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EDITORIAL BOARD

Editor-in-Chief: Prof. N. Udupa, Ph.D Executive Editors: Ajay G. Pise, M. Pharm C. Dinesh Kumar, M. Pharm A. Ranjth Kumar, M. Pharm P. Vasanth Raj, M. Pharm

Editorial Board Members

Prof. M. Sreenivasa Reddy, Ph.D Prof. Sureshwar Pandey, Ph.D Prof. C. Mallikarjuna Rao, Ph.D Prof. B. S. Jayashree, Ph.D Prof. A. N. Kalia, Ph.D Prof. P. G. Yeole, Ph.D Prof. M. D. Burande, Ph.D Prof. Raja Wege, Ph.D Prof. S. S. Bhat, Ph.D Prof. Prashant L. Kolhe, Ph.D Prof. Purushottam Bhat, Ph.D Prof. Y. Srikant, Ph.D Prof. B. G. Nagavi, Ph.D Prof. N. Gopalan Kutty, Ph.D Prof. K. Sreedhara Ranganath Pai, Ph.D Prof. Gayatri Devi, Ph.D Prof. C. S. Shridhara, Ph.D Prof. K. B. Koteshwara Rao, Ph.D Prof. R. O. Ganjiwale, Ph. D. Prof. S. Wadher, Ph. D.

Administrative Team

P. C. Jagadish, M. Pharm D. Sreedhar, M. Pharm Manthan Janodia, M. Pharm Virendra Ligade, M. Pharm

Official Address:

International Journal of Community Pharmacy, Manipal College of Pharmaceutical Sciences, Manipal University Manipal – 576 104 India E-mail: ijcp.acpi@manipal.edu

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Editorial

Greetings! I take this opportunity to extend my greetings to the IJCP readers. The first quarter of the year 2009

witnessed special achievements and growth in the field of community Pharmacy. In the context of

development in the third world, introduction of Pharm D programme for fortifying the community

Pharmacy profession in India has become a landmark achievement in Pharmacy profession. It is expected

that new initiatives taken by world leaders and WHO for strengthening the community Pharmacy

profession would set another landmark in the days to come.

Retail pharmacy chain has grown as a big business field today. The current pharmacy retail market size in

India is estimated to be of US$ 4.5 billion and it is expected to grow to US$ 8.7 billion by 2010. Retail

pharmacy is growing at the rate of 25% annually. The organized pharmacy retail chain is dominated by 12-

15 big players. There are more than 3500 organized retail pharmacy outlets in India and it is expected to

grow to 10,000 by the end of 2010. The organized pharmacy retail market is dominated by big industrial

houses like Ranbaxy's Fortis, Manipal Cure and Care, Pantaloon’s Tulsi, Reliance Retail's Reliance Health

and Pharma and Subhiksha as well as health care players like Apollo Hospitals Group's Apollo Pharmacy,

Medicine Shoppe, Zydus Cadilla's Dial for Health, Sagar Drugs & Pharmaceuticals' Planet Health,

Morepan's Life Spring, Lifetime Healthcare's LifeKen, Global Healthline’s 98.4, Guardian Lifecare's

Guardian Pharmacy and MedPlus to name a few. Many more companies and organizations will come up

soon in the same segment.

The Indian Pharmaceutical Association (IPA) organised the Indian Congress of Pharmacy and

Pharmaceutical Sciences—2009 on March 14-15 at Delhi Institute of Pharmaceutical Sciences and

Research (DIPSAR), New Delhi. The theme of the congress cum convention was 'Re-engineering

pharmacy profession in India'. Various topics were discussed regarding the upliftment of the community

pharmacy profession including the need for cheaper drugs (generics) rather than branded products for one

and all so that more patients could afford medicines. The need for nano-technology and genetic engineering

in the pharmaceutical sciences was also deliberated.

Today it is high time to work for popularizing the concept of community pharmacy in third world

countries. The activities like National Pharmacy Week celebrations give a proper platform for popularizing

the concept; student activities like walkathon, marathon, and several competitions on the theme of

community pharmacy would also help. We expect that introduction and awareness of Pharm D course in

developing countries would help in strengthening the profession.

Let us all make a firm stand to come forward to build our profession!

Dr. N. Udupa M.Pharm., PhD

Editor-in-Chief, IJCP

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MESSAGE FROM ACPI

The Association of Community Pharmacy has launched its novel annual program of Continuing

Pharmacy Education (CPE) for practicing pharmacists at Mangalore for the practicing pharmacists in retail

pharmacy, hospital pharmacy and other settings.

The practicing pharmacists have requirements of updating their professional knowledge to give

competitive services. The knowledge of pharmacists needs to be updated as many new drugs get introduced

into practice and many diseases emerge in the society. For example the Swine Flu, lot of good information

becomes useful if pharmacists are trained to handle the situation in an intelligent manner. The program is

six days all Sundays in May to June 2009. There are six days in which 12 deliberations are planned. The

resource persons are from nearby pharmacy institutions and as programs are held on Sundays. It is most

convenient for Pharmacists and resource persons. The topics proposed touch upon recent issues of

profession and it also trains the pharmacists in basic clinical skills like Blood pressure; body mass Index

and Blood sugar etc, which help in the management of diseases like diabetes, blood pressure and obesity in

a cost effective manner. By providing such services in the community, it is for sure that the professional

image of community pharmacy likely to emerge.

The resources of power point presentations of the continuing Pharmacy education will be made

available to all members, who can take up and begin training the pharmacists in their location,

The association acknowledges the generous support by Cipla Critical Care Pvt. Ltd., for

sponsoring the sessions and Manipal University for provision of seminar hall for conducting the CPE.

Dr. Anantha Nagappa Naik

President Association of Community Pharmacists of India

5

DRUG INTERACTIONS IN CURRENT

PRACTICE: OLD WINE IN A NEW

BOTTLE

Venkatraghavan.S*a, Surilivel Rajan Ma, Thiyagu

Ra, Sriram.Sb, Sarathi Kumarb, Sakthi Kumarb

aDepartment of Pharmacy Practice, Manipal

College of Pharmaceutical Sciences,

bDepartment of Pharmacy Practice, Sri

Ramakrishna Institute of Paramedical Sciences,

Coimbatore,India.

Venkatraghavan84@gmail.com

Abstract:

Although thousands of articles on drug

interactions have been published and numerous

computerized screening systems have been

developed, patients continue to suffer from

adverse drug interactions. A handful of methods

are available for the prevalence and assessment

of drug interactions. Moreover it is not enough to

monitor but also to evaluate the severity of drug

interactions. Possible methods for reducing the

risk of drug interactions include improving the

knowledge of health care providers, improving

computerized screening systems, providing

information on patient risk factors, increased use

of pharmacogenetic information, more attention

to drug administration risk factors, and

improving patient education on drug interactions.

Introduction:

While the beneficial effects of medication are

manifold, medication use also implicitly involves

a risk of drug interactions, side effects and other

drug-related problems. Medicines are often used

concomitantly with other drugs, and some degree

of drug-drug interaction occurs with concomitant

use. As high as 10–20% of hospital admissions

may be attributed to drug-related problems and

toxic effects of medication. For example

interactions, particularly with drugs having a

narrow therapeutic range may have serious

adverse consequences. A drug-drug interaction

represents a specific type of adverse drug

reaction, and the risk of drug-interactions is

proportional to the number of drugs taken

.Therefore, in the evaluation and clinical

application of drugs, appropriate efforts should

be made to predict the nature and degree of drug

interactions so that patients will not be adversely

affected. Humans are genetically diverse, and

disease states are likewise diverse and it should,

therefore, be kept in mind that drug interactions

might readily cause clinically significant changes

in blood drug levels (concentration in whole

blood, plasma, or serum) in patients having

pharmacokinetic parameters markedly deviating

from those of the standard population especially

the elderly are at increased risk, as are patients

with diseases that alter drug metabolism (e.g.

renal or liver disease). Potential drug – drug

Interactions may affect 40–65% of all

hospitalized patients, the clinical consequences

of these drug interactions are highly variable,

and adverse effects rarely occur.1-8

Drug-interaction information is required on

different levels of drug therapy. First, the

prescription of drug combinations should be

supported by appropriate information technology

to maintain high quality standards already at the

6

point of care. In addition to the support of

physicians in drug selection and dosing, the

dispensing pharmacies should also have access

to comprehensive information on drug

interactions, in order to assess combinations

prescribed by several independent physicians in

charge of a patient, and also to detect risks

arising from combinations with drugs dispensed

without prescription. 9-11

Methods for screening of potential drug

interactions using medical records of prescription

in order to effectively prevent any further

adverse drug related outcomes and not all

potential drug interactions are clinically

significant, especially with proper management;

any observed clinical drug interaction is most

important because it has real impact on the

patients. However, reports of investigations of

clinical outcomes resulting from the interactions

of prescribed drugs are rare.12-14

History and background:

As long as mankind has used plants, animals and

inorganic substances to cure and alleviate health

disorders, drugs have most likely been used in

combinations to potentiate their intended effects.

