions. The first session was initiated to explore the prior knowledge and experiences of each participant in their institution/office about prescription errors and existent efforts to prevent ADRs. The second session sought to examine the method to overcome the problems that were identified and discussed in the first session. A transcript of the FGDs was made manually by a trained enumerator. Data analysis was performed by Atlas Ti software to code the components. The classified transcript was analyzed manually. The coding and analysis were carried out by a clinical pharmacologist who did not participate in the FGD. The module’s draft was then developed in accordance with the FGD’s results and enriched with relevant published literature.
Focus group discussion question list
Focus group discussion question list
Nonsteroidal anti-inflammatory drugs (NSAIDs); Primary health center (PHC).
Experts who participated the FGDs were included in one group to review the module. The group comprised experts in clinical pharmacology, internal medicine (rheumatology and gastroenterology), community medicine and pharmacovigilance. The reviews were conducted in two rounds. In the first round, the investigator met each expert individually to obtain their opinion on the module. In the second round, all experts were invited in one meeting to discuss the results obtained from the individual consultations. At the end of the meeting, the experts agreed on the final module to be piloted.
Pilot implementation
The pilot implementation was conducted to test the module and evaluate its feasibility in PHCs. In order to achieve the objective, we selected PHCs where doctors’ delegations of nurses and midwives prescribed NSAIDs for elderly patients. The module was delivered in two-day workshops, after working hours at two PHCs independently. To evaluate the effects of the module on the understanding of NSAID’s adverse effects, as well as the therapeutic effect, the knowledge was assessed by validated pre- and post-questionnaires.
The pre- and post-scores of participants were compared using a t-test. After the post-test, participants were asked to provide feedback by filling in Likert scale questionnaires about the feasibility of the module’s implementation in PHCs (see Appendix).
Results
Focus group discussion
In total, 21 participants, which consisted of 10 representatives of PHCs, four experts, four representatives of professional organizations, and one representative each of the Ministry of Health (MOH) and the Local Health District Office and Indonesia National Agency of Drug and Food Control (NADFC), were invited. In total, 19 participants joined the FGD: six representatives from PHC, four experts, one from MOH, two from the Local Health District Office and one from the Indonesian NADFC.
The participants were divided into four groups:
Group 1: MOH, Indonesian NADFC, Local Health District Office and experts in pharmacovigilance. Group 2: Representatives from Indonesia Medical Association, Indonesian Clinical Pharmacologist Association, and experts from Internal Medicine and Community Health. Group 3: PHC nurses, midwives and their organizations’ representatives. Group 4: PHC doctors and experts in clinical pharmacology.
From the FGDs we found that the components and subcomponents of the module highlight the need for: capacity building of the HCPs’ knowledge of NSAIDs, developing intra-HCP cooperation, and developing SOPs of NSAIDs prescription. The following three sections describe the themes that emerged from the FGDs.
All participants agreed that increasing and updating knowledge in particular about NSAIDs would avoid prescribing errors.
“I guess it is needed the most because doctor decides the diagnosis, the drug’s dose and finally writes the prescription. The doctor should participate in continuing education programs to update his/her knowledge of medicine... while in puskesmas (PHC) we have too many patients”. (Doctor, Group 4)
“We’re only doing medical actions, handling diseases, but did not learn about certain drugs”. (Midwife, Group 3)
Developing intra-HCP cooperation (between medical doctors, nurses and/or midwives)
The participants proposed the need of cooperation among the HCP in PHC.
“We have the sources, so it depends on the management, how to manage, how to give instructions to all HCP based on their fields.. so the point is puskesmas (PHC) is actually a team work”. (Doctor representative of the Ministry of Health, Group 1)
“We need team work improvement, it should be delivered in a kind of SOP. It should explain who would serve patients, who would write prescription, who would be in charge to delegate, who would give the medicine to the patients.. if there were a human error (in prescription) or the medicine is not available, what should be done.. so there should be a formulation”. (Midwives, Group 3)
Participants mentioned that authorizing the doctor to delegate certain clinical duties to nurses and midwives is a consequence of the dearth of doctors at the PHC.
