Pharmaceutical Claims Research Articles

Effect of electronic prescribing with formulary decision support on medication tier, copayments, and adherence.

BackgroundMedication non-adherence is prevalent. We assessed the effect of electronic prescribing (e-prescribing) with formulary decision support on preferred formulary tier usage, copayment, and concomitant adherence.MethodsWe retrospectively analyzed 14,682 initial pharmaceutical claims for angiotensin receptor blocker and inhaled steroid medications among 14,410 patients of 2189 primary care physicians (PCPs) who were offered e-prescribing with formulary decision support, including 297 PCPs who adopted it. Formulary decision support was initially non-interruptive, such that formulary tier symbols were displayed adjacent to medication names. Subsequently, interruptive formulary decision support alerts also interrupted e-prescribing when preferred-tier alternatives were available. A difference in differences design was used to compare the pre-post differences in medication tier for each new prescription attributed to non-adopters, low user (<30% usage rate), and high user PCPs (>30% usage rate). Second, we modeled the effect of formulary tier on prescription copayment. Last, we modeled the effect of copayment on adherence (proportion of days covered) to each new medication.ResultsCompared with non-adopters, high users of e-prescribing were more likely to prescribe preferred-tier medications (vs. non-preferred tier) when both non-interruptive and interruptive formulary decision support were in place (OR 1.9 [95% CI 1.0-3.4], p = 0.04), but no more likely to prescribe preferred-tier when only non-interruptive formulary decision support was in place (p = 0.90). Preferred-tier claims had only slightly lower mean monthly copayments than non-preferred tier claims (angiotensin receptor blocker: $10.60 versus $11.81, inhaled steroid: $14.86 versus $16.42, p < 0.0001). Medication possession ratio was 8% lower for each $1.00 increase in monthly copayment to the one quarter power (p < 0.0001). However, we detected no significant direct association between formulary decision support usage and adherence.ConclusionInterruptive formulary decision support shifted prescribing toward preferred tiers, but these medications were only minimally less expensive in the studied patient population. In this context, formulary decision support did not significantly increase adherence. To impact cost-related non-adherence, formulary decision support will likely need to be paired with complementary drug benefit design. Formulary decision support should be studied further, with particular attention to its effect on adherence in the setting of different benefit designs.

Intradermal and virosomal influenza vaccines for preventing influenza hospitalization in the elderly during the 2011–2012 influenza season: A comparative effectiveness study using the Valencia health care information system

BackgroundThe use of intradermal vaccination or virosomal vaccines could increase protection against influenza among the vulnerable population of older adults. Studies assessing the comparative effectiveness of these two influenza vaccine types in this age group are lacking. MethodsWe conducted a retrospective cohort study to estimate the comparative effectiveness of intradermal seasonal trivalent-influenza vaccine (TIV) delivered by a microneedle injection system and a virosomal-TIV intramuscularly delivered for prevention of influenza hospitalization in non-institutionalized adults aged ≥65 years. We obtained administrative data on immunization status and influenza hospitalization for the 2011–2012 influenza season, and used Cox regression models to assess comparative effectiveness. We estimated crude and adjusted (age, sex, comorbidity, pharmaceutical claims, recent pneumococcal vaccination and number of hospitalizations for all causes other than influenza between the previous and current influenza seasons) hazard ratios (HR). ResultsOverall, 164,021 vaccinated subjects were evaluated. There were 127 hospitalizations for influenza among 62,058 subjects, contributing 914,740 person-weeks at risk in the virosomal-TIV group, and 133 hospitalizations for influenza among 101,963 subjects, contributing 1,504,570 person-weeks at risk in the intradermal-TIV group. The crude HR of intradermal-TIV relative to virosomal-TIV was 0.64 (95% confidence interval (CI): 0.50–0.81), and the adjusted Cox estimated HR was 0.67 (95% CI: 0.52–0.85). ConclusionsDuring the 2011–2012 influenza season the risk of hospitalization for influenza was reduced by 33% in non-institutionalized elderly adults who were vaccinated with intradermal-TIV compared with virosomal-TIV.

Are high coronary risk patients missing out on lipid-lowering drugs in Australia?