Indeed, it may be favorable to use a combination

of drugs if that combination is well documented

to enhance the effect or to reduce adverse effects.

More than 5,000 medical papers were published

in 2005 and indexed as ‘drug interactions’ at

PubMed. Since 1972, when the term ‘drug

interactions’ was introduced as a medical subject

heading (MeSH), the increase in published

articles on drug interactions has been linear

figure 1. Before that time, the interaction

between chemical substances in the human

organism had been indexed as ‘drug synergism’,

and ‘drug antagonism’, indicating the two

principal interactive effects, namely that drugs

may both enhance and diminish each others

expected biochemical response.15-17

Drug interactions fall into a number of

categories

Drug – drug interactions occur when the

administration of a drug results in decreased

effectiveness or increased toxicity of other drugs

that are also being taken (e.g., Heparin when

combined with aspirin increases risk of

bleeding).

Drug – herbal interactions occur when the

effectiveness of the administered drug is

decreased or the toxicity is increased because of

the interactions with herbal preparation

containing either a single or complex herbs (e.g.,

St.John’s Wort when administered with MAOI’s

cause’s additive serotonin toxicity.

Drug – food interactions occur when the

effectiveness of the drug is decreased or the

toxicity increased because of its interaction with

foods (e.g., Tetracycline when taken with milk or

calcium rich foods it decreases the effect of

tetracycline).

Drug - chemical interactions occur when drug

which are extensively metabolized by the hepatic

450 enzymes is administered while consuming

alcohol or by inhaling aromatic poly

hydrocarbons during smoking and thereby

resulting in increased or decreased hepatic drug

metabolizing enzyme activity.

7

Drug – condition interactions may occur when an

existing medical condition makes certain drug

potentially harmful (e.g., Tobramycin in

combination with frusemide in renal failure

patients worse the condition by increasing the

nephrotoxicity).

Pharmacogenetic drug interactions occur when

pharmacokinetic effect of the drug id altered by

the genetic factors that affect the process of

metabolism

There are multiple factors that can influence the

outcome of a drug interaction. These factors are

based on the properties of the object drug and the

precipitating drug.18-19 Drug interactions are

classified based on mechanism, into

pharmacokinetic and pharmacodynamic

interactions. The former interaction is the

phenomenon that is induced by changes in blood

levels and tissue distribution of a drug or its

active metabolites by the interaction of the drugs

in the processes of absorption, distribution,

metabolism, and excretion. Most clinically

important drug interactions involve the effect of

one drug metabolism to another. The liver is the

principal site for of drug metabolism and phase I

and II reactions is greatly influenced by the

Cytochrome P450 enzyme apparatus. For the

prediction and evaluation of the clinical

significance of a drug interaction, it is necessary

to evaluate how much the process where the

interaction was observed determines the

pharmacokinetics of the drug. The latter

interaction is the phenomenon that occurs when

the effects of a drug are additive/synergistic or

antagonistic to the effects of a concomitant drug,

or when a drug changes the tissue

sensitivity/reactivity to the investigational drug.

In clinical practice, this phenomenon is

occasionally used to the advantage of patients as

a concomitant therapy. For the purpose of

predicting pharmacodynamics-related drug

interactions, a thorough understanding of the

main pharmacologic effect that leads to a given

therapeutic effect, any potential secondary

pharmacologic effect that may lead to side

effects and toxicological effects is necessary.1, 20

and 21

Many thousands of experimental studies in

animals and humans, clinical observations, and

epidemiologic studies have been reported.

Hundreds of review articles on interactions

between drugs have appeared, and more than a

dozen books have been entirely devoted to the

subject. These intensive efforts have greatly

increased the understanding of the mechanisms

and of the clinical consequences of drug

interactions.22

PREVALENCE AND ASSESSMENT OF

DRUG INTERACTIONS:

Potential drug interactions are highly prevalent,

but the number of adverse drug reactions caused

by drug interactions is probably low. 23-25

Drug interaction may make a drug less effective,

and cause unexpected side effects or increase the

action of a particular drug and the overall

prevalence of drug interactions is 50% to 60% in

USA. Those that affect pharmacodynamics or

pharmacokinetics have a prevalence of

approximately 5% to 9%. About 7% of

hospitalizations are due to drug interactions.26

Drug interactions are believed to occur in 3% to

7% of patients taking up to 10 medications, and

8

in as many as 20% in patients taking 10 to 20

medications. It is estimated that drug interactions

cause up to 2.8% of all hospitalizations. This

translates to nearly 2, 50,000 hospitalizations per

year in USA at a cost of $1.3 billion.27

Reported incidences in outpatients range from

9.2% to 70.3% for drug interactions of any

severity, and from 1.2% to 23.3% for those

considered of major relevance. A German

primary care study showed that of all observed

major or moderate potential drug interactions

only 11.7 % offered no management options, and

such drug combinations should thus be avoided.

The majority of the potential drug interactions do

not result in clinical manifestations if they are

managed adequately, e.g. by dose adjustment or

a coordinated sequence of administration.

However, given the frequency of combination

treatment, even a low penetrance of

complications caused by drug interactions will

substantially impact drug safety.9-11

Studies conducted in various, mainly western,

countries report rates of potential drug – drug

interactions ranging from approximately 1 to

52%. The incidence of actual occurrence of drug

interactions has been reported to be much

smaller ranging from 0-1.3%. Difference in

methods used, including criteria for data

collection, study periods and target population,

contribute to these discrepancies.12-14

SHOUD DRUG INTERACTIONS BE

MONITORED AND EVALUATED?

Clinically significant drug interactions include

those, whose onset of action is rapid, within 24

hours, whose severity is considered either life-

threatening or able to cause permanent damage

or deterioration of patient status, or whose

documentation is established and based on

supporting biomedical literature, or with very

high likelihood of occurring in clinical practice.28

A large number of drugs are introduced every

year, and new interactions between medications

are increasingly reported. Recognizing drug

interactions is a daily challenge for physicians

and remembering all potential interactions has

become virtually impossible.29

Over-the-counter (OTC) drugs can be used for

self medication without advice of a pharmacist or

a physician. Freely available, their use is often

perceived as safe by customers. The lack of

professional supervision may increase the risk of

adverse drug effects including those caused by

drug interactions.9-11

The prescribing of safe and effective drug

therapy is becoming increasingly complex. More

and more patients are receiving multiple drug

therapies for acute and chronic conditions or

diseases. As the number of medications taken by

the individual patient increases, so does the

potential for drug–drug interactions that have

clinically important consequences.30

The unavoidable consequence is that

increasingly frail patients are being treated with

multiple pharmaceutical preparations, i.e.

Polypharmacy. However, patient’s compliance

with a drug regimen is compromised as the

regimen becomes more complex, and the risk of

drug-drug interactions substantially increases

with each additional medication.31

9

The assessment of drug interactions remains an

integral component of patient management. This

is especially true in elderly patients who often

have various chronic diseases for which they

receive multiple medications. Patients who

receive their care from more than one provider

and their medications from more than one

pharmacy are also prone to interactions. In

addition, drug interactions are common in

disease states for which multidrug therapy is the

standard of care, such as tuberculosis, HIV

infection and cancer.32

Some drug interactions have been accepted as

occurring clinically on evidence limited to in

vitro studies. Such studies can suggest at times

that two drugs might interact during therapeutic

use. For example, considerable displacement

from human albumin in vitro of a highly bound

drug by another drug raises the suspicion that an

interaction may occur when these drugs are

administered together. However, the occurrence

of a clinically important interaction between

such drugs depends on many additional factors,

such as their apparent volume of distribution,

therapeutic margin, daily dose, sequence of

administration, elimination half-life and extent of

accumulation during chronic therapy, and their

propensity to interact pharmacokinetically by

other mechanisms, or to interact

pharmacodynamically. Evaluation of all these

factors requires studies in human beings. Many

commonly cited drug interactions have been

observed only during animal experimentation.

For two reasons extrapolation of such

information to the clinical situation is apt to be

misleading. First, there are profound differences

between species in the metabolic fate of many

drugs, particularly binding at inactive sites and

biotransformation. Thus, pharmacokinetic

interactions between drugs demonstrated in

animal experiments may not occur in man.

Second, many drug interactions have been

demonstrated in experimental animals only when

the drugs were administered in amounts

incomparably greater on a dose per unit body

weight basis than those used therapeutically.

Such information is clinically meaningless

unless confirmed in humans given therapeutic

doses.22

In recent years serious drug interactions with

some widely used drugs have emerged. We need

to reevaluate how we screen for potential drug

interactions and ensure that preventable drug

interactions are to be identified and information

regarding the same should be passed on to the

healthcare professionals.

