Traditionally -over 65 is considered as "elderly“. Elderly Suffer from or having chances of Alzheimer’s disease, Parkinson’s disease, Vascular dementia, stroke, Visual impairment, cataracts and macular degeneration, Atherosclerosis, coronary heart disease, heart failure, Diabetes, Arthritis, osteoporosis, and fractures, Cancer, Incontinence. Hence ,Needed more number of drugs for the treatment. There are changes in responses to some drugs with advanced age and also the drug usage patterns changed due increase in number of drugs. Many diseases ,nutritional problems and reduced financial resources lead to reduced dosing compliance in elderly.1
There are several pharmacokinetic and pharmacodynamics changes that occur in geriatric patients.
a. There is age related decrease in renal function. Blood urea nitrogen (BUN) and serum creatinine levels are markers for renal function. BUN gives idea about concentration of urea in blood, much of this is obtained from ingested protein. Malnourished old person does not consume more protein hence no more increase in BUN in elderly . Serum Creatinine is produced by muscles .As muscle mass decreases, there is no enough production of creatinine to reflect changes in renal function. Hence, normally appearing bun and creatinine level in elderly under estimate degree of renal failure. Dosing recommendations is done by the Cockcroft-Gault formula in elderly patient. This formula can be applied for the ages 40 – 80 years. For women, the result should be multiplied by 0.85 (because of reduced muscle mass).2,3
b. Aging process in elderly leads to decreased liver mass and decreased hepatic blood flow and reduced hepatic metabolism ( up to 25% ) .Regional blood flow to liver at 65 years is reduced by 40-45% at the age of 25 years.7 Reduced clearance of drug depend on hepatic metabolism and hepatic blood flow (1st pass effect). Hence, metabolism of the drugs like Verapamil, Lidocaine and labetalol is afftected as depend hepatic blood flow.8
e. Elderly are more "sensitive" to the action of many drugs. These changes in results are due to altered pharmacokinetics or diminished homeostatic responses. Elderly are more sensitive to some sedative-hypnotics and analgesics. There is decrease in responsiveness to adrenoceptor agonists. Certain homeostatic control - blunted with the advanced age in elderly. .Physiologic alterations in response is seen in elderly. Average blood pressure goes up with age. Incidence of symptomatic orthostatic hypotension increased. 2-hour PP blood glucose increased by about 1 mg/dL for each year of age above 50.Temperature regulation is also impaired, and hypothermia in poorly tolerated in the elderly.1,9,10,11
f. Major changes with the aging process are: eg, forgetting to take one’s pill related to cognitive changes associated with vascular or other pathology. Economic stresses due to reduced income and increased expenses due to illness. Most important change is loss of a spouse.1
Drug like antihistaminics, hypnotics, hidden contents in Herbal drugs) can cause incontinence, confusion, fatigue, depression, and many times these symptoms are attributed to disease condition. Gingko cause bleeding when used with Aspirin. These problems can be modified by appropriate diagnosis and therapeutic actions.1 There is need for high index of suspicion for drug induced illness in elderly. Any symptoms in an elderly patient may be a drug side effect until proved otherwise.1
Aim of drug therapy elderly is 1. to improve QOL in elderly and 2. to prolong the life span. Hence there is need for the intelligent use of drugs and recognize practical obstacles for the compliance of drug treatment. Drug therapy has considerable potential for both helpful and harmful effects in elderly: Maintain balance.1
Hence for prescription of drugs in elderly there role of careful drug history and analyzing the prescription for rationality of the medication in elderly patient. Disease to be treated may be drug-induced.1
Principals of prescription in elderly mention that there should be high index of suspicion for drug reactions & interactions and know the other drugs the elderly patient is being taking.1
By knowing the drug taken by elderly we can simplify regimen as much as possible when multiple drugs are prescribed and can reduce the number the drugs taken by the elderly person.1
The American Geriatric Society updated Beers criteria for potentially inappropriate medication use in older adults. The criteria are intended for use in all ambulatory, acute, and institutionalized settings of care for populations aged 65 and older in the United States, with the exception of hospice and palliative care. Consumers, researchers, pharmacy benefits managers, regulators, and policymakers also widely use the AGS Beers Criteria. The intentions of the criteria are to: improve medication selection; educate clinicians and patients; reduce adverse drug events; and serve as a tool for evaluating quality of care, cost, and patterns of drug use of older adults.12
Polypharmacy and inappropriate prescribing are well known risk factors for adverse drug reactions (ADRs), which commonly cause adverse clinical outcomes in older people.13
The recently published NICE guidance on Medicines Optimisation14 recommends using a screening tool – for example the STOPP/START tool in older people – to identify potential medicines-related patient safety incidents for those on multiple medicines or with long term conditions. NHS Wirral Clinical Commissioning Group had given START/STOP tool to support medication review in elderly person.15 Also O’Mahony et al. 16 also updated their tool STOPP/ START Criteria in 2015. This tool had shown previously that there is reduction in adverse drug events and average length of hospital when it was used within 72 hours of hospitalization. STOPP/START tool will determine the rate of underutilization of drugs if any as it recommend the use of drug for certain condition. This requirement of drug may be different in Indian scenario. This tool will be used in this study.
