Medication Packaging Research Articles

Factors contributing to incidents in medicine administration. Part 2

The lack of empirical research on nurses' views of the factors contributing to medication errors, and particularly of studies conducted in the UK, formed the starting point for this study. Part 2 of this two-part article aims to inform the wider nursing population about the views of nurses working in the medicine directorate of a large London teaching hospital, and to explore the reporting of medication incidents and the effect of this on the practice of the nurses involved. Quantitative results of a self-administered questionnaire indicated that this group of nurses felt that the most important factors contributing to medication incidents were interruptions by patients and relatives/visitors and telephone calls during the process of administration. Suggested ways of reducing errors were 'protected' medicine rounds, unique or distinct packaging of medications and regular revision sessions on mathematical calculations. These nurses' views confirmed that factors identified in the literature as contributing to medication incidents were problematic for them too. Simple changes to practice could help to reduce the number of such incidents.

FDA mulls over paperless labeling

Electronic medication package inserts (PIs), or “paperless” labeling, would give health care providers immediate access to the most current prescribing information, said Thomas F. Willer, director of global regulatory affairs for Hospira. Electronic PIs would allow manufacturers to rapidly

Ensuring the competence of pharmacy technicians

Over the past several months, we have heard reports of medication errors involving pharmacy technicians that have led to serious injury or death. In some cases, the technicians or supervising pharmacists were terminated from their positions. Moreover, the institutions in which the incidents occurred announced immediate changes in their procedures and systems. In one instance, calls were made for legislative intervention at the state and federal levels. What is there to be learned from these events? How should pharmacy respond to these tragedies? Can such incidents be prevented? Accidents serve as primary learning tools for the prevention of similar misadventures. For example, awareness of rudder problems in Boeing 737 aircraft resulted in the inspection of thousands of 737s worldwide for possible repair.1 More than likely, this action prevented accidents. Careful analysis of tragic mistakes made by pharmacy technicians generally results in the detection of substantial systems failures. Such failures involve shortcomings in medication packaging and labeling, inconsistent verification methods (e.g., bedside barcode verification), lack of process controls, and a host of other systems problems. Accidents also reveal defects in human performance, some of which are grounded in issues of competence, such as the capacity to perform job requirements and the effect of certain psychological phenomena (e.g., fatigue, cognitive processes). In short, accident investigation allows for a compilation of factors that contribute to failure and, hence, serves as the basis for systematic improvement for the prevention of similar accidents.

Assessing Geriatric Patients’ Ability to Functionally Manage Medication Packaging

ABSTRACT Background: Various studies have recommended that a skills assessment for safe medication management be incorporated into routine evaluation of geriatric patients. It has previously been demonstrated that pharmacists are more likely than other health care professionals to discover obstacles to self-administration of medication among older patients and to undertake interventions to ameliorate these barriers. Objectives: To identify the proportion of geriatric hospital patients with functional inability to manipulate medication packaging and to determine any specific patient characteristics that might be used to predict this problem. Methods: For this prospective, nonrandomized, observational study, 60 consenting geriatric patients were asked to perform a variety of timed tasks related to medication management. Results: One-third of the patients in this study demonstrated overall impairment of ability to functionally manage medication packaging. Many of the patients were unable to distinguish different pill colours (25 or 42%) or to open and remove tablets from a non-child-resistant container (17 or 28%) or a blister pack (7 or 12%). Individual risk factors could not be identified, although those who demonstrated impaired functional ability were somewhat older (85.8 years versus 81.7 years, p = 0.003). The average time spent by the pharmacist to conduct the skills assessment exceeded 30 min. Conclusion: Many of the geriatric inpatients in this study had impairment of their ability to perform specific function-related tasks in a simple and straightforward screening tool. However, the ideal screening tool to assess medication management skills among older people, incorporating the functional and cognitive components of these tasks and suitable for administration by any member of the health care team, has not yet been identified. RESUME Historique : Diverses etudes ont recommande qu’une evaluation de l’aptitude des patients âges pour la manipulation securitaire des medicaments soit incorporee a leur evaluation de routine. Il a deja ete demontre que les pharmaciens sont plus susceptibles que d’autres professionnels de la sante de decouvrir les obstacles a l’auto-administration des medicaments chez les patients âges et de prendre les mesures necessaires pour lever le plus possible ces obstacles. Objectifs : Determiner la proportion de patients âges hospitalises qui presentent des incapacites fonctionnelles les empechant de manipuler les emballages de medicaments et determiner les caracteristiques particulieres de ces patients qui pourraient servir a predire ce probleme. Methodes : Dans le cadre de cette etude d’observation prospective non randomisee, 60 patients âges ont ete selectionnes et on leur a demande d’executer diverses tâches minutees relatives a la manipulation des medicaments. Resultats : Le tiers des patients de cette etude presentaient une incapacite fonctionnelle generale a manipuler les emballages de medicaments. Un grand nombre de ces patients etaient incapables de distinguer les differentes couleurs des comprimes (25 ou 42 %) ou d’ouvrir et de prendre des comprimes d’un contenant sans fermeture de protection a l’epreuve des enfants (17 ou 28 %) ou d’une plaquette alveolee (7 ou 12 %). Les facteurs de risque individuels n’ont pas pu etre determines, bien que les patients qui presentaient une incapacite fonctionnelle etaient un peu plus âges (85,8 ans contre 81,7 ans, p = 0,003). Les pharmaciens ont passe en moyenne plus de 30 minutes a evaluer ces aptitudes. Conclusion : Plusieurs de ces patients âges hospitalises presentaient une incapacite fonctionnelle dans leur aptitude a executer des tâches specifiques, lors d’un test d’aptitude simple administre par le pharmacien. Toutefois, il a ete impossible de determiner le test ideal pour evaluer les aptitudes a la manipulation des medicaments chez les personnes âgees, qui englobe a la fois les aspects fonctionnels et cognitifs des tâches evaluees et peut etre administre par n’importe quel membre de l’equipe de soins de sante.

