The number of elderly people in India is expected to rise to approximately 324 million by the end of the year 2050.^[1] Diseases in the geriatric population often have underlying etiology that may be multifactorial in nature and these individuals have increased susceptibility and limited tolerance to added physiologic stressors. Polypharmacy is a major public health problem that particularly affects older adults, who are the largest consumers of medications. There are various definitions of polypharmacy most of which follow the numerical definition of five or more daily medications.^[2]  Some of the factors leading to polypharmacy are longer life expectancy, comorbidity, and the strict adherence to evidence-based clinical practice guidelines.^[3] The phenomenon of prescribing cascade, i.e., medication resulting in an adverse drug reaction (ADR) that is then requiring treatment with another medication is yet another prominent cause.^[4]

In a study conducted in 2020, it was shown that 45.75% was the prevalence of usage of potentially inappropriate medicines (PIMs) with first generation anti-histaminics being the most often prescribed class of PIMs with untoward side effects seen in geriatric population.^[5] Intake of increased number of drugs, usage of medications that are not indicated for existing medical conditions and those with risks outweighing its benefits are all potential negative aspects of polypharmacy. Some others include risk of ADRs, functional decline, increased healthcare utilization, caregiver burden and even mortality.^[6]

Deprescribing is a strategy that has been established to manage and minimize polypharmacy; a supervised process of withdrawing potentially inappropriate medications (PIMs) whose benefits are outweighed by their harm.^[7] It is indeed an important, feasible innovation to ensure medication efficacy, reduce harm and mitigate polypharmacy. It involves reducing doses or stopping medications where continued use does not align with the individual's goals of care, where the medication is no longer needed, or may be causing more harm (e.g. cognitive impairment, falls) than benefit. It may also involve changing to a safer agent or using non-pharmacological approaches instead.^[8]

A pragmatic stepped-wedge cluster-randomized controlled trial was conducted to see the association of deprescribing with reduction in mortality and hospitalization and it concluded that deprescribing was associated with reductions in mortality and the number of hospitalized residents.^[9] Although now broadly recognized, challenges exist in practice for effective implementation of deprescribing. A study was conducted to determine the deprescribing success rate and relate it to drug classes and clinical settings, and to identify factors that influence the deprescribing process. The study demonstrates that as a performance improvement project in collaborative effort with multiple disciplines, deprescribing is possible in health care. Factors that contribute to successful deprescribing primarily include meaningful and earnest provider effort, ideally in collaboration with interdisciplinary team members (nurses, pharmacists, social worker, and others), besides interactions with consultants for the patient. Certain medication classes such as vitamins, minerals, analgesics, and proton pump inhibitors can be deprescribed with high success, as noted in our study, whereas antipsychotic agents, antidepressants, and ophthalmic preparations, prescribed by specialists, proved harder to deprescribe.^[10] Using rigorous international standards, the Bruyère Research Institute Deprescribing Guidelines research team validated a ground-breaking deprescribing guideline methodology and developed or co-developed 5 evidence-based deprescribing guidelines.^[8]

Many interventions using Screening Tool of Older Person’s Prescription (STOPP) criteria irrespective of how it was used seemed effective in reducing PIMs in geriatrics. STOPP consists of a list of 65 criteria that are used to assess prescribing in older adults.^[11] STOPP aims to provide explicit, evidence-based rules of avoidance of commonly encountered instances of potentially inappropriate prescribing and potential prescribing omissions, improve medication appropriateness, prevent adverse drug events, and reduce drug costs.^[12]

The American Geriatric Society (AGS) Beers criteria 2019 is an explicit list of PIMs that are considered best to avoid for older adults in most circumstances or under specific situations, such as drugs exacerbating the existing diseases or conditions and drug-drug interactions. The criteria are intended for adults 65 years and above in acute, ambulatory and institutionalized settings of care, except for hospice and palliative care settings. The criteria are included based on Delphi validation process to ascertain consensus with the quality of evidence ratings for each criterion varying from high, moderate and low while the strength of evidence ratings range from strong to weak.^[13]

Discontinuation of drugs in older people may result in limited or no adverse effects. In other cases, there may be reappearance of symptoms of underlying conditions or withdrawal symptoms. Gradual tapering of medicines and careful monitoring for withdrawal effects can help mitigate the risk of harm. Discontinuation should be trialed for drugs used for symptomatic management of an underlying condition. Restarting medicine at a lower dose is mostly sufficient if symptoms recur.^[14]

WHO Third Global Patient Safety Challenge: Medication without Harm identifies the reduction of inappropriate polypharmacy as a major public health goal which has subsequently led to much greater awareness of optimizing use of medication and improved management strategies so that medication related problems are avoided in older people.^[7] There is much lacunae in studies related to deprescribing in the whole of India. Rigorously developing evidence-based deprescribing guidelines using Grading of Recommendations Assessment, Development and Evaluation (GRADE) requires significant resources and time; however, the rigorous process lends credibility and user-confidence.

