Prescription writing

Dr. Zainab Ghazala. MBBS, MD

Associate professor
Dept. Of Pharmacology
KBN University- Faculty Of Medical Sciences
• A prescription (℞) is defined as a healthcare program implemented by a
physician in the form of instructions that govern the plan of care for an individual
patient.
• It is a written order for the medication to be used for diagnosis, prevention and
treatment of specific patient, directed by physician.

• ℞  Latin verb recipe  “take”

• A prescription is an instruction of a physician to a pharmacist on what medication
must be dispensed to the patient.
• The term ‘prescription’ has broadened to also include clinical assessments,
laboratory tests, and imaging studies relevant to optimizing the safety or
efficacy of treatment
 Objectives of learning prescription writing
• To learn basic concepts of prescription writing, including terms and
abbreviations.
• To encourage `rational` use of drugs.
• To enhance understanding of use of medications in accordance with scientific
knowledge.
• To know how to prescribe ‘prescription drugs’ and ‘controlled drugs’
• To ensures that patient gets `right medicine` in `right doses`.
• To get familiar with organization of Physician’s Desk Reference (PDR) to help in
selecting medication
 Who can write prescriptions?
• Only a Registered Medical Practitioner who has registered with the respective
State Council is authorized to prescribe allopathic drugs that include an
allopathic doctor, a dentist, and a veterinarian.

• Who CANNOT prescribe: A nurse, pharmacist, unqualified persons or persons

with dubious and unauthorized degrees, not recognized by the government,
quacks
FORMAT OF PRESCRIPTION WRITING1
• The document on which prescriptions are written
• Prescription Order or Prescription Pad or Prescription Blank.
• Prescription order is a LEGAL DOCUMENT.
• It should be clear, concise, accurate and legible.
• It should include complete information
• It should preferably be written with an indelible ink pen
• Prescriptions are made for prescription drugs
• There are 3 categories of drugs
• Over-the-Counter (OTC) Drugs: can be dispensed
to patient without a prescription.
• Prescription medications or Legend Drugs: cannot
be dispensed without a prescription from a
physician. “Schedule H” drugs
• Controlled Drugs: strict guidelines for prescription
 Elements of prescription
• Superscription
• Inscription
• Subscription
• Transcription or Label or Signatura
• Signature
• Superscription
• Patient’s name, address, age, date of birth, date of admission, weight and
date of prescription writing
• Prescription Symbol ( R/ and not ℞).

• The patient’s medication allergies should be specified in space labeled as allergy

box.

• Inscription  body of prescription  right side of superscription.

• Drug name and dose form (e.g. Tablet. paracetamol, lotion. Lactocalamine)
• Note: use of generic drug names is to be preferred over brand names
• Subscription  Prescriber`s direction to pharmacist
• Written in a line below the inscription
• Dose form and total amount to be dispensed, e.g. Total 28 tablets to be given.
• ‘Repeat dispensing or Refill instruction’,
• ‘PRN’ meaning ‘as required’ not a valid refill designation

• Prescriptions will also contain instructions on whether prescriber will allow

pharmacist to substitute a generic version of drug as “dispense as written” or
“substitution permitted”.
Transcription or label or signatura  Prescriber`s direction for patient.
Signatura  Latin ‘signa,’ meaning ‘write,’ ‘make,’ or ‘label.
It should preferably be written in a language understandable to patient
The use of abbreviations or symbols is discouraged.

