PRESCRIPTION
&
OTC MEDICATION
PRESENTED BY:
Sharique Raza
M.PHARM (PHARMACY PRACTICE) 1st SEM
JAMIA HAMDARD
Definition
• A prescription is an instruction from a
prescriber to a dispenser. The prescriber is not
always a doctor but can also be a paramedical
worker, such as a medical assistant, a midwife
or a nurse. The dispenser is not always a
pharmacist, but can be a pharmacy technician,
an assistant or a nurse
LEGAL REQUIREMENT
• Information on a prescription
There is no global standard for prescriptions and
every country has its own regulations. The most
important requirement is that the prescription be
clear. It should be legible and indicate precisely
what should be given. The local language is
preferred. If you include the following
information, not much can go wrong.
• Name and address of the prescriber, with
telephone number (if possible)
This is usually pre-printed on the form. If the
pharmacist has any questions about the
prescription (s)he can easily contact the
prescriber.
• Date of the prescription
In many countries the validity of a prescription
has no time limit, but in some countries
pharmacists do not give out drugs on
prescriptions older than three to six months.
• The strength of the drug indicates how many
milligrams each tablet, suppository, or
milliliter of fluid should contain.
• Internationally accepted abbreviations should
be used: g for gram, ml for milliliter. Try to
avoid decimals and, where necessary, write
words in full to avoid misunderstanding.
• For example, write levothyroxin 50
micrograms, not 0.050 milligrams or 50 ug.
• Badly handwritten prescriptions can lead to
mistakes.
• Instructions for use must be clear and the
maximum daily dose mentioned. Use indelible
ink.
• Dosage form and total amount
Only use standard abbreviations that will be
known to the pharmacist.
• Prescriber's initials or signature
• Name and address of the patient; age (for
children and elderly)
SUMMARY
A prescription should
include:
* Name, address,
telephone of prescriber
* Date
* Generic name of the
drug, strength
* Dosage form, total
amount
* Label: instructions,
warnings
* Name, address, age of
patient
* Signature or initials of
prescriber
PRESCRIBING ERRORS
– Medication prescribed for a wrong patient with a similar room
number
– Wrong chart selected during prescribing
– Patient given the wrong prescription
– Patient prescribed the dose for another patient on the same
medication
– Patient prescribed medication based on data of another patient
– Medication prescribed for a wrong patient with a similar name
– Wrong chart selected in the computerized prescriber order
entry system from multiple open charts
Approaches for reduction
• Improve Patient Verification for all Patient Encounters
• Electronic prescribing may help to reduce the risk of
prescribing errors resulting from illegible handwriting.
• Computerized physician order entry systems eliminate
the need for transcription of orders by nursing staff.
RESPONDING TO SYMPTOMS
HEADACHE
SYMPTOMS:
Symptoms are usually vague and specific and may be
associated with symptoms of other conditions including
tension depression, anxiety
Drug therapy:
Salicylates : aspirin,choline salicylate,magnesium salicylate
NSAIDS: ibuprofen,ketoprofen
Caffeine
Pyrexia
Symptoms:
• Sweating.
• Chills and shivering.
• Headache.
• Muscle aches.
• Loss of appetite.
• Irritability.
• Dehydration.
• General weakness
Drug therapy:
Paracetamol: mild to moderate pain and fever
NSAIDs:ibuprofen,ketoprofen, naproxen
Salicylates:aspirin,choline salicylate magnesium
salicylate
menstrual pain
Symptom:
• Lower back pain.
• Leg pain, radiating down the legs.
• Nausea.
• Vomiting.
• Diarrhea.
• Headaches.
• Irritability.
• Weakness.
Drug used:
Ibuprofen
Naproxen
acetaminophen
Food allergy
Symptom:
• Pain areas: in the abdomen
• Gastrointestinal: diarrhoea,
indigestion, nausea, passing
excessive amounts of gas,
vomiting, or flatulence
• Skin: hives or rashes
• Also common: baby colic,
cramping, flushing, itching,
or tingling lips
• Drug allergy:
• Symptom:
• hives or skin rash, itching,
• wheezing,
• light headedness or
dizziness,
• vomiting and even
anaphylaxis.
• Otc drugs:
• Cetirizine (Zyrtec),
fexofenadine (Allegra),
levocetirizine (Xyzal),
and loratadine (Claritin,
Alavert)
• Otc drugs:
• Cetirizine (Zyrtec,
Zyrtec-D)
• Clemastine (Tavist)
• Fexofenadine (Allegra,
Allegra D)
• Loratadine (Claritin,
Claritin D, Alavert)
OTC DRUGS
• Over-the-counter medicine is also known as
OTC or nonprescription medicine.