To examine whether high coronary risk patients in Australia, where use of lipid-lowering drugs (LLD) is very high by international standards, are receiving LLD. Assessment of Pharmaceutical Benefits Scheme pharmacy payment claim records between January 2006 and May 2013 for a 10% random sample of Australian concession card holders. Co-prescriptions were used as a surrogate for high coronary risk groups - coronary heart disease (CHD): antiplatelet drugs (not including solo aspirin) and anti-anginal drugs; diabetes: all standard drugs; hypertension: all standard drugs (not including solo diuretics). Proportions of patients in high-risk groups not receiving LLD (statins, fibrates or ezetimibe). The database yielded information on 276,212 patients defined as being at high coronary risk (mean age, 66.1 [SD, 14.8] years; 44% male). Of this group, 115,477 patients (42%) had not received any LLD during the study period. For patients in the risk group for CHD in combination with diabetes and hypertension, only 8% (1111/14,257) were not receiving LLD. Across all risk groups, the proportions not receiving LLD were generally highest in those aged ≥ 81 years and, to a lesser extent, < 41 years, and were lowest in those aged 51-70 years. A large proportion of concession card holders at high coronary risk, especially those in middle age with CHD and multiple risk factors, are being appropriately prescribed LLD in Australia.

Quantifying Prognostic Impact of Prescription Narcotics Use Before Kidney Transplantation through Linked Registry and Pharmaceutical Claims Data.

Concern for an epidemic of complications related to prescription opioids has not spared the kidney transplant (KT) population. We examined a novel database wherein OPTN identifiers for KT recipients were linked to records from a U.S. pharmaceutical claims clearinghouse (2005 to 2010). Adult KT recipients with 1yr of captured pre-transplant pharmacy fill records were included (N=29,882). Narcotics fills in the year prior to KT were normalized to Morphine Equivalents (ME), and expressed as average mg/kg/d exposures. Associations of ME with post-transplant graft and patient survival (adjusted hazards ratio, aHR) were quantified by Cox regression adjusted for recipient, donor and transplant factors as well as propensity for narcotics use. 28.9% of the sample filled narcotics in the year before KT. Among narcotics users, the 25th, 50th and 75th percentiles of ME were: 0.01, 0.02, and 0.06 mg/kg/d, respectively. 3-yr survival of deceased donor (DD) recipients declined with higher quartiles of ME exposure, from 88.9% among non-users to 87.6% (Q2), 85.3% (Q3), 83.2% (Q4) (P<0.0001). After multivariate adjustment, the risks of post-transplant death and graft loss in DD recipients with the highest quartile ME exposure were 1.6-times and 1.4-times that of narcotic non-users, respectively (Table). Patterns were similar among live donor KT recipients, with the upper quartile of pre-transplant narcotics exposure predicting 2.4 times the risk of death (P<0.0001) and 1.8 times the risk of all-cause graft loss (P<0.0001) (Table).Table: No Caption available.Table: No Caption available.While observed associations may in part reflect underlying conditions that require pain management, KT recipients who use chronic narcotics should be identified as a high-risk group warranting focused clinical attention before and after KT.

Racial Variation in the Use of Antihypertensive Medications After Living Kidney Donation.

We linked Organ Procurement and Transplant Network (OPTN) registry data for living kidney donors (LKD, 1987-2007) with pharmaceutical billing claims (2000-2007) from a private health insurer to identify post-donation antihypertensive medication (AHM) use. Multivariate Cox regression with left and right censoring was used to estimate associations of demographic factors (adjusted hazards ratios, aHR) with use of any AHM and medication subclasses. LKD were also matched 1-to-1 with non-donor general insurance beneficiaries by sex and age at start of benefits. The maximum observation time in each LKD-control pair was limited to the shortest available in the pair. Medication Possession Ratio (MPRs) were computed as (Days of AHM dispensed)/(Days observed). Among 4,650 LKD, average age at donation was 37 yrs and 13% were African American (AA). Median times from donation to start and end of captured insurance records were 4.9 and 7.7 yrs, respectively. As compared with white LKD, AA LKD had 37% higher relative likelihood of AHM use after donation (aHR 1.37, P<0.0001), including more than twice the likelihood of diuretic use (aHR 2.25, P<0.0001) and significantly higher ACEi/ARB (aHR 1.46, P<0.01) and calcium channel blocker (aHR 1.56, P=0.03) use (Table). AHM MPRs were higher among LKD captured after, compared with before, the median time from donation to enrollment, 18% vs 5% (Figure). However, MPRs for any AHM and subcategories were lower among LKD compared with age- and sex-matched non-donors.Figure: No Caption available.Use of AHM after living kidney donation is higher among AA vs white LKD, and also appears to increase with time after donation. However, AHM use in LKD is lower than in age and sex-matched matched general beneficiaries. Further research should compare AHM medication use in LKD versus persons selected for baseline good health, across demographic groups.

