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Gossell-Williams M, Adebayo SA. The PharmWatch programme: challenges to engaging the community pharmacists in Jamaica. Pharmacy Practice (Internet). 2008 Oct-Dec;6(4):187-190. Original Research
The PharmWatch programme: challenges to
engaging the community pharmacists in Jamaica
Maxine GOSSELL-WILLIAMS, Sarafadeen A. ADEBAYO.
ABSTRACT*
In February 2006, there was a renewed effort to PROGRAMA PHARMWATCH: EL RETO DE
encourage reporting of adverse drug reactions INVOLUCRAR A LOS FARMACÉUTICOS
(ADRs) in Jamaica. It involved renaming the COMUNITARIOS EN JAMAICA
process the “PharmWatch” programme and revising Objectives: The aims of this study were to assess En febrero de 2006 hubo un nuevo esfuerzo para the attitudes of community pharmacists to ADR animar a la comunicación de reacciones adversas reporting and to assess their utilization of the (RAM) en Jamaica. Conllevó el cambio de nombre a “PharmWatch” y la revisión del formulario de Methods: The survey was conducted in January 2007, involving 102 community pharmacists Objetivos: Los objetivos de este estudio fueron islandwide. A questionnaire was designed to assess evaluar las actitudes de los farmacéuticos their attitudes towards ADR reporting, their comunitarios a la comunicación de RAM y evaluar awareness of the PharmWatch programme and also su utilización del programa PharmWatch. to collate number of ADRs through recall. Métodos: La investigación corrió en enero de 2007, Pharmacists were then followed prospectively to involucrando a 102 farmacéuticos comunitarios de collect ADRs occurring over the next three months toda la isla. Se diseñó un cuestionario para evaluar sus actitudes hacia la comunicación de RAM, su Results: Although most of the pharmacists involved conocimiento del programa PharmWatch y parta in the survey had more than five years of recopilar algunas RAM por reclamo. Se siguió a los experience, the majority (67%) were not aware of farmacéuticos prospectivamente para recoger las the PharmWatch programme; however, 86% of the RAM que ocurrieron en los tres meses siguientes responding pharmacists indicated that they accepted that ADR reporting was a professional Resultados: Aunque muchos de los farmacéuticos responsibility. They identified “reaction already involucrados en el estudio tenían más de 5 años de known”, “more information needed about reporting experiencia profesional, la mayoría (67%) no ADRs” and “lack of time” as key factors that would conocía el programa PharmWatch; sin embargo, el cause non-reporting. One hundred and twenty eight 86% de los respondentes indicaron que aceptaban retrospective ADRs were collected; none were que comunicar RAM era una responsabilidad reported to the Ministry of Health directly, while two profesional. Identificaron “reacción ya conocida”, were reported to the respective drug companies. A three month prospective follow-up with pharmacists comunicación de RAM” y “falta de tiempo” como yielded 45 reports. The most common ADR reports los factores que podrían causar la no comunicación. among both the retrospective and prospective data Se recogieron 128 RAM retrospectivas; ninguna fue comunicada directamente al Ministerio de Conclusions: The results suggest that awareness of the PharmWatch programme is not adequate to directamente a los laboratorios fabricantes. Un facilitate active participation in ADR reporting. More seguimiento prospectivo de 3 meses rindió 45 proactive interventions, such as continuous training comunicaciones. Las RAM más comúnmente and encouragement in the use of ADR reporting comunicadas, tanto en el retrospectivo como en el prospectivo, estaban asociadas a antiinfecciosos. Conclusiones: Los resultados sugieren que el Keywords: Adverse Drug Reaction Reporting
conocimiento del programa PharmWatch no es adecuado para facilitar la participación activa en la comunicación de RAM. Deberían considerarse intervenciones más proactivas, como la formación continua y el aliento de la comunicación de RAM. Palabras clave: Sistemas de comunicación de
Maxine GOSSELL-WILLIAMS. PhD (Pharmacology). reacciones adversas. Farmacéuticos. Jamaica. Department of Basic Medical Sciences, Pharmacology Section, University of the West Indies. Kingston (Jamaica). Sarafadeen A. ADEBAYO. PhD (Pharmaceutics). School of Pharmacy and Health Science. University of Technology, Kingston (Jamaica). www.pharmacypractice.org
Gossell-Williams M, Adebayo SA. The PharmWatch programme: challenges to engaging the community pharmacists in Jamaica. Pharmacy Practice (Internet). 2008 Oct-Dec;6(4):187-190. report ADRs. This form is currently available to all healthcare professionals and patients from the Ministry of Health and Pharmacology section of UWI. INTRODUCTION