Very few epidemiologic studies on the adverse

outcomes of drug interactions have been

performed. Therefore, drug-interaction

information sources generally lack data on

clinical importance of potential drug interactions

and information on risk factors that contribute to

their adverse outcomes.

Methods to evaluate drug interactions:

There are about 6000 drugs available worldwide,

along with traditional medicines and herbal

remedies that can potentially interact. The range

of possibilities is considerable. It is important to

use pharmacological knowledge together with

the medical literature to evaluate a potential

interaction. It is important that pharmacies are

familiar with and use this information which is

available from a wide range of sources such as

10

1) In vitro and animal data

Information form in vitro studies and animal

experiments is helpful in identifying mechanisms

for a drug interaction. Recent works on the

CYP450 isoenzyme systems is an example of the

value of in vitro experimentation. Animal and in

vitro information cannot reliably predict that an

interaction will occur in humans, as human

pharmacodynamic process and physiology are

not represented.

2) Case reports

Interactions are often first identified as case

reports or letters published in medical journals or

reported to a pharmacovigilance program. The

reliability of information in letters and case

reports requires careful evaluation, as letter

sections do not undergo peer review in most

journals. Case reports are a useful source for

identifying interactions between infrequently

used drug combinations or for rarely occurring

interactions.

3) Clinical trials

Clinical trials provide the most reliable evidence

to support an interaction through controlling for

extraneous factors (that could also explain the

effect of drug interaction), and by providing a

statistical estimation for the effect arising by

chance.

4) Review, monographs and hand books

Review on drug interactions often appears in the

pharmacy literature, for example recent series

have been published in the Pharmaceutical

Journal (UK) and Annals of Pharmacotherapy.

The purpose of these articles is education,

although some reviews will provide reliable lists

for interaction screening. Some useful books

which contain complications of drug

interactions, for example Stockley IH Drug

Interactions is a standard book that provides

details about drug interactions. It is also very

important to check for more recently published

information in the medical literature especially

for recently introduced medicines and infrequent

interactions or rarely used drug combinations.

5) Tables, charts and data sheets

Quick reference sources for screening known

drug interactions come in a variety of forms, of

which the British National Formulary (BNF)

tables is one of the better known. There are also

wall or pocket sized charts and interaction

warnings with dispensing computer programs

that can assist rapid identification of an

interaction. A particular disadvantage with many

charts is that further searching will be required

for more depth information. Product data sheets

can provide useful information provided they

have undergone independent review.

6) Interaction websites

There is an increasing number of websites,

which contain information on drug interactions.

Some sites cover specific classes of drugs or

conditions, for example, herbal medicines or

medicines used to treat HIV/AIDS. As with all

web-based information, reliability needs to be

considered. Some sites like Dave Flockhart’s

Cytochrome P450 isoenzyme site is accurate and

current. This site is particularly useful for

screening for suspected metabolic interactions,

but it does predict clinical relevance and

excludes many metabolized drugs for which the

isoenzyme system involved have not been

identified.

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Methods for monitoring and preventing drug

interactions:

Review therapy for interactions can occur as part

of a medicine review process or before a patient

takes a new drug. Frail or malnourished patients,

and those with renal or hepatic impairment or

multiple pathologies, are at greater risk of

developing adverse drug interactions. Some

drugs pose a greater risk due to their inherent

toxicity, non-linear pharmacokinetics or potent

enzyme inducing or inhibiting ability. Ready

reference systems such as tables or computer-

based programs can help with screening.

Providing patient education can further help

avoid potential interactions. Verbal advice

should be given to all patients, and particularly

to those who illiterate. Patient information

leaflets can be useful or a simple warning

message printed on the medication label can

avoid potential interactions. For example,

patients prescribed with ciprofloxacin, the

warning ‘do not take with iron’ could be added

to the label.

With newly introduced drugs, additional

monitoring and care is required as clinical

experience and exposure to potentially

interacting drugs will be limited. When a newly

introduced drug is used in combination with

drugs with known severe toxic effects such as

immunosuppressants (e.g. methotrexate or

azathioprine), anticoagulants or those with a non-

linear kinetic profile, this is especially

important.33

More over pharmacogenetic information is

required to finally assess and as well as curtail

the silent epidemic: drug interactions.

Swedish researchers reported monitoring of

potential drug interactions might improve the

quality of prescribing and dispensing. Potential

drug interactions were present in 13.6 per cent of

prescriptions studied. Interactions with potential

serious clinical consequences were detected in

1.4 per cent of prescriptions. 34 and 35

fig : 1

0

10000

20000

30000

40000

50000

1983 : 1988

1988 : 1993

1993 : 1998

1998 : 2003

2003 : 2008

TIME PERIOD /year

Number of hits

Fig. 1 Published articles indexed with the keyword “drug interactions”

(MeSH, medical subject heading) at PubMed for every five years

12

Conclusion:

Since there are thousands of drug interactions to

be evaluated, it would be easy to perform in vitro

research and predict in-vivo from data base

analysis. Computerized approaches are ideal for

this because reliability can approach 100%,

while methods that rely on human inspection

will always miss some errors. Potential drug

interactions should be predicted and dealt with

by close teamwork of physician and pharmacist

at the moment medication is prescribed.

Therefore complete database of drugs and its

interactions must be embedded in validated

software which could detect the drug interactions

from the prescriptions at the level of prescribing

or dispensing and which could be updated on a

day to day basis itself will turn out to be a

significant advancement in having a check to

minimize serious drug interactions.

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Thomson B, Kirum H. Polypharmacy in

a major Australian teaching hospital.

Aust J Hosp Pharm 1998;28(6):432-5.

32. Alfaro CL, Piscitelli SC. Drug

interactions. In:Atkinson AJ, Daniels

CE, Dedrick RL, Grudyinllas CU,

Markey SP, editors. Principles of

clinical pharmacology San Diego, USA:

Academic press; 2001.P.167-80.

33. Ruth Ferguson. Drug interactions. In:

Parthasarathi G, Karin NH, Milap CN,

Editors. A textbook of clinical

pharmacy practice: Essential concepts

and skills. 1st ed. Chennai, India:Orient

Longman Pvt Ltd;2004.P.103-17.

34. Monitoring potential drug interactions

might improve prescribing

(editorial).The pharmaceutical journal

2001 Sep 1:243 of 251.

35. Pharmacist could prevent more drug

interactions (editorial). The

pharmaceutical journal 2001 Oct 13:234

of 251.

DOTS THERAPY AND PREVALENCE OF

TUBERCULOSIS IN ASSAM AND

JALPAIGURI DISTRICT (NORTH

BENGAL) IN INDIA

S.Vijaya Kumar*, M. Sasi Kala, S.Gangulay,

P.K.Kar, K.Gauthaman, Manoj Kumar Deka.

Department of Pharmacology, Himalayan Pharmacy Institute,

Sikkim-737136.

vijayvijay66@yahoo.co.in.

Abstract

Objective: To study the Direct Observed

Treatment Short Course (DOTS) and Prevalence

Tuberculosis in Assam and Jalpaiguri district

(North Bengal),India. Method: The data were

collected from the DOTS centre, Karbi

Anglong, Diphu in Assam, using a well designed

questionnaire. This consists of patient’s profile,

social status, signs and symptoms diagnosis,

medication, ADRs etc. The Physicians,

Pharmacists and Patient were interviewed and

their responses were filled into the questionnaire.

15

Result: A Total of 520 cases (both male and

female) were observed during this study. Our

survey report revealed that male patients (65%)

affected more compared to female patients. Age

group distribution revealed that more than 35%

were in 30 to 40 years age group. It was

observed that pulmonary tuberculosis patients

are more compared with extra pulmonary ones.

The treatment given for management of

tuberculosis was WHO guidelines. We found

that, treatment outcome shows that 66% patients

were cured whereas 17% patients defaulted. At

the end of the Intensive Phase it has been found

that 69% were Smear Negative and 29% were

Smear Positive. We observed that urban patients

(63%) are more affected than the rural

population. Conclusion: It has been concluded

that the tuberculosis is more prevalent in males

and older age patients. Usually combination

drugs were used for treating tuberculosis. Proper

monitoring is an essential component of

management of tuberculosis.

Key words: Patient survey, DOTS Therapy,

TB in India.

Introduction:

A world health organization (WHO) report

estimates that there are about 500,000 new cases

of multidrug resistant TB annually, or about 5%

of the nine million total new TB cases each year.

India and China together account for 40% of all

TB cases in the world. WHO estimates that one-

third of the world population-that’s about two

billion people- is exposed to TB, carry the bug or

microbe. In addition to that, DOTs has been

successful only in China and Peru.

