Regulating Pharmaceutical Promotional Activities in Canada - Research Proposal Example

? Regulating pharmaceutical promotions in Canada Topic Regulating pharmaceutical promotional activities through political channels to provide complete and accurate information regarding prescription drugs. Goal The purpose of this study is to investigate potential methods of regulating and compelling pharmaceutical companies to reveal to the public information as regards promotion of prescription drugs to the extent that it’s within the legal limits as set by the Food and Drugs Act of Canada. It is critical at this point to note that in Canada due to the technological advancements around, advertising is more widespread and reaches more people than ever, and the pharmaceutical industry has taken full advantage of this. A deep and thorough analysis and understanding of the various prescriptions drug promotion methods (advertising methods) used by pharmaceutical companies is necessary to design policies that regulate these practices to prevent the public’s exploitation by the highly aggressive and profit oriented pharmaceutical companies. Objectives To analyze the pharmaceutical advertisements carried out by the pharmaceutical companies targeting the public in an effort to decipher the kind of information that they convey. The fundamental purpose of this is to collect data that overtly demonstrates the kind of information that the various forms of advertising present to the public and then use this information to formulate regulatory policy with regard to this forms of advertisement, and the interests of all stakeholders in mind (Palumbo, & Mullins, 2002). To investigate the current regulatory policies in place and whether they are effective in controlling the promotion of prescription drugs available in Canada. This will give invaluable insight into whether the current policies are effective and how suggested changes to these policies will be beneficial to the public at large (Noris, herxheimer, Lexchin, & Mansfield, 2004). To investigate the current status of healthcare due to widespread advertising of prescription drugs to consumer. The idea is to examine the impact of advertising on healthcare and whether effective regulation via formulation and implementation of effective policies will be beneficial (Mintez, 2006). Hypothesis and Questions The questions to be addressed by this proposal include: What kind of information is contained within the pharmaceutical advertisements? Is there currently any policy in place that clearly stipulates regulatory guidelines as pertains to the kind of information that can be disclosed to the public with regard to prescription drugs? Are these policies effective? Has the current state of health been affected by the advertisements? Are there any necessary changes to be made to these policies? The hypotheses of this proposal include: Pharmaceutical companies carry out advertising campaigns on prescription drugs and in the process provide information to the public in contravention of established regulatory frameworks e.g. the Food and Drugs Act of Canada. The current regulatory policies in Canada are ineffective in controlling the promotion of prescription drugs to the public by pharmaceutical companies. The current status of healthcare in Canada is better as a result of the widespread promotional activities by the pharmaceutical companies. Rationale Pharmaceutical companies are obsessed with hitting profit targets and maximizing their sales volume to the extent that they contravene already established legislature spelt out unequivocally on the kind of information that can be revealed to the public as regards prescription drugs (Department of Justice, 2011). There is legislation governing the kind of information to be revealed to the public one such legislation is the Food and Drugs Act which expressly stipulates that there shall be no advertisement to the general public of any drug intended for the purposes of preventing, curing, or treatment of serious diseases (Health Canada, 2008). It also prohibits the promotion or advertising of prescription drugs regardless of the indication. This Act was amended in 1978 to allow for the inclusion of a clause that permitted advertisers of schedule F drugs (Prescription drugs) to include information on price of the drug. This individual is only allowed to give details of common name of the drug, brand name, quantity and price of the drug and the proper name. Revelation of any other information contravenes this act. This amendment was made to promote competition between pharmacies. In order for us to then determine whether there is contravention of this Act, its imperative to critically analyze the information contained in this advertisements to then make justifiable conclusions and recommendations. My hypothesis states that indeed pharmaceutical companies