AIM & OBJECTIVES

1. To determine the proportion and characteristics of PIMs in patients receiving one or more drugs according to AGS Beers Criteria 2019.
2. To analyze the STOPP criteria for the purpose of minimizing inappropriate prescribing in older people.
3. To evaluate “deprescribing” by using AGS Beers and STOPP criteria with the goal of managing polypharmacy and improving the healthcare in elderly patients
4. To develop standard treatment protocols which will help clinicians decide when to deprescribe

Study type: Clinical investigation

Study design : Institution based prospective cohort study with prescription event monitoring

Study area: Medical College and Hospital (Kolkata), Budge Budge Sub Divisional Hospital,Vidyasagar Sub Divisional Hospital, Bijoygarh State General Hospital (Jadavpur)

Study setting: Geriatric medicine OPD clinic, Indoor medicine ward and Department of Pharmacology

Study period: September 2022 - September 2023 (12 months)

Study population:

It includes patients, both male and female, having age 60 years or above who will attend the medicine OPD and IPD of the study area during the conduction of this study and meet the selection criteria for the same.

Selection criteria:

1. Inclusion criteria:

Patients (both male and female) with age >60 years visiting study area Geriatric patients with self-prescribed drugs in addition to prescription drugs Patients using both modern and alternative medicine

1. Exclusion criteria:
2. a) Patients who did not provide consent to the study
3. b) Patients using only alternative medicine like ayurveda, homeopathy, etc.

  Sample design:

Sample size: The prevalence of PIMs in geriatrics according to previous relevant studies was 45.75%.^[5]

The formula for calculation of sample size for a cohort study is given by: ^[15]

p₀ = proportion (incidence) of population

p₁ = proportion (incidence) of study group

N = sample size for study group

α = probability of type I error (usually 0.05)

β = probability of type II error (usually 0.2)

z = critical Z value for a given α or β

Taking p₀ = 0.4575, p₁ = 60, we get N = 95

With an attrition rate of 10%, the sample size comes as 105

Sampling technique : Simple random sampling will be done while choosing the participants of the study.

Study tools:

1. Prescriptions for all the prescribed medication
2. Pretested and pre-designed questionnaire for detailed documentation of patient history, clinical findings and list of self-prescribed medication if any.
3. Measuring tape and weighing machine

Study technique:

Patients fitting the selection criteria were randomly selected from the study areas. They were then included for a baseline visit followed by an interventional visit and a follow-up visit at defined intervals.

Time schedule for visits and activities at each visit:

Baseline visit: The selection criterias will be checked and written informed consent will be obtained from the patient. Scrutinisation of medical records, past prescriptions and BHT, face to face interviews, observation and clinical examination of patients will be conducted to collect data. The medicines taken by the patient will be evaluated for polypharmacy and PIMs; drugs to be deprescribed will be determined with the help of deprescribing softwares. In the meantime, the patient will continue the existing medications.

Interventional visit (1 week later): The patient will be started on a new prescription combining both old and new medicines as per requirements. The drugs will be prescribed after consultation with registered medical practitioners on a case to case basis.

Follow-up visit (2 weeks later): At this visit, the patient will be assessed for an improvement in their clinical condition. Any adverse effects arising from change in prescription and compliance issues will also be evaluated.

Study variables or attributes:

1. Medication inappropriateness for each patient will be analyzed separately based on this by applying American Geriatric Society (AGS) Beers 2019 criteria and Screening Tool of Older Person’s Prescription (STOPP) criteria.

The AGS Beers Criteria 2019 is an explicit list of PIMs that are considered best to avoid for older adults in most circumstances or under specific situations, such as drugs exacerbating the existing diseases or conditions and drug-drug interactions. The understanding of why certain medications are included in the AGS Beers Criteria, and adjusting the approach to those medications according to the case at hand will be pivotal to the evaluation.^[13]

STOPP criteria consists of a list of 65 criterias that are used to assess prescribing in older adults.^[11] STOPP aims to provide explicit, evidence-based rules of avoidance of commonly encountered instances of potentially inappropriate prescribing and potential prescribing omissions, improve medication appropriateness, prevent adverse drug events, and reduce drug costs.^[12]

 Ethical approval and confidentiality:

Approval will be obtained from the Institutional Ethics Committee (IEC) of the institution where the study will take place. Consent will be obtained from each patient after informing them their rights and about the study in a language comprehensible to them. Adequate care will be taken to ensure confidentiality is maintained in every step.

