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DEPARTMENT OF
CLINICAL PHARMACY
By
Dr. Anam Sohail (PharmD)
Dr. Rachana Shetty (PharmD)
Dr. Beegum Sheena Karim (PharmD)
INTRODUCTION
The American College of Clinical Pharmacy defines clinical
pharmacy as a health science discipline in which pharmacists
provide patient care that optimizes medication therapy and
promotes health, wellness, and disease prevention.
ORGANOGRAM
CLINICAL
PHARMACISTS’
DMA
QAD
RESPECTIVE
DEPT.
STANDARD OPERATING PROCEDURE
Review
Medical
Records of
In-patients
Plan
Standard
Drug
Therapy
Assess
if given therapy
is compliant
with the
standard
Discuss &
Implement
modification
in therapy if
required
Follow up
Monitor/
Evaluate,
Discharge
Counseling Patient
Centered
Care
COLLABORATE
CLINICAL PHARMACY
SERVICES
(A) PHARMACEUTICAL CARE
1. Before the prescription
 Drug information
 Drug-related policies
 Formularies
2. During the prescription
 Standardization of therapy
 Monitors, detects and prevents Medication related problems.
3. After the prescription
 Patient Counselling- Compliance & Adherence
 Drug use evaluation – (Underutilization, Overutilization, Poly-pharmacy)
 Outcome research
 Pharmacoeconomic studies
Medication-related Problems
 Untreated indications
 Irrational drug use
 Improper drug selection
 Sub-therapeutic dosage
 Supra-therapeutic dosage
 Failure to receive drug
 Adverse drug reactions
 Drug interactions
(B) MEDICATION ERROR
 NCCMERP defined medication errors as ‘any preventable event that may
cause or lead to inappropriate use or patient harm while the medication is in the
control of the health care professional, patient or consumers’
 PROCESS
DEFINITIONS- ADE, ADR & SE
 ADR: Any noxious, unintended, undesirable, or unexpected response to a drug that occurs at
doses normally used in man for prophylaxis, diagnosis, therapy of disease, or for modification of
psychological function.
 ADE: “An injury resulting from the use of a drug”. ADE includes
 Harm caused by the drug (Adverse drug reactions and overdoses) and
 Harm from the use of the drug (including dose reductions and discontinuations of drug therapy).
 Allergy vs Side Effect:
 An allergy is an adverse drug reaction mediated by an immune response (e.g., rash, hives).
 A side effect is an expected and known effect of a drug that is not the intended therapeutic
outcome. The term “side effect” tends to normalize the concept of injury from drugs.
Identify and monitor patients most susceptible to ADRs
 Age groups- Geriatric/ Pediatric patients
 Poly-pharmacy
 Drugs known to have a high incidence of adverse effects. (Avoid use of
when an equally effective and safer alternative exists or ensure appropriate
use to minimize the risk.)
 Drugs associated with serious adverse effects
 Drugs having narrow therapeutic index (Phenytoin)
 Drug Interactions
 Patients with compromised Pharmacokinetic profile
EDUCATION ON ADR
 Encourage medical and nursing staff to report ADRs
 Ensure patients receives an ADR CARD & Education
on the correct use,
storage and
disposal of their medicine at discharge
 Educate patients to recognize ADRs and what action to take if they
experience an ADR
 Identify patients who have had previous ADRs, intolerance or hypersensitivity
to a particular Medication or class of Medications (provide with ADR card)
(C) ADR REPORTING PROCESS
(within 30 min of occurrence)
ADR Identification and
Discussion by
Clinical
Pharmacists/Pharmacists/
Nurses/Doctors
Reported To and
Documented By
Clinical Pharmacists
Root Cause Analysis &
CAPA
Clinical Pharmacists
Finding forwarded to
Pharmacy QE,
Pharmacovigilance
Department
Presented and
Discussed In
PTC meeting
Quality Meeting
(D) DRUG INTERACTION
Defined as an interaction between a drug and another substance that prevents the drug
from performing as expected.