Abstract 169: The Role Of Clinical Prediction Factors On Anticoagulant Selection In Atrial Fibrillation

Background: Atrial fibrillation (AF) often benefits from the use of anticoagulants for prevention of stroke or systemic embolism. While novel oral anticoagulants have emerged as possible alternatives to warfarin, it is unknown how treatment selection is determined in practice with clinical guidelines still evolving. This study examined whether and to what extent anticoagulant selection has been driven by clinical predictions of stroke risk (treatment benefit) and bleeding risk (treatment harm) in real-world practice in the US. Methods: A nationwide database of commercial and Medicare Part D supplement claims from 2009-2011 was used to extract a cohort of non-valvular AF patients who were newly-initiating therapy after dabigatran availability in Oct 2010. Patients were excluded if they had claims associated with a reversible AF condition. Risk scores of ischemic stroke (CHADS2 and CHA2DS2-VASc) and bleeding (ATRIA) were used to examine associations with either warfarin or dabigatran use, calculated via claims in the outpatient pharmaceutical, inpatient medical, outpatient, and provider claims files. Baseline demographic and clinical characteristics were also measured as covariates, including concomitant diseases and medications. Multivariable log-binomial regression models assessed the association between each risk score and anticoagulant use, adjusting for the measured covariates. C-statistics were also used to examine the variation in treatment selection explained by inclusion of the risk scores. Results: In total, 37,401 patients were identified with 31% initiating dabigatran. New users of dabigatran were more likely to be younger, male, and have comorbidities. Patients at intermediate stroke risk (CHADS2 or CHA2DS2-VASc =1) were equally likely to receive warfarin and dabigatran (RR, 95% CI: 0.98, 0.93-1.02), while selection for warfarin was significantly associated with high ischemic stroke risk (CHADS2 or CHA2DS2-VASc ≥2) (RR, 95% CI: 0.87, 0.83-0.92). New users of dabigatran were significantly less likely to have high bleeding risk (ATRIA≥5) versus warfarin (RR, 95%: 0.70, 0.66-0.74). The c-statistic of the base model, which included the other measured covariates, was only marginally increased with the addition of any of the risk scores. Conclusions: Despite controlling for other patient characteristics, bleeding risk was strongly associated with the selection of a specific anticoagulant. However, the extent of selection explained by predictions of treatment harm was minimal. Providers appear to base anticoagulant selection on factors other than predictions of treatment benefit, which has implications for studying the anticoagulants’ comparative effectiveness.

Associations of drug burden index with falls, general practitioner visits, and mortality in older people.

On a population level in people aged ≥65 years old living in New Zealand, the aim of this study is to quantify each individual's cumulative exposure to anticholinergic and sedative medicines using the Drug Burden Index (DBI) and examine the impact of DBI on fall-related hospitalisations, general practitioner (GP) visits, and all-cause mortality. The study used data extracted from Pharmaceutical Claims Data Mart (2011), National Minimum Data set (2012), Births, Death and Marriages (2012) and GP Visits (2012) for patient demographics, hospitalisations and mortality. Cumulative anticholinergic and sedative exposure was measured using the DBI. Polypharmacy was defined as greater than or equal to five medicines dispensed concurrently at any time during the study period. Amongst the study population (n = 537,387; 45% male), 43.22% were exposed to DBI drugs (95% confidence intervals (CIs) = 43.09-43.35). The odds of DBI exposure for individuals with polypharmacy are 4.92 (95%CI = 4.86-4.98) times greater than that for individuals without polypharmacy. DBI drugs were associated with fall-related hospitalisations (incidence rate ratio (IRR) 1.56, 95%CI = 1.47-1.65) and greater number of GP visits (IRR 1.13, 95%CI = 1.12-1.13). Individuals with DBI > 0 had a 1.29 times higher mortality risk (95%CI = 1.25-1.33). Polypharmacy is also associated with a higher mortality risk with a hazard ratio (HR) of 1.66 (95%CI = 1.59-1.73). Polypharmacy and exposure to DBI drugs were independently associated with fall-related hospitalisations, frequency of GP visits, and risk of mortality. On a population level, DBI may be useful as a quality indicator to guide policy to improve prescribing and optimize clinical outcomes in older people.

