Contents. Turkey 66 United Arab Emirates 67 United Kingdom 68 Uruguay 69 USA 70 Venezuela 71 Vietnam 72. Abstract 3. Ten Leading Pharm.

Size: px
Start display at page:

Download "Contents. Turkey 66 United Arab Emirates 67 United Kingdom 68 Uruguay 69 USA 70 Venezuela 71 Vietnam 72. Abstract 3. Ten Leading Pharm."

Transcription

1

2 Contents Abstract 3 Ten Leading Pharm. Markets 5 Accuracy 9 Retail Validation 1 Algeria 15 Argentina 16 Austria 17 Bangladesh 18 Bolivia 19 Brazil Bulgaria 21 Canada 22 Central America 23 Chile 24 Colombia 25 Croatia 26 Czech Republic 27 Dominican Republic 28 Ecuador 29 Egypt 3 Estonia 31 Germany 32 Greece 33 Hungary 34 India 35 Indonesia 36 Ireland 37 Italy 38 Japan 39 Jordan 4 Korea 41 Kuwait 42 Latvia 43 Lebanon 44 Lithuania 45 Malaysia 46 Mexico 47 Morocco 48 New Zealand 49 Pakistan 5 Paraguay 51 Peru 52 Philippines 53 Poland 54 Portugal 55 Saudi Arabia 56 Singapore 57 Slovak Republic 58 Slovenia 59 South Africa 6 Spain 61 Sri Lanka 62 Switzerland 63 Thailand 64 Tunisia 65 Turkey 66 United Arab Emirates 67 United Kingdom 68 Uruguay 69 USA 7 Venezuela 71 Vietnam 72 OTC Validation 73 Argentina 75 Austria 76 Brazil 77 Bulgaria 78 Czech Republic 79 Germany 8 Greece 81 Hungary 82 Mexico 83 Poland 84 Slovak Republic 85 South Africa 86 Switzerland 87 Venezuela 88 PharmaTrend Validation 89 Austria 91 Czech Republic 92 Finland 93 Germany 94 Hungary 95 Italy 96 Poland 97 Portugal 98 Spain 99 Switzerland 1 Hospital Validation 11 Austria 13 Bulgaria 14 Canada 15 China 16 Germany 17 Italy 18 Korea 19 Philippines 11 Spain 111 Switzerland 112 Thailand 113 Specialty Markets Validation 114 Forecasting Validation 116 Accuracy (continued) 119 Timeliness 124 Contact acts 12

3 Abstract Dear Client: The 26th Annual Report on IMS Quality, ACTS, serves as a regular update on the accuracy of our data and delivery speed for our reports and services. It is an IMS tradition to provide our customers with this important publication, demonstrating our strong commitment to quality, defined as accurate information provided at the right time. Every year, we work closely with around 2,5 customers worldwide to compare their sales records with our published data on more 7, individual pharmaceutical product forms. To measure timeliness, we screen more than 7, deliveries throughout the year and hold them against our company delivery standards. The results of the accuracy measurement for 11 became available at different points in time during 12. Once the last country provided results for its retail and hospital services, we were able to calculate world totals. This year, we are proud to report a significant overall improvement in precision to nearly 95 - a gain of.8 percentage points over 1. This positive trend was visible in many places and for many different types of data services a pleasant reward for the concerted effort we've made throughout the years and around the world toward ongoing improvement. This achievement is even more impressive in view of the changing market dynamics and evolving economic situations both in emerging and mature markets. The delivery side, where market challenges and dynamics have forced us to re-think our traditional operating models, has produced a different picture. Our solution to this business environment has been to pool production resources into powerful centers of excellence in different locations around the world. Given that such sweeping reengineering rarely goes without any impact on delivery performance, we consider a decline in delivery speed of.9 days in the first year of operating under this new model an acceptable impact. The intensive knowledge transfer taking place as staff in our off-shore sites scale steep learning curves gives us confidence that we will be able to turn this year's decline into forward progress after one or two years. Further details about our 12 results, in terms of both achievements and challenges, can be found in this 26th edition of the ACTS Report. We, the IMS Statistical Services Team, would like to thank you for your continuous interest in IMS's global quality results and for your collaboration in making this report possible. We are, of course, available to answer any questions you might have. Have you comments or suggestions? Please feel free to get back to me personally. Yours sincerely, Stefan Ziegele Vice President Global Statistical Services 3 acts 12

4 Key Achievements and Challenges 11/12 Accuracy Timeliness World retail precision index improved from 94. in 1 to 94.8 in 11 Twelve countries showed significant improvement in precision terms, facing six countries with documented decline Leading markets precision index improved from 95. in 1 to 95.6 in 11 Average number of delivery days increased from 24.7 days in 11 to 25.6 days in the first three quarters of 12 Average on-target percentage declined from 84.5 in 11 to 81.1 in the first three quarters of 12 Leading markets delivery increased by.6 days to 26.6 days in the first three quarters of 12 PharmaTrend precision index up by 2.2 percentage points to 95.9 in 11 Hospital data accuracy slightly up from 9.1 in 1 to 91.3 in 11 NEW: Specialty markets analysis now included, showing improvement from 93.9 in 1 to 95.1 in 11 Key drivers of accuracy all showed improvement or at least stability: o Universe Update Index from 92.4 in 11 to 93.7 in 12 o o Four countries with a significant expansion of their wholesaler panels Overall design fulfillment index stable at 9+ 4 acts 12