• They are safe and effective when you follow
the directions on the label and as directed by
your health care professional.
• These have little signigicant pharmacological
activity and therefore the physician need not
to be very much concerned about their use by
the patients themseves.
Significance
• Comparatively cheaper.
• Chemist himself may prescribe OTC.
• consumers are able to:
• Self diagnose
• Self treat
• Self manage
• OTC considered as time saving medications. Some
patients do not want to spend much time at physicians
clinic.
• Lesser number of side effect compared to prescription
medications.
Rules for the proper use of otc drugs
• Always know what you are taking.
• Know the effects.
• Read and heed the warnings and cautions.
• Don’t use anything for more than 1 to 2 wks.
• Be particularly cautious if also taking
prescription drugs.
• If you have questions, ask a pharmacist.
• If you don’t need it, don’t use it!
OTC DRUGS CAN BE HARMFUL IN THE
FOLLOWING WAYS
• OTC drugs can change the effect of
prescription medications.
• OTC drugs can mask symptoms of disease.
OTC drugs can lead to overdose.
• If misused even common over-the-counter
drugs, such as aspirin, vitamins, or cold
remedies can be harmful.
OTC medication counseling
• Counseling patients about self-care and
nonprescription drugs is not the same and cannot
follow the same procedure as for prescription drugs.
• That is why OTC counseling requires much more
exploratory open or close- ended questions on the part
of the pharmacist which are especially useful to clarify
information gathered about the patient’s condition.
• It allows gathering the most abundant amount of
information. These questions usually start with who,
what, how, why or where.
CONTD….
• For example:
• “Which of the prescription medications do you take on
regular basis?”
• “Which of the nonprescription and herbal medications
do you use?”
• “What types of conditions do you routinely see your
doctor for?”
• Some other questions are also possible:
• “Have you ever experienced any side effects after
taking the OTC medication?”
• “Have you taken this OTC medication before?”
PATIENT INFORMATION LEAFLET
• A patient information leaflet contains everything you
need to know about your medicine. For example:
• what the medicine is intended for
• how you should use the medicine
• when you should not use the medicine
• when caution is advised
• which adverse events are possible
• which ingredients the medicine contains
MEDICAL ADHERENCE
DEFINITION
• The extent to which patients take medications
as prescribed by health care providers.
Factors
1. SOCIAL AND ECONOMIC DIMENSION
• Limited English language proficiency
• Low health literacy
• Lack of family or social support network
• Unstable living conditions; homelessness
• Burdensome schedule
• Limited access to health care facilities
• Lack of health care insurance
• Inability or difficulty accessing pharmacy
• Medication cost
• Cultural and lay beliefs about illness and treatment
• Elder abuse
HEALTH CARE SYSTEM DIMENSION
• Provider-patient relationship
• Provider communication skills (contributing to lack of patient knowledge
or understanding of the treatment regimen)
• Disparity between the health beliefs of the health care provider and those
of the patient
• Lack of positive reinforcement from the health care provider
• Weak capacity of the system to educate patients and provide follow-up
• Lack of knowledge on adherence and of effective interventions for
improving it
• Patient information materials written at too high literacy level
• Restricted formularies; changing medications covered on formularies
• High drug costs, copayments, or both
• Poor access or missed appointments
• Long wait times
• Lack of continuity of care
CONDITION RELATED DIMENSION
• Chronic conditions
• Lack of symptoms
• Severity of symptoms
• Depression
• Psychotic disorders
• Mental retardation/developmental disability
THERAPY RELATED DIMENSION
• Complexity of medication regimen (number of daily
doses; number of concurrent medications)
• Treatment requires mastery of certain techniques
(injections, inhalers)
• Duration of therapy
• Frequent changes in medication regimen
• Lack of immediate benefit of therapy
• Medications with social stigma attached to use
• Actual or perceived unpleasant side effects
• Treatment interferes with lifestyle or requires
significant behavioral changes
PATIENT RELATED DIMENSION
• Physical Factors
• Visual impairment
• Hearing impairment
• Cognitive impairment
• Impaired mobility or dexterity
• Swallowing problems
Psychological/Behavioral Factors
• Knowledge about disease
• Perceived risk/susceptibility to disease
• Understanding reason medication is needed
• Expectations or attitudes toward treatment
• Perceived benefit of treatment
• Confidence in ability to follow treatment regimen
• Motivation
• Fear of possible adverse effects
• Fear of dependence
• Feeling stigmatized by the disease
• Frustration with health care providers
• Psychosocial stress, anxiety, anger
• Alcohol or substance abuse
stragey
• Medication synchronization. This process coordinates
all of a patient’s chronic medications to be filled at the
same time each month. It moderates barriers to
adherence (e.g., forgetfulness, complex drug regimens,
difficulty taking medications, patient’s understanding
of either the medication or disease state), helps
eliminate therapy interruptions, identifies non-
adherence in the home or changes in therapy, reduces
first-fill abandonment and improves patient-
pharmacist interactions. At my two pharmacy
locations, we proactively process about 55 percent of
our total prescription volume through medication
synchronization.
