Quality Of Drug Stores: Storage Practices & Regulatory .

2y ago
39 Views
2 Downloads
771.33 KB
6 Pages
Last View : 1d ago
Last Download : 2m ago
Upload by : Wren Viola
Transcription

Open AccessOriginal ArticleQuality of drug stores: Storage practices &Regulatory compliance in Karachi, PakistanSyed Shaukat Ali Muttaqi Shah1, Baqar Shyum Naqvi2, Mashhad Fatima3,Asif Khaliq4, Abdul Latif Sheikh5, Muhammad Baqar6ABSTRACTObjective: To assess and evaluate the drug storage quality and regulatory compliance among privatelyoperated drug stores of Karachi Pakistan.Methods: A cross-sectional survey of drug stores located in Karachi was conducted from May to December2013. A total of 1003 drug stores that were involved in the sales, purchase and dispensing of pharmaceuticalproducts were approached by non-probability purposive sampling technique, and the information wascollected using a close ended, structured questionnaire.Results: Out of 1003 drug stores inspected only 4.1%(n 41) were found compliant to regulatory requirements.Most of the stores 74.9%(n 752) were selling general items along with the drugs. Only 12%(n 124) storeswere having qualified person working on the store, out of which 33% were pharmacist. 47.4%(n 400) of thestores had drug sales license displayed in the premises and 33.4%(n 282) of the stores had expired drugsales license. 11.4%(n 94) stores were found selling vaccines without proper refrigerator and only 11.7%stores had the power backup for the refrigerator. Only 40.2%(n 403) of stores were protected from directsunlight and 5.4%(n 54) having air conditioning in the premises.Conclusion: The regulatory compliance of majority of the drug stores operated privately in different areasof Karachi is below standard. Only a few drugs stores have adequate facilities to protect the drugs fromextreme temperature, sunlight and provision of refrigeration. Very few of the drug stores carry out drugsales under the supervision of qualified pharmacist. There is a dire need to improve the storage practicesin the drug stores by complying with the regulatory standards/laws as specified by the Drug RegulatoryAuthority of Pakistan.KEY WORDS: Drug Stores, Regulatory Compliance, Storage Practices, Quality.doi: http://dx.doi.org/10.12669/pjms.325.9705How to cite this:Shah SSAM, Naqvi BS, Fatima M, Khaliq A, Sheikh AL, Baqar M. Quality of drug stores: Storage practices & Regulatory compliance inKarachi, Pakistan. Pak J Med Sci. 2016;32(5):1071-1076. doi: http://dx.doi.org/10.12669/pjms.325.9705This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0),which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.1.2.3.4.5.6.Mr. Syed Shaukat Ali Muttaqi Shah, M Pharm. PhD Scholar,Department of Pharmaceutics, Faculty of Pharmacy,University of Karachi, Karachi, Pakistan.Dr. Baqar Shyum Naqvi; PhD.Professor, Department of Pharmaceutics,Faculty of Pharmacy, Hamdard University, Karachi, Pakistan.Ms. Mashhad Fatima, MPhil. PhD Scholar,Dept. of Chemistry, University of Karachi, Karachi, Pakistan.Mr. Asif Khaliq, MPH, MBA, Pharm D.Baqai Medical University, Karachi, Pakistan.Mr. Abdul Latif Sheikh; MS(NY), R.Ph(NYS Board)Director, Pharmacy Services, Aga Khan University Hospital Karachi& Outreach Programme, Karachi, Pakistan.Mr. Muhammad Baqar, Pharm D.Pharmacist, Medilink Clinics Pharmacy, Karachi, Pakistan.Correspondence:Mr. Syed Shaukat Ali Muttaqi Shah, M Pharm.E-mail: shaukat muttaqi@yahoo.com****Received for Publication:1st Revision Received:2nd Revision Received:Final Revision Accepted:January 5, 2016January 9, 2016August 3, 2016August 25, 2016INTRODUCTIONDrug storage and usage is one of the most importantcomponents in healthcare system. In many lowincome countries, failure of government bodies toprovide free healthcare, regulatory reforms andprivatization have increased the unrestricted accessof drugs to the general population through privatepharmacies.1,2 These private pharmacies are oftenthe first point of contact for patients seeking healthcare because of its proximity and being less sociallydistant compared to other providers, includingmedical doctors and traditional practitioners.3Primarily activities carried out at the drug stores arebuying and selling of drugs; most of the time overthe counter and without a proper prescription. ThePak J Med Sci 2016 Vol. 32 No. 5www.pjms.com.pk 1071

