The only problem with the information is that it’s from a 20-month period between January 2005 and August 2006. I hate to break it to you Joint Commission Journal on Quality and Patient Aafety, but that makes the information all but useless. Interesting, but useless.

Anyway, there’s nothing particularly interesting about this article, but Mitch Fields, RPh left the following comment:

Well, yet another article re: dangerous and ambiguous “pharmacy” abbreviations in a pharmacy journal. I’ve seen dozens such articles over the past 30+ years, and they all suffer from the same problem: they don’t belong in the journals of practitioners who READ prescriptions, they belong in the journals of the practitioners who WRITE prescriptions!

That is one of the most logical things I’ve ever read. Mitch makes a great point.

Case in point is an email I received this morning letting me know that the Medscape app is available for the Kindle Fire from the Amazon Appstore. I have the Medscape app for Android on my Nexus. I use it on occasion and consider it a secondary reference, but hey it’s free and it has some good information in it.

From the Amazon Appstore website:

Product Features
Access Medscape’s extensive database of medical information (the largest available)
Gain information about more than 8,000 drugs, 4,000 diseases and conditions, thousands of clinical images and procedure videos, drug interaction checker tools, daily medical news, and more
Access the clinical reference database and drug interaction checker anywhere without an Internet connection (Requires full installation of clinical reference database on device)
Receive daily medical news and critical alerts in 34 specialty areas
Check medications for drug interactions and complications, up to 30 at a time
Product Description
Medscape from WebMD (medscape.com) is the leading medical resource most used by physicians, medical students, nurses, and other healthcare professionals for clinical information. this mobile app is used by over one million healthcare professionals.

Save medical news articles and read offline. No Internet connection is required. Access prescribing and safety information for more than 8,000 brand and generic drugs, OTC drugs, and herbals and supplements. This includes pill images, drug pricing, pregnancy and lactation guidelines, and more. Save commonly searched drugs to a personalized saved list for easy access.

Diseases, Conditions & Procedures:
- More than 4,000 evidence-based articles authored by leading physician experts (with images and videos)
- Over 600 step-by-step procedure videos, plus more than 100 tables and protocols
- Includes pathophysiology, epidemiology, differential diagnoses, workup, treatment, medication options, and more

Continuing Medical Education:
- Vast selection of CME/CE activities in 32 specialty areas
- Save and e-mail activities, track credits earned, and more

Failing to employ available dose error-reduction software (DERS) as intended and to heed important clinical alerts are common contributors to these errors. In particular, the misuse of custom concentration options (i.e., user must fill in the concentration) that do not employ a hard (requires reprogramming) minimum concentration limit is a prime example. This issue contributes largely to preventable errors with smart pumps given the counterintuitive, inverse relationship between concentration and volume. More concentrated drugs require less volume to deliver a specified dose; less concentrated drugs require more volume to deliver a specified dose. When using “fill-in-the-blank” custom concentrations, the concentration must be programmed into the pump so it can calculate the volume needed to deliver the prescribed dose. If the programmed concentration is lower than the actual concentration in the infusion bag or syringe, the pump will deliver an overdose. If the programmed concentration is higher than the actual concentration in the bag or syringe, the pump will deliver an underdose. Without a hard minimum concentration limit, the former scenario has led to life-threatening events, such as those described below.

Here’s a great example from the article that made the light bulb go off in my mind:

A physician prescribed IV HYDROmorphone 20 mg/100 mL (0.2 mg/mL) to infuse at 2.5 mg/hour. In this hospital, the standard concentration for this infusion was 0.1 mg/mL, so the custom concentration of 0.2 mg/mL had to be entered into the smart pump. The nurse selected the custom concentration option then mistakenly entered 2.5 mg/100 mL as the concentration instead of 20 mg/100 mL. Given the erroneously programmed concentration of 0.025 mg/mL, the pump issued a soft (can be overridden) low concentration alert. The nurse overrode the warning, mistakenly believing the warning was inconsequential. Based on the erroneous concentration, the smart pump infused the drug at a rate of 100 mL/hour, while the intended rate was 12.5 mL/hour. The pump delivered the entire bag of HYDROmorphone 20 mg to the patient in 1 hour.

ABSTRACT

Background: Adverse drug reactions (ADRs) are an important source of morbidity and mortality during medical care.
Objective: To examine the trends in mortality related to ADRs reported through the US vital statistics system since January 1999.
Methods: Demographic characteristics of people reported as dying as a result of ADRs from 1999 to 2006 were evaluated. The National Mortality Statistics database was queried for International Classification of Diseases, Tenth Revision, codes Y40-Y59, which are specific for deaths due to adverse effects of drugs in therapeutic use. The data were subgrouped based on demographic factors to identify important trends. Crude rates were calculated based on incidents per 100,000 population. Odds ratios and 95% confidence intervals for subgroups were calculated by logistical regression.
Results: During the 8-year study period 2,313,902,748 person years were evaluated and 2341 ADR-related deaths were identified. Annual rates ranged from 0.08/100,000 to 0.12/100,000, and rates increased significantly over time at a rate of 0.0058 per year. ADR deaths were significantly more likely in persons older than 55 years. The risk was greatest in those aged 75 years or older (OR 6.96, 95% CI 6.30 to 7.69). ADR deaths were higher among men than women. Rates varied by race and ethnicity and were highest among blacks (OR 1.38, 95% CI 1.23 to 1.54). Geographically, rates varied widely between states. Based on urbanization, rates were highest in extremely rural (non-core) areas (OR 2.05, 95% CI 1.76 to 2.38). The most common drug classes associated with death were anticoagulants, opioids, and immunosuppressants.
CONCLUSIONS: ADR death rates have a clear association with age, race, and urbanization subgroups. Older individuals, males, blacks, and individuals residing in extremely rural areas experienced higher ADR death rates; these findings warrant further study to develop prevention strategies.

1. Ann Pharmacother February 2012 vol. 46 no. 2 169-175

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 basically a search engine for the Food and Drug Administrations (FDA) Adverse Event Reporting System (AERS). Acording 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