Are older Western Australians exposed to potentially inappropriate medications according to the Beers Criteria? A 13‐year prevalence study

To examine time trends and factors associated with exposure to potentially inappropriate medications (PIMs) by the Beers Criteria. PIM consumption days accumulated from the pharmaceutical claims of 251 305 Western Australians aged ≥65 years (1993-2005) and person follow-up times produced counts/rates. Logistic/Poisson regression generated odds/rate ratios. A total of 187 616 participants (74.7%) took ≥1 PIM (1993-2005), the cohort consuming 109 415 PIM daily doses/1000 person-years. Annual exposure decreased from 45-47% to 40%, and annual consumption rate declined from 117 836 to 90 364 daily doses/1000 person-years. Temazepam had the highest exposures (>17 000 daily doses/1000 person-years). Number of medications taken (OR 35.03; 95% CI 34.37-35.71 for ≥10 vs. 0-2 drugs), annual drug intake (2.08; 2.04-2.12 for highest vs. lowest quartile), and high-level residential aged care (1.96; 1.91-2.01) were most predictive of PIM exposure. PIM exposure remains high in older Western Australians. Our findings identify patients most at risk and medications to consider on Australia-specific PIM lists.

Impact of Specific Beers Criteria Medications on Associations between Drug Exposure and Unplanned Hospitalisation in Elderly Patients Taking High-Risk Drugs: A Case-Time-Control Study in Western Australia

Certain broad medication classes have previously been associated with high rates of hospitalisation due to related adverse events in elderly Western Australians, based on clinical coding recorded on inpatient summaries. Similarly, some medications from the Beers Criteria, considered potentially inappropriate in older people, have been linked with an increased risk of unplanned hospitalisation in this population. Our objective was to determine whether risk estimates of drug-related hospitalisations are altered in elderly patients taking 'high-risk drugs' (HRDs) when specific Beers potentially inappropriate medications (PIMS) are taken into consideration. Using the pharmaceutical claims of 251,305 Western Australians aged ≥65years (1993-2005) linked with other health data, we applied a case-time-control design to estimate odds ratios (ORs) for unplanned hospitalisations associated with anticoagulants, antirheumatics, opioids, corticosteroids and four major cardiovascular drug groups, from which attributable fractions (AFs), number and proportion of drug-related admissions were derived. The analysis was repeated, taking into account exposure to eight specific PIMs, and results were compared. A total of 1,899,699 index hospitalisations were involved. Of index subjects, 12-57 % were exposed to each HRD at the time of admission, although the proportions taking both an HRD and one of the selected PIMs were much lower (generally ≤2%, but as high as 8% for combinations involving temazepam and for most PIMs combined with hypertension drugs). Included PIMs (indomethacin, naproxen, temazepam, oxazepam, diazepam, digoxin, amiodarone and ferrous sulphate) all tended to increase ORs, AFs and drug-related hospitalisation estimates in HRD combinations, although this was less evident for opioids and corticosteroids. Indomethacin had the greatest overall impact on HRD ORs/AFs. Indomethacin (OR 1.40; 95% confidence interval [CI] 1.27-1.54) and naproxen (OR 1.22; 1.14-1.31) were associated with higher risks of unplanned hospitalisation than other antirheumatics (overall OR 1.09; 1.06-1.12). Similarly, among cardiac rhythm regulators, amiodarone (OR 1.22; 1.13-1.32) was riskier than digoxin (OR 1.08; 1.04-1.13). For comparisons of drug-related hospitalisation estimates, temazepam yielded the greatest absolute increases, especially with hypertension drugs. Indomethacin and temazepam should be prescribed cautiously in elderly patients, especially in drug combinations. Furthermore, it appears other antirheumatics should be favoured over indomethacin/naproxen and, in situations where both drugs may be appropriate, digoxin over amiodarone. Our methodology may help assess the safety of new medications in drug combinations in preliminary pharmacovigilance investigations.