5 The Ten Leading Pharmaceutical Markets One of the most important assets IMS Health offers its clients is the global reach and consistently high standards of our market research data. With this in mind, the 12 edition of the ACTS Report provides insight into the quality of our services around the world. While pharmaceutical companies clearly plan and operate globally, they nonetheless concentrate their research and marketing activities in the largest markets. And rightfully so. The ten leading pharmaceutical markets constitute around 8 percent of total pharmaceutical revenues. In recognition of our clients interest in these ten leading markets, we provide a special focus within the ACTS Report on this group of key countries. The ranking of the leading markets typically shows only marginal changes from year to year. Compared to 1, the same countries were placed among the top ten, only China & France and Brazil & the United Kingdom have swapped places in 11: USA Japan Germany China France Italy Spain Canada Brazil United Kingdom Data precision and speed of delivery are the fundamental characteristics that best define the overall quality of IMS services. The ACTS Report, therefore, summarizes the results of measures taken in these areas. Data The way that we measure the preciseness of IMS data is duly described in the Accuracy section of this ACTS report. We consider the measure of precision the most relevant statistic to describe the quality of our data because it pertains more to the variability of deviations than to the deviations themselves. The following graph displays the precision measurement for those countries for which we have data spanning at least five consecutive years. China is included in the calculation with hospital validation results, however, due to low participation from our clients side, the results should be considered representative for the group of participants only and not for the entire audit. France is not included as there are no validation results available for the last seven years. 5 acts 12

6 Index Top 1 World The aggregated precision index for the remaining nine markets turned out at 95.6 in 11, a.6 percentage points improvement over 1. The world average came out.8 percentage points lower, at a similar improvement of.8 percentage points over the previous year. Leading Markets 7 11 (excluding France) USA Japan Germany China Italy Spain Canada Brazil United Kingdom Japan continued to hold the lead, with a nearly perfect precision value of 99.7 in 11, followed by Canada with 99.1 and Italy with Five leading market reports showed improvement over 1 and four countries were facing decline. All were well above the 9 margin except the United Kingdom with The data for China refer to the hospital market segment; there were no retail validation results available. In France, again and now in the seventh year, no validation study was conducted for 11. More details on the countries can be seen in the Accuracy section of this report. 6 acts 12

7 Timeliness Over the past years, delivery time across all world markets had stabilized below 25 days on average. Today, the average delivery time for all IMS services increased by.9 days over 11 to 25.6 days, which is one day shorter than the average delivery time for the top ten markets (26.6 days) that increased by.6 days. Elapsed Days after Reporting Period 4 35 Days Jan.-Sep. 12 Top 1 World Delivery Performance by Country IMS AREA ELAPSED DAYS OF DELIVERY Jan.-Sep DAYS EARLIER (-) / LATER (+) PERCENTAGE ON-TARGET * Jan.-Sep. 12 USA ± Japan Germany China France Italy Spain Canada Brazil United Kingdom * measured against delivery targets of 15/3/45 days for weekly/monthly/quarterly services Only France improved their delivery speed, from 27.7 to 27.5 days on average. The USA maintained their previous result of 22.9 days. The remaining eight countries all slowed down, most significantly Spain by 1.8 days, followed by Brazil (1.6 days) and Germany with 1.4 days. 7 acts 12

8 Measuring on-target delivery, Canada managed to improve their 11 delivery performance in the first three quarters of 12 to 97. Eight countries were facing decline, most significantly France with a reduction of eight percentage points to 69. Japan continued to hold the lead with an almost perfect score of 99 on-target delivery of their services. On-target indices below 8 need to get addressed and shall trigger appropriate action. This affects China, France, Spain, Brazil and particularly Italy. 8 acts 12

