INTRODUCTION:

Diabetes Mellitus (DM) is a chronic condition that occurs when the pancreas doesn't produce enough insulin or when the body is unable to effectively use insulin. This results in an increase in blood glucose levels. Hyperglycemia is a medical condition in which there is an increase in blood glucose levels beyond the normal range.

This often occurs in several diseases, especially T2DM, but can occur in various other medical conditions as well. Type 2 DM is now a serious threat to global health¹^,²^,³.

According to the International Diabetes Federation (IDF), there are approximately 537 million adults living with diabetes worldwide. Indonesia ranks fifth in the number of T2DM patients (19,5 million people) after China, India, Pakistan, and the USA⁴. The Basic Health Research in 2018 showed that the prevalence of T2DM in Indonesia based on a doctor's diagnosis in individuals aged ≥ 15 years was 2%, compared to 1,5% in 2013. The prevalence of T2DM in West Nusa Tenggara Province based on a doctor's diagnosis in the entire population according to districts or cities is 1,16%, with a total of 21,308 patients. Meanwhile, the prevalence in individuals aged ≥ 15 years is 1,64%, with a total of 14,825 patients. Based on prevalence data, the incidence of T2DM in Indonesia continues to increase every year. Various studies show that the incidence and prevalence of T2DM are increasing. One of them is T2DM, which has the highest prevalence compared to other types⁵. As an effort to prevent the increasing incidence of T2DM, management efforts are made through pharmacological therapy. Pharmacological therapy can improve the condition of patients, but on the other hand, it can also cause problems such as the use of antidiabetic drugs that may worsen complications in hypertension or other comorbidities.

Complications that occur in T2DM add to the diversity of drugs used. The use of many types of drugs (polypharmacy) and inappropriate pharmacotherapy are known to increase the risk of DRPs⁶^,⁷^. Type 2 DM patients are often given combinations of drugs, such as oral hypoglycemic agents, insulin, antihypertensive drugs, and cholesterol-lowering drugs⁸. The use of these drug combinations requires careful monitoring by pharmacists to identify potential DRPs that may occur. Pharmacists have an obligation to know and identify the possible occurrence of DRPs, with the aim of improving the safety and effectiveness of therapy in patients and preventing complications due to inappropriate drug use⁹. Drug Related Problems (DRPs) are events or conditions involving drug therapy that actually or potentially interfere with desired health outcomes. Drug Related Problems (DRPs) can be addressed or prevented when the causes of the problems are clearly understood. Thus, it is necessary to categorize DRPs. Pharmaceutical Care Practice categorizes Drug Therapy Problems including drugs without indication, additional drug therapy, ineffective drugs, too low dosage, Adverse Drug Reactions (ADR), excessive dosage, and drug interactions. Previous studies recorded the highest percentage of DRPs in geriatric patients in the category of problems as unnecessary drug therapy with 74 occurrences (90,24%), ADR with 3 occurrences (3,66%), and suboptimal treatment effects with 2 occurrences (2.44%). Meanwhile, in the category of causes, drug selection accounted for 77 occurrences (84,62%) and dosage selection for 14 occurrences (15,38%)¹⁰. This research is important because there is no data on the incidence of DRPs specifically in T2DM patients in that hospital. Therefore, this research is expected to be beneficial for the hospital, especially in terms of the quality of medical treatment services for patients.

MATERIALS AND METHODS:

Materials:

The research conducted was observational descriptive with retrospective data collection through the medical records of T2DM patients. Variables in this study include single variables such as age, gender, treatment profile, and the percentage of DRP occurrences in T2DM patients. The sampling technique used was Purposive Sampling. Purposive Sampling is a sampling technique based on specific considerations. The inclusion criteria for this study were T2DM patients during the period of January to December 2022, complete and readable medical records. The exclusion criteria for this study were patients who died during treatment, missing or damaged medical records. The sample size was calculated using Slovin's calculation and resulted in a sample of 88. The data collection method in this study used secondary data obtained from the medical records of T2DM patients at the Provincial General Hospital of West Nusa Tenggara in 2022.