Tuberculosis is an ancient disease, more than

7000 years old associated with mankind and

cattle. Tuberculosis is caused by acid fast

bacteria M. Tuberculosis identified by Robert-

Koch in 1882.1 In India, 2 million develop active

disease and about 500,000 people die every year,

Tuberculosis has troubled humankind throughout

history. It has been a leading cause of death

throughout the world, and still is in low-income

and middle-income countries. The disease has

assumed alarming proportions in countries like

Asia, Africa, Eastern European countries and

South America. Recently researchers at the

Harvard University in the USA reported that a

decade after the DOTS (Directly Observed

Treatment Short Course) plan was introduced,

the world remains no closer to the control of

tuberculosis, DOTs has been successful only in

China and Peru. It was highly effective means of

treating patients infected with TB2. WHO

estimates that atleast one third of the world

16

population are infected with TB. More than eight

million people develop active TB annually and

nearly three million TB deaths occur worldwide,

in which 95% of TB cases and 98% of deaths are

in developing countries.3

TB was caused by mycobacteria are aerobic non-

spore forming, nonmotile bacilli with a waxy

coat that causes them to retain the red dye when

treated with acid (“red snapper”) in the acid –fast

stains. Two species of Mycobacterium cause

tuberculosis is transmitted by inhalation of

infective droplets coughed or sneezed into the air

by a patient with tuberculosis. M. bovis is

transmitted by milk from diseased cows and first

produces intestinal or tonsillar lesions4.Whereas,

the multidrug-resistant (MDR) tuberculosis

resistant to at least isoniazid and rifampicin, is an

increasingly important public health and clinical

issue, especially in countries with a high burden

of HIV reports of MDR tuberculosis isolates

resistant to second-line drugs have amplified

these concerns. In March 2006, the first data

were published on the world wide occurrence of

tuberculosis with resistance to second-line drugs,

termed extensively drug resistant (XDR)

tuberculosis 5. Majority of the tuberculosis

patients fail to maintain their drug therapy in the

optimum level. Therefore present study was

conducted with objectives like to assess

important aspect of drug therapy, distribution

pattern of tuberculosis, prevalence and survival

rate of tuberculosis.

Material and Methods

Study Design

The tuberculosis patients about diseases were

assessed using designed Annexure I. Counselling

was provided to the patients about the disease

and drug management. The survey was taken in

Jalpaiguri District Government Hospital, located

in Jalpaiguri, and District TB control Society,

Sonitpur Assam, in India. All the tuberculosis

used to visit the pharmacy in out-patient

Departments. Around 200 patients regularly visit

this hospital every week for routine medical

follow up to procure medicines supplied by the

hospital.

Method

During the month of Dec 2006 to May 2008, 520

cases were studied in District TB control society

hospitals (Jalpaiguri & Assam) district hospital.

This imparts light on increased incidence of

Tuberculosis. A Total number of patient’s data

were collected data by using Annexure I from

the patient of the hospitals. According to the

Annexure I the questions were asked to patients

individually. The data were collected to the

17

survey was compared with standard guidelines.

Clinicians who do the medical follow up, and

order for refilling of medicines were appraised of

the study and requested to send the patients for

counselling.

Collection of Data

Informed consent was obtained from each

patient. The questionnaire was used for assessing

the patient’s knowledge and state of control of

Tuberculosis. The questionnaire included

questions on demographic details knowledge

about disease and its complications, knowledge

about the medication of Tuberculosis. The

questionnaires were prepared and analyzed.

Whenever the patient was not able to read the

questionnaire the researchers explained the

questions to the patient and recorded the

answers and reported in Annexure: 1.

Results

A Total of 520 cases (both male and female)

were observed during this study. Our survey

report revealed that male patients (65%) affected

more compared to female patients. Age group

distribution revealed that more than 35% were in

30 to 40 years age group. It was observed that

pulmonary tuberculosis patients are more

compared with extra pulmonary ones. The

treatment given for management of tuberculosis

was WHO guidelines. We found that, treatment

outcome shows that 66% patients were cured

whereas 17% patients defaulted. At the end of

the Intensive Phase it has been found that 69%

were Smear Negative and 29% were Smear

Positive. We observed that urban patients (63%)

are more affected than the rural population.

Meanwhile, 73% of the patients had persistent

cough for more than 2 weeks, where as 82%

patients having abnormal radiographic findings.

It has been observed among the tuberculosis

patients, 19% had taken NSAIDs and 16% had

consumed Paracetamol as a largely consumed

OTC drug.

Table No :1

Sl.No Number of Patients Percentage

Sex

Male

Female

340

180

65

35

Marital Status

Unmarried

182

35

18

Married 338 65

Occupation

Govt.Job

Private Job

Business

Housewife

Student

102

124

164

90

40

19

23

31

17

07

Type of Tuberculosis

Pulmonary Tuberculosis

Extra Pulmonary Tuberculosis

477

43

92

08

Place

Urban District

Non Urban District

330

190

63

37

Cough lasting >2weeks at

time of diagnosis

Cough > 2 Weeks

No Cough > 2 Weeks

380

140

73

27

Chest Radiograph

Normal

Abnormal

96

424

18

82

Sputum Culture Result

Growth of MTB

No Growth

393

127

75

24

19

Table No : 2

Sl.NO Number of Patients Percentage

Social Habit

Smoking

Drinking

Both

None of these

215

143

98

64

41

27

18

12

BMI (Kg/M2 )

Under weight

Acceptable Weight

Over weight

Obese

286

116

77

41

55

22

15

08

OTC Drugs

Paracetomal

NSAIDS

83

97

16

19

Treatment outcome at the end of

Intensive Phase

Smear-Negative

Smear-Positive

Died

Default

358

134

18

10

69

26

3

2

20

Treatment outcome

Cured

Failure

Died

Transfer out

On Treatment

345

97

18

12

48

66

19

03

02

09

Table No :3 Prevalence of Tuberculosis in different age groups

Age in years Number of Patient Percentage

0- 10 09 02

10-20 19 04

20-30 98 18

30-40 182 35

40-50 118 22

50-60 65 13

60-70 21 04

70-80 08 02

Figure No:1 Histogram showing Number of Patients Vs Age in Years

Age in years

N

u

m

b

er

of

P

at

ie

nt

s

21

Discussion

Out of 520 patients were counseled in the study,

comprised of both male and female, where male

patients are more sufferers. The majority of

patients were found to be in the age group of 30

to 40 years. At this income producing age,

disease related complications might have a

negative impact on the individuals, family and

society at large. In the study, 68% of the patients

were suffering from pulmonary tuberculosis. The

pharmacists, who provided patient education,

were in a position to clear their doubts or

uncertainties, which patients expressed regarding

their treatment. The pharmacists routinely

discussed drug therapy and important life style

factors such as smoking, drinking and

adherences to medication, diet and hygiene. The

goal of the study was to reduce complications,

optimize the quality of life and improve the food

habits at an acceptable cost. Our results clearly

showed that the patients had developed a

positive attitude towards life after the study.

Pharmacist is often considered as the first point

of contact in health care system.6 This is because

easy access by the patients to the pharmacist

without any consultation fees. Pharmacist can

contribute to achieve satisfactory outcome

regarding the below-cited aspects.

1. Mobilize people for BCG Vaccination and for

re-vaccination at proper intervals.

2. Motivate the patients for treatment and ensure

the treatment completion by supervision.

3. Pharmacist can effectively communicate the

information to the patient by counseling 7 about-

a. Colour change in urine due to tuberculosis

drugs (isoniazid, rifampicin) during the

therapy.

b. Food should be taken 30 minutes before

taking T.B. Drugs (Isoniazid,rifampicin).

c. Avoidance of breast feeding by the infected

mother.

d. Mantaining proper sanitation.

e. Disinfectant procedure to be followed for

disinfecting house and articles.

f. Advising the identified patients to follow the

course of medicine properly. Consequences of

drug resistance and development of 10 to 15 new

cases through the patient will occur if proper

medical treatment was not followed should be

communicated to the patient.

g. Information about free medical treatment,

detection tests world class medicines in

22

government primary health centers, government

hospitals should be communicated to the patient.

Conclusion

It has been concluded that the tuberculosis is

more prevalent in males and older age patients.

Usually combination drugs were used for

treating tuberculosis. Proper monitoring is an

essential component of management of

tuberculosis.

Acknowledgements

The authors thank B.Pharm final years, student

for constant encouragement and support. Authors

also thank Head Department of Pharmacology

and Staff/Colleagues of Himalayan Pharmacy

institute for their valuable suggestions and

support.

Annexure -1

Hospital Name………………………………………………….. Date :………………….

Name of the patient: …………………………………………… Place :……………

Age: …………………………

Height……… Weight………….

Sex: Male Female

Occupation: …………….

Marital Status: Unmarried /Married

Social Habit: Smoking/Drinking/None of these.

