PHARMACOVIGILANCE

The word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep
watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any
response to a drug which is noxious and unintended, including lack of efficacy.

DEFINITION:
Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection,
detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products

SCOPE:
Pharmacovigilance conducting advanced drug monitoring study based Adverse drug
reactions, adverse events report of new drugs include:

1. Medication errors and irrational use of medicines.

2. Herbal, traditional and complimentary medicines

3. Substandard medicines and counterfeit medicines

4. Blood products, biologicals, medical devices and vaccines ADR Pharmacovigilance main aim is to give clear
information regarding drug safety and its Risk or benefits of drugs to the patients.

Patients are main end users of medicine. Patient information leaflet relating to medicine to be provided to the patient to
increase the advantages of the medication and to reduce the risk associated with them. It is essential for Risk
Minimization by making an early detection and preventing the progression of the adverse effects.
 AIMS OF PHARMACOVIGILANCE:

Events such as the thalidomide tragedy highlight the extreme importance of effective drug monitoring systems for all medicines.
The principal aims of pharmacovigilance programmes are:

• To improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions;

• To improve public health and safety in relation to the use of medicines;

• To contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more
effective (including cost-effective) use;

• To promote understanding, education and clinical training in pharmacovigilance and its effective communication to health
professionals and the public.

Over the last decade, it has been increasingly recognized that the scope of pharmacovigilance needs to be extended beyond the
strict confines of detecting new signals of safety concerns. Globalization, consumerism, the resulting explosion in free trade and
communication across borders, and increasing use of the Internet have all contributed to a change in the way people access
medicinal products and information about them. These changing patterns in drug use require a shift in the approach to
pharmacovigilance, more specifically, towards one that is more closely linked, and thus better able to respond, to the prevailing
patterns of drug use within society.

ADVERSE DRUG REACTIONS

DEFINITION:
“Any harmful or seriously unpleasant effects occurring at doses intended for therapeutic (incl.
prophylactic/ diagnostic) effect and which requires reduction of dose or withdrawal of drug & /or forecasts hazard from
future administration.”

CLASSIFICATION:
1) Type-A reactions:-
An exaggerated but otherwise normal pharmacological action.
Type A. Reactions have the following characteristics:
• Rarely predictable
• Usually dose-dependent
• Incidence and morbidity high
• Mortality low.
Examples of type-A reactions include respiratory depression with opioid
Analgesia, cough with angiotensin-converting enzyme (ACE) inhibitors, and
Withdrawal effects with benzodiazepines or alcohol.
2) Type-B reactions :-
Idiosyncratic, aberrant, or bizarre drug effects that are unrelated to the pharmacology of the drug.
Type B reactions have the following characteristics:
• Usually unpredictable
• Might not be picked up by toxicological screening
• Not necessarily dose-related
• Incidence and morbidity low
• Mortality high.
Type B reactions are most commonly immunological (e.g. penicillin allergy).
MECHANISMS:
As research better explains the biochemistry of drug use, fewer ADRs are Type B and more are Type
A. Common mechanisms are:

Abnormal pharmacokinetics due to

 comorbid disease states

 genetic factors

Synergistic effects between either

 a drug and a disease

 two drugs

Abnormal pharmacokinetics

1) Comorbid disease states

Various diseases, especially those that cause renal or hepatic insufficiency, may alter drug metabolism. Resources are
available that report changes in a drug's metabolism due to disease states.
2) Genetic factors

Abnormal drug metabolism may be due to inherited factors of either Phase I oxidation or Phase II
conjugation. Pharmacogenomics is the study of the inherited basis for abnormal drug reactions.
Phase I reactions

Inheriting abnormal alleles of cytochrome P450 can alter drug metabolism. Tables are available to check for drug
interactions due to P450 interactions.
Inheriting abnormal butyrylcholinesterase (pseudo cholinesterase) may affect metabolism of drugs such
as succinylcholine
Phase II reactions

Inheriting abnormal N-acetyltransferase which conjugated some drugs to facilitate excretion may affect the metabolism of
drugs such as isoniazid, hydralazine, and procainamide.
Inheriting abnormal thiopurine S-methyltransferase may affect the metabolism of
the thiopurine drugs mercaptopurine and azathioprine.

Interactions with other drugs

The risk of drug interactions is increased with polypharmacy.

Protein binding

These interactions are usually transient and mild until a new steady state is achieved. These are mainly for drugs without
much first-pass liver metabolism. The principal plasma proteins for drug binding are:

1. albumin

2. α1-acid glycoprotein

3. lipoproteins
Some drug interactions with warfarin are due to changes in protein binding.
Cytochrome P450

Patients have abnormal metabolism by cytochrome P450 due to either inheriting abnormal alleles or due to drug
interactions. Tables are available to check for drug interactions due to P450 interactions.
Synergistic effects

An example of synergism is two drugs that both prolong the QT interval.

Factors predisposing to ADRs
Factors that predispose to ADRs are many and varied, and some are related only to specific disease–drug interactions,
such as
EXAMPLES:
 rash with amoxicillin
 In patients with glandular fever.
However, the following factors are generally considered to i patient risk:
• Age
• Renal impairment
• Hepatic impairment
• ‘frailty’
• Polypharmacy
• Previous history of ADRs
• Genetics.

The first four factors predispose to type A reactions because they are determinants of drug toxicity, but the remaining
factors predispose to type A or type B reactions.

CASUALITY ASSESSMENT (DIFFERENT SCALES USED):

Why causality assessment?

An inherent problem in pharmacovigilance is that most case reports concern suspected adverse drug reactions. Adverse
reactions are rarely specific for the drug, diagnostic tests are usually absent and a re-challenge is rarely ethically justified.
In practice few adverse reactions are ‘certain’ or ‘unlikely’; most are somewhere in between these extremes, i.e. ‘possible’
or ‘probable’. In an attempt to solve
this problem many systems have been developed for a structured and harmonised assessment of causality. None of
these systems, however, have been shown to produce a precise and reliable
quantitative estimation of relationship likelihood. Nevertheless, causality assessment has become a common routine
procedure in pharmacovigilance. The advances and limitations of causality assessment are reviewed in Table:-

-: Advances and limitations of standardised case causality assessment:-

DIFFERENT SCALES USED IN CASUALITY ASSESSMENT:

1) The WHO-UMC causality assessment system (the UPPSALA MONITORING SYSTEM): The WHO-UMC system
has been developed in consultation with the National Centres participating in the Programme for International Drug
Monitoring and is meant as a practical tool for the assessment of case reports.

categories
Causality
term
Assessment criteria (all points should be reasonably
complied)
Causality
term
Assessment criteria (all points should be reasonably
c
Causality term Assessment criteria
Certain •
•
•
•
•
Event or laboratory test abnormality, with
plausible time
relationship to drug intake
Cannot be explained by disease or other
drugs
Response to withdrawal plausible
(pharmacologically,
pathologically)
Event denitive pharmacologically or
phenomenologically
(ie, an objective and specic medical
disorder or a
recognized pharmacologic phenomenon)
•
•
•
•
•
Event or laboratory test abnormality, with
plausible time
relationship to drug intake
 Cannot be explained by disease or other
drugs
Response to withdrawal plausible
(pharmacologically,
pathologically)
Event denitive pharmacologically or
phenomenologically
(ie, an objective and specic medical
disorder or a
recognized pharmacologic phenomenon
1) Event or laboratory test abnormality,
with plausible time relationship to drug
intake.
2) Cannot be explained by disease or
other drugs.
3) Response to withdrawal plausible
(pharmacologically, pathologically).
4) Event definitive pharmacologically or
phenomenological (i.e, an objective and
specific medical disorder or a recognized
pharmacologic phenomenon).
5) Rechallenge satisfactory, if needed.

