PRESENTER;Maganga M.Gabriel(Pharmacist) Pharmacy Department (drug inf &Emer)

PRESENTER;Maganga M.Gabriel(Pharmacist)Pharmacy Department

(drug inf &Emer)

Presentation outline• Definition of medication error• Pharmacovigilance overview• The different types of medication errors• Factors that can contribute(cause) to

medication errors• The suggested ways of reducing

medication errors

Definitions

A Medication error (ME) is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of health professional, patient or consumer. (US National Coordinating Council for Medication Error Reporting and Prevention)

Definition of Medication Error An error in prescribing, dispensing or

administering of a drug, irrespective of whether such errors lead to adverse consequences or not

Pharmacovigilance overview

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Why do we need pharmacovigilance?

Will PV prevent these?

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What is Pharmacovigilance?The science and activities relating to the

detection, evaluation, understanding and prevention of adverse drug reactions (ADR) or any other drug-related problems (WHO, 2002)

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.(wikipedia)

pharmakon (Greek for drug),and vigilare (Latin for to keep watch).

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The Goal of Pharmacovigilance and Medicines Safety

The goal of Pharmacovigilance is to safeguard public health and improve rational medicines use .

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Aims of Pharmacovigilance A.To identify/quantify

New adverse drug reactions (ADRs)Risk factors/populations at riskIncrease in frequency of known ADRs

B.Detect Drug interactions with other drugs administered concomitantly

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Aims of Pharmacovigilance cont..• C.To monitor

• ADR profile of medicines within therapeutic class

• the safety profile of medicines during their whole life cycle

• To contribute to good clinical practice in pharmacotherapy

• To prevent patients from unnecessary harm.

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Pharmacovigilance From Historical PerspectiveDrugs’ potential for harm has been

recognized very early.In 1937 a sulfonamide elixir containing

over 70% of diethylene glycol (DEG) was given to over 300 patients in US.

→ 105 deaths (34 children) due to renal failure.

Growing awareness of the importance of ADRs in pharmacotherapy since the Thalidomide tragedy1961 phocomelia in babies born to mothers

treated with thalidomide while pregnant (>470 babies in one year in Germany alone).

In 1970 Inman discovered the causal relationship between thromboembolic disease and high dose oestrogen oral contraceptives.

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16th World Health Assembly 1963Assembly Resolution 16.36 - Clinical and

Pharmacological Evaluation of Drugs INVITES Member States to arrange for a systematic collection of information on serious adverse drug reactions observed during the development of a drug and, in particular, after its release for general use.

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Pharmacovigilance History...

International community response

1968 the WHO International ADR monitoring programme was founded.

In 1971, WHO international ADR database was established

Tanzania joined the program in 1993

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WHO Collaborating Centre for Drug Monitoring

DRUG SAFETY MONITORING BY THE TFDA

Pharmaceutical industry

KilimanjaroKCMC

MbeyaMRH

MuhimbiliMNH

BugandoBMC

PATIENT HEALTH PROFESSIONNALS

Medication Errors…ME may be related to professional

practice, products, procedures, working environment or systems.

They may occur at any stage during : Prescribing (doctor)Dispensing (pharm)Administration of medicines. (Nurse

etc)Use of medicines by patients.

Prescribing Errors cont…

Prescribing errors may be described as incorrect medicine selection (not indicated or contraindicated), wrong dose or quantity for a patient.

Prescribing Errors cont..Example:

Prescribing adult dose to a childPrescribing medication for a prolonged

durationPrescribing antimicrobials for viral diseasesPrescribing contraindicated medicines eg.

Prescribing zidovudine to anaemic patients

Dispensing ErrorsMay occur at any stage of dispensing process, from the

receipt of the prescription to issuing medicine to the patient.

The errors may include: Selection of the wrong strength or product. For example

Amiloride 5mg instead of Amlodipine 5 mg tablets. Dispensing wrong doseDispensing medicines to wrong patient.

Administration Errors:May occur when there is difference

between the medicine or dose received by the patient and what was prescribed.

Examples Medicine given to the wrong patient

Administration Errors cont… Wrong medicine or IV fluid administered Wrong dose or strength given-Overdosing

or underdosing Wrong dosage form given Medicine given for wrong duration

Administration Errors cont… Wrong preparation of a dose (e.g.

Incorrect dilution) Incorrect administration technique (e.g.,

unsterile injection)

Administration Errors: Medicine given to a patient with known

allergy Wrong route of administration use Wrong time or frequency of

administration Wrong administration duration

Medication Error at Patient Level This may occur when a patient fails to

follow treatment instructions. Lack of adherenceOverdose

What are causes of Med errors?

What are causes of Med errors?Too many telephone calls ? Overload/ unusually busy day ? Too many customers ? Lack of concentration ? No one available to double check ? Staff shortage ? Similar drug names ? No time to counsel ? Illegible prescription ? Misinterpreted prescription

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Possible Causes classified….Human Factors

Errors in interpreting prescriptions(abbreviations etc), Illegible handwriting, lack of experience, lack of training, poor handwriting, verbal orders, heavy staff workload and fatigue ,(errors in calculations?)

Workplace factors

Poor lighting, Interruptions, Excessive workload 

Pharmaceutical factors

, confusion of medicine names, packaging, or labeling,, complexity of calculations needed to prescribe, dispense, or administer a medicine,  

Problem: Look alikes medicines from same company (falls under which factor?)

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Easy to read…

Difficult to read..

Fluid not understood ….

What is that insulin type ?

Required to apply indomethacin?

Piroxicam frequency?

……………………?

Meloxicam ,…..?

Extremely…..

………………?

Same drug family

Medication Errors - ImplicationsWhat are the consequences of medication

errors?

Medication Errors - Implications 1.Therapeutic failure

– Increased Morbidity–Prolonged hospital stay–Mortality

Medication Errors - Implications 2.Economic consequences

–Wasted resources–Increased cost of care , prolonged

hospital stay –Loss of man hours/ absenteeism

3.Adverse Drug Reactions

Enhance communication(landlines, mobiles

Supervise , develop SOP,

guidelines(seniors to supervise Juniors

Adhere to quality

improment programsOther

ways………?

Let us Report ADR,s

Take Home Messages

Medication errors are one of the most preventable causes of patient injury although the incidence of such errors varies widely.

The majority of medication errors occur as a result of poor prescribing, emphasizing the need to improve prescribing skills.

A non-punitive approach should be adopted to improve the rate of reporting of medication errors, allowing further investigation of these important causes of preventable patient harm 

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