Adverse Drug Reaction Reporting: a Novel Approach

ADVERSE DRUG REACTION REPORTING, A NOVEL APPROACH

Author: Abdul Latif Sheikh*, Ale Zehra*, Salwa Zubair*, Muhammad Zeeshan Khan*

ABSTRACT:

Globally adverse drug reactions (ADRs) has major contribution in public health cost & mortality ratio. Therefore it’s a crucial time for an ongoing ADR-monitoring and new easy advance reporting program which provides benefits to the health care professionals & patients. The aim of hosting a ADRs reporting modern tactic by the Department of Pharmacy Services,Aga Khan University Hospital ,Karachi,Pakistan(AKUH)(a tertiary care setup), is to perceive the outcome of spontaneous reporting of ADRs through call in name of Hot line service & its awareness campaign. In addition to manual yellow form and online reporting system,AKUH has launched the program with ADR’s awareness session, memorandum sent through mail & small spot quiz with ADRs card to all Doctors, Nurses & Pharmacists. The department has fixed its one telephone line for voluntarily reporting of ADRs. Total 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 ADR’s awareness memo mail was sent to all hospital professionals and ADRs flyers distributed to the wards. Impact of 05 month activity has assessed for its achievement or not. Reporting of ADRs was increase(09%) from 43 to 52 in count with contribution of 29 ADRs, reported via hot line service 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 compaign

Introduction:

Adverse drug 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 impact on the health of the population lead to contribution in health care costs due to hospital admissions (approx.5-6%), suggested the enormous direct and indirect social and economic costs for a society.^{2, 3, 4, 5, 6,7,14, 15,16,17,18}. Globally the burden of ADRs is high, accounting for considerable morbidity, mortality and extra cost²⁸

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Thalidomide is the first drug whose ADRs was reported in 1960¹⁹, estimated that 5000-6000 new born infants were effected by drug with characteristic of thalidomide-induced phocomelia, limb defects, often accompanied by deformities of internal organs^20,21. Due to reporting of its adverse reaction, it was withdrawn from the world market in late 1961, remaining available only for strictly defined research purposes, ²²diverted the attention of health caregiver to chore on reporting system 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 timely manner. Spontaneous reporting is most accessible and easiest method 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.²⁴

Spontaneous reporting is helpful but is usually prone to under reporting and poor quality reports ²⁵Other methods include intensive monitoring (resource and time consuming)²⁶, chart review (prospective and retrospective), FDA MEDWATCH reporting. One of the most common method is yellow card system which was started 30 years before but the main problem associated with it is under reporting (less than 10%)²⁷

Due to remarkable burden of ADRs globally, ^{28, 42}measures are needed to reduce the frequency of ADRs, healthcare costs and readmissions^{34, 35}and to improve the benefit harm ratio of drug. Fatal ADRs appear to be the 4^th or 6^th leading cause of death³¹; it can be reduced 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 analysis of this data³² ( 70% were known ADRs ,17% signals requiring further evaluation)³³ .Spontaneous reporting is the most common method used in pharmacovigilance and most effective 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.³⁶

Pakistan has been plagued with many health related problems, including ADRs. In Lahore, on Jan- 2012, at least 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, 38}However laws for monitoring and forms for reporting ADRs exist in Pakistan but there is no National ADR database.³⁹

In Pakistan, medicines are used on a large scale, but still ADRs reporting is a little known concept. Ministry of health (MOH) has been involved in developing an ADR program, but requires major improvements; widespread implementation being 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 made via telephones). Having multiple technologies available to healthcare professionals to report ADRs makes the task easy and ultimately results in improved patient care.⁴¹

Methodology:

To 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 patient’s Medical record number, time & date of reaction, suspected drug & nature of reaction.

Program started from 5^th August, 2013 with adoption of following strategies.

1. 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.
2. 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.
3. On weekly basis advertise through mail, sent to all hospital’s professional with different theme of ADRs.
4. Acknowledged with appreciation words to those user who report the ADRs through hot line service for future courage.
5. Collect the monthly data of ADRs reporting count with contribution of hot line service.
6. At end of month Calculate how much this service was affective?