9 Accuracy The IMS Validation Studies, with their global reach and standardized measures, provide pharmaceutical companies with an impartial and forthright reference with which to judge the quality of IMS data. By thus reporting on the precision of IMS decision-support tools, validation studies facilitate pharmaceutical companies international decision making. The Validation Process IMS conducts its Validation Studies in close co-operation with our service subscribers. Once we complete our year-end pharmacy audit, we supply our subscribers with software that presents our estimated yearly sales volume for each product pack. Subscribers then enter their actual sales volume based on what they supplied to retail pharmacies. We then calculate an R-Value representing the ratio of estimated sales as projected by IMS to actual sales as reported by our industry partners. For each product examined, we calculate an individual R-Value. We also calculate an average R-Value across all validated product forms. R-Values indicate the scale of overestimation or underestimation in IMS results. An R-Value of 1. is the ideal and would mean that our projection matched reality exactly. Due to the nature of statistical sampling, R-Values typically deviate from 1., and it is only practical to strive for individual R-Values that are clustered tightly around this theoretical ideal. We express audit precision (or the degree of clustering) as the percentage of all individual R-Values that fall within a predefined range of deviation around the average R-Value. The standard precision range is ±22.5 percentage points, sometimes paired with a tighter range of ±17.5 percentage points around the average over/underestimation. The greater the data precision, the more tightly R- Values will be clustered in the centre of this range. A precision value of 9 percent, paired with a zero percent bias, can be interpreted as follows: On average, IMS audit data reflect a high degree of homogeneity since 9 percent of the validated product forms lie between 22.5 percent and percent of the reported industry numbers. If we were to apply the tighter ±17.5 percent precision range to the same data as an additional measure, an 85 percent value would indicate that: 85 percent of the validated product forms were between 17.5 percent and percent of the average R- Value and 5 percent deviated by more than ±17.5 percent but less than ±22.5 percent. The remaining 1 percent were outside the ±22.5 percentage range. 9 acts 12

10 Conceptually, comparing IMS audit estimates with manufacturer sales data requires that the numbers be fully compatible. This compatibility hinges on the ability of companies participating in the validation study to segregate their internal sales data, isolating those sales channeled to the pharmacy retailing sector. The degree to which they can do this correlates closely with the technical infrastructure of the country and the complexity of the distribution system. When sales to other market sectors (e.g., tenders, exports) are not segregated and instead are included in a company s sales, the assumption is that IMS data have underestimated reality, and consequently they are viewed as incorrect. Parallel trade practices add another element of incompatibility to the data. Typically, manufacturers are unaware of the sales volume that sub-distributors and pharmacies export to other countries (parallel exports) or import from other countries (parallel imports). In parallel export situations, the industry numbers are usually inflated by sales that never entered the domestic pharmacy market. Conversely, in parallel import situations in which the imported items are not isolated, for example through official parallel traders, IMS numbers are usually inflated. Due to growing issues with data incompatibility, validation studies are gradually losing some of their potency as an objective measure of accuracy. Thus we are in the process of evaluating measures of data relevance for those regions highly affected by parallel business (e.g., European rim). Nevertheless, we believe that once we exclude products typically traded in parallel from the validation process, the exercise still provides a good overall picture of the accuracy and trends achieved in the individual markets. Validation Study results are considered to be representative of the survey universe if more than percent of the market is reflected in what our data partners send us. If the total market coverage reported by our data partners falls between 1 and percent, validation results may still give a good indication of change from one year to the next, but otherwise must be used with care. Studies with participation rates less than 1 percent are included in the ACTS report but marked as not representative. The 11 Retail Validation Results Our clients often ask us why it takes us so long to publish validation studies, given that clients begin sending us their validation figures about 8-1 months before we complete the ACTS report. The answer is simply that it can take up to ten months for all clients in all countries to complete the survey. In the meantime, we regularly feed individual country results back to clients in those countries that are finished, and do so in relatively short time spans. This year, the last completed materials for 11 were returned to us in December 12. The 11 participation level decreased to a total of 4 companies on average participating in a country s validation process, compared to 44 companies in 1. In total, 2,469 company affiliates world-wide participated in the 11 validation surveys and supplied 74,195 product forms for analysis. 1 acts 12

11 Global Results For the 11 validation studies, 59 countries provided analyzable results. No validation study was necessary in Finland, the Netherlands and Norway because we collect full census data in these countries. There, precision results are assumed to be 1 percent. This makes a total of 62 sets of validation results, of which 55 had uninterrupted five-year results. The overall degree of precision in IMS pharmaceutical reports is best described by an aggregated precision index for these 55 countries. China is included in the calculation with hospital validation results, however, due to traditionally low participation in the CHPA validation, the results should be considered representative for the group of participants only rather than for the entire audit. World Index Overall, the World Index over the 5-year period documents solid outcome in maintaining existing levels of data quality. In 11, the index showed improvement of.8 percentage points over 1 and with 94.8 reached the same high precision level as in acts 12

12 Regional Results The 62 countries are distributed over the greater IMS regions as follows: Regional Distribution of North America Latin America North Europe & Africa Central Europe East Europe South Europe & Mid East 14 9 AsiaPacific Japan 7 3 China Regional Index 1/11 World North America Latin America North Europe & Africa Central Europe East Europe South Europe & Mid East Improvement Deterioration AsiaPacific Japan China acts 12