Campaign to Eliminate Use of Error-Prone Abbreviations

The FDA and the Institute for Safe Medication Practices (ISMP) announced a new campaign focused on the elimination of the use of error-prone abbreviations in medicine. It has long been recognized that the use of abbreviations in prescriptions and drug orders has been a root cause of a number of medication errors. The Joint Commission on Accreditation of Health Care Organizations (JCAHO) has even specified that certain abbreviations must appear on an accredited organization’s do-not-use list since this type of error is easily preventable by avoiding the use of those abbreviations for drug names, dosage forms, dosage units, and within the SIG of a medication order. Despite this knowledge and previous efforts, medication errors still occur because the use of errorprone abbreviations in medical communications has not been eliminated. The new campaign includes a national education effort to eliminate the use of ambiguous medical abbreviations that are frequently misinterpreted and can lead to mistakes that result in patient harm. The target audience for the campaign is everyone involved with medical communication, including written medication orders, computer-generated labels, medication administration records, pharmacy or prescriber computer order entry screens, and commercial medication labeling, packaging, and advertising. These groups will include health care professionals, health care students, medical writers, the pharmaceutical industry, and FDA staff. The message will be delivered with targeted educational materials, articles for professional journals, and presentations at various conferences and meetings. By broadening the scope of this type of campaign, we can only hope that its impact will be greater than previous efforts targeted at only health care professionals. Components of this campaign include a brochure to be distributed to medical professionals, the pharmaceutical industry, and medical publishing professionals; a print public service ad that will be sent to professional trade publications; posters with reminders about commonly used error-prone abbreviations for health care facilities; an online tool kit of materials, including PowerPoint slides for presentations at conferences and meetings; and a patient safety video. All of these components can be accessed at www.fda.gov/cder/ drug/MedErrors and www.ismp. org/tools/abbreviations. Another useful tool is the list of error-prone abbreviations, symbols, and dose designations developed by ISMP. This list is easily accessible on the ISMP Web site (www.ismp.org) and makes a great reference piece near work stations and office computers. The success of this program in reducing medication errors is dependent on practitioner acceptance and implementation of these recommendations. We all need to do our part to ensure that this is a successful program, so we can decrease the risk of avoidable error from causing harm to our patients. So the next time you see one of these abbreviations, let the person that used it know about the problem and share some of these wonderful resources (brochure, posters, or Web sites) with them. You may also want to consider adding a section on or reference to this topic to your educational presentations (eg, inservices, continuing education, public forums). Each of these is an important step in decreasing the risk of a medication error and should be implemented whenever possible.

Patient safety, systems design and ergonomics

The complexity of the health care environments necessitates an holistic and systematic ergonomics approach to understand the potential for accidents and errors to occur. The health service is also a socio-technical system, and design needs must be met within this context. This paper aims to present the design challenges and emphasises the specialised needs of the health care sector, when dealing with patient safety. It also provides examples of approaches and methods that ergonomists can bring to help inform our knowledge of these systems and the potential towards improving their safety. Mapping workshops provide an example of such methods. Results from these are used to illustrate how the knowledge base required for better design requirements can be generated. The workshops were developed specifically to help improve the design of medication packaging and thereby reduce the probability of medication error. The issues raised are now the subject of further research, design requirements guidance and new design concepts. The paper illustrates the need to engage with the design community and, through the use of robust scientific methods, to generate appropriate design requirements.