TYPES:
 Drug-Drug interactions,
 Drug-Food interactions
 Drug Disease interaction
DI Identification by
Clinical Pharmacists
Reported and
Documented By
Clinical Pharmacists
Management suggested to
Doctor verbally/ written form-
providing info on DI ( Severity,
PK/PD profile and
Management/ alternative)
Required measures
implemented by:
Doctor (alter/continue the
therapy with caution)
Presented and
Discussed In
PTC meeting
Quality Meeting
(To be reported
within 24Hrs)
(E) CLINICAL AUDIT
Clinical audit is a quality improvement process that seeks to improve patient care and outcomes
through systematic review of care against explicit criteria and the implementation of change.
PROCESS
(DOS- doctors order sheet, MAR- Medication Administration Record, CAPA- Corrective and preventive
actions)
Randomly select
patient’s Medical
Records
(sample size: 278 as per NABH
Standard for audit: total no. of
bed ratio)
Review (DOS), (MAR)
and transfer criteria
Check all parameters
of DOS, MAR, Transfer
Sheet as per check list
Negative marking for
error prone abbr.,
Incomplete Rx,
Improper Doc
Analyze retrieved
data
Present the findings
with CAPA in Quality
meeting, DTC meeting
(F) PATIENT COUNSELING
It’s a process of providing medication information orally or in written form to the
patients or their representatives on directions of use (Timing, advice on
ADR/side effects, precautions, storage, diet and life style modifications)
PROCESS
Prepare for the session
 Gather knowledge about the patient & treatment details from Medical record
 Prepare the session based on mental and physical state of the patient.
Opening the sessions
 Self-introduction
 Confirm Patient identity
 Collect background information
STEP 1
STEP 2
Counseling- Provide information
 Characteristics of disease
 About the Medications
 Lifestyle modifications
End of session
 Ask questions to assess
 Check the patients’ understanding
 Feed-back questions: Do u know…/Can u tell…
 Summarize the main points
 About satisfaction & queries
 Visit your doctor regularly and ensure good
health
 Plan follow up
 Wish you speedy recovery
 Contact us: place/time/phone no
STEP 3
STEP 4
AGE groups – Geriatric/ pediatric
Diabetic care
Medication aid- MDI, Insulin pen, etc
Multiple drug therapy
Asthma, COPD, CKD, etc
Any patient if requested by doctor
WHO TO COUNSEL???
POLICY DEVELOPMENT
High-alert medications are drugs that bear a heightened risk of
causing significant patient harm when they are used in error.
(a) HIGH RISK MEDICATION
Medications that are visually similar in physical appearance or packaging and
names of medications that have spelling Similarities and/or similar phonetics.
(b) LASA DRUGS POLICY
LOOK ALIKE/ SOUND ALIKE
&
The expiry date is the point in time when a pharmaceutical product is no longer within
an acceptable condition to be considered effective. The medication reaches the end of its
‘shelf life’.
(c) EXPIRY DATE OF MEDICINES IN
PATIENT CARE AREA
DRUG INFORMATION
AND EDUCATIONAL
SERVICES
(A) DRUG INFORMATION
Drug information aims to provide clear, concise, unbiased and accurate drug
related information in response to patient oriented drug problems that are received
from health care professionals in a variety of settings.
These activities are undertaken by clinical pharmacists in providing information to
optimize drug use.
Scientific literature Classification:
Tertiary-
Textbooks
Secondary- Bibliography,
Reviews, Abstracting and
Indexing services
Primary- Patents, Conference paper
(abstract), Case reports, Journal
Articles, Thesis
DRUG INFORMATION PROCESS
Step 1: Secure Demographics of the requestor
Step 2: Obtain Background Information
Step 3: Determine and Categorize the actual Question.
Step 4: Develop the Search Strategy and Conduct the Research.
(Tertiary, Secondary and Primary)
 A tertiary source to familiarize yourself with the topic.
 Secondary to identify appropriate primary literature.
 Carefully evaluated primary literature
Step 5: Perform Evaluation, Analysis and Synthesis.
 Introduction to clinical studies
 Introduction to critical appraisal of clinical study
 Evaluation of websites that provide health information.