• Medication therapy management (MTM). Two types of MTM —
comprehensive medication review (CMR) and targeted
interventions — identify patients with less-than-optimal adherence
and address it through pharmacist-patient interactions.
• CMR involves real-time discussion of the patient’s medications
(including prescriptions, over-the-counter medications, herbal
therapies and dietary supplements). At the conclusion of the CMR,
the pharmacist provides a summary to the patient in a standardized
Medication Action Plan format.
• Targeted interventions focus on resolving and/or preventing the
occurrence of one or more medication-related problems. MTM not
only flags patients with poor adherence, but also establishes a
purpose for counseling and pharmacy-provided services such as
additional medications or immunizations.
• Patient adherence counseling. We know that patients don’t
want to be non-adherent. At the same time, they often
look to the pharmacy to help them find a solution. While
counseling is not an inherent skill — admittedly it
definitely improves with practice and experience.
• Fostering a positive and productive conversation helps the
patient realize why he or she needs to take their
medication and become more adherent in that therapy.
Start by asking open-ended questions along these lines:
How do you take your medication? If you miss a dose, what
is the most common reason why? How many doses do you
miss per week? Would you like me to offer some
recommendations?
Contd….
• Pharmacy-provided solutions. A community pharmacy
should be able to offer an array of services such as
medication synchronization, late refill calls, patient
medication administration records, compliance packaging,
prescription delivery, health or medication literature, and
mobile apps/alarms — all with a role in improving
adherence. However, bear in mind that not every solution
will be right for every patient. The pharmacy should stand
ready to help find the appropriate resolution or
combination of offerings. Concentrate on services that are
successful, sustainable and expandable, and be certain that
staff members know how to offer and execute each
solution.
Patient referals to the doctors
• Quality healthcare outcomes depend upon patients' adherence to
recommended treatment regimens.
• Patient nonadherence can be athreat to health and wellbeing and carry an
appreciable economic burden as well. These include realistic assessment
of patients' knowledge and understanding of the regimen, clear and
effective communication between health professionals and their patients,
and the nurturance of trust in the therapeutic relationship.
• Patients must be given the opportunity to tell the story of their unique
illness experiences. Knowing the patient as a person allows the health
professional to understand elements that are crucial to the patient's
adherence: beliefs, attitudes, subjective norms, cultural context, social
supports, and emotional health challenges, particularly depression.
• Physician–patient partnerships are essential when choosing amongst
various therapeutic options to maximize adherence.
• Mutual collaboration fosters greater patient satisfaction, reduces the risks
of nonadherence, and improves patients' healthcare outcomes.
ADR MONITORING
• Adverse drug reactions (ADRs) have been reported to be among
leading causes of morbidity and mortality The spontaneous
reporting of ADRs is considered as the foundation of post marketing
surveillance of drug safety. The main function of spontaneous
reporting is the early detection of signals of new, rare and serious
ADRs.
• It is also one of the cheapest methods of monitoring the safety of
medicines as utilized by many drug regulatory agencies worldwide.
• Therefore, pharmacovigilance programme plays a vital role in
ensuring the drugs’ safety. In many countries (including India) a
pharmacovigilance system is operational; however, under-reporting
is a major problem
• .
• An increase has been observed in the current reporting
culture of ADRs under Pharmacovigilance Programme of
India (PvPI) after conducting regular training and awareness
programme and circulating the ‘PvPI Drug Safety
Newsletter.
• Healthcare professionals (HCPs) reports ADRs to nearest
ADR Monitoring Centres (AMCs) under PvPI and the same is
collected and collated by the Indian Pharmacopoeia
Commission (IPC), National Coordination Centre (NCC).