Compliance and persistence to oral bisphosphonate therapy following initiation within a secondary fracture prevention program: a randomised controlled trial of specialist vs. non-specialist management

Following initiation of oral bisphosphonate therapy through a secondary fracture prevention program, 2-year treatment compliance and persistence remained high and were similar in patients randomised to follow-up by either the program or primary care physician. Thus, community-based and specialist management are equally effective in supporting compliance and persistence with anti-osteoporotic treatments. The purpose of this study was to determine whether management by a secondary fracture prevention (SFP) program (aka "fracture liaison service") results in better compliance and persistence to oral bisphosphonate therapy than follow-up by the primary care physician, after initiation within an SFP program. This prospective RCT included 102 patients with incident osteoporotic fractures referred to a SFP program in Sydney, Australia. Following oral bisphosphonate therapy initiation, patients were randomised to either 6-monthly follow-up with the SFP program (group A) or referral to their primary care physician with a single SFP program visit at 24 months (group B). Compliance and persistence to treatment were measured using pharmaceutical claims data. Predictors of compliance and persistence and associations between compliance and persistence, and changes in bone mineral density (BMD) or bone resorption marker, urinary deoxypyridinoline over 24 months were analysed. The median medication possession ratio at 24 months was 0.78 (IQR, 0.50-0.93) in group A and 0.79 (IQR, 0.48-0.96) in group B (p = 0.68). Persistence at 24 months was also similar in both groups (64 vs. 61%, respectively; p = 0.75). After adjusting for confounders, patients in group A were not more likely to be compliant (OR, 1.06; 95% CI, 0.46-2.47) or persistent (HR, 0.83; 95% CI, 0.27-1.67) than those randomised to group B. Time-based changes in BMD or bone turnover were not associated with compliance or persistence. Compliance and persistence to oral bisphosphonate therapy remain high amongst patients initiated within an SFP program, with community-based and SFP program management being equally effective in maintaining therapeutic compliance and persistence over 2 years. These results indicate that one of the main functions of an SFP program may be the initiation of therapy rather than continuous patient monitoring.

Association Between Potentially Inappropriate Medications From the Beers Criteria and the Risk of Unplanned Hospitalization in Elderly Patients

Predisposition to adverse drug events with advancing age has led to the development of lists of potentially inappropriate medications (PIMs) to be avoided in the elderly, such as the Beers Criteria. The prevalence of Beers medications has been studied widely, but it is still unclear whether PIM use is predictive of adverse events in older people. To examine potential associations between exposure to PIMs from the general Beers list and unplanned hospitalizations in elderly Western Australians. Using an enhanced case-time-control design and conditional logistic regression applied to the pharmaceutical claims and other linked health data of 251 305 Western Australians aged ≥65 years (1993-2005), odds ratios for unplanned hospitalization were obtained, from which attributable fractions, number and proportion of hospitalizations associated with drug exposure were derived. Based on the health profiles of 383 150 hospitalized index subjects, overall PIM exposure was associated with an elevated risk of unplanned hospitalization (adjusted odds ratio = 1.18; 95% confidence interval = 1.15-1.21), this estimated risk increasing with the number of different PIMs and PIM quantity taken. Fifteen percent of unplanned hospitalizations in exposed index subjects (1980 per year) were attributed to PIM exposure. Patients taking meperidine (pethidine), nitrofurantoin, promethazine, indomethacin, and thioridazine appeared to be at particularly high risk of unplanned hospitalization, whereas temazepam, oxazepam, diazepam, digoxin, amiodarone, ferrous sulfate, and naproxen were attributed the greatest numbers of unplanned hospitalizations. Due caution prescribing Beers medications in the elderly seems justified, paying particular attention to PIMs listed above and to the concurrent use of multiple PIMs. Our results also support the retention of specific medications on PIM lists in future developments.

The State Of The Art Defence: Defining the Australian Experience in the Context of Pharmaceuticals

One of the defences within Part 3-5 of the Australian Consumer Law is the state of the art, or development risk defence. This defence, although significant, has often been neglected in Australian jurisprudential analysis and has triggered at most generic academic analysis. However, with the rise of pharmaceutical and medical device litigation in Australia, it could become a vital weapon for Australian manufacturers against product liability claims. This paper will firstly review the two ways this defence could operate. It will also discuss the three types of defects which the defence could apply to. This paper aims to determine exactly when and how this defence should apply in Australia, in the context of pharmaceutical product liability claims.

Are high-care nursing home residents at greater risk of unplanned hospital admission than other elderly patients when exposed to Beers potentially inappropriate medications?