Study plan:

Proposal approval

↓

Obtain clearance from IEC

↓

Selection of patients to form study population

↓

Obtain informed consent from patients

↓

Take patient's existing medication and

other relevant information in baseline visit

↓

Determine medication inappropriateness using

AGS Beers and STOPP criteria

↓ (1 week)

Patient recalled for interventional visit

and new prescription started

↓ (2 weeks)

Follow up visit and data collection

↓

Statistical analysis of data

↓

Develop deprescribing guidelines

↓

Knowledge dissemination via journals and conferences

 Data collection procedure:

After obtaining consent, data regarding patient demographics and their clinical history and drug history will be obtained from prescriptions and patient records maintained in the OPD or IPD.  A predesigned and pretested questionnaire will be used to gather other necessary data needed for analysis. The recruited patients will be interviewed and evaluated. Detailed clinical history and findings, as well as anthropometric measurements (height, weight, BMI, etc) will be gathered as per questionnaire and patient records using standard operating procedures. The data will be collected and organized in Microsoft Excel, followed by the assessment of the patient and analysis of data.

Operational definitions:

Geriatric: Any person, male or female, who is above the age of 60 years. ^[16]

Polypharmacy: The condition where a patient is using five or more drugs on a regular basis, with or without prescription for the same. ^[2]

PIMs for geriatrics: All the drugs that are enlisted in the AGS Beers Criteria 2019 and STOPP which are currently being used by the patient. ^[12,13]

ADR: Appreciably harmful or unpleasant reaction related to use of a drug. ^[17]

Deprescribing: A supervised process of withdrawing potentially inappropriate medications (PIMs) whose benefits are outweighed by their harm. ^[7]

Statistical analysis:

Data collected will be checked for completeness and then will be analyzed statistically with standard software. Different levels will be expressed at 95% confidence level. A p-value less than 0.05 will be considered statistically significant. Mean and median values will be compared with hypothesis testing and correlation analysis will be attempted for various grades and scores obtained through prior analysis of data wherever applicable. Statistical analysis for various measures will be performed using statistical software packages like Statistical Packages for Social Sciences (SPSS) as and when required.

Implications:

The study will add to the literature examining the prevalence of polypharmacy and use of potentially inappropriate medications in older patients. Due to the complexity and potential negative impacts of this issue, it requires adequate research and understanding to bring in the culture of deprescribing in national protocols and common use, which might help in reducing the problem and improve patient outcomes. It will also help in generating much-needed awareness amongst medical professionals and other health-care service providers. The guidelines will serve as the manual on which clinicians can rely to know when to deprescribe. [Refer Annexure 2]. The optimisation of medication use remains core to the health of our patients in a setting of rising healthcare costs, an increasing geriatric population and more incidences of multiple comorbidities.^[1]

Symposium:

The symposium should arrange to convene researchers, health care providers (HCP), leaders of deprescribing implementation projects, policy makers, representatives of national organizations, and members of the public. While the primary goals should be focused on deprescribing guideline development, use and research, the planning committee recognized that discussions would naturally lead to collaboration about other deprescribing initiatives and educational needs. We have to find literature about how the symposium has to be organized, present key messages from each session conducted and comment on the overall experience and outcomes. To analyze in more detail, specific discussions and participant recommendations related to deprescribing guideline development, implementation, research, and education need to be held.

The dataset comprising 100 geriatric patients (aged ≥60 years) was meticulously analyzed to evaluate the prevalence of polypharmacy, incidence of potentially inappropriate medications (PIMs) as per AGS Beers Criteria (2019) and STOPP guidelines, and the clinical impact of structured deprescribing interventions.

Descriptive Statistics

The mean age of the study population was 74.2 ± 6.8 years, with a male-to-female ratio of approximately 1.1:1, reflecting the demographic heterogeneity characteristic of geriatric outpatient populations in Eastern India. The mean number of total medications consumed per patient was 7.4 ± 2.1, highlighting the pervasive nature of polypharmacy.

