Introduction to the Clinical Pharmacy in Detail

Clinical Pharmacy
Sreenu Thalla
Associate Professor
Department of Pharmacology

• Clinical pharmacy is defined as the branch of pharmaceutical science dealing with
utilization of pharmacist knowledge, skills and judgments related to biomedical and
pharmaceutical sciences, to prove the safety, the cost and the precision of the drug usage in
the patient care
Clinical Pharmacy

Objective
• The objective of clinical pharmacy practice is to optimize patient outcomes by working to
achieve the best possible quality use of medicine (QUM)
Definitions
• Clinical pharmacy practice is the practice of pharmacy in a multidisciplinary healthcare team
directed towards achieving patient treatment goals by ensuring
 That the right patient receives the optimum dose of the most appropriate medication
for specific condition via a rational dosage form and regimen, over an appropriate
time period
 That untoward effects and interactions of drugs are identified, resolved and where
possible prevented
 Involvement in patient education and counseling, monitoring of drug therapy,
prescriber education and research
 That the quality use of medicines is promoted through other activities as appropriate

Clinical Pharmacy Services
• A pharmacy service should provide suitable trained and qualified pharmacists to facilitate the
most effective, efficient and economical utilization of drug therapy with the aim of optimizing
patient care
• The service includes supply, administration, drug therapy monitoring, drug information, patient
counseling and pharmacokinetic interventions (drug-drug ; herb-drug interactions)
• Monitoring of drug therapy and outcomes should optimally be performed on a daily basis;
however some patient groups may require less intensive monitoring

• Clinical pharmacists should also be involved in activities which may not be directly related to
individual patient care but are directed at enhancing the quality medication use eg: DUE,
teaching and research and development of multidisciplinary care plans.
• Clinical pharmacy should not be restricted to hospital pharmacy practice.
• Communication and cooperation between institute-based and community-based pharmacists is
an essential element of a patient’s ongoing care
• Ensuring the continuity of supply and drug therapy monitoring in the community is an
important role of clinical pharmacists

Clinical Pharmacy Service Include
 Medication history interview
 Drug therapy monitoring
 Medication order review
 Adverse drug reaction management
 Clinical review and TDM
 Participation in ward rounds and meetings
 Selection of drug therapy
 Prevention, assessment and management of drug interactions
 Provision of drug information
 Patient medication counseling
 Liaison with community services

Role of Clinical Pharmacists in Education and Research
• Involvement in education and research is essential components of contemporary clinical
pharmacy practice
• Pharmacists practicing clinical pharmacy should undertake research into optimum utilization of
drug therapy and the practice of clinical pharmacy
• Clinical pharmacists should support, initiate and participate in research projects whenever
possible.

• Areas of specific focus may include
 Development of clinical pharmacy services
 Individual case reviews
 Clinical trials
 Quality assurance
 Guideline and protocol formulation and evaluation
 Clinical pharmacists involved in research activities should adhere to the principle and
procedures in Declaration of Helsinki, other relevant guidelines of ethical considerations

• The expertise and resources of other health professionals should be utilized whenever possible
• Collaboration with other pharmacists interested in the same field may be of assistance
• Clinical research (experience!) must be published in reputed journals
• Contribute to other co-workers, pharmacists , pharmacy students and other healthcare
professionals

Involvement include
 Experiential education of pre-registration pharmacists
 Orientation and training of pharmacists in specific fields of practice
 Patient and career education
 Education of other health professionals in areas relevant to quality use of medicines
 Specific UG pharmacist education
 Design, format and methods of undergraduate and post graduate pharmacy course
programs
 Design of patient focused education programs
 Development of specific training programs and courses on selected aspects of clinical
pharmacy practices Publication of training programs and education tools

Development of Clinical Pharmacy
• First Pharmacy Degree 70 years ago @ BHU
• The Pharmacy Act – 1948 was developed by PCI
• Education regulation was drafted for D. Pharm 1953, 1972, 1981 and 1991
• Till today pharmacy education oriented towards the pharmaceutical industry
• Production, formulation, quality control and marketing
• Growth of pharma industry – self sufficient
• Various types of dosage forms including controlled release or sustained release are available
(approx 75, 000 formulations)

• The first change in ER 1991 Clinical, hospital and community pharmacy, drug store management
subject included
• In 1980 s and 1990 s consequences of drug misuse, such as poor health outcomes from drug
treatment, antibiotic resistance, adverse drug reactions and economic loss to patients
• In late 1990s pharmacy profession realized the need of training the pharmacists to contribute to
improving medication use in the country
• Problem remained – education system trained in pharmaceutics, chemistry, pharmacology and
industrial pharmacy
• Patient care – based on the knowledge of pathophysiology, applied therapeutics, clinical
pharmacokinetics, practice skills such as drug information, drug therapy review

History of Clinical Pharmacy
 The term clinical pharmacy was first used in 1953.
 First, in 1962 "The Thalidomide Tragedy", wherein it was found that consumption of popular
sedative thalidomide resulted in birth of babies with sealed limbs.
 Second, in 1968 Phenytoin toxicity was reported in Australia which was because of change in
formulation i.e. switching over from calcium sulfate to lactose as an inert excipient in the tablets.

