Abstract

Satisfactory adherence to aptly prescribed medications is essential for good outcomes of patient care and reliable evaluation of competing modes of drug treatment. The measure of satisfactory adherence is a dosing history that includes timely initiation of dosing plus punctual and persistent execution of the dosing regimen throughout the specified duration of treatment. Standardized terminology for initiation, execution, and persistence of drug dosing is essential for clarity of communication and scientific progress. Electronic methods for compiling drug dosing histories are now the recognized standard for quantifying adherence, the parameters of which support model-based, continuous projections of drug actions and concentrations in plasma that are confirmable by intermittent, direct measurements at single time points. The frequency of inadequate adherence is usually underestimated by pre-electronic methods and thus is clinically unrecognized as a frequent cause of failed treatment or underestimated effectiveness. Intermittent lapses in dosing are potential sources of toxicity through hazardous rebound effects or recurrent first-dose effects.

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

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.

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.”

We’ve been fortunate in the United States as the American Society of Health System Pharmacists (ASHP) have been instrumental in helping pharmacists deal with the issue. In fact the article goes as far as to say that the shortages “have prompted physicians, pharmacists and other health care professionals to call for a national registry or portal modelled on one hosted by the American Society of Health System Pharmacists” Kudos to ASHP.

Don’t expect shortages to go away anytime soon. In the meantime creating a registry to track them might be the way to go.

The article is available for free here.

A similar study conducted by NEHI found that poor medication adherence results in illnesses and ensuing treatments that cost some $290 billion in unnecessary spending each year, $100 billion of that in avoidable hospitalizations alone.

Two members of Congress recently introduced bills to allow Medicare reimbursement for more patients to sit down with therapists one-on-one and equip patients with pill boxes or text message services that help patients become more adherent, the USA Today report said.

The Toronto University College of Pharmacy conducted a study that found medication therapy saved about $93.78 per patient annually in a study of 23,798 people, USA Today reports.”

Problems with medication adherence are nothing new. A recent study in the March 2011 issue of Academic Emergency Medicine ¹ looked at the impact of poor medication adherence on emergency department visits. According to the article “risk for medication nonadherence due to cost concerns was identified in a quarter of nonemergent urban ED patients in our sample and was more likely to be reported by patients experiencing other economic and psychosocial risks. These findings indicate a need to include discussions about medication affordability and referrals to social services as part of ED discharge planning.”

Several options exist to help curb the impact of the medication adherence problem here in the United States. The use of simple technologies like the GlowCap, the Pill Timer and MedReady can go a long way in improving compliance, as can the use short message services (SMS) (i.e. text messages delivered to mobile phones). While SMS has been shown to be beneficial in several disease states ^2-5, it doesn’t work for everyone.⁶

While technology certainly plays a role in improved medication compliance, it’s important that we don’t forget the human element involved in the process. Pharmacists are linchpins in the medication use system. They can play a significant role in improving the medication use process and reducing healthcare costs through medication therapy management (MTM). MTM has been shown to improve medication compliance and reduce overall healthcare cost.^7-8 While the concept of MTM isn’t new, the approach has received renewed interest in light of the PPMI and via pharmacy organizations like the American Pharmacists Association.

With over $200 billion at stake it shouldn’t be a question of which approach to use (i.e. technology or pharmacist intervention), but rather when do we start. Based on the size of the opportunity, the answer should be now.

References:

1. Mazer M, Bisgaier J, Dailey E, et al. Risk for Cost-related Medication Nonadherence Among Emergency Department Patients. Academic Emergency Medicine. 2011; 18: 267–272.
2. Lester, R., Ritvo., Mills, E., et al. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomized trial. The Lancet. 376:1838-1845.
3. Strandbygaard,U., Francis, ST., Backer, V. A daily SMS reminder increases adherence to asthma treatment: A three-month follow-up study. Respiratory Medicine. 2009; 104:166-171.
4. Hanauer DA, Wentzell K, Laffel N, Laffel LM. Computerized Automated Reminder Diabetes System (CARDS): e-mail and SMS cell phone text messaging reminders to support diabetes. Diabetes Technology & Therapeutics. 2009; 11:99-106.
5. Miloh T, Annuziato R, Arnon R, et al. Improved adherence and outcomes for pediatric liver transplant recipients by using text messaging. Pediatrics. 2009; 124:e844-e580. (free full text PDF)
6. Hou MY, Hurwitz S, Kavanagh E. Using daily text-message reminders to improve adherence with oral contraceptives: A randomized controlled trial. Obstetrics & Gynecology. 2010; 116:633-640.
7. Smith M, Giuliano MR, Starkowski MP. In Connecticut: Improving patient medication management in primary care. Health Affairs. 2011; 30:646-54.
8. Hirsch JD, Gonzales M, Rosenquist A, et al. Antiretroviral therapy adherence, medication use, and health care costs during 3 years of a community pharmacy medication therapy management program for medi-cal beneficiaries with HIV/AIDS. Journal of Managed Care Pharmacy. 2011; 17:213-23.

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.