RESULT:

The research was conducted at the Provincial General Hospital of West Nusa Tenggara No. 00.9.1/12/KEP/2023. The research was carried out in April – May 2023. A total of 88 medical records that met the inclusion and exclusion criteria were obtained as samples. Based on the number of samples, an assessment was conducted, and the results obtained were in the form of patient characteristics, profiles of T2DM treatment, identification of drug-related problems to be discussed, and presented in percentage form.

Patient Characteristics:

The research results from the medical records data of inpatients at Provincial General Hospital of West Nusa Tenggara in 2023 revealed patients diagnosed with T2DM who met the criteria amounted to 88 patients. Based on this number of patients, data on patient characteristics were obtained, including gender, age, and length of hospital stay. The characteristics of T2DM patients based on the research results can be seen in Table 4.1.

Table 4.1 Characteristics of T2DM Patients

Gender	Total	Percentage (%)
Male	42	48
Female	46	52
Total	88	100
Age (years)	Total	Percentage (%)
17-25	1	1
26-35	1	1
36-45	8	9
46-55	27	31
56-65	32	36
>65	19	22
Total	88	100
Length of Stay	Total	Percentage (%)
1-3 hari	18	21
4-6 hari	32	36
7-9 hari	16	18
10-12 hari	18	20
13-15 hari	4	5
Total	88	100

Table 4.2 T2DM Treatment Profile

Drugs	Classification	Total	Percentage (%)
Metformin	Biguanid	32	19,2
Glimepiride	Sulfoniurea	11	6,6
Gliquidone	Sulfoniurea	5	3,0
Pioglitazone	Tiazolidindion	1	0,6
Novorapid	Insulin	54	32,3
Lantus Solostar		38	22,8
Levemir		19	11,4
Ryzodeg		5	3,0
Apidra Solosal		2	1,2
Total		167	100

Table 4.3 Issues and Number of DRP Incidents

Problems	Code V9.1	Total	Percentage (%)
Indication not treated	P1.3	6	7,4
Drug interactions	P2.1	42	51,9
Inappropriate drug according to guidelines/formulary	C1.1	0	0
Drug without indication	C1.2	31	38,3
Inappropriate drug dosage form (for patients)	C2.1	0	0
Drug dosage too low	C3.1	0	0
Dosage too high	C3.2	1	1,2
Incorrect drug, strength, or recommended dosage	C5.3	1	1,2
Drug used with incorrect route	C6.6	0	0
Total		81	100

The distribution above indicates that the category of DRPs with the highest number is Drug interactions with a total of 42 incidents (51,9%), followed by Drug without indication with 31 incidents (38,9%), Indication not treated with 6 incidents (7,4%), and Dosage too high and Incorrect drug, strength, or recommended dosage (OTC) each with 1 incident (1,2%) respectively.

DISCUSSION:

Prevalence of T2DM patients is higher in females, with a total of 46 individuals (52%) compared to males, which is 42 individuals (48%). This aligns with previous research indicating that women are more at risk of developing diabetes due to physical factors such as a higher likelihood of increased body mass index¹¹. Conditions like premenstrual syndrome and post menopause make it easier for body fat to accumulate due to hormonal changes, thus increasing the risk of women developing T2DM. According to the Basic Health Research in 2018, diabetic patients in Indonesia are predominantly female (1,78%) compared to male (1,21%)⁵.

Age is one of the major risk factors for T2DM. Although not everyone who ages will develop Type 2 DM, the risk increases with age due to factors such as decreased insulin sensitivity, fat accumulation, and lifestyle. Based on the research results, T2DM patients are predominantly in the age range of 55-65 years (early elderly) with 32 individuals (36%). According to Rosita's study, the age group of 45 years and older is at high risk of developing T2DM, and as age increases, changes in the body's metabolism system occur, resulting in inhibited glucose release. Apart from age, unhealthy lifestyle patterns and genetic history can also increase the likelihood of developing this disease¹¹.

