|Year : 2023 | Volume
| Issue : 1 | Page : 22-28
Drug-related Problems among Inpatients of General Medicine Department of a Tertiary Care Hospital in South India
Janice Jacson Mandumpala1, Aleena Manoj1, Neha Baby1, Sneha Elizabeth Mathai1, Siji Antony2, Antriya Annie Tom1
1 Department of Pharmacy Practice, Nirmala College of Pharmacy, Ernakulam, Kerala, India
2 Department of Computer Science, Santhigiri College, Vazhithala, Kerala, India
|Date of Submission||11-Oct-2022|
|Date of Decision||16-Dec-2022|
|Date of Acceptance||28-Dec-2022|
|Date of Web Publication||31-Mar-2023|
Antriya Annie Tom
Department of Pharmacy Practice, Nirmala College of Pharmacy, Muvattupuzha, Ernakulam, Kerala
Source of Support: None, Conflict of Interest: None
Background: Identification of drug-related problems (DRPs) is a medication management service that can add value to individual patient care. Determination of DRPs daily is a promising approach for optimizing treatment. Objective: The objective of this study was to analyze the incidence of DRPs identified along with the risk factors that contribute to its development. Setting: This study was conducted in a tertiary care hospital in Central Kerala, India. Methods: A cross-sectional study was conducted among 300 newly admitted patients to the general medicine department. Patient medical records were reviewed in 3 stages – medication reconciliation, medication order review, and discharge summary review, and DRPs were categorized based on the Pharmaceutical Care Network Europe V9.1. Patient characteristics such as age, gender, polypharmacy, comorbidities, nonadherence, and type of illness were recorded. Results: Out of 300 patients, 78.7% had DRPs. The incidence of DRPs was found to be 0.26 cases/people-months. Although age >60 years, gender, polypharmacy, nonadherence, comorbidities, and chronic ailments were risk factors for DRPs, only polypharmacy and comorbidities could be proven statistically. Conclusion: DRPs are an emerging issue within the confines of the health-care system and should be scrutinized to avoid negative outcomes. A stage-wise analysis of patients who are at risk will ensure better patient care.
Keywords: Discharge summary review, drug-related problems, general medicine, medication order review, medication reconciliation
|How to cite this article:|
Mandumpala JJ, Manoj A, Baby N, Mathai SE, Antony S, Tom AA. Drug-related Problems among Inpatients of General Medicine Department of a Tertiary Care Hospital in South India. Asian J Pharm Res Health Care 2023;15:22-8
|How to cite this URL:|
Mandumpala JJ, Manoj A, Baby N, Mathai SE, Antony S, Tom AA. Drug-related Problems among Inpatients of General Medicine Department of a Tertiary Care Hospital in South India. Asian J Pharm Res Health Care [serial online] 2023 [cited 2023 Jun 8];15:22-8. Available from: http://www.ajprhc.com/text.asp?2023/15/1/22/373379
| Introduction|| |
A drug-related problem (DRP) can be defined as “any undesirable event experienced by a patient that involves or is suspected to involve drug therapy and interferes with achieving the desired goals of therapy and which requires professional judgement to resolve” as per the Cipolle-Strand Morley 2012 criteria.,, DRPs are common in hospitalized patients on average accounting for 8.3% of which 50% are avoidable and are currently becoming the fourth to sixth largest cause of death in the medical community., Unresolved DRPs can lead to clinical complications with substantial medical and economic devastation to the patients. In the hospital setting, DRP occurs at all stages during admission, during the hospital stay, and during discharge., Inadequate transfer of information at different levels of care triggers medication discrepancies and medication reconciliation is an important step that should be performed to avoid medicine-related issues. According to the Pharmaceutical Care Network Europe (PCNE), a medication review is defined as “a structured evaluation of a patient's medicines to optimise the outcomes of therapy.”, To minimize risk and maximize benefits, patients' medication should be properly monitored at all stages during medication reconciliation, medication order review, and discharge summary review. The use of drugs is the pillar of care for elderly people. Nevertheless, age-related changes, comorbidities, and polypharmacy may put elderly patients more vulnerable to the development of DRPs.,
To resolve DRPs, the cause should be identified and DRPs should be classified appropriately. For this, there should be a uniform, structured, and validated classification system to micro-analyze and track all the DRPs. Although there are many classification systems, none of them meets the essential criteria. The PCNE classification system with technical DRP category is proved to be useful as it is validated and revised periodically.,,