Talking about…

Talking about…

Look-Alike, Sound-Alike Oncology Medications

Confusing medication names and packaging may cause or contribute to potentially harmful medication errors. The names of several chemotherapy and supportive agents can look or sound like the names of other chemotherapy agents or unrelated medications and can be inadvertently interchanged, or mixed up. Poor handwriting, abbreviations of medication names, unclear verbal medication orders, memory lapses, and the large volume of medications currently in use are risk factors for look-alike, sound-alike medication errors. Risk reduction strategies include being aware of medications that look or sound like other medications, installing pop-up alerts in computer systems, prescribing medications by their generic and trade names, placing eye-catching labels and warning stickers on storage bins, storing medications in nonadjacent areas, and advising patients to be alert for potential mix-ups with look-alike, sound-alike medications.

Evaluating Costs for Onychomycosis Treatments

Onychomycosis is a common problem. The desired outcome of treatment for patients and clinicians is complete cure (negative culture and negative potassium hydroxide examination results plus a completely normal nail). This cost analysis sought to determine the cost-effectiveness of treatments for onychomycosis using complete cure as a unit of effectiveness. A simplified cost-effectiveness analysis was conducted using complete cure rates from randomized, blinded clinical trials involving at least 50 participants. Trials were identified by searching the literature, manually searching for review articles, and reviewing medication package inserts. For each trial that met the entry criteria, three levels of cost were used to calculate medication cost per complete cure: commercial price, average wholesale price, and Veterans Affairs pharmacy price. In addition, a computerized economic model was used to determine total cost per complete cure, including all medical costs. The most cost-effective treatments were those that involved terbinafine: pulse, continuous, or in combination with other agents. Itraconazole, griseofulvin, and fluconazole were less cost-effective. Ciclopirox nail lacquer was at least three times more expensive than all other agents when evaluating total costs per complete cure. Overall, the lowest cost per complete cure resulted from terbinafine treatment, with most evidence supporting 3 months of continuous therapy.

Bar-coding medication administration overview and consensus recommendations

Bar-coded medication administration (BCMA) technology comprises a number of hardware and software components that may include a bar-code printing system for both wristbands and medication packages in the pharmacy, portable bar-code scanners interfaced to computers located near the patient, a

Drug Information Obscured on Over-the-Counter Medication Labels by External Tags

The objective of the study was to determine the quantity and quality of information obscured by anti-theft and price tags on over-the-counter (OTC) medication labels. A cross-sectional field study was conducted by examining OTC medication packages in two cities: Houston, Texas and East Lansing, Michigan. A total of 849 packages of 124 products containing acetaminophen or combinations which included acetaminophen were evaluated for the presence of external tags and the information obscured by them. The results illustrated that more price tags (60.7%) were present than antitheft tags (21.0%). Information concealed by tags was predominantly from the Drug Facts box (50.4%), namely, warnings (23.6%), active ingredients (9.3%), and product use (4.4%). The results revealed that inappropriate tagging practices obscure Food and Drug Administration-mandated information on OTC medication labels. These tags may make it difficult for consumers to make informed decisions regarding product selection and use, thus, strategies for improvement are suggested.

Obstruction of Critical Information on Over-the-Counter Medication Packages by External Tags

Over-the-counter (OTC) medication packages are important sources of information for consumers during product selection and use. Consumers may not be able to access information from OTC packages if external tags, namely price or anti-theft tags, are improperly placed. To determine the amount and type of information concealed by anti-theft tags and price tags affixed on OTC drug packages. A field study was performed by evaluating packages containing acetaminophen and combinations of acetaminophen in stores located in Houston. Five packages for 4 products selected from each store after an initial survey for presence of an external tag were examined. A data collection sheet was prepared that extracted the type and amount of information concealed by these tags. Data were analyzed by performing descriptive analyses to provide an understanding of the information obscured. A total of 24 stores were considered in the study, and 67 products and 285 packages were evaluated. External tags, both anti-theft and price tags, obscured significant amounts of information on the principal display panel (53.4%) and the Drug Facts panel (47.7%) of OTC packages. These tags concealed crucial information on various aspects of labels such as brand names (42.3%), product description (36.3%), warnings (51.5%), uses (10.4%), and purposes (7.2%). Results suggest that improper use of external tags clearly obscured important information on OTC medication packages necessary for consumers to make informed decisions regarding product selection and use. Tagging practices should be altered to allow consumers full access to drug information on the product.

