Adverse Drug Reaction Reporting: a Novel Approach

Adverse medicine Reaction Reporting a romance ApproachADVERSE DRUG REACTION REPORTING, A NOVEL APPROACHAuthor Abdul Latif Sheikh*, Ale Zehra*, Salwa Zubair*, Muhammad Zeeshan Khan*ABSTRACTGlobally unfavourable dose chemical reactions (ADRs) has study contri plainlyion in public health cost mortality ratio. Therefore its a crucial time for an ongoing ADR-monitoring and new faint progress describe program which provides benefits to the health care professionals unhurrieds. The aim of hosting a ADRs physical compositioning modern tactic by the section of Pharmacy Services,Aga Khan University Hospital ,Karachi,Pakistan(AKUH)(a ordinal care setup), is to perceive the outcome of spontaneous reporting of ADRs through call in name of Hot line of merchandise operate its awareness oppose. In increment to manual yellow form and online reporting trunk,AKUH has launched the program with ADRs awareness session, memorandum sent through berth small spot quiz with ADRs account to all Doctors, Nurses Pharmacists. The department has fixed its one telephone line for voluntarily reporting of ADRs. native 08 awareness session has been taken at different forum of AKUH including its associated secondary hospital from August to December with 274 participants while 396 professionals participated in spot quiz activity. On weekly basis ADRs awareness memo mail was sent to all hospital professionals and ADRs flyers distributed to the covers. Impact of 05 calendar month activity has assessed for its achievement or not. Reporting of ADRs was increase(09%) from 43 to 52 in count with region of 29 ADRs, describe via hot line return while the awareness campaign boosted the professionals to report ADRs as pharmacist participation appeared to be increased from 35% to 64%. However different countries and organizations have different technologies for reporting ADRs but by adoption of such a type of modern smart approach which is easy for professionals to report ADRs awareness compaign of ADRs enhance the professional to report ADRs for positive patient out comes safety.Key word Report ADR through call, Novel technology in ADR reporting, ADRs awareness compaignIntroductionAdverse medicate reactions (ADRs), occurs at normal doses (used for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiologic function), have a considerable adverse intrusion on the health of the population lead to contribution in health care cost due to hospital admissions (approx.5-6%), suggested the enormous direct and indirect sociable and economic costs for a society.2, 3, 4, 5, 6,7,14, 15,16,17,18. Globally the burden of ADRs is senior high school, accounting for considerable morbidity, mortality and extra cost28Thalidomide is the first drug whose ADRs was reported in 196019, estimated that 5000-6000 new innate(p) infants were effected by drug with characteristic of thalidomide-induced phocomelia, limb defects, often accompanied by deformit ies of internal organs20,21. Due to reporting of its adverse reaction, it was withdrawn from the world food market in late 1961, remaining available only for strictly defined research purposes, 22diverted the attention of health care bringr to chore on reporting transcription of adverse drug reaction.ADR monitoring or a reduction in their frequency simply cannot happen until and unless they are reported in an efficient and by the way manner. Spontaneous reporting is most accessible and easiest regularity for ADR reporting. WHO has implemented two methods in its public health program, cohort event monitoring (CEM) and targeted spontaneous reporting (TSR). CEM encompasses all drug related issues including poor quality, drug interactions, storage and medication errors23 while in TSR health professionals in specific setting (e.g. patients on drug resistant infection) reports about drug related issues, safety.24Spontaneous reporting is helpful but is usually prone to under reporting and poor quality reports 25Other methods embroil intensive monitoring (resource and time consuming)26, chart review (prospective and retrospective), FDA MEDWATCH reporting. One of the most common method is yellow broadsheet system which was started 30 years forward but the main problem associated with it is under reporting (less than 10%)27Due to remarkable burden of ADRs globally, 28, 42measures are needed to reduce the frequency of ADRs, healthcare costs and readmissions34, 35and to improve the benefit harm ratio of drug. Fatal ADRs appear to be the 4th or 6th leading cause of death31 it can be cut by making changes in systems for preventing and detecting adverse drug event(ADEs)29. A study indicates that a computer alert system prevented ADRs which were otherwise not recognizeable29.WHO database contains over 2.5 million case report epitome of this data32 ( 70% were known ADRs ,17% symptoms requiring further evaluation)33 .Spontaneous reporting is the most common method u sed in pharmacovigilance and most good in generating signals on new or rear adverse drug reactions28.Reduction in ADRs will occur only if ADRs are properly reported and the patterns can be studied to identify the causes of ADRs, which will in the end, help to reduce their occurrence.36Pakistan has been plagued with many health related problems, including ADRs. In Lahore, on Jan- 2012, at to the lowest degree 125 patients died due to an adverse drug reaction(ADRs) due to one of the cardiac medicine, which was adulterated with an antimalarial agent, found on investigation.37, 38However laws for monitoring and forms for reporting ADRs exist in Pakistan but thither is no National ADR database.39In Pakistan, medicines are used on a large scale, but still ADRs reporting is a subaltern known concept. Ministry of health (MOH) has been involved in ontogenesis an ADR program, but requires major improvements widespread implementation cosmos a critical factor. Majority of the hospitals have no ADRs reporting system, others are reporting ADRs restricted to some drugs, and only few hospitals have a proper established ADRs reporting system40. The Aga Khan University Hospital (AKUH), being the premier hospital of Pakistan, also has an established ADRs program, which includes utilizing various technologies to report ADRs Yellow cards, online reporting, and a recently established ADR reporting hotline service (where reports can be make via telephones). Having multiple technologies available to healthcare professionals to report ADRs makes the task easy and ultimately results in improved patient care.41MethodologyTo enhance the ADRs reporting system in an easiest more efficient way, The Department of Pharmacy services-AKUH, in addition to yellow card online ADRs reporting, tune up to a new spontaneous service in name of ADRs hot line service in which pharmacy fix its one telephone extension for receiving ADRs reporting calls. Caller is the reporting person but the login of ADRs in system is the responsibility of pharmacy by asking the information of about patients Medical record number, time date of reaction, surmise drug nature of reaction.Program started from 5th August, 2013 with adoption of following strategies.Aware session at different forum of doctors, pharmacists nurses, distribution of ADRs flyers to different unit of ward ADRs cards inform them about the importance outcomes of ADRs reporting.By taking a small spot quiz of ADRs (policies, how to login, and its outcome e.t.c) to different staff randomly give small prizes for their appreciation encouragement.On weekly basis advertise through mail, sent to all hospitals professional with different theme of ADRs. declare with appreciation words to those user who report the ADRs through hot line service for future courage.Collect the monthly data of ADRs reporting count with contribution of hot line service.At end of month Calculate how much this service was affective?Initially the data of 05 month activity was collected to try impact of new services.Table01Table02Table03ResultADRs reporting trendPRE ADRs hot line servicesTotal voluntarily ADR reported = 43Graph01Post ADRs Hot line ServiceTotal voluntarily ADR reported including Hot line service= 52Total ADR via Hot line service = 29Graph02 of ADRs Reported Doctor, Nurses Pharmacists.Pre ADRs Hot line serviceGraph03Post ADRs Hot line serviceGraph04Discussion impertinently methodologies in any set up always helpful for its goal achievement. In a current scenario, along with yellow card online reporting system, The Department of Pharmacy Services-AKUH introduces a new spontaneous method of ADRs reporting in name of ADRs Hot Line Service. Program( hot line service its awareness compaign) was started on 5th August -2013 to all hospitals Doctors, Nurses Pharmacists. Program features includes awareness session,spot quiz, memo through mail. Pre post service comparison indicate the increased in quantity of voluntaril y reporting ADRs, from 43 to 52 ( as shown in graph 01 02).Increase in 09% ADRs reporting status indicate that service along with campaign was effective but still need continuous effort in field of ADR reporting technologies34,35. Reporting via manual yellow card has almost vigour ( pre post evaluation showed zero reporting)which whitethorn be due to presence of online reporting as it is easy convenient as compare to yellow card while globally yellow card reporting is also underreporting27. Globally the burden of ADR28, 42 alarm each health care setup to narrow its way of reporting methodology so as large amount of ADR would be reported.Total reporting trend through hot line service in around 05 month campaign was 29 including from its associated secondary hospitals (06 ADRs reported by Secondary hospitals doctors Pharmacist) while before campaign there was zero reporting from there. Awareness sessions spot quiz campaign (as shown in table 01 02) over there boost the profess ionals to report the ADRs for future patient safety.As the campaign also include weekly memo (importance of ADR reporting new service) mail sent to to all professionals, act as enhancement factor for reporting. Total 20 memos have been mailed in 140 days program assesment as shown in table 03.Highest number of total ADRs has been reported in month of kinfolktember, 2013 (shown in graph 02) i.e 19 its was 2nd month of campaign while least number has been reported in month of November i.e only 2 which may be due to non occurrence of ADRs. Reporting via hot line service was seem to be high in month of September also (as shown in graph 02) while moderate in month of October December (as shown in graph 02) but over all contribution of hot line service in ADRs reporting was good satisficatory certified program to continue in future for patient safety.Though the doctors, pharmacist nurses have an equal accountability to report ADRs but Pharmacist have an vital role in direct patient care through counseling on ADRs, identification and documentation in the patients medical record of high-risk patients43 thus in current adopted approach contribution ofPharmacist to report ADR appeared to be high as compare to the pre awareness campaign indicate the positive outcome of compain.Reporting of ADRs is high in high income incoutries as compare to low income countries. As per World Health Organization,Pakistan stand among low income countries so there is need of development of such a smart approach for reporting ADRs its awareness for patient safety.ConclusionADRs have a major contribution in death mortality so there is need to continue effort in developing an easy and smart technology like spontaneous reporting of ADRs through call( ADRs hot line service) its awareness comapign seems to be very effective boosting professionals .ReferencesBiswas, P., Pharmacovigilance in Asia. J Pharmacol Pharmacother. 4(Suppl1) p. S7-S19.Goettler, M., S. Schneeweiss, and J. Hasford, Adverse drug reaction monitoringcost and benefit considerations. Part II cost and preventability of adverse drug reactions leading to hospital admission. Pharmacoepidemiol Drug Saf, 1997. 6 Suppl 3 p. S79-90.Einarson, T.R., Drug-related hospital admissions. Ann Pharmacother, 1993. 27(7-8) p. 832-40.Muehlberger, N., S. Schneeweiss, and J. 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