Why we need clinical pharmacy practice in India?

Scope of Clinical Pharmacy
• Obviously, this job was mainly given to pharmacology and clinical pharmacology developed as a
subject in medical institutions.
• Clinical pharmacy practice is concerned with the promotion of effective, safe and economical drug
therapy
• Pharmacy Practice – includes clinical pharmacy services and other activities performed by
pharmacists in the hospital and Community pharmacy setting including
 Dispensing and drug distribution
 Drug information
 Health promotion
 Patient counseling
 Pharmacovigilance
 Medication reviews
 Academic detailing

Preparation of patient medication histories
 Any hypersensitivities or allergies to specific drugs observed in the past, any particular drug
or food habits, drug dependence or intoxication with chemicals due to occupational hazards,
all of which are likely to interfere with the therapy.
 This will help in saving physicians time and efforts and thus will result in faster and more
accurate selection of drug therapy.
Rational Prescription
 The clinical pharmacist can suggest the physician and help him in selecting the right drug.
 Some of the examples of irrational combinations identified by pharmacist are
 Haloperidol + Diazepam + Amitriptiline
 Reserpine + Sintamil

Bioequivalence and generic equivalence of pharmaceutical
formulations
 Number of factors influence the bioavailability of drugs from the dosage forms.
 Selection of proper drug therapy based on bioequivalence studies on different dosage forms of
the same drug moiety.

 Observes the signs and symptoms that indicate the need for or reaction to drugs.
 Clinical pharmacist who knows correct route of administration, the signs and symptoms of
over dosages, contraindications, desired effects, undesired effects and side effects can help in
monitoring the drug therapy for safety and efficiency, a necessity with the increasing
applications of potent and toxic chemicals and drugs.
 Drugs with narrow therapeutic index, or when drugs administered in patients who are
critically ill or are suffering from chronic diseases.
Patient monitoring
Disease condition Class of drug
used
Parameter measured
Hypertension Diuretics Blood pressure changes
Diabetes Insulin therapy Urine glucose levels

Adverse Drug Reactions & Drug Interactions
The clinical pharmacist
 Can compile and process data using computers and make it available to
 the medical staff.
 May suggest an alternate therapy if applicable
 Identify drug effect modifications due to interactions with several foods, alcohol,
smoking, environmental chemicals, as well as due to pregnancy

Drug diagnostic test inferences
Intravenous admixtures

Drug Information Specialist
 A clinical pharmacist being an expert on drugs may operate a drug information service.
 Through effective utilization and retrieval of clinical drug literature, the pharmacist can
actively communicate drug information.
 He can help during medical emergencies, by providing immediate information on antidotes
in case of poisoning or overdosing.

Retail pharmacy stores
• Many OTC drugs have the potential to interact with prescription drugs
• A clinical pharmacist at retail drug stores can maintain patient drug profiles, family drug
profiles and family records based upon which the pharmacist can counsel the patient each time
while filling the prescription
• He can determine the patient's responses to drug therapy and help him in the selection and
use of OTC drugs.

Discharge counseling and patient compliance
 The compliance to drug therapy can be improved several times, by educating and counselling
the patient at the time of discharge from hospital or while dispensing the prescription at the
retail counter.
 The patient may be made aware of the purpose of medication, proper mode of
administration, dosage schedule and storage conditions.
 He may be told of any potential adverse or side effects to expect and any food or activities to
be avoided during therapy.

Clinical research and continuing education program
 The clinical pharmacist can participate in an evaluation program on investigational drugs.
 He can help in conducting clinical trials based on sound principles of biostatislical
methods of evaluation.
 He can also develop training programs for pharmacists, nurses and interns.

Medical Audit
 Medical audit is a logical and necessary procedure within organized teamwork.
 The clinical pharmacist is either the initiator or a very active member of a functioning committee.
 Following are the activities, concerning medical audit
 Legislation.
 Contractual obligation.
 Regulation and registration of pharmacotherapy orders and administration.
 Regulation of clinical experiments with drugs
 Information per subject and per patient
 Pharmacotherapy-committee policy
 Regulation of information from the Pharmaceutical Industry
 Local or regional micro symposia per patient
 Formulary policy
 Retrospective study of drug use patterns
 Medical audit committee work.

Pharmaceutical Industry
• >75, 000 formulations
• Irrational drug combinations and non-essential medicines (vitamin tonics)
• Doctors rely in promotional material from pharma industries for drug information
• Biased information, does not provide independent advice regarding indications for treatment
and safety issues
• Many pharma industry do not have full fledged medical information dept
• Package inserts contain technical information for prescribers not for patients
• Thus, Clinical pharmacy practice address these issues by providing un-biased, independent
drug information to doctors and by providing patient care through counseling.