Out-of-hospital medication storage temperatures:: a review of the literature and directions for the future

The United States Pharmacopeia (USP) National Formulary prescribes the packaging, storage, and distribution of medications. Most of the medications commonly used by emergency medical services (EMS) are intended for storage at “controlled room temperature.” The USP definition of controlled room temperature is multifaceted and complex, and cannot be easily described as a simple range of acceptable temperatures, or even as an average temperature. The out-of-hospital environment is notoriously uncontrolled, and one of the uncontrolled aspects of that environment is temperature. This report reviews and summarizes the past 15 years of published research relating to out-of-hospital medication temperature exposures. Although the evidence is clear that EMS medication storage is not consistent with the USP definition of controlled room temperature, the impact of EMS medication storage on medication stability and potency remains unclear. Further research is needed to determine the true extent of the EMS medication storage problem, and to develop and validate appropriate solutions.

OUT-OF-HOSPITAL MEDICATION STORAGE TEMPERATURES: A REVIEW OF THE LITERATURE AND DIRECTIONS FOR THE FUTURE

The United States Pharmacopeia (USP) National Formulary prescribes the packaging, storage, and distribution of medications. Most of the medications commonly used by emergency medical services (EMS) are intended for storage at “controlled room temperature.” The USP definition of controlled room temperature is multifaceted and complex, and cannot be easily described as a simple range of acceptable temperatures, or even as an average temperature. The out-of-hospital environment is notoriously uncontrolled, and one of the uncontrolled aspects of that environment is temperature. This report reviews and summarizes the past 15 years of published research relating to out-of-hospital medication temperature exposures. Although the evidence is clear that EMS medication storage is not consistent with the USP definition of controlled room temperature, the impact of EMS medication storage on medication stability and potency remains unclear. Further research is needed to determine the true extent of the EMS medication storage problem, and to develop and validate appropriate solutions.

MEDICATION INCIDENTS (ERRORS) RELATED TO THE PRESCRIBING, DISPENSING AND ADMINISTRATION OF MEDICINES TO THE OLDER PERSON

Objectives To present the best available evidence related to the identification and management of medication incidents (errors) associated with the prescribing, dispensing and administration of medicines in the older person in the acute, subacute, and residential care settings. Questions The specific review questions to be addressed are: • What types of medication incidents (errors) have been identified in the acute, subacute and residential care settings? • What causes of medication incidents (errors) have been identified in the acute, subacute and residential care settings? • What strategies/interventions are most effective in reducing the incidence of medication incidents (errors) in the acute, subacute and residential care settings? Criteria for considering studies for this review Types of participants Those people who are involved in the prescribing, dispensing or administering of medication to the older person (aged 65 years and older) in the acute, sub acute or residential care settings will be included in the review, namely: • Registered nurses • Enrolled nurses (or equivalent eg. LPN) • Pharmacists • Physicians/medical practitioners (or equivalents) • Personal care attendants/ancillary staff (or equivalent) Types of interventions All studies reviewing the following will be included in the review: 1. Identification of different types of medication incidents (errors)in the acute, sub-acute and residential settings 2. a. preventable • incidents (errors) in prescribing of medication (dose, route, time, patient, legibility, known allergies) • incidents (errors) in dispensing of medication (packaging, labelling) • incidents (errors) in method of administration of a drug (drug, dose, route, time, patient, known allergies) b. non-preventable 3. Strategies to prevent medication incidents (errors) in the acute, sub-acute and residential settings Types of outcome measures The outcome measures of interest to be considered will include: • Identification of the causes of medication incident (error) • Strategies that reduce the number and type of medication incident (error)

Instructions Leaflets On Antiepileptic Drugs Prescribed For Migraine Prophylaxis May Compromise Compliance

Objective: Prophylactic treatment of migraine may be done with a variety of drugs, including antiepileptic drugs (AEDs). However, the leaflets inserted in the medication seemed to discourage patients to use these AEDs. Methods: Individual interviews with forty individuals suffering from migraine who claimed to follow prescriptions given by doctors they trusted, independently of instructions inserted in medication packages. Results: After reading these leaflets about AEDs used for migraine, two-thirds of these individuals said they would not take the drug, which was too strong, specific for epilepsy or had serious side effects. Conclusion: The instruction leaflets accompanying AEDs apparently discourage patients to comply with prescriptions based on good results from clinical trials. This result seems to add to the high burden of migraine to the public and private health systems. Work performed at the Department of Neurology, Faculty of Medicine, Universidade Metropolitana de Santos, SP, Brazil. Work performed with financial support, no conflicts of interest to declare. This work was presented in a poster format at the XVII Brazilian Congress of Headache, Recife, Brazil, August 2003.

