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Assessing prescriptions for potentially inappropriate medications using Beer's criteria in elderly in-patients at a tertiary care hospital.

INTRODUCTION

The population of the elderly is increasing rapidly worldwide, and as per Population Census 2011, there are nearly 104 million elderly persons (aged 60 years or above) in India. [1] Elderly people are prone to chronic and degenerative pathophysiology leading to polypharmacy. Various characteristics of aging affect medication prescribing for the elderly population and render the selection of appropriate pharmacotherapy a challenging and complex process. [2,3] Prescription of medicines is an essential element in the care of elderly people, and optimization of drug prescribing for this group of patients has become an important public health issue worldwide. [2,4]

Use of drugs in elderly people is often inappropriate, partly due to the complexities of prescribing in elderly patients and presence of several comorbidities and associated poly-medication, exposing them not only to adverse drug reactions (ADR) but also to drug interactions and compliance errors. [5] Beers criteria are the most frequently cited comprehensive set of explicit criteria in older persons to assess inappropriate prescriptions. [6] It has proven useful in identifying drugs to be potentially avoided in older adults, to reduce adverse drug events and drug-related problems and improve medication selection and overall medication safety. The original Beers criteria published in 1991 are regularly reviewed and updated by the American geriatric society (AGS). [7] The present beers criteria 2015 are an updated version that includes drugs to always avoid, drugs to use with caution, drug-disease interactions, drug-drug interactions, and drugs to be avoided or dose reduced with varying levels of kidney function.

Inappropriate prescribing can cause substantial morbidity, with the unfavorable clinical outcome and add to the economic burden of the patients and society. [2] Hence, this study was conducted to review the prescriptions of all elderly inpatients in the medicine ward for potentially inappropriate medication using AGS Beers criteria 2015.

MATERIALS AND METHODS

After obtaining clearance from the Institutional Ethics Committee, this cross-sectional study was conducted in the inpatient ward of the department of general medicine at a tertiary care teaching hospital in Bengaluru for a period of 3 months. Patients of age 60 years and above of both sexes were enrolled in the study after taking informed consent. Patients on ventilators or critically ill patients requiring intensive care unit admission were excluded.

The relevant data were collected from case records and evaluated for the World Health Organization (WHO) core prescribing indicators, average number of drugs per prescription, percentage of drugs prescribed by generic name, percentage of encounters with an antibiotic prescribed, percentage of encounters with an injection prescribed, percentage of drugs prescribed from national list of essential medicine (NLEM), distribution of comorbidities, category-wise distribution of drugs (taking into consideration the number of active ingredients in a multidrug formulation), and reviewed for potentially inappropriate medication using AGS Beers criteria 2015. The data thus obtained were analyzed using descriptive statistics.

2015 AGS Beers Criteria [7]

Beers criteria for potentially inappropriate medicine (PIM) Use in Older Adults are an explicit list of PIMs avoided in older adults:

A. Drugs that generally should be avoided in older adults

B. Drugs to be avoided in combination with specific comorbidities

C. Drugs to be used with caution

D. Drug-drug interactions that should be avoided in elderly

E. Drugs to be avoided or dosage reduced with varying levels of kidney function.

RESULTS

A total of 300 in-patients records were reviewed. 59.34% of patients were males (178/300). The age of patients ranged from 60 to 98 years, 74% of (222) patients belonged to 60-75 years age group [Figure 1]. The morbidity pattern was respiratory disorders 28.3%, neurological disorders 19.3%, and infectious diseases 15.7% [Figure 2]. The comorbidity pattern was diabetes mellitus 35.8%, hypertension 30.7%, and both 24.33%.

A total of 2175 drugs were prescribed with an average of 7.25 drugs per prescription (Range: 2-18), of which 24.8% were drugs acting on gastrointestinal (GI) system followed by antimicrobials (22.5%) [Figure 3]. Among the GI drugs, antiulcer drugs and antiemetics were the most frequently prescribed drugs (8.4% and 6.4%, respectively). 22.5% were antimicrobials with ceftriaxone being most commonly used. In the present study, 16.5% of the drugs were prescribed by its generic name. 57% of drugs were given parenterally, 36% by oral route and 7% through inhalational route. 16.5% of prescriptions had at least three antimicrobial drugs (Range-0-5), and 37% of prescriptions were having two antibiotics. 15% of the drugs prescribed were fixed-dose combinations (FDC), with the majority of them being drugs acting on the respiratory system and antimicrobials. 90.8% of prescribed drugs were present in the NLEM list.

