Bruce L. Wolf

Accidental needle sticks, the Occupational Safety and Health Administration, and the fallacy of public policy

BACKGROUND Current Occupational Safety and Health Administration (OSHA) guidelines mandate the use of safety needles when allergy injections are given. Safety needles for intradermal testing remain optional. Whether safety needles reduce the number of accidental needle sticks (ANSs) in the outpatient setting has yet to be proven. OBJECTIVE To determine the rate of ANSs with new (safety) needles vs old needles used in allergy immunotherapy and intradermal testing. METHODS Allergy practices from 22 states were surveyed by e-mail. RESULTS Seventy practices (28%) responded to the survey. Twice as many ANSs occurred in practices giving immunotherapy when using new needles vs old needles (P < .01). The rate of ANSs was roughly the same for intradermal testing with new needles vs old needles. CONCLUSIONS These findings further question whether OSHAs guidelines for safety needle use in outpatient practice need revision and if allergy practices might be excluded from the requirement to use safety needles.

Unexpected decrease in total IgE in a patient with allergic bronchopulmonary aspergillosis treated with omalizumab.

Inhaled aspergillus in the sensitized allergic host can lead to the activation of Th2 lymphocytes and an intense inflammatory process known as allergic bronchopulmonary aspergillosis (ABPA). Often relapsing, patients with ABPA can go on to have bronchiectasis and/or extensive fibrosis. The algorithm of clinical treatment starts with high-dose tapering oral steroids and may require chronic steroid use and/or antifungal (azole) therapy. Omalizumab, a monoclonal anti-IgE that the US Food and Drug Administration indicated for the treatment of moderate-to-severe persistent allergic asthma, has also been used to treat other IgE mediated diseases, including ABPA. Dosing of omalizumab is based on a nomogram that factors baseline total IgE and a patient’s weight in kilograms. A now 80-year-old, 66-kg man presented to us 3 years ago with lifelong cough and chest congestion, and a history of recent hospitalization for right and possible bilateral lower lobe pneumonia. He was referred to our office by a pulmonologist, already prescribed prednisone 20mgQD, to consider possible ABPA after finding a total IgE of 4163 kU/L. Percutaneous skin testing was positive for Aspergillus fumigatus. Subsequently, IgG-precipitins to A fumigatus were found to be negative. The A fumigatus-specific IgE was positive at 4.30 kUa/L. FEV1 was 1.61 L (61% of predicted) and unchanged with albuterol. A chest computed tomography of the patient showed emphysematous changes and bibasilar infiltrates consistent with pneumonia but no bronchiectasis. The patientmet the criteria for ABPA-S and was started on prednisone 40 mg every day (QD), tapering over months. The referring pulmonologist added Sporanox (Janssen Pharmaceuticals, Titusville, NJ) 200 mg twice a day (BID) for 16 weeks to his regimen. Initially, the patient’s total IgE lowered to 1064 kU/L. However, even when his IgE was at its nadir, the patient continued to have some “congestion” of his airways and rhonchus sounds on lung examination. Once free from prednisone for 2 months, chest congestion and cough worsened, which coincided with a total IgE of 3405 kU/L. He was given a longer course of prednisone, tapering over 5 months. He became less symptomatic, and his IgE decreased to 1428 kU/L; when off prednisone, his IgE rose to 3766 kU/L. The patient was started on a prednisone taper yet again. For the better part of a year, he was maintained on daily prednisone. Subsequently, he reported increasing adverse effects (weight gain, lower extremity edema, altered mental status). When his steroid dose was reduced (<20 mg every other day [QOD]), the circulating total IgE level invariably started to rise significantly. In an effort to minimize steroid adverse effects, Voriconazole (Pfizer, New York, NY) 100 mg BID was added for 6 months. IgE diminished 20% to 2020 kU/L. Voriconazole was then discontinued, and the patient remained on prednisone 10 mg/ d alternating with 5 mg/d. His other medications included Advair (GlaxoSmithKline, Research Triangle Park, NC) 500/ 50 mcg BID, Aggrenox (Boehringer Ingelheim, Ridgefield, Conn) (aspirin and dipyridamole) 25/200 mcg BID, omeprazole 40 mg QD, amlodipine 2.5 mg QD, glucosamine chondroitin QD, Co-Q-10 200 mg 2 QD, and vitamins QD. Two months later, in August 2012, total serum IgE level was 2678 kU/L. The patient felt well clinically, and it was agreed that we would continue to closely observe him. Six weeks later, he had an asthma exacerbation that hospitalized him. Prednisone was started at 60 mg BID for 1 week, then 40 mg QD for 2 weeks, then 40 mg QOD. A baseline total IgE was not drawn at that time. In October 2012, the patient was started on omalizumab 375 mg every 2 weeks. Eight weeks later, after 6 doses of omalizumab, the total IgE by using the ADVIA Centaur Immunoassay System (Solstas Lab, Greensboro, NC) was 246 IU/mL (0.0-180). When serology was repeated by using ImmunoCAP (IBT Reference Lab, Lee’s Summit, Mo), his serum total IgE was 1117 IU/L (3-48, labs reported normal range) and A fumigatusspecific IgE was 0.93 kUa/L. These values were confirmed by the Johns Hopkins DACI Laboratory, Baltimore, Maryland, by using ImmunoCAP at 1181 IU/L and 0.77 kUa/L, respectively. Aspergillus precipitins also was rechecked and again found to be negative. Eighteen weeks later, after 11 successive doses of omalizumab, the patient had been tapered to prednisone 20 mg QOD. Serum IgE by ImmunoCAP was 1226 IU/mL. Most recently, after 10 months of omalizumab, the patient’s total IgE was 1089 IU/mL. Clinically, the patient continues to experience cough and dyspnea, yet his steroid dosing has been reduced by 85% to prednisone 5 mg QOD (Figure 1).