Probable / Event or laboratory test abnormality,

Likely with reasonable time relationship to
drug intake
• Unlikely to be attributed to disease or
other drugs
• Response to withdrawal clinically
reasonable
• Rechallenge not required.
POSSIBLE • Event or laboratory test abnormality,
with reasonable time relationship to
drug intake
• Could also be explained by disease or
other drugs
• Information on drug withdrawal may be
lacking or unclear
UNLIKELY • Event or laboratory test abnormality,
with a time to drug intake that
makes a relationship improbable (but not
impossible)
• Disease or other drugs provide
plausible explanations
Conditional / • Event or laboratory test abnormality
Unclassified • More data for proper assessment
needed, or
• Additional data under examination
Unassessable • Report suggesting an adverse reaction
/ • Cannot be judged because information
Unclassifiable is insufficient or contradictory
• Data cannot be supplemented or
verified

The use of the WHO-UMC system:

To illustrate how the system works, we suggest to first make a comparison of the criteria and wording of ‘Probable’ and
Certain’. First of all there is one more criterion in the category ‘Certain’,
the fourth: ‘Event definitive pharmacologically or phenomenologically, i.e. an objective and specific medical disorder or a
recognised pharmacological phenomenon (for instance ‘grey baby syndrome’
and chloramphenicol, or anaphylaxis immediately after the administration of a drug that had been given previously). This
means that any other event is automatically excluded and can never qualify
for ‘Certain’ (even in the case of a positive rechallenge observation). For ‘Certain’, rechallenge information with a
satisfactory outcome is requested (i.e. what has happened when the drug was first stopped and later on resumed),
unless the evidence in the report is already convincing without a re-exposure. For ‘Probable’, on the other hand, a
rechallenge is not required. To qualify as ‘Certain’ the interval between the start of the drug and the onset of the event
must be ‘plausible’;
this means that there is in sufficient detail a positive argument in support of the view that the drug is causally involved,
pharmacologically or pathologically. For ‘Probable’ the time relationship should be ‘reasonable’; this is a more neutral
term covering everything that is not unreasonable. Also, with regard to the second criterion, ‘alternative causes’, the
wording is different in ‘Probable’. For ‘Certain’ the occurrence of the event cannot be explained by any disease the patient
is known to have or any other drug taken. For ‘Probable’, on the other hand, the event is ‘unlikely’ to be
attributable to another cause. Also the dechallenge situations (i.e. what happened after stopping) are
different. In a ‘Certain’ case report, the course of events constitutes a positive argument in favour
of holding the suspected drug responsible, in pharmacological or pathological respects, whereas in a
‘Probable’ case it is sufficient if it is ‘clinically reasonable’ (i.e. not unreasonable).
The essential distinctions between ‘Probable’ and ‘Possible’ are that in the latter case there may be
another equally likely explanation for the event and/or there is no information or uncertainty with
regard to what has happened after stopping.
The criteria that may render the connection ‘Unlikely’ are firstly the time relationship is improbable (with the knowledge at
the time), and/or another explanation is more likely. The term ‘Unclassified/ Conditional’ is of a preliminary nature and is
appropriate when, for a proper assessment, there is more data needed and such data are being sought, or are already
under examination. Finally when the information in a report is incomplete or contradictory and cannot be complemented
or verified, the verdict is ‘Unclassifiable’. Since by far the most frequent categories in case reports are ‘Possible’ and
‘Probable’, the usual approach to using the system is to choose one of these categories (depending on the impression of
the assessor) and to test if the various criteria fit with the content of the case report. If the report seems stronger one can
go one step ‘higher’ (e.g. from ‘Possible’ to ‘Probable’), if the evidence seems weaker one should try a ‘lower’ category.
To see if that category is the right one or if it does again not seem to fit, the next adjacent term is tried.

For drug-drug interactions the WHO-UMC system can be used by assessing the actor drug, which influences the kinetics
or dynamics of the other drug (which has usually been taken over a longer period), in the medical context of the patient.
REPORTING OF ADRs:
Most ADRs are not reported and this can lead to delays in identifying important reactions. The reasons for failure to report
ADRs have been called the ‘seven deadly sins’. Pharmacists should attempt to address these and encourage their
medical and nursing colleagues to report ADRs, in addition to sending in their own reports. The regulatory authorities in
many countries have systems for reporting
ADRs, and it is important to find out how ADRs are reported and whether pharmacists can submit reports. In the UK,
doctors, dentists, pharmacists,
nurses, and patients can report ADRs to the Medicines and Healthcare products Regulatory Agency (MHRA) through the
yellow card scheme. New drugs are labelled with a black inverted triangle in the British National Formulary ( BNF ), and
the MHRA requests that all ADRs to these drugs are reported. For established drugs, unusual or significant reactions
should be reported. Yellow card data can be accessed online.

Failure to report ADRs: the ‘seven deadly sins’:

1 Complacency — a mistaken belief that only safe drugs are allowed

onto the market and that these will not cause serious ADRs
2 Fear of involvement in litigation, or of a loss of patient confidence
3 Guilt that a patient has been harmed by a prescribed treatment
4 Ambition — to collect and publish a personal series of cases
5 Ignorance of what should be reported or how to make a report
6 Diffidence — a reluctance to report an effect for which there is only
a suspicion that it is drug-related
7 Lethargy — this may include a lack of time or interest, inability to find
a report card, etc.

EVALUATION OF ADRs
The cause(s) of each suspected ADR should be evaluated on the basis of the:
 Patient’s medical and medication history
 The circumstances of the adverse event,
 The results of dechallenge and rechallenge(if any),
 Alternative aetiologies and a literature review.
Questions used in the Evaluation of ADR:

 Was there a temporal relationship between the onset of drug therapy and the adverse reaction?
 Was there a dechallenge ; i.e., did the signs and symptoms of the adverse reaction subside when the drug was withdrawn?

 Can signs and symptoms of the adverse reaction be explained by the patient’s disease state?
 Were there any laboratory tests that provide evidence for the reaction being an ADR?
 What was the patient’s previous general experience with the drug
 Did symptoms return when the agent was re-administered
Drug monitoring:
 To assess the reaction:Emergency care/admission if ADR is Serious or life threatening; primary care; or seeks
specialist advice.
 To review the treatment: Either withdraw the suspected drug or reduce the dose.
 To manage the symptoms of ADR and provide supportive therapy.
 To record the ADR in the individual’s health record.
Consider the submission of an ADR report (Yellow Card) if appropriate documentation for the future purpose.

Detection and Monitoring of ADR

1. Premarketing Studies:

Preclinical studies done in animals (can not extrapolate data with the human)Clinical trials prior marketing done in small
number of patients, long duration effects not in study, special populations not considered, co morbidities not considered
and polypharmacy not considered. Type A reactions are mostly the known ones. Infrequent ADRs are not known.

2. Post Marketing Surveillance:

Information from the healthcare system spontaneous adverse reaction reporting. Record linkage.
Prevention of ADRs
Cannot be totally avoided. It can only be minimized.

Steps taken include:

 Avoid inappropriate drugs in the context of clinical condition.

 Use appropriate dose, route, frequency based on the patient variables (age, sex, other drugs, other disease
conditions, etc.,)
 Elicit medication history;
 considered untoward incidents;
 Rule out drug interactions.
 Elicit history of allergies.
 Carryout appropriate monitoring.

Adverse drug reaction management

1. Assess the nature and severity of the reaction:

Whether an urgent action is required or can be managed by primary care.

E.g.: whether a anaphylactic shock or something minor.

2. Review on the presenting symptoms:

Timing: Time of start of the reaction after giving the drug; Time taken to abate after the stopping of drug or reducing the
dose.

Relationship to dose: Whether reaction minimized with reducing the dose; symptoms resolve when the medicine
withdrawn and recur when reintroduced.

Other possible causes: Possibility of underlying illness or other disease; other medications (including OTC and Herbals);
drug interactions (including diet).