On application of Beers criteria, 2015 to all the 300 prescriptions, 86 (28.6%) of them had one or more PIM. A total of 2175 drugs were prescribed, of which 48 drugs were identified as drugs that generally should be avoided in older adults. Prescriptions with nitrofurantoin were 14 and prescriptions with hyoscine were 12. Prescriptions with nifedipine, chlorpheniramine, and atropine were 6 each followed by 4 prescriptions of lorazepam. Prescriptions containing the drugs to be avoided in combination with specific comorbidities were 10, in which, 5 cases of heart failure were prescribed nonsteroidal anti-inflammatory drugs (NSAIDs), and 5 cases of delirium received lorazepam or ranitidine. In the present study, 76 medications were to be used with caution in the elderly. These were diuretics 17.33% (52) and vasodilators 5.6% (17) followed by aspirin 2% and carbamazepine 0.3%. A total of 16 potential drug-drug interactions were identified that could have been avoided in elderly. 6 cases with reduced creatinine clearance received ranitidine [Table 1].

DISCUSSION

Toxic effects of medications and drug-related problems can have profound medical and safety consequences for older adults and economically affect the health-care system. [8] Polypharmacy is one of the major risk factors for drug-related problems. The definition polypharmacy is variable, but the most frequently used definition is, the use of five or more medications in a single prescription. [9] In the present study, an average of 7.25 drugs was prescribed per prescription, to the high prevalence of Helicobacter pylori infection and increasing prescriptions of drugs damaging gastro-duodenal mucosa, such as NSAIDs and/or aspirin (acetylsalicylic acid) in the elderly population. [14] This was followed by systemic antimicrobials to combat infections such as LRTI, urinary tract infection, and gastroenteritis which were common ailments in the study population, due to the age-related progressive impairment in immune function making them more susceptible to infections. [15] This pattern was similar to the study done by Veena et al.
Figure 1: Age and gender distribution of the patients

                Age group

               Male         Female

60-74         44.34         29.66
75-89         14.66         10
90-104         0.34          1

Note: Table made from bar graph.

Figure 2: Morbidity pattern of the elderly patients

Respiratory system              28.3
Central nervous system          19.3
Infections                      15.7
Gastroenteric system            11.7
Diabetes                        10.3
Hanging, Poison. Snake bite      6
Cardiovascular system            5.7
Anemia                           2.7
CKD                              0.3

Note: Table made from pie chart.

Figure 3: System-wise drug utilization pattern in elderly patients

                 N=2175

Gastro intestinal system   24.8
Antimicrobials             22.5
Cardiovascular system      10.9
Respiratory system          7.4
Antihypertensive drugs      7.1
Miscellaneous               6
Nutrients                   5.8
Analgesics                  5
Steroids                    4.8
Anti-diabetic drugs         4.6
Central nervous system      1.1

Note: Table made from bar graph.


In the present study, the majority of drugs were given through parenteral route mainly injections followed by inhalational route, as the study populations were in-patients and parenteral route in the elderly gives the benefit of faster action, less gastrointestinal irritation, and higher systemic availability. The drugs given by parenteral route were IV fluids and antimicrobials, mainly ceftriaxone, metronidazole, and the combination of piperacillin and tazobactam for infections such as pneumonia, gastroenteritis, and sepsis. Bronchodilators and inhalational corticosteroid were administered by inhalational route for COPD and pneumonia. The percentage of drugs given by parenteral route is comparatively lower to the findings in the studies conducted by Shankar et al. [13] and Mandavi and Tiwari. [16] This is because both the studies have included in-patients of surgical specialties and medical specialties, whereas the present study, included only in-patients of the medicine department.

Drugs prescribed by its generic name were higher compared to studies conducted by Nayaka et al. (8.9%) [17] and Narvekar et al., [18] this could be attributed to increasing awareness about prescribing medicines using generic names. However, it was low as per the WHO recommendation of 100%, thus requiring more effective promotion of better prescription practices.