Duration of illness:

Past History & Family History of Aliments:

Social-economic status: Lower/Middle/Upper middle/Rich

Previous History of Allergic to Medicaments:

OTC products consumed if any with purpose, duration and frequency

Laboratory Examination (If Suggested)

Finding of Laboratory Examinations:

Treatment (medicaments with indication, dose & duration):

Adverse effects (if any) :

Name and address of prescriber:

23

Reference:

1. Dr.C.J.Shishoo, Search for a New

Antitubercular Cure-A Daunting Task December

2004

2. Martens G, Wilkinson R.J, Tuberculosis.

December 15 2007, Vol 370:2030-43,

www.thelancet.com

3. R.J.Patel, G.C.Patel, M.M.Patel and N.J.Patel,

HIV infection and Tuberculosis,Indian

J.Pharm.Educ.Res.41(2). Apr-Jun2007; Page no

95.

4. Cotran R.S, Kumar V, Collins T, 2003,

Infectious diseases, Robbins Pathologic Basis of

Diseases, Sixth edition, Harcourt Private Limited

Publication, New Delhi: 349-350.

5. Basu Sanjay, Andrews Janson R, Poolman

Eric M, Gandhi Neel R, Shah N Sarita and et.al.

Prevention of noscomial transmission of

extensively drug-resistant tuberculosis in rural

south African district hospitals: an

epidemiological modeling study. October 27

2007 Vol 370:1500-07, www.thelancet.com

6. Smith, M.C. and Knapp, D.A., Eds., In,

Pharmacy Drugs and Medical Care, Williams

and Wilkins Baltimore 5th Edn 1992, 3.

7.Whittington Z., Judith c., Karen H., Fiona B.,

Peter N. Community Pharmacy Management of

minor conditions- the “care at the chemist

scheme “. Pharm J. 2001; 266: 425-428.

EVALUATION OF BODY MASS INDEX

AND PATIENT COMPLIANCE IN

ESSENTIAL HYPERTENSION

Dolcy Varghese1,*Dixon Thomas2, Molly

Mathew3 and Fazal Rahman4

dixon.thomas@gmail.com

ABSTRACT

OBJECTIVES: This study we expect to

figure out body mass index (BMI) and patient

compliance in essential hypertension and put

forward some suggestions for future

research and better practice of treatment of

hypertension in Kasaragod. METHODS: The

study was conducted on patients of main

hospitals in Kasaragod. The indicators for patient

compliance selected are mainly patient related

factors such as regular dosing, regular sleep,

prescribed diet, regular exercise and managed

stress. These factors were evaluated on a scale of

how often they are occurring. Body mass index

of the patients were also calculated using body

weight in kilo grams divided by body height in

meter square. RESULTS: Patient compliance in

regular dosing, sleep, diet, exercise and stress

24

were 83.2%, 33.2%, 15.2%, 15.8% and 35.6%

respectively. Different age groups in years and

average body mass index were 31-40 (25.33),

41-50(28.61), 51-60(25.18), 61-70(38.18), 71-

80(28.36), and 81-90 (22.08). CONCLUSIONS:

Most of the patients take care of their daily doses

but not on the diet, exercise, sleep or stress

conditions. Body Mass Index was found to be

increased rapidly after 60 years of age. Extended

future research in this area is greatly needed to

improve management of hypertension.

KEYWORDS: Body Mass Index, Patient

Compliance, Hypertension

INTRODUCTION

Cardiovascular diseases caused 2.3 million

deaths in India in the year 1990; this may be

projected to double by the year 2020.

Hypertension is directly responsible for 57% of

all stroke deaths and 24% of all coronary heart

disease deaths in India.1

The primary goal in the treatment of

hypertension is to reduce the incidence of

cardiovascular events in hypertensive patients.2

Recent reports on patient noncompliance have

focused on patient-provider relationships,

psychosocial barriers, home blood pressure

monitoring, and electronic monitoring systems to

improve blood pressure control. 3 Most of the

factors related to poor compliance have

implications for patient management. 4

Noncompliance has been identified as the

predominant reason for the failure of medical

therapy and disease progression. Compliance has

been defined as 'the extent to which a person's

behavior coincides with medical care or advice'. 5

Hypertension is a silent killer. Indians are

racially predisposed to cardiovascular disease,

and the increasing burden of hypertension has

only added to the problem. Lifestyle

modification is recommended as initial therapy

in stage 1 hypertension before initiation of drug

therapy and as an adjunct to medication in

persons already on drug therapy. 6 Researchers

have hypothesized that the impact of body mass

index on chronic disease may be greater in

Asians than in Whites; however, most studies are

cross-sectional and have no White comparison

group. 7 There is a positive correlation between

BMI and blood pressure in general, and with

hypertension prevalence in particular. There is a

BMI threshold at which further increase in BMI

leads to increased blood pressure. 8

Anthropometric measurements and indices like

weight, height, waist hip ratio, abdominal

obesity and body mass index were higher in

hypertensive women. 9 In one of the cohort study

25

by Arno Lukas et al, BMI was the single

strongest parameter associated with arterial

hypertension. 10 Augustine et al reported 24%

prevalence of overweight/obesity (BMI>23)

among urban college going girls aged between

seventeen and eighteen in Ernakulam, Kerala. 11

The purpose of our study is to evaluate the

patient compliance for the patients specific

factors such as, missing dose, lack of sleep,

wrong diet, lack of exercise, stress and to

evaluate the body mass index in different

age group of hypertensive patients.

MATERIAL AND METHODS

The study was conducted on main hospitals in

Kasaragod and directly contacting hypertensive

patients at home. The health and treatment

related information was taken from patients only

after taking the consent from them. A peer

reviewed questionnaire was developed with

thorough literature review. The key aspect on

this medication evaluation study was focused on

patient compliance. The indicators for patient

compliance selected were mainly patient related

factors such as missing a dose, lack of sleep,

wrong diet, lack of exercise and stress. These

factors were evaluated on a scale of how often

they are occurring such as for example how often

a particular patient miss a dose, is it an every day

condition or the patient missing the dose once or

more in every week or missing the dose at least

once or more in every month or once or more in

every three months or once or more in every six

months or finally the patient missing a dose is

happening less often than once in six months.12 &

13

Body mass index of the patients were also

calculated using body weight in kilo grams

divided by body height in meter square.

RESULTS

Out of 88 patients studied are having an average

age of 60.72 years. Their age group was between

32 and 92 years. They have an average weight of

65.495 kg and an average height of 1.545 meters.

Average body mass index of those patients were

27.40. And they were suffering from

hypertension for an average of 6.95 years.

Average score of patient compliance in total of five is given below; Regular dosing 4.16 (83.2%)

Regular sleep 1.66 (33.2%)

Prescribed diet 0.76 (15.2%)

Regular exercise 0.79 (15.8%)

Managing stress 1.78 (35.6%)

26

BODY MASS INDEX IN DIFFERENT AGE GROUP WAS AS FOLLOWS;

AGE GROUP NO: OF PATIENTS AVERAGE BODY MASS INDEX

31-40 02 25.33

41-50 14 28.61

51-60 30 25.18

61-70 26 38.18

71-80 14 28.36

81-90+ 02 22.08

DISCUSSION

From the above results it is understand that most

of the patients take care of the daily doses; so the

patient compliance is very good for that. May be

this value is biased that patient may feel like to

give the best responses to the health care team; in

reality 83.2 % is a very high compliance score.

The least compliance 15.2% was seen for the

dietary control, which is one of the most

important non- pharmacological control in

hypertension. Usually it is also seen that as the

length of disease patients reduce their

compliance in general. Most of the patients do

not take care in the prescribed diet and regular

exercise. Managing stress condition and regular

sleep is also crucial factors of hypertension as

reported by patients. Patient noncompliance

increases the hypertensive disease conditions.

Based on our studies most of the patient takes

care in the daily dose, hence there is a good

patient compliance. But the same patient neither

care in their food or exercise nor stress and lack

of sleep.

There is a remarkable and immediate increase in

the Body Mass Index seen from above 60 years

of age and it decreases after 70 years of age. In

our own region (Kasaragod) many of the patients

are not very obese. Body mass index is not

showing a great impact on patient compliance.

Patient compliance is relatively lower except in

regular dosing, even that may be biased. As a

part of future research prospects these patients

are unaware about the seriousness of diseases

and adverse drug effects. Lack of awareness and

patient counseling is a stumbling block in our

region. Hence proper counseling to the patient

we can achieve the good patient compliance.

ACKNOWLEDGMENT

27

We acknowledge all the intellectual

contributions done by Ms. Seeba Zachariah,

Senior Lecturer, Malik Deenar College of

Pharmacy, Kasaragod 671321. We admire the

dedication with which Mr. Anwar Hussain, Mr.

Jijo Raj, Mr. Shahul Hameed and Ms.

Valenteena S, Final year B. Pharm students of

Malik Deenar College of Pharmacy, contributed

their whole hearted efforts to the study.

REFERENCE

1. Gupta R Trends in hypertension

epidemiology in India Journal of

Human Hypertension, 2004; 18:73–78.

2. Neutel Joel M. and Smith David H.G.

Improving Patient Compliance: A

Major Goal in the Management of

Hypertension. The Journal of Clinical

Hypertension 2007; 5(2), 127 – 132.