3. Take complete drug history - Review any History of Allergy or previous ADR:

When the drug was started, dose, other drugs, OTC and herbal. Past ADRs.

Long duration of action or long term use effect can be expected for some drugs.

Review the adverse effect profile of the drugs, and check how common it is.

4. Further Examination and Investigations if required:

Specific investigations and laboratory tests required.

E.g. : Liver and Renal Function Tests

Role of the Pharmacist

 Pharmacists should exert leadership in the development, maintenance, and on-going evaluation of ADR programs. They
should obtain formal endorsement or approval of such programs through appropriate committees (e.g., a pharmacy and
therapeutics committee and the executive committee of the medical staff) and the organization’s administration. In
settings where applicable, input into the design of the pro‐gram should be obtained from the medical staff, nursing staff,
quality improvement staff, medical records department, and risk managers.

• The pharmacist should facilitate:

1. Analysis of each reported ADR,

2. Identification of drugs and patients at high risk for being involved in ADRs,

3. The development of policies and procedures for the ADR‐monitoring and reporting program,

4. A description of the responsibilities and interactions of pharmacists, physicians, nurses, risk managers, and other
health professionals in the ADR program,

5. Use of the ADR program for educational purposes,

6. Development, maintenance, and evaluation of ADR records within the organization,

7. The organizational dissemination and use of information obtained through the ADR program,

8. Reporting of serious ADRs to the FDA or the manufacturer (or both), and

9. Publication and presentation of important ADRs to the medical community.

Direct patient care roles for pharmacists should include patient counselling on ADRs, identification
and documentation in the patient’s medical record of high‐risk patients, monitoring to ensure that serum drug
concentrations remain within acceptable therapeutic ranges, and adjusting doses in appropriate patients (e.g., patients
with impaired renal or hepatic function).
PATIENT COUNSELLING AND COMMUNICATION SKILLS:
DEFINITION:
Patient counselling is abroad term which describes the process through which healthcare professionals attempt to
increase patient knowledge of health care issues.

 Patient counselling may be verbal or written performed on an individual basis or in groups, & provide directly to the
patient or care giver.
 The process provides for the exchange of information between the patient & health practitioner.
 The information gathered is needed to assess the patient’s medical condition to further design, select, implement,
evaluate & modify health interventions.

Outcomes of patient counseling:

● Patient recognizes the importance of their wellbeing.

● It encourages the patient to establish a working relationship with a pharmacist & foundation for
continual interaction and consultation.

● Improves the coping strategies to deal with medication side effects and drug interactions.

● Motivates the patient to take medicine for improvement of his/her health status.

● The patient becomes an informed, efficient and active participant in disease treatment and self-
care management.

● Develops the ability in patient to take appropriate medication related decision concerning the
compliance or adherence to their medication regimen.
 Patient counseling methods:

The structure of the counselling session is divided into four groups:

● Introduction of the session.

● Content of the session.

● Process followed.

● Conclusion of the session.

Counselling contents items:

● Discuss the name and indication of the medication.

● Explain the dosage regimen including duration of therapy when appropriate.

● Assist the patient in developing a plan to incorporate the medication regimen into his/her daily routine.

● Explain how long it will take for the drug to show its effect.

● Discuss storage and refilling information.

● Emphasize the benefits of completing the medication as prescribed.

● Discuss the potential side effect.

● Discuss how to prevent or manage the side effects of the drug.

● Discuss the precautions.

● Discuss the significant drug‐drug, drug‐food, and drug‐disease interaction.

● Explain precisely what to do if the patient misses the dose.

● Explore the potential problems of the patient.

● Provide accurate information.

● Use language that the patient is likely to understand.

● Use the appropriate counselling aids to support counselling.

● Present the fact and order in a logical order.

● Maintain control & direction of the counselling session.

● Probes for additional information.

● Use open‐ended question.

● Display effective non‐verbal behaviours.

Counseling conclusion steps:

● Verify the patient understanding via feedback.

● Summaries by acknowledging or emphasizing key points of information.

● Provide an opportunity for final concerns or questions.

● Help the patient to plan, follow up and next consecutive steps.

Interactive communication skills requires five key elements:

1. open‐ended questions;

2. awareness of nonverbal cues;

3. active listening;

4. reflective responses; and

5. Verification of understanding.

Open ended questions:

● A key component of interactive communication is using open‐ended questions.

• Open‐ended questions are questions that start with who, what, where, when, how and why and require more than a
yes/no response to these questions encourage disclosure of information.

• Closed‐ended questions and leading/restrictive questions elicit yes/no responses and limit the information sought
 from the receiver. These types of questions should be avoided.

Example:

Closed‐ ended: "Do you know how to take your medication?" "Yes"

Leading/restrictive: "You're familiar with your medications, aren't you? “Yes”

Open‐ ended: "What did the doctor tell you about taking the medications?

Nonverbal cues:

● Appropriate nonverbal cues are also critical for effective communication.

● Facial expressions, body posture, gestures, tone of voice and use of eye contact are all forms of nonverbal
communication.

Skilled use of our nonverbal communication can make the difference between successful interactive dialogues and
frustrating non-productive encounters. What we say and how we say it must have the same meaning. When nonverbal
cues are inconsistent with the words spoken, people tend to believe the nonverbal message.
 32

Appropriate non‐verbal clues:

● Friendly and smiling facial expressions.

● Varied eye contact (consistent, but not startling.)

● Professional appearance

● Relaxed, warm and comfortable gestures.

● Attentive body posture(slightly leaning forward)

● Appropriate personal space(18‐48 inches)

● Varied voice rate and volume to keep the individual interested.

However, a high pitched voice should be avoided.

Distracting non‐verbal clues:

● Lack of eye contact may indicate little confidence or interest.

● Insufficient spatial discomfort(causing discomfort)

● Unfavourable tone of voice(can upset the people and create an

unintended meaning)

● Slouching or weight shifted to one side(may indicate lack of

interest)

● Messy work environment.

Active listening:

● When we think of communication skills, we usually think of skills relating to the

manner in which we speak. However, equally important, and perhaps more
difficult to learn, is the ability to listen well. Studies show that most people are
not good listeners. In pharmacy practice environments, listening skill may be
further challenged by the perception or reality of little time and by the attitudes
 33

of the listener and/or the speaker.

The following are specific habits that may interfere with an individual's ability to
listen. Also listed are recommendations for improving one's listening ability.

 Trying to do two or more things at once. This lack of attention comes

across as a lack of interest in the other person and what they are saying to
you.
Solution: Get rid of distractions.

 Jumping to conclusions before a person has completed his or her message.

The result is you only hear part of what was said.
Solution: Stop talking, you can't listen if you are talking.

 Communicating stereotypes that you have internalized.

Solution: React to the information, not the person.

 Faking interest in what is being discussed.

Solution: Use good eye contact, this will help you concentrate.

 Judging the individual based upon his or her appearance or condition.

Solution: Focus on content, nonverbal cues and the manner in which something
is said.

There are additional skills that can be used to enhance listening. These include
paraphrasing, clarifying, summarizing and feedback.

 Paraphrasing allows you (the listener) to convey back to the sender the
message, and allows the sender to know that the receiver is listening. This
technique encourages a dialogue.
 Clarifying provides opportunities to comprehend what is being said by helping
the listener or receiver to understand the message.
 Summarizing assesses whether you accurately understand the information
that you heard and enables you to verify that you process the information from
the sender correctly.
Phrases and questions that facilitate listening:

Paraphrasing:

● Are you saying that…..?

 34

● Do I understand you to mean…?

● What I’ve heard so far…?

● Let me tell you what I understand…..

● What I hear you say is…..

Clarifying:
● What do you mean by….?

● How do you know….?

● What do you mean….?

● I don’t understand what do you mean….?

