MGMCRI, SBV

Mahatma Gandhi Medical College and Research Institute (MGMCRI)

A constituent college of

Sri Balaji Vidyapeeth (SBV), PUDUCHERRY

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Tertiary Care Hospital

Only Hospital to be NABH certified pre-accreditation entry-level in Pondicherry

Quality and Safety Measures

Drug Safety / Pharmacovigilance

DRUG SAFETY

The primary motto of any drug safety system is primum non nocere (first, do no harm) in the field of heavily drug-reliant modern medicine. A drug safety personnel has to practice it considering the delicate balance between benefits and risks associated with any medication. The Pharmacovigilance unit, Quality management Service (QMS) department, Nursing Superintendent (NS) Office, and the Pharmacy are the birds of a feather that flock together at MGMCRI towards drugs safety. The unit functions under the guidance of the Department of Pharmacology.

Major activities involve adverse drug reaction (ADR) reporting by any clinician, faculty, student, trainees, etc. The query boxes are meant to handle any ADR reports from the clinical departments. Software and systems for more convenient online reporting are available in the unit.

Adverse Drug Reaction

The unit involves in adverse drug reaction (ADR) reporting that includes regular monitoring of such unintentional events, communicating with the stakeholders as per the protocol, identifying the specific circumstances associated with an event while considering contributory human errors and e-reporting the drug-related events to the Government of India authorized adverse drug reaction monitoring center. The Pharmacovigilance unit of MGMCRI strives hard to add a humanistic touch to this, by counseling the concerned patient party, educating them regarding the ways to prevent future events and providing ADR alert cards to the needful in case of preventable ADR under VigiCare Program.

The unit also offers drug information on the need to know basis to the QMS department. Regular training is provided to the nursing staff in the management of specific medication, cancer chemotherapy administration, medication errors and hospital antibiotic policy. Orientation program for the fresh batch of interns is conducted regularly for ADR awareness. Cytotoxic Biosafety Self-Regulation manual has been provided to the wards in order to track hazardous drugs inside MGMCRI. In case of multiple ADR with any specific product, the committee and the authorities are notified to take necessary remedial measures.

Medication Errors

A critical part of improving the system for drug safety is remembering, admitting and learning from past mistakes in order to avoid them. The doctors are briefed on the consolidated report of avoidable events in their respective wards during patient care meeting. If ADR is related to a medication error, it is notified to the QMS department. The QMS department monitors medication errors regularly by inspecting the case sheets. For Continuous Quality Improvement (CQI) the medication errors are segregated in order to statistically analyze the trend in monthly data. The clinical pharmacist at QMS department regularly update the NS office with pamphlets regarding drug information which is circulated to the wards.

Pharmacy Auditing

Refrigerator and room temperature records at Pharmacy are also checked regularly in order to maintain the quality of drugs. In case of suspicion of quality of the specific product, batch recall is considered. Near expiry, drugs are also sent back to the pharmaceutical manufacturer to replace with a new batch of drugs. Record of Narcotics is maintained by the experienced nursing staff while a licensed Pharmacist regularly checks the management of narcotics in MGMCRI. Lookalike and sound-alike medications are maintained in racks with proper Tallman lettering style at the Pharmacy. Cancer chemotherapy, high-risk medication and hazardous chemicals are maintained in proper racks with Red Color Code at the Pharmacy with proper division of racks for a different dose of drugs.

MGMCRI Hospital

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