Critical care is the specialized, integrated services provided to critically ill patients that promote faster recovery from illness, prevent unnecessary admissions to hospitals, and maximize independent living. The complexity of intensive care units (ICUs), the use of high-tech drugs, and sophisticated drug delivery methods creates an environment that is vulnerable to harmful patient outcomes. Clinical pharmacists can provide timely recommendations in complex pharmacotherapies and play a key role in medication management in ICU settings.,,
Clinical pharmacy can be defined as “a health speciality which describes the activities and services of clinical pharmacists to develop and prompt the rational appropriate use of medicinal products and services.” Experiences and studies from developed countries suggest that clinical pharmacists are trained in therapeutics and they are the right people to tackle the DRPs. Clinical pharmacists can ameliorate patient safety by proper detection of DRPs and providing recommendations.,,
In India, clinical pharmacy services are in the infancy stage and only limited data are available on the incidence of DRPs in South India. A total of 0.20% of hospital admissions in South India were determined to be attributable to drugs. The prevalence of DRPs is high, and clinical pharmacist intervention may help to reduce these issues in developing nations such as India.
The current study aimed to identify the incidence of DRPs, distribution, and number of DRPs at various stages and probable risk factors contributing to the development of DRPs in the general medicine department of a tertiary care hospital in South India.
| Methods|| |
Study design and setting
This cross-sectional study was performed in the general medicine department of a tertiary care hospital in the central region of the southern state of Kerala, India, from January to March 2022. The medical records of newly admitted patients were analyzed in three stages – medication reconciliation (patients were interviewed for their past medical history and medication history), medication order review (review of current medication chart), and discharge summary review (review of discharge medication chart) using a regularly updated standardized tool PCNE.
Study participants include all the inpatients admitted to the general medicine department for more than 48 h. The total number of patients admitted during the study period was 300. Among these, patients with missing or incomplete data, patients admitted for <48 h, patients admitted for diagnostic tests only, patients who left against medical advice, patients who expired during treatment in the hospital, and patients receiving palliative care due to short life expectancy were excluded from the study.
Data collection and statistical analysis
Data of all patients admitted to the general medicine department during the study period were collected. Data collection was conducted by four clinical pharmacy students, and the identified DRPs were cross-verified and communicated to the respective physician through a head clinical pharmacist. Patient demographics and clinical information such as age, gender, social history, allergic history, type of illness, polypharmacy, and comorbidities were obtained.
Details were pooled in three steps: Medication reconciliation that is the current medical and medication information was collected within 24–48 h of admission and later an advanced medication order review and discharge summary review were performed. The DRPs were characterized using the pharmaceutical care network Europe classification Version 9.1, published by Pharmaceutical Care Network Europe Association, (Drenthe, Netherlands) classification system. The association between risk factors and DRP were assessed using the Chi-square test, and P < 0.05 was deemed to be statistically significant.
Ethical approval and informed consent
The patients were informed of all the aspects and details of the study. They were also provided with an informed consent form before enrolling in the study. Informed consent was obtained from all the patients included in the study. The study was conducted in line with the Declaration of Helsinki and approved by the Ethics Committee of the hospital and the Institutional Review Board of the study site (Approval Letter Number – CH/EC/FEB/2022/022).
| Results|| |
Incidence of drug-related problem
A total of 300 patients were newly admitted to the general medicine department during the study time. Their medical records were analyzed from the admission till discharge. [Table 1] categorizes the number of DRPs among total patients (i.e., DRPs in each patient). The incidence of DRPs among newly admitted hospitalized patients in the general medicine department was found to be 0.26 cases/people-months.