13 Seven regions managed to improve or maintain their 1 result also in 11. Japan continued to hold the lead with 99.7, followed by East Europe at Two regions showed slight deterioration compared to 1. All regions in detail and their main contributors are listed below: IMS REGION PRECISION 11 IN CHANGE VS. 1 IN PERCENTAGE POINTS MAIN DRIVERS North America USA Latin America 91.7 ±. No change North Europe & Africa United Kingdom Central Europe Austria, Germany East Europe Poland South Europe & Mid East Greece, Jordan, Morocco AsiaPacific India, Korea, Singapore Japan No significant change China No significant change More details on the markets with an improved or declining precision are given in the following table: Results by Country IMPROVEMENT IN DETERIORATION IN COUNTRY 1 11 COUNTRY 1 11 Austria Bolivia Colombia Ireland Dominican Rep Latvia Ecuador Lebanon Estonia Paraguay Greece South Africa India Jordan Korea Morocco Poland Singapore Twelve countries showed significant improvement (>2 percentage points) over 1. Remarkable growth of more than 1 percentage points can be reported for India. Six countries showed more accentuated decline (>2 percentage points) over 1; four of them declined by more than 1 percentage points. All these countries are in the focus of our quality-improving initiatives acts 12

14 Country-specific Results The validation studies mentioned on the following country pages refer to the IMS retail reports, with the following exceptions: COUNTRY Croatia, Czech Republic, Hungary, India, Poland, Slovak Republic, Slovenia, United States Indonesia, Vietnam Malaysia, Singapore, South Africa MARKET COVERED Hospital market included Total market Total private market Further parts of this accuracy section, which follow the retail validation pages, highlight other validation initiatives of high interest to our data subscribers: OTC Validation Studies PharmaTrend Validation Studies Hospital Validation Studies Specialty Markets Validation Results Validating IMS Forecasting Services In addition, we are providing updates on the latest measures we ve taken to sustain today s quality levels: Universe Updates Data Capture Sample Fulfillment 14 acts 12

15 Algeria Retail Validation Study 11 Number of companies 11 The 11 LMNPA validation study was attended by 11 companies, two more than in Validated market share The participants supplied 258 product forms for evaluation, of which 14 (5) Number of R-Values 258 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 14 market share of the participating manufacturers was 26 in terms of units The overall underestimation improved from 4.4 in 1 to 1.3 in 11. Low sales volume products were underestimated by 3.1, medium by 1.7, and high sales volume products showed a.9 underestimation ±17.5 ±22.5 The overall precision index improved from 83.1 in 1 to 84.2 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 7.9 and 78.5, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved from 84.8 in 1 to 85.4 in 11. Analyze regional projection levels Review validation process 15 acts 12

16 Argentina Retail Validation Study 11 Number of companies 64 The 11 PMA validation study was attended by 64 companies, eleven less than in 1. Validated market share 63 The participants supplied 3,74 product forms for evaluation, of which 5 (2) Number of R-Values 3,74 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 5 market share of the participating manufacturers was 63 in terms of units The overall underestimation improved from 5.6 in 1 to 3.7 in 11. Low sales volume products were underestimated by 2.2, medium by 3.1, and the high sales volume group showed a 4.3 underestimation ±17.5 ±22.5 The overall precision index declined further, from 92.8 in 1 to 91.3 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 9.8 and 89.8, respectively. Looking only at forms validated in both years, 1 and 11, the precision index declined from 94.1 in 1 to 92.1 in 11. Review wholesaler projection structure Quality assessment of wholesale data 16 acts 12

17 Austria Retail Validation Study 11 Number of companies 16 The 11 DPMOE validation study was attended by 16 companies, four more than in Validated market share 3 1. The participants supplied 791 product forms for evaluation, of which 3 (<1) Number of R-Values 791 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 3 market share of the participating manufacturers was 3 in terms of units The overall underestimation improved slightly, from 1.5 in 1 to 1.3 in 11. Low sales volume products were underestimated by 2., medium by 2.2, and the high sales volume group showed a.8 underestimation ±17.5 ±22.5 The overall precision index improved from 95.6 in 1 to 97.8 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 96.7 and 97.4, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved from 97. in 1 to 98.5 in 11. No action required from the statistical point of view 17 acts 12

18 Bangladesh Retail Validation Study 11 Number of companies 12 The 11 BCP validation study was attended by 12 companies, two less than in 1. The Validated market share 36 participants supplied 1,36 product forms for evaluation, of which 71 (5) showed Number of R-Values 1,36 extreme deviation and had to be excluded from the bias analysis. The validated market Number of extreme values 71 share of the participating manufacturers was 36 in terms of units The overall underestimation improved from 23.4 in 1 to 18.7 in 11. Low sales volume products were underestimated by 23.2, medium by 18.6, and the high sales volume group showed a 18. underestimation ±17.5 ±22.5 The overall precision index declined slightly, from 78.2 in 1 to 77.2 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 52.7 and 65.3, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved from 71.3 in 1 to 74.4 in 11. Expand audit coverage 18 acts 12

