This tragic incident happened due to multiple system failures and human errors including the mix-up between drugs for different patients and the fact that the vial of vincristine was not labeled and packaged according to the manufacturers’ recommendations which require display of the warning, “Fatal if given Intrathecally. For IV use only.” The nurse or the physician failed to check the label and failed to comply with the “five rights” (5Rs)—”right drug, right dose, right time, right route, right patient,” of medication administration before administering the medication and caused a loss of life that could have been prevented. As per the report by Institute of Medicine (USA-2006), every year an estimated 380,000- 450,000 preventable adverse drug events (ADEs) occur in hospitals in USA. Situation would be no better in other countries of the world. These errors mostly occur either during prescribing medications or during administering them. Although, many medication errors may not cause serious harm to patients, some medications have a known higher and serious risk than others and any errors in their administration may cause catastrophic clinical outcomes. These medications are termed as high risk or high alert medications (HAM).
They are involved in a majority of medication errors or sentinel events and are associated with a high risk of abuse, error, or other adverse outcomes. The medicines in this category may include some or all of the items listed in annexure 7, depending on the type of hospital and the drugs being prescribed there. All these medications require special precautions. National Quality Forum (USA) has included “identification of all high-alert drugs, and implementing policies and processes to minimize the risks associated with their usage,” among the 30 safe practices for better health care. JCAHO Standard MM.7.10 also requires that the organization develops processes for managing high-risk or high-alert medications used, within the organization. Further, the organization must develop additional processes for selecting, procuring, storing, ordering, transcribing, preparing, dispensing, administering, and monitoring the usage of these high- risk/high-alert medications.
The list should also include any specific precautions required to be used during storage, ordering or administration of these medications. For example, chemotherapeutic agents must be stored separate from other medications, and the prescription should include an extra step to verify dosage calculations. The drugs must be prescribed and administered only by staff especially qualified/trained and authorized.
The usage must be monitored in view of the high-risk of toxicity. Similarly, drugs with names that sound alike or packing that looks alike should be stored separately to prevent any mix up. The safe management of high-risk medication or high-alert medication involves: 1. Identifying the drugs in the formulary that are high-risk and problem prone. 2. Documenting and implementing a standard procedure for use of high-risk medications.
3. The procedure must include all the precautions and safe practices required to be observed while using high-risk medicines, especially the following aspects: i. Prescription to be in writing and in legible capital letters ii.
Verbal /telephonic orders not to be accepted, except in rare emergency situations when the name of the drug will be spelt out by the doctor, written down by the nurse and read back to the doctor by the second nurse to confirm the veracity. The order will be written down and authenticated by the doctor in the case records at the earliest possible iii. In case of written orders, the first dose of medication will invariably be preceded by verification of orders by the nurse from the treating doctor iv. The dosage, the route, the timing and speed of injection/infusion will be rechecked v. Crash cart would be kept ready to handle any adverse drug effects vi.
The patient will be under observation for any adverse effects for a reasonable period. 4. Allowing only senior/experienced nurses to administer high risk medications. Some drugs such as chemotherapy drugs for cancer patients should be prescribed and administered only by the staff qualified, trained and authorized. 5.
Informed consent of the patient after full briefing about the drug, its effects and adverse effects. 6. Education and training of concerned staff in the protocols for use of high risk medications. 7. System of monitoring the implementation of the protocol.
8. Reporting of breach of protocols, if any and investigations to identify the failure mode caused followed by corrective measures.