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Layers of protection, and still mismatch errors.

A statistic I came across the other day indicates that 6.3 billion prescriptions were dispensed in the United States in 2020. Combine that with another statistic indicating that 1.5 million errors occur annually in the United States harming the prescribed individual. That is approximately 1 in 5,000 prescriptions issued per year are wrong. I admit this scared me. I have many friends and family members that if they were given 25 mg of a prescribed drug versus the 50 mg needed, we might be talking about life or death. Not to mention what could happen with just the wrong drug. Within maintenance, repair, and operations (MRO) spares within manufacturing, these same types of mismatch errors can exist. Is there anything from the pharmaceutical sector that we can apply to our MROs to reduce the potential of a mismatch?

Medication errors are among the most common medical errors, harming at least 1.5 million people every year. The extra medical costs of treating drug-related injuries occurring in hospitals alone are at least $3.5 billion a year, and this estimate does not take into account lost wages and productivity or additional health care costs. - Erin Wendel - Journal of the American Pharmacists Association

Unique identifier

Similar to issuing spare parts for proactive and reactive maintenance, many of the best practices in your MRO facility exist in the pharmaceutical sector. Consider that prescriptions have bar coding on the bottle that correlates to a National Drug Code (NDC) number. This unique number identifies the drug, the form of the drug, and its strength. Similarly, MROs typically have a unique number for their spare parts that uniquely identifies the size, specification, model number, etc. Just like the label on a bottle of capsules, in MROs, this identification number is traditionally attached as a tag, a bar/QR code, or just a handwritten number on the spare. But the pharmacies and MROs still issue out wrong parts too sometimes. Remember, 1 in 5000 most likely means that there is someone you love who experienced a mismatch. What else can we do?

Auditable electronic transaction

In the drug distribution sector there exists an electronic prescription record (EPR) that validates the legal transaction to indicate the fill, label, dispense and the submitted payment request for a prescription. Within an MRO, we transact spare parts to work orders within our computerized maintenance management system (CMMS) and have checks and balances to ensure that the part being issued is a valid spare attached to the work order’s asset electronically. This transaction is heavily scrutinized not only for the reliability of the asset but for inventory costs and accuracies. But errors continue to happen. Is there something else we can do?

Automated distribution

You might start seeing automated medication dispensing systems shortly versus the manual counting and bottling processes. Similarly, within manufacturing, you are starting to see vending machines and vendor management inventories (VMIs) that are intended to be fast and accurate disbursements of spares. However, even these cannot be foolproof. We still experience errors here in the distribution of parts just like medication.

Layers of quality control

Throw in all of the internal quality control procedures, training, and audits in manufacturing and the pharmacies, and we have layers of quality control. Regulatory audits are in place in MROs that capitalize their inventories to validate the inventory accuracies by count and value. We have required training and procedure reviews to underwrite organizational certifications and qualifications. But still, just like the pharmaceutical sector with even more layers of quality control, errors exist.

Personalizing the statistics

Recently, someone I know received a bottle of their medication from a local pharmacy. It was a different color than normal but they didn’t think much about it. Pharmacies routinely change drug manufacturers as part of the market dynamics of generic drugs. However, about a day later they received a phone call with an extremely nervous tone in their voice, “what color were the drugs you received in your most recent prescription?” Responding, “They were a peach-like color.” The nervous voice indicates, “We made a mistake. You were given the wrong dose of your prescription.”

With the such wide variation in a single medication’s appearance, and with constant interchanging of products due to drug shortages and generic equivalents, both patients and healthcare professionals have become somewhat complacent about doublechecking when the tablet, capsule, or liquid look different. - PharmacyToday

Looking at the bottle, my friend noticed that there was an opportunity missed to help mitigate the mismatch. Written on the side was, “This medicine is a(n) blue, round-shaped, double-scored tablet, imprinted with E341.” There was a poka-yoke opportunity missed that we were never aware of. Interestingly, this last check-and-balance isn't required nor offered by all pharmacies. Here is the last step in the process flow for the user to validate that what is in the bottle. After all of the systems, controls, and processes a mismatch failure slipped through. The last check and probably the most important one, the user has to commit to validating.

Even if the generic manufacturer is different each time the prescription is renewed, the description on the label will match the NDC number. So patients can quickly determine if the medication in the bottle matches the description on the label. If not, something is wrong and needs to be questioned. - Michael Cohen - The Inquirer

My takeaways from this statistic

To improve our MRO distribution activities and minimize the potential of a mismatch, we can improve our accuracy with a description of the part within the part’s attached tag. Giving specific details to uniquely describe the spare part would give the individual that is using the part an opportunity to validate that the spare they are installing is the right one. And with this information, we have to ensure we are training our employees to match the details of the tag to the contents to be installed. If we can successfully do that, we will significantly decrease the potential of a mismatch.



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