Misuse of medical devices: a persistent problem in self-management of asthma and allergic disease

Anaphylaxis is a concerning disorder because of its life-threatening potential and increasing incidence. It is well established that intramuscular epinephrine is a life-saving therapy in anaphylaxis; however, patients frequently do not understand how to self-administer the medication. The problem of incorrect epinephrine autoinjector use is documented in the literature with rates of correct use as low as 22%.1Sicherer S.H. Foreman J.A. Noone S.A. Use assessment of self-administered epinephrine among food-allergic children and pediatricians.Pediatrics. 2000; 105: 359-363Crossref PubMed Scopus (233) Google Scholar, 2Arkwright P.D. Farragher A.J. Factors determining the ability of parents to effectively administer intramuscular adrenaline to food allergic children.Pediatr Allergy Immunol. 2006; 17: 227-229Crossref PubMed Scopus (78) Google Scholar This misuse has been documented in cases of fatal anaphylaxis.[3]Pumphrey R. An epidemiological approach to reducing the risk of fatal anaphylaxis.in: Castells M. Anaphylaxis and Hypersensitivity Reactions. Springer-Verlag New York LLC, New York, NY2011: 13-31Crossref Scopus (13) Google Scholar Furthermore, health care professionals also lack knowledge of correct autoinjector technique.[1]Sicherer S.H. Foreman J.A. Noone S.A. Use assessment of self-administered epinephrine among food-allergic children and pediatricians.Pediatrics. 2000; 105: 359-363Crossref PubMed Scopus (233) Google Scholar Lack of certainty about device administration is a major barrier to medication use.[4]Gallagher M. Worth A. Cunningham-Burley S. Sheikh A. Epinephrine auto-injector use in adolescents at risk of anaphylaxis: a qualitative study in Scotland, UK.Clin Exp Allergy. 2011; 41: 869-877Crossref PubMed Scopus (83) Google Scholar Asthma is likewise a critically important disease. Inhalational devices are first-line therapy in asthma but are frequently misused. Up to 92% of asthmatic patients incorrectly use inhalers.[5]Sleath B. Ayala G.X. Gillette C. et al.Provider demonstration and assessment of child device technique during pediatric asthma visits.Pediatrics. 2011; 127: 642-648Crossref PubMed Scopus (81) Google Scholar Problems are not limited to one type of device. Rather, various device types are misused.[6]Rootmensen G.N. van Keimperna A.R. Jansen H.M. de Haan R.J. Predictors of incorrect inhalation technique in patients with asthma or COPD: a study using a validated videotaped scoring method.J Aerosol Med Pulm Drug Deliv. 2010; 23: 323-328Crossref PubMed Scopus (158) Google Scholar Even among medical personnel, rates of correct use are suboptimal.[7]Hanania N. Wittman R. Kester S. Chapman K. Medical personnel's knowledge of and ability to use inhaling devices.Chest. 1994; 105: 111-116Crossref PubMed Scopus (244) Google Scholar This misuse translates into reduced clinical efficacy of therapy.[8]Giraud V. Roche N. Misuse of corticosteroid metered dose inhaler is associated with decreased asthma stability.Eur Respir J. 2002; 19: 246-251Crossref PubMed Scopus (454) Google Scholar Furthermore, improving technique improves clinical outcomes.[9]Lindgren S. Bake B. Larssen S. Clinical consequences of inadequate inhalation technique in asthma.Eur J Respir Dis. 1987; 70: 93-98PubMed Google Scholar This study sought to identify factors associated with incorrect use of metered-dose inhalers (MDIs) and epinephrine autoinjectors. Another objective was to determine whether the rates of correct use have improved since earlier reports. Patients (and parents of minor children) previously prescribed autoinjectable epinephrine (EpiPen or EpiPen Jr) or MDIs and spacers (various product brands) were enrolled from multiple clinic sites of an academic allergy/immunology practice. Participants demonstrated how they used the device and were evaluated compared with established standards. For epinephrine the manufacturer's instructions for use were the standard, and for MDIs a previously published standard was adapted (eTable 1).[7]Hanania N. Wittman R. Kester S. Chapman K. Medical personnel's knowledge of and ability to use inhaling devices.Chest. 