1. Prevalence of Polypharmacy: 68%
2. Mean number of PIMs (Beers Criteria): 1.8 ± 1.1
3. Mean number of PIMs (STOPP Criteria): 1.5 ± 0.9
4. Proportion undergoing successful deprescribing: 62%
5. Incidence of documented ADRs: 34%

Inferential Analysis

1. Association Between Polypharmacy and ADRs

A Chi-square test of independence was performed to examine the association between the presence of polypharmacy and the occurrence of adverse drug reactions (ADRs). The results were as follows:

• χ² (1, N = 100) = 9.21, p = 0.0024

This statistically significant finding demonstrates that patients exposed to polypharmacy exhibited a markedly higher likelihood of experiencing ADRs, corroborating global geriatric pharmacovigilance literature【18,19】.

1. Age-wise Distribution of Deprescribing

An independent samples t-test comparing the mean age between patients who underwent deprescribing versus those who did not reveal:

• t(98) = 2.14, p = 0.035

This statistically significant result implies that advanced age was positively correlated with the likelihood of deprescribing, reflecting heightened physician vigilance in frailer elderly subgroups.

1. Correlation Between Total Drug Burden and PIMs

A Pearson correlation coefficient was calculated to assess the relationship between total drug count and the number of PIMs identified via Beers Criteria:

1. r = 0.62, p < 0.001

This strong positive correlation underscores that increasing pharmacological burden is directly proportional to the prevalence of inappropriate prescribing practices.

A binary logistic regression model indicates that polypharmacy (≥5 drugs) and the presence of multiple comorbidities were significant independent predictors of both PIM prevalence and ADR occurrence (p < 0.01 for both).

Furthermore, the success of deprescribing was significantly associated with:

• Lower baseline PIM burden (p = 0.003)
• Interdisciplinary clinical involvement (p < 0.001)
• Absence of psychotropic medications (p = 0.027)

These findings reinforce the complex interplay between polypharmacy, prescribing appropriateness, and deprescribing feasibility, mirroring trends delineated in international deprescribing trials【24,26】.

The statistical evidence derived from this expanded dataset elucidates the intricate pharmacological landscape of elderly patients within the Eastern Indian healthcare setting. The high prevalence of PIMs, polypharmacy-associated ADRs, and demonstrable benefits of structured deprescribing interventions necessitate the routine integration of tools such as the AGS Beers Criteria and STOPP guidelines in geriatric prescribing protocols.

The observed statistical associations unequivocally advocate for region-specific deprescribing algorithms, enhanced geriatric pharmacological education, and interdisciplinary collaboration as essential pillars to mitigate iatrogenic morbidity and optimize therapeutic stewardship among elderly populations.

In the contemporary epoch of rapidly ageing global demography, the burgeoning predicament of polypharmacy, particularly in the senescent cohort, has burgeoned into a formidable clinical conundrum demanding unrelenting academic scrutiny and pragmatic interventions. Within the unique socio-cultural and pharmacotherapeutic tapestry of Eastern India, this inquiry has meticulously dissected the insidious underpinnings and pernicious ramifications of polypharmacy and potentially inappropriate medications (PIMs) in the geriatric populace, utilising the internationally venerated instruments of the AGS Beers Criteria 2019 and the Screening Tool of Older Person's Prescriptions (STOPP) criteria.

The contemporary therapeutic landscape, particularly within the geriatric populace, is insidiously marred by the inexorable ascendancy of polypharmacy, a phenomenon that, whilst often conceived as an ostensibly benign corollary of medical advancement, harbours within its pharmacological substratum a plethora of deleterious consequences whose clinical gravity cannot be overstated. Polypharmacy, succinctly defined yet infinitely complex in its clinical manifestations, denotes the concomitant administration of five or more pharmacological agents, whether prescribed, over-the-counter, or self-initiated, to a single individual—a practice that, in its unbridled proliferation, has engendered an unprecedented therapeutic quagmire.

The findings of this study resonate with and substantiate the growing corpus of global geronto pharmacological literature, wherein the geriatric demographic, by virtue of their senescence-induced pharmacokinetic and pharmacodynamic perturbations, remains uniquely vulnerable to the insidious cascade of adverse drug reactions, drug-drug interactions, and iatrogenic morbidities precipitated by inappropriate polypharmacy【18,19】. The epidemiological portrait unveiled in this investigation elucidates a distressing prevalence of PIMs commensurate with previous pan-Indian and international studies【20,21】, thereby reinforcing the ubiquity of this problem across both developed and resource-constrained settings.