“Our PHC just completed the accreditation, and there was such a SOP to delegate health workers. For example, there were 2 doctors for morning shift and one of them went for a meeting, or one of them then was absence due to sickness... things like these have led to the authorities given to nurses to make certain prescriptions”. (Doctor, Group 4)
“For the accreditation, there was a legal letter to delegate health workers…it didn’t mention the names, only the professions. So there was an official decree, when there was no doctor available, midwife and nurse could work at the policlinic and do the prescribing…due to lack of doctors.. for example in our PHC, B”. (Midwife, Group 3)
In the nurses and midwives’ group, it was explained how they prescribe NSAIDs. They said that they were instructed to assist the doctors, and they would only make copies of what the doctors had prescribed.
“OK, while we were working at the puskesmas, we were frequently delegated by doctors to help them... writing prescriptions under doctor’s supervision.. we only wrote drugs the doctors instructed to”. (Nurse, Group 3)
The policy maker and the medical experts said that there should not be a prescribing authority delegation.
“There should be no delegation… for example if there is a patient who continued his medication and the drug is not associated with serious adverse reactions, this should be no problem.. but when the drug is a NSAID and the patient is elderly, delegation should not take place”. (Community medicine expert, Group 2)
“The NSAIDs are not really controlled by the government, so that anyone could buy them without a prescription.. However, the rule is the NSAIDs classified as limited drugs that need doctor’s prescription.. So that, I would not agree that the NSAIDs should be prescribed by non-physicians.. We still have the problems with doctors, we should give them more education.. and now their duties to other health practitioners?” (Internal medicine expert, Group 2)
Developing a SOP of NSAIDs prescription for elderly patients
The FGD participants agreed that there should be a SOP for NSAIDs prescription for elderly patients. They proposed that the SOP should specify workflow/algorithm to organize patient management.
“Maybe the first thing to do is creating special SOPs for drugs controlling.. new SOP since there was no SOP especially about drugs problem”. (Doctor, Group 4)
“Doctor, midwife, nurse and pharmacist are one team, so they should remind each other, giving notes to do precautions or something like that.. so such an SOP is needed.. to remind the health workers that there were ADRs (from various drugs)”. (Nurse, Group 3)
The FGD participants suggested that in order to determine whether the educational method is sustainable, the PHC should monitor and evaluate the prescriptions periodically. Moreover, the results of the evaluation should be included as part of the PHC accreditation credits. This will nudge the PHC to always follow the module.
“We could monitor which drug was given to patient, the process is already strict in puskesmas (PHC), then we could find out which drug was prescribed frequently, which was combined (with other drug).. they could be identified”. (Midwives, Group 3)
“I suggest periodic evaluation, hopefully it could be included for accreditation.. As if I were the auditor, I would like to know the percentage of prescribing error, the rational prescription, ADRs cases…The target should be made, no prescribing errors or at least less than 1%, the rational drug use should be more than 90%, ADRs should be less than 10%... then the guideline how to do the evaluation should be made”. (Doctor representative of the Indonesia Medical Association, Group 2)
Module development
Based on the results of the FGDs and expert and literature reviews, the module was developed by the authors. The modules developed are workshop guidelines, workshop modules, and prescribing SOPs. The workshop topics and how to deliver them was key to change behavior in prescribing so that the NSAIDs-associated upper GI ADR would be prevented. Table 2 shows the topics that could be delivered through lectures, case discussion and simulation.
Contents of workshop module
Contents of workshop module
Nonsteroidal anti-inflammatory drugs (NSAIDs).