The form was also placed on the website of the While clinical trials involving drugs provide Jamaica Pharmaceutical Society in an effort to significant information on the efficacy of encourage pharmacists to become actively involved pharmaceuticals, they provide limited information on in the reporting process. Many countries have the the safety of their use because of the controlled active participation of pharmacists, especially conditions under which pre-marketing clinical trials community pharmacists in ADR reporting and have take place. These trials occur with small numbers, indicated that pharmacists’ involvement in this sometimes excluding the elderly, children, patients process can make significant contributions to the with co-morbidities or on multi-drug therapy and are benefit verse risk analysis among populations.9-12 also of limited duration.1 Therefore there are Therefore it is important to engage the Jamaican inherent risks when drugs enter the general market and their usage essentially becomes a balancing act of benefits verses adverse drug reactions. In January 2007, an islandwide survey of practicing community pharmacists was done. The aims of the An adverse drug reaction (ADR), as defined by the survey were to assess the attitudes of community World Health Organization2, is ‘the response to a pharmacists to ADR reporting and their awareness drug which is noxious and unintended and which occurs at doses normally used for the prophylaxis, diagnosis or therapy of a disease, or for the modification of physiological functions. These ADRs may be previously described or appear with use of The study design employed a retrospective opinion the drug in the general market. To ensure that an survey of community pharmacists in Jamaica. The ADR is not missed, it is estimated that at least list of registered pharmacies as of August 2006 was 30,000 persons need to be treated with a drug to obtained from the Pharmacy Council of Jamaica. produce an incidence of 1 in 10,000 exposed One hundred and two pharmacies were randomly persons.3 Therefore, adequate assessment of the selected from the three counties of Jamaica safety profile of a drug requires active (Cornwall, Middlesex and Surrey) to conduct the survey. The survey required one pharmacist from Pharmacovigilance, as defined by the World Health each pharmacy to complete a short questionnaire Organisation, is the pharmacological science and that was designed by nine pharmacists, each with activities relating to the detection, assessment, over five years of community pharmacy practice understanding and prevention of adverse effects, experience. It was then validated by pharmacists in particularly short- term and long -term side effects of the pharmacy training programme at the University medicines, or any other drug related problems.4 of Technology, Jamaica (UTech). The final Therefore pharmacovigilance will effectively questionnaire was drafted, taking reviewers encourage safe, rational and more effective use of comments into consideration. The questionnaire drugs. It has been estimated that through included demographic information, as well as their pharmacovigilance, 1 in every 5 drugs on the opinions on the importance of ADR reporting and market has been discovered to have a serious whether they were aware of the PharmWatch ADRs (e.g. requiring hospitalization or causing programme. They were also asked to indicate the death) resulting in changes made to drug factors that affect their reporting of ADRs and to monographs or withdrawal from the market.5 It was record all the ADRs they could recall occurring in through pharmacovigilance that incidence of the last twelve months. They were then provided cardiovascular complications occurring with with copies of the PharmWatch form, which they Cisapride, Terfenadine, Tegaserod and Rofecoxib were required to use to record all ADRs occurring in warranted their removal from the market.6-8 the next three months (prospectively). Pharmacists were called on a weekly basis as a way to In Jamaica, through the Pharmaceutical and Regulatory Unit of the Ministry of Health, all healthcare professionals are encourage to report The information on the questionnaires was treated ADRs using the spontaneous ADR monitoring form. with the SPSS version 12 for frequency analysis. This unit collects these reports, undertakes further investigations and takes appropriate actions. Oral communication with the Ministry of Health indicated that there is very little use of the spontaneous ADR form by health professionals. In 2006, through a community pharmacies islandwide (Cornwall = 36, collaborative effort involving the Ministry of Health Middlesex = 36 and Surrey =30) participated in the and the Pharmacology Section of the University of survey; this represents 28.8% (total number of the West Indies, there was a renewed effort to registered pharmacists = 354) of the pharmacies encourage utilization of spontaneous ADR reporting registered with Ministry of Health, as of August with the design of the PharmWatch programme. 