With this background, we want to conduct this study in elderly person to find out usefulness of these tool in improving prescription and reducing adverse drug reactions to medication also to check for recommendation of drug in elderly persons.
To find out the usefulness of STOPP/START and Beers Criteria for prescribing in elderly in a tertiary care center in Central India.
Primary end points to achieve primary objective:
1.Percentage of patients requiring change in prescription as per STOPP/START and Beers Criteria at 1st follow up and at the end of 1 month.
2. Percentage of patients had benefitted clinically and had improved quality of life at the end of one month.
1.To analyse the prescription in elderly person as per WHO prescription evaluation indicator.
2. If any deviation from drug used apart from the criteria then identify the reasons as per need of clinical condition for that particular patient.
Secondary end points to evaluate the prescription:
1.Percentage patients requiring ≥ 5 drugs drug at baseline, 1st follow up & at the end of 1 month.
2. Percentage of patients not fulfilling STOPP/START criteria, but require change of therapy or continuation of existing therapy.
Study design: Longitudinal observational study
Selection of study participation and study procedure:
Patient attending medicine/geriatric OPD and fulfilling inclusion and exclusion criteria will be recruited for this study. Informed written consent (Annexure II) will be obtained from each of the study participant. Patient will be given information about the study and study procedure with the help of patient information sheet (Annexure II). Information collected will be recorded in case record form cum questionnaire (Annexure III).
Information to be collected in Questionnaire cum case record form:
Demography, Education, occupation, family history, diagnosis for which visited hospital, dietary history, history of chronic illnesses with medication, history of constipation, peptic ulcer disease, history consumption of herbal medications, OTC medications, clinical finding (Weight, Height, Blood pressure, Pulse), laboratory findings (LFT, KFT, Lipid profile, Blood sugar,etc) if available and revised creatinine clearance will be calculated from available creatinine clearance by Cochcroft Gault formula, list of drugs prescribed with dose and frequency of drug administration, information about ADRs to previously prescribed drugs.
Also the quality of life will be assessed with the help of Health Related Quality of Life (HRQOL) -14 measures (Annexure IV), Center for disease control and Prevention (CDC).20
Cockcroft –Gault Formula= (140-age) X (body weight in Kg)
Serum creatinine X 72
Review with STOPP/ START Criteria and Beers Criteria:
Information collected from prescription and elderly person above 65 years will be reviewed and analysed with the help of STOPP/START4 and Beers Criteria1 for appropriateness in the Department of Pharmacology. If any change in drug therapy needed in the form of drug stop/start and change of the drugs will be discussed with treating physician. If physician agrees for the change of medication as per present clinical condition of the patient that will be advised to patient after giving full information to the patient by the physician.
Follow up after change of the therapy:
If change in therapy agreed by treating physician, patient will be called for 1st follow up after 7 days for the changes in treatment and after 1 month to evaluate the effect of the changed therapy with the help of structured questionnaire.