The SOP for NSAID prescription was included in the workshop module. It comprised a collaborative workflow of doctors, nurses, and midwives based on their competences. The doctors would conduct regular medical procedures including history taking, physical examination, deciding diagnosis and writing prescription. The symptomatic drugs were prescribed only for a certain amount of time, usually three to five days. The nurse could collect the data to classify patients as low, moderate or high risk in gastrointestinal complication [10], which would be confirmed by the doctor. The doctor or nurse would educate the patients and family about the adverse reaction of NSAIDs. If nurses are unavailable, midwives could participate in the workflow. When doctors are temporarily unavailable in the PHC, their delegates can prescribe OTC drugs as temporary treatment for elderly patients, such as acetaminophen and ibuprofen with lower dose (200 mg), instead of only prescribing NSAID to ease the pain [7].
The number and characteristics of the participants in each PHC are shown in Table 3. The pilot implentation was carried out in two PHCs. The module was delivered in two days, after working hours, with doctors, nurses and midwives as participants. The module was delivered by the clinical pharmacologist as the chief investigator who was responsible for all phases of the module development. Dentists and pharmacists also participated in the workshop. To evaluate the module’s impact on HCP’s understanding of NSAID, their knowledge was assessed before and after the workshop. The module was handed to every participant after the pre-test, so they could learn more by themselves.
Characteristics of the pilot implementation participants
Characteristics of the pilot implementation participants
The results of the pre-test and post-test are described in Table 3. PHC A had a low mean score of pre-tests (54.38), and the post-tests reached over 80. PHC B a had higher pre-test score (72.14) and the post-test also reached over 80. The highest possible score was 100.
On the first day, the participants were informed about NSAIDs and offered explanations about the SOP to prevent ADR. On the second day, the participants followed simulations on how to collect gastrointestinal risk data and how to educate elderly patients about NSAIDs. After the simulation, the participants discussed the result and were given feedback.
Almost all participants of PHC A completed the two-day workshop. Only two participants did not attend the second day of the workshop due to work on duty outside the health center. In PHC B, less than 50% participants completed the workshop. The reasons why they did not complete the workshop included arrving late, still working, on duty outside the health center, and leaving the class earlier. There was a significant difference between pre-tests and post-tests among HCPs in group A (delta = 28.12; p < 0.001). PHC B had a higher pre-test score, and we observed no difference in pre-test and post-test scores (delta = 12.86; p = 0.129). However, the participants in PHC B had a higher post-test score compared to PHC A (85 vs 82.5) (see Table 3).
Nineteen out of 25 participants filled in the questionnaires for feasibility of the module. All participants (strongly) agreed that the module is important for PHC (68,42% agreed, 31,58 strongly agreed), is easy to understand (73,68% agreed, 26,32% strongly agreed) and is applicable in the PHC (94,73% agrees and 5,27% strongly agrees), and the workflow is feasible to be conducted at the PHC (94,73% agreed and 5,27% strongly agreed).
Discussions
The results of this study have led to the design, development and implementation of a pharmacovigilance module for the prevention of NSAIDs-associated upper GI ADRs in elderly patients at PHCs. To the best of our knowledge this is the first attempt at developing such a module.
Training is a good method to increase knowledge, skill and competency in PHCs. South Africa has developed a training program for primary care providers, clinical nurse practitioners or primary care doctors to counsel patients with risky lifestyle behaviors. The training program could increase the competence of primary care providers to provide brief behavior change counseling as part of everyday primary care [11]. In England, another training program was developed for primary care mental health staff to support management of depression and anxiety in long-term conditions. The training program aimed to improve participants’ knowledge, understanding and confidence in providing effective support to people with long-term conditions and was considered successful because it could increase knowledge and skill [12].
Updating knowledge by training for health workers decreases prescription errors. There were two previous studies in Indonesia where training was employed to improve rational drug-prescribing patterns in a PHC setting. One study in East Kalimantan showed that the prescription error detected in the baseline study was incorrect drug selection. Six months after training intervention, the prescription errors decreased significantly. Incorrect drug selection in adults with acute respiratory infection decreased from 81,27% to 41,56% [13]. Another study in West Sumatera was conducted to improve the rational drug use for acute respiratory infection and myalgia at the PHC. The baseline study showed that there was over-prescription for patients with acute respiratory infections and myalgia. The rational drug use workshop was able to decrease antibiotic prescription for acute respiratory infections and injection drug for myalgia, six months after the intervention [14]. In our study, the results of the pilot implementation showed that the module could improve the level of knowledge about NSAIDs for the primary HCPs. At the end of the workshop, the mean score reflected a good level of knowledge.