19 Bolivia Retail Validation Study 11 Number of companies 62 The 11 PMBO validation study was attended by 62 companies, five less than in Validated market share The participants supplied 1,535 product forms for evaluation, of which 491 Number of R-Values 1,535 (32) showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 491 market share of the participating manufacturers was 63 in terms of units The overall underestimation showed marginal improvement, from 11.9 in 1 to 11.7 in 11. Low and high sales volume products were underestimated by 13.1 each, and the medium sales volume group showed a 7.6 underestimation ±17.5 ±22.5 The overall precision index deteriorated strongly by 1.7 percentage points, from 51.5 in 1 to 4.8 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 25.6 and 34.3, respectively. Looking only at forms validated in both years, 1 and 11, the precision index deteriorated from 53.2 in 1 to 44.8 in 11. Improve panel fulfillment Re-design internal quality control processes 19 acts 12

20 Brazil Retail Validation Study 11 Number of companies 28 The 11 PMB validation study was attended by 28 multinational companies, thirteen Validated market share 16 more than in 1. The participants supplied 997 product forms for evaluation, of which Number of R-Values (3) showed extreme deviation and had to be excluded from the bias analysis. The Number of extreme values 26 validated market share of the participating manufacturers was 16 in terms of units The overall underestimation improved by 2.7 percentage points, from 6.5 in 1 to 3.8 in 11. Low sales volume products were underestimated by 5.6, medium by 3.9, and the high sales volume group showed a 3.2 underestimation ±17.5 ±22.5 The overall precision index declined by one percentage point, from 94.9 in 1 to 93.9 in 11. The medium and high sales volume groups surpassed this score at 95.7 and 95., respectively. Low sales volume products had a precision value of Looking only at forms validated in both years, 1 and 11, the precision index declined from 96.5 in 1 to 94.7 in 11. Validation of direct sales by wholesaler and product Retroactive correction of products with reference issues acts 12

21 Bulgaria Retail Validation Study 11 Number of companies 49 The 11 BGPI validation study was attended by 49 companies, 19 less than in Validated market share The participants supplied 718 product forms for evaluation, of which 1 (1) Number of R-Values 718 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 1 market share of the participating manufacturers was 51 in terms of units The overall underestimation improved 3.3 in 1 to 1. in 11. Low sales volume products were underestimated by 2.4, medium by 1.2, and the high sales volume group showed a.6 underestimation ±17.5 ±22.5 The overall precision index declined slightly from 97.7 in 1 to 96.7 in 11. The high sales volume group surpassed this score at 99.. Low and medium sales volume products had precision values of 93. and 94.8, respectively. Looking only at forms validated in both years, 1 and 11, the precision index declined slightly from 98.1 in 1 to 97.6 in 11. No action required from the statistical point of view 21 acts 12

22 Canada Retail Validation Study 11 Number of companies 87 Data from 87 companies, two more than in 1, was available for the 11 CDH Validated market share 95 drugstores validation study. In total, 3,179 product forms were processed, of which 7 Number of R-Values 3,179 (<1) showed extreme deviation and had to be excluded from the bias analysis. The Number of extreme values 7 validated market share equaled 95 in terms of units, representing the highest participation rate across all countries The overall overestimation improved slightly, from.7 in 1 to.6 in 11. Low sales volume products were overestimated by.7, medium by 1.2, and the high sales volume group showed a.2 overestimation ±17.5 ±22.5 The overall precision index improved by.3 percentage points, from 98.8 in 1 to 99.1 in 11. The high sales volume group surpassed this score at a perfect 1. Low and medium sales volume products had precision values of 97. and 98.6, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved also from 98.8 in 1 to 99.1 in 11. No action required from the statistical point of view 22 acts 12

23 Central America Retail Validation Study 11 Number of companies 29 The 11 PMCA validation study was attended by 29 companies, four more than in Validated market share 3 1. The participants supplied 1,692 product forms for evaluation, of which 53 (3) Number of R-Values 1,692 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 53 market share of the participating manufacturers was 3 in terms of units The overall underestimation improved further, from 3. in 1 to 1.5 in 11. Low sales volume products were underestimated by 3.6, medium by 2.1, and the high sales volume classes showed a.7 underestimation ±17.5 ±22.5 The overall precision index declined by 1.5 percentage points, from 88.9 in 1 to 87.4 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision results of 79.4 and 84.3, respectively. Looking only at forms validated in both years, 1 and 11, the precision index declined from 9.6 in 1 to 88.7 in 11. Adjust projection level 23 acts 12