2006. The majority, 75%, of the pharmacists had The original ADR reporting form was revised in more than five years of professional experience in February 2006 to produce a “PharmWatch” form to www.pharmacypractice.org
Gossell-Williams M, Adebayo SA. The PharmWatch programme: challenges to engaging the community pharmacists in Jamaica. Pharmacy Practice (Internet). 2008 Oct-Dec;6(4):187-190. ensuring the safe use of drugs6; therefore the unavailability of reports to the Ministry of Health will Awareness of PharmWatch programme and
affect the success of the PharmWatch programme. challenges
For example, the most common ADRs reported in The majority of the pharmacists involved in the this survey were associated with anti-infective survey, 67%, were not aware of the PharmWatch drugs; while this is an expected trend13,14, their programme. However, 86 % of the responding benefits are significantly influence by resistance pharmacists indicated that they accepted that ADR development and therefore evaluation of these reporting was a professional responsibility and only ADRs may be critical for resistance detection. 5% thought ADR reporting was a low priority task. Another factor that requires community pharmacists’ active involvement in ADR reporting is the need to contribute to them not reporting problems to the facilitate confidence in the efficacy of drugs. In the Ministry of Health, the top three reasons given were, United States, through active surveillance of ADRs, “reaction already known”, “more information needed it was determined that “failure of therapy” rated as about ADR reporting” and “lack of time” (Table 1). the top ADR outcome during the period 1969 to However fifty percent of them indicated that 2002.6 Promoting ADR reporting to ensure efficacy reporting ADRs would increase if an incentive for is of particular importance in the Jamaican setting, where pharmacists are mandated to offer patients generic alternatives to the more expensive Table 1. Reasons given by pharmacists for not reporting physicians) have expressed lack of confidence in many generics15,16; however, with non-reporting of ADRs, the Ministry of Health would be unable to Community pharmacists in this survey indicated reaction already known, lack of information about ADR reporting and confidence in making reports, as reasons for not reporting ADRs. Therefore, insufficient knowledge is a major challenge to * Pharmacists were able to tick more than one reason. community pharmacists’ participation in ADR reporting. Lack of time and motivation were also Retrospective and prospective ADR reports
given as predominant reasons for non-reporting. These major challenges of Jamaican community The questionnaire asked pharmacists to list any pharmacists are consistent with those identified by ADRs they could recall in the past twelve months. pharmacists in other countries1,9,17,18, and suggests Over the three counties, 128 ADRs reports were that pharmacists’ awareness of the PharmWatch collected of which none were reported to the programme is inadequate to promote the current Ministry of Health; but, two were reported to the pharmacovigilance system. This fact was very clear from quality of the prospective ADR reports Once pharmacists agreed to participate in the collected; while this part of the survey netted 45 reports, in most cases, only the name of the drug, programme, they were then asked to participate in a the reaction that occurred and the action taken were monthly follow-up for three months. During this time noted. Continuous training and encouragement in they were expected to record any ADRs occurring the use of the PharmWatch programme should using the PharmWatch form. For this time period, therefore be considered; as such interventions can 45 forms were collected, but in most cases only the improve pharmacists’ participation in ADR name of the drug, the reaction that occurred and the action taken were noted. For both the retrospective and prospective ADRs, anti-infective drugs CONCLUSIONS