It is to be written as follows: • Frequencies of administration or dosing intervals

• Route or method of administration–chew,
apply.
• Number of dose forms–1 or 2 tablets, (no
trailing zeroes as 5mg NOT 5.0mg).
• Quantities less than 1g should be written in
milligrams (500mg NOT 0.5g)
• The term ‘milliliter’ is abbreviated to ml NOT
cc or cm3
• The words micrograms, nanograms and
units must not be abbreviated.
should be mentioned clearly,
• instead of `every 6 hours or 3 times daily`, the
exact time schedule should be given as 8am,
12pm, 6pm.
• Avoid abbreviations like TDS or 1-1-1
• Length or duration of therapy
• Purpose: for pain, fever, infection or to relieve
itching.
• Special instructions–e.g. shake well, refrigerate
• Signature:
• Handwritten signature, professional degree,
• registration number, seal/stamp, address of prescriber
 NMC draft guidelines
Prescribing Generic Medicine:
• Every RMP is expected to prescribe drugs using generic names
• Should be written legibly and prescribe drugs rationally
• Avoid unnecessary medications and irrational fixed-dose combination tablets.
(L1, L2) (Generic Drugs and Prescription guidelines)
 Example of a
good prescription
 Levels of Disciplinary Action as per Breach
of Conduct
• Level 1: Reformation-This may be awarded singly or in conjunction
with other levels, in the form of advisory, instruction or warning
• Level 2: Even when role of the doctor in causing direct harm was
not conclusively proved  suspension of the license to practice for
up to one month (30 days)
 Common mistakes in prescription writing
• No format or no plan.
• No clarity in writing or Spelling mistakes
• Illegible or Bad handwriting  misread and misinterpreted.
• Instructions not in patients language.
• Insufficient information or ambiguous directions to patient or a pharmacist.
• Look-alike or Sound-alike drugs mix-up– these may get easily substituted for
each other because of their similar names
• e.g. Zyrtec and Zantac, Fosomax and Flomax.
• Inappropriate drug or wrongly prescribed drug or drug name written incompletely.
• Incorrect Dosage–too much or too little dose or doses
• Use of informal ways for dosage or use of abbreviations–hs, qid, bid, sos.
• too many drugs in a prescription
• prescribing a contraindicated drug to a person.
• Missing  Purpose or diagnosis for which prescription is written
• May not be economic, no consideration is given to the cost.
• Drug interactions– new drugs not checked with drugs already being taken
• Lack in patient`s detail, poor history taking or prescribed without examining patient.
• Eccentrically written.
• Unsigned or not prescribed on prescription order.
• Mistakes in the prescriptions received through phone calls.
• prescribed as per physicians convenience or simply because patient demand
them.
• Prescriptions made in the interest of pharmacist or drug companies or employers’
commercial or financial benefit
 Tips to reduce errors
• Electronic entry devices and pre-printed prescriptions.
• Provide concise dosage information.
• Use of metric measures in place of apothecary and
older measurement units
• Directions should be written preferably in language
understood by patients
• Avoid units such as “teaspoons” or “table spoons.”
• Always specify times (7am, 3pm, 11pm) rather than
simply frequency (three times a day)
• Do NOT write  ‘Continue…..’ or ‘Take as directed’
• D/C’ for discontinue, ‘TCA’ for ‘to come again’,
• ‘CST’ for continue same treatment
• Discontinue 1, 2, 5, rest to continue
• Errors due to mix-ups between numbers and alphabets: ‘l’ & ‘1’; ‘O’ & ‘0,’; ‘Z’ &
‘2,’; ‘1’ & ‘7.’
• Q1d can easily be mistaken for QID leading to four times the dose.
• For refills  minimum duration between repeats and number of repeats should
be specified.
• Provide indication for all prescriptions (Ex: for fever, for allergy, for acidity.. etc)
• Numbers should be written in numerals as well as in words (Ex: 5 (five)
milligram)
• Do not abbreviate ‘units’ as U  (‘U’) can be misread as 0
• Abbreviations for medicine name should not be used
• PCM (paracetamol), CPM (chlorpheniramine), CPZ (chlorpromazine),
carbamazepine (CBZ), chlorpromazine (CPZ), Trihexyphenidyl (TFT) and TFP
(Trifluoperazine)
• Use of ‘0’ zero: Leading zeroes should be preferred (e.g. 0.25 mg). Trailing zeros
should not be used e.g. 5.0 mg)
• Instructions: Any special instruction like methods of administration (before/after
food), unpleasant taste or drug interactions/side effects must be written on the
prescription.
• Never pre-sign a blank prescription.
• Do not make any changes or cross-outs, avoid overwriting.
• Chronology of prescription
• Core Medicine  Supplementary Medicine  Symptomatic medicine
Or
• Injections Oral medicines (Tablets, Capsules, Syrups) Topical
medicines (Ointments, Drops, Creams)
• Avoid stemmed medicine names
• “Nitro’ drip for nitro-glycerine can be mistaken as sodium nitroprusside
infusion.
• “Norflox” for norfloxacin can be mistaken as Norflex (Orphenadrine)
 Conclusion
• What and how the prescription is written shows the diagnostic acumen and
therapeutic efficiency of the physician.
• Prescription becomes useless unless it communicates clearly with patient and
the pharmacists.
• Drug prescription errors are largely preventable.
• Proficiency at writing a prescription order accurately and speedily requires
practice and dedication
Thank you
 Pharmacovigilance
Dr. Zainab Ghazala. MBBS, MD
Associate professor
Dept. Of Pharmacology
KBN University- Faculty Of Medical Sciences
 THALIDOMIDE DISASTER,1961
• History of Pharmacovigilance
• Australian Obstetrician, William Mcbride 1961 withdrew Thalidomide
• Pharmacovigilance is the science relating to the
detection, assessment, understanding and
prevention of Adverse Drug Reactions (ADRs)-
WHO

