There has been one report of serious injury when a pharmacist mistakenly gave an eye surgery patient Durasal, the salicylic acid–containing wart remover, instead of the prescribed Durezol eye drops. Durezol is approved for treatment of inflammation and pain association with ocular surgery.”

Seems like I’ve read about this mistake before. Being their typical efficient self, the FDA alert was issued on December 28, 2011, more than three months after ISMP alerted everyone.

Some things you can do to prevent stuff like this from happening include (taken from a Pharmacy Times article):

• Include both brand and generic names, along with indication, when prescribing look- or sound-alike drug names.
• Spell out drug names that have been confused when accepting telephone orders. Require staff to write down the prescription and then perform a read back (and spell back for drugs that are known to cause confusion) of the complete prescription for verification.
• Assign time to provide counseling to patients and/or caregivers, especially for new prescriptions.

DrugCite is a database hosted by the FDA that houses all the reported side effects associated with a drug. According to the website:

“One of the primary ways that the United States Food and Drug Administration monitors the safety of marketed drugs is the collection and analysis of reported adverse events (an event that was not the intended outcome of the prescribed drug and has a negative impact on health) through the Adverse Events Reporting System (AERS). These reports are submitted by physicians, healthcare consumers, lawyers amongst others, and then the FDA scientific staff will assess these events in the context of other databases to determine if a particular safety concern is associated, and possibly caused by, exposure to a particular drug. Since this is a public database and useful to prescribers and patients alike to know if “has what I’m experiencing been described in patients taking this drug before?” DrugCite has created a more friendly interface to answer that question. Use of this data should in no way be confused with the FDA’s rigorous process of evaluating the potential link of adverse events to drugs as causal but merely represents a portal into what is currently being reported to the Agency.”

It’s a neat concept, but please take the information with a grain of salt. Remember that the FDA will list anything that is reported while an individual is on a medication, whether or not the drug is truly the offending agent or not. For example, I searched for acetaminophen and received the graphs below. Looks pretty scary on the surface, but I consider acetaminophen to be one of the safest medications on the U.S. market when used properly. Something to consider when using this tool.

Several methods have been used to prevent errors associated with high-alert medications. Examples include the use of tallman lettering – which I don’t think actually works – physical separation of the SALAD pairs, the use of brightly-colored warning labels, double checks, etc. All these prevention methods sound promising on the surface, but people are prone to error regardless of the precautions put in place to prevent them. The best we can hope for is to eventually remove humans from the equation.

The Pharmacy Times article recommends the following to help reduce errors associated with high-alert medications:

• Include both brand and generic names, along with indication, when prescribing look- or sound-alike drug names.
• Spell out drug names that have been confused when accepting telephone orders. Require staff to write down the prescription and then perform a read back (and spell back for drugs that are known to cause confusion) of the complete prescription for verification.
• Assign time to provide counseling to patients and/or caregivers, especially for new prescriptions.
• The pharmacist who intercepted the methotrexate error [mentioned in the article] made 2 recommendations that can help catch wrong-drug errors involving highalert medications:
• With all high-alert medications, even if a DUR verification was previously completed, review the prescription’s directions and strength as well as confirm that it is for the right patient before placing it in the bag for pickup.
• Some pharmacy computer systems allow a pharmacist to put a “register hold” on prescriptions so that when the patient picks up the medication they are flagged to speak to a pharmacist. Require an automatic hold to be placed on all high-alert medications so that mandatory counseling occurs, increasing the chance that errors can be discovered. PT

Abstract
Objective To identify the frequency of medication administration errors and their potential risk factors in units using a computerized prescription order entry program and profiled automated dispensing cabinets.

Design Prospective observational study conducted within two clinical units of the Gastroenterology Department in a 1537-bed tertiary teaching hospital in Madrid (Spain).

Measurements Medication errors were measured using the disguised observation technique. Types of medication errors and their potential severity were described. The correlation between potential risk factors and medication errors was studied to identify potential causes.

Results In total, 2314 medication administrations to 73 patients were observed: 509 errors were recorded (22.0%)—68 (13.4%) in preparation and 441 (86.6%) in administration. The most frequent errors were use of wrong administration techniques (especially concerning food intake (13.9%)), wrong reconstitution/dilution (1.7%), omission (1.4%), and wrong infusion speed (1.2%). Errors were classified as no damage (95.7%), no damage but monitoring required (2.3%), and temporary damage (0.4%). Potential clinical severity could not be assessed in 1.6% of cases. The potential risk factors morning shift, evening shift, Anatomical Therapeutic Chemical medication class antacids, prokinetics, antibiotics and immunosuppressants, oral administration, and intravenous administration were associated with a higher risk of administration errors. No association was found with variables related to understaffing or nurse’s experience.

Conclusions Medication administration errors persist in units with automated prescription and dispensing. We identified a need to improve nurses’ working procedures and to implement a Clinical Decision Support tool that generates recommendations about scheduling according to dietary restrictions, preparation of medication before parenteral administration, and adequate infusion rates.

