Adverse drug reaction programme in a multispeciality hospital

Dr M C Joshi, Tariq K, Ejaj A and Prayag S

Because of a rapid increase in the list of newer drugs launched in the market in the last few decades; adverse drug reaction monitoring of these drugs has assumed prime importance. Since India is a country, which caters to the maximum number of human population for the final assessment of drug safety as a part of post marketing surveillance studies, it becomes necessary to report any untoward reaction of any pharmaceutical product.

The drugs, which are marketed in India, are pretested on very small population groups of European countries in an optimal environment and the data about the drug safety collected from that population could not be applied straight in our population because of the climactic and corporal differences. The Adverse Drug Reactions (ADRs) are the fourth to sixth leading cause of death among hospitalised patients and it occurs in 0.3 per cent to 7 per cent of all hospital admissions. The incidence of serious ADRs is 6.7 per cent and 30 per cent to 60 per cent of these ADRs are preventable.

ADR Programme

WHO definition of ADR accepted in our hospital (Apollo Hospital, New Delhi) is as follows: Any response to a drug that is noxious and unintended and that occurs at doses used in humans for prophylaxis, diagnosis, therapy of disease or for the modification of physiologic function.

FDA definition of serious ADRs is also follows: For reporting purposes, FDA categorises serious adverse event (event related to drug or devices) as one in which “the patient outcome is death, life-threatening (real risk of dying), hospitalisation (initial or prolonged), disability (significant, persistent, or permanent), congenital anomaly, or required intervention to prevent permanent impairment or damage.”

ADR Monitoring and Detection

Adverse drug monitoring and detection is carried out in our hospital by the prescription audit department as a part of their routine checking of prescriptions for drug name, strength, route of administration, doses, frequency and duration. The computerised drug order entry is screened here for events related to adverse drug reaction and a detailed investigation is done if any clue is found.

• Medication order screening
• Abrupt medication discontinuation.
• Abrupt dosage reduction.
• Orders for tracer substances.
• Orders for special tests or serum drug concentrations.
• Orders for high risk drugs, which are likely to cause ADRs are screened and their use is monitored

Examples of high risk drugs are aminoglycosides, amphotericin, antineoplastics, corticosteroids, digoxin, heparin, lidocaine, phenytoin, theophylline, thrombolytic agents, and Warfarin.

• Medication utilisation review.
• Computerised screening.
• Chart review and concurrent audits.
• Lab tests & checklist.
• Standard laboratory tests.
• Adverse drug event questionnaire- extensive checklist of symptoms categorised by body system.

Severity scale of ADRs

The ADRs are classified into severity levels and all the ADRs with a severity level of 5 and 6 are investigated in detail by doing a Root-Cause-Analysis (RCA).

Level 1- ADR occurred but required no change in treatment with suspected drug.

Level 2- Drug held, discontinued or changed but no antidote or additional treatment needed.

Level 3- Drug held, discontinued or changed and/or antidote or additional treatment.

Level 4- ADR required patient transfer to an intensive care setting.

Level 5- ADR caused permanent harm to the patient.

Level 6-ADR either directly or indirectly led to the patient’s death.

The Joint Commission as minimal areas for analysis of a medication area suggests the following areas:

• Patient identification process
• Staffing levels
• Orientation and training of staff
• Competency assessment/credentialing process
• Supervision of staff
• Communication among staff members
• Availability of information

Dr Joshi is a clinical pharmacologist and Tarik K and Ejaj A are clinical pharmacists at Indraprastha Apollo Hospital, New Delhi