Abstract
Objective
To control the workflow for surgical patients, we in-cooperate radio-frequency identification (RFID) technology to develop a Patient Advancement Monitoring System (PAMS) in operation theater.
Methods
The web-based PAMS is designed to monitor the whole workflow for the handling of surgical patients. The system integrates multiple data entry ports Across the multi-functional surgical teams. Data are entered into the system through RFID, bar code, palm digital assistance (PDA), ultra-mobile personal computer (UMPC), or traditional keyboard at designated checkpoints. Active radio-frequency identification (RFID) tag can initiate data demonstration on the computer screens upon a patient’s arrival at any particular checkpoint along the advancement pathway.
Results
The PAMS can manage the progress of operations, patient localization, identity verification, and peri-operative care. The workflow monitoring provides caregivers’ instant information sharing to enhance management efficiency.
Conclusion
RFID-initiate surgical workflow control is valuable to meet the safety, quality, efficiency requirements in operation theater.

I like the concept that the article presents, but take a look in the methods section and note the presence of “palm digital assistance (PDA)”. That made me a little suspicious about the age of the article. Even though it was published in December 2011, it was received by the journal December 4, 2009; received in revised form August 16, 2010; accepted August 27, 2010 and finally published more than a year later in December 2011. So it took two years from the time the article was received until it was published. This just fuels my opinion that methods used to disseminate medical and scientific information is completely outdated.

_________________________

1. Computer Methods and Programs in Biomedicine Vol. 104, Issue 3, Pages 435-442, December 2011

Reliance on pharma-sponsored digital resources among online U.S. adults is significant. The research found “51% of online U.S. adults (ages 18+) use pharma-sponsored digital resources, such as condition and treatment information, disease management tools, doctor discussion guides, or mobile apps or websites.” This validates that the interactive information and tools produced by biopharma are being utilized and appreciated.

Use of these materials results in action: a conversation about a prescription drug. The study learned “43% of consumers using pharma-sponsored digital resources have discussed prescription drugs with a doctor, nurse, or pharmacist as a result.” This data point supports the business objective behind providing these interactive resources: generating a conversation with a healthcare professional. Note that the study was fielded online among 6,634 U.S. adults, ages 18+ during Q4 2011.

For comparison, Prevention Magazine’s Direct to Consumer Study 2011 found that as a result of seeing an advertisement – not necessarily online – 77% of survey respondents talked to a doctor and 23% asked for a prescription.

How scary is this! Getting consumers to talk about their medication with their physician is a good thing; talking with their pharmacist even better. However, many times this type of advertising (“digital resource”) results in consumers asking about something completely inappropriate. Which, as we all know, can lead to  a physician prescribing an unnecessary medication, using something that they’re not familiar with or prescribing something they wouldn’t consider first line.

All you have to do is look at the top 5 “patient and caregiver groups to agree that pharma should be involved in online health consumer communities” to understand why this is such a bad idea.

1. ADD/ADHD Caregivers
2. Bipolar Disorder Caregivers
3. Epilepsy Caregivers
4. Cystic Fibrosis Patients
5. Rheumatoid Arthritis Patients

Yikes! Choosing drug therapy is quite a bit different than picking out a book on Amazon and it should be treated that way.

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.

Their Board of Director’s and Executive Committee is a who’s who of generic pharmaceutical manufacturers. Go figure.

Anyway, in a press release dated December 15 the GPhA announced an initiative to help with the drug shortage problem that’s been plaguing the healthcare industry for the better part of two years. According to the GPhA, the initiative, known as the Accelerated Recovery Initiative (ARI) "is predicated on voluntary communication between an independent third party and stakeholders involved in the manufacturing and distribution of generic injectable medications currently in shortage. It is designed to use real-time supply and distribution information to give stakeholders — including, but not limited to, manufacturers, wholesalers, distributors, Group Purchasing Organizations (GPO’s) and the FDA — a better understanding of current conditions and expand the supply of critical medications to patients in need."

I have to give the GPhA credit for doing something positive to help with drug shortages. Someone would have forced them into doing something eventually, but it’s nice to see them take a proactive role nonetheless.

The Accelerated Recovery Initiative calls for:

• An independent third party to gather current and future supply information from stakeholders for products identified as meeting the critical criteria;
• That information to be used to determine current and potential supply gaps, with a focus on those products where a shortage is expected to last longer than 90 days; and
• A high-level SWAT team to be formed within FDA with the ability to quickly respond to critical shortages and work with the current Drug Shortage Staff expanded through the President’s drug shortage initiative.

More information on the initiative can be found here.

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

Anyway, the ISMP alert shared several examples of oral overdoses with Lugol’s solution secondary to confusion between drops and mL’s. However, mixed in with all the “typical” errors, was the little gem below. Even though the error is more than a decade old, I can’t help but wonder “what the heck were they thinking!”. By the way, my initial read through had me thinking cursive “OS” (oculus sinister, i.e. LEFT eye). With that said, I wouldn’t have actually dispensed it because nothing else on the prescription fits.

One of the errors reported more than a decade ago involved an order to administer 10 drops of Lugol’s solution mixed with "OJ" (orange juice), but nurses misinterpreted "OJ" as OD (right eye). The patient received several doses of Lugol’s solution in his right eye. The error was identified when the patient complained to the physician about how painful the eye drops were.

Abstract

Background: People with cystic fibrosis have a high treatment burden. While uncertainty remains about individual patient level of adherence to medication, treatment regimens are difficult to tailor, and interventions are difficult to evaluate. Self- and clinician-reported measures are routinely used despite criticism that they overestimate adherence. This study assessed agreement between rates of adherence to prescribed nebulizer treatments when measured by self-report, clinician report, and electronic monitoring suitable for long-term use.

Methods: Seventy-eight adults with cystic fibrosis were questioned about their adherence to prescribed nebulizer treatments over the previous 3 months. Self-report was compared with clinician report and stored adherence data downloaded from the I-Neb [2] nebulizer system. Adherence measures were expressed as a percentage of the prescribed regimen, bias was estimated by the paired difference in mean (95% CI) patient and clinician reported and actual adherence. Agreement between adherence measures was calculated using intraclass correlation coefficients (95% CI), and disagreements for individuals were displayed using Bland-Altman plots.

Results: Patient-identified prescriptions matched the medical record prescription. Median self-reported adherence was 80% (interquartile range, 60%-95%), whereas median adherence measured by nebulizer download was 36% (interquartile range, 5%-84.5%). Nine participants overmedicated and underreported adherence. Median clinician report ranged from 50% to 60%, depending on profession. Extensive discrepancies between self-report and clinician report compared with nebulizer download were identified for individuals.

Conclusions: Self- and clinician-reporting of adherence does not provide accurate measurement of adherence when compared with electronic monitoring. Using inaccurate measures has implications for treatment burden, clinician prescribing practices, cost, and accuracy of trial data.

1. CHEST August 2011 vol. 140 no. 2 425-432
2. Detailed information on the I-neb AAD System.