24 Chile Retail Validation Study 11 Number of companies 13 The 11 PMCH branded products validation study was attended by 13 companies, nine Validated market share 14 less than in 1. The participants supplied 669 product forms for evaluation, of which Number of R-Values 669 only one (<1) showed extreme deviation and had to be excluded from the bias analysis. Number of extreme values 1 The validated market share of the participating manufacturers was 14 in terms of units The overall bias result improved strongly, from 4.8 underestimation in 1 to a slight.1 overestimation in 11. Low sales volume products were underestimated by.5 and medium were overestimated by.4. As there were only few forms available in the high sales volume class, these were grouped into the medium class for analysis ±17.5 ±22.5 The overall precision index improved slightly by.2 percentage points, from 93.4 in 1 to 93.6 in 11. The low sales volume group surpassed this score at Medium sales volume products had a precision value of Looking only at forms validated in both years, 1 and 11, the precision index declined slightly from 95.5 in 1 to 95.3 in 11. Conduct new distribution channel survey 24 acts 12

25 Colombia Retail Validation Study 11 Number of companies 8 The 11 PMC validation study was attended by 8 companies, ten less than in 1. The Validated market share 14 participants supplied 554 product forms for evaluation, of which 29 (5) showed extreme Number of R-Values 554 deviation and had to be excluded from the bias analysis. The validated market Number of extreme values 29 share of the participating manufacturers was 14 in terms of units The overall underestimation increased from 3.5 in 1 to 9.8 in 11. Low sales volume products were underestimated by 8.6, medium by 6., and the high sales volume group showed an 11.7 underestimation ±17.5 ±22.5 The overall precision index improved by 7.2 percentage points, from 77.1 in 1 to 84.3 in 11. The medium and high sales volume groups surpassed this score at 87.3 and 88.2, respectively. Low sales volume products had a precision value of Looking only at forms validated in both years, 1 and 11, the precision index improved from 78.5 in 1 to 84.9 in 11. Conduct distribution channel survey Adjust projection level 25 acts 12

26 Croatia Retail+Hospital Validation Study 11 Number of companies 8 The first validation study, combining the Croatian retail and hospital audits, was attended by 8 companies. The participants Validated market share 13 supplied 262 product forms for evaluation, Number of R-Values 262 of which 17 (6) showed extreme deviation and had to be excluded from the bias analysis. Number of extreme values 17 The validated market share of the par- ticipants equaled 13 in terms of units Low Medium High Total The bias analysis revealed an overall slight overestimation of.6. Low sales volume products were overestimated by.4 and medium sales volume products showed a.6 overestimation. As there were only few forms available in the high sales volume class, these were grouped into the medium class for analysis The overall precision index turned out at 95.. The high sales volume class surpassed this score at Low sales volume products had a precision value of Low Medium High Total ±17.5 ±22.5 No action required from the statistical point of view 26 acts 12

27 Czech Republic Retail+Hospital Validation Study 11 Number of companies 25 The 11 validation study, combining the Czech retail and hospital audits, was attended by 25 companies, three less than in Validated market share The participants supplied 1,55 product Number of R-Values 1,55 forms for evaluation, of which eight showed extreme deviation and had to be excluded Number of extreme values 8 from the bias analysis. The validated market share of the participants was 46 in terms of units The 1 overestimation of.5 turned into a.7 underestimation in 11. Low sales volume products were underestimated by 1.5 and medium and high sales volume products both showed a.6 underestimation ±17.5 ±22.5 The 1 overall precision improved by.3 percentage points, from 98.7 in 1 to 99. in 11. The high sales volume group surpassed this score at a perfect 1. Low and medium sales volume products had precision values of 95.1 and 99.4, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved slightly from 99.3 in 1 to 99.4 in 11. No action required from the statistical point of view 27 acts 12

28 Dominican Republic Retail Validation Study 11 Number of companies 31 The 11 PMDR validation study was attended by 31 companies, seven more than Validated market share 46 in 1. The participants supplied 1,953 product forms for evaluation, of which 174 Number of R-Values 1,953 (9) showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 174 market share of the participating manufacturers was 46 in terms of units The overall underestimation increased by 5.7 percentage points, from 2.7 in 1 to 8.4 in 11. Low sales volume products were underestimated by 7.1, medium by 6.4, and the high sales volume group showed a 9.6 underestimation ±17.5 ±22.5 The overall precision index improved by 5.2 percentage points, from 73.3 in 1 to 78.5 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 71.5 and 75.4, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved from 73.3 in 1 to 78. in 11. Update pharmacy universe 28 acts 12

29 Ecuador Retail Validation Study 11 Number of companies 88 The 11 PME validation study was attended by 88 companies, two more than in 1. Validated market share 74 The participants supplied 2,478 product forms for evaluation, of which 35 (1) Number of R-Values 2,478 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 35 market share of the participating manufacturers was 74 in terms of units The overall underestimation increased from 3. in 1 to 4.8 in 11. Low sales volume products were underestimated by 2.7, medium by 4.2, and the high sales volume group showed a 5.6 underestimation ±17.5 ±22.5 The overall precision index improved by 2.5 percentage points, from 91.9 in 1 to 94.4 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 9.5 and 94.1, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved from 93.1 in 1 to 94.8 in 11. No action required from the statistical point of view 29 acts 12

