Clinical Pharmacy

Dr Sitaram Khadka,PharmD

Clinical Pharmacist Shree Birendra Hospital,Chhauni

Health Care SystemComposed of physician (including other medical and dental staffs), pharmacist , nurse and other paramedics

Physician ; diagnosis, prescription, monitoring, medical care

Pharmacist; prescription*, dispensing, counseling, monitoring, pharmaceutical care

Nurse ; administering, monitoring, nursing care

Other paramedics ; their own work

Load to physician & nurse ; high due to the system of "physicians are all in all in hospital for the treatment of patient, with the help of nurse."

Concept of normal public/patient ; same

Perceptions of Pharmacists

How do others see us?

“They just count a few tablets”

“They just weigh and measure things”

“A bunch of shop-keepers”

“Tell me how and when to use the Medicine”

“Counter-prescribing”

“Not really health care practitioners – they’rebusinessmen”

“Do you need a degree to be a pharmacist”?

For practising Clinical Pharmacy

• Competence of health care practitioners-BPharm to Mpharm to PharmD*

-PharmD+ Pre-registration + registration

-Residency programs

-Continuing Professional Development

• Informed general public – increased expectation

Introduction; Clinical Pharmacy Clinical pharmacy may be defined as the science and practice of rationale use ofmedications, where the pharmacists are more oriented towards the patient carerationalizing medication therapy promoting health , wellness of people.

It is the modern and extended field of pharmacy.

“ The discipline that embodies the application and development (by pharmacist) ofscientific principles of pharmacology, toxicology, therapeutics, and clinicalpharmacokinetics, pharmacoeconomics, pharmacogenomics and other alliedsciences for the care of patients”.(Reference: American college of clinical pharmacy)

HistoryUntil the mid 1960’s ; Traditional role.The development of clinical pharmacy started in USA.More clinically oriented curriculum were designed with the award of PharmD degree. These developments influenced the practice of pharmacy in U.K.,Initially prescription and drug administration records were introduced followedby an increasing pharmacy practice in hospital wards. Master degree programsin clinical pharmacy were introduced for first time in 1976.

The progress of clinical pharmacy development remained at low profile in thefirst decade after its birth in U.K. However, Nuffield report in1986 geared up themomentum for progression of clinical pharmacy.

Until today, the clinical pharmacy practice in Nepal is in embryonic stage.

How does clinical pharmacy differ from pharmacy?How does clinical pharmacy differ from pharmacy?

The discipline of pharmacy embraces the knowledge onsynthesis, chemistry and preparation of drugs

Clinical pharmacy is more oriented to the analysis ofpopulation needs with regards to medicines, ways ofadministration, patterns of use ,drugs effects on thePatients, ‘the overall drug therapy management’.

The focus of attention moves from the drug to the singlepatient or population receiving drugs.

Clinical Pharmacy Requirements

Knowledge of nondrug therapy

Therapeutic planning

skills

Drug Information Skills

Physical assessment

skills

Patient monitoring

skills

Communication skills

Knowledge of laboratory

and diagnostic skills

Knowledge of the disease

Knowledge of drug therapy

Patient care

Level of Action of Clinical Pharmacists

Clinical pharmacy activities may influence the correct useof medicines at three different levels: Before the prescription Before the prescription During the prescription During the prescription andAfter the prescription is written.After the prescription is written.

1. Before the prescription

• Clinical trials• Formularies• Drug information• Drug-related policies

2. During the prescription

• Counselling activity

• Clinical pharmacists can influence the attitudes and priorities of prescribers in their choice of correct treatments.

• The clinical pharmacist monitors, detects and prevents the medication related problems

• The clinical pharmacist pays special attention to the dosage of drugs which need therapeutic monitoring.

• Community pharmacists can also make prescription decisions directly, when over the counter drugs are counselled.

Medication-related Problems• Untreated indications. • Improper drug selection. • Subtherapeutic dosage. • Medication Failure to receive • Medication Overdosage.• Adverse drug reactions. • Drug interactions. • Medication use without indication.