To compare the risk of unplanned hospitalization in high-care nursing home residents taking Beers potentially inappropriate medications (PIM) against that of other elderly. Using an enhanced case-time-control design and conditional logistic regression applied to the pharmaceutical claims and other linked data of 245436 Western Australians aged ≥ 65 years (1993-2005), the study derived odds ratios for unplanned hospitalization in each group, from which attributable fractions, numbers, proportions and rates of PIM-related admissions were derived. Overall, 383150 unplanned hospitalizations were identified. PIM exposure was associated with a similar proportional increase in unplanned hospitalizations in high-care nursing home residents as in other older people; adjusted OR 1.21 (95% CI 1.10-1.34; attributable fraction 17.5%) versus OR 1.19 (95% CI 1.16-1.21; attributable fraction 15.7%). However, high-care nursing home residents had much higher estimated rates of hospitalizations attributed to Beers medications than other elderly (3951 vs 1394 per 100000 person-years). The relative risk of unplanned hospitalization rose similarly in both groups with increasing numbers of different PIM taken (OR 5.1 for 10 vs 0 PIM), but was affected more markedly by 3-month PIM consumption in nursing home residents (OR 4.85, 95% CI 2.40-9.83 for 900 vs 0 PIM daily doses) than in other older adults (OR 2.10, 95% CI 1.73-2.55). High-care nursing home residents do not appear to have a greater relative risk of unplanned hospitalization when given PIM, but do incur a higher absolute burden than other older adults. Physicians should exert caution with Beers medications in all older patients, restricting the number of different PIM and PIM quantity prescribed whenever possible.

Adverse selection? A multi-dimensional profile of people dispensed opioid analgesics for persistent non-cancer pain.

ObjectivesThis study investigates utilisation patterns for prescription opioid analgesics in the Australian community and how these are associated with a framework of individual-level factors related to healthcare use.MethodsSelf-reported demographic and health information from participants in the 45 and Up Study cohort were linked to pharmaceutical claims from 2006–2009. Participants comprised 19,816 people with ≥1 opioid analgesic dispensing in the 12-months after recruitment to the cohort and 79,882 people not dispensed opioid analgesics. All participants were aged ≥45 years, were social security pharmaceutical beneficiaries, with no history of cancer. People dispensed opioid analgesics were classified as having acute (dispensing period <90 days), episodic (≥90 days and <3 ‘authority’ prescriptions for increased quantity supply) or long-term treatment (≥90 days and ≥3 authority prescriptions).ResultsOf participants dispensed opioid analgesic 52% received acute treatment, 25% episodic treatment and 23% long-term treatment. People dispensed opioid analgesics long-term had an average of 14.9 opioid analgesic prescriptions/year from 2.0 doctors compared with 1.5 prescriptions from 1.1 doctors for people receiving acute treatment. People dispensed opioid analgesics reported more need-related factors such as poorer physical functioning and higher psychological distress. Long-term users were more likely to have access-related factors such as low-income and living outside major cities. After simultaneous adjustment, association with predisposing health factors and access diminished, but indicators of need such as osteoarthritis treatment, paracetamol use, and poor physical function were the strongest predictors for all opioid analgesic users.ConclusionsPeople dispensed opioid analgesics were in poorer health, reported higher levels of distress and poorer functioning than people not receiving opioid analgesics. Varying dispensing profiles were evident among people dispensed opioid analgesics for persistent pain, with those receiving episodic and long-term treatment dispensed the strongest opioid analgesics. The findings highlight the broad range of factors associated with longer term opioid analgesics use.

Incidence of Sudden Sensorineural Hearing Loss

Recent data regarding the incidence of sudden sensorineural hearing loss (SSNHL) in the United States is lacking. The objective of this study was to assess the current day incidence of SSNHL in the United States using data from a medical and pharmaceutical claims database containing information for more than 60 million unique patients. Population-based cross-sectional analysis. Inpatient and outpatient. Patients in the database are reported to be representative of the national, commercially insured population on a variety of demographic measures including age, sex, health plan type, and geographic location. During 2006 and 2007, the annual incidence of SSNHL was 27 per 100,000 in the United States. The incidence increased with increasing age, ranging from 11 per 100,000 for patients younger than 18 years to 77 per 100,000 for patients 65 years and older. There was an overall slight male preponderance with a male-to-female ratio of 1.07:1. This was more pronounced in patients 65 years and older, with a ratio of 1.30:1. More than 66,000 new cases of SSNHL are seen annually in the United States. The disorder is more common in men and the elderly.

Do pharmaceutical claims accurately reflect oncology prescribing practice? Evidence from an Australian HER2+ early breast cancer cohort (HER2EBC).