Initially the data of 05 month activity was collected to evaluate impact of new services.

Table:01

Table:02

Table:03

Result:

ADRs reporting trend:

PRE ADRs hot line services:

Total voluntarily ADR reported = 43

Graph:01

Post ADRs Hot line Service:

Total voluntarily ADR reported including Hot line service= 52

Total ADR via Hot line service = 29

Graph:02

# of ADRs Reported Doctor, Nurses & Pharmacists.

Pre ADRs Hot line service:

Graph:03

Post ADRs Hot line service:

Graph:04

Discussion:

New 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 5^th August -2013 to all hospital’s Doctors, Nurses & Pharmacists. Program features includes awareness session,spot quiz, memo through mail. Pre & post service comparison indicate the increased in quantity of voluntarily 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 technologies^34,35. Reporting via manual yellow card has almost zero ( pre & post evaluation showed zero reporting)which may 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 ADR^{28, 42} alarm each health care setup to concentrate 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 hospital’s 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 professionals 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 September, 2013 (shown in graph 02) i.e 19 & its was 2^nd 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 patient’s medical record of high-risk patients⁴³ thus in current adopted approach contribution of

Pharmacist 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.

Conclusion:

ADRs 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 .

References:

1. Biswas, P., Pharmacovigilance in Asia. J Pharmacol Pharmacother. 4(Suppl1): p. S7-S19.
2. Goettler, M., S. Schneeweiss, and J. Hasford, Adverse drug reaction monitoring–cost 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.
3. Einarson, T.R., Drug-related hospital admissions. Ann Pharmacother, 1993. 27(7-8): p. 832-40.
4. Muehlberger, N., S. Schneeweiss, and J. Hasford, Adverse drug reaction monitoring–cost and benefit considerations. Part I: frequency of adverse drug reactions causing hospital admissions. Pharmacoepidemiol Drug Saf, 1997. 6 Suppl 3: p. S71-7.
5. Lazarou, J., B.H. Pomeranz, and P.N. Corey, Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 1998. 279(15): p. 1200-5.
6. S., O., The role of the WHO program on International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Saf 19, 1998: p. 1–10.
7. Rawlins, M.D., Clinical pharmacology. Adverse reactions to drugs. Br Med J (Clin Res Ed), 1981. 282 : p. 974-6.
8. Edwards, I.R. and J.K. Aronson, Adverse drug reactions: definitions, diagnosis, and management. Lancet, 2000. 356: p. 1255-9.
9. Bandekar, M.S., S.R. Anwikar, and N.A. Kshirsagar, Quality check of spontaneous adverse drug reaction reporting forms of different countries. Pharmacoepidemiol Drug Saf. 19(11): p. 1181-5.
10. Munir Pirmohamed, S.J., Shaun Meakin, Chris Green, Andrew K Scott,Thomas J Walley,Keith Farrar,B Kevin Park,Alasdair M Breckenridge., Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004. 329: p. 15-19.
11. Mellin GW, K.M., The saga of thalidomide (concluded). . N Engl J Med 1962. 24: p. 1238-44.
12. V, G., Thalidomide in human immunodeficiency virus (HIV) patients. A review of safety considerations. Drug Saf, 1992. 7(2): p. 116-34.
13. D’Arcy PF, G.J., Thalidomide revisited. . Adverse Drug React Toxicol Rev 1994. 13: p. 65-76.
14. Stephanie Tseng, G.P., Kenneth Washenik, Miriam Keltz Pomeranz, Jerome L Shupack., Rediscovering thalidomide: A review of its mechanism of action, side effects, and potential uses. Journal of the American Academy of Dermatology, 1996. 35(6): p. 969-979.
15. Pal, S.N., et al., WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems. Drug Safety, 2013. 36(2): p. 75-81.