3. After the prescription

– Counselling – Preparation of personalised formulation – Drug use evaluation – Outcome research – Pharmacoeconomic studies

Functions of Clinical PharmacistsFunctions of Clinical Pharmacists1. Taking the medical history of the patient 2. Patient Education

3. Patient care

4. Formulation and management of drug policies

5. Drug information

6. Teaching & training to medical and paramedical staff

7.Research and development

8.Participation in drug utilization studies

9.Patient counseling

10.Therapeutic drug monitoring

11.Drug interaction surveillance

12.Adverse drug reaction reporting

13.Safe use of drugs

14.Disease management cases

15.Pharmacoeconomics

Objective

• Define clinical pharmacy• Differentiate between traditional pharmacists role and

Clinical Pharmacist• Explain the qualification required for clinical pharmacists• List the clinical pharmacists responsibility• Describe the daily work activity of clinical pharmacists• Define what is Therapeutic Drug Monitoring • Discuss the different types of Therapeutic Drug

Monitoring

Clinical pharmacy specialists

• Usually requires residency in a specialty area, in addition to a pharmacy practice residency

• Job functions depend on the specialty and the institution

• Usually has teaching and/or research responsibilities

• Represent pharmacy for medication use meeting/committee in specialty areas

Clinical Pharmacy Practice areas

Ambulatory care Critical care Drug Information Geriatrics and long –term

care Internal medicine and

subspecialties Cardiology Endocrinology Gastroenterology Infectious disease Neurology Nutrition Support ADR/DUE Transplant

Investigational Drugs Pharmacoeconomics Nephrology Obstetrics and gynecology Pulmonary disease Psychiatry Rheumatology Nuclear pharmacy Pediatrics Pharmacokinetics Surgery

Various ambulatory servicesVarious ambulatory services Anticoagulation Management Cholesterol Management Renal Management (CKD) Oncology Services Home Health Pharmacy Services Impact Pharmacy Services (Drug Conversion Program) Neonatal ICU Hypertension Management Integrated Coronary Vascular Disease (CVD) HIV/ID New Member Program (assist new MD in prescribing NF

to formulary drugs) Heart Failure Management Asthma Management

Hospital pharmacist Vs Clinical pharmacist

The service including clinical pharmacy/clinical pharmacistThe service including clinical pharmacy/clinical pharmacist

-Patients get right care from all the facets (all the drug related problems can easily be eliminated)

-Physicians n other health care professionals get more focused in theirown, work-load to them is low

-Patients feel more comfortable "Every drug is poison, it’s the dose that differentiate poison or drug the

substance is." "To kill ill by pill, not by bill" The last person to be involved in health care team with the patient;

Pharmacist, so the system has to rely upon him/her.

The service without clinical pharmacy/clinical The service without clinical pharmacy/clinical pharmacistpharmacist

-Due to high load to physicians and other health care professionals,the quality of patient care will be low

-Most of the drug related problems cannot be easily eliminated

-Patients may not feel comfortable

"In developing countries like Nepal; Physicians are incompetent, Nurses are careless, Pharmacists don’t know anything(??), System is corrupted, Public is foolish, Patient load is high."...Prof Furqan Hashmi

"Medicine is for those who need them, not for those who want them."

"If your medicine is not working it may not be your medicine, it may be you"

Medicines are Dangerous

Pharmaceutical care• “ A practice in which a practitioner takes responsibility for a

patient’s drug related needs and holds him or herself accountable for meeting these needs.”....... Linda Strand 1997

• It describes specific services & activities through which an individual pharmacist cooperates with patients and other health care professionals in designing, implementing & monitoring a therapeutic plan that will produce specific outcomes for the patient.

• Wherein the pharmacist is engaged in; Drug monitoring, Disease monitoring,

Drug therapy & disease management/collaborative practice • Pharmaceutical care is that component of pharmacy practice which entails the

direct interaction of pharmacist with the patient for the purpose of caring for that patient’s drug related needs

Goal of Pharmaceutical CareGoal of Pharmaceutical Care• Goal of pharmaceutical care is to optimize the patient’s health-related quality

of life and achieve positive clinical outcomes, within realistic economic expenditures

Essential Components of Pharmaceutical Care

1.Pharmacist-patient relationshipCollaborative effort between pharmacist & patient

