Nora Wulandari, Tuti Wiyati*, Keshit Nolasari
Faculty of Pharmacy and Science, University of Muhammadiyah Prof. DR. HAMKA Jl Delima II/IV Malakasari, Duren Sawit, Jakarta Timur 13460
Submitted :... Reviewed :... Accepted:...
ABSTRACT
Heart failure is a growing health problem with high mortality and morbidity rates in developed and developing countries, including Indonesia. This study aimed to determine the incident of DRPs and to identify associated factors related to DRPs. This was a retrospective cross-sectional study. The study sample is patients aged ≥ 18 years and hospitalized with a diagnosis of heart failure. DRPs were identified based on domain cause of Pharmaceutical care Network Europe (PCNE) V.8 measurement tool, which included drug selection, dose selection, and treatment duration. Associated factors were analyzed their relation statistically using student's T-test and chi-square test. The sample of heart failure patients was 87 patients. The average age of patients was 64 years, with a predominance of women of 54%. Out of the 87 patients showed a risk of DRPs of 74.7% and without risk of DRPs of 25.3%. Overall cases of DRPs included inappropriate in drug selection, dose selections, and treatment duration domains of 86.8%, 9.89%, and 3.29%, respectively. Polypharmacy (p 0.007) and length of stay (p 0.001) found a significant association with the incident of DRPs. In conclusion, the incidence of DRP in heart failure patients was still high, and pharmacists must be more cautious about patients with a high number of drugs and duration of hospitalization.
Keywords: Heart Failure, DRP, Risk Factor
Corresponding author:
Name: Tuti Wiyati
Affiliation of author: Faculty of Pharmacy and Science, University of Muhammadiyah Prof DR.
HAMKA
Address: Jl. Delima II/IV Islamic Center Malakasari, Duren Sawit, East Jakarta 13460 Email: [email protected]
INTRODUCTION
Heart failure, often also called congestive heart failure, is the inability of the heart to pump adequate blood to meet the tissue's need for oxygen and nutrients. The term congestive heart failure is often used if left, and right-side heart failure occurs (DiPiro, Wells, Schwinghammer, & DiPiro, 2015). Heart failure is a progressive health problem with high mortality and morbidity rates in developed and developing countries, including Indonesia. In Indonesia, the age of heart failure patients is relatively younger than Europe and America, accompanied by a more severe clinical appearance (Indonesian Hearth Association (PERKI), 2015).
Heart failure is a cardiovascular disease that continues to increase the incidence of prevalence. The risk of death from heart failure ranges from 5-10% per year in mild heart failure, which will increase to
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30-40% in severe heart failure. In addition, heart failure is a disease that most needs re-treatment in the hospital (readmission) even though outpatient treatment has been given optimally (DiPiro et al., 2015).
WHO estimated that 17.9 million people died from cardiovascular disorders in 2016, representing 31% of total global deaths (World Health Organization (WHO), 2017). Every year more than 36 million people die due to Non-Communicable Diseases (PTM) (63% of all deaths). Cardiovascular disease is a PTM that causes the highest number of deaths every year, where heart failure included in it (Ministry of Health of Republic of Indonesia, 2013).
Based on a doctor's diagnosis, the prevalence of heart failure in Indonesia in 2013 was 0.13% or estimated at 229,696 people, while based on doctor's diagnosis or symptoms of 0.3% or estimated at around 530,068 people (Ministry of Health of Republic of Indonesia, 2013). The prevalence of heart disease based on doctor's diagnosis in a population of all ages, according to the Province of Indonesia in 2018 for Java Island, was the highest in the Special Province of Yogyakarta (Ministry of Health of Republic of Indonesia, 2018). Most heart failure patients are accompanied by accompanying diagnoses such as hypertension, diabetes mellitus (Rahmawati & Nurwahyuni, 2017).
In previous studies, the prevalence of DRPs in congestive heart failure patients hospitalized at Prof.