30 Egypt Retail Validation Study 11 Number of companies 3 The 11 PIE validation study was attended by 3 companies, 34 less than in 1. The Validated market share 3 participants supplied 748 product forms for evaluation, none of which showed any extreme Number of R-Values 748 deviation. The validated market share of the participating manufacturers equaled 3 in terms of units. Number of extreme values The overall underestimation increased by 1.2 percentage points, from 2.8 in 1 to 4. in 11. Low sales volume products were underestimated by 4.9, medium by 4.2, and the high sales volume class showed a 3.7 underestimation The overall precision index showed a perfect result of 1 in 11. This excellent result is also distributed over all sales volume groups. Looking only at forms validated in both years, 1 and 11, the precision index remained at ±17.5 ±22.5 Observe the projection level 3 acts 12

31 Estonia Retail Validation Study 11 Number of companies 6 The 11 ESTPI validation study was attended by 6 companies, five less than in Validated market share The participants supplied 4 product forms for evaluation, of which 5 (2) Number of R-Values 4 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 5 market share of the participating manufacturers equaled 17 in terms of units The overall underestimation improved strongly by 13.3 percentage points, from 15.3 in 1 to 2. in 11. Low sales volume products were underestimated by 5.3, medium by 1., and the high sales volume group showed a 2.1 underestimation ±17.5 ±22.5 The overall precision index improved by 7.4 percentage points, from 8.7 in 1 to 88.1 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 85.3 and 87.7, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved from 74. in 1 to 86.5 in 11. Fine-tune projection methodology Motivate more companies to participate in the validation study 31 acts 12

32 Germany Retail Validation Study 11 Number of companies 33 The 11 DPM validation study was attended by 33 companies, the same number Validated market share 24 as in 1. The participants supplied 3,23 product forms for evaluation, of which 45 Number of R-Values 3,23 (1) showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 45 market share of the participating manufacturers was 24 in terms of units The overall underestimation increased slightly, from 2.5 in 1 to 3.7 in 11. Low sales volume products were underestimated by 2.4, medium by 2.9, and the high sales volume group showed a 4.4 underestimation ±17.5 ±22.5 The overall precision index improved from 95.5 in 1 to 97.1 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 92.9 and 96.5, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved from 96. in 1 to 97.9 in 11. No action required from the statistical point of view 32 acts 12

33 Greece Retail Validation Study 11 Number of companies 68 The 11 GPI validation study was attended by 68 companies, 24 less than in 1. The Validated market share 6 participants supplied 962 product forms for evaluation, of which 35 (4) showed extreme Number of R-Values 962 deviation and had to be excluded from the bias analysis. The validated market Number of extreme values 35 share of the participating manufacturers was 6 in terms of units The overall bias analysis revealed no bias at all in 11. Low and medium sales volume products were overestimated by 1.5 and 2.7, respectively, while the high group showed a 1.7 underestimation ±17.5 ±22.5 The overall precision index improved by 2.7 percentage points, from 82.8 in 1 to 85.5 in 11. The high sales volume group surpassed this score at 9.2. Low and medium sales volume products had precision values of 7.7 and 85.1, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved from 84.8 in 1 to 87.4 in 11. New quality control and projection system implemented in acts 12

34 Hungary Retail+Hospital Validation Study 11 Number of companies 9 The 11 validation study, combining the Hungarian retail and hospital audits, was attended by 9 companies, two more than in Validated market share The participants supplied 1,697 product Number of R-Values 1,697 forms for evaluation, of which three (<1) showed extreme deviation and had Number of extreme values 3 to be excluded from the bias analysis. The validated market share of the participating companies equaled 77 in terms of units The overall underestimation increased from 1.8 in 1 to 4.1 in 11. Low sales volume products were underestimated by 2.9, medium by 4., and the high sales volume group showed a 4.5 underestimation ±17.5 ±22.5 The overall precision index declined slightly, from 98.9 in 1 to 98.6 in 11. The medium and high sales volume groups surpassed this score at 98.8 and 99.1, respectively. Low sales volume products had a precision value of Looking only at forms validated in both years, 1 and 11, the precision index declined slightly from 99.3 in 1 to 98.9 in 11. Separate projection of OTC products 34 acts 12

35 India Retail+Hospital Validation Study 11 Number of companies 11 The 11 validation study, combining the Indian retail and hospital audits, was attended by 11 companies, 3 less than in Validated market share 7 1. They supplied 77 product forms for Number of R-Values 77 evaluation, of which 39 (5) showed extreme deviation and had to be excluded Number of extreme values 39 from the bias analysis. The validated market share was 7 in units and, therefore, not representative for the entire audit The overall underestimation improved by 5.6 percentage points, from 1.3 in 1 to 4.7 in 11. Low sales volume products were underestimated by 8.2, medium by 6.9, and the high sales volume group showed a 2.3 underestimation. As the 11 results were not representative, they are presented in orange ±17.5 ±22.5 The overall precision index improved from 7.4 in 1 to 81.3 in 11. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 7.2 and 77.7, respectively. Looking only at forms validated in both years, 1 and 11, the precision index declined from 74.9 in 1 to 71.8 in 11. Extended census coverage Motivate more companies to participate in the validation study 35 acts 12