Step 6: Formulate and Provide a Response
Communication
Skills
(B) EDUCATION AND TRAINING
o Educating health care professionals on safe and effective medication-use policies and
processes, including development of resources to communicate this information.
o Leading or participating in continuing education services for health care
professionals. (CME, CNE)
o Precepting and educating pharmacy students and residents.
o Participating in quality improvement research projects and drug cost analyses.
STANDARD OPERATING PROCEDURE OF CLINICAL PHARMACY DEPARTMENT

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STANDARD OPERATING PROCEDURE OF CLINICAL PHARMACY DEPARTMENT

  • 1. DEPARTMENT OF CLINICAL PHARMACY By Dr. Anam Sohail (PharmD) Dr. Rachana Shetty (PharmD) Dr. Beegum Sheena Karim (PharmD)
  • 2. INTRODUCTION The American College of Clinical Pharmacy defines clinical pharmacy as a health science discipline in which pharmacists provide patient care that optimizes medication therapy and promotes health, wellness, and disease prevention.
  • 4. STANDARD OPERATING PROCEDURE Review Medical Records of In-patients Plan Standard Drug Therapy Assess if given therapy is compliant with the standard Discuss & Implement modification in therapy if required Follow up Monitor/ Evaluate, Discharge Counseling Patient Centered Care COLLABORATE
  • 6. (A) PHARMACEUTICAL CARE 1. Before the prescription  Drug information  Drug-related policies  Formularies 2. During the prescription  Standardization of therapy  Monitors, detects and prevents Medication related problems. 3. After the prescription  Patient Counselling- Compliance & Adherence  Drug use evaluation – (Underutilization, Overutilization, Poly-pharmacy)  Outcome research  Pharmacoeconomic studies
  • 7. Medication-related Problems  Untreated indications  Irrational drug use  Improper drug selection  Sub-therapeutic dosage  Supra-therapeutic dosage  Failure to receive drug  Adverse drug reactions  Drug interactions
  • 8. (B) MEDICATION ERROR  NCCMERP defined medication errors as ‘any preventable event that may cause or lead to inappropriate use or patient harm while the medication is in the control of the health care professional, patient or consumers’  PROCESS
  • 9. DEFINITIONS- ADE, ADR & SE  ADR: Any noxious, unintended, undesirable, or unexpected response to a drug that occurs at doses normally used in man for prophylaxis, diagnosis, therapy of disease, or for modification of psychological function.  ADE: “An injury resulting from the use of a drug”. ADE includes  Harm caused by the drug (Adverse drug reactions and overdoses) and  Harm from the use of the drug (including dose reductions and discontinuations of drug therapy).  Allergy vs Side Effect:  An allergy is an adverse drug reaction mediated by an immune response (e.g., rash, hives).  A side effect is an expected and known effect of a drug that is not the intended therapeutic outcome. The term “side effect” tends to normalize the concept of injury from drugs.
  • 10. Identify and monitor patients most susceptible to ADRs  Age groups- Geriatric/ Pediatric patients  Poly-pharmacy  Drugs known to have a high incidence of adverse effects. (Avoid use of when an equally effective and safer alternative exists or ensure appropriate use to minimize the risk.)  Drugs associated with serious adverse effects  Drugs having narrow therapeutic index (Phenytoin)  Drug Interactions  Patients with compromised Pharmacokinetic profile
  • 11. EDUCATION ON ADR  Encourage medical and nursing staff to report ADRs  Ensure patients receives an ADR CARD & Education on the correct use, storage and disposal of their medicine at discharge  Educate patients to recognize ADRs and what action to take if they experience an ADR  Identify patients who have had previous ADRs, intolerance or hypersensitivity to a particular Medication or class of Medications (provide with ADR card)
  • 12. (C) ADR REPORTING PROCESS (within 30 min of occurrence) ADR Identification and Discussion by Clinical Pharmacists/Pharmacists/ Nurses/Doctors Reported To and Documented By Clinical Pharmacists Root Cause Analysis & CAPA Clinical Pharmacists Finding forwarded to Pharmacy QE, Pharmacovigilance Department Presented and Discussed In PTC meeting Quality Meeting