RSUP Dr. R. D. Kandou Manado identified from 46 research subjects obtained 89% potentially experiencing DRPs (Sinjal, Wiyono, & Mpila, 2018). One study detected 29.8% admissions showing DPRs with variables associated with a higher risk were polypharmacy female sex and first admission (Urbina et al., 2014). Another study showed that the most common DRPs were the need for laboratory tests (32.7%), followed by potential interaction (29.6%), nonallergic side effects (13.3%) (Zaman Huri, Xin, Sulaiman, & Lo, n.d.).
Drug-Related Problems (DRP) or drug-related problems are events or circumstances involving drug therapy that truly or potentially interfere with the desired health outcomes (Pharmaceutical Care Network Europe Foundation (PCNE), 2017). Identification and resolving is the main activity in pharmaceutical care (Adusumilli & Adepu, 2014). Several factors were found to be related to the occurrence of DRPs, including aging, length of stay in the hospital, polydrug therapy, and patients having multiple comorbidities (Huri, Xin, & Sulaiman, 2014). There are many classification systems in DRPs, and one of them is the classification issued by Pharmaceutical Care Network Europe (PCNE) (Adusumilli & Adepu, 2014)(Pharmaceutical Care Network Europe Foundation (PCNE), 2017).
In Indonesia, the application of PCNE is still rare. Given the importance of the DRPs study and the high prevalence of heart failure in the Yogyakarta region, it is crucial to assess the incidence of DRPs in heart failure patients as well as to detect the factors associated.
.
MATERIALS AND METHOD
This was a non-experimental research. A cross-sectional design was used with data collected using a purposive sampling method retrospectively, by recording the data needed for research from the medical records of patients with a primary diagnosis of heart failure who were hospitalized in a general hospital in Yogyakarta during the 2018 period.
The inclusion criteria of this study were patients aged 18 years or older and hospitalized with a diagnosis of heart failure. Patients with incomplete data and with cancer-comorbid disease were excluded from this study.
This study did not use informed consent, and researchers did not interact with patients directly.
Data obtained from the medical record of the patients from the medical records section at the Hospital.
The data that has been collected is data in accordance with the sample criteria which include: medical record number, date of visit, age, sex, diagnosis, drug given (generic name, trade name, dosage form) drug dosage, duration of use, route administration, time of administration, and comorbidity.
Pharmaceutical Care Network Europe (PCNE) classification version 8.0 was used to classify the DRPs. In this study, we only identified the domain of causes for potential problems with code C1, C3, and C4 of classification (Pharmaceutical Care Network Europe Foundation (PCNE), 2017).
Potential DRPs was determined based on standard guidelines used both in national therapy standards such as the PERKI (Indonesian Hearth Association) Guidelines 2014 and other standard literature such as Drug Information Handbook 2018, Pharmacotherapy Handbook 2015, and Drugs.com, and Medscape (Indonesian Hearth Association (PERKI), 2015)(Lacy, Amstrong, Goldman, & Lance, 2019)(DiPiro et al., 2015)(Drugs.com, 2020)(Medscape, 2020). All collected data were counted in
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number and percentage, then the T-test and Chi-Square test were used to find out the characteristics associated with the incidence of DRPs.
Result and Discussion
A. Patients Characteristics
The number of samples obtained by the purposive sampling technique was 87 (eighty- seven) patients with characteristics that can be seen in Table 1.
Table 1. Characteristics of the Study Population Characteristics N=87 Percentage (%) Demography
Age (year) Min-Max
< 60
≥ 60 Gender Male Female
64.10 ± 14.67 18-96
29 58 40 47
33.3 66.7 46 54 Clinical
Hospitalized Duration (day)
< 5 ≥ 5
34 53
39.1 60.9 Number of regular drugs
≤5
>5
12 75
13.8 86.2 Number of Comorbid
< 3 ≥ 3
52 35
59.8 40.2
N= Number
Based on Table 1, the total sample of hospitalized female patients with heart failure was slightly greater than males. The table shows that most heart failure sufferers are the elderly or 60 years or more, with an average age of 64.10 ± 14.67. Based on the results of the study listed in Table 1, the length of stay for heart failure patients was more than five days.
B. DRPs Overview
Of the 87 study samples obtained by patients at risk for DRP are illustrated in Figure 1. Out of 87 patients, 25% of the patients found to be indicated DRPs.