100 Background: Pharmaceutical claims are used increasingly to investigate the real-world use and impact of prescribed medicines. Claims databases are established for payment purposes, lack clinical data and only capture prescriptions for which insurers pay a contribution. We compare Pharmaceutical Benefits Scheme (PBS) dispensing claims of HER2EBC patients, with prescriptions written in oncology clinics to determine the accuracy of dispensing data to identify treatment protocols and estimate treatment cycles and durations of therapy. Methods: Our cohort comprised 110 female HER2EBC patients commencing treatment at 4 Sydney cancer centres between 2008 and 2011. Patients consented to medical chart audit and linkage to PBS claims. We constructed protocols from prescribing and dispensing records independently, based on the timing of trastuzumab and cytotoxic treatments; estimated the median number of treatment cycles and duration of therapy by protocol; and compared prescription and dispensing data. Results: Patients’ median age was 53 years (range 21.1-86.2). Based on prescribing data, 67 patients received anthracycline-containing protocols, 43 received taxane only protocols. ACTH and TCH accounted for 90% of all protocols. 75 patients (68.2%) were assigned the same protocols based on prescribing and claims data; 26 did not match as cyclophosphamide falls below the patient copayment for general PBS beneficiaries and is not captured in the claims data. Compared with prescription data, number of treatment cycles was underestimated in dispensing data (ACTH: median 30 vs 44; TCH 26 vs 29); trastuzumab-based treatment is administered weekly in ACTH but only dispensed 3-weekly. Durations of therapy differed by ≤5% in dispensing versus prescription data (ACTH 422 days vs 466; TCH 368 vs 367). Conclusions: PBS dispensing data is reliable for establishing treatment protocols in concessional beneficiaries and duration of therapy in all patients. Claims data underestimates treatment cycles as administration occurs more frequently than dispensing. These limitations must be considered when undertaking population-based studies using claims data in HER2EBC.

Understanding Medical Care of Transplant Recipients through Integrated Registry and Pharmacy Claims Data

Background: Limited data exist on medication use aside from immunosuppression among large samples of kidney transplant recipients. Methods: We examined a novel database wherein Organ Procurement and Transplantation Network (OPTN) registry data were linked to records from a US pharmaceutical claims clearinghouse (2005-2010 claims) to examine pharmaceutical care at the first transplant anniversary (n = 16,157). We quantified the use of the following medication types within ±60 days of the first-year OPTN report according to estimated glomerular filtration rate (eGFR): antihypertensives, lipid-lowering, bone and mineral, and anemia treatments. Adjusted associations of medication use with eGFR and other clinical factors were quantified by multivariate logistic regression. Results: Requirements for multiple antihypertensive agents rose with lower eGFR, with β-blockers comprising the most commonly used antihypertensive agent. The adjusted likelihood of vitamin D (adjusted odds ratio (aOR) 2.07, 95% CI 1.19-3.59) and especially erythrocyte-stimulating agents (aOR 19.94, 95% CI 7.01-56.00) rose in a graded manner to peak with eGFR <15 versus >90, whereas statin use was most common with eGFR 30-59 ml/min/1.73 m². Black race was independently associated with increased use of all classes of antihypertensives and vitamin D, but lower adjusted statin use. Rapamycin-based immunosuppression was associated with increased use of statins and erythrocyte-stimulating agents. Conclusions: Integrated registry and pharmacy fill data provide a novel tool for pharmacoepidemiologic investigations of delivered post-transplant care. Transplant recipients with reduced renal function have increased requirements for pharmaceutical care of comorbidities. Causes of racial variation in medication fills warrant further investigation.

Anticholinergic Component of the Drug Burden Index and the Anticholinergic Drug Scale as Measures of Anticholinergic Exposure in Older People in New Zealand: A Population-Level Study