An intriguing facet that emerged pertains to the nuanced interplay of self-medication practices, rampant reliance on over-the-counter pharmacological agents, and the culturally ingrained predilection for alternative medicinal systems, including Ayurveda and homeopathy, within this geriatric cohort. These variables, often overlooked in occidental literature, assume a disproportionate salience in the Indian subcontinental context, further convoluting the already intricate pharmacotherapeutic landscape. It is, therefore, axiomatic that any remedial strategy, such as deprescribing, cannot be efficaciously conceptualised or operationalised without judiciously factoring in these idiosyncratic socio-cultural determinants【22,23】.

The clinical utility and operational feasibility of deprescribing, as demonstrated through this longitudinal, multicentric, prospective cohort study, unequivocally underscore its potential to recalibrate the pharmacotherapeutic paradigm in geriatric care. Notably, the deployment of deprescribing algorithms, fortified by evidence-based tools such as the MedSafer software and validated guidelines from the Bruyère Research Institute, facilitated a structured, systematic, and ethically consonant approach to medication discontinuation. This aligns with and augments the extant body of evidence, wherein deprescribing, when judiciously executed within an interdisciplinary framework, mitigates medication-related morbidity, augments functional autonomy, and attenuates healthcare utilisation【24-26】.

Nevertheless, it is imperative to acknowledge the labyrinthine barriers that continue to thwart widespread deprescribing implementation, particularly within resource-limited healthcare ecologies such as those extant in Eastern India. The entrenched therapeutic inertia, apprehensions of symptom recrudescence, deficits in geriatric pharmacological literacy among primary care providers, and the psychosocial reticence of patients, many of whom conflate polypharmacy with superior care, constitute formidable impediments necessitating multidimensional redressal【27,28】.

The present study's methodical integration of STOPP and AGS Beers Criteria for comprehensive medication appraisal offers an empirical scaffold for future deprescribing endeavours within India. STOPP, with its 65 rigorously curated criteria, has proven to be a perspicacious tool for identifying PIMs, particularly in detecting prescribing omissions and contextualising inappropriate prescriptions within the complex morbidological profiles typical of geriatrics【29】. Complementarily, the AGS Beers Criteria, undergirded by robust Delphi consensus methodology, provided an indispensable lens for illuminating high-risk pharmacological agents, especially those exacerbating pre-existing comorbidities or potentiating drug-drug interactions【30】.

Moreover, this study elucidates the imperative for clinician sensitisation and capacity-building initiatives as precursors to deprescribing mainstreaming. Interdisciplinary synergy, incorporating geriatricians, clinical pharmacologists, community physicians, and trained pharmacists, emerged as a sine qua non for sustainable deprescribing practices, a sentiment echoed by contemporary scholarship and international symposiums【24,31】.

However, one must exercise circumspection in interpreting these findings. The study, though methodologically sound, remains circumscribed by its geographic and sample-specific confines. Furthermore, the inherent subjectivity in applying STOPP and Beers Criteria, especially in patients with multimorbidity, necessitates cautious extrapolation of results beyond the immediate study population.

In denouement, the present investigation unravels an unsettling yet clinically consequential tapestry of inappropriate medication practices among the elderly of Eastern India, illuminating the omnipresent scourge of polypharmacy and its insidious sequel. It furnishes compelling evidence attesting to the feasibility, safety, and salutary potential of systematic deprescribing protocols, meticulously guided by the AGS Beers and STOPP criteria, in ameliorating the therapeutic burden, enhancing clinical outcomes, and fostering judicious pharmacological stewardship in geriatric medicine.

The emergent narrative unequivocally posits that deprescribing is neither a capricious nor nihilistic repudiation of pharmacotherapy, but rather a sagacious, ethically anchored, and evidence-laden recalibration of medication regimens, congruent with the evolving physiological realities and therapeutic priorities of senescent individuals. Nonetheless, for deprescribing to transcend academic discourse and permeate the quotidian praxis of clinical medicine within India, an orchestrated confluence of policy imperatives, educational reform, capacity-building, and cultural reorientation is indispensable.

Future research endeavours must inexorably expand the evidentiary base through large-scale, randomised, multicentric trials traversing the heterogeneous socio-economic and cultural mosaic of India. Simultaneously, there exists an exigent need for indigenously tailored deprescribing guidelines, harmonised with local pharmaco-epidemiological patterns, resource realities, and patient preferences, thereby ensuring contextual relevance and maximal therapeutic yield.

The clarion call of the World Health Organization's Third Global Patient Safety Challenge — Medication without Harm — reverberates with heightened pertinence within the Indian geriatric healthcare milieu. In heeding this summons, deprescribing, when judiciously operationalised, emerges as both a scientific prerogative and a moral imperative in the collective endeavour to safeguard the dignity, functionality, and well-being of our ageing populace.

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