Length of stay (LOS) is an indicator of the quality of medical services provided by hospitals to patients and an important indicator for determining the success of T2DM patient therapy. In this study, LOS is predominantly in the range of 4-6 days with 32 individuals (36%). The average length of stay for T2DM patients is 5 to 6 days, and usually, after inpatient care, patients will undergo regular follow-up. If patients are not controlled, there is a high likelihood of them needing inpatient care again¹².

Based on the distribution of data above, it is evident that the most commonly prescribed drug for T2DM patients is Novorapid (Insulin Aspart) with 54 individuals (32,3%). The extensive use of Novorapid insulin is due to its rapid-acting properties and advantages in terms of administration. The commonly prescribed oral antidiabetic is Metformin (Biguanide) with 32 individuals (19,2%). Metformin is recommended as first-line therapy for most T2DM patients. The main reasons for this choice are its good effectiveness, low risk of hypoglycemia, neutrality towards weight gain, positive effects on cardiovascular outcomes, and affordability. DRPs in T2DM inpatients were obtained from the assessment of medical record data. Identification of DRPs used the PCNE V9.1 classification consisting of DRP issues¹³.

Based on the research results from the assessment of medical records of 88 patients, 34 patients (39%) had non-DRPs, and 54 patients (61%) experienced DRPs with a total of 81 DRP incidents. The classification and number of DRP incidents are presented in Table 4.3.

4.3.1 Untreated Indications (P1.3):

Untreated indications refer to a condition where there is a medical need for appropriate drug therapy but the medication is not provided¹⁴. In the research results, the criterion for untreated indication DRPs was observed in 6 individuals (7,4%), where 5 cases were related to anemia and 1 case was related to T2DM. In cases of anemia, initiation therapy such as supplements or vitamins that could help increase blood production was not administered. Untreated indication for T2DM occurred where patients were diagnosed but initiation therapy such as antidiabetic medication like metformin to prevent blood sugar elevation was not provided. Untreated indications accounted for the highest occurrence of DRPs (47%), with ischemic stroke being a commonly associated issue¹⁵.

Drug interactions occur when the pharmacological effects of one drug alter the potency or effects of another drug. Whenever two or more drugs are taken together, there is a possibility of interaction between them, which can result in increased or decreased effectiveness, adverse reactions, or new side effects that are not observed when the drugs are used separately. These new side effects can be serious enough to affect clinical outcomes and necessitate hospitalization, with incidence rates ranging up to 3,8%. It is important to always consider the possibility of drug interactions when differentiating unusual responses that occur during drug therapy¹⁶^,¹⁷^,¹⁸.