3. Teresa M. Zyezynski and Karin S.

Coyne Hypertension and current issues

in compliance and patient outcomes,

Current Hypertension Reports

December, 2000; 2(6):510-514.

4. Gascon JJ, Sánchez-Ortuno M, Llor B,

Skidmore D and Saturno PJ Why

hypertensive patients do not comply

with the treatment. Family Practice,

2004; 21: 125–130.

5. Thrall G, Lip GYH and Lane D,

Compliance with pharmacological

therapy in hypertension: can we do

better, and how? Journal of Human

Hypertension, 2004; 18:595–597.

6. Bhatt SP, Luqman -Arafath TK, Guleria

R. Non-pharmacological management

of hypertension. Indian J Med Sci.,

2007 [cited 2008 Sep 22]; 61:616-24.

Available

from: http://www.indianjmedsci.org/tex

t.asp?2007/61/11/616/32928.

7. June Stevens, Kimberly P. Truesdale,

Eva G. Katz and Jianwen Cai. Impact of

Body Mass Index on Incident

Hypertension and Diabetes in Chinese

Asians, American Whites, and

American Blacks. American Journal of

Epidemiology, 2008; 167 (11):1365-

1374.

8. Mufunda J, Body mass index and blood

pressure: where are we now? Journal of

Human Hypertension, 2007; 21:5–7.

9. Kaur K and Mogra R, Association of

Body Mass Index, Body Fat and

Hypertension among Postmenopausal

28

Women J. Hum. Ecol., 2006; 20(3):

171-175.

10. Lukas Arno, Kumbein Friedrich,

Temml Christian, Mayer Bernd and

Oberbauer Rainer. Body mass index is

the main risk factor for arterial

hypertension in young subjects without

major comorbidity. European Journal of

Clinical Investigation 2003; 33 (3):

223 – 230.

11. Ajay VS, Ruby Gupta, Jeemon

Panniyammakkal, Vivek Chaturvedi,

Dorairaj Prabhakaran andSrinath Reddy

K. National Cardiovascular Disease

Database, Ministry of Health and

Family Welfare, Government of India

and World Health Organization, IC

HEALTH Sticker No: SE / 04 /

233208,.

12. Ponnusankar S, Chintan Maniar,

Karthikeyaen S. and Suresh B, Use of

Antihypertensive Drugs at Rural India:

Prescription Trend in General Practice,

The Indian Journal of Hospital

Pharmacy 2007; XL.IV(5): 181-183.

13. Balakeshwa R, Ramesh M,

Basavanagowdappa and Parthasarathi

G, A Prospective Study on Prescribing

Pattern of Antihypertensive Therapy in

Medical Wards at a Teaching Hospital,

IJHP 2008; 45: 126-131.

STATISTICAL COMPARISON AND

EVALUATION OF ADRS OF HERBAL

MEDICINES OVER CONVENTIONAL

OTC MEDICINES

Yogesh Murti *, Neelam Maheshwari, Hridaya

Shankar, Vijay Sharma and Devender Pathak

Rajiv Academy for Pharmacy, N.H.#2, Delhi-

Mathura Bye Pass, Mathura, 281001

ymurti@rediffmail.com

ABSTRACT

In India, herbal medicines or phytomedicines are

increasingly being used by the general public on

a self-selection basis to replace conventional

medicines. One of the reasons for the popularity

of herbal medicines is the belief among many

users of herbal medicines that these preparations

are natural and therefore, safe for use. The

present study was conducted to determine

whether Adverse Drug Reactions (ADRs) of

herbal medicines would be reported differently

from similar to those of conventional over-the-

29

counter (OTC) medicines; face to face interview

was conducted with 600 consumers of herbal

medicines in Mathura region. Collected data was

evaluated and further analyzed by applying

Friedman Test and Paired Test. The results

showed that ADRs were also associated with

herbal medicines as in case of conventional OTC

medicines. This study provides evidence that

herbal medicines users would be less likely to

consult their doctors for suspected ADRs than

for similar ADRs to conventional OTC

medicines. This has implications for herbal

pharmacovigilance and implies that many

suspected ADRs to herbal medicines will go

unmonitored and they also required undergoing

Monadic testing. Our study illustrate the need for

great public awareness that ADRs to herbal

medicines can also occur and that such cases

should be reported to the authorities

immediately.

Keywords: Herbal medicine, OTC medicine,

ADRs, pharmacovigilance

INTRODUCTION

Herbal medicine, also called botanical medicine

or phytomedicine, refers to the use of any plant’s

seeds, berries, roots, leaves, bark or flowers for

medicinal purposes. The herbal medicines

available in most stores come in several different

dosage forms- tea, syrup, oil, liquid extract,

tincture and dry extracts available in the form of

pills or capsules. These medicines have low risk

of side effects when they are used occasionally

by healthy adults. Recently, the World Health

Organization estimated that 80% of people

worldwide rely on herbal medicines for some

aspect of their primary healthcare. In India,

herbal medicines are increasingly being used by

the general public on a self-selection basis to

replace or complement conventional medicines.

Reasons for the popularity of herbal remedies are

belief among many users and suppliers of herbal

medicines that these preparations are natural and

therefore safe1 and increasing public

dissatisfaction with the cost of prescription

medications, combined with an interest in

returning to natural or organic remedies. This

however, is a misconception that herbal

medicines can not produce adverse drug

reactions (ADRs)2,3 whereas it has been observed

that the ADRs produced by herbal medicines are

very serious and even fatal4,5. This study was

designed to determine whether ADRs to herbal

medicines would be reported differently from

similar ADRs to conventional OTC medicines

and to identify experiences of ADRs of herbal

remedies and how they are perceived by

30

consumers. Present study was conducted to

identify the status of ADRs because herbal

medicines contain a combination of chemicals,

each with a specific action, many are capable of

eliciting complex physiological responses, some

of which may create unwanted or unexpected

results when combined with conventional drugs.

Even if ADRs are reported by patients, their

general physicians (GPs) may not be fully

briefed about the use and effects (adverse or

otherwise) of herbal medicines.

EXPERIMENTAL METHOD

The data was collected by conducting face to

face interview at various medical shops taking

600 customers as population. Customers were

asked if they would be willing to be interviewed

as part of a present study on herbal medicines.

Those agreeing to be interviewed were asked if

they ever use herbal medicines; if they answered,

‘No’ the interview was terminated and if

customer answered, ‘Yes’ the interviewer

continued with the questionnaire.

Respondents were asked what herbal remedies

they used, how often and for what purpose. The

same questions were asked from conventional

OTC medicines consumers. Data on how

respondents choose their herbal remedies and

from where they obtain them was also registered.

In addition, respondents were asked if they had

ever experienced any ‘Adverse effects’ after

taking herbal medicine and if so, they were asked

to provide the following details- name of herbal

medicine and associated adverse-effect; apart

from this if they stopped taking the medicine due

to reported adverse effect were also registered.

Respondents were also asked for demographic

information (gender, age, occupation); social

grade and ethnic group.

The key part of the interview sought to obtain

information on what action respondents would

take if they experienced adverse effect to a

conventional OTC medicine and to a herbal

medicine. Respondents were allowed to select

one or more of the following responses: continue

taking and see if symptom(s) resolved; stop

taking immediately; consult your General

Physician (GP)/ Healthcare practitioner; other

action as shown in table no. 1. The data is

presented in a manner to clearly identify the

number of respondents who would act differently

for ADRs to herbal medicines than for similar

ADRs to conventional OTC medicines. Data

collected on the basis of interview was

statistically evaluated and was further validated

31

by applying Friedman’s Test, Paired t-Test and

Monodaic Test.

STATISTICAL EVALUATION

The Friedman’s Test was applied at degree of

freedom 3 with 5% α-level of significance used

to measure the extent of significant difference

between various types of decision making. The

paired test was applied to determine the

difference between continuation of herbal and

conventional drug after side effects which was

further validated by applying Monodaic Test

having ranking 3 (no side effect), 2 (minor side

effects) and 1 (major side effects).

RESULTS AND DISCUSSION

Table No. 1 Number of respondents (% of total) that would choose a particular course of action

after experiencing a suspected ADR to a conventional OTC medicine and herbal medicine.

Type of decision Likely action following

ADRs Yes for both No for both Yes for OTC;

No for herbal

No for OTC;

Yes for herbal

Continue taking and see

if symptom(s) resolved

9 (1.56%) 125 (21.7%) 3 (0.05%) 439 (76.2%)

Stop taking immediately 27 (4.7%) 180 (31.25%) 358 (62.13%) 11 (1.9%)

Consult General

physician (GP)/

Healthcare practitioner

100 (17.36%) 5 (0.08%) 421 (73.1%) 50 (8.68%)

Six hundred individuals agreed to be

interviewed, among them thirty four (5.67 %)

stated that they did not use herbal remedies and

therefore these interviews were terminated. The

approach shifted towards the remaining

population, for which the face-to-face interview

was conducted with five hundred sixty six

consumers of herbal remedies. The registered

conversation showed that fifty three percent

among all respondents used one or more herbal

medicines regularly, whereas forty seven percent

used one or more herbal medicines occasionally.