• The objective of this study was to ascertain the
contribution of different stakeholders in reporting of ADRs,
reporting status of government medical institutions (GMI),
non government medical institutions (NGMI) and corporate
hospitals (CH) under the fold of PvPI.
THANK YOU

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Prescription

  • 1. PRESCRIPTION & OTC MEDICATION PRESENTED BY: Sharique Raza M.PHARM (PHARMACY PRACTICE) 1st SEM JAMIA HAMDARD
  • 2. Definition • A prescription is an instruction from a prescriber to a dispenser. The prescriber is not always a doctor but can also be a paramedical worker, such as a medical assistant, a midwife or a nurse. The dispenser is not always a pharmacist, but can be a pharmacy technician, an assistant or a nurse
  • 3. LEGAL REQUIREMENT • Information on a prescription There is no global standard for prescriptions and every country has its own regulations. The most important requirement is that the prescription be clear. It should be legible and indicate precisely what should be given. The local language is preferred. If you include the following information, not much can go wrong.
  • 4. • Name and address of the prescriber, with telephone number (if possible) This is usually pre-printed on the form. If the pharmacist has any questions about the prescription (s)he can easily contact the prescriber. • Date of the prescription In many countries the validity of a prescription has no time limit, but in some countries pharmacists do not give out drugs on prescriptions older than three to six months.
  • 5. • The strength of the drug indicates how many milligrams each tablet, suppository, or milliliter of fluid should contain. • Internationally accepted abbreviations should be used: g for gram, ml for milliliter. Try to avoid decimals and, where necessary, write words in full to avoid misunderstanding.
  • 6. • For example, write levothyroxin 50 micrograms, not 0.050 milligrams or 50 ug. • Badly handwritten prescriptions can lead to mistakes. • Instructions for use must be clear and the maximum daily dose mentioned. Use indelible ink.
  • 7. • Dosage form and total amount Only use standard abbreviations that will be known to the pharmacist. • Prescriber's initials or signature • Name and address of the patient; age (for children and elderly)
  • 8. SUMMARY A prescription should include: * Name, address, telephone of prescriber * Date * Generic name of the drug, strength * Dosage form, total amount * Label: instructions, warnings * Name, address, age of patient * Signature or initials of prescriber
  • 9. PRESCRIBING ERRORS – Medication prescribed for a wrong patient with a similar room number – Wrong chart selected during prescribing – Patient given the wrong prescription – Patient prescribed the dose for another patient on the same medication – Patient prescribed medication based on data of another patient – Medication prescribed for a wrong patient with a similar name – Wrong chart selected in the computerized prescriber order entry system from multiple open charts
  • 10. Approaches for reduction • Improve Patient Verification for all Patient Encounters • Electronic prescribing may help to reduce the risk of prescribing errors resulting from illegible handwriting. • Computerized physician order entry systems eliminate the need for transcription of orders by nursing staff.
  • 11. RESPONDING TO SYMPTOMS HEADACHE SYMPTOMS: Symptoms are usually vague and specific and may be associated with symptoms of other conditions including tension depression, anxiety Drug therapy: Salicylates : aspirin,choline salicylate,magnesium salicylate NSAIDS: ibuprofen,ketoprofen Caffeine
  • 12. Pyrexia Symptoms: • Sweating. • Chills and shivering. • Headache. • Muscle aches. • Loss of appetite. • Irritability. • Dehydration. • General weakness
  • 13. Drug therapy: Paracetamol: mild to moderate pain and fever NSAIDs:ibuprofen,ketoprofen, naproxen Salicylates:aspirin,choline salicylate magnesium salicylate
  • 14. menstrual pain Symptom: • Lower back pain. • Leg pain, radiating down the legs. • Nausea. • Vomiting. • Diarrhea. • Headaches. • Irritability. • Weakness.
  • 16. Food allergy Symptom: • Pain areas: in the abdomen • Gastrointestinal: diarrhoea, indigestion, nausea, passing excessive amounts of gas, vomiting, or flatulence • Skin: hives or rashes • Also common: baby colic, cramping, flushing, itching, or tingling lips • Drug allergy: • Symptom: • hives or skin rash, itching, • wheezing, • light headedness or dizziness, • vomiting and even anaphylaxis.