The prescriptions containing FDCs of the study population were low, and the combinations were rational. Commonly prescribed FDCs were the combination of piperacillin and tazobactam, salbutamol and ipratropium, and aspirin and atorvastatin followed by the combination of telmisartan and hydrochlorothiazide. All of these combinations were synergistic and rational. Prescription of rational FDCs is known to decrease the pill burden thus increasing medication compliance in the elderly population.

When analyzing the prescriptions of the present study using 2015 Beers criteria, the most common PIMs prescribed to the elderly were diuretics, vasodilators, nitrofurantoin, and anticholinergics. Diuretics have to be used with caution in elderly as these are known to cause or exacerbate syndrome of inappropriate antidiuretic hormone secretion or cause hyponatremia and thereby making it mandatory to monitor sodium levels when starting or changing the dose of diuretics. [7] Vasodilators are known to increases the risk of syncope in the elderly. Anticholinergics such as hyoscine, atropine, and the first generation antihistaminics, all are known to have reduced clearance in elderly [15] causing anticholinergic toxicity resulting in dry mouth, constipation, delirium, and confusion. Nitrofurantoin, as a urinary antiseptic in elderly, is one of the drugs that have been included in updated Beers criteria 2015 as PIMs because it has the potential for pulmonary toxicity, hepatotoxicity, and peripheral neuropathy, especially with long-term use and has to be avoided in patients with creatinine clearance <30 mL/min. [7]

The number of prescriptions containing PIMs was relatively low as compared to the study done by Narvekar et al. [18] (44%). In previous studies, [12,13] PIMs are relatively lesser than the present study as they followed Beers criteria 2012. This inconsistency is because the 2015 Beers Criteria have several significant updates, including the addition of new drugs, the addition of selected medications for which dose adjustment is required based on kidney impairment, and the addition of selected drug-drug interactions. This was done using a comprehensive, systematic review, and grading of the evidence on drug-related problems and adverse drug events. The prescriptions of PIMS may be attributed to the less awareness about the evidence-based guideline for appropriate prescribing in the elderly patients and the existence of particulars justifying exceptions to the rules in individual persons. Elderly patients suffer ADRs caused by suboptimal or inappropriate drug prescriptions, but Beers criteria do not address the suboptimal prescriptions.

Limitations of the study were that it was a cross-sectional study with only PIMs were noted using Beers criteria 2015 and the follow-up of the patients receiving PIMs was not done to verify the real-time adverse reactions in the elderly population.

CONCLUSION

Polypharmacy and PIMs are prevalent in elderly and are potential risk factors for drug-related problems. Hence, optimization of drug prescribing for the elderly is the need of the hour, and there is an urgent need for guidelines in India, to define and categorize appropriate prescribing in the elderly. It also calls for a critical review of the tools that are available to measure the inappropriate prescriptions and their effects and discuss their predictive validity in Indian population. More so physicians have to integrate clinical and pharmacological perspectives when reviewing medications for the elderly.

ACKNOWLEDGMENTS

The authors would like to thank the Faculty of the Department of Pharmacology, BMC, and RI, Bengaluru, for their support in conducting the study.

REFERENCES

[1.] Borah H, Shukla P, Jain K, Kumar SP, Prakash C, Gajrana KR. Elderly in India Central Statistics Office Ministry of Statistics and Programme Implementation, Government of India; 2016 Available from: www.mospi.nic.in/sites/default/files/publication_reports/ElderlyinIndia_2016.pdf. [Last cited on 2018 Aug 07].

[2.] Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, et al. Appropriate prescribing in elderly people: How well can it be measured and optimised? Lancet 2007;370:173-84.

[3.] Hedna K, Hakkarainen KM, Gyllensten H, Jonsson AK, Petzold M, Hagg S. Potentially inappropriate prescribing and adverse drug reactions in the elderly: A population-based study. Eur J Clin Pharmacol 2015;71:1525-33.

[4.] Straand J, Rokstad KS. Elderly patients in general practice: Diagnoses, drugs and inappropriate prescriptions. A report from the more and Romsdal prescription study. Fam Pract 1999; 16:380-8.

[5.] Zaveri HG, Mansuri SM, Patel VJ. Use of potentially inappropriate medicines in elderly: A prospective study in medicine out-patient department of a tertiary care teaching hospital. Indian J Pharmacol 2010;42:95-8.

