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LSP cay GIB OLS Ge Rig By! ale BAHRAIN PHARMACY NEWSAyla Ainol (2010-2008 &2jLuu! 6ygaU) AuscoaU sjun ate Casi uly dolls ans) dial duis (ey ous eetn ee ae yout eb Beet AGL oe Sr dA apa Was gt Aiea gle eal 5S pt Slgall Jem et 2 Gabe gue al gas bya) Wola ee 2 dpe ‘ Beg tala ae ena sl = LS ade jauly God Gaol 4a Ble BSH RR pl coal sall GS Ge panels or yal (U8) Dias dale hatin sal pg Sire EES al Lela ou a sls (vs) Jule 831 BLN pitt Ws Lal gy hee eae ll ip Sill (9845 apt) SSE UF oe at gn apaal AAA ahs Gyololl diabs INTRODUCTION: The Drug Quality assurance laboratory at Ministry of Health ‘works under the umbrella of directorate of pharmaacy and drug conteol was started asa small activity in Salmaniya Complex in October 1997, The lab started analyzing sainples in February 1998 and analysed total 2343 samples till Dec 2000. 4 new lab was established and started functioning in July 2002. Initially lab was analyzing registration ‘amples only, and then in Jan 2001 it started analysing samples from Directorate of Materials Management (DMM) that deals ‘with medicines to be used for Ministry of Health facilities. During last 7 years (Jan 2001 Ul Dec. 2007) the laboratory had analysed 4221 samples consisting of Registration/ ‘re-registration products, unknown products, health food, herbals and DMM products, (65%). ‘The Lab have been participating in Lab Proficiency testing program conducted by Laboratory of Dutch Pharmacists, a apartment of Scientific Institute of the Dutch Pharmacists (=WINAp) under the auspices of Laboratory & Medicine control OBJECTIVE: A nationwide, primary care-based prescription audit in infants todetermine the preseribing pattern and prescribing errors of topical corticosteroid preparations in Bahrain OCTOBER2009 Is conducts Bacterial endotoxin test on DRUG QUALITY ASSURANCE LABORATORY IN BAHRAIN section ofthe International Pharmaceutical Federation since 2000 regularly and we are happy to inform that our results were always within permissible range (# 390). The Lab continuously cooperates with other labs e.g. Public Health & Arabian Gulf University (AGU), The laboratory has facilities and qualified staff for analysis of drugs in following. sections: Physicochemical section: This section is equipped with all the sophisticated equipment and carries out following tests + Chromatography by HPLC, GC and thin layer + Spectrophotometry by UV- Visible, Infrared atomic absorption and fuorescence technique. + ‘Diimetric analysis + Dissolution test on solid dasage forms like tablets, capsules. Disintegration test on solid dosage forms like tablets, capsules and suppositories, + Other physical and chemical tests ‘Microbiology Section: This section conducts Sterility test om injectables, eye ‘raps & eye ointments, Antibiaic assays, Bacterial and fungal count for non sterile products Pharmacology Section: This section STUDY: TOPICAL CORTICOSTEROIDS IN INFANTS; "kit4! sea! to ature Injectables and Particulete contamination test for injectables. FUTURE PLANS: Drug Quality assurance laboratory has come a long way since its inception however there is still long way to {go and achieve different goals, The plans are: + To work towards accreditation of the laboratory as a reference laboratory in GOC countries, + Inthis direction the Lab started implementation of Good Laboratory Practices (GLP) by preparing about 81 Standard Operating Procedures (SOPs) for the working of equipments and other laboratory activities. The Lab needs to establish a section of Quality Assurance in the aboratery which will work as a coordinater to ensure that data generated by laboratory is genuine & reliable. This section shall be responsible for periodic quality auciting of the work done by staff This section will also be responsible for periodic calibration of measuring equipments in the laboratory, rechecking of test results, ‘maintaining various documents, records review of somple analysis records ote In microbiology section the Lab intend to Introduce tests for vitamin assays, antibiotic assay by turbid metric method! and microbial limit tests on all samples at random basis so as to assess quality of products in this aspect Prescribing Pattern and Prescribing Errors in Bahrain METHODS: Prescriptions dlspended for infants vere collected for two successive weeks from 20 primary care health centers in Babrain. RESULTS: Among 2282 out of 102,084 prescriptions 2.29) dispensed for infants 296 (1335) had corticosteroids for topical application to the ski, eye and ea. Pain corticosteroids comprised 6.7%, whereas corticosteroids with anti- infective accounted for 63% of topical corticosteroids preparations. Based on potency the proportions of corticosteroids preseribed were: mild (6.7%) moderately potent (2.6%) and potent (3.7%). The Frequency of dasing and length of corticosteroids presenibed were: mild (6.7%), ‘moderately potent (2.6%) and potent (2.7%) ‘The frequency of dosing and length of therapy were not stated in 21.6% and 43.6% of prescriptions, respectively. Base ‘ream a¢ a dilation vehicle was preseribed in 11.2% (11/98) and 32.495 (12/37) prescriptions containing hydrocortisone ‘acetate 1% cream and betamethasone valerate 0.1%, respectively. In few instances two corticosteroids were concomitantly prescribed. CONCLUSION: Prescribing maderate ~to potent topical preparations in approximately half of the infants, co-prescriptions of multiple