Post-market Review of Chronic Obstructive Pulmonary Disease Medicines ToR 5 Final Report August 2017
MedicineInsight data source and limitations
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- 5.8 MedicineInsight COPD patient profile
- 5.9 MedicineInsight drug utilisation
- 5.9.2 Co-prescribing in 2016
- 5.9.3 Initial therapy for COPD
- 5.9.4 Associated care for COPD patients
- 5.9.5 Adverse events
5.7 MedicineInsight data source and limitationsThis analysis investigates the use of medicines by patients with COPD, with or without asthma, in the MedicineInsight data. The information presented is based on GP clinical data collected from volunteer practices recruited to the MedicineInsight program. Further information on the MedicineInsight program is available at the NPS MedicineWise webpage. The MedicineInsight Post-Market Surveillance Report 11 was developed with the purpose to inform the post-market review and medicines policy for COPD. Results from Report 11 are summarised below. The full Report is available at Appendix T. For this analysis on COPD medicines prescribing practices, MedicineInsight data was drawn from 423 clinically relevant practice sites, 3,835 active GPs, and 2,230,658 active patients, to 31 December 2016 inclusive. This analysis uses the following information from the clinical data: Patient demographics (including age, sex, Department of Veterans Affairs (DVA) status, rurality of residence, socioeconomic status). Medicines prescribed (including medicine generic name, trade name, ATC classification, reason for prescription). Encounters (including reason for encounters). Diagnosis/Condition. Test results, Observations and MBS service items (Spirometry tests). Allergy/Adverse event status. All analyses were cross-sectional. The study time period was 1 January 2016 to 31 December 2016 inclusive, unless otherwise specified. All PBS/RPBS prescriptions for COPD medicines were extracted for the period from 1 January 2012 to 31 December 2016. All PBS/RPBS prescriptions for the smoking cessation therapies were extracted up to 31 December 2016. The list of COPD medicines of interest used in this analysis included all PBS listed SABA, SAMA, LAMA, LABA, ICS, ICS/LABA, and LAMA/LABA medicines. Medicines used in smoking cessation analysis include: nicotine, bupropion and varenicline. The subset of regular patients ‘active’ in the clinical information system (CIS) 35 years and over who attended a clinically relevant practice 3 or more times in the past 2 years, were included in the main analysis population (n=1,283,107). The report presents data addressing specific questions on the following topics: patient profile, patterns of drug utilisation, co-prescribing, initial therapy, associated care, and adverse events. The following limitations and issues with using data extracted from GP clinical information systems (CIS) should be noted: MedicineInsight data are dependent on the accuracy and completeness of data recorded in and available for extraction from the GP CIS. It is likely that there is under-reporting of clinical information, such as diagnoses, reasons for the encounter or medical history, as information may not be consistently recorded. Information entered in ‘progress notes’ is not currently collected by MedicineInsight. The classification of COPD, asthma and other respiratory conditions is based on commonly accepted definitions, and has been reviewed by two GPs. However, there is likely to be variability in GPs’ actual diagnostic labelling practices. Practices are recruited to MedicineInsight using non-random sampling, and systematic sampling differences between regions cannot be ruled out. Patients in the MedicineInsight database are currently unable to be uniquely identified across the program, although this functionality will be available in the future. Patients are uniquely recorded within a practice, and are recorded as a different patient if they move between practices. Medicine use information from MedicineInsight relates to records of GP prescribing, and therefore differs in several important ways from national PBS dispensing data. Not all prescriptions and repeats will be dispensed, i.e. prescription counts are an overestimate of dispensed prescription counts; specialist and hospital prescriptions are not included; and there may be a delay of up to 12 months between prescribing and dispensing. There is no visibility of instructions to patients about the use of different regimens for exacerbations versus maintenance therapy, and medicines may have been ceased without a record in the clinical system. The proportion of patients with a condition in the dataset does not necessarily reflect the prevalence of that condition. In fact patients with more severe disease/conditions will be more frequently represented in the dataset because they visit the doctor more often. A proportion of adverse reactions known to the GP may go unrecorded, e.g. when the reaction is unremarkable or symptoms are managed elsewhere, such as in hospital. Some adverse events may be recorded in the ‘progress notes’ which are not collected by MedicineInsight for confidentiality reasons. Coding of adverse reactions may differ slightly between MedicineInsight and TGA terms for some reactions. The report presents data addressing specific questions on the following topics: patient profile, patterns of drug utilisation, co-prescribing, initial therapy, associated care and adverse events. Refer to Appendix T for further detail on the methodology used in the MedicineInsight analysis.
The age-specific prevalence of patients diagnosed with COPD increased with patient age. The prevalence of COPD among MedicineInsight active patients 45 years and over was 5.9%, compared with 5.1% reported by the 2014–15 ABS National Health Survey. This somewhat higher prevalence estimate in the MedicineInsight data may be partially explained by the restriction in the report to the patient population that regularly visits GP practices (3 visits in the past 2 years). These patients are more likely to have chronic conditions than the general population from the Australian Health Survey who might visit the GP less regularly. The patient profile was similar to that reported elsewhere, with higher COPD prevalence rates among patients who were older, male, residing in regional and remote areas and in areas of higher socioeconomic disadvantage. As might be expected, MedicineInsight patients who were ex-smokers and current smokers were more likely to have a diagnosis of COPD compared to non-smokers. Patients who were underweight (BMI < 18.5) had a higher prevalence of COPD than those in the healthy or overweight ranges.