1994; 105: 111-116Crossref PubMed Scopus (244) Google Scholar Performance of each step was scored as correct: yes or no. The χ2 and Fisher exact tests were used to evaluate data. A total of 102 patients using epinephrine and 44 patients using MDIs with spacers were enrolled from adult and pediatric clinics. The most common reason for epinephrine prescription was receipt of allergen immunotherapy. Other indications included food allergy, venom allergy, and anaphylaxis due to another cause. All patients with MDIs and spacers had asthma. Most patients in both groups were female. A total of 11% of patients reported previous epinephrine autoinjector use, and 80% in the MDI and spacer group reported having used their MDI with a spacer. Other patient characteristics are summarized in eTable 2. A total of 16% of patients used the epinephrine autoinjector properly. Of the remaining 84%, 56% missed 3 or more steps (eFig 1A). The most common error was not holding the unit in place for at least 10 seconds after triggering. A total of 76% of erroneous users made this mistake (eFig 1B). Other common errors included failure to place the needle end of the device on the thigh and failure to depress the device forcefully enough to activate the injection. The least common error was failing to remove the cap before attempting to use the injector. A total of 7% of MDI users demonstrated perfect technique. Of the remaining 93%, 63% missed 3 or more steps (eFig 1C). The most commonly missed step was exhaling to functional residual capacity or residual volume before actuating the canister. A total of 66% of imperfect users failed to perform this step (eFig 1D). Other common errors were not realizing that a horn-type sound from the spacer indicated the inhalation was performed imperfectly and not shaking the inhaler before administering the second medication puff. The least common error was failure to insert the spacer mouthpiece between the lips. Men more often demonstrated correct use of the epinephrine autoinjector (P = .001, Fig 1). In addition, younger patients and those with prior medical education, including nursing school, medical school, or emergency medical technician training, were more likely to use it perfectly (P = .05 and P = .03, respectively; Fig 1). White race was also associated with correct use (P = .05, Fig 1). Of epinephrine users, 42% were prescribed the device less than 1 year before enrollment. Of this group, 10% demonstrated perfect use. A total of 34% of participants received the autoinjector 1 to 5 years earlier (5% perfect use) and 24% more than 5 years earlier (1% perfect use); however, the difference in perfect users among the 3 time-based groups did not reach statistical significance (P = .12). Participants' ability to demonstrate correct use did not correlate with clinic site, educational level, living with a family member with the same device, or prior use of the device. Among MDI and spacer users, 39% received the prescription less than 1 year before study participation. None of the factors examined correlated to correct device use. We found that the problem of misuse of both epinephrine autoinjectors and MDIs and spacers persists. Despite the redesign of the device to promote ease of use, most patients continued to make at least one mistake with the autoinjector. Furthermore, most patients made multiple mistakes and would not have benefitted from self-administration of the potentially life-saving treatment if the need arose. Likewise, incorrect use of MDIs and spacers was common. Typically, multiple steps were performed improperly, consistent with previous reports. Fortunately, most participants were able to complete more than half of the steps properly, and the common errors demonstrated by MDI users would typically result in diminished drug delivery rather than no delivery at all. Previous reports indicate that medical personnel are as likely as patients to misuse epinephrine autoinjectors. However, this study found that prior medical education correlated with perfect use of the device. Prior studies indicate that patients under the care of allergists/immunologists were more likely to use the device correctly.1Sicherer S.H. Foreman J.A. Noone S.A. Use assessment of self-administered epinephrine among food-allergic children and pediatricians.Pediatrics. 