16. WHO, A practical handbook on the pharmacovigilance of medicines used in the treatment of tuberculosis: enhancing the safety of the TB patient. 2012, 20 Avenue Appia, 1211 Geneva 27, Switzerland: WHO Library Cataloguing-in-Publication.
17. Figueiras A, H.M., Polónia J, et al., An Educational Intervention to Improve Physician Reporting of Adverse Drug Reactions: A Cluster-Randomized Controlled Trial. JAMA, 2006. 296(9): p. 1086–1093.
18. Bates DW, C.D., Laird N, et al., Incidence of adverse drug events and potential adverse drug events – implications for prevention. JAMA, 1995. 274: p. 307–311.
19. Rawlins, M.D., Pharmacovigilance: paradise lost, regained or postponed? The William Withering Lecture 1994. J R Coll Physicians Lond, 1995. 29(1): p. 41-9.
20. Al., G.J.e., Why Learn about Adverse Drug Reactions (ADR)? Am J Med, 2000. 109(2): p. 87-94.
21. Davies, D.E.C., Emergency re-admissions to hospital due to adverse drug reactions within 1 year of the index admission. British Journal of Clinical Pharmacology, 2010. Volume 70(Issue 5).
22. Kass, B.L. Reducing and Preventing Adverse Drug Events To Decrease Hospital Costs. [cited; Available from: www.ahrq.gov/qual/aderia/aderia.htm.
23. Bate, A., et al., A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol, 1998. 54(4): p. 315-21.
24. AGENCIES, Drug regulation follows heart patient deaths., in Daily Dawn. 2012-03-12: Lahore, Pak.
25. Saeed, A., Pakistan heart drugs: Lahore death toll reaches 100, in BBC News. 26 January 2012: Lahore, Pak.
26. Jooma, P.D.R., Pakistan. Pharmaceutical Country Profile 2010, Health Ministry of Pakistan: Pakistan. P. 1-56.
27. Al., G.e., adverse drug reaction reporting system at different hospitalsof lahore, pakistan – an evaluation and patient outcome analysis. journal of applied pharmacy, 2013. 4(1): p. 713-719.
28. AKUH Pharmacy newsletter, Sep 2013, Vol.23, 02.
29. www.ahrq.gov/qual/aderia/aderia.htm
30. www.worstpills.org/public/page.cfm?Op_id=4‎
31. Lazarou, Jason, Bruce H. Pomeranz, and Paul N. Corey. “Incidence of adverse drug reactions in hospitalized patients.”JAMA: the journal of the American Medical Association279.15 (1998): 1200-1205.
32. Bate, Andrew, et al. “A Bayesian neural network method for adverse drug reaction signal generation.”European journal of clinical pharmacology54.4 (1998): 315-321.
33. Evans, S. J. W., P. C. Waller, and S. Davis. “Use of proportional reporting ratios (prrs) for signal generation from spontaneous adverse drug reaction reports.”Pharmacoepidemiology and drug safety10.6 (2001): 483-486.
34. Muehlberger N,Schneeweiss S,Hasford J. “Adverse drug reaction monitoring–cost and benefit considerations. Part I: frequency of adverse drug reactions causing hospital admissions.” Pharmacoepidemiol Drug Saf.1997 Oct;6 Suppl 3:S71-7.
35. Dr Emma C. Davies et al. “Emergency re-admissions to hospital due to adverse drug reactions within 1 year of the index admission”British Journal of Clinical pharmacologyvolume 70, Issue 5, Article first published online: 14 JUL 2010
36. Anthony R cox et al. “Assessing, managing and reporting
37. Adverse drug reactions may better equip us to minimize medicines-related harm”, 2008 volume 18, issue-2/5 PIP Basic pharmacy skills Mar08
38. www.dawn.com/news/702090/drug-regulation-follows-heart-patient-deaths
39. www.bbc.co.uk/news/world-asia-16742832
40. WHO’s Pharmaceutical country profile: Pakistan.
41. Gulamet al., 2013, “adverse drug reaction reporting system at different hospitalsof lahore, pakistan – an evaluation and patient outcome analysis”, journal of applied pharmacy04(01): 713-719; January, 2013
42. AKUH Pharmacy newsletter, Sep 2013, Vol.23, 02
43. www.fda.gov/Drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm114848.htm
44. ASHP Guidelines on Adverse Drug Reaction Monitoring and Reporting, www.ashp.org.