• Pharmakon (Greek)- drug

vigilare (Latin)- “to keep awake or alert”

*Excludes therapeutic failures, overdose, drug abuse, noncompliance and

medication errors
Adverse drug reaction (ADR)
‘Any noxious change which is suspected to be due to a drug, occurs at doses
normally used in man, requires treatment or decrease in dose or indicates
caution in the future use of the same drug’
 Why so many ADRs ?

• Large number of prescriptions

• Multiple drug therapy – polypharmacy
• ADRs increase exponentially with 4 or more medicines
• Irrational prescribing
• Lack of proper system to detect/monitor and preventADRs
 • Extremes of age (children and elderly)
• Multiple medications
• Multiple co-morbid conditions
• Inappropriate prescribing practices, use or
monitoring
ADRs : risk factors • End-organ dysfunction
• Altered physiology
• Prior history of ADRs
• Extent (dose) and duration of exposure
• Genetic predisposition
 ADR Reporting sensitization: Goals

• Increase awareness about medicines/ medicine product induced morbidity

• Foster a culture of ADR reporting in professionals
• To know what to report and what not to report?
• Causality not pre-requisite for reporting
• Set up a mechanism for reporting
• Provide feedback to health professionals about safety issues
 ADR Reporting : Misconceptions

• All serious ADRs are known before drug is marketed

• Causality assessment is difficult
• Reporting only when absolutely certain
• A stray report is of no particular significance
• A person reporting ADR will land up in legal/administrative trouble

----NO----
Pharmacovigilance ….why?
In the general interest of all stake holders
 Need of PVi in India
• To protect patients from unnecessary harm and increasing healthcare cost from
medicines
• ADRs are a huge burden !!
• Insufficient evidence of safety of a drug from clinical trials
• For Signal detection and risk minimisation measures
• Early detection of new ADRs on patients subgroups of exceptional sensitivity
(Paediatrics, Geriatrics, Pregnant women)
• Promoting rational use of medicines and medication adherence
• To support regulatory agencies in decision making process for safe use of
medicines
• Boosting public confidence for safe and proper use of medicines
 PV : A Continuous Process…
• Pharmacovigilance
starts with clinical development continues throughout the product life cycle of
the drug