Syed Shaukat Ali Muttaqi Shah et al.sale of drugs in private stores has been associatedwith varying affordability, irrational use of drugsand availability of substandard and/or counterfeitdrugs, which make the regulatory framework morechallenging for developing countries.1,2In low and middle income countries, theevidence related to the quality of professionalcommunity pharmacy services is limited, but dataavailable refers to the deficiency of standards in thepractice. Problems such as shortage of adequatelytrained human resource and lack of enforcementof regulatory structures are confronted by mostof the developing countries, which results in freeaccess of even prescription drugs to the patients.4,5This unregulated sales of drugs is coupled withself-medication, being one of the prevalentphenomenon in developing countries, with varyingpercentages between 6.3-76% in different settingsand demographic groups and is seen in both highand low income level populations. These factorsmakes medication usage more dangerous for thepopulation and does warrants strict policy changesand implementation to curtail the issue.6-9In Pakistan drug manufacturing companies don’tsell medications directly to the retail outlets on thecontrary appoint distributors and/or wholesalersto supply drugs to the retailers from where it is dispensed to the patient. All these drug distributionfacilities need to be licensed in the country. As perthe Drug Act 1976, Government of Pakistan (GoP)has delegated regulation of: sale and specificationof pre-conditions for sale of drugs to provincialgovernment.10 The key requirements for the sale ofdrugs as described in the Sindh Drug Rules 1979amended 27th April 2010 are as follows: (i). Premisessize must be 100 square feet for retail and 200for pharmacy and wholesale, (ii) Proper facilitiesfor drug storage for preserving drug quality and(iii) Drug Sales must be supervised by a registeredpharmacist under Pharmacy Act 1967. Furthermoreat every drug store the original valid drug sales license should be displayed prominently in the store.There is no complete database of drug stores inthe country, but roughly its estimated that thereare around 45,000-50,000 retail drug and wholesaleoutlets in the country, out of which 15,000 storesare located in the province of Sindh.11 Onlycouple of small scale studies have been conductedpreviously in Pakistan to assess the storage anddispensing practices of drug stores in Pakistan,and the available data suggest the drug stores areoperating below par with compromised storageconditions, with only 19.3% of the store meeting1072 Pak J Med Sci 2016 Vol. 32 No. 5www.pjms.com.pklicensing requirements established by governmentauthorities. Very few of the stores i.e. 12-22% werefound to have staff with diploma or degree relatedto medical sciences or drugs.11-13There is insufficient data on the operations ofdrugs stores in Pakistan, and none of the study explored the storage practices and regulatory compliance of drug stores in Karachi. This study is one ofits kind to elaborate the storage practices and compliance of the drug stores to the established regulatory requirements. Karachi being the largest andmost densely populated city and financial capital ofPakistan, is assumed to be well regulated comparedto rural areas of Pakistan. The study would alsoserve as baseline for regulatory authorities to highlight the specific issues and formulate the focusedaction plan to enhance safe handling of drugs in theretail and wholesale drug stores in the region.METHODSThis is a descriptive cross-sectional study thatwas conducted from May 2013 to December 2013among privately operated drug stores in Karachi,by non-probability purposive sampling technique.In order to keep consistency of information thedrug stores which are solely dealing with herbal orother alternative medicine and the store operatinginside government hospitals/clinics were excludedbecause of different nature of products andoperations respectively.To estimate the number of drug stores, list of drugstores served by two renowned pharmaceuticaldistributors operating in Karachi was obtainedand combined. The lists were incomplete becausethese distributors were not supplying drugs to allthe areas of Karachi. Moreover Online Phonebookreveals information of 729 drug stores of Karachi.Therefore to correctly represent the population asample size of 1003 drug store was selected.A self-made structured closed ended questionnairewas developed for data collection. The questionnairewas designed to collect demographic informationregarding drug store, drug storage conditionsand practices. The questions were also includedto check the regulatory requirements laid downby government authorities including availabilityand display of valid drug sales license. A team offour data collectors was trained by the principalinvestigator for a period of one week. A pilot studywas done in 51 drug stores to validate and modifythe questionnaire and validation of the qualityof data. To ensure the quality and consistency ofdata all the data collectors were asked to meet on