Summarizing:
● Would an example of that be…?

● Is that like when….?

● As you’ve described it…?

Active feed-back:
● I see…

● Uh huh…

● No, I don’t feel that way, but tell me why you do…

● Yes, that’s how I’ve found it to be...

Paraphrasing:

● Are you saying that…..?

● Do I understand you to mean…?

● What I’ve heard so far…?

● Let me tell you what I am understanding…..

● What I hear you say is…..

 35

Clarifying:
● What do you mean by….?

● How do you know….?

● What do you mean….?

● I don’t understand what do you mean….?

Summarizing:
● Would an example of that be…?

● Is that like when….?

● As you’ve described it…?

Active feed back:

● I see…

● Uh huh…

● No, I don’t feel that way, but tell me why you do…

● Yes, that’s how I’ve found it to be...

Reflective (empathic) responses:

● I gather that…

● Sounds like you’re….

● You seem to be saying….

● So you believe….

● It seems like you….

● You appear to be feeling….

Verification of understanding:
 36

● Verifying understanding prevents misunderstandings. It is an important

skill in the communication process because it is a checkpoint for
communication.

● This process involves asking the receiver to state back the message that
was sent by the sender and enables confirmation of what a person knows
... not what we think they know. This tool confirms that the sender's
message was translated as intended.

● In a pharmacist‐patient interaction, verifying understanding confirms that

the patient has received the information necessary to take his or her
medication(s) properly. Verifying understanding can be achieved as
discussed earlier by asking open‐ended questions. For example,

● "Just to make sure I've discussed everything, can you tell me how you are
going to take your medication?"

● The manner in which the questions are phrased is important. Remember,

active communication skills foster a discussion in which both parties
participate.

● Asking a question using phases such as, "Now tell me how you are going
to take your medication." are likely to be perceived more as a pop quiz
than as part of a discussion and may make the patient feel uncomfortable
or angry.

● Effective communication is a dynamic process that requires using a wide

variety of skills.
37
 38

Medication History Interview

Introduction
 Patient Medication history interviews help the pharmacist to establish rapport
with the patient, commence preliminary counselling and help to devise an on-
going pharmaceutical care plan
 Sources: Patient, medication records from the hospital and other sources.

Goals
To gather information to be utilised to

 Compare medication profiles with the medication administration record and

investigate discrepancies
 Verify medication histories taken by other staff and provide additional
information where appropriate
 Document allergies and adverse reactions
 Screen for drug interactions assess patient medication compliance
 Assess the rationale for drugs prescribed
 Assess for evidence of drug abuse
 Appraise drug administration techniques
 Examine the need for medication aids
 Document patient-initiated medication administration

Documentation
Documentation of medication history include

 Current medication administration record

 Previous prescriptions
 Current admission details
 Referral letter from local doctor or other sources
 The patient’s own medication list

Preparing for the Interview

 Determine specific goals of the interview
 Establish the identity of the patient
 Introduce yourself
 Explain the purpose of the interview
 Respect the patient’s right to decline an interview
 Adopt a suitable physical position to enable the interview to take place
comfortably and effectively
 If the patient is not in a position to manage the care, the interview should be
done with the relevant person
 39

Information to be obtained in the Interview

 Prescription medication use
 Non-prescription medication use
 Allergies, previous adverse drug reactions and their manifestations
 Use of alternative therapies
 Social drug use (e.g. Alcohol, smoking)
 Illicit drug use
 Immunisation status
 Community pharmacies and general practice surgeries visited

Seeking Specific Information

 The patient’s perception of the purpose and effectiveness of the medication(s)
 The dose and dosage schedule used
 The duration of the therapies used
 The perceived effectiveness of the medication(s)
 A general impression of the likelihood that the patient has the medication(s)
as prescribed
 The reasons for discontinuation or alteration of medications
 The storage of medications
 Any problems with the medication therapy

Conclusion
 Summarise the important information
 Answer patient’s questions regarding therapy
 Encourage the patient for further information

Follow-up
 Comparison of medication profile with medication administration record
 Identify and resolve drug related problems
 Counsel the patients about alterations to their medications.
 40

PRESENTATION OF CASES
1. General Description –
Giving an oral presentation on ward rounds is an important skill for medical student
to learn. It is medical reporting which is terse and rapidly moving. After collecting the
data, you must then be able both to document it in a written format and transmit it
clearly to other health care providers. In order to do this successfully, you need to
understand the patient’s medical illnesses, the psychosocial contributions to their
HPI and their physical diagnosis findings. You then need to compress them into a
concise, organized recitation of the most essential facts. The listener needs to be
given all of the relevant information without the extraneous details and
should be able to construct his/her own differential diagnosis as the story unfolds.
Consider yourself an advocate who is attempting to persuade an informed,
interested judge the merits of your argument, without distorting any of
the facts. Depending on the purpose of the presentation, different parts of the
database are included. The same patient will be presented very differently to the
cardiology consultant who is asked to give advice on the optimal treatment for their
CHF, the surgeon who is considering aortic valve replacement, the social worker who
is helping obtain disability funding and the attending who needs to know who was
admitted last night. As you progress in your training, you will become expert at
adapting and editing the story to serve its various purposes. Last year you learned to
collect and organize the complete database and do a complete writeup. In taking
your history you have gathered more information than you will include in your write-
up and likewise, your write-up contains more information than you will include in an
oral presentation.

2. Basic principles

a. An oral case presentation is NOT a simple recitation of your write-up. It is a

concise, edited presentation of the most essential information.
b. A case presentation should be memorized as much as possible by your 3rd year
rotations. You can refer to notes, but should not read your presentation.
c. Length – this will vary depending on your service. A full medicine presentation in
attending rounds should be under 5 minutes. A presentation in the hallway on walk
rounds on medicine should take no more than 3 minutes.

3. Similarities and differences between written and oral presentations

a. Both are an organized reconstruction of the patient’s narrative into a coherent HPI,
not a random assortment of facts.
b. Both follow the same organizational format (see #4 below)
c. Separation of subjective data – derived from the patient, family and medical record
and objective data which includes your physical exam and today’s lab/radiographic
data.

4. Basic structure for oral case presentations – the order parallels that of the
write-up.
 41

a. Identifying information/chief complaint (ID/CC)

b. History of present illness (HPI) including relevant ROS only
c. Other active medical problems
d. Medications/allergies/substance use (note:
e. The complete ROS should not be presented in oral presentations
f. Brief social history (current situation and major issues only)
g. Physical examination (pertinent findings only)
h. One line summary
i. Assessment and plan

4. Organization and Content of Case Presentation.

1. Identifying Information/Chief Complaint (II/CC) – you want flesh out the bare
bones enough to make your presentation engage the listener and give them a feel
for the patient as a person.

a. Structure: “Mr/Mrs/Ms ___ is a ___year-old man/woman who presents with a chief

complaint of ___ (or who was electively admitted for evaluation of ___, or who
comes in to clinic for follow up of_____)”.

b. Only include the race or ethnicity of the patient if it is relevant and will make your
listener weigh diagnostic possibilities differently.

c. To orient your listener, the identifying information should include the patient’s
relevant active medical problems, of which there are usually no more than four. You
will list these problems here by diagnosis only, and will elaborate on them later in the
“HPI” or “other medical problems.” Your small group facilitator should help you
identify which problems are relevant when this is not obvious.

