Table 2.
Failure Mode Effect Analysis (FMEA).
| Stage | Potential Failure Modes | Potential Effect(s) | Causes | O | S | D | RPN 0 | Recommendations/Actions taken | New O | New S | New D | RPN 1 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Medication receipt from the main Drug store | Medication without tracking barcode. is not mapped in the system. The medication batch is not found in the system. |
-Manual process. –No database. |
9 | 6 | 7 | 378 | -Full Mapping of the Health Information System (HIS). System shall not allow expired medication dispensing. |
3 | 3 | 5 | 45 |
| 2 | Medication filling and arranged on shelves | Manual process, no inventory or expiry track that is linked to Health Information System (HIS) | –No database. | 8 | 9 | 9 | 648 | -Full Mapping on the HIS. | 5 | 3 | 5 | 75 |
| 3 | Prescriptions, including outsourced drugs, are unavailable. | Service delay leads and inadequate time management. | -Physical check by pharmaceutical professionals by going to the drug rack and checking it, then returning to the call to clarify with the prescriber. -Manual method. |
7 | 6 | 9 | 378 | -Full HIS Mapping. -Notify the clinician that substitutes are available -Allow adding non-formulary medications into the system. |
3 | 3 | 6 | 54 |
| 4 | Multiple modifications on the same day of the patient's regimen | A medication order is not dispensed. Manual process. |
-Wrong order that requires clarification/modification. -Missed order that needs to be processed. –No alert of duplication or interaction. |
10 | 10 | 10 | 1000 | -Introduce the clinical decision support that will follow the proper drug that is mapped | 4 | 5 | 4 | 80 |
| 5 | The patient's medical history shall be checked and reconciled at admission and discharge. | If not done, the drug is not ordered or dispensed and could be missing. This causes a delay in service; the wrong medicine or dose maybe not be given. -Hand-driven operation. -The quantity available cannot be estimated |
-Faulty order requiring explanation due to mismatch of diagnosis or improper reconciliation. -Risk of missed order that needs to be processed. -Prescribing the wrong medication based on the patient or relatives' feedback. |
8 | 10 | 10 | 800 | -Making a master list of all active and inactive medicines given to the patients throughout all visits. -Computerize the reconciliation process much more than possible when it comes to -- Mandatory reconciliation upon admission and discharge. -For nonformulary drugs: manual entries; are to be filled in the very same screen from a data set that allows additions on the HIS |
5 | 9 | 5 | 225 |
| 6 | Order Review | -Medication mishaps -There is no documentation of the prescriptions' appropriateness review or the procedure of checking order clarity and suitability. |
-The system does not highlight interactions, duplications, and cross allergies (it depends on the pharmacist's manual review). -When dispensing medications to patients, there is no routine alert for medications that always seem to be expired or near expiry. -Dose calculations and numbers need to be corrected. -Drops, ointment, and inhaler quantities are miscalculated. -Clarification, if done, will be over the phone audibly with no records. |
7 | 9 | 10 | 630 | -Prescriptions must be filled out using drop-list options and minimizing free texts as much as possible. –On the order entry stage, pharmacy clarification shall be documented HIS-wise. -The order's status and progress are to be displayed. -The system is designed to prevent off-readings and restrictions specified by the pharmacy and the assistance of the clinical decision-support system. |
4 | 6 | 3 | 72 |
| 7 | Order validation | -The possibility of orders that are not processed or dispensed because they were missed -If processing is delayed, the wrong medicine or dose may be given. |
-The patient's medication may not be appropriate. | 6 | 9 | 9 | 486 | -The orders' status of processing is displayed. -The system is designed to prevent off-readings and restrictions specified by the pharmacy and the assistance of the clinical decision-support system. |
3 | 7 | 5 | 105 |
| 8 | Preparation and dispensing | - Adverse drug events may occur if there is a shortage of pharmacy stock, increased workload, and poor time management. -Dispensing the incorrect drug that is not appropriate for the patient due to mode of administration, cross allergy, or even duplication of therapy errors on printed labels -Inadequate double-checking by staff who alter labels manually -Inconsistencies in stock on HIS displays -Dispensing expired medications -There needs to be detailed information on the label. -Except for high-alert medications, there is no double-checking, and it is up to the employees involved. -There needs to be traceable documentation of the medicine receipt. |
-There is no retroactive verification and validation. -There are no appropriateness review checkpoints. -Printable labels cannot be edited. -A shortage of Personnel. –On the HIS, the label needs to be correctly mapped. -Labels only include some of the information required by the labeling policy. –No modification options for the label shall be printed on HIS. |
7 | 7 | 10 | 490 | -Ready batches/quantities for fast-moving pharmaceuticals. -Allow label editing. -Medicines identified by date and time and linked to a patient for tracking -Actions are recorded and tracked electronically. |
3 | 6 | 5 | 90 |
| 9 | Health Information System (HIS) | Medication incidents of the wrong patient or dose | HIS screens have no fixed headers, causing mix-ups between patients' medications upon printing labels, especially in the manual issue. | 10 | 10 | 10 | 1000 | Standardize the screens to follow the standard pharmacy requirements per national and international elements. mapping the drugs with templates and linking them to the clinical decision support system |
8 | 7 | 7 | 392 |
| Total RPN (RPN 0) | 5810 | Total New RPN (RPN 1) | 1138 | |||||||||