1. J Am Med Inform Assoc. 2012 Jan 1;19(1):72-8. Epub 2011 Sep 2.

The Food and Drug Administration Wants to Hear How Drug Shortages Impact Patients

The Food and Drug Administration has opened a comment period to gain insight about the causes and impact of drug shortages. The agency is seeking feedback as a follow up to a public workshop on the impact of shortages.

You know first-hand the devastating effect that drug shortages are having on patient care.  Today, ASHP’s Drug Shortages Resource Center lists 208 shortages. That’s nearly the same number of shortages that were reported in all of 2010.

This is your chance to speak up.

Write a letter to the FDA that describes your experiences and challenges managing drug shortages.  Here’s what you should include:

• Impact on patient care.  Share examples from your practice site, such as patients who’ve had to delay care or who’ve experienced adverse affects from second-line therapies.

• Impact on pharmacy department operations: Discuss how the time spent researching availability of drug products and the redeployment of pharmacists from patient care roles affects the pharmacy department.

Be sure to ask your colleagues in the pharmacy department as well as your nursing and physician colleagues to join you. Enlist your patients as well. Every voice counts!

The deadline to submit comments is December 23, 2011. You can post comments on www.regulations.gov or send comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.  See the Federal Register notice for more details.

Your input and expertise are not only welcome, they are essential to achieving a solution to this critical issue.

Use the resources below to familiarize yourself with ASHP’s messages on drug shortages.

• ASHP Statement for the Record House Energy and Commerce Committee Subcommittee on Health Hearing: "Examining the Increase in Drug Shortages" [PDF]
• Drug Shortages FAQs
• Drug Shortages Threaten Patient Care
• Drug Shortages Resource Center

The ReVac Retracting Safety Syring by Revolutions Medical “use a proprietary patented technology in which a vacuum causes the needle to retract into the barrel of the syringe or device after an injection is administered or blood is drawn.”

According to the Revolutions Medical website “[t]he RevVac™ Safety Syringe and Phlebotomy (blood drawing) Device operate the same as a standard syringe and device. No additional training, skills, or procedures are necessary. The both products work on a vacuum principle, where pressing the plunger in them creates a vacuum. When the plunger reaches the bottom, the needle is captured. A further push on the plunger breaks the seal, and the needle retracts into the plunger barrel. The vacuum is maintained, so the needle cannot be removed from the plunger.”

I avoided the more traditional sessions on therapeutics, choosing instead to focus on the informatics and medication safety sessions. Based on the information presented it was obvious to me that these two disciplines are intimately linked. After all, the idea behind much of the technology we use in healthcare today is to improve patient safety.

In 1999, the Institute of Medicine (IOM) published the now infamous To Err Is Human: Building a Safer Health System. The information presented in that report sent shockwaves through the healthcare industry. More than a decade later we haven’t seen much improvement in the number of mistakes made in hospitals, but To Err Is Human effectively changed the foundation of healthcare forever. While healthcare remains squarely focused on caring for patients, the approach to how we provide that care has changed dramatically. The interest on patient safety has generated an immense body of literature aimed at using automation and technology to improve patient care.

Before diving too deep, it’s important to understand where the errors within the healthcare system occur. Leape’s landmark paper in 1995(1) analyzing ADEs in hospitalized patients found that adverse events occurred as follows: ordering 38%, transcription 12%, dispensing 11%, and administration 39%. Bates found similar results in a study also published in 1995 in the same issue of JAMA (2). Bates found that of ADEs that were considered preventable, 49% occurred during the ordering stage, 11% occurred during the transcription stage, 14% occurred during the dispensing stage and 26% occurred during the administration stage.

Since the publications by Leape and Bates much work has gone into making the medication use process safer. At the forefront of this work has been an advance in automation and technology. Among those technologies being explored include: 1) computerized provider order entry (CPOE) for ordering; 2) pharmacy information systems and clinical decision support for transcription; 3) automated carousels, barcoding and automated dispensing cabinets for dispensing; and 4) barcode medication administration (BCMA) and smart pumps for administration. This isn’t an all-inclusive list, but rather an example to demonstrate the extent to which healthcare has gone to improve patient safety through the use of automation and technology.

With that said, I find it interesting that one of the most error prone steps in the medication distribution phase is often overlooked. I’m speaking specifically about the process of returning/restocking medications in the pharmacy. I have observed the process many times and outside the use of robotics, the system is completely manual, open to selection bias, full of interruption and fraught with error.

Example return/restocking process:

1. A series of medication are returned to the pharmacy.
2. The medications are placed in a return bin regardless of medication type, dosage form, storage requirements, etc.
3. Tablets in the return bin are sorted for restocking.
4. Someone, most likely a pharmacy technician takes the sorted medications and places them back into pharmacy stock.
5. The medications are now ready for use.

Notice that step number three above is highlighted in red. This is the step in the process that is most open to error.

Let’s just say that during the sorting process the medications are not sorted properly and a hydrALAZINE tablet finds its way into a hydrOXYzine bin. I’ve seen this happen many, many times. The packaging and names are similar so the single hydrALAZINE tablet goes undetected in the wrong bin. So the next time hydrOXYzine is needed in bulk, i.e. for an ADC replenishment, the hydrALAZINE ends up in the pile of hydrOXYzine tablets. Since the tablets are loose, the pharmacist checking the bag full of hydrOXYzine fails to see the single hydrALAZINE tablet.