Table 4.4 Drug Interaction Categories

Category	Drug-drug Interactions	Total	Percentage (%)	Mechanism
Mayor	Aspilet +Ramipril	1	1,5	NSAID can reduce the antihypertensive effects of ACE inhibitors
Mayor	Aspilet+Lisinopril	1	1,5	NSAID can reduce the antihypertensive effects of ACE inhibitors
Mayor	Spirunolactone+KSR	1	1,5	Both drugs can increase serum potassium levels
Mayor	Levofloxacin+ Ondansetron	1	1,5	Levofloxacin and ondansetron both prolong the QTc interval
Moderate	Amlodipine+Metformin	7	10,6	Amlodipine reduces the effect of metformin through pharmacodynamic antagonism
Moderate	Aspilet+Bisoprolol	10	15,2	Aspirin reduces the effects of bisoprolol through pharmacodynamic antagonism
Moderate	Aspilet+Clopidogrel	1	1,5	Both increase each other's toxicity through pharmacodynamic synergism
Moderate	Aspilet+Novorapid	7	10,6	Aspirin enhances the effect of insulin aspart through pharmacodynamic synergism
Moderate	Atorvastatin+Valsartan	1	1,5	Atorvastatin can increase the level or effect of valsartan.
Moderate	CaCO3+Amlodipine	1	1,5	Calcium carbonate reduces the effect of amlodipine through pharmacodynamic antagonism.
Moderate	CaCO3+Lisinopril	1	1,5	Calcium carbonate reduces the effect of lisinopril through an unspecified mechanism of interaction.
Moderate	CaCO3+Ramipril	1	1,5	Calcium carbonate reduces the effect of ramipril through an unspecified mechanism of interaction.
Moderate	Candesartan+Bisoprolol	1	1,5	Both increase serum potassium levels.
Moderate	Candesartan+KSR	1	1,5	Candesartan enhances the effect of insulin glargine through an unspecified mechanism of interaction.
Moderate	Candesartan+Lantus	1	1,5	Candesartan enhances the effect of insulin detemir through an unspecified mechanism of interaction.
Moderate	Candesartan+Levemir	3	4,5	Calcium carbonate reduces the effect of ramipril through an unspecified mechanism of interaction.
Moderate	Candesartan+Novorapid	2	3,0	Candesartan enhances the effect of insulin aspart through an unspecified mechanism of interaction.
Moderate	Candesartan+Spirunolactone	1	1,5	Both increase serum potassium levels.
Moderate	Metformin+Lantus	2	3,0	Both enhance each other's effect through pharmacodynamic synergism.
Moderate	Metformin+Levemir	2	3,0	Ramipril increases the toxicity of metformin through an unspecified mechanism of interaction.
Moderate	Metformin+Ramipril	1	1,5	Candesartan enhances the effect of insulin aspart through an unspecified mechanism of interaction.
Moderate	Metformin+Lisinopril	1	1,5	Lisinopril increases the toxicity of metformin through an unspecified mechanism of interaction.
Moderate	Metformin+Nimotop	1	1,5	Nimodipine reduces the effect of metformin through pharmacodynamic antagonism.
Moderate	Metformin+Novorapid	5	7,6	Both enhance each other's effect through pharmacodynamic synergism.
Moderate	Propanolol+Novorapid	1	1,5	Pharmacodynamic antagonism
Moderate	Ramipril+Novorapid	1	1,5	Ramipril enhances the effect of insulin aspart through pharmacodynamic synergy.
Moderate	Spirunolactone+Aspilet	1	1,5	Both increase serum potassium levels.
Moderate	Spirunolactone+ Furosemid	1	1,5	Spironolactone increases and furosemide decreases serum potassium levels.
Moderate	Valsartan+Novorapid	1	1,5	Valsartan enhances the effect of insulin aspart through a nonspecific interaction mechanism.
Minor	Aspilet+Furosemide	1	1,5	Aspirin reduces the effect of furosemide through pharmacodynamic antagonism.
Minor	Dexametason+Ca Gluconas	1	1,5	Dexamethasone lowers calcium gluconate levels by increasing elimination.
Minor	Lansoprazole+ Mecobalamin	1	1,5	Lansoprazole decreases cyanocobalamin levels by inhibiting GI absorption.
Minor	Aspilet+Glimepiride	2	3,0	Aspirin enhances the effect of glimepiride through plasma protein binding.
Minor	Metformin+KSR	2	3,0	Potassium chloride enhances the effect of metformin through pharmacodynamic synergy.
	Total	66	100