25%
75%
DRPs Without DRPs
Figure 1. The incidence of DRP in hospitalized heart failure patients in hospitals
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This study obtained DRPs based on PCNE V.8.0 in 2017, which includes inaccurate drug selection, dose selection, and treatment duration. The number of DRPs cases that occurred was 82 cases with the domain of inappropriate drug selection 85.37%, dose selection 10.98%, and treatment duration 3.66%
(Table 2).
Table 2. DRPs Events Based on PCNE 2017
Code V8.01 Cause N (%)
Drug selection
C1.1 Inappropriate drug according to guidelines/formulary 11(13.41) C1.2 Inappropriate drug (within guidelines but otherwise contra-
indicated)
8(9.76)
C1.3 No indication for the drug 5(6.10)
C1.4 Inappropriate combination of drugs or drugs and herbal medication 42(51.22) C1.5 Inappropriate duplication of a therapeutic group or active ingredient 2(2.44) C1.6 No drug treatment in spite of existing indication 2(2.44)
C1.7 Too many drugs prescribed for an indication 0
Subtotal 70(85.37)
Dose selection
C3.1 Drug dose too low 5(6.10)
C3.2 Drug dose too high 0
C3.3 Dosage regiment not frequent enough 2(2.44)
C3.4 Dosage regimen too frequent 2(2.44)
Subtotal 9(10.98)
Treatment duration
C4.1 Duration of treatment too short 3(3.66)
C4.2 Duration of treatment too long 0
Subtotal 3(3.66)
Total 82(100)
N= Number
Inappropriate drug, according to guidelines/formulary found in this study, was the case where patients only given digoxin. Based on the algorithm for management of heart failure, the treatment of heart failure after being diagnosed is the diuretic group, ACE inhibitors, and beta-blockers. Digoxin therapy is only given when patients are on a combination of three drugs but are still symptomatic (Indonesian Hearth Association (PERKI), 2015)(Yancy et al., 2013).
DRPs categories of contraindicated in this study were drugs that are not recommended for the patient based on the guidelines. In this domain, the most common cause is the administration of potassium supplements in conjunction with the drug spironolactone. According to PERKI (2015), spironolactone is contraindicated if given together with potassium-sparing diuretics or potassium supplements as well as a combination of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) (Indonesian Hearth Association (PERKI), 2015). Concurrent use of potassium supplements and Spironolactone can increase the risk of hyperkalemia. The combination of these drugs can cause life-threatening and fatal hyperkalemia, especially when the combination of these drugs is used in patients with risk factors such as kidney disorders, diabetes, old age, severe or worsening heart failure, dehydration and the use of other agents together can inhibit the renin-angiotensin- aldosterone system or increase serum potassium levels (Drugs.com, 2020).
The solution carried out by clinical pharmacists, in this case, was to always monitor the patient's serum potassium levels regularly and write it on the patient's medical records so that it becomes the concern of every colleague who treats the patient and immediately reports to the doctor in charge of the patient if side effects occur. Furthermore, oral potassium supplementation should be avoided in patients with severe congestive heart failure if serum potassium levels are above 3.5 meq/L (Drugs.com, 2020).
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DRPs categories of an improper combination of drugs found in this study included a combination of aspirin and clopidogrel. Based on the latest treatment strategies, the combination of oral anticoagulants with antiplatelet therapy has shown promising results in randomized phase II and III random trials, that the use of oral anticoagulants in addition to standard antiplatelet therapy can reduce the rate of recurrent ischemic events but at the same time, there is an increased risk of massive bleeding (Panahi, Vadgama, Kuganesan, Ng, & Sattler, 2018). The role of pharmacists in Pharmaceutical care is to identify, prevent, and overcome the occurrence of DRPs (Rufaidah, Putu Pramanta, & Ika, 2015). This has been carried out by Clinical Pharmacists in Hospitals by providing recommendation notes on patient medical records in the CPPT (Integrated Patient Development Record) section.
The duplication of therapeutic events contained in this study was the duplication of the Benzodiazepine class of drugs. Metamizole and diazepam were in were found used together with alprazolam, which has the same benzodiazepine class. Both of these drugs are present in therapy in the same patient. The use of these two drugs in concurrent therapy can increase the effect of sedation in patients, so it needs to be monitored carefully (Medscape, 2020).