act in contravention to this Act and then the intention is to justify this assertion (Regis, 2006). The pharmaceutical companies advertise prescription drugs aggressively and in the process violate established regulatory frameworks which discourage against the revelation of certain information regarding prescription drugs to the general public beyond a certain point. There are axiological reasons that form the foundation of the Food and Drugs Act which terms the advertisement of prescription drugs beyond a certain point as illegal. The regulatory bodies and the government at large found it imperative to impose these restrictions and it’s all in public interest. These policies however have to be evaluated for loop holes. It then becomes necessary to carry out research to find out whether these policies in place are effective (Mintzes, Basset, Lexchin, 2001). Is the public being exposed to certain information about prescription drugs that has a negative effect on their overall well being? If they are not, then what is the position of key stakeholders with regard to this issue? What suggestions do they have that will strengthen these policies and in effect eliminate all possible short comings of these policies. My hypothesis asserts that indeed the policies in place are inadequate and have been interpreted differently to allow for the advertisement of prescription drugs within Canada. The widespread advertising of prescription drugs has an impact on the status of health of many Canadians (NIHCM Foundation, 2001). Whether the impact is positive or negative is subject to research. Pharmaceutical companies have aggressively advertised their drugs to the general public and in essence it can be deduced that this has led to increased awareness of the general public of effective drugs available for the cure, prevention and or treatment of various diseases. The general public are then equipped with information that enables them to get access to drugs that they require and hence improved health status. Having stated this, then it can be concluded that the current state of health in Canada is better as a result of widespread promotional advertisement of prescription drugs by the pharmaceutical companies as my hypothesis states. After research, and it is proven to be true that actually the widespread advertisement of prescription drugs by pharmaceutical companies has contributed to better health status, then other fundamental issues arise like; whether it is agreeable to amend the regulatory policies and Acts to allow for full advertising of the drugs. At that point then the pros and cons of such an action will dictate the way forward (NIHCM Foundation, 2002). Methodology The sought of data that will be collected is both qualitative and quantitative in nature. The main method that will be used in carrying out the research is by use of questionnaires. Other methods of data collection include face to face interviews with the target group, and focus groups. The questionnaires will particularly focus on the information that is obtained from the advertisement. The target group in this case will be required to state the media forms they use most frequently, how frequent is it? Any adverts about drugs that they have come across, what particular information about the drug did the advert contain, whether this information has ever influenced his or her decision when it comes to choice of drugs to buy (Beltramini, 2006), whether such adverts are important and whether he or she is aware of any legislation governing the advertisement of these drugs (Engh, & Bonertz, 2010). The same questions will also be asked to the focus groups. Face to face interviews will be used on experts and stakeholders of the pharmaceutical industry. The experts would be required to give their opinion with regard to the regulatory policy in place. They would state whether they believe that these policies are effective or not and if they feel that they are ineffective what remedial steps can be taken in order to make the policy more effective. They can also give their own reasons as to why this regulation is important and why we are not better of without the regulations. The sample will be selected based on a predetermined formula such that the sample will cut across individuals of all economic abilities. This will ensure that the views and recommendations made at the end of the research will be all inclusive and will not favor a particular class of people. Again the sample will be selected such that different areas of the country are fully represented. The data obtained from this research will promote a wholesome approach to policy evaluation/review with the interests of all individuals and stakeholders being taken into consideration (Wiktorowicz, Lexichin, Moscou, Silversides, & Eggertson, 2010). Sample recruitment will be targeting the youth who are most of the