PHARMACOVIGILANCE AND ADVERSE DRUG REACTIONS (ADR)

PHARMACOVIGILANCE AND ADVERSE DRUG REACTIONS (ADR)

• Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• In Ayurveda, though natural, drugs may still produce undesirable effects if improperly prepared, used in wrong dose, or without considering Desha, Kala, Prakriti etc.

• Both classical Ayurvedic texts and modern Rasashastra recognize the importance of drug safety and observation.

DEFINITION OF PHARMACOVIGILANCE

• The WHO defines pharmacovigilance as:
  "The science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems."

• In Ayurveda, a similar concept is embedded under terms like:

  • Viparyaya – unexpected or opposite action

  • Vyapad – complications

  • Vikāra – disease or adverse reactions from drugs

AIM AND OBJECTIVES OF PHARMACOVIGILANCE

• To enhance patient care and safety.

• To improve public health and confidence in medicines.

• To identify previously unrecognized adverse reactions.

• To assess the risk–benefit ratio of medicines.

• To promote rational use of medicines.

IMPORTANCE IN AYURVEDA

• Many Ayurvedic medicines include metals, minerals (Rasaushadhis) which, if improperly processed, can lead to toxicity.

• Use of herbs with known toxic potential (e.g., Vatsanabha, Bhanga) requires careful monitoring.

• Classical emphasis on proper Shodhana (purification), Marana, and Bhavana procedures ensures safety.

सिद्धं पुनर्विवेक्तव्यं युक्त्या तद्विपरं न यत् ।
— Charaka Samhita, Sutrasthana 1/124
(A prepared drug must be carefully re-evaluated; one which is not so, should not be used.)

ADVERSE DRUG REACTIONS (ADR)

• ADRs are harmful or unpleasant reactions resulting from the use of a medicinal product.

• In Ayurveda, ADRs are discussed under:

  • Vyapad – complications during preparation or administration

  • Vikāra – pathological consequences due to improper usage

  • Upadrava – secondary complications

ADRs CAN BE CAUSED BY:

• Improper Shodhana (purification)

• Incorrect Anupana (vehicle)

• Overdose or wrong dose

• Improper Desha, Kala, Prakriti consideration

• Drug-drug interaction or herb-metal interaction

CLASSIFICATION OF ADRs (MODERN)

• Type A (Augmented): Dose-dependent, predictable

• Type B (Bizarre): Not dose-related, unpredictable

• Type C (Chronic): Long-term use

• Type D (Delayed): Occur after some time of use

• Type E (End of Use): Withdrawal effects

• Type F (Failure of Therapy)

CLASSICAL CONCEPTS RELATED TO DRUG SAFETY

• Yukti: Rational combination of drugs

• Anupana: Proper vehicle to reduce toxicity

• Matra: Proper dosage

• Kala: Appropriate timing of administration

• Shodhana: Detoxification of Dravyas

षड्भावे द्रव्यसम्बन्धो दोषाणां सन्निपातजः ।
दोषधातुमलैः सार्धं याति वृत्तिं निरामयाम् ॥
— Ashtanga Hridaya, Sutrasthana 1/18
(Only when all six factors — substance, dose, time, place, mode, and user — are properly aligned, the medicine works without causing harm.)

PHARMACOVIGILANCE IN MODERN RASASHASTRA

• Emphasis on:

  • Standardized preparation methods

  • Clinical trials of Ayurvedic drugs

  • Safety profiles through animal studies

  • Monitoring toxic elements using modern equipment like AAS/ICP-MS

  • Integration with AYUSH Pharmacovigilance Programme

PHARMACOVIGILANCE PROGRAMME OF INDIA (PvPI)

• Launched in 2010 under the Ministry of Health and Family Welfare

• Monitored by Indian Pharmacopoeia Commission (IPC)

• AYUSH Pharmacovigilance cell formed for traditional medicine systems

• Encourages ADR reporting from Ayurvedic institutions

TOOLS FOR MONITORING ADR IN AYURVEDA

• Yellow card system: For reporting ADRs

• Patient Information Leaflets (PILs): Drug safety info

• Electronic medical records: To track reactions over time

• Therapeutic Drug Monitoring (TDM): For metallic preparations

PREVENTION OF ADR IN AYURVEDA

• Strict adherence to classical guidelines for drug preparation and administration

• Proper Pariksha (examination) of:

  • Rogi (Patient)

  • Roga (Disease)

  • Aushadhi (Drug)

  • Desha, Kala, Satmya, Prakriti, etc.

• Usage of correct Anupana and Pathya-Apathya

• Clinical monitoring during Rasaushadhi use

ROLE OF PHYSICIAN IN PHARMACOVIGILANCE

• Should be well-versed in classical and modern aspects of drugs

• Must monitor patients during and after treatment

• Responsible for documenting and reporting ADRs

• Should ensure good manufacturing practices (GMP) are followed

सर्वं औषधमत्यर्थं युक्तियुक्तं प्रशस्यते ।
युक्तिहीनं तु तद्विद्धि विषवत् परिकीर्तितम् ॥
— Charaka Samhita, Sutrasthana 26/12
(All drugs, if used properly with rationality, are beneficial; otherwise, they act like poison.)

MODERN STRATEGIES TO ENHANCE PHARMACOVIGILANCE

• Electronic surveillance and reporting systems

• Patient feedback mechanisms

• Integration with global databases

• Use of AI in detecting signals of ADRs

• Multicentric studies on Ayurvedic formulations