corticosteroid preparations, omission ‘of important components of prescription, and resorting to the controversial vehicle diluting technique suggest that topical corticosteroid therapy is sub-optimal. ‘m infants, topical corticosteroids should be rationally prescribed, Establishing the treatment guidelines pharmacovigilance programme and revision of the primary care essential drug list are needed in Babrain.Self-es appreciative opinion cE On Realistic em is a realist el means you deal in the truth understanding r n and weakness. Havi iative unders g of oneself suggests that you fee! good about and are at peace with the Low self-esteem can lead to a prejudice ‘against your B) self. When you are prejudiced against yoursel, you are guilty of distorting or ignoring information that disputes your skewed perception of yourself, OBJECTIVE: The nationwide preseription- based study was undlertaken to evaluate antimicrobial prescribing for infants and to identify prescribing errors in infants in 20 primary care health centers of Bahrain. METHODS: Data was collected ona dally basis by pharmacists in May 2004. RESULTS: Antimicrobials ranked the 5th most common drugs preseribed in infants; B-lactams, notably amoxiailin and cephalexin, comprised 81.6% of overall preserihed antimicrobials, Antimicrobials ‘were prescribed fo approximately one out of four infants (23 856) prescribed more often to infants aged 9-l2months of age Approximately one-fifth (22%) of infants received antimicrobials at subtherapeutic daily doses. ‘The prescribing errors were related to dosage (39.295), strength/doses (26.4%), dosage (39.2%), strength/doses (26.4%), frequency of dosing (19.2%), and duration of therapy (4.5%). Antimicrobial dosage prescribed in relation to infants’ age revealed a To strengthen your self-esteem, burry your internal naysayer who makes negative predictions about your success and biases your expectations. Imagine that the ‘negative interna tal is nothing more than gratfti painted on the walls of your mind, and you need a janitor coming along. painting aver that graffiti, replacing it with affirmations that are positive and affirming, Other methods for improving your self esteem include: + Asking others to identify your strengths, Laughing at your weaknesses (because no one is perfect), Putting your failures in perspective, as they allow you to learn and grow. positive correlation for amoxicillin ‘erythromycin (™=0.127; p=0.284), and a negative correlation for metronidazole ( 0.415), * Finding someone whe needs your assistance and offering to help them, * Taking on a challenge to stratch your self + Getting comfortable with compliments and accepting praise. * Focusing your mental chatter on the positive aspects of your experiences DEVELOPING SELF- People who lack self-confidence are apprehensive, frustrated resentful, and often demoralized ‘To improve your self-confidence, ask yourself “How would { behave if F were reclly confident?" Or how confident people know handle this? Just adapting the behavior of self-confidence will help you feel more confident. Learn from your mistakes and mave on People with high self-esteem and self confidence are assertive and not 2 wich build rather than destroys good ‘working relations. oul (0.264; p<0.0001), cephalexin (r-0.223; p-0.029) 183; CONCLUSIONS: Overt use of antimicrobials in infants and prescription-writing errors {in dosages and frequency of dosing) were common in primary care. Dosage adjustment in relation to developmental stages has received inadequate attention, Elfective strategies to improve prescription writing silane urgently required. Thore i a nee o introdice programmes to enhance rational antimicrobial therap in infants, BAHRAIN PHARMACY NEWS 6SSRI Antidepressants ‘Clinically Insignificant’ For Most People A new study published recently is sure to set off another storm in the ongoing, debate about the widespread prescription of antidepressants. Professor Irving Kirsch at the University of Hull and colleagues in the US and Canada report that new generation “SSRI antidepressants like Prozac or Seroxat mostly fall, “below the recommended criteria for clinical significance” (Kirsch et al. 2008), In other words, the most moder drugs prescribed for depression generally don’t work, The study was particularly interested in whether the drugs had different effects on people with different levels of depression. Here is what they found: ‘Mild depression: not tested as mild depression is usually treated with a ‘talk therapy’ rather than antidepressants ‘Moderate depression: antidepressants ‘made “virtually no difference” Severe depression: antidepressants hadl “small and cliniclly insignificant” effect. Most severe depression’ antidepressants had a significant clinical benefit - but see below. EFFECTIVENESS LIMITED EVEN FOR SEVERE DEPRESSION When Professor Kirsch and colleagues looked more closely at the data for those who were most severely depressed they uncovered more bad news for drug ‘manufacturers. The antidepressant effect ‘the drugs appeared to have, though smal, ‘was largely due to differences in the effects that the placebo had on the control group rather than better response to the drug, LET'S UNPACK THIS A LITTLE The placebo effect means that even when vyou give someone a ‘fake’ antidepressant they stil improve a litle, simply because they expect to, Tis effect is so powerful and reliable that to be taken seriously drug studies have to