dominated the reports (39.1% and 37.8% of the reports respectively). Spontaneous ADR monitoring is a standard process proven to be an important part of evaluating the
DISCUSSION
safety of drugs in the general market. This is the first report that assesses the attitudes of community Pharmacovigilance on a national level is important pharmacists in Jamaica towards pharmacovigilance for assessing the occurrence of differences that can and specifically their willingness to participate in result from factors related to diet, genetics, herbal ADR reporting. While it is encouraging that most of product use or cultural practices.3 In this survey, we the pharmacists were aware that they have a found that while community pharmacists were significant role in ADR reporting, much needs to be aware that they have a critical role in ADR reporting, done to engage their participation including programme. Pharmacists involved in the survey were able to list 128 ADRs that occurred in the ACKNOWLEDGMENTS
twelve months prior to participating in the survey; of which none were ever reported to the Ministry of This survey was made possible through funding Health. Reporting of ADRs plays a significant role in provided by HD Hopwood and Company Limited, www.pharmacypractice.org
Gossell-Williams M, Adebayo SA. The PharmWatch programme: challenges to engaging the community pharmacists in Jamaica. Pharmacy Practice (Internet). 2008 Oct-Dec;6(4):187-190. Medi-Grace Limited and Cari-Med Limited. The CONFLICT OF INTEREST
survey was conducted by practising pharmacists The authors declare that they have no competing enrolled the Post-Diploma Pharmacy programme at References

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2. World Health Organization. Safety of Medicines. Guidelines for setting up and running a pharmacovigilance centre. 3. World Health Organization. Safety of Medicines. A guide to detecting and reporting adverse drug reactions. Why health professionals need to take action. Geneva:WHO;2002. 4. Edwards IR , Aronson JK. Adverse drug reaction: Definitions, diagnosis and management. Lancet. 2000;356:1255-1259. 5. Lasser KE, Allen PD, Woolhandler SJ Himmelstein DU, Wolfe SM. Timing of new blackbox warnings and withdrawals for prescription medication. JAMA 2002;287:2215-2220. 6. Wysowski D, Swartz L. Adverse Drug Surveillance and Drug Withdrawals in the United States, 1969-2000. Arch Intern 7. Rainsford KD. Anti-inflammatory drugs in the 21st century. Subcell Biochem 2007;42:3-27. 8. Sanger GJ, Alpers DH. Development of drugs for gastrointestinal motor disorders: translating science to clinical need. Neurogastroenterol Motil. 2008;20(3):177-184. 9. van Grootheest K, Olsson S, Couper M, de Jong-van den Berg L. Pharmacists’ role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf. 2004;13:457-464. 10. Terceros Y, Chahine-Chaktoura C, Malinowski JE, Rickley WF. Impact of a pharmacy resident on hospital length of stay and drug-related costs. Ann Pharmacother. 2007;41(5):742-748. 11. Phansalkar S, Hoffman JM, Nebeker JR, Hurdle JF. Pharmacists versus nonpharmacists in adverse drug event detection: a meta-analysis and systematic review. Am J Health Syst Pharm. 2007;64(8):842-849. 12. Viktil KK, Blix HS. The impact of clinical pharmacists on drug-related problems and clinical outcomes. Basic Clin 13. Bigby M. Rates of cutaneous reactions to drugs. Arch Dermatol. 2001;137(6):765-770. 14. Svensson CK, Cowen EW, Gaspari AA. Cutaneous drug reactions. Pharmacol Rev. 2001;53(3):357-379. 15. Gossell-Williams M. Generic Substitutions: A 2005 survey of the acceptance and perceptions of physicians in Jamaica. 16. Gossell-Williams M, Harriott K. Generic substitution in Jamaica:challenges to improving effectiveness. WHO Drug 17. Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol. 2001;51(1):81-86 18. Irujo M, Beitia G, Bes-Rastrollo M, Figueiras A, Hernández-Díaz S, Lasheras B. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf. 2007;30(11):1073-1082 19. Bracchi R, Houghton J, Woods F, Thomas S Small SA, Routledge P. A distant-learning programme in pharmacovigilance linked to educational credits is associated with imporved reporting of suspected adverse drug reactions via the UK yellow card system. Br J Clin Pharmacol. 2005;60(2):221-223. 20. Sweis D, Wong ICK. A survey on factors that could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain. Drug Saf. 2000;23:165-172. 21. Herdeiro MT, Polonia J, Gestal-Otero JJ, Figueiras A. Improving the reporting of adverse drug reactions : a cluster- randomized trial among pharmacists in Portugal. Drug Saf. 2008; 31(4):335-344. www.pharmacypractice.org

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