In the underdose, the domain was found in gabapentin given to patients. Gabapentin dose for neuropathic pain is 900 mg/day and for maintenance 1800-3600 mg/day (Lacy et al., 2019). In patients, the drug was given 300 times two times daily, which was 600 mg/day. The dose given is lower than the usual dose. Based on discussions with clinical pharmacists in the hospital, the dose of Gabapentin in the treatment was indeed given lower because of the side effect of severe drowsiness. If the patient is given a high dose, the patient cannot move because he would be sleepy. In another case, it was found the duration of administration of Azithromycin in pneumonia given three days to five days, while the guideline suggests seven days (DiPiro et al., 2015).
C. Associated Factors
The results of the study obtained factors related to the incidence of DRP, namely polypharmacy, and length of stay, as shown in Table 3.
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Table 3: Overview of Association of Characteristics and DRP in Heart Failure Patients
Factors DRPs
N (%)
Without DRPs N (%)
p-value
Age 65 22
0,717a Mean±Sd 63,77 ±15,458 65,09 ± 12,328
Gender Male 31 (47,7) 9 (40,9)
0,581b
Female 34 (52,3) 13 (59,1)
Polypharmacy 65 22
0,007a*
Mean±Sd 9,89±3,518 7,59±2,840
Hospitalized duration
65 22
0,001a*
Mean±Sd 4,83±2,369 7,05±2,578
Comorbid 65 22
0,365a
Mean±Sd 2,66±1,461 3,00±1,633
*Significant (p<0,05)
aStudent’s T-test
bChi-Square test
The study obtained polypharmacy and length of stay related to the incidence of DRP. According to WHO, polypharmacy is one form of irrational drug use. That is, giving more than five kinds of drugs to one patient in one prescription (World Health Organization (WHO), 2019). Some studies also found that the number of drugs associated with DRPs incidence (Urbina et al., 2014)(Huri et al., 2014)(Dasopang, Harahap, & Lindarto, 2015)(Lorensia & Wijaya, 2016).
In regard to the length of stay, one study also found that the length of stay was related to the incidence of DRP (Huri et al., 2014). The longer the patient stays in the hospital, the patient has a greater risk for ADR (Adverse Drug Reaction) and problems related to drug selection.
CONCLUSION (11pt)
Drug-related problems among hospitalized patients with heart failure were high, especially for the drug selection domain. Polypharmacy and length of stay of the patient showed an association with the incident of DRPs.
ACKNOWLEDGEMENT
The authors would like to express their appreciation to patients and staff of Hospital who helped in the process of the study. We are grateful to the Institute of Research and Development University of Muhammadiyah Prof. DR. HAMKA who kindly supported to publish the article.
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LAMPIRAN 2. ARTIKEL ILMIAH II (STATUS SUBMISSION) Status Luaran Tambahan: Draft
Comorbidity and Treatment of Patients with Heart Failure in in General Hospital Yogyakarta
Nora Wulandari, Tuti Wiyati, Keshit Nolasari
Fakultas Farmasi dan Sains Universitas Muhammadiyah Prof. DR. HAMKA Jl Delima II/IV Malakasari, Duren Sawit, Jakarta Timur 13460
Korespondensi: [email protected]
Tinginya prevalensi penyakit gagal jantung di Yogyakarta belum disertai dengan data mengenai karakteristik dan gambaran penyakit penyerta dan penggunaan obatnya. Penelitian ini bertujuan untuk mengetahui gambaran penyakit dan pengobatan pada pasien gagal jantung di Yogyakarta. Penelitian ini menggunakan rancangan cross-sectional dengan data retrospektif dari rekam medik pasien. Sampel penelitian yaitu pasien yang berusia ≥ 18 tahun yang di rawat inap dengan diagnosis gagal jantung. Jumlah sampel pasien gagal jantung sebanyak 87 pasien. Rata- rata usia pasien 64 tahun, dengan dominasi perempuan sebanyak 54%. Gambaran Kesimpulan penelitian bahwa angka kejadian DRP pada pasien gagal jantung masih tinggi serta karakteristik pasien yang berhubungan dengan kejadian DRP yaitu polifarmasi (p-value 0,007) dan lama rawat inap (p-value 0,001).