Quality of drug stores in Karachiweekends with the principle investigator for datasharing. In order to check the transparency of datacollection principal investigator randomly used thetelephonic verification from the respondents to helpovercoming the over or under reporting of the datafrom the drug stores.The approval of the study was obtained from theBoard of Advanced Studies University of Karachiand formal permission to conduct a survey wasobtained by the District Health Office Karachi. Aninformed consent was obtained from every drugstore. All the filled questionnaires were checkedand verified by the principal investigator. The dataentry was done and descriptive statistics wereperformed through Stata 11.2. Logistic regressionanalysis was performed by generating dependentvariable “stores meeting licensing requirements”by combining variables i.e. size of store 100sqft,refrigerator present, stores not exposed to sunlight,pharmacist present and valid drug sale licensedisplayed, which are the requirements for thelicensing as laid down by government authorities.Another dependent variable was created separatingthe stores located in the upscale area of Karachii.e. Defense and Clifton, where majority of thepopulation is high income as compared to restof areas of Karachi. A univariate analysis wasperformed to estimate the association of selectedfactor with the dependent variables and oddsratios, 95% confidence intervals and p-values werecalculated to determine likelihood of association.RESULTSIn this study, 1003 retail and wholesale drugstores were inspected, with only 3%(n 31) dropout.There were 99.4%(n 997) stores owned by soleproprietors, 79.5%(n 798) were situated nearTable-I: Drug Stores: location, product mix,and operating ation of drug storeMarket205(20.4%)Near clinics & hospitals798(79.5%)Sale of general items along with drugs752(74.9%)Operating hours of store14.04(SD 3.25)Staffing levelOne staff190(18.9%)2-3 staff548(54.6%)4 staff and above265(26.4%)Stores with qualified person.124(12.3%)Type of qualified )1-sign indicate the breakup of medical professionals working onstores, 2-licensing requirement.hospitals/clinics and only 20.4%(n 205) werelocated near market. Most of the stores 74.9%(n 752)were selling general items along with the drugs andhad a mean operating hours of 14h(SD 3.25). Therewere 19%(n 190) of stores having only one personworking on the store, while 55%(n 548) of thestores have the staffing level of 2-3 person. Therewere only 12%(n 124) stores, in which qualifiedperson (dispensers or pharmacists) were working,out of which 33%(n 41) were pharmacist (Table-I).In this study only 5.4%(n 54) stores had workingair-condition. About 88.6%(n 729) stores inspected,were involved in the sale of vaccines and other refrigerated drugs, out of which 75.6%(n 759) storeshad refrigerator for the storage of these products,only 0.2%(n 2) stores had biological refrigeratorwith proper temperature monitoring. The percentage of stores that were selling refrigerated drugswithout proper storage was 11.4%(n 94). Only11.7%(n 117) stores had the provision of powerbackup connected to the refrigerators. However1.4%(n 14) stores were found to demonstrate temperature recording for refrigerators. The washablefloor was selected as an indicator of tidiness and89.8%(n 901) stores were having washable floor,and 40.2%(n 403) stores medicines were protectedfrom direct sunlight. 56%(n 566) stores were foundto store drugs directly on the floor (Table-II).In this study there were 84%(n 844) drug storeclaiming that have license issued by governmentTable-II: Storage practices and factors associatedas elaborated by Sind drug rules 1979.Variable/categoriesF(%age)Stores having Air-conditioningTemperature monitoring devicespresent and usedRefrigerator present.1.Biological refrigerator present.2.Designated refrigerator for drugs.2.Refrigerator with general items.2.Refrigerator on power-backupStores selling vaccines without refrigeratorsFloor tidy and washable .1.Drugs protected from sunlight .1.Drugs stored on the floorStorage area 100sqft .1.Out let licensed by Health departmentLicensed issued to.3.DispenserPharmacistType of license.3.By way of pharmacyBy way of retail saleBy way of wholesaleValid License displayed andvisible to customers.1,3.License found icensing requirement, 2-breakup of refrigerator available,3-breakup of outlet that are licensedPak J Med Sci 2016 Vol. 32 No. 5www.pjms.com.pk 1073