32

Seventy two percent of all respondents were

reported to be regular or occasional consumers of

conventional medicines.

Following serious ADR, 100 (17.36%)

respondents would consult their GP/healthcare

practitioner irrespective of whether the ADR was

associated with the use of a herbal medicine or

conventional OTC medicine; 5 (0.08%)

respondents would not consult their

GP/healthcare practitioner for serious ADR

associated with either type of preparation. 421

(73.1%) respondents would consult their

GP/healthcare practitioner for serious ADR to

conventional OTC medicine, but not for similar

ADR to herbal medicine, whereas 50 (8.68%)

respondents would consult their GP/healthcare

practitioner for serious ADR to herbal medicine,

but not for similar ADR to conventional OTC

medicine.

On applying various statistical tests it was found

that in case of Friedman’s Test, the χ2 (cal.)= 12

and χ2 (tab.)= 7.81 at degree of freedom 3 with 5%

α-level hence it was concluded that at least two

type of decision making have significant

difference. Further it indicated that the use of a

herbal drug is entirely different from that of

conventional OTC medicine, since even after

having side effects consumers continue the use

of herbal drug but rarely do the same for

conventional OTC medicines.

In case of Paired t-Test, the assumption was that,

the chances of continuous use of herbal and

conventional drug are same after having side

effects and alternatively the proportion is

different. Result of test (Zcal=12.458 and

Ztab=1.96 at 5% α-level) shows that consumers

treat side effect of herbal drugs as normal and

continue their use even after having side effects.

On applying Monodaic Test for acceptability of

side effect the following rank order was used, 3-

no side effect, 2-for minor side effects and 1-

major side effects. It was found that tcal= 4.5 and

ttab= 1.69 at degree of freedom 18 at 5% α-level

which shows, most of the people use herbal

drugs in comparison to conventional OTC

medicines on the basis of acceptability of side

effects. It was also observed that, people

frequently use herbal medicines on self

prescription basis unaware of the side effects

they have but the approach was significantly

different in case of OTC medicines. The

acceptability of side effects is higher in case of

herbal drugs as the consumers have the

assumption that herbal drugs do not have any

side effects or they are acceptable.

33

The present study also revealed that 50% of the

total consumer population under study has

chosen herbal medicines, after getting suggestion

from friends or family members, by

recommendation or advertisements, 32% on the

basis of their own knowledge and 18% on the

basis of prescription or recommendation from

their General physician (GP)/healthcare

practitioner.

CONCLUSION

Herbal preparations are best taken under the

guidance of a trained professional. Many herbs

are considered safer than conventional

medications, but because they are unregulated,

herbal products are often mislabeled and may

contain undeclared additives and adulterants.

Some herbs are also associated with allergic

reactions or interact with conventional

medicines. Self-prescribing herbal products will

increase consumer’s risk. Hence it is important

to consult a doctor and an herbalist before self-

treating. This has implications for herbal

pharmacovigilance and implies that many

suspected ADRs to herbal remedies will go

unmonitored. It is suggested that, there is need

for a holistic approach to the health care, and the

untapped potential of the traditional medicines

should be utilized. Our findings illustrate the

need for greater public awareness that ADRs to

herbal remedies can occur, and that such events

should be reported to an appropriate authority.

Professionals also need to be aware of the

potential for herbal remedies to cause ADRs and

routinely question their patients about their use

of such remedies.

REFERENCES

1. Newall CA, Anderson LA, Phillipson

JD. Herbal medicines. A guide for

health-care professionals, 1st ed.

London: The Pharmaceutical Press,

1996: 3-12.

2. Abbot NC, Ernst E, White AR.

Complementary medicine. Nature 1996;

381: 361.

3. De Smet PAGM. Health risks of herbal

remedies. Drug Safety 1995; 13 (2): 81-

93.

4. De Smet PAGM. An introduction to

herbal pharmacovigilance. In: Adverse

Effects of Herbal Drugs, Vol. 3, eds de

Smet PAGM, Keller K, Hänsel R,

Chandler RF. Berlin, Heidelberg:

Springer-Verlag, 1997: 1-13.

5. Ernst E, de Smet, PAGM. Risks

associated with complementary

therapies. InMeyler's Side Effects of

34

Drugs, 13th ed., Dukes MNG.

Amsterdam: Elsevier, 1996: 1427.

6. Fisher RA. Statistical methods for

research works, Oliver & Boyd,

Edinburgh.

7. Khan, Irfan A, Biostatistics for

pharmacy.

DRUG USAGE IN GERIATRICS

1Sathya Prabha.G*, Prudence .A. Rodrigues,

2Vijay kumar.A, and Lavanya.S.

1Department of pharmacy practice, PSG College

of Pharmacy, Peelamedu, Coimbatore-641004

2Drug and poison information center,

Department of pharmacy practice,

Kovai medical center and hospital, KMCH

College of pharmacy, Coimbatore-641014

thivishaprabha@gmail.com

ABSTRACT:

Population aging is considered as the most

serious problem in developed countries and is

going to be a threat for developing countries.

Aging is associated with various physiological

changes and multiple diseases like diabetes,

hypertension, arthritis etc. which alter the

pharmacological response to a drug. Moreover,

elderly people are more sensitive to frequently

used drugs like NSAIDs, benzodiazepines,

opioids etc. By avoiding irrational prescribing,

minimizing ADRs and maximize benefits of

drugs in elderly patients is essential.

KEY WORDS: Geriatrics, Drug Prescribing In

Geriatrics, Drugs For Elderly Patients.

INTRODUCTION

Geriatrics is the branch of general medicine

concerned with the clinical, preventive, remedial

and social aspects of illness in elderly1. Life span

of humans has increased in the recent years due

to social, economical and health care

improvement. Medical society has identified

persons aged over 65 as elderly while those

above 75 as geriatric population. By 2050 the

worldwide elderly population is expected to

reach 1.4 billion which means that one out of ten

people will be more than 65 years of age.

Currently population aging is most serious in

Europe and Japan. China is expected to have an

increase in the proportion of elderly people by

next century. The present elderly population in

India is over 77 million, constituting 7.7% of the

35

total population and is expected to rise to 100

million by 20132.

INCREASED PREVALENCE OF DISEASE

Cardiovascular diseases

Cerebrovascular diseases

Alzemiers disease

Depression Diabetes

Osteoporosis and osteoarthritis

Visual and hearing impairment.

Many of the problems that affect the elderly are

of chronic nature, and may require long term

drug therapy. Elders are highly susceptible to

medication errors and drug related problems due

to their special needs and uncoordinated care.

Since the elderly are widely variable and drugs

must be carefully monitored to minimize the risk

of poor outcomes.

Targeting patients taking unnecessary multiple

prescriptions (often duplicate or triplicate

therapies) that can cause serious harm and waste

valuable resources.

Reducing the number of serious at risk for side

effects of drugs considered inappropriate for use

in the elderly.

Working with physicians to optimize drug

therapies by increasing the use of medications

considered to be best for individual’s practices.

Providing therapeutic interchange for certain

drugs to provide equal or better

clinical outcomes.3,4

Table 1. Age related physiological changes and their consequences on drug therapy in geriatrics.5

System Age related physiological

changes

Consequences

General Increased body fat. Decreased total body water.

Vd of lipid soluble drugs is increased requiring higher dose eg. Diazepam. Vd of water soluble drugs

Gastrointestinal tract Decreased gastric acidity. Decreased gastrointestinal motility Decreased hepatic and splanchhic blood flow Decreased renal blood flow, gomerular filtration rate and tubular secretion

Absorption of basic drugs is enhanced eg:propranolol. Absorption of acidic drug is decreased eg: barbiturates Decreased absorption of drug Decrease metabolism of drug eg:lignocain

Renal Decreased renal blood flow, glomerular filtration rate and tubular secretion

Renal clearance is decreased and hence excreted through kidneys should be used cautiously eg.aminoglycosides, digoxin, lithium.

Musculoskeletal Decreased muscle mass Decreased bone density

Resulting in functional impairment and fracture requiring treatment, hospitalization, etc.

Cardiovascular system Increased blood pressure Cardiovascular complications requiring treatment, hospitalization, etc.

36

Central nervous system

Brain atrophy Decreased brain catecholamines synthesis. Decreased dopaminergic synthesis. Decreased sleep

Results in forgetfulness, depression, parkinsons, insomnia etc,requiring therapy

Genitourinary Vaginal/urethral mucosal atrophy. Prostrate enlargement

Bacteriuria, increased residual urine volume requiring hormonal or drug therapy

Endocrine Decreased BMR. Vulnerable to stress. Glucose intolerance

Resulting in Diabetes mellitus which needs life long treatment.