Good Examples:
 Mr Smith is a 55 year-old man with a long history of diabetes mellitus,
cirrhosis, and chronic obstructive lung disease, who presents with a chief
complaint of fever and productive cough…

 Mrs Jones is a 39 year-old woman who was electively admitted for evaluation
of exertional dyspnoea. Her active problems include rheumatoid arthritis and
hypertension. She was in her normal state of health until…

Avoid presentation of distracting information, such as an overly detailed discussion

of the patient’s medical problems in your introductory remarks:

Examples:

BAD # 1: …his problem list includes coronary artery disease – myocardial infarction
x 2, the last in 1996, multiple negative rule-outs since, ejection fraction equalled 35%
in 1994; diabetes mellitus x 10 years, insulin requiring for five years, complicated by
retinopathy; chronic obstructive lung disease – with a FEV1* of 1.2 litres and steroid
Dependence…
 42

GOOD #2: …his active problems include coronary artery disease, diabetes mellitus,
and chronic obstructive lung disease….

In example 1 the listener will forget the chief complaint by the time you reach the
history of present illness.

Example2 is concise and does not interrupt the listener’s train of thought between
the chief complaint and the history of present illness; relevant information about each
of these problems should be introduced when appropriate in the “HPI” or “other
medical problems.”

2. History of Present Illness (HPI)

a. Introductory sentence:

Mr/Mrs/Ms____ was in his/her usual state of ____ (e.g., excellent health/poor health)
until ____(e.g., three days prior to admission) when he/she developed the ___
(acute/gradual) onset of _____. The introductory sentence may include details of
past medical history if the patient’s illness directly relates to an On-going
chronic disease.

b. Don’t mention that an event occurred “on Saturday”, rather refer to the time
relative to the day of admission, e.g.

3 days prior to admission.

Examples:

1. Mr Smith has a long history of chronic obstructive lung disease characterized

by two block dyspnoea on exertion, FEV1 of 1.0 litre, and home oxygen
therapy. He was in this usual state of health until three days prior to admission
when he developed the gradual worsening of his shortness of breath,
associated with a cough productive of yellow sputum and a fever of 102_…..

2. Mr White has a long history of coronary artery disease characterized by three

myocardial infarctions, the most recent in 1995, ventricular tachycardia
treated with amiodarone, and congestive heart failure. He was in his usual
state of health, with angina occurring once per week, until the night of
admission when, while watching a football game, he developed the acute
onset of severe sub sternal chest heaviness…

b. Content of history of present illness –

specifically characterize the major presenting symptoms including patient

attributions (what the patient thinks is causing the symptoms), any prior episodes,
and complications and the relevant ROS questions (these includes x related to the
major and adjacent organ systems, constitutional complaints such as fever and
weight loss and epidemiological risk factors or exposures. If there was any
evaluation of the chief complaint prior to hospital admission, this should be included.
 43

The following is a useful mnemonic to make sure all those bases are covered:

C- character, circumstances
L -location – deep or superficial, well or poorly localized
E -exacerbating factors
A -alleviating factors
R -radiation of pain
A -associated sx
S -severity on a 1-10 scale
T -temporal features - timing (intermittent/constant), duration, frequency, changes
over time (progressive, stable or improving)

Examples:

A poorly characterized and too brief history of present illness:…admitted for

evaluation of chest pain. He was well until three weeks prior to admission when he
began to feel chest heaviness whenever he exerted himself. He saw his local doctor
who prescribed antacids with little benefit. The pain woke him last night so he came
into the emergency room for evaluation. His other problems include…….

A more complete example:

….admitted for evaluation of chest pain. He was in his
usual state of excellent health until three weeks prior to admission when he
developed the gradual onset of intermittent chest pain, characterized as poorly
localized deep sub sternal heaviness which radiated to his left shoulder, lasting
about five minutes per episode, occurring several times a day, aggravated by
exertion and relieved by rest. Associated with the pain were shortness of breath and
nausea. One week prior to admission he was seen by a local doctor who, without
other testing, diagnosed gastritis and prescribed antacids without benefit. The chest
pain was stable until two hours prior to admission, when the patient awoke with a
more severe version of the same pain that lasted until he came to the emergency
room. He was quickly transferred to the coronary care unit. There was no history of
cough, heartburn, weight loss, or fever, chills or sweats. The patient’s risk factors for
coronary artery disease include a positive family history and cholesterol of 310 in
1998. He has no history of high blood pressure or diabetes and has never smoked
cigarettes.

3. Other Medical Problems:

a. Include here details of those problems that are active and you feel are relevant to
the present illness.These are usually the same problems you mentioned in
“identifying information”.

For example,

Diabetes mellitus is relevant to a patient admitted with angina. Consider each

condition separately, recounting the details in a chronological fashion. In other
words, first explain the patient’s h/o coronary disease, telling the story from the
beginning to the present. Then discuss their peptic ulcer, and then his/her COPD. In
 44

general, discuss the most important problem first, and then present the others from
next most important to least important.
Example:
…his other medical problems include insulin-requiring diabetes for 12
years, complicated by retinopathy, polyneuropathy, and nephropathy. His recent
creatinine was 1.7…..

b. Key words and phrases summarize an on-going chronic illness and are discussed
in this section (or may be included with the HPI if they are related to the current
problem as discussed above). The key words vary with the nature of the problem.
You will learn these as you gain clinical experience and by listening to others
summarize and present cases. In general, key words emphasize date of diagnosis,
its treatment, current symptoms, complications, and any recent objective tests.

Examples (key words underlined):

….long history of chronic obstructive lung disease with

steroid dependence and the requirement for home oxygen therapy, a 1994 FEV1 of
0.8L, and three hospital admissions for exacerbations in the last year. He has never
been intubated……two year history of congestive heart failure, felt to be secondary
to alcoholic cardiomyopathy, characterized by chronic two block dyspnoea on
exertion, three pillow orthopnoea, and ankle oedema. In addition to his long term
therapy with furosemide and enalapril, digoxin was added six months ago. An
echocardiogram four months prior to admission showed four chamber enlargement
and global hypo kinesis……

c. In the case presentation you avoid presentation of irrelevant diagnoses. What is

irrelevant is not always obvious to you at your level of training and also improves
with your clinical experience. Consultation with your facilitator and preceptor will help
you make this determination. “gonorrhoea in 1945, malaria in 1940, cataract
extraction in 1972, and tinea pedis” are probably not relevant during presentation of
the diabetic with crescendo angina.

You must know all of the patient’s problems and include them in your write-up,
but presentation of problems which are not relevant to the current active
problems only distracts your listener.

4. Medications, Allergies, Substance Use:

a. Provide a list of all prescribed medications and a list of any relevant non-
prescription medications.
Unless you have the chance to review the patient’s chart, you will only be able to
give as much detail about medications as the patient can give you.

b. Report any relevant drug allergies and the type of reaction (for example, “the
patient developed a skin rash approximately 20 years ago after receiving penicillin
and carries the diagnosis of penicillin allergy”).

c. Summarize substance use not already mentioned in HPI. However, f it has been
mentioned in the HPI, do not repeat it.
 45

5. Social History (brief) –

we are more than our habits and marital status. Please don’t try and reduce patients
to these facts alone. Summarize their social history into a brief (2-3 sentences)
paragraph commenting on their current life situation including work, living situation,
and support systems, and any on-going social issues of note. It is often the social
history that explains why the patient has fallen ill now, as opposed to some other
time or not at all:

patients may have chaotic lives and little social support so don’t have the help they
need to follow therapeutic recommendations, few financial resources and can’t afford
their meds, depression and feelings of hopelessness about their conditions, etc.

These factors, if not addressed, will tend to lead to re-hospitalizations. If

appropriate, include information about the patient’s personal wishes for health such
as advance directives (their living will and durable power of attorney) including
discussion concerning these issues.

6. Physical Examination:

a. General description – be colourful, allow the listener to visualize the patient. “The
patient was short of breath” is inferior to “the patient was sitting on the edge of the
bed, leaning forward and gasping for breath.”

b. Vital signs should always be mentioned, including postural changes if relevant.

c. Mention only the relevant positive findings and relevant negative findings. An
example of the latter includes (in the dyspnoeic patient) “the exam is remarkable for
clear lungs bilaterally.” Use concise but complete descriptions of positive findings.