Syed Shaukat Ali Muttaqi Shah et al.authorities. Out of these 844 drug stores, onlyone drug store had license by way of Pharmacy,95.14%(n 803) drug stores were having retail saleslicense and remaining 4.7%(n 40) stores had wholesale license. Only 47%(n 400) stores had visiblevalid drug sale license displayed to the customers,which is the regulatory requirement by the Ministryof Health, and in 33%(n 282) drug store the drugstore license were found expired, 32%(n 321) storeswere not able to show the drug sale license. In total16%(n 159) stores were selling medicines withoutthe drug sales license (Table-II). Based on the aboveresults only 4.1%(n 41) stores were observed to becompliant to the regulatory requirements laid downby government authorities for the sale of drugs.Univariate analysis was performed to find thelikelihood of selected independent variables againstthe regulatory compliant v/s non-compliant groupsidentified in the study. Drug stores compliantto the regulatory requirements were more likelyto have air-conditioning (OR 3.2,p-value 0.01),temperature monitoring practices (OR 10.2,pvalue 0.00), and power backups for refrigerator(OR 2.2,p-value 0.01) showing the statisticallysignificant odd ratio, 95% confidence interval andP-values. On the other hand there was no significantdifference in likelihood found between the locationof store near hospital/clinic (OR 0.6,p-value 0.3)and practice of storing drugs on the floor (OR 0.5,pvalue 0.05) between the regulatory compliant andnon-compliant groups (Table-III).Logistic regression was also performed to assessthe association of independent variables withgroups made based on the location of stores indifferent areas of the city. Drug stores located in theupscale areas of Karachi were more likely to have airconditioning (OR 18.2,p-value 0.00), temperaturemonitoring practices (OR 14.2,p-value 0.00) andpower backup (OR 8.2,p-value 0.00) as comparedto the stores located in other areas of Karachi. At thesame time these stores had less likelihood of drugsbeing stored on the floor (OR 0.6,p-value 0.00) andexposure to direct sunlight (OR 0.05,p-value 0.00).Furthermore these stores had three times morelikelihood of displaying valid drug sales license(OR 3.0,p-value 0.05) as compared to the othergroup of stores (Table-IV).DISCUSSIONThe results shows an alarmingly low number ofstores 4.1%(n 41) compliant to the regulatory requirements laid down by government authorities,the number is much less than the study conducted inthe capital of Pakistan showing 19.3% compliance.12Out of the five criteria of the licensing requirementsthat were assessed the lowest was the sales of medicine under the supervision of pharmacist, which isalso observed in the other studies of the region.11,12Drug outlets being the first point of contact for thepatients and prevailing practice of self-medicationcoupled with such low regulatory compliancemakes the safe use of drug even more challengingin the largest urban population of the country.3,7,9Only 19% of the stores show the presence of drugsellers with degree in medicine/pharmacy or having dispenser diploma which means the majority ofthe drug sales are carried out by people without anyformal education about medicine. The findings areconsistent with the other studies ranging from 1222% of drug sellers who are qualified or trained.11,12Only 25% of the stores were selling drugsexclusively, majority of the stores were also sellinggeneral items, food items, cosmetics etc, making theTable-III: Univariate analysis for association of independent variableswith regulatory compliant and non-compliant group.VariableRegulatory compliantstores (n 41), n(%)Regulatory non-compliantstores (n 962), 5%)Yes6(14.6%)48(4.9%)3.21.3-8.1T-monitoring .23.1-34.4Refrigerator on power .21.1-4.4Drugs stored on 50.2-1.0Store near 68(79.8%)0.60.3-1.31074 Pak J Med Sci 2016 Vol. 32 No. 5www.pjms.com.pk0.0110.0000.0190.0520.303

