Available online at www.sciencedirect.com
ScienceDirect Procedia - Social and Behavioral Sciences 172 (2015) 749 – 753
Global Conference on Business & Social Science-2014, GCBSS-2014, 15th & 16th December, Kuala Lumpur
Development of Validated Questionnaire to Access Public Knowledge on Registered Drugs Nur Wahida Zulkiflia*, Noorizan Abd. Aziza, Yahaya Hassana, Mohamed Azmi Hassalib, Nur Liyana Zainal Bahrina a
University of Technology MARA, Bandar Puncak Alam, Selangor, 40450, Malaysia b Universiti Sains Malaysia, Pulau Pinang, 11800, Malaysia
Abstract Ministry of Health (MOH) Malaysia statistic has shown the increasing trend of unregistered drugs from the raid at the premises in Malaysia. This finding has also reflecting unknowledgeable of community on this issue. At present no validated questionnaire been developed. The content validity and clarity of the questionnaire would be evaluated by expert panels from academia and enforcement pharmacy division. The production of a validated questionnaire are expected to guide might give a guideline to the enforcement pharmacist or any health care professional to identify type of knowledge community lacking that cause using of unregistered drugs. © Published by by Elsevier Ltd.Ltd. This is an open access article under the CC BY-NC-ND license ©2015 2015The TheAuthors. Authors. Published Elsevier (http://creativecommons.org/licenses/by-nc-nd/4.0/). Peer-review under responsibility of GLTR International Sdn. Berhad. Peer-review under responsibility of GLTR International Sdn. Berhad.
Keywords: Public knowledge; registered drugs; validated questionnaire; Malaysia; pharmacist role.
1. Introduction Modern medications and traditional supplements has been used for the prophylaxis or treatment of diseases in the health intervention internationally. The environment and the abundance of drugs available in the market as well as the attractive advertisement have the ability of influencing consumers to purchase them. The counterfeit drugs or in Malaysia known as unregistered drugs has been advertised widely in the community.
* Corresponding author. Tel.: +603-32584647; fax: +603-32584602. E-mail address:
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1877-0428 © 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Peer-review under responsibility of GLTR International Sdn. Berhad. doi:10.1016/j.sbspro.2015.01.428
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Their usage has increased tremendously including not only as the "lifestyle" products but the vital medicines as well. According to National Pharmaceutical Control Bureau (NPCB), a registered drug is a drug that is approved by the Drug Control Authority (DCA) for sale or to be used in Malaysia. This drug has been evaluated and tested for its efficacy and safety (Pharmaceutical, 2013). Unregistered drugs are dangerous and a serious threat to public health and safety around the world (Ames et. al. 2012) (Furman-Assaf et. al. 2010). The percent of the contribution of unregistered drugs in the market is high in the developing countries compared to developed countries (Sugita & Miyakawa 2010). Pharmaceutical Security Institute had a report in 2008 showing that there are many reported incidents of unregistered drugs from over that 100 countries. The report is increasing throughout the year, and some of the private sectors claimed that the incidence of unregistered drugs on the market increased approximately 25% each year over the past years back (Shepherd, M. 2010). The challenge in the developed and developing countries to overcome this problem is related with lacking of information on prevalence and reasons for the purchase of the unregistered drugs (Tamir et. al 2010) (Hassali et. al. 2012) (Martino et. al 2010) (Alfadl et. al. 2013). Health care professionals especially pharmacist need to provide the current information and educate public regarding the registered drugs identification that they will consume (Hassali et. al. 2012) (Bansal et. al. 2013) (Law & Youmans 2011). In Malaysia there is a programme known as ‘Know Your Medicine’, which is one of the essential components in the Malaysia National Medicines Policy, which emphasised on the “Quality Use Medicine” concept among consumers of this nation (Azmi et. al. 2012). Therefore, to ensure consumers get the benefit from the program, the assessment tools of knowledge will enable the health care professionals to measure public understanding from the programmes (Bonin et. al. 2014). This aim of this study is to develop a validated questionnaire for evaluating publics’ knowledge on registered drugs. 