  • 17. • Otc drugs: • Cetirizine (Zyrtec), fexofenadine (Allegra), levocetirizine (Xyzal), and loratadine (Claritin, Alavert) • Otc drugs: • Cetirizine (Zyrtec, Zyrtec-D) • Clemastine (Tavist) • Fexofenadine (Allegra, Allegra D) • Loratadine (Claritin, Claritin D, Alavert)
  • 18. OTC DRUGS • Over-the-counter medicine is also known as OTC or nonprescription medicine. • They are safe and effective when you follow the directions on the label and as directed by your health care professional. • These have little signigicant pharmacological activity and therefore the physician need not to be very much concerned about their use by the patients themseves.
  • 19. Significance • Comparatively cheaper. • Chemist himself may prescribe OTC. • consumers are able to: • Self diagnose • Self treat • Self manage • OTC considered as time saving medications. Some patients do not want to spend much time at physicians clinic. • Lesser number of side effect compared to prescription medications.
  • 20. Rules for the proper use of otc drugs • Always know what you are taking. • Know the effects. • Read and heed the warnings and cautions. • Don’t use anything for more than 1 to 2 wks. • Be particularly cautious if also taking prescription drugs. • If you have questions, ask a pharmacist. • If you don’t need it, don’t use it!
  • 21. OTC DRUGS CAN BE HARMFUL IN THE FOLLOWING WAYS • OTC drugs can change the effect of prescription medications. • OTC drugs can mask symptoms of disease. OTC drugs can lead to overdose. • If misused even common over-the-counter drugs, such as aspirin, vitamins, or cold remedies can be harmful.
  • 22. OTC medication counseling • Counseling patients about self-care and nonprescription drugs is not the same and cannot follow the same procedure as for prescription drugs. • That is why OTC counseling requires much more exploratory open or close- ended questions on the part of the pharmacist which are especially useful to clarify information gathered about the patient’s condition. • It allows gathering the most abundant amount of information. These questions usually start with who, what, how, why or where.
  • 23. CONTD…. • For example: • “Which of the prescription medications do you take on regular basis?” • “Which of the nonprescription and herbal medications do you use?” • “What types of conditions do you routinely see your doctor for?” • Some other questions are also possible: • “Have you ever experienced any side effects after taking the OTC medication?” • “Have you taken this OTC medication before?”
  • 24. PATIENT INFORMATION LEAFLET • A patient information leaflet contains everything you need to know about your medicine. For example: • what the medicine is intended for • how you should use the medicine • when you should not use the medicine • when caution is advised • which adverse events are possible • which ingredients the medicine contains
  • 26. DEFINITION • The extent to which patients take medications as prescribed by health care providers.
  • 27. Factors 1. SOCIAL AND ECONOMIC DIMENSION • Limited English language proficiency • Low health literacy • Lack of family or social support network • Unstable living conditions; homelessness • Burdensome schedule • Limited access to health care facilities • Lack of health care insurance • Inability or difficulty accessing pharmacy • Medication cost • Cultural and lay beliefs about illness and treatment • Elder abuse
  • 28. HEALTH CARE SYSTEM DIMENSION • Provider-patient relationship • Provider communication skills (contributing to lack of patient knowledge or understanding of the treatment regimen) • Disparity between the health beliefs of the health care provider and those of the patient • Lack of positive reinforcement from the health care provider • Weak capacity of the system to educate patients and provide follow-up • Lack of knowledge on adherence and of effective interventions for improving it • Patient information materials written at too high literacy level • Restricted formularies; changing medications covered on formularies • High drug costs, copayments, or both • Poor access or missed appointments • Long wait times • Lack of continuity of care
  • 29. CONDITION RELATED DIMENSION • Chronic conditions • Lack of symptoms • Severity of symptoms • Depression • Psychotic disorders • Mental retardation/developmental disability
  • 30. THERAPY RELATED DIMENSION • Complexity of medication regimen (number of daily doses; number of concurrent medications) • Treatment requires mastery of certain techniques (injections, inhalers) • Duration of therapy • Frequent changes in medication regimen • Lack of immediate benefit of therapy • Medications with social stigma attached to use • Actual or perceived unpleasant side effects • Treatment interferes with lifestyle or requires significant behavioral changes
  • 31. PATIENT RELATED DIMENSION • Physical Factors • Visual impairment • Hearing impairment • Cognitive impairment • Impaired mobility or dexterity • Swallowing problems
  • 32. Psychological/Behavioral Factors • Knowledge about disease • Perceived risk/susceptibility to disease • Understanding reason medication is needed • Expectations or attitudes toward treatment • Perceived benefit of treatment • Confidence in ability to follow treatment regimen • Motivation • Fear of possible adverse effects • Fear of dependence • Feeling stigmatized by the disease • Frustration with health care providers • Psychosocial stress, anxiety, anger • Alcohol or substance abuse
  • 33. stragey • Medication synchronization. This process coordinates all of a patient’s chronic medications to be filled at the same time each month. It moderates barriers to adherence (e.g., forgetfulness, complex drug regimens, difficulty taking medications, patient’s understanding of either the medication or disease state), helps eliminate therapy interruptions, identifies non- adherence in the home or changes in therapy, reduces first-fill abandonment and improves patient- pharmacist interactions. At my two pharmacy locations, we proactively process about 55 percent of our total prescription volume through medication synchronization.
