1 EVIDENCE LIVE 16 OXFORD UNIVERSITY 22end to 24th of June-2016

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1 1 EVIDENCE LIVE 16 OXFORD UNIVERSITY 22end to 24th of June-2016 Author: Dr. Laila J. Badran (Ph.D. Pharmacy) * Ph.D. in: Strategies,Policies, Administration, Management, Quality Control & Quality Assurance of Pharmacy.(From Strathclyde University UK in 1998). *Former Advisor to the Minister of Health for Drug Affairs ( ). * Independent Expert from 2007 up to date. Fax: Mobile: dr_ljb@go.com.jo

2 The First Pioneer Two Studies Which Created the Essential Basic Motives Evidence Based Behind the Present: Drug Quality Control Laboratory Reform in Jordan

3 Aim of these Two Studies: IA-1989 & IB-1995 The Provision for Physico -Chemical, Microbiological Quality Control of Every Batch of Each Pharmaceutical Preparation available in the Governmental and Private Sectors (Imported and Locally Manufactured). In addition of establishing the Research Division for performing specific research studies mainly : Stability Studies. 3.

4 Summary *There is a Large demand to make major changes in the regulatory system in order to ensure Thorough Control of all batches of imported and locally manufactured medicinal Products. Especially when we found that: *80% of the consumed medicines are imported Pharmaceutical Preparations. * *Not all the Pharmacopoeial tests required for various dosage forms were performed in the DQCL. Thus there is a Massive Workload on the Analysts in the Jordanian DQCL. 4

5 Methodology For the first study IA-1989 it was based on studying the actual work load per year within the system during the first ten years i.e the actual number of tested batches per year for different Pharmaceutical products. While for the second study IB-1995 it was based on studying the ratios between the analysts and instruments and the actual number of batches tested and comparing these variables between the different International leading systems (UK, Japan, &USA) and the Jordanian system. 5

6 Additional Facts- Study 1-A The % of QC Reports for Governmental Tender Drugs compared to total Laboratory QC Reports released in 1988 was 72.4%. 2-The % of QC Reports of Pre-registered drugs in comparision to total number of Laboratory QC reports released in 1988 was 17.3%. 3-The % Laboratory QC Reports for Post-marketing inspection samples comprised 10% of the total Reports released from the Laboratory in

7 Additional Facts- Study 1-A 1989 In 1988 the following data were available: a- The Number of different registered pharmaceutical preparations (including different dosage forms of the same active ingredient was=4230. b- The Actual number consumed was =3701. I- One third of (b) consists of Products for serious, life threatening indications (Essential Drugs) =1234, and the average number of imported batches for each product in this group per year is approximately 8 batches.therefore the total number of batches for this group of medicines was =9872. II-Two thirds of (b) consists of OTC Preparations=2467. The Average number of Batches for products in this group was Approximately 3 batches. Thus the total number of this group was= Therefore in 1988 the total number of batches that needed to be tested was: I+II= and the full QC of every batch would have generated the same corresponding number of reports from the QC Laboratory. 9

8 Conclusions from Study 1A-1989 *After thorough examination of details in Table 1A-1989 Study : it shows that the total number of reports released from the laboratory in 1988 was only This meant that only 8.1% of the available batches in Jordan were tested. *Therefore there was an urgent need for expansion of the working capacity of the national Drug Quality Control Laboratory in Jordan by approximately : 12 times. To enable the QC Laboratory to perform full QC on All batches of all pharmaceutical Preparations ( for Local and imported, of different dosage forms for Pre-and Post Licensed Pharmaceutical Preparations). 10

9 Therefore the following changes needed to be accomplished: 1- To increase the number of qualified analysts to: = 228 Analysts. 2- If each analyst could use only one analytical instrument at a time (e.g Dissolution App. Or UV Spectrophotometer or HPLC..) =then we need= = 228 instruments. 3-The Area of the QC Laboratory should be expanded to 5400 sq.ms.covering five floors each of at least 8 working rooms.(for Physico- Chemical, Microbiological, Pharmacological and Future Research and Storage Areas).Expected cost: =1.512 MillionJDs. 11

10 Study IB-1995 Methodology: Based on Comparison between different Drug QC Laboratories in different Leading countries: * Japan: Ministry of Health and Welfare: Drug Quality Control Laboratory. * USA: FDA Division of Drug Analysis. * UK : Medicines Testing Laboratory. Compared with the Jordanian Drug Quality Control Laboratory : by applying certain indicators(variables)in the data analysis.. 12

11 Discusions for Study IB The % of Samples fully Analyzed for approval are comparable in the UK (5%), the USA (5%) and Japan (7.7%), in Contrast to the Jordanian QC Laboratory which should evaluate the 100% of all (imported and Local manufactured products) which indicated the immense workload on this Laboratory. 2-The UK has 3.3 times the number of computerized instruments available in Jordan,. 3-The number of specialized analysts in Jordan is 1.5 times that in UK, while the USA Laboratory has 1.7 times those available in Jordan. 4-While the average total number of products evaluated per year in Jordan is about 7 times that in UK and about 6 times that in the USA. This shows the immense workload on the Jordanian QC Laboratory and this explains why the Jordanian DQCL is not able to do all the required Pharmacopoeial QC tests for each sample for every tested batch as shown in the table.