2. Research problem Unregistered drugs is illegal to be in the market including in country like Malaysia. Based on Annual Report of Enforcement Pharmacy in 2012, the number of raiding is increasing in trends since 2010 till 2012; 1026, 1081 and 1177 raid being reported. The value of seize has achieved up to RM 27 million per year (Farmasi, 2012), and there is a high possibility that the value of seizing will keep on increasing year by year. From the previous statistic, it has clearly indicated that the value of seizing of unregistered drugs keep on increase by time. Although, the various campaigns run by MOH to educate the public the importance of buying the registered drugs and the legislation enforced to prevent the unregistered drugs to be available in Malaysia. This situation has clearly gives the impression that there is lacking in the effectiveness of the existing programs done. There is a knowledge gap between the efficacy of existing programs and the reasons that lead to the buying of unregistered drugs among public. The need of this research is to full fill the gap exist and provides answers to the current problems. Quality Use of Medicines (QUM) is one of the main objectives of Malaysia’s National Medicines Policy. Within the context of QUM framework, it is crucial to get current data from the general population in order to assess their understanding on issues related to rational use of medicines. There is a National Survey On the use of Medicines (NSUM) by Malaysian Consumers conducted by Pharmaceutical Services Division in order to evaluate the performance of the campaign ‘Know You Medicines’ 2012. The main purpose of this study will help to establish the Quality Use of Medicines nationwide and directly embark the initiatives done in 10 th Malaysia Health Plan. According to the result from the NSUM, up to 76.4% of the participants were aware of the requirement for registration with the MOH for all modern and traditional medicines prior to marketing. (Azmi et al., 2012). Furthermore, only 38.7% of the participants were aware of Meditag® availability (Azmi et al., 2012). This result showed that the majority of the Malaysian consumer didn’t know what is Meditag and the function of Meditag. The result of the awareness is high; showed that participants aware of the requirement of registration but at the same time; they didn’t know what Meditag is. To know what is Meditag; is some of the crucial information that user need to know in order to prevent consumer to buy unregistered drugs. There has been limited studies to investigate the importance of education assessment on registered drugs. This questionnaire or tool can provide baseline data of level of public education in Malaysia and also would help to identify types of knowledge that the public are still lacking.
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3. Review of relevant literature 3.1. Sources related in management of unregistered drugs x Public awareness Public awareness on the registered drugs in Malaysia is one of the major issues which need strong attention from government. Previous study done has shown that Malaysian citizens have lack of general knowledge in terms of reading the side effects of the products they consumed (Hassali et. al. 2012). From the same finding, the author has concluded that an effective of unregistered drugs awareness education should be done strategically. Among the strategies that need to be implemented are teach the public to read and understand the drug label before purchasing, giving counselling in segregated information and finally educate them on identification of registered drugs. x Pharmacist role Pharmacist play an important role to educate public on the registered drugs. This is due to the fact that pharmacists are known as a drug expert hence they held the responsibilities to ensure the public understand the correct information regarding of the registered drugs. Many studies conducted have shown that public do not know or understand about the medication they are taking (Hassali et al., 2012). Therefore, pharmacist must always provide the latest information and knowledge regarding medications to the public. The purpose of the update is to let the public remain updated on the products’ knowledge. As a conclusion, there is a must for both pharmacist and public to aware and understand the knowledge of the registered drugs. It is their own responsibilities to have an iniatives to understand the safety, quality and efficacy of the products or drugs. 4. Method 4.1. Study design This study is a cross-sectional study, consist of three groups and non-probable samples (Group 1, 2, 3), carried out for 90 days; from October 2014 - December 2014. Group 1 consist of ten people from academia experienced in the development of the questionnaire and ten people from enforcement pharmacy division experienced in enforcement more than 3 years, who’s participated in the content validity and clarity evaluation stages of the tools. Group 2 consist of ten general public, participating in the clarity evaluation and reproducibility stages of the tools. Group 3 consist of 100 general public, participating in the internal consistency stages. 4.2. Inclusion criteria The inclusion criteria for Group 2 and Group 3; Malaysian, age, 18 years and over; no cognitive impairment and understand Bahasa Melayu and English. The study sites selected were in Klang Valley. All respondents are required to provide written consent. This study will be requested approval from the Ethics Community University Technology MARA, Malaysia. 4.3. Tool development The development of the questionnaire based on the current campaign known as ‘Know Your Medicine’. In the campaign has one sub campaign known as, ‘Choose a Registered Drugs’. All of the questions in the tools are related with the campaign. The main construct of interest is knowledge of registered drugs.