Based on the research findings, there are 4 drug interactions categorized as major interactions. Major interactions occur when there is an interaction between drugs that can result in serious clinical consequences, including harmful effects, and require medical intervention. Managing major interactions can also be done by avoiding the simultaneous use of these drugs. The drugs involved in major interactions in this study are aspirin with ACE antihypertensive drugs, where the antihypertensive effects of ACE drugs may be reduced by aspirin. Concomitant administration can lead to significant renal dysfunction. This interaction mechanism is likely related to NSAID ability to reduce renal prostaglandin synthesis, which vasodilates¹⁹. Potential interaction between spironolactone and potassium chloride drugs can increase the risk of severe hyperkalemia. Spironolactone acts as a non-selective aldosterone antagonist that can increase blood potassium levels. Aldosterone plays a role in binding mineralocorticoid receptors in the kidneys, resulting in simultaneous sodium and water reabsorption and potassium excretion. Therefore, concomitant administration can increase the risk of hyperkalemia²⁰. Levofloxacin and ondansetron therapy both prolong the QTc interval. It is advisable to avoid using these drugs if there is an underlying long QTc syndrome, and it is also recommended to monitor EKG if using both drugs together with other drugs that can prolong the QTc interval, electrolyte abnormalities, CHF, or bradycardia. In previous studies, the interaction between levofloxacin and ondansetron was found to be moderately significant; fluoroquinolone antibiotics like levofloxacin can interfere with antidiabetic therapy (metformin). The use of levofloxacin can disrupt glucose homeostasis, possibly originating from effects on the pancreatic beta cells regulating insulin secretion. The subsequent effects that can occur are severe hyperglycemia or hypoglycemia. Generally, severe hyperglycemia is a significant risk factor for pneumonia, but hypoglycemia is at risk of causing greater morbidity and mortality²¹.

Moderate interactions are interactions where the effects can alter the patient's clinical condition and require therapy adjustment, but the effects are generally milder or more limited compared to major drug interactions²². In this study, potentially moderate interactions occurred in 55 cases, with the most frequent being the combination of aspirin and bisoprolol with 10 cases (15,2%). Interactions with antidiabetic drugs in the combination of amlodipine and metformin had 7 cases (10,6%), and aspirin and novorapid had 7 cases (10,6%).

Metformin hydrochloride is an oral medication used to reduce blood glucose levels in patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM). The plasma half-life of metformin is relatively short and requires frequent dosing. With this aim in mind, metformin hydrochloride microcapsules were prepared using hydrophobic polymers such as Eudragit S100, ethyl cellulose, and cellulose acetate with the o/o solvent evaporation technique. Several batches of microcapsules were prepared by varying the drug-to-polymer ratio. The optimized formula was evaluated for drug-polymer interaction using IR spectra and X-ray diffraction to identify any polymorphic changes. Electron microscopy indicated that the prepared microcapsules had discrete spherical shapes and were coated with a continuous layer²³^,²⁴.

The case observed in this study involved amlodipine and metformin being used simultaneously in the morning, potentially leading to interaction. Amlodipine can reduce the effects of metformin through pharmacodynamic antagonism, leading to significant blood sugar reduction or hypoglycemia. Aspirin with insulin aspart, where aspirin can enhance insulin effects, concomitant administration can increase the risk of hypoglycemia. Patients need to be carefully monitored to ensure stable blood glucose control, and blood glucose levels need to be routinely monitored²⁵.

Aspirin, as one type of NSAID, is an integral part of basic healthcare systems. The potential for drug interactions when using multiple medications concurrently is a significant clinical concern. Many patients are unaware that the use of over-the-counter (OTC) analgesics can lead to serious side effects when combined with other common medications such as anticoagulants, corticosteroids, or antihypertensive agents. The use of aspirin, an NSAID, significantly increases the risk of upper gastrointestinal issues in patients who also take conventional NSAID. This risk is influenced by dosage and is further heightened in patients who consume more than one type of NSAID or use NSAID concurrently with several other types of medications²⁶.

The next level of interaction is minor interactions. An interaction is categorized as minor if the effects are mild and can be well managed without therapy changes²². Research results showed 7 minor interaction cases, with occurrences in aspirin with furosemide with 1 case (1,5%), aspirin with glimepiride with 2 cases (3%), metformin with potassium chloride with 2 cases (3%), lansoprazole with mecobalamin with 1 case (1,5%), and dexamethasone with calcium gluconate with 1 case (1,5%). An example of a minor interaction level in the use of the combination drug potassium chloride with metformin is a pharmacodynamic interaction where potassium chloride can synergistically enhance the effects of metformin, which risks causing hypoglycemia²⁷.