  • 34. • Medication therapy management (MTM). Two types of MTM — comprehensive medication review (CMR) and targeted interventions — identify patients with less-than-optimal adherence and address it through pharmacist-patient interactions. • CMR involves real-time discussion of the patient’s medications (including prescriptions, over-the-counter medications, herbal therapies and dietary supplements). At the conclusion of the CMR, the pharmacist provides a summary to the patient in a standardized Medication Action Plan format. • Targeted interventions focus on resolving and/or preventing the occurrence of one or more medication-related problems. MTM not only flags patients with poor adherence, but also establishes a purpose for counseling and pharmacy-provided services such as additional medications or immunizations.
  • 35. • Patient adherence counseling. We know that patients don’t want to be non-adherent. At the same time, they often look to the pharmacy to help them find a solution. While counseling is not an inherent skill — admittedly it definitely improves with practice and experience. • Fostering a positive and productive conversation helps the patient realize why he or she needs to take their medication and become more adherent in that therapy. Start by asking open-ended questions along these lines: How do you take your medication? If you miss a dose, what is the most common reason why? How many doses do you miss per week? Would you like me to offer some recommendations?
  • 36. Contd…. • Pharmacy-provided solutions. A community pharmacy should be able to offer an array of services such as medication synchronization, late refill calls, patient medication administration records, compliance packaging, prescription delivery, health or medication literature, and mobile apps/alarms — all with a role in improving adherence. However, bear in mind that not every solution will be right for every patient. The pharmacy should stand ready to help find the appropriate resolution or combination of offerings. Concentrate on services that are successful, sustainable and expandable, and be certain that staff members know how to offer and execute each solution.
  • 37. Patient referals to the doctors • Quality healthcare outcomes depend upon patients' adherence to recommended treatment regimens. • Patient nonadherence can be athreat to health and wellbeing and carry an appreciable economic burden as well. These include realistic assessment of patients' knowledge and understanding of the regimen, clear and effective communication between health professionals and their patients, and the nurturance of trust in the therapeutic relationship. • Patients must be given the opportunity to tell the story of their unique illness experiences. Knowing the patient as a person allows the health professional to understand elements that are crucial to the patient's adherence: beliefs, attitudes, subjective norms, cultural context, social supports, and emotional health challenges, particularly depression. • Physician–patient partnerships are essential when choosing amongst various therapeutic options to maximize adherence. • Mutual collaboration fosters greater patient satisfaction, reduces the risks of nonadherence, and improves patients' healthcare outcomes.
  • 38. ADR MONITORING • Adverse drug reactions (ADRs) have been reported to be among leading causes of morbidity and mortality The spontaneous reporting of ADRs is considered as the foundation of post marketing surveillance of drug safety. The main function of spontaneous reporting is the early detection of signals of new, rare and serious ADRs. • It is also one of the cheapest methods of monitoring the safety of medicines as utilized by many drug regulatory agencies worldwide. • Therefore, pharmacovigilance programme plays a vital role in ensuring the drugs’ safety. In many countries (including India) a pharmacovigilance system is operational; however, under-reporting is a major problem • .
  • 39. • An increase has been observed in the current reporting culture of ADRs under Pharmacovigilance Programme of India (PvPI) after conducting regular training and awareness programme and circulating the ‘PvPI Drug Safety Newsletter. • Healthcare professionals (HCPs) reports ADRs to nearest ADR Monitoring Centres (AMCs) under PvPI and the same is collected and collated by the Indian Pharmacopoeia Commission (IPC), National Coordination Centre (NCC). • The objective of this study was to ascertain the contribution of different stakeholders in reporting of ADRs, reporting status of government medical institutions (GMI), non government medical institutions (NGMI) and corporate hospitals (CH) under the fold of PvPI.