  • 13. (D) DRUG INTERACTION Defined as an interaction between a drug and another substance that prevents the drug from performing as expected. TYPES:  Drug-Drug interactions,  Drug-Food interactions  Drug Disease interaction DI Identification by Clinical Pharmacists Reported and Documented By Clinical Pharmacists Management suggested to Doctor verbally/ written form- providing info on DI ( Severity, PK/PD profile and Management/ alternative) Required measures implemented by: Doctor (alter/continue the therapy with caution) Presented and Discussed In PTC meeting Quality Meeting (To be reported within 24Hrs)
  • 14. (E) CLINICAL AUDIT Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. PROCESS (DOS- doctors order sheet, MAR- Medication Administration Record, CAPA- Corrective and preventive actions) Randomly select patient’s Medical Records (sample size: 278 as per NABH Standard for audit: total no. of bed ratio) Review (DOS), (MAR) and transfer criteria Check all parameters of DOS, MAR, Transfer Sheet as per check list Negative marking for error prone abbr., Incomplete Rx, Improper Doc Analyze retrieved data Present the findings with CAPA in Quality meeting, DTC meeting
  • 15. (F) PATIENT COUNSELING It’s a process of providing medication information orally or in written form to the patients or their representatives on directions of use (Timing, advice on ADR/side effects, precautions, storage, diet and life style modifications) PROCESS Prepare for the session  Gather knowledge about the patient & treatment details from Medical record  Prepare the session based on mental and physical state of the patient. Opening the sessions  Self-introduction  Confirm Patient identity  Collect background information STEP 1 STEP 2
  • 16. Counseling- Provide information  Characteristics of disease  About the Medications  Lifestyle modifications End of session  Ask questions to assess  Check the patients’ understanding  Feed-back questions: Do u know…/Can u tell…  Summarize the main points  About satisfaction & queries  Visit your doctor regularly and ensure good health  Plan follow up  Wish you speedy recovery  Contact us: place/time/phone no STEP 3 STEP 4 AGE groups – Geriatric/ pediatric Diabetic care Medication aid- MDI, Insulin pen, etc Multiple drug therapy Asthma, COPD, CKD, etc Any patient if requested by doctor WHO TO COUNSEL???
  • 18. High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. (a) HIGH RISK MEDICATION
  • 19. Medications that are visually similar in physical appearance or packaging and names of medications that have spelling Similarities and/or similar phonetics. (b) LASA DRUGS POLICY LOOK ALIKE/ SOUND ALIKE &
  • 20. The expiry date is the point in time when a pharmaceutical product is no longer within an acceptable condition to be considered effective. The medication reaches the end of its ‘shelf life’. (c) EXPIRY DATE OF MEDICINES IN PATIENT CARE AREA
  • 22. (A) DRUG INFORMATION Drug information aims to provide clear, concise, unbiased and accurate drug related information in response to patient oriented drug problems that are received from health care professionals in a variety of settings. These activities are undertaken by clinical pharmacists in providing information to optimize drug use. Scientific literature Classification: Tertiary- Textbooks Secondary- Bibliography, Reviews, Abstracting and Indexing services Primary- Patents, Conference paper (abstract), Case reports, Journal Articles, Thesis
  • 23. DRUG INFORMATION PROCESS Step 1: Secure Demographics of the requestor Step 2: Obtain Background Information Step 3: Determine and Categorize the actual Question. Step 4: Develop the Search Strategy and Conduct the Research. (Tertiary, Secondary and Primary)  A tertiary source to familiarize yourself with the topic.  Secondary to identify appropriate primary literature.  Carefully evaluated primary literature Step 5: Perform Evaluation, Analysis and Synthesis.  Introduction to clinical studies  Introduction to critical appraisal of clinical study  Evaluation of websites that provide health information. Step 6: Formulate and Provide a Response Communication Skills
  • 24. (B) EDUCATION AND TRAINING o Educating health care professionals on safe and effective medication-use policies and processes, including development of resources to communicate this information. o Leading or participating in continuing education services for health care professionals. (CME, CNE) o Precepting and educating pharmacy students and residents. o Participating in quality improvement research projects and drug cost analyses.