5.9.1 Number of prescriptionsIn MedicineInsight data in 2016, 51,903 prescriptions for the medicines of interest were ordered for regular patients with COPD only. The most commonly prescribed medicine classes for patients with COPD only were ICS + LABA (31.8%), SABA (27.1%) and LAMA (26.2%). The most commonly prescribed medicines (original prescriptions) for patients with COPD only were salbutamol (26.0%), tiotropium (21.8%) and fluticasone + salmeterol (18.4%). In 2016, 54,197 prescriptions for the medicines of interest were ordered for patients with COPD plus asthma. The most commonly prescribed medicines (by class) for patients with COPD plus asthma were: ICS/LABA (36.3%), SABA (31.4%) and LAMA (19.2%). The most commonly prescribed medicines (original prescriptions) for patients with COPD plus asthma were: salbutamol (30.1%), fluticasone propionate/salmeterol (20.9%) and tiotropium (15.8%). Refer to Table 5.8 for the proportion of prescriptions by class/medicine for COPD only and COPD plus asthma patients, for the most commonly prescribed classes/medicines. Table 5.8 Most commonly prescribed medicines of interest for patients with COPD only, and COPD plus asthma, in 2016 (MedicineInsight)
From 2012 to 2016, the annual rate of all COPD prescriptions for COPD only patients increased from 9.0 to 11.2 scripts per 100 GP visits. The annual rate of all COPD prescriptions for COPD plus asthma patients was higher than for COPD only patients, and remained relatively stable with a mean average between 2012 and 2016 of 18.6 scripts per 100 GP visits. A relatively high proportion (41.6%) of patients with COPD (with or without asthma) had no prescriptions for medicines of interest printed in 2016. There are a number of potential explanations for this somewhat surprising result including: a proportion of patients with mild COPD treated with over-the-counter salbutamol, patients being prescribed medicines for COPD elsewhere (e.g. another practice or specialist), patients having enough prescriptions ordered at the end of 2015 to last all of 2016, poor adherence, true management (under-treatment gap), or patients who left the practice in 2016 but were included in the report because they had 3 visits in the last 2 years. 5.9.2 Co-prescribing in 2016According to patients’ current medications, 52.7% (n=20,352) of the patients with COPD only and 80.8% (n=16,558) of the patients with COPD plus asthma were currently on at least one maintenance therapy (i.e. LAMA, LABA or ICS). With regard to medicine combinations associated with safety concerns, these analyses suggest that around 3.9% of patients with COPD only on maintenance therapy may be at risk of having duplicated therapy and an additional 1.6% had concomitant use of a SAMA and a LAMA. Of patients with COPD plus asthma on maintenance therapy, 6.1% may be at risk of having duplicated therapy and 3.2% had concomitant use of a SAMA and a LAMA. Uses of ICS/LABA with a LABA, LAMA/LABA or a second ICS/LABA were the most common duplicated therapy combinations. This suggests that there may be some confusion among practitioners about the composition of the different formulations and the possibility of adverse events when certain formulations are combined. 5.9.3 Initial therapy for COPDOf the 30,650 regular patients 35 years and over with COPD only, the MedicineInsight research project identified 3,043 who started therapy with a COPD medication (excluding SABA) between 1 July 2015 and 31 December 2016. Of these, 48.6% were prescribed only one medicine of interest as initial therapy, 46.3% were prescribed dual therapy, and 5.1% triple therapy. The most common choices of initial therapy by class were: dual therapy with ICS + LABA (38.5%), LAMA monotherapy (35.9%), and LAMA + LABA dual therapy (7.4%). A significant amount of combination use of COPD medications was therefore observed to be outside clinical guidelines (51.4%). The most common choices of initial therapy by individual medicine(s) were: tiotropium (23.5%), fluticasone propionate/salmeterol (17.5%) and budesonide/formoterol (16.4%). When comparing initial therapy for COPD only in the earlier period (July 2013 to June 2015) with the current period (July 2015 to December 2016), initial therapy with: LAMA increased from 27.3% to 35.9% LAMA + LABA increased from 1.9% to 7.4% ICS + LABA decreased from 47.1% to 38.5% ICS + LABA + LAMA decreased slightly from 5.5% to 5.1%. Overall, while prescribing for patients with COPD only appeared to conform to guidelines in many cases, there was good evidence of inappropriate prescribing. It was not possible to provide definitive evidence of inappropriate prescribing without an understanding of the severity and stage of the disease. However, the COPD-X guidelines recommend a stepwise approach to the initiation of COPD therapy, irrespective of treatment severity, until adequate control has been reached. This analysis found that 46.3% of patients with COPD only were prescribed dual therapy at initiation and 5.1% triple therapy.
Overall, among patients with COPD (all), 26.3% (n=15,584) had ever been prescribed smoking cessation therapies. Among the 17,082 current smokers with COPD, 54.5% (n=9,313) had ever been prescribed smoking cessation therapy and of the 29,140 ex-smokers, 20.1% (n=5,865) had ever been prescribed smoking cessation therapy. 5.9.5 Adverse eventsThe number of AEs were recorded in the MedicineInsight program for COPD regardless of the indication for therapy. Refer to Table 5.9 for the number of AEs by medicine class and a description of common AEs. Table 5.9 The number of adverse events recorded by drug class (MedicineInsight)
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