7. Summary and Assessment (brief):

a. This takes the following form: “…the patient’s major presenting problem is ____
(best positive statement you can make; say “chest pain” and avoid statements like
“rule-out myocardial infarction”). The differential diagnosis includes ____, ______,
and _____. The diagnosis of _____ appears to be the most likely of these because
______..

Example:

…..the patient’s main problem is chest pain, which could be due to a myocardial
infarction, a dissecting aortic aneurysm, pericarditis, and a variety of other diagnoses
such as pneumonia, pulmonary embolus, or oesophageal disease. MI seems most
likely, because his description of chest pain is classic for angina and because his
ECG reveals a new injury current in the inferior leads.

5. Common Mistakes in Oral Presentation

1. Slow laboured rhythm –

a wandering, disorganized and desultory presentation is the most common problem
encountered in early students. The ability to convert a written history and physical
 46

examination into a compressed presentation requires careful thought and practice.

Ask your attending or facilitator how long a presentation they would like. You should
maintain eye contact with your listener during the presentation, which means that
you should refer to notes and not read your write-up. In order to keep it under 5
minutes, you will need to PRACTICE it two or three times in advance. This is helpful
to do with a classmate who can give you feedback and then let you try again. It is
also worth taping yourself and listening to the tape – you would often give yourself
feedback.

2. History of present illness too brief - 90% of correct diagnoses come from the
history alone; do not sabotage your listener’s understanding of the case by omitting
important information. The HPI portion of the oral presentation, as a general rule,
should take 1/3 to 1/2 of the presentation time. Common pitfalls include incomplete
characterization of the major symptoms, omitting pertinent negatives or positive ROS
questions, and omitting specific information about past history that relates to the
present problem.

3. Failure to use parallel reference points - in both write-ups and oral

presentation, relate time in “hours/days/weeks prior to admission”. Avoid “at 2:00 in
the morning of last Wednesday” or “on May 25th; instead, say “three hours prior to
admission”, or “at 2:00 am, three days prior to admission”.

4. Editorializing in the middle of the presentation - avoid comments like “do you
even want to hear this?” or “cardiac examination revealed a systolic murmur….well, I
thought heard it, but the resident didn’t…so maybe it isn’t there….I don’t really
know….”

5. Use of negative statements instead of positive statements. Positive

statements add colour and accuracy to your presentation. “Chest X-ray shows
normal heart size” is better than “chest X-ray shows no cardiomegaly”. “In summary,
this patient’s problem is acute dyspnoea” is better than “the patient’s problem is rule-
out pneumonia”.

6. Repetition- varies your sentence structure. An overly repetitious presentation is

monotonous for the listener.
“On pulmonary exam, the lungs were normal…on cardiac exam, the heart sounds
were…, on lymph node exam, there were no cervical nodes…etc” is difficult to listen
to and unnecessary – your listener knows that S1 and S2 are part of the cardiac
exam! Use brief descriptive sentences: “an S3 gallop was heard at the left lower
sternal border.”

7. Disorganization – this problem is a result of lack of rehearsal. Stopping at the

end of the HPI to say “Oh, I can’t believe I forgot to tell you this” will kill a
presentation. Or “…in summary, this patient…wait, I forgot to tell you the most
important thing…” You need to be aware that this can happens even with careful
preparation. The best advice when you forget something crucial to your presentation,
is to work it in as soon as possible and don’t make a big deal about it.

8. Physical findings presented without proper terminology - for example, “lymph

node exam shows some small cervical nodes” is not as descriptive as “…there were
 47

three soft tender mobile nodes in the left anterior cervical chain which measure 1 x 1
x 2 cm each… “Commitment to accuracy will improve your physical examination
skills.

9. Diagnoses used instead of descriptions in the physical examination -

diagnoses belong in the assessment, descriptions in the physical examination. For
example, avoid “exam showed the murmur of mitral regurgitation” …instead say “a
2/6 holosystolic murmur was heard at the apex when radiated to the axilla”. Avoid
“skin exam showed psoriatic lesions on the elbows…”: instead, say “there were
several 2cm diameter round plaques with silver scale distributed on the extensor
surface of the elbows…”.
 48

PHARMACEUTICAL CARE
DEFINITION:
It is defined as the responsible provision of drug therapy for the purpose of
achieving definite therapeutic outcomes that improve the patient’s quality of
life.

These outcomes are:

 Cure of the disease

 Elimination or reduction of patient’s symptomology

 Arresting or slowing of a disease process

 Preventing a disease or symptoms.

FUNCTIONS:
 COLLECTION OF PATIENT DATA

 IDENTIFICATION OF PROBLEMS

 ESTABLISHING OUTCOME GOALS THROUGH A GOOD THERAPEUTIC

PLAN

 EVALUATING TREATMENT ALTERNATIVES , BY MONITORING AND

MODIFYING THERAPEUTIC PLAN

 INDIVIDUALISING DRUG REGIMENS

 MONITORING OUTCOMES.

1) COLLECTION OF PATIENT DATA

 Demographics

 Current problems

 Past medical history

 Current medication

 Social habits

 Relevant laboratory data.

 49

2) IDENTIFICATION OF PROBLEMS
 The data collected can be used to identify actual or potential drug related
problems.

 ACTUAL: A condition that requires the initiation of a new or additional

drug.

 POTENTIAL: The patient may be at risk to develop a new medical

problem.

These problems may be related to the patient’s current drug therapy, drug
administration, drug compliance, drug toxicity, ADR’s and a failure to achieve
desired outcomes by the treatment.

3) ESTABLISHING OUTCOME GOALS

Drug therapy can produce positive outcome:

 Cure of the disease

 Elimination or reduction of patient’s symptomology

 Arresting or slowing of a disease process

 Preventing a disease or symptoms

 It may also produce negative result, i.e. resulting in disease morbidity

and sometimes mortality.

4) EVALUATING TREATMENT ALTERNATIVES BY MONITORING AND

MODIFYING THERAPEUTIC PLAN

 Efficacy, safety, availability and cost of treatment and suitability of the

treatment to the patient should be considered while evaluating.

 The risk-benefit ratio factors should also be considered: seriousness of the

disease, complications if untreated, efficacy of drug, ADR’s.

5) INDIVIDUALISING DRUG REGIMENS

When more than one therapeutic alternative exist, the following factors to be
considered:

 Patient factors:- diagnosis, treatment goals, past medical and

medication history, contraindication, allergies, compliance

 Drug factors: - efficacy, adverse effects, dosage form, cost, drug-drug

interactions.
 50

6) MONITORING OUTCOMES
The goals are: Cure of the disease, elimination or reduction of patient’s
symptomology, arresting or slowing of a disease process, preventing a disease or
symptoms.

But often leads to suboptimal outcomes due to inappropriate or unnecessary

prescribing or drug regimen, dispensing error, non-compliance, inappropriate
monitoring.

To ensure good monitoring outcomes:-

 Regularly should review whether satisfactory progression is made or

not according to the therapeutic plan.

 To determine whether original plan should continue or any treatment

modifications to be made or not.

 Reviews ongoing progress and provides report to patient’s other

healthcare providers.

 Should regularly update patient’s medical/pharmacy records with

information concerning patient’s progress.

7) PHARMACEUTICAL CARE IN HOSPITALS

 Prescription monitoring

 Prescribing advice to medical and nursing staff

 Medication errors and adverse reaction monitoring

 Medication history interview

 Patient education and counseling

 Pharmacokinetics and therapeutic drug monitoring

 Hospital formulary.

8) PHARMACEUTICAL CARE FOR THE COMMUNITY

 Participate in health screening

 Participate in health promotion and education

 Serve as a source of drug and poison information

 Collaborate with other health care professionals to develop treatment

guidelines
 51

 Design and monitor procurement and drug distribution system including

storage and disposal.