The hydrALAZINE is mistakenly sent to an ADC cabinet along with the hydrOXYzine where a nurse pulls the hydrALAZINE from the ADC thinking it is hydrOXYzine. Sometimes the nurse fails to recognize the error and the hydrALAZINE is administered to the patient in place of hydrOXYzine.

Hopefully the facility utilizes BCMA and the error is avoided. However, only about 35% of hospitals in the country were using BCMA as of 2010(3). However, if the facility is not utilizing technology like BCMA, the incorrect medication is administered to the patient where it could potentially cause harm.

Although the example above involves several failures during the medication use process, it all began with a breakdown during the restocking phase. I’ve seen this exact error many times during my career, as well as many others caused by sound-alike-look-alike medications.

It’s clear to me that the return/restocking phase of the medication distribution process is the weakest link, and is rarely acknowledged when thoughts of improving the process come to mind. So what’s the answer? Does the process need to be automated or is a better manual process the answer? I don’t know what the solution is, but I think it’s time we gave it some thought.

References

1. Leape L.L., D.W. Bates, D.J. Cullen, J.W. Cooper, H.J. Demonaco and T. Gallivan et al. 1995. “Systems Analysis of Adverse Drug Events.” ADE Prevention Study Group. JAMA 274: 35-43.
2. Bates D.W., D.J. Cullen, N. Laird, L.A. Petersen, S.D. Small and D. Servi et al. 1995. “Incidence of Adverse Drug Events and Potential Adverse Drug Events: Implications for Prevention. ADE Prevention Study Group.”JAMA 274: 29-34.
3. Pedersen C.A., Schneider P.J., Scheckelhoff D.J. 2011. “ASHP National Survey of Pharmacy Practice in Hospital Setting: Prescribing and Transcribing – 2010” Am J Health-Syst Pharm 68: 669-88.

The video below talks about the integration of smart pumps with Cerner at WellSpan Health in New Jersey. Interesting stuff.

The requirements will affect makers of long-acting and extended-release opioids, which include oxycodone, morphine and methadone.

Letters have been sent to manufacturers of the drugs describing the medication guides and tools for physician training that are now required, FDA Commissioner Margaret Hamburg said. The FDA will approve the materials, which will also be accredited by professional physician-education providers, she said, a step meant to combat bias in the materials.”

Oh. My. Gosh. Let me see if I can wrap my brain around this. The FDA is going to require that manufacturers of certain “painkillers” tell physicians how to properly use the drugs instead of requiring physicians to read the literature and do exactly what they’re trained and paid to do. Crud, it’s nothing a good pharmacist couldn’t fix. Why doesn’t the FDA simply require physicians to run these same prescriptions through a pharmacist for approval or give pharmacist prescriptive authority instead. It makes a lot more sense than putting the manufacturers in charge of the asylum. I would be utterly embarrassed if a drug manufacturer had to tell me how to properly use a drug because I couldn’t get it right. I think the healthcare system has officially reached a new low. Unfortunately this ain’t no limbo contest.

Most medication inconsistencies could be avoided if reconciliation were performed at patient admission, transfer and discharge. Hospital information systems are helping some wired hospitals rdo this across the care continuum despite the lack of a universal solution.

Medication reconciliation was designated a 2005 National Patient Safety Goal by the Joint Commission, which recommended that organizations accurately and completely reconcile medications across the continuum of care. In 2009, however, the commission announced it would no longer score medication reconciliation during on-site accreditation surveys, because of difficulties with implementation strategies. Then, in December 2010, the commission announced a new version of the NPSG (08.01.01), to be effective July 1 of this year. According to the commission, the new streamlined version focuses on critical-risk points in the medication reconciliation process.

The Institute for Safe Medication Practices still is disappointed in the current status of medication reconciliation. “It’s not what we expected for a process that on the surface seems so simple,” says Stu Levine, an ISMP informatics specialist.”

I received a link to this article through the Healthcare IS – Pharmacy IT/Pharmacy Informatics CPOE Group on LinkedIn. The article is titled “Medication Reconciliation Only as Good as the IT Allows”. I find the title a little strange, and a bit misleading. Consider that the medication reconciliation process is best handled by diligence among healthcare providers, not IT. The technology to provide clinicians with medication lists is only a tool to make the process easier. Reconciling a patient’s medications is at best a difficult task. The “general public” knows surprisingly little about their own medications; including the simplest of things like names and doses. Getting physicians to reconcile a medication list isn’t much better. More often than not they simply sign the “transfer med list” without really scrutinizing what’s on it.

Unfortunately the article makes it sound like a simple process of looking at the medication list on admission, transfer and discharge. It really isn’t as simple as that. We utilized this process at my previous hospital and I can tell you that we were lucky to have a patient medication list that was accurate. Most were haphazard attempts that lead to confusion and lots of phone calls and clarification.