• Pharmacovigilance
• pre-marketing (pre-approval)
• post marketing (post-approval)
• More info is needed about specific groups like children, elderly, pregnant women,
etc.
• Also after chronic use, and in combination with other drugs
• Experience has shown that, ADRs, interactions with drugs and food, and risk
factors surface several years after release of these medicines (WHO, 2004)
 How to prevent ADRs
• Careful medical history:
• allergies, herbs, OTCs, H/O interactions,
• abuse, genetic factors
• Rich knowledge base about drug actions/
interactions
• Identify high risk cases:
• More than 4 drugs (polypharmacy)
• Antibiotics, antiepileptics, digoxin,warfarin
• Prevent irrational prescriptions
• Consult other members of health
care system: clinical pharmacologist,
hospital pharmacist, nursing staff
• Use computer data bases, update
them periodically: source of
information
• Promote ADR reporting culture
• Some ADRs are unavoidable, but mostly are predictable and preventable (70-
80% )
• Allergic reactions, dose-related effects, idiosyncracy, drug interactions,
prescribing errors –all fall in the preventable category
• Determination of ADR preventability should be part of ADR reporting and
reviewing process
 Questionnaire (7 questions)
• Was the drug causing ADR not appropriate ?
• Was the dose, route and frequency of admn. inappropriate for pt’s Age, Weight and
Disease ?
• Was TDM or other lab tests not performed ?
• Was there H/O allergy or other reaction to drug ?
• Was a drug interaction involved ?
• Was a toxic serum level documented ?
• Was poor compliance involved in the reaction ?

An answer of YES to one or more of these questions would suggest that the ADR
could have been prevented
 Barriers to ADR monitoring for HCPs
• HCPs workload
• Unfamiliarity with/ ignorance about ADRs
• Uncoordinated care/ no team work
• Lack of standardized monitoring systems in patient safety
• Communication failures
• Patient non-adherence (accidental, deliberate, informed or
uninformed)
 How to improve ADR reporting?
• The HCPs should be trained about the necessity and procedure of
adverse event reporting through CME, workshops, conferences
• Post training reminders : periodic E-mails and SMS alerts should be
regularly sent to HCPs
• Dedicated curriculum hours in medical (UG and PG level), nursing and
pharmacy courses
• Incentives (financial or non financial) to promote the reporting
• Involvement of patient advocacy/support group
Role of health care professionals in pharmacovigilance
Physician’s Role In Pharmacovigilance
 Conclusions..
• ADRs and PV remains a challenging clinical and scientific discipline
• It continues to expand its domain due to the ever increasing number of medicinal
products
• The benefits of drug therapy should always be greater than the risks
• Risk can be minimized by ensuring good quality, safe, efficacious, and rationally
used medicines
• Knowledge, education and risk management strategies crucial for
preventing/minimizing ADRs
 Conclusion..

• ADRs are an inherent risk of using medications and does not signify
negligence of healthcare providers
• ADRs detected must be reported, analyzed and communicated
• Foster a sense of trust among patients with regard to the medicines they
use and improve communications between HCPs and public
• Provide regulators with necessary information to amend
recommendations on drug use
 Take home message !!!
• We must always remember that
‘‘there are no biologically safe drugs; there are only safe physicians, nurses and
pharmacists’’.
• You need not be certain about ADR to report it
• Have a high degree of suspicion
• Report any suspected ADR
• Be a life saver
 Thank you
To report ADRs in KBN teaching and general hospital
Contact:
Dept of Pharmacology, KBN University-FOMS
Whatsapp No: 7892548362
• Program roadmap..
• •2010 –2015 –now extended
• •05 phases, year wise objectives framed
• •At present > 200 centers
• •Collaboration with WHO-UMC
• •Access to Vigibase software which contains worldwide drug safety data
• •Bottom line : safer medicines for population
• Need for Pharmacovigilance
• Sultana J, Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug
reactions. Journal of Pharmacology and Pharmacotherapeutics. 2013;4(5):73. Patel K,
Kedia M, Bajpai D, Mehta S, Kshirsagar N, Gogtay N. Evaluation of the prevalence and
economic burden of adverse drug reactions presenting to the medical emergency
department of a tertiary referral centre: a prospective study. BMC Clinical
Pharmacology. 2007;7(1):8.
• Type of Reports (Resource)
• •Spontaneous report: healthcare professionals, consumer

• •Health authority (FDA), or drug manufacturer itself.