Prescribers
• Patient load is extremely high OP dept is over crowded “a pill for every ill”
• Un-necessary drug related problems
• ADR Not adequate
• Pharmacotherapeutic training
• Rely on information from pharma companies
• Brand name prescription – with the risk of duplication of therapeutic equivalents
• Infectious diseases often treated empirically; hence antibiotic resistance found
• Thus, Clinical pharmacists can help by providing doctors with advice and information to
deliver safer and more effective drug therapy

Pharmacists
• Do not offer any professional services include patient counseling, labeling information on
medication use, drug interactions etc
• Due to poor knowledge base, lack of training and confidence; lack of financial benefits
• Statutory bodies control on medical stores – not satisfactory
• Pharmacies are managed by non-pharmacists; hence community pharmacy practice does not exist
• Hospital pharmacists manage business formalities – such as drug inventory, maintenance of OPD
dispensing and record keeping.
• Thus – With appropriate education and training, graduate pharmacists can help to improve
medication use, by providing services, ward round participation, and ADR reporting and
monitoring

Patients
• >50% cannot Read & Write
• Medication compliance is poor
• Patient counseling
• PIL and advisory labels in local language assist in improved medication use
• Thus, Clinical pharmacists can advice on patients and their doctors on the most cost-effective
medications for a particular condition, and help to reduce spending on unnecessary and
irrational medications

Government
• National health policy focused on pharmaceutical industry rather than patient
• Technical and commercial matters such as price control and licensing of mfgs have given
priority
• Advertising and promotional claims by the mfg – not strictly regulated
• Govt. is not ready to initiate uniform ADR documenting system; which indirectly help to
initiate medication safety
• No guidelines on STGs on pediatric; geriatric patients
• Thus, Monitoring and reporting the ADRs should be initiated by the clinical pharmacy practice
and pharmacists can play a meaningful role in the healthcare system of India.

Status of Clinical Pharmacy in India
• In developed countries like United States of America. Canada etc. Clinical Pharmacy has
already taken good shape.
• In India, it is in the infancy stage.
• The role of the retail pharmacist is viewed by many people as simply transferring pills from
a large bottle to a small one - counting tablets, typing labels and calculating the price.
• Today there is 'drug-explosion' and 'information explosion' in relation to the drugs
• On one hand there is development of newer and more-effective drugs and on other hand
their potential hazards of side effects are on rise

Medical Record
 Admission Information
 Initial history
 Physical examination
 Progress notes
 Consultations
 Nursing notes
 Laboratory data
 Diagnostic Procedures
 Radiology
 Surgery
 Orders
 Medication administration orders
 Consent forms

Clinical Pharmacy Practice areas
 Ambulatory care
 Critical care
 Drug Information
 Geriatrics and long –term care
 Internal medicine
 Cardiology
 Endocrinology
 Gastroenterology
 Infectious disease
 Neurology
 Nephrology
 Obstetrics and gynecology
 Pulmonary disease
 Psychiatry
 Rheumatology
 Nuclear pharmacy
 Nutrition
 Pediatrics
 Pharmacokinetics
 Surgery

Clinical Pharmacokinetics
• Clinical pharmacokinetics is the process of applying pharmacokinetic principles to
determine the dosage regimens of specific drug products for specific patients
• To maximize pharmacotherapeutic effects and minimize toxic effects.
• TDM stands for therapeutic drug monitoring
• Application of these principles requires an understanding of the absorption, distribution,
metabolism, and excretion characteristics of specific drug products in specific diseases and
patient populations

Why request TDM?
 Noncompliance
 Inappropriate dosage
 Poor bioavailability
 Drug interaction
 Kidney and liver disease
 Altered protein binding
 Fever
 Cytokines
 Genetically determined fast or slow metabolizers

Responsibilities
 Designing patient-specific drug dosage regimens
 Recommending or scheduling measurements of drug concentrations in biological fluids
 Monitoring and adjusting dosage regimens
 Evaluating unusual patient responses to drug therapy for possible pharmacokinetic and
pharmacologic explanations.
 Communicating patient-specific drug therapy information to physicians, nurses, and other
clinical practitioners and to patients orally and in writing, and including documentation of
this in the patient’s health record.

 Educating pharmacists, physicians, nurses, and other clinical practitioners about
pharmacokinetic principles and appropriate indications for clinical pharmacokinetic monitoring,
including the cost-effective use of drug concentration measurements.
 Developing quality assurance programs for documenting improved patient outcomes and
economic benefits
 Promoting collaborative relationships with other individuals and departments involved in drug
therapy Designing and conducting research
 Developing and applying computer programs and point-of-care information systems to enhance
the accuracy and sophistication of pharmacokinetic modeling and applications to pharmaceutical
care
 Serving as an expert consultant to pharmacists with a general background in clinical
pharmacokinetic monitoring

Introduction to the Clinical Pharmacy in Detail

More Related Content

Similar to Introduction to the Clinical Pharmacy in Detail

More from Sreenivasa Reddy Thalla

Recently uploaded

Introduction to the Clinical Pharmacy in Detail