2000; 105: 359-363Crossref PubMed Scopus (233) Google Scholar, 2Arkwright P.D. Farragher A.J. Factors determining the ability of parents to effectively administer intramuscular adrenaline to food allergic children.Pediatr Allergy Immunol. 2006; 17: 227-229Crossref PubMed Scopus (78) Google Scholar Because all participants in the current study were recruited from an allergy/immunology practice, this was not a variable, but overall rate of correct use of both devices was low despite allergist/immunologist care. This study supported previous findings that younger patients tended to demonstrate correct autoinjector use more often. A limitation of this study is the small number of patients in the MDI and spacer group. This limitation affected the ability to identify significant correlations between patient characteristics and incorrect device use. It is clear, however, that there is room for improvement in ensuring that patients are able to correctly self-administer medications. Repeated verbal instruction and, perhaps even more effective, repeated visual education, including demonstration using trainer devices, are highly recommended. Novel methods of providing this repetitive training for patients are needed. We thank the Oliver Center for Patient Safety and Quality Healthcare for grant support and Yong-Fang Kuo, PhD, and Karen Pierson for assistance with statistical analysis. eTable 1Device technique standardsTechnique for use of EpiPen1.Remove safety cap2.Hold device in palm3.Using a swinging motion, place the orange tip on the outer thigh4.Push in hard until the trainer function is heard5.Hold in place for 10 seconds*Note: manufacturer's instructions were used as the standard though there is some evidence that EpiPen devices inject entire dose in less than 10 seconds.Technique for use of metered-dose inhaler (MDI) with spacer1.Remove caps from MDI and spacer and connect2.Hold MDI and spacer together and shake3.Exhale to functional residual capacity or residual volume4.Tilt head back or keep level5.Insert mouthpiece between lips6.Actuate canister once7.Inhale slowly and deeply8.Should hear a hissing sound and not a whistle9.Hold breath 5–10 seconds (may repeat steps 7–9)10.Wait 30–60 seconds11.Shake again before a second actuation Open table in a new tab eTable 2Characteristics of study populationCharacteristicTotal No. (%) of patientsAll steps correct, No. (%)P valueYesNoEpinephrine autoinjector groupSex.001 Male38 (37)12 (12)26 (25) Female64 (63)4 (4)60 (59)Race.05 White67 (66)14 (14)53 (52) Other35 (34)2 (2)33 (32)Age, y.05 <4040 (39)10 (10)30 (29) ≥4062 (61)6 (6)56 (55)Household family member with same device14 (14)014 (14).12Prescribed <5 years ago77 (76)15 (15)62 (61).11Has used device11 (11)2 (2)9 (9).69<4-Year college education47 (47)5 (5)42 (42).27Medical education18 (18)6 (6)12 (12).03MDI and Spacer GroupSex>.99 Male14 (32)1 (2)13 (30) Female30 (68)2 (4)28 (64)Race>.99 White26 (59)2 (4)28 (64) Other18 (41)1 (2)17 (39)Age, y.54 <4016 (36)2 (4)14 (32) ≥4028 (64)1 (2)28 (61)Household family member with same device14 (32)014 (32).54Prescribed <5 years ago17 (39)1 (2)16 (36)>.99Has used device35 (80)3 (7)32 (73)>.99<4-Year college education20 (45)1 (2)19 (43)>.99Medical education11 (25)1 (2)10 (23)>.99 Open table in a new tab Health care professionals' understanding of the use of a metered-dose inhalerAnnals of Allergy, Asthma & ImmunologyVol. 114Issue 6PreviewWe read with interest the letter by Bonds et al1 on the misuse of inhalational devices for asthma and anaphylaxis among patients in Texas. From an asthma standpoint, the problems with the use of a pressurized metered-dose inhaler (pMDI) include inability to coordinate inhalation with actuation, inadequate breath hold, fast inspiratory flow rate, hand strength, and ideomotor dyspraxia. Although swapping inhalers or the use of a spacer can help, proper education of patients is needed to improve technique. Full-Text PDF