9) BARRIERS TO PHARMACEUTICAL CARE

 Pharmacist barrier

 Practice setting constraints

 System impediments

 Intra professional barrier.

 52

Critical Evaluation of Biomedical

Literature
Introduction:
There are more than 20,000 biomedical journals available
worldwide, approximately 9000 articles are being published every day, and
Updating scientific knowledge is a Herculean task for the healthcare
professionals.

The Vancouver guidelines format include

 Format of abstract

 Text

 Tables/graphs

 Reference

 Permissible abbreviations and symbols

 Authorship recommendation

 Acknowledgements.

The journal:
Reputed journal usually demonstrate:

o The editorial policy specifying types and format of articles

o Publishes results of well-conducted research
o Articles undergo peer review
o Texts exceed pages of advertising /promotional material.

Selecting the Article:

Primary step in evaluation of a literature is to select an article which has a greater
impact in clinical practice. Initially, read the title, authors and abstract. The title
 53

should be comprehensive that the reader can efficiently analyse the article’s potential
and its importance in current clinical practice. If not, reader can reject it and move on
to the next article.

Reading the Literature:

Reviewing begins with reading and understanding the abstract or short summary that
gives a brief background about the research. Initial reading gives the concept of
objectives, methodology, results and proposed significance of the study. A proper
understanding of research study’s nature is must for a reader.

Title:
‘Title’ describes the breadth and depth of the current study and indicates the
methodology used. It is the limited possible words that adequately describe contents
of the study. The title of an article should be brief, definite and concise and should
catch the attention of the readers interested in the study.

Evaluation of Title:
1) Based on the title itself reader cannot review or discard the study.
2) Title should not contain abbreviations, proprietary names,
chemical formulae, and jargons.
The title should inform the real subject of the article.
3) Title should not reflect its content. First impression is the best
impression; the title should be specific and studied well.
4) Title should not indicate author’s preference for any specific
subject.
Abstract:

 An abbreviated accurate representing the contents of a

document, mainly prepared by its author(s) for publication in it.
 Abstract can be defined as a summary of the information in a
document.
 A synopsis (not more than 250 words) should be mentioned
before introduction in the article.
 54

Evaluation of Abstract:

 “Abstract” should outline a brief

Summary of each section; Introduction, objectives, scope of
investigation, materials and brief
 Methodology, results, and conclusion which indicate study
findings. Abstract does not provide
 Complete information about the study and should not be used
alone to evaluate the study.

Introduction:
It serves two purposes in the study, creating readers interest
in subject and providing them with enough information to
understand the study.
Evaluation of Introduction:

o Introduction should be presented, with all possible clarity,

the nature and scope of the problem investigated.
o It should provide pertinent literature to orient the reader.
o It should explain the reason why the current research is
needed?
Objective:
‘Objective’ of a study is what the author is trying to achieve. It is a
specific, clear and succinct statement of intended outcomes from
research. Objective should be stated in a clear and concise manner.
Evaluation of Objective:
1. Establishing new health programs
2. Implementing new policies
3. Trying to settle a controversy
 55

4. Showing the validity of a new technique

5. Opening up a new field of inquiry.
Study Designs:
The first part of this section is generally an overview of
the type of study design that is utilized in doing research. A sound
study design supports study conclusion and result. Study design
should be clear and provide enough details so that potential reader
can repeat the research.

Various types of Study design:

Observational studies
Data collected from one or more group of subjects, Observational
studies may be prospective or retrospective.
Single blind
Either subjects or investigators are unaware of treatment allocation.
Double blind
Neither subjects nor investigators are aware of treatment allocation.
Triple blind
Subjects and investigators are unaware of treatment allocation;
another group involved with interpretation of data is also unaware of
treatment allocation.
Parallel study
All subjects receive only one treatment.
Prospective
Data is collected forward in time from the start of the study.
Retrospective
 56

Historical data (i.e., data referring to past events) is collected.

Cohort studies
Cohort studies consist of prospective observation of one or more
groups with certain characteristics.
Randomized control trial
Subjects are randomly allocated to either an intervention group or
control group. Randomized controlled trials are described as the
“gold standard” in clinical research.

Evaluation of Study Designs:

The study design selected by an investigator should be sound and
likely to answer the research questions.
Author(s) must describe study population well enough so that the
reader is able to visualize the sample population precisely under
investigation.
Bias:
It is a systemic variation in which treatment groups under study are
treated or measured differently on a consistent basis. Bias can
mislead one to get into an erroneous outcome. The reader should
be able to find out the source of bias and its influence on the final
outcome of study.

Types of bias:
Missing clinical data bias
Certain clinical data may be missing because they were normal,
negative or never measured.
Withdrawal bias
Patients who withdraw from a study may differ from those who
remain.
 57

Sample size bias

Too small Samples are insignificant; samples which are too large
are proved to be helpful.
Instrument bias
Defects in the calibration or maintenance of instruments may lead
to systematic deviations in results.

Statistics:
Knowledge of ‘Statistics’ can help an individual to
evaluate whether the statistical tests used in a study are
appropriate or not. Different types of data (or variables) are
encountered in statistics. Errors in statistical analysis of data lead to
invalid result/conclusion.
 58

Evaluation of Statistics:
 Readers should determine whether appropriate statistical
methods were used for data analysis.
 Use of inappropriate methods will results in misleading
conclusion.
 Method section of any scientific literature should include a
summary description of the statistical tests that were used to
evaluate data. Qualitative and quantitative data are examined
differently.

Study Results and Analysis:

 Results’ should be described and presented in figures, tables,
and charts, as they are the heart of the scientific literature.
 Figures, tables, and charts will assist the reader in deciding
whether it is worth to read the rest of the article or to discard it.
 A properly conducted study should present data on subjects
involved in the study. All the data collected in the method
section should also be presented.

Evaluation of Study Results and Analysis:

 Reader should have a proper understanding of study and

should evaluate clinical and statistical reliability of the study
 Sometimes authors try to present results in a confusing way,
which most likely reflects hap hazardous data collection and
lack of clearly defined study objectives.
 Are the negative results been quoted? In case of any negative
results those should be quoted and the limitations have to be
specified.

Discussion and Conclusion:

 59

 ‘Discussion Section’ of a study provides an opportunity for the

author to interpret results and explain their clinical importance
by relating or comparing with previous work or practice.
 ‘Conclusion’ is the author’s generated inferences, opinions
and hypotheses about results. This section should contain
views that the author draws from data obtained by the study.

Evaluation of Discussion and Conclusion:

 Is the conclusion over-generalized? The ‘Conclusion’ must be

clear and understandable to the reader. Conclusion must be
consistent with study objectives and justified by results.
 Conclusion should not be a matter of dispute.
 How does the research fit into the context of its conclusion? It
should give the answer of the study objective for which claim
was made prior to study.
 Readers must understand the relationship between the data
and the conclusions.

References:
 While writing article, authors always refer to some information
from other sources.
 All these sources are listed in ‘Reference Section’, sometimes
referred to as ‘Bibliography’.
Evaluation of References:
1) Are the references given? Whether appropriate and adequate
references are used in the study?
2) Are the references quoted appropriately in the research article?
3) Are the references given recent and important?
4) What is the size of ‘Reference Section’?
5) How the references are used for support, rebuttal etc.?
6) Do the references match citations in the text?
 60

7) Authors should avoid citing their own research efforts and

publication.