2.Pharmacist’s workup of drug therapy (PWDT)Provision of pharmaceutical care is centered around this,although the methods used for this purpose may vary.Components are:

I.Data collection; Collect, synthesize & interpret relevant informationPatient’s demographic data: age, sex, race etc.Pertinent medical information

Medical history (current & past)

Family historyDietary historyMedication history (prescription, OTC, allergies)Physical findings (weight, height, B.P)Lab results (serum drug levels, potassium levels, serum creatinine levels relevant to drug therapy)Patient complaints, symptoms & signs

II. Develop or identify the CORE pharmacotherapy plan

C = condition or patient need

O = outcome desired for that condition R = regimen selected to achieve that outcomeE = evaluation parameters to assess outcome achievement

III.Identify PRIME Pharmacotherapy Problems

This includes pharmacist's intervention

The goal is to identify actual or potential problems that couldcompromise the desired patient outcomeP = pharmaceutical based problemsR = risks to patientI = interactionsM = mismatch between medication & condition or patient needsE = efficacy

3.Documentation of pharmaceutical careFormulate a FARM note or SOAP note to describe or document theinterventions needed or provided by pharmacist FARM Progress NoteFARM Progress NoteDescription & documentation of interventions intended or provided bypharmacistF = Findings,

pt-specific information—gives basis for recognition of pharmacotherapyproblems or indication for pharmacist intervention.

A = Assessment,

The pharmacist’s evaluation of the findings, including a statement of:Any additional information needed to best assess the problem to makerecommendationThe severity, priority or urgency of the problem The short term & long term goals of the intervention proposed

Short term goals: elimination of symptoms , Lowering of BP ,Management of acute asthma without requiring hospitalization

Long term goals:Prevent recurrence of disease,Control B.P.,Prevent progression of diabetes

R = Resolution, including prevention

Observing & reassessing Counseling or educating the patients & care giversInforming the prescriberMaking recommendation to prescriberWithholding medication or advising against use

M = Monitoring to assess the efficacy, safety & outcome of the intervention

This should include The parameters to be followed (e.g. pain, depressed mood, serum levels)The intent of monitoring e.g. efficacy, toxicity, adverse eventsHow the parameters will be monitored e.g. interview patients, serum druglevel, physical examination

Frequency of monitoring—weekly or monthly Duration of monitoring e.g. until resolved, while on antibiotics,then monthly for one yearAnticipated or desired finding e.g. no pain, healing of lesion Decision point to alter therapy when or if outcome is not achieved e.g. pain still present after 3 days, mild hypoglycemia more than 2 times a week.

SOAP Note ;

This is used primarily by physicians,S=subjective findingsO=objective findingsA=assessmentP=plan

Clinical skills & pharmacist’s role in Pharmaceutical Care

Patient assessmentPhysical assessmentBarriers to adherence Psychosocial issues

Education & counselingInterview skillsCommunication skills (e.g. empathy, listening, speaking orwriting at patient's level of understanding)Ability to motivate & inspire Develop & implement patient education plan based on an initialeducation assessment Identification & resolution of compliance barriers

Patient Specific Pharmacist Care Plan Recognition, prevention & management of drug interactionsPharmacology & therapeuticsInterpretation of lab testsKnowledge of community resources, professional referralsCommunication & support with community medical providers

Drug Treatment ProtocolDevelop & maintain (update) protocolsFollow protocols as pharmacist-clinicianMonitor,aggregate adherence to the treatment protocols e.g. drugutilization evaluation, especially for managed care or healthsystem facility

Dosage adjustment Identify patients at high risk for exaggerated orsubtherapeutic responseApply pharmacokinetic principles to determine patientspecific dosing

Prescriptive authorityIn designated practice site and positions

Aims of Pharmaceutical

Care

Effective drug therapy

Safe drug therapy

Economic drug therapy

Improve quality of life

Will the patient take the therapy?

What does the patient view as an improved quality of

life?

A case 44 year old lady with fever and green sputum and cough – no known

previous medical history – Diagnosed with URTI, Prescribed: Co-Amoxiclav 1 tds Doxycycline 100mg D Prednisolone 40mg D Theophylline 200mg bd Omeprazole 20mg D Metoclopramide 10mg tds Salbutamol 2 puff inhale prn

Pharmaceutical problems

Common organisms for URTI?