36 Indonesia Total Market Validation Study 11 Number of companies 78 Data from 78 companies, two less than in 1, was available for the 11 ITMA validation study. In total, 5,641 product forms Validated market share 48 were processed, of which 97 (16) Number of R-Values 5,641 showed extreme deviation and had to be excluded from the bias analysis. The validated market share equaled 48 in terms of units. Number of extreme values The overall bias analysis showed no bias at all in 11. Low sales volume products were underestimated by 3.7, medium by 2.8, and the high sales volume group showed a slight overestimation of ±17.5 ±22.5 The overall precision index showed minimum improvement to 69.6 in 11. The low sales volume class surpassed this score at Medium and high sales volume products had precision results of 67.4 and 69.3, respectively. Looking only at forms validated in both years, 1 and 11, the precision index declined slightly from 72.4 in 1 to 71.8 in 11. Enhance panel composition Review consolidation of input components 36 acts 12

37 Ireland Retail Validation Study 11 Number of companies 23 The 11 IPI validation study was attended by 23 companies, three more than in 1. Validated market share 9 The participants supplied 261 product forms for evaluation, of which 1 (<1) showed Number of R-Values 261 extreme deviation and had to be excluded from the bias analysis. The validated market Number of extreme values 1 share of the participating manufacturers was 9 in terms of units and, therefore, not representative for the entire audit The overall underestimation increased slightly, from.6 in 1 to 1.2 in 11. Low sales volume products were underestimated by.9, medium by.8, and the high sales volume group showed a 1.6 underestimation. Results presented in orange are not representative due to low validated market coverage ±17.5 ±22.5 The overall precision index declined from 98.2 in 1 to 95.4 in 11. The low and medium sales volume groups surpassed this score 96.4 and 98.4, respectively. High sales volume products had a precision result of Looking only at forms validated in both years, 1 and 11, the precision index declined from 99. in 1 to 98.1 in 11. Motivate more companies to participate in the validation study 37 acts 12

38 Italy Retail Validation Study 11 Number of companies 28 The 11 IMF validation study was attended by 28 companies, four less than in 1. Validated market share 33 The participants supplied 997 product forms for evaluation, of which six (<1) showed Number of R-Values 997 extreme deviation and had to be excluded from the bias calculation. The validated Number of extreme values 6 market share of the participating manufacturers was 33 in terms of units The overall underestimation increased slightly by.3 percentage points, from 1.9 in 1 to 2.2 in 11. Low and medium sales volume products were both underestimated by 2.3, and the high sales volume class showed a 2.2 underestimation ±17.5 ±22.5 The overall precision index improved from 97.3 in 1 to 98.7 in 11. The high sales volume group surpassed this score at a perfect 1. Low and medium sales volume products had precision results of 96.1 and 97.7, respectively. Looking only at forms validated in both years, 1 and 11, the precision index improved from 96.9 in 1 to 99. in 11. No action required from the statistical point of view 38 acts 12

39 Japan Retail+Hospital Validation Study 11 Number of companies 51 The 11 JPM validation study was attended by 51 companies, the same number as in Validated market share The participants supplied 2,989 product forms for evaluation, of which three Number of R-Values 2,989 (<1) showed extreme deviation and were excluded from the bias analysis. The validated Number of extreme values 3 market share of the participating manufacturers was 68 in terms of units The overall bias showed a slight increase to +.3 in 11. Low and medium sales volume products were both overestimated by.7 and the high sales volume group showed a.3 overestimation The overall precision index showed again a nearly perfect result in 11, ending at The high sales volume group surpassed this score at Low and medium sales volume products had precision indices of 99.4 and 99.6, respectively ±17.5 ±22.5 No action required from the statistical point of view 39 acts 12

40 Jordan Retail Validation Study 11 Number of companies 15 The 11 JPI validation study was attended by 15 companies, one less than in 1. The Validated market share 31 participants supplied 594 product forms for evaluation, of which 52 (9) showed extreme Number of R-Values 594 deviation and had to be excluded from the bias analysis. The validated market Number of extreme values 52 share of the participating manufacturers was 31 in terms of units The overall underestimation improved by 5.1 percentage points, from 21.7 in 1 to 16.6 in 11. Low sales volume products were underestimated by 17.1, medium by 12.8, and the high sales volume group showed an 18.2 underestimation ±17.5 ±22.5 The overall precision index improved by 6.2 percentage points, from 62.9 in 1 to 69.1 in 11. The high sales volume group surpassed this score at 73.. Low and medium sales volume products had precision values of 63.3 and 65.5, respectively. Looking only at forms validated in both years, 1 and 11, the precision index declined from 71.2 in 1 to 69.4 in 11. Stabilize projection level 4 acts 12