Quality of drug stores in KarachiTable-IV: Univariate analysis for association of independent variableswith location of drug stores in different areas of Karachi.VariableStores in upscale areasof Karachi (n 72), n(%)Store in rest of Karachi(n 931), ring 24.8-41.70.000Refrigerator on power .24.9-13.60.000Drugs stored on .02-0.140.000Store near 52(80.7%)0.420.25-0.690.001Drug exposed to .050.02-0.120.000Valid License %)3.01.85-5.060.000drug stores a commercial facility rather professionalhealth care delivery service. More than one third ofthe stores were located near the hospitals and clinic,and majority operating for 11-17 hours showingthey serve a large number of populations andare viable business entities. Similar business-likeenvironment at pharmacies is also reported fromIndia and other developing countries.14Almost 95% of the stores didn’t have the provisionof air conditioning in the store, and almost noneof them have temperature monitoring practices inplace, further more half of the stores inspected hada design where by drugs are exposed directly tosunlight. These compromised practices of storage ina hot and humid city like Karachi, makes the qualityof the products questionable. A previous s

for pharmacy and wholesale, (ii) Proper facilities for drug storage for preserving drug quality and (iii) Drug Sales must be supervised by a registered pharmacist under Pharmacy Act 1967. Furthermore at every drug store the original valid drug sales li-cense should be displayed prominently in the store.

Related Documents:

Cost Transparency Storage Storage Average Cost The cost per storage Cost Transparency Storage Storage Average Cost per GB The cost per GB of storage Cost Transparency Storage Storage Devices Count The quantity of storage devices Cost Transparency Storage Storage Tier Designates the level of the storage, such as for a level of service. Apptio .

Susser Holdings Corporation Susser Petroleum Partners Analyst Day March 21, 2013 . 2 . 1992 27 stores 1995 105 stores 1996 10 stores 1998 7 stores . 2008-2012 Big Box Build-Out Build-out 2008-2012 Stores open by 2000 Coastal/Tex-Mart stores acquired (2001) .

One of the Jewels of the Tata Group. 5 . B2C businesses: Retail 299 stores 301584 sq ft 116 stores 2,68511 sq ft 27 stores,13607 sq ft 95 stores 80914sq ft 2 stores 4,534 sq ft 2 stores 6,

member requests a refill of the drug, at which time the member will receive a 60-day supply of the drug. If the Food and Drug Administration deems a drug on our formulary to be unsafe or the drug’s manufacturer removes the drug from the market, we will immediately remove the drug from our formulary and provide notice to members who take the drug.

This publication is designed to help you understand California's Sales and Use Tax Law as it applies to liquor stores. It is not designed to apply to grocery stores, drug stores, department stores selling liquor, or bars having off-sale licenses. Separate publications are available explaining the application of taxes to those businesses.

If the Food and Drug Administration deems a drug on our formulary to be unsafe or the drug’s manufacturer removes the drug from the market, we will immediately remove the drug from our formulary and provide notice to members who take the drug. Other changes. We may make other changes that affect members currently taking a drug. For

(drug-drug interaction), food, beverages, dietary supplements the person is consuming (drug-nutrient/food interaction) or another disease the person has (drug-disease interaction). A drug interaction is a situation in which a substance affects the activity of a drug, i.e.

A.R. Paterson, A First Course in Fluid Dynamics, Cambridge University Press. (The recommended text to complement this course - costs ˇ 50 from Amazon; there are 6 copies in Queen’s building Library and 3 copies in the Physics Library) 2. D.J. Acheson, Elementary Fluid Dynamics. Oxford University Press 3. L.D. Landau and E.M. Lifshitz, Fluid Mechanics. Butterworth Heinemann Films There is a .