Unindicated Drugs (C1.2):

Unindicated drugs refer to the administration of antidiabetic medication that does not align with the patient's indications or diagnosis. Providing medication without clear medical indications can not only harm patients by potentially causing side effects but also result in unnecessary financial burden. Based on the research findings of DRPs criteria, unindicated drugs were observed in 29 patients with a total of 31 DRPs occurrences (38.3%).

Table 4.5 Unindicated Drugs Category

Drugs	Total	Percentage (%)
Omeperazole	16	52%
Alprazolam	8	29%
Valsartan	1	3%
Antasida Sirup	1	3%
Clobazam	2	6%
Lansoperazole	1	3%
Gabapentin	1	3%
Total	31	100

Based on the data distribution above, it shows that unindicated drugs most commonly occur with omeprazole, with 16 occurrences (52%), followed by Alprazolam with 9 occurrences (29%), Clobazam with 2 occurrences (6%), and syrup antacid, Clobazam, Lansoprazole, Gabapentin each with 1 occurrence (3%). Omeprazole and Lansoprazole injections are Proton Pump Inhibitor (PPI) drugs used to treat excessive stomach acid. These drugs are commonly indicated for conditions such as Zollinger-Ellison Syndrome, duodenal ulcers, gastric ulcers, GERD, gastritis, and dyspepsia. Alprazolam and Clobazam belong to the benzodiazepine class, used to treat anxiety and panic disorders. Specifically, clobazam can be used as adjunctive therapy in epilepsy. Gabapentin is an anticonvulsant indicated for epilepsy, neuropathic pain, and postherpetic neuralgia. Valsartan is an angiotensin receptor blocker (ARB) antihypertensive drug that works by inhibiting angiotensin II receptors. Valsartan is generally indicated for hypertension, post-myocardial infarction, and heart failure.

High Dosage (C3.2):

The category of high dosage can be interpreted as when someone uses a medication dose that exceeds the recommended or usual dosage limit as per medical recommendations. Administration of excessive doses can lead to toxic effects, which are effects that can cause poisoning or serious negative impacts on the body. In the research results, the category of high dosage was observed in 1 occurrence (1,2%). The patient received tranexamic acid therapy, 6 doses of 1 gram each, to address complaints of post-traffic accident headache, dizziness, and a lump on the head. The dosage given was too high based on the literature, which suggests tranexamic acid doses of 2,5 ml injected intravenously or intramuscularly divided into 1-2 doses. During or after surgery, 5-25 ml is administered intravenously via infusion.

Incorrect Medication, Strength, or Dosage Recommendation (C5.3):

Based on the DRPs research results, 1 occurrence (1,2%) was identified in the category of incorrect medication, strength, or dosage recommendation, namely the medication Fleet Enema. The research findings indicate that the prescription and use of Fleet Enema were given as 2 doses of ½ bottle, where the dosage and strength did not align with the literature. The literature describes Fleet Enema as a medication for relieving constipation and bowel cleansing before rectal examination, containing sodium biphosphate 19 g and disodium phosphate 7g. The adult dosage is 1 bottle administered rectally.

CONCLUSION:

Drug Related Problems (DRPs) occurred in (61%) of patients with T2DM. This research is categorized into the following DRPs identified: adverse drug reactions may occur at (51,9%), unindicated drug use at (38,3%), untreated indications at 7,4%, high dosage of drugs at (1,2%), and incorrect medication strength or dosage at (1,2%).

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

ACKNOWLEDGMENTS:

University of Muhammadiyah Mataram and The Provincial General Hospital of West Nusa Tenggara

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Received on 03.04.2024 Revised on 12.07.2024

Accepted on 01.10.2024 Published on 10.04.2025

Available online from April 12, 2025

Research J. Pharmacy and Technology. 2025;18(4):1597-1603.

DOI: 10.52711/0974-360X.2025.00229

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