Findings from the ISMP Medication Safety Self-Assessment® for Hospitals

Hospital medication practices should be assessed, awareness of the characteristics of a safe medication system heightened, and baseline data to identify national priorities established. A cross-sectional survey of U.S. hospitals (N = 6,180) was conducted in May 2000. The survey instrument contained 194 self-assessment items organized into 20 core characteristics and 10 larger domains. Hospitals were asked to voluntarily submit their confidential assessment data to the Institute for Safe Medication Practices (ISMP) for aggregate analysis. A weighting structure was applied to the individual items and used to calculate core characteristic scores, domain scores, and overall self-assessment scores. These scores were then compared to identify areas most in need of improvement. The 1,435 participating hospitals scored highest in domains related to drug storage and distribution; environmental factors; infusion pumps; and medication labeling, packaging, and nomenclature issues. These hospitals scored lowest in domains related to accessible patient information, communication of medication orders, patient education, and quality processes such as double-check systems and organizational culture. Enormous opportunities exist to improve medication safety, especially in domains related to culture, information management, and communication.

Package Inserts and the Standard of Care

A number of pending and new claims involve diet drugs, hormone replacement therapy, cerivastatin (Baycol), oxycodone (OxyContin), troglitazone (Rezulin), thimerosal, and nefazodone hydrochloride (Serzone). One issue is intertwined in all of these claims: the relation between a medication's package insert (also referred to as product information, prescribing information, or Physicians' Desk Reference [PDR] listing) and the standard of care applicable to a prescribing physician. In a lawsuit, the manufacturer will attempt to use this information to deflect blame away from it and toward the prescribing physician as part of a general defense strategy or to establish the applicability of the “learned intermediary” doctrine. In addition, juries often attach a great deal of significance to package insert information and can be led to believe that this information sets forth a standard of care or practice guideline. Therefore, package insert information is used by claimants in drug litigation claims and mainstream malpractice cases to establish and/or support opinions about the applicable standard of care and deviations from that standard. For these reasons, the purpose of package insert information (whether in the form of product information, prescribing information, or PDR entry) and its relation to the practice of medicine needs to be understood and communicated to the court and jury throughout the defense of a claim that centers on the use of a medication. Otherwise, the prescribing physician runs a risk of being unfairly judged on information that is not meant to establish or reflect the applicable standard of care, does not contain or set forth a standard of care, and is not a practice guideline.

Manufacturers' compliance with the US Food and Drug Administration's Over‐the‐counter Human Drugs: Labeling Requirements

AbstractThe use of over‐the‐counter (OTC) medications is increasing every year among consumers for symptomatic relief of ailments. Consumers have difficulties in reading and comprehending information on the OTC medication packages. A standardized format to present information on OTC medication packages was necessary; hence the FDA announced guidelines, Over‐the‐counter Human Drugs: Labeling Requirements, on 11 March 1999. Manufacturers have been given 6 years since 1999 to comply with the FDA guidelines. The objective of our study was to evaluate marketed OTC medication packages to determine the extent of adoption of the FDA guidelines by manufacturers. Packages (n ± 104) of OTC medication products from three different categories, viz. pain relievers, cough and cold remedies and stomach remedies, were evaluated for general information, written information and product claims. The Compugraphic point system scale was used to measure the font size of written information. In addition variables recommended by the FDA, such as bullets, paragraphs and hyphenations, were also evaluated. All the variables were coded in a database and analysed using the SAS (Version 8.2) statistical package. The study found that some manufacturers have adopted the FDA guidelines. However, many manufacturers did not implement several aspects of the guidelines. Although manufacturers still have a few more years to adhere to the guidelines, early implementation could benefit the consumers. Copyright © 2003 John Wiley & Sons, Ltd.

Reported Likelihood of Reading Over-the-Counter (OTC) Medication Labeling and Contacting a Physician

The present research examined the extent to which consumers reported reading information on over-the-counter (OTC) packaging and labels. Two studies consisting of a total of 652 participants were conducted. Study 1 participants completed a survey in which they reported their OTC medication behaviors in terms of saving the packaging from the medication and the likelihood that they would contact a physician with OTC medication questions. In Study 2, participants completed a survey in which they reported the likelihood of reading information on the medication packaging and label both before and after using the product the first time. Results indicated that participants frequently discard the box after using medication and rarely call a physician with questions regarding OTC medications. Findings also indicated that information is more likely to be read prior to using medication than afterwards. Age, sex, and student status differences in reading behaviors were also found. Implications for the delivery of OTC medication information are discussed.