Risk factors for the development of drug-related problems
From the study, we observed that increasing age, chronic health conditions, presence of polypharmacy, comorbidities, and nonadherence were the factors that were detrimental to the occurrence of DRPs. Among these, a statistically significant association was established between DRP-polypharmacy and DRP-comorbidities (P < 0.05). [Table 2] represents the characteristics of the people included in the study.
Drug-related problems in various stages of identification
The patients admitted were screened for the relevant DRPs in various stages. Most of the patients developed DRPs during the stage of medication order review (64%) followed by discharge summary review (22.3%) and medication reconciliation (10.3%) [Figure 1].
|Figure 1: Distribution of DRPs in various stages of identification. MR: Medication Reconciliation, MOR: Medication Order Review, DS: Discharge Review, DRPs: Drug-related problems|
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Drug-related problem during medication reconciliation
A total of 31 DRPs were obtained during medication reconciliation. Unnecessary drug treatment (P3.1) was found to be higher in this stage which is followed by effects of drug treatment not optimal (P1.2) and unclear problems (P3.2) [Figure 2].
Drug-related problem during medication order review
During medication order review, the medication charts were scrutinized for the existence of DRPs. Out of the 337 DRPs collected in this stage, 98 (29.1%) of them were the effect of drug treatment not optimal (P1.2) and 76 (22.6%) of them were unclear problem/compliant (P3.2) [Figure 3].
Drug-related problem during discharge summary review
A total of 69 DRPs were obtained from the discharge summary. Unclear problem/compliant (P3.2) was found to be greater in number, which was followed by untreated symptoms or indication (P1.3) [Figure 4].
[Table 3] summarizes the DRPs detected in each stage based on PCNE.
|Table 3: Detected drug-related problems according to the Pharmaceutical Care Network Europe drug-related problems classification V9.1|
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[Table 4] represents examples of DRPS obtained during the study based on PCNE.
|Table 4: Examples of drug-related problems obtained based on the Pharmaceutical Care Network Europe|
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As per the PCNE acceptance of proposed intervention criteria, following were the observation in the study. 59.5% of interventions proposed were accepted, 38.9% of the intervention were proposed and acceptance rate unknown and 1.6% of the interventions not proposed (Due to lack of access to discharge summary before patient leaves the hospital-DRPs identified during discharge summary review were not proposed). Most of the proposed interventions were accepted and implemented fully.
| Discussion|| |
Proper use of drugs is defined as “the use of the right product, in a correct dosage, during an adequate length of time, for a given patient and provided he has no side effects.” Nevertheless, with the abundance of substances for treatment on the market, it is possible that mistakes can be made. The inappropriate use of medications can be harmful, and sometimes fatal in the inpatient hospital setting. Health-related quality of life is compromised and heightens the risk of future morbidity and mortality. Our study showed that a clinical pharmacist-led team can identify DRPs efficiently and deliver timely interventions which is consistent with the findings of numerous studies.,, The incidence of DRPs in the current study was found to be 0.26 cases/people-months, emphasizing the need for a clinical pharmacist in a health-care team.
Identification of risk factors is an important area to be addressed. In this study, it was found that the majority of DRPs were in patients above or equal to 60 years of age (80.6%) and more than one DRP was higher in this group of patients. Similarly, a study conducted by Hailu et al. has shown that geriatric patients are prone to DRPs (81.5%). Elderly people are at greater risk due to cognitive changes and pharmacokinetic and pharmacodynamic alterations associated with aging.,
Both males (81.4%) and females (75.7%) carry a near-equal risk of developing DRPs. These results are similar to a study conducted by Veehof et al. where being a female does not pose the risk of developing ADRs. However, studies during the 1990s report women having a greater risk of developing ADRs.,
The proportion of drugs prescribed to a patient increases with age. In the present study, polypharmacy poses a significant risk for the development of DRPs, which were reported in 84.6% of the patients with polypharmacy. Polypharmacy is a complex issue widely challenged within the health-care setting., Another study has found a strong correlation between polypharmacy and DRPs. Furthermore, our frequency of unnecessary drug treatment (32.2%) is slightly higher than their frequency (30.6%). Unnecessary drug treatment could be a potential reason for DRPs as seen during the medication history interview stage of the present study.