compare depressed people = taking an antidepressant to a control group taking a placebo. What Professor Kinch and colleagues found was that while the placebo effect was present for moderately i depressed people, it disappeared for those ‘who were the most severely depressed ‘This meant that antidepressants ‘weren’t having any more effect on those who were more depressed, its just that in comparison tothe control group ‘thats how it appeared. in reality what ‘was happening was that the contol group ‘weren't responding tothe placebo. The authors, therefore, conclude that there's no point prescribing SSRI antidepressants to anyone but the most severely depressed peal, unless other treatments have bee ‘ried and have falled a So the question is: can we believe the results? Well, the study used data from 47 clinical trials that had been submited to the US Food and Drugs Administration (FDA). The FDA already has a rigorous set of criteria for including studies, so this suggests only quality studies were included. ‘The data from all these studies were then combined using a statistical technique called ‘meta-analysis. This means all the studies were collected together and analysed as though they were all one huge study. By doing this you can increase the pawer of the study significantly. Like many statistical techniques, though, there is some debate about the use of meta~ ‘analyses. For example itis often argued that they lump together studies with different protocols so that effectively you end up comparing apples with oranges. Whether this sort of eticism is valid depends on the study’ nitty-gritty detail WE BELIEVE THIS STUDY? HIGH STAKES More broadly, we have to be careful about drawing conclusions from a single piece of work. There's no doubt how high the stakes are for everyone: Professor Irving Kirsch has built a career on showing the power of the placebo effect, ‘pharmaceutical companies have built thelr fortunes on studies proclaiming the benefits of SSRI antidepressants, while patients are stuck in the middle Despite this, the evidence does seem to be mounting up against SSRI ‘antidepressants. Although previous studies seemed to show SSRs were effective, recent work has suggested this might be ddue to a bias in the way research is reported (Farner et al, 2008). Studies which show no effect have a tendency to be “fled” rather than being submitted for publication. This, ‘an result in a much more rosy picture being painted of a drug’ effectiveness than is really the case. Either way, considering the number of people worldwide currently taking SSRI antidepressants, we can be sure this isn’t the end of the storyGood Manufacturing ‘What is GMP? GMP stands for (GOOD MANUFACTURING PRACTICE) which is one part of the required quality element needed by drug authority to get a approve for the drug ‘manufacturing plants. Usually we use cGMP where the ¢in this case means (current GMP), Using GMP is more precise because GMP usually pertain a standard guidelines approved by certain authorities ie. local (e.g. Directorate of Pharmacy and Drug Control (DPDC), regional, SGH or International, FDA & WHO), that might change from time to time. GMP concept generated at the beginning of 1970s but its implementation was in 1980's. GMP top concern isto have an up- to-standard quality medicine during manufacturing process that starts from the raw materials, premises, equipment, personnel, documentation, till the packaging of the final product Nowadays, only GMP-approved ‘manufacturers will be allowed to produce, «a > SERVIER export and market their products. Therefore it becomes a compulsory for ‘manufacturer to have a GMP approval GMP approval is must before the starting of the pharmaceutical plant and also in periodic intervals (1-2 years) either by local or international drug authorities. Each country should have well-trained GMP inspectors or auclitors (mostly phanmacist). These auditors should be trained to latest cGMP guidelines. The United States Food and Drug Administration (FDA) is the most recognized CGMP approval organization, ‘There is also European Medicines Agency (EMEA) a well-recognized GMP approval establishment. In the Cooperation Council forthe Arab States ofthe Gulf (GCO), drug registration 1s done centrally through central registration committee. GCC usually delegates an inspection team (usually 3 members from 3 different countries) to Visit the applicant facilities and to write a technical report studying the condition of the manufacturer. Practice (MP) 2By Ph, Hasan Al Majed The report must be submitied to the central committee to take a decision ‘whether or not to register the plant. Itis not enough to register one site even for the same product by the same ‘manufacturer, but every site should be registered separately after attaining all pre-request conditions Some companies (regardless of names or reputation) fail to adhere to GMP Tequitements from the first round of inspection, In this case, manufacturer must fulfill and rectify the deviations or violations. If not, company registration will be suspended tl ll violations comected. If the visiting committee found critical violations, this can lead to a recommenciation to reject the registration file of the company. Getting the GMP certificate does not mean the end of the story; in deed each product produced by this plant should he analyzed the by nation's QA Lab to get it Jicense for the market. BAHRAIN PHARMACY NEWS 8.