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4.4. Content validity and clarity evaluation For the content validity and clarity evaluation, expert panels from academia and enforcement were asked to give scale for two aspects. The two aspects are semantic, the sentence compatible with target population (public in Malaysia); and content, the questions is suitable and adequate to verify the objective of this study (Bonin et. al. 2014) (PasqualI 1998) (PasqualI 2010). The assessment of clarity and content used intervals. For each question tested, a scale was organized with values from 1 to 10, as follows: from 1 to 4, the question was considered ‘confused’; from 5 to 7, ‘unclear’; and from 8 to 10, ‘clear’ (Bonin et. al. 2014) (PasqualI 1998) (Martin-Albo 2006). Every question will have a column for suggestions towards semantic and content of every questions. 4.5. Reproducibility In two week's gap interval, ten of the same subjects sample from public will replicate the same procedures of answering the questionnaires. This phase will be using the test-retest method. 4.6. Descriptive analysis Demographic data from the subjects will be analysed; age, sex, race, level of education, residential location and profession. The objective to analyse the demographic data is to assess the relationship between the level of knowledge of registered drugs and the other variables. 5. Data analysis For the reproducibility, the Intra Class Coefficient analysis will use the total scores generated by the survey, based on a value greater than 0.8. (Ghisi GL et. al. 2010) (Dancey CP & Reidy J. 2005). The reliability of the questionnaire will assess by using Cronbach’s alpha in all subjects, considering the minimum value of 0.6. (Ghisi GL et. al. 2010) (Dancey CP & Reidy J. 2005) (Damásio BF. (2012). Descriptive statistics consist the following: absolute and relative frequencies; mean; median; and standard deviation (SD). For the normality test will use the Kolmogorov-Smirnov to check the normality of the variables which are demographic details and the questionnaire score, which do not meet the criteria stated. 6. Conclusion The study would produce a validated tool which consist of questionnaire to be used by MOH. The purpose of the tool is to evaluate and monitor knowledge on registered drugs. As a conclusion, more strategic approaches can be recommended to increase the public knowledge in sustaining the safety of life and ensuring the quality, safety and efficacious products. References Alfadl, A. A., Hassali, M. A., & Ibrahim, M. I. M. (2013). Counterfeit drug demand: Perceptions of policy makers and community pharmacists in Sudan. Research in Social and Administrative Pharmacy, 9, 302–310. doi:10.1016/j.sapharm.2012.05.002 Ames, J., & Souza, D. Z. (2012). Counterfeiting of drugs in Brazil, 46(1), 3–7. Azmi, M., Akmal, A., With, C. G. N., Fauziah, S., St, L., Ak, N., Lj, S. (n.d.). (2012) A NATIONAL SURVEY ON THE USE OF MEDICINES ( NSUM ), 1–120. Bansal, D., Malla, S., Gudala, K., & Tiwari, P. (2013). Anti-counterfeit technologies: a pharmaceutical industry perspective. Scientia Pharmaceutica, 81, 1–13. doi:10.3797/scipharm.1202-03 Bonin, C. D. B., Santos, R. Z. Dos, Ghisi, G. L. D. M., Vieira, A. M., Amboni, R., & Benetti, M. (2014). Construction and Validation of a Questionnaire about Heart Failure Patients’ Knowledge of Their Disease. Arquivos Brasileiros de Cardiologia. doi:10.5935/abc.20140032 Damásio BF. (2012). Uso da análise fatorial exploratória em psicologia. Aval Psic.;11(2):213-28. Dancey CP, Reidy J. (2005). Statistics without maths for Psychology: using SPSS for Windows. 3rd ed. London: Prentice Hall.
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