Kata kunci: gagal jantung, DRP, rawat inap, faktor resiko PENDAHULUAN
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Gagal jantung merupakan masalah kesehatan yang progresif dengan angka mortalitas dan morbiditas yang tinggi di negara maju maupun negara berkembang termasuk Indonesia. Di Indonesia, usia pasien gagal jantung relatif lebih muda dibanding Eropa dan Amerika disertai dengan tampilan klinis yang lebih berat (PERKI 2015). Istilah gagal jantung kongestif sering digunakan jika terjadi gagal jantung sisi kiri dan kanan (Kasron 2012).
Menurut data WHO, 17,9 juta orang meninggal akibat gangguan kardiovaskular pada tahun 2016, mewakili 31% dari total kematian global (WHO 2017). Setiap tahunnya lebih dari 36 juta orang meninggal karena Penyakit Tidak Menular (PTM) (63% dari seluruh kematian). Secara global, PTM yang menjadi penyebab kematian nomor satu setiap tahunnya adalah penyakit kardiovaskular. Penyakit kardiovaskular adalah penyakit yang disebabkan gangguan fungsi jantung dan pembuluh darah, seperti: penyakit jantung koroner, penyakit gagal jantung atau payah jantung, hipertensi dan stroke (Riskesdes 2013).
Berdasarkan diagnosis dokter prevalensi penyakit gagal jantung di Indonesia tahun 2013 sebesar 0,13% atau diperkirakan sekitar 229.696 orang, sedangkan berdasarkan diagnosis dokter atau gejala sebesar 0,3% atau diperkirakan sekitar 530.068 orang (Riskesdes 2013). Prevalensi penyakit jantung berdasarkan diagnosis dokter pada penduduk semua umur menurut Provinsi di Indonesia tahun 2018 untuk Pulau Jawa prevalensi tertinggi terdapat di Provinsi Derah Istimewa Yogyakarta (Riskesdas 2018). Sebagian besar pasien gagal jantung disertai dengan diagnosis penyerta seperti hipertensi, diabetes mellitus (Rahmawati 2018). Obat yang paling sering diresepkan untuk pasien CHF di RSUP Dr. Sardjito adalah obat golongan β-bloker dan antikoagulan sebanyak 88,7%, diikuti dengan pemberian diuretik sebanyak 86,6% (Ikawati dkk.
2015).
METODE
Penelitian ini merupakan penelitian non- experimental. Dengan rancangan cross- sectional, data yang digunakan dikumpulkan secara retrospektif, yaitu dengan mencatat data- data yang diperlukan untuk penelitian dari rekam medik pasien dengan diagnosis utama gagal jantung yang menjalani rawat inap di Rumah Sakit selama periode tahun 2018.
Kriteria Inklusi pada penelitian yaitu pasien yang berusia ≥ 18 tahun dan merupakan pasien rawat inap dengan diagnosis Gagal Jantung. Kriteria Ekslusi yaitu pasien dengan data yang tidak lengkap dan pasien dengan penyakit kanker. Data diperoleh dari catatan rekam medik yang terdapat di bagian rekam medik di Rumah Sakit. Semua data yang dikumpulkan dihitung jumlah serta persentasenya dan disajikan dalam bentuk tabel dan gambar.
HASIL DAN PEMBAHASAN
Jumlah sampel yang diperoleh dengan teknik purposive sampling adalah 87 (delapan puluh tujuh) pasien.
D. Gambaran Penyakit Penyerta pada Gagal Jantung
Tabel 1. Daftar Komorbiditas Pasien Gagal Jantung
Penyakit Jumlah (%)
Muskoskeletal Hiperurisemia, Gout 4 (3,8)
Kardiovaskular
Mitral Regurgitation, LVNC, ASD, CVT, Stroke, AR, Takikardia, ASAR, Bradikardia, PH, Stenosis, Dislipidemia, IM, VES, HHD, Hipertensi, STEMI, Syok Kardiogenik, IHD
57 (54,28)
Hematologi Thrombositopenia, Anemia 3 (2,8)