To decrease the possibility of ADRs in the elderly, doctors, nurses and midwives should collaborate based on their competences. Nurses and midwives could cooperate with doctors to obtain patients’ medical history to compile basic information and symptoms of elderly patients. Nurses and midwives may also get involved in educating patients and their families about drug adherence and the possibility of ADRS. In the absence of a physician at a PHC, nurses or midwives could take up certain roles delegated from the doctor in charge, with due limitations. For instance, nurses could administer OTC drugs for symptomatic management of the elderly patients. All NSAIDs, except 200 grams of ibuprofen, which is classified as an OTC drug, need a doctor’s prescription so nurses cannot prescribe them [7].
The workflow of the study is described in Fig. 1. Some factors might have influenced the different results of PHC A and B in the trial implementation. The participants of PHC A showed more efforts to update their knowledge so they completed the whole workshop. The PHC B participants seemed to take less effort to complete the training. To understand the cause, we scrutinized the individual data to examine why they did not complete the training, possibly because they were already knowledgeable. Surprisingly, we found that the PHC participants who had a good pre-test score, continued to complete the workshop. The workshop in PHC A was conducted in a smaller room compared to a large room for PHC B where the two-way communication among the trainer and the participants was more intense. These differences should be taken into consideration for subsequent HCP workshops. The meeting room should allow good interaction between the participants. The PHC staff were more willing to express their opinions and pose relevant questions because of their familiarity with all participants. To maintain concentration, the workshop should be completed within three hours. Additionally, to ensure that the module content is well received by all participants, the material should be simplified and oriented to daily practice. To avoid distractions, the number of participants should be kept to a maximum of 10 persons. Designing the module as a part of continuous professional education where every participant would be rewarded professional credit points from their professional organizations might increase the motivation to attend the whole workshop.

The workflow algorithm of prescribing NSAIDs by doctors.
This study is not without limitations. This is related to the trial implementation site as only two PHCs were included. However, our data highlights the need of such a module in PHC settings. Nevertheless, implementing and evaluating this module at more PHCs will help ascertain its validity at preventing NSAIDs-associated ADRs, especially gastrointestinal complications, which was not measured in our study. This study is limited to examine the effect of the module only on the HCP knowledge as a start. This can draw more attention to the need of pharmacovigilance in Indonesia and which will further be followed by adaptation of more modules for ADR prevention of other drugs in PHC settings.
Our module was developed by gathering input from representatives from all major prescribers and policy makers in the PHC setting. In addition, we drew input from experts in related fields and referred to the latest literature. We believe that by taking this bottom-up and top-down approach, we can see the problem as a whole, which is useful as input for the final module.
The pilot implementation showed that PHCs might have different characteristics, allowing us to realize and take into considerations that using a specific module will work best.
Conclusion
We developed and piloted a module for the prevention of NSAIDs-associated upper GI ADRs in elderly patients with musculoskeletal diseases at PHCs by gathering input from representatives from all major prescribers and policy makers in PHC settings. In addition, we drew input from experts in related fields and referred to the latest literature. The module is useful in increasing knowledge of the HPC and feasible to be used in PHC.
Footnotes
Acknowledgements
This research was supported by the University of Indonesia’s Directorate of Research and Community Engagement, funded by the TADOK (Tugas Akhir Doktor/Doctoral Research) research grant.
We would like to thank the Faculty of Medicine, State Islamic University Syarif Hidayatullah Jakarta for providing facilities to support this study, in particular all lecturers and administration staff who participated in the FGDs and other activities. We would like also to thank the supporting team of this study, and all respondents for their participation.
Conflict of interest
The authors have no conflicts of interest associated with the material presented in this paper.
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A. Module implementation (workshop)
B. Module evaluation