[6.] Ryan C, Mahony D, Kennedy J, Weedle P, Byrne S. Potentially inappropriate prescribing in an Irish elderly population in primary care. Br J Clin Pharmacol 2009;68:936-47.

[7.] American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American geriatrics society 2015 updated beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc 2015;63:2227-46.

[8.] Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the beers criteria for potentially inappropriate medication use in older adults. Arch Intern Med 2003;163:2716-24.

[9.] Vrdoljak D, Borovac JA. Medication in the elderly-considerations and therapy prescription guidelines. Acta Med Acad 2015;44:159-68.

[10.] Sapkota S, Pudasaini N, Singh C, Sagar GC. Drug prescribing pattern and prescribing error in elderly: A retrospective study of inpatient record. Asian J Pharm Clin Res 2011;4:129-32.

[11.] Abraham F, Varughese G, Mathew JC, John PM, Sam GK. Drug utilization pattern among geriatric patients admitted in medical intensive care unit of a tertiary care teaching hospital. Asian J Pharm Clin Res 2015;8:281-3.

[12.] Veena DR, Padma L, Patil S. Drug prescribing pattern in elderly patients in a teaching hospital. J Dent Med Sci 2012;1:39-42.

[13.] Shankar PR, Upadhyay DK, Subish P, Bhandari RB, Das B. Drug utilisation among older inpatients in a teaching hospital in western Nepal. Singapore Med J 2010;51:28-34.

[14.] Pilotto A, Franceschi M, Maggi S, Addante F, Sancarlo D. Optimal management of peptic ulcer disease in the elderly. Drugs Aging 2010;27:545-58.

[15.] Montecino-Rodriguez E, Berent-Maoz B, Dorshkind K. Causes, consequences, and reversal of immune system aging. J Clin Invest 2013;123:958-65.

[16.] Mandavi, Tiwari P. Profile of pharmacotherapy in elderly Indian patients; Preliminary finding. Int J Risk Saf Med 2006; 18:151-7.

[17.] Nayaka SR, Rajeshwari B, Venkatadri TV. Drug utilization pattern in geriatric inpatients of medicine department in a tertiary care teaching hospital. Int J Basic Clin Pharmacol 2015; 4:568-73.

[18.] Narvekar RS, Bhandare NN, Gouveia JJ, Bhandare PN. Utilization pattern of potentially inappropriate medications in geriatric patients in a tertiary care hospital: A retrospective observational study. J Clin Diagn Res 2017;11:FC04-8.

Shukrath Chandrappa, Divya R, Kavitha Rajarathna

Department of Pharmacology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India Correspondence to: Kavitha Rajarathna, E-mail: kavitharajarathna@gmail.com

Received: November 18, 2018; Accepted: December 11, 2018

DOI: 10.5455/njppp.2019.9.1236011122018
Table 1: Potentially inappropriate medications using Beer's criteria in
elderly patients

Drugs that generally should be avoided in older adults

Drugs             Number of prescription

Nitrofurantoin    14
Hyoscine          12
Nifedipine         6
Chlorpheniramine   6
Atropine           6
Clonazepam         3
Lorazepam          1
Total             48

Drugs to be avoided in combination with specific comorbidities

Comorbidities  Drugs       Number of prescription

Heart failure  NSAIDs      5
Delirium       Ranitidine  4
               Lorazepam   1

Drugs to be used with caution

Drugs              Number of prescription

Diuretics          52
Vasodilators       17
Aspirin(<80 Crcl)   6
Carbamazepine       1

Drug-drug interactions that should be avoided in Elderly

Drug-drug interaction  Number of drug-drug
                       interactions

NSAIDs-corticosteroid  16

Drugs to be avoided or Dosage reduced with varying levels of kidney
function

Drugs                  Number of prescription

Ranitidine (<50 Crcl)  6

NSAIDs: Nonsteroidal anti-inflammatory drug
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Title Annotation:RESEARCH ARTICLE
Author:Chandrappa, Shukrath; Divya, R.; Rajarathna, Kavitha
Publication:National Journal of Physiology, Pharmacy and Pharmacology
Article Type:Clinical report
Date:Feb 1, 2019
Words:2677
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