A distortion of sample size

The costs and needs of health care continue to increase in a down-trending economy. Pharmaceutical companies have pared down their sales forces; it is hypothesized that fewer field representatives are leaving fewer sample medications. We have surveyed sample medications (and their average wholesale price costs) given to our allergy practice during the last 12 years and first 4 months of 2009 (Table 1).1,2 This calendar year, we estimate that the pharmaceutical industry is extrapolated to give our practice

Economic realities and the health plight of Americans.

340,000 worth of samples and an additional

The diagnosis and management of anaphylaxis: An updated practice parameter

65,000 in free vouchers. Comparisons to past years must take into account not only escalating drug costs but also that our practice has oscillated between 1 and 2 physicians and 1 and 2 nurse practitioners straddling 2 to 3 offices.3 Taking all factors (eg, inflation, type of health care professional, practice locations) into account, we estimate that the number of donated samples has decreased 25%. The provision of 1 drug, fluticasone propionate (Advair) decreased substantially in sample volume from

Near-fatal anaphylaxis after Hymenoptera venom immunotherapy

125,000 to

Reality testing: In reply to Fuhlbrigge and Sullivan

88,000 when comparing 2005 with 2009. This difference was made up for by other drugs in its class entering the marketplace. In addition, vouchers for free medication, noticeably on the rise, made the total amount of medicine given relatively stable. The corporate strategy of sampling seems healthy, albeit changing. Sample medications, often maligned,4,5 remain a key marketing vehicle for pharmaceutical companies and an important adjunct to help patients experience a drug before incurring its cost. Sample medications may also help indigent patients with acute care needs and help bridge them to patient assistance programs that supply medications for chronic disease states. One nonprofit organization, TheDispensary ofHope (www. dispensaryofhope.org), has provided a conduit for interested physicians of all types to contribute a portion of their samples to less fortunate individuals. To date, samples worth upwards of

282 Retrospective review of 89 patients (P) with anaphylaxis (A)

20,000,000 have been given and, in turn, forwarded to both uninsured and underinsured patients in 7 states who earn less than 200% of the federal poverty guidelines. Pharmaceutical companies’ contributions remain significant over time and, although somewhat less relative to the past, may be more meaningful than ever to patients at this time.

Largess, excess, and tithing.

Advair 100/50 193 210 234 259 274 Advair 250/50 240 262 291 321 340 Advair 500/50 316 344 383 422 448 Symbicort 80/4.5 199 212 229 247 267 Symbicort 160/4.5 228 242 262 283 305 Dulera 100/5 226 237 251 288 309 Dulera 200/5 226 237 251 288 309 Nexium 20 195 207 226 268 284 Nexium 40 195 206 226 268 284 repeats itself countless times. People are finding it difficult to catch their breath. They feel hungry for air. They have trouble completing even the smallest, simplest task. Much of their waking time is spent worrying and imagining how they might breathe better given that their medicines are unaffordable. The cost of living invariably increases over time. That said, medication prices have increased at an exorbitant and alarming rate during the past several years. Take the example seen with combination inhaler therapy (longacting b-agonist and corticosteroid), the first choice to treat moderate to severe asthma.1 There are no generic alternatives. The 3 branded combination options, Advair, Symbicort, and Dulera, have seen their average wholesale prices increase 34% to 42% from 2010 through 2014 (Table 1).2 In contrast, during the same period, the consumer price index (commonly estimated as 3% per year) increased only a total of 10%.3 Thus, the reality of medication pricing far exceeds the forces of inflation alone. Why do drug prices increase so much? Isn’t there the expectation that in a free marketplace, one with multiple competitors, prices would be driven down, not up? Economic theory teaches that if demand exceeds supply, then prices reasonably might increase. (The demand for breathing medicines is not inelastic; the need for the medicinemight be). Otherwise, competition is a prerequisite to lower prices, right? For these 3 asthma drugs, the reality is counterintuitive. Consider 3 gas stations at an intersection, locally owned competitors, cater-cornered across the street from one another. Commonly, to increase business, 1 gas station would lower prices to gain business. However, prices of individual drugs have dramatically increased, not decreased, in parallel with one another. This trend is not limited to asthma medication but is seen with other branded medications such as proton pump inhibitors used to treat gastrointestinal reflux (Table 1). Moreover, prices may be even more grossly exaggerated for specialty drugs and generics, many of which report price increases exceeding 1,000% during short intervals.4