Older people are exposed to multiple medicines that possess anticholinergic properties. The use of anticholinergic medicines is associated with the risk of morbidity, mortality and cognitive decline, particularly in older people. Anticholinergic exposure can be measured using tools such as the Drug Burden Index-Anticholinergic component (DBI-ACh) and the Anticholinergic Drug Scale (ADS). The aim of this population-level study was to determine the extent of anticholinergic exposure in older people, particularly among those receiving acetylcholinesterase inhibitors in New Zealand. The study used data extracted from Pharmaceutical Claims Data Mart (Pharms) for the year 2011. A total of 537,387 individuals aged 65 years and older were included in the study, of whom 45.10 % were men. Individuals dispensed donepezil at any time during 2011 were selected as the acetylcholinesterase inhibitor (AChEI) group (n = 4,258) and the remainder were included in the non-acetylcholinesterase inhibitor (non-AChEI) group (n = 533,129). Anticholinergic exposure was measured using the DBI-ACh and the ADS. Analysis of the Pharms dataset revealed that, in 2011, anticholinergic exposure as defined by the DBI-ACh and the ADS was 31.80 % and 52.66 %, respectively. The mean number of medicines dispensed was 5.64 ± 3.91 (± SD) with a 95 % confidence interval of 5.63-5.65. In the AChEI group, anticholinergic exposure using the DBI-ACh and the ADS was 42.93 % (median 0; interquartile range (IQR) 1) and 58.50 % (median 0; IQR 0), respectively. ADS level 3 medicines such as amitriptyline, nortriptyline and oxybutynin were commonly prescribed in both groups. Amitriptyline, nortriptyline, oxybutynin and paroxetine are medicines considered to have significant anticholinergic potency. Of these medicines, nortriptyline and oxybutynin were more frequently prescribed in individuals taking donepezil. A significant proportion of older people are exposed to medicines with anticholinergic properties, including those dispensed acetylcholinesterase inhibitors. Further research is required to explore associations between different measures of anticholinergic exposure and clinically relevant outcomes in older people on a population level.

Ethnic disparities in asthma treatment and outcomes in children aged under 15 years in New Zealand: analysis of national databases

Background:Mãori and Pacific children experience poorer outcomes relating to asthma management than other ethnicities.Aims:To measure recommended treatment and outcomes for asthma in all New Zealand children by age, sex, and ethnic group.Methods:Children aged <15 years dispensed ≥2 asthma medicines (N=80,514) were identified from the national pharmaceutical claims database. We measured the number of children dispensed oral steroids ≥2 times and hospital admissions with a primary diagnosis of asthma and compared asthma treatment steps and hospitalisation by age and ethnicity.Results:16.0% of children were dispensed asthma medicines, 9.2% were dispensed medicine ≥2 times, 3.6% of children were hospitalised at least once for asthma and 98.9% of admissions were acute. Mãori (OR 1.46, 95% CI 1.41 to 1.51) and Pacific children (OR 2.38, 95% CI 2.28 to 2.47) were more likely to remain on the lowest step of treatment. At all steps of treatment, Mãori and Pacific children had higher rates of oral steroid use. In all age groups, more Mãori children (5.1%, OR 1.88, 95% CI 1.73 to 2.04) and Pacific children (5.6%, OR 2.05, 95% CI 1.84 to 2.29) were hospitalised for asthma than children of other ethnicities (2.8%).Conclusions:Mãori and Pacific children are less likely to have their treatment escalated to a higher step than other children. They are also more likely to use oral steroids to control asthma exacerbations and be admitted to hospital for severe asthma episodes. New Zealand databases can be used to monitor these outcomes.

Use of case–time–control design in pharmacovigilance applications: exploration with high‐risk medications and unplanned hospital admissions in the Western Australian elderly

To use a case-time-control design to derive preliminary estimates of unplanned hospitalisations attributable to suspected high-risk medications in elderly Western Australians. Using pharmaceutical claims linked to inpatient and other health records, the study applied a case-time-control design and conditional logistic regression to estimate odds ratios (ORs) for unplanned hospital admissions associated with anticoagulants, antirheumatics, opioids, corticosteroids and four major groups of cardiovascular drugs. Attributable fractions (AFs) were derived from the ORs to estimate the number and proportion of admissions associated with drug exposure. Results were compared with those obtained from a more conventional method using International Classification of Diseases (ICD) external cause codes to identify admissions related to adverse drug events. The study involved 1 899 699 index hospital admissions. Six of the eight drug groups were associated with an increased risk of unplanned hospitalisation, opioids (adjusted OR = 1.81, 95%CI 1.75-1.88; AF = 44.9%) and corticosteroids (1.48, 1.42-1.54; 32.2%) linked with the highest risks. For all six, the estimated number of hospitalisations attributed to the medication in the exposed was higher (two to 31-fold) when derived from the case-time-control design compared with identification from ICD codes. This study provides an alternative approach for identifying potentially harmful medications and suggests that the use of ICD external causes may underestimate adverse drug events. It takes drug exposure into account, can be applied to individual medications and may overcome under-reporting issues associated with conventional methods. The approach shows great potential as part of a post-marketing pharmacovigilance monitoring system in Australia and elsewhere.