Vd- Volume of distribution BMR- Basal metabolic rate.

POLYPHARMACY WITH ELDERLY

Polypharmacy significantly increases the risk of

drug-drug interactions. Psychotropic medications

have been consistently and significantly

associated with an increased risk of falls in the

elderly. The tricyclic antidepressants serotonin

reuptake inhibitor, antidepressants,

benzodiazepines and antipsychotic need to be

monitored closely in the geriatric population

with regard to falls.6 Discomfort, pain or

difficulty swallowing medication is a problem

faced by many elderly patients. Dysphagia is

seen in patients with Parkinson’s disease, altered

mental status or as a result of a cerebal vascular

accident.7

Factors causing ADRs15

.

Age related multiple

diseases

Age related physiological

changes

Impaired functions of organs

like liver and kidney

Altered response to drugs

Increased incidence of adverse drug

reactions

37

INCIDENCE OF ADVERSE DRUG REACTIONS IN GERIATRICS

These may be due to the following factors:

A. Changes in pharmacokinetics

B. Changes in pharmacodynamics

C. Drug interactions

D. Inappropriate prescribing in elderly

E. Co-morbidities8

Table 2. Changes in pharmacokinetics with aging.

Pharmacokinetic parameter Changes

Absorption Nil

Distribution of Lipid soluble drugs

Water soluble drugs Acidic drugs Basic drugs

Increased Decreased Increased Decreased

Metabolism Phase I Phase II

Decreased Nil

Excretion

Decreased

Table 3. Some common changes in pharmacodynamics with aging 9-10

.

Drugs

Changes

Antihypertensive agents

Increased risk of orthostatic hypotension

Benzodiazepines

Increased sensitivity

b-adrenergic blockers

Decreased b-adrenergic responsiveness

Coumarin anticoagulants

Increased sensitivity

Diuretics

Increased susceptibility for complication

Polypharmacy

38

INAPPROPRIATE PRESCRIBING IN

ELDERLY

It is defined as overuse of drugs, irrational choice

of drugs and/or under use of appropriate drugs.

In elderly, overuse of drugs is quite common and

they often keep using drugs beyond Prescription.

Moreover, they are prone to self medication. Use

of fixed dose combinations often adds to the

problem.11, 12

CO MORBIDITY

Comorbidity, or the simultaneous presence of

two or more chronic diseases, is common in the

elderly. The rate of comorbidity in the elderly

population has increased steadily since the early

20th century. This increase may be attributed to a

rise in the number of diagnosis and to increased

longevity.13

Table 4 Co morbidity.

Comorbid diseases

Potential drug-drug

interactions

Adverse effects

Arthritis and High blood pressure

High bloodpressure and diabetes Arthritis & Diabetes Arthritis and Heart Disease

NSAIDs + Digoxin NSAIDs + ACE Inhibitors Thiazides + Insulin Cortisone + Insulin NSAIDs + Warfarin

Some NSAIDs may increase levels resulting in potential Digoxin toxicity Some NSAIDs may blunt the anti-hypertensive effects of some ACE inhibitors Reduce the effectiveness of insulin Harmful increase in blood glucose levels in diabetics With NSAID use, the anti-coagulant (Blood thinning) effect of warfarin may be enhanced Also , there is increased risk of bleeding in the Gl tract

COMPLIANCE

The elderly are generally more compliant than

the younger population. However, many factors

can lead to poor compliance in this group,

resulting in treatment failure. Over 10% of

hospital admissions are attributed to medical

non-compliance.

STRATEGIES TO IMPROVE

COMPLIANCE IN ELDERLY

1. Making drug regimens and instructions as

simple as possible:

Link it with daily routine like meals

Use same dose schedule whenever possible and

avoid frequent changes.

39

Keep burden of pills low and assure pills can be

taken easily, i.e. easy to swallow (small size),

patient has no swallowing problem.

Easy handling of drugs - easy to open drug

bottles / packs, clear and large labeling and

instructions

Educate patient and care givers - counseling,

clear instruction both verbal and written, in

hospital training on drug regimen and their

problems.

2. Keep update medicine record/use aids such as

medicine calendars

3. Review periodically for knowledge of drug

regimens/compliance and inspect drug list.14

PHARMACIST ROLE &

RESPONSIBILITIES IN GERIATRIC

CARE

1. Design, recommend, monitor and

evaluate patient specific

pharmacotherapy for geriatric patients.

2. Build the information base needed to

design a medication therapy regimen for

a geriatric patient.

3. Design pharmacotherapeutic regimens

for geriatric patients.

4. Provide medication-use education to

geriatric patients and their caregivers

5. Consider non-drug alternatives

including physical exercise, physical

therapy, counseling and relaxation

techniques.

6. Written instruction, information

leaflets, special containers, and special

package for appropriate use of

medication.

7. Document pharmaceutical care

activities provided for geriatric patients

appropriately. Provide in-service

education to physicians, nurses and

other practitioners serving geriatric

patients.

8. Participate in the medication-use

evaluation (MUE) program in the care

of geriatric patients and develop a

proposal for a new geriatric pharmacy

service.

9. Provide instruction to pharmacy

technicians, pharmacy students and

pharmacy aides.

10. Perform prospective and retrospective

financial and clinical outcomes

analysis15

CONCLUSION

40

Rational drug use, though important at all

ages becomes more relevant in the elderly as

they use more medications than the younger

population in the form of prescribed or over

the counter drugs. Due to various factors,

they have 3 to 7 times greater incidence of

adverse drug reaction as compared to the

later. Use medication in the smallest

number, lowest dosage for the shortest

period and with simplest regimen. The

success of a drug therapy in elderly depends

on considering the factors like correct

diagnosis, treatment plan, prescription,

patient education and dose adherence.

REFERENCES

1. Geriatric pharmacy practice: Rohan

Elliot. In: G. Parthasarathy, Karin

Nyfort-Hansen& Milap C Nahata eds.

clinical pharmacy practice.1st ed .India:

Orient Longman Private Ltd; 2004. p.

190-217.

2. Shah Naseem. Oral health care system

for elderly in India. Geriatrics and

Gerontology International 2004; 4:162-

64.

3. Bertram G Katzung. Special aspects of

geriatric pharmacology. In: Bertram G

Katzung, editor. Basic and Clinical

Pharmacology. New York: McGraw

Hill; 2007. p.983-90.

4. Hanlon JT, Schmader KE ,

Koronkowski MJ,et al. Adverse drug

events in high risk older patients. J Am

Geriatr Soc 1997; 45(8), 945-8.

5. Cusack BJ, Neilson CP, Vestal Re.

Geriatric Clinical pharmacology and

Therapeutics In: Speight TM, Holford

NHG, editors. Avery’s drug treatment.

Auckland : Adis press Ltd ; 1987

.p.174-223.

6. Leipzig RM, Cumming RG, Tinatti ME

Drugs and falls in older people: a

systematic review and meta-analysis II,

Cardiac and analgesic drugs. J Am

Geriatrics Society 1999; 47(1), 40-50.

7. Goodman LS, Goodman and Gilman’s

.The Pharmacological Basis of

Therapeutics. 7th ed. New York:

MacMillan; 1980.p.1-7, 28.

8. Kiniross MT, Crome P. Clinical

pharmacokinetic considerations in the elderly: an

update. Clin Pharmacokinetic 1997; 33:

302-312.

9. Hammerlein A, Derendorf H, Lowenthal

DT. Pharmacokinetic and

pharmacodynamic changes in the elderly:

clinical implications. Clin

Pharmacokinetic 1998; 35:49-64.

41

10. Feely J, Coakley D. Altered

pharmacodynamics in the elderly. Clin

Geriatr Med 1990; 6: 269-283.

11. Beers MH. Explicit criteria for

determining potentially inappropriate

medication use by the elderly. Arch Intern

Med 1997; 157:1531-36.

12. Fick DM, Cooper JW, Wade WE et al.

Updating the Beers criteria for potentially

inappropriate medication use in older

adults: results of a US. Consensus panel

of experts. Arch Intern Med 2003;

163:2716-24.

13. Guralnik JM, LaCroix A, Everett D, Kovar

M. Aging in the eighties: The prevalence

of comorbidity and its association with

disability, National Center for Health

Statistics, 1989; 170;1-8.

14. Rameshwar Nath Chaurasia, Alok Kumar

Singh, I S Gambhir. Rational Drug

Therapy in Elderly .Journal of The Indian

Academy of Geriatrics. 2005; 1:9-13.

15. Hanlon JT, Schmader KE, Kornkowski MJ

et al. Adverse drug events in high risk

older outpatients. J Am Geriatric Soc

1997; 45:945-48.

16. http://www.omnicare.com/Geriatric

17. http://www.ashp.org /rtp/Geriatric