History of asthma – risk vs benefit?

Need for acid suppression?

Why is she nauseous?

Benefit of brochodilation?Does she know what to take?Will she take it?

Question?

• Think of someone in your family or a friend that has had something go “wrong” with their medicines?– Caused an adverse or unwanted effect ? – Had medicines stopped when should

have continued?– Not worked?– What happened ?– Could it have been avoided ?

High Profile Examples•A patient with leukaemia received Intrathecal vincristine

instead of intravenously. Died beginning of February 2001. 14th such case over the last 16 years.

•Patient being operated for a AAA received bupivicaine intravenously rather than epidurally. Patient died 3 days later.

•A 3 year old girl, who had a convulsion post flu vaccine. Attended hospital to get “checked out”. Received nitrous oxide instead of oxygen in casualty

Elderly lady was prescribed Methotrexate in 1997 for her rheumatoid arthritis. Dose increased to 17.5mg WEEKLY over a 6 month period.

•Jan 2000 patient undergoes right TKR in hospital. MTX given as one tablet a week (only 2.5mg).

Prescription for MTX 10mg/daily written and dispensed.•30th April patient dies.

Deaths from medicines in the UK1999 - 2000 (ICD9 & 10 data)

A spoonful of sugar - Audit Commission (2001)

So drugs are safe..………………

Photosensitivity from Amiodarone

Severe extravasation of amiodarone infusion

NSAID induced peptic ulcer

Goitre – HypothyroidismSecondary to Amiodarone

Bleeding due to anticoagulation

Erythemal rash from penicillin – in patient with a previous Known allergy/ adverse drug reaction

Necrotising fascititis – secondary to infection at site of IV injection

Acute Liver failure from Black Cohosh - herbal medicine

Human Error(Mistakes, Slips, Lapses)

Error is inevitable due to “our” limitations:- limited memory capacity- limited mental processing capacity- negative effects of fatigue other stressors

We all make errors all the time Generalised lack of awareness that causes errors Patients suffer adverse events much more often than previously

realised Errors often NOT immediately observed

The same error, even a minor one, can have quite different consequences in different circumstances.

“I assumed the brown glass ampoule was frusemide”

The System: Only as safe as it’s designed to be!

The Accident Causation Model(Adopted from Reason & Dean)

Active Failures

-Slips&lapses -Mistakes

Errorproducingconditions Accident

Defences

Latent Conditions

Sources of Error•Prescribing error - selecting the wrong or inappropriate

drug/dose/formulation/duration etc•Communicating those instructions

•Supply error - timely; wrong drug, dose, route; expired medicines, labelling.

•Administration error - timing; wrong route; wrong rate/technique.

•Lack of user education - actions to take.

Drug therapy assessment

Six types of problems which may result in treatment

failure:1.Inappropriate selection of medication

2.Inappropriate formulation of medication

3.Inappropriate administration of drug therapy

.14.Inappropriate medication-taking behaviour

5.Inappropriate monitoring of drug therapy

6.Inappropriate response to drug therapy

Formulary

Prescribing protocols

Prospective review

Clinical pharmacy

Admission medication history

Allergy check

Drug distribution system

Opportunity For Error

Administration instructions

Clinical Pharmacy Role in Reducing Risks

Formulary

Prescribing protocols

Prospective review

Clinical pharmacy

Admission medication history

Allergy check

Drug distribution system

Opportunity For Error

Administration instructions

What if we are not there!

Patient Assessment QuestionsPatient Assessment Questions

•Does the patient need this drug? •Is this drug the most effective and safe?

•Is this dosage the most effective and safe? •If side effects are unavoidable does the patient need

additional drug therapy for these side effects?•Will drug administration impair safety or efficacy?

•Are there any drug interactions? •Will the patient comply with prescribed regimen?

To be a drug expert,society needs practitioners who ……..…

Today’s pharmacists

Ideal Pharmacist Candidate?

• Competent• Motivated/Enthusiastic• Teamwork spirit• Good communication skills• Responsible• Problem solver• Dedicated

The End

Any Questions?