MEDICATION ERRORS: CAUSES &

PREVENTION
Introduction
 61

Drug use is a complex process and there are many drug related challenges at
various levels, involving prescriber, pharmacists and patients. While medication
misadventure can occur any where in the health care system from prescriber to
dispenser to administration and finally to patient use, the simple truth is that many
errors are preventable, and pharmacists assume active role in appropriate use of
drugs. Pharmacy entails a health science specialty which embodies the
Knowledge of pharmacology, toxicology, pharmacokinetics and therapeutics for the
care of patients. Health care is nearly 10 years behind other industries in its efforts to
reduce the errors. According to studies cited in the institute of Medicine report, “to Err
is Human; Building a Safer Health System” 44,000 to 98,000 Americans die each
year
as a result of medical errors. Medication error may be nobody’s baby, but when it
happens, it could well turn out to be everyone’s worry and the reasons given for
medication error range from silly to the
Downright serious.
Medication errors:

“A medication error is an preventable event that may cause or lead to inappropriate

medication use or patient while the medication is in the control of the health care
professional, patient, or consumer. Such events may be related to professional
practice, health care products, producers and systems, including prescribing; order
communication; product labelling packaging and nomenclature; compounding
;dispensing; distribution; administration; education; monitoring; and use”3 Most
medication errors are considered latent.
For example,
When a pharmacist fills a prescription with the incorrect medication, patients
typically realize this mistake once they have returned home and have taken the first
dose. Latent errors can be described as “accidents waiting to happen “The causes of
these types of errors are usually identifiable and can be corrected before the error
Re occurs.

 Incomplete patient information (not knowing about patients’ allergies, other

medicines they are taking , previous diagnoses, and lab results for example)
 Unavailable drug information (such as lack of up-to date warnings)
 Miscommunication of drugs orders, which can involve poor handwriting ,
confusion between drugs with similar names, misuse of zeroes and decimal
points, confusion of metric and other dosing units, and inappropriate
abbreviations.
 Lack of appropriate labelling as a drug is prepared and repackaged into
smaller units and
 Environmental factors, such as lighting, heat, noise, and interruptions that can
distract health professionals from their medical tasks.

Dispensing errors:
“Error of wrong interpretation of doctor’s prescription and inaccurate calculation of
doses especially in children.” Dispensing error refers to medication errors linked to
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the pharmacy and includes error of commission (dispensing the wrong drug or dose)
and those of omission (failure to counsel on safe use of medicine).
Most dispensing errors involve the dispensing of an incorrect
Medication, dosage strength or dosage form. Lookalike and sound alike drug often
causes confusion with ineligible prescriptions or verbal medication orders and errors
are likely.

Causes for errors:

In a data report indicates that pharmacists perceived the following as causative
factors for medication errors:-

1. Too many telephone calls (62%)

2. Overload/ unusually busy day (59%)
3. Too many customers (53%)
4. Lack of concentration (41%)
5. No one available to double check (41%)
6. Staff shortage (32%)
7. Similar drug names (29%)
8. No time to counsel (29%)
9. Illegible prescription (26%)
10. Misinterpreted prescription (24%)

Common types of medication errors:

The Institute for Safe Medication Practices (ISMP) identifies the following areas as
potential causes of medication errors.

 Failed communication: handwriting and oral communications, especially over

the telephone, drugs with similar names, missing or misplaced zeroes and
decimal points, confusion between metric and apothecary systems of
measure, use of nonstandard abbreviations ambiguous or incomplete orders
Poor drug distribution practices.
 Workplace environmental problems increasing the job stress.
 Complex or poorly designed technology.
 Access to drugs by non-pharmacy personnel
 Dose miscalculations
 Lack of information to prescribers
 Lack of patient information

 Lack of patient understanding about his therapy.

Medication error rate:

“Medication error rate” is determined by calculating the percentage of errors. The

numerator in the ratio is the total number of errors. The numerator in the ratio is the
total number of errors that they observe, the denominator is called “opportunities for
errors” and includes all the doses observed being administered plus the doses
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ordered but not administered. The equation for calculating a medication error rate is
as follows:

Number of Errors Observed

Medication Error Rate = ———————-————— x 100
Opportunities for Errors

Medication error rate (MER) A-medication error rate of 5% or above indicates that
the facility has systemic problems with its drug distribution system and a deficiency
should be written.

Medication errors due to failure to follow label instruction:

1) Failure to “shake well”: The failure to “shake” a drug product that is labelled
“shake well “. This will almost always lead to an
under dose or over dose depending on the suspending abilities of the diluent’s and
the elapsed time since the last “shake “. Also
included under this category is the failure to “roll” insulin suspensions. Insulin
suspensions should not be shaken, they should be “rolled” in order to mix the insulin
particles with the
diluents without creating air bubbles.

2) Crushing medications: Crushing tablets or capsules that the label states “do not
crush”.
For example: sustained or extended release dosage form, coated tablets.

3) Medications taken with food or antacids:

The administration of medications without food or antacids when the instruction
specifies that food or antacids is taken with or before the medication in order to
prevent Gl irritation.
For example:
Nonsteroidal Anti-Inflammatory Drugs (NSAID’s) taken with food or antacids and
whereas, some of the medication is administered in empty stomach or before taking
food for better pharmacological & therapeutical action.

4) Sublingual tablets which should not be swallowed: Swallowing a sublingual

tablet (e.g. nitroglycerin, isosorbide dinitrade).If it is swallowed; its absorption is
greatly reduced.
This will result in less symptom relief.

5) Use of inappropriate solvents :

Some of the drugs (e.g. anticancer drugs) which require reconstitution before
administration. Use of inappropriate solvent may reduce the efficacy and potency of
the main drug.
For example: Oxaliplatin must be reconstituted with 5%dextrose only.

Medication error prevention:

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The National Coordinating Council for Medication Error Reporting and Prevention
and Institute for Safe Medication Practices emphasize that illegibility of prescriptions
and medication
orders has resulted in injuries to, or deaths of patients. the following
recommendations to help minimize errors.

1. The Institute for Safe Medication Practices suggests a number of error prevention
tools ranging from forcing functions to independent double-check systems.
Prescription orders should include a brief notation of purpose (e.g. for cough), unless
considered inappropriate by the prescriber. Notation of purpose can help further
assure that the proper medication is dispensed and creates an extra safety check in
the process of prescribing and dispensing a medication Independent double-check
systems can reduce the risk of error by way of having one person independently
check another’s work. When this procedure is properly carried out, the likelihood that
two individuals would make the same error with the same medication for the same
patient is quite low.

2. Forcing functions and constraints they allow for designing processes to ensure
that errors are virtually impossible or at least difficult to make. Examples include
software programs with “forcing functions “that require the entry of additional
pertinent patient information before the order is completed and the medication is
dispensed. Automation and computerization of medication use processes and tasks
can lessen human fallibility by limiting reliance on memory. Examples include use of
technologically and clinically sound computerized drug information system.

3. All prescription orders should be written in the metric system except for therapies
that use standard units such as insulin, vitamins, etc. Units should be spelled out
rather than writing “U”. The change to the use of the metric systems from the archaic
apothecary and avoirdupois systems will help avoid misinterpretations of these
abbreviations and symbols, and miscalculations when converting to metric, which is
used in product labelling and package inserts.

4. Prescribers should include age, and when appropriate, weight of the patient on the
prescription or medication order. The most common errors in dosage result in
paediatric and geriatric populations in which low body weight is common. The age
(and weight ) of a patient can help dispensing health care professionals in their
double check of the appropriate drug and dose
.
5. The medication order should include drug name, exact metric weight or
concentration, and dosage form. Strength should be expressed in metric amounts
and concentration should be specified. Each order for a medication should be
complete. The pharmacist should check with the prescriber if any information is
missing or questionable.

6. A leading zero should always precede a decimal expression of less than one. A
terminal or trailing zero should never be used after a decimal. Ten-fold errors in drug
strength and dosage have occurred with decimals due to the use of a trailing zero or
the absence of a leading zero.
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7. Prescribers should avoid use of abbreviations including those for drug names
(e.g., MOM, HCTZ) and Latin directions for use. The abbreviations in (table-1) are
found to be particularly dangerous because they have been consistently
misunderstood and therefore, should never be used.