• •Solicitedreport from patient support programmes like organized data collection systems
which include clinical trials, other patient support and disease management programs,
surveys of patients or healthcare providers.

• •Marketing program, literature source, lay media, web page social sites
• Type of Reports (Resource)
• •Spontaneous report: healthcare professionals, consumer

• •Health authority (FDA), or drug manufacturer itself.

• •Solicitedreport from patient support programmes like organized data collection systems
which include clinical trials, other patient support and disease management programs,
surveys of patients or healthcare providers.

• •Marketing program, literature source, lay media, web page social sites
• Aggregate Reporting (PSUR/PBRER)
• •Key role in safety assessment of Drugs.
• •It involves compilation of safety data of drug over a prolonged period of time.

• Advantage :Provides broader view of safety profile of a drug.

• •PSUR/PBRER (periodic benefit risk evaluation report)
• •Worldwide, the most important aggregate report is the Periodic Safety Update
Report (PSUR).
• Two crucial aspects of Pvig..
• •ADR detection (signal)

• •Causality assessment
• Stepwise discovery of an ADR
• -Signal generation (detection)
• -Signal strengthening
• -Signal follow-up
• Causality assessment
• Hutchison defined causality assessment as a “method for eliciting a state of
information about a particular drug-event connection as input and delivering as
output a degree of belief about the truth of the proposition that the drug caused
the event to occur”.
 Causality Assessment
• Prior reports of reaction
• Temporal relationship
• De-challenge
• Re-challenge
• Dose-response relationship
• Alternative etiologies
• Objective confirmation
• Past history of reaction to same or similar medication
 Causality Assessment scales

• Naranjo’s scale

• WHO causality assessment scale

 WHO -causality assessment scale
• Certain

• Probable

• Possible

• Unlikely

• Conditional / Unclassified

• Unassessible / Unclassifiable
• WHO Initiative
• •Initially 10 countries : pilot project
• •Network has since expanded, and currently 153member countries are having
national PVig programmes
• •They coordinate with the WHO and the collaborating Uppsala Monitoring Centre
(UMC) in Sweden, the International Drug Monitoring Centre, came up in 1978
• •Global ADR database maintained (Vigibase)
• •Currently, database contains >7 million reports
• PV in India : the evolution…
• •1986 : ADR monitoring system -12 centers (ICMR)
• •1997 : WHO programme based in Uppsala, Sweden coordinated PV in India (AIIMS, Delhi,
KEM, Mumbai, JLN (Aligarh)

• (unsuccessful attempts)
• •2005 : WHO-World Bank sponsored National PV programme of India–had Zonal centers –2,
Regional centers -5, Peripheral centers –28
• •2010 -2015 and extended –CDSCO sponsored Pharmacovigilance programme of India
(IPC co-ordinated)
• Pharmacovigilance Programme of India (PvPI) for
• Assuring Drug Safety
• 2010-2015 now extended
• Central Drugs Standard Control Organization (CDSCO),
• Directorate General of Health Services,
• Ministry of Health & Family Welfare, Govt. of India
• in collaboration with
• Indian Pharmacopoeia Commission (IPC), Ghaziabad,
U.P.(www.cdsco.nic.in/pharmacovigilance_intro.htm)
 Summary
• ADRs are common entity in Indian health care system
• It is an inherent risk of using medications and does not signify negligence of healthcare
providers
• HCPs are important stakeholders for reporting and prevention of ADRs
• Safety improvement activities include identification, reporting and analysis of the errors
by dedicated team lead by a clinical pharmacologist
• Nursing and Pharmacists curriculum should include pharmacovigilance to strengthen
Pharmacovigilance program of India
• Patient information, empowerment and engagement on pharmacovigilance will
strengthen PVPI further.
 Pharmacovigilance: Where ?

• New chemical moities

• Biotech derived products and vaccines
• Change in established products
• New dosage form
• New route of administration
• New manufacturing process
• Introduction to new repopulation
• New indication
• New major safety concern