In particular, mortality and hospitalization significantly have a negative correlation with medication nonadherence. The number of DRPs was greater in nonadherent patients (88%) in our study. Likewise, in the study conducted by Paisansirikul et al., it was demonstrated that medication nonadherence plays a role in the development of DRPs. Therefore, improving medication adherence to maximize the therapeutic benefit of pharmacotherapy remains a cornerstone of patient care.
As the number of diseases increases in an individual, the more intricate the medication management. This study has found that DRPs were greater among patients with comorbidities (85.3%). Firomsa Bekele et al. specified that, in comparison to patients without comorbidities, patients with co-occurring disease conditions were 1.8 times more likely to develop DRPs. From the statistical analysis, it is perceptible that comorbidities are a risk factor for DRPs (P = 0.001).
In our study, the patients with chronic ailments had a greater number of DRPs (82%). Chronic diseases require a greater length of treatment and more complex treatment resulting in noncompliance among the patients. In addition, a study conducted in Jordan by Al-Azzam et al. indicated that an average of 11.2 DRPs per patient was identified in patients with chronic diseases.
The most crucial stage in pharmaceutical intervention is medication reconciliation. Incomplete medication reconciliation can conceal DRPs and further lead to potential harm., The present study encountered about 10.3% of DRPs at the stage of medication reconciliation. Notably, a study conducted by Byrne et al. accounts for about 56.7% of DRPs during medication reconciliation.
Likewise, conducting comprehensive medication reviews is crucial to prevent DRPs., In this study, a greater number of DRPs (64%) were noticed in this stage. In a previous study, ineffective drug/inappropriate drug and unnecessary drug therapy were the most frequent among all other DRPs.
The practice of discharge summary review includes the incorporation of pharmacist evaluation and also identifies and fixes errors formed during drug therapy., A study conducted by Bishop et al. highlighted the importance of reviewing discharge summaries. In this study, after medication order review, the development of DRPs was higher in discharge summary review (22.3%) In a previous study, it was noticed that 41% of patients had at least one medication discrepancy. Furthermore, in a study by Pourrat et al., it was specified that the overall number of errors was significantly decreased in this stage.
We encountered some limitations during the study. First, the study was single centered making the results less reliable. Second, the general medicine department has only been the sole area of focus for the conduct of this study. Furthermore, COVID-19 has negatively influenced the intake of patients in the hospital. In addition, increased workload due to COVID-19 on the health-care professionals created a communication barrier, thus decelerating the smooth conduction of this study. Furthermore, access to the COVID-positive patient medical record in the general medicine department was denied following the hospital protocol.
| Conclusion|| |
This is one of the few studies conducted to evaluate the incidence of DRP and risk factors during hospital admission in real clinical practice in South India. It was observed that patients with comorbidities and polypharmacy had a much higher chance of developing DRP. It is noteworthy that most of the DRPs identified by clinical pharmacists were preventable and the interventions provided were highly accepted. In nutshell, there is increasing evidence that participation and interventions of clinical pharmacists in health care positively influence clinical practice in India whereas clinical pharmacy service is still in its nascent state in India. It is crucial for Indian clinical pharmacists to get trained enough to participate systematically in pharmaceutical care so that these aspiring pharmacists could provide excellent patient care leading to the accomplishment of better patient outcomes. Furthermore, such services should be welcomed by the health-care fraternity and society in India.
Janice Jacson Mandumpala contributed to the study conception. Janice Jacson Mandumpala, Aleena Manoj, Neha Baby, and Sneha Elizabeth Mathai contributed to the study design, material preparation, and data collection. Aleena Alex supervised the identification and confirmation of DRPs followed by the proposal of interventions. Siji Anthony conducted the data analysis and interpretation. Antriya Annie Tom supervised and guided throughout the entire study period and with comments during the manuscript preparation. All authors read and approved the final manuscript.
We thank the Department of Clinical Pharmacy, Caritas Hospital, and Department of Pharmacy Practice, Nirmala College of Pharmacy, for their continuous guidance and support during the conduct of the study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4]