12 Conclusions from Study IB 1995 In order to enable the Jordanian DQCL to perform the analysis and evaluation of all the pharmaceutical products available in Jordan in an efficient manner, then there is an Urgent need to recruit more specialized analysts and to increase the number of computerized instruments and to increase the area of the DQCL. 18

13 Conclusions in Numbers Considering the Ratios stated in the study IB-1995 : 1- The number of analysts in the Jordanian DQCL needs to be 104 analysts (compared with the UK Laboratory) or 218 analysts ( compared with the USA Laboratory). 2-Due to the fact that the computerized instruments are extremely expensive, thus if it is assumed only one instrument is used by one analyst at a time then the Jordanian DQCL needs 104 or 218 respectively. 3-Concerning the expansion of the Area of the Laboratory: according to the ratio of the ( Jordanian/ UK) this will require the expansion up to: 7000Sq.Met. 19

14 Overall Conclusions from the two studies: IA-1989 & IB-1995 Thus these suggested expansion numbers of Study IA-1989 to 104 Analysts of 34 Ph.Ds and 70 BSc according to UK System or 218 Analysts of 56 PhDs and 24 MSc Specialized Analysts and 138 BSc and Bpharmacy according to USA system. The need for 104 or 218 of computerized instruments if each is used by one analyst,or double the numbers if each analyst uses two instruments at a time. The need to expand the area (based on the Jordan/UK ratio) into 7000Sq.Met. 20

15 Continue:Overall Conclusions from the two studies: IA-1989 & IB-1995 Comparing the above conclusions with the study IA- 1989: which was based on the number of tested batches of pharmaceutical products per year compared with the actual work load in the same Laboratory at the time of this study : claimed for 228 Specialized Analysts and 228 Analytical Instruments and 5400 Sq.Met area of the Laboratory. The Results of the two Studies IA-1989& IB-1995 were very similar to a certain extent. 21

16 22 * What has been achieved until the end of 2003? Knowing the importance of these two studies (IA & IB-1995) being considered the first Bench-Mark for the Reform of the Jordanian DQCL, both had been referred to and used extensively when the budget was available : on March 2002 the new constructions for the Purpose built DQCL had commenced with the total Area of 7100Sq.Met. With the total cost of 1.8 Million JDs which were very close to the proposed figures in my two studies. The Laboratory was expected to start working by the end of year 2003.

17 What has been achieved until the end of 2003? *In addition to the Purchase of the Analytical Instruments with the cost of 1.5 Million JDs (very close to the estimated cost in my study). *While the total number of the specialized analysts (university degree holders) is still far less by 4.5 to 9.5 times less than the proposed numbers in these studies. *Training programs (short term/long term) and advanced Legislations were presented by the Author parallel with the above two studies. 23

18 Bridging the Gap: What has been achieved until Now in 2015? The value of these two studies is that they are feasible and applicable and are still valid: What had been achieved until now? the actual area of the newly built QC Laboratory, and additional computerized instruments were accomplished but the number of specialized Analysts is still far below the required number in my two Studies. Also the Drug QC Rules and Regulations & Guidelines need to be changed and upgraded. 24

19 Bridging the Gap Until November 2015 the number of Specialized Analysts are as follows: Total numbers of MSc degree Holders: 7 Total number of Bachelor Degree Holders in different specializations : 16 Total number of B.Pharmacy : 15 Grand Total for the available University degree Holders as Analysts= 38 only While: Total Number of Tested Batches by the end of 2014= Batches. 25

20 Final Conclusions & Recommendations As we can observe from the final discussion table that the estimated total batches were for 1989while the actual tested batches in 2014 is batches, so this is the evidence that not all the batches are tested because if we look at the population in 1989 it was only which needed an estimate of batches, therefore if we want to correlate with the populations in 2014 and 2015 the estimated numbers of batches needed would be much bigger number than the actual tested number of batches( 18729), thus only a small fraction of the actual number of batches are tested. This is due to shortages in the Specialized Analysts in the DQCL. 27

21 Final Recommendations 1-These Studies were made in order to Convince the Highst Authority (the Minister of Health) and the JFDA for the Urgent need to employ Specialized Analysts in the DQCL. 2-Although the required numbers of Graduates B.Sc. & Postgraduates M.Sc. and Ph.D. of the required specializations of Pharmacists Chemists and Biologists are available: But always the excuse is : Economical Constraints. 3-The Drug Quality Control Regulations need to be updated, in order that all batches should be tested. To insure that our patients are receiving high quality medicines which will reflect positively on their Health.

22 Thanks to Evidence Live 16 Team for giving me this opportunity to give my Oral Presentation and Thank you for your Hospitality and GREETINGS From JORDAN 29

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