time engaged in a media related activity. Youth more often will be on the internet, Televisions, Radio, reading magazines etc. and are likely to have encountered various pharmaceutical advertisements. The parent will also be targeted. They have been to hospitals many times and have in many instances made an effort to find out information about a certain drug and in the process encounter the advertisements. The sample recruitment will also include industry experts and stakeholders who are the pharmaceutical companies, members of the regulatory and oversight board of these promotions, Medical doctors, and government representatives. Data will be collected mainly via two ways; by filling of questionnaires and use of audio tapes. This is definitely after assuring all participants that the information will be used for purposes of research only and under no circumstances will the information be used in an manner that subjects them to any from of harm. The questionnaires and tapes will then be analyzed for both qualitative and quantitative data. References Beltramini, R. F. (2006). Consumer believability of information in direct to consumer advertising of prescription drugs. Journal of Business Ethics, 63. Retrieved from http://www.jstor.org/pss/25123716 Engh, M.,& Bonertz, L. (2010). The effects of direct-to-consumer advertising on patients in a northern Canadian community: A cross-sectional survey. Retrieved from http://www.cpjournal.ca/doi/pdf/10.3821/1913-701X-143.3.126 Department of justice (2011). Food and Drug Regulations. Retrieved from http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/ Francis B. Palumbo, F. B.,& Mullins, C.D. (2002). The development of direct-to-Consumer prescription drug advertising regulation. Food and drug Law Journal, 57. Retrieved from http://www.kff.org/rxdrugs/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=1 4372 Health Canada (2008). Canada's Food and Drugs Act and regulations. Retrieved from http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/act-loi_reg-eng.php Mintzes, Kazanjian, A., Bassett, K. , Lexchin, J. (2001). An Assessment of the health system impacts of direct-To-Consumer advertising of prescription medicines. Centre for Health Services and Policy Research, 4. Retrieved from http://www.chspr.ubc.ca/files/publications/2002/dtca-v4-expertsurvey.pdf Mintez, B. (2006). What are the public health implications? Direct-to-Consumer advertising of prescription medicines. http://www.healthcouncilcanada.ca/docs/papers/2006/hcc_dtc- advertising_200601_e_v6.pdf NIHCM Foundation (2001). Prescription drugs and mass media advertising. Retrieved from http://www.nihcm.org/pdf/DTCbrief.pdf NIHCM Foundation (2002). DTC Advertising: Is it helping or hurting. Retrieved from http://www.nihcm.org/pdf/DTCAdversitingIsItHelpingorHurting.pdf Norris, P., Herxheimer, A. , Lexchin, J. , & Mansfield, P.(2004). Drug promotion what we know, what we have yet to learn. Reviews of materials in the WHO/HAI database on drug promotion. Retrieved from http://apps.who.int/medicinedocs/pdf/s8109e/s8109e.pdf Regis, C. (2006).Direct-to-consumer advertising for prescription drugs in Canada: Beyond good or evil. Health Law Review, 14. Retrieved from http://www.law.ualberta.ca/centres/hli/userfiles/4_Regis.pdf Wiktorowicz, M. E., Lexichin, J., Moscou, K., Silversides, A., & Eggertson, L. (2010)Keeping an eye on prescription drugs, keeping Canadians safe: Active monitoring systems for drug safety and effectiveness in Canada and internationally. Health Council of Canada. Retrieved from http://www.healthcouncilcanada.ca/docs/rpts/2010/DSE/DSE_E_FINAL_Nov17.pdf Annotated references Health Canada (2008). Canada's Food and Drugs Act and regulations. Retrieved from http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/act-loi_reg-eng.php NIHCM Foundation (2002). DTC Advertising: Is it helping or hurting. Retrieved from http://www.nihcm.org/pdf/DTCAdversitingIsItHelpingorHurting.pdf Mintzes, Kazanjian, A., Bassett, K. , Lexchin, J. (2001). An Assessment of the health system impacts of direct-To-Consumer advertising of prescription medicines. Centre for Health Services and Policy Research, 4. Retrieved from http://www.chspr.ubc.ca/files/publications/2002/dtca-v4-expertsurvey.pdf These three references are the most important to my proposal because they directly have an impact on my proposal. Canada’s Food and Drugs Act regulation stipulates clearly the legislation available and used to control the advertisement of prescription drugs in Canada. Again my proposal question the effectiveness of this legislation and asks the question whether regulation of DTCA is useful or not. Also my proposal seeks to find out whether the DTCA has had a positive or negative impact on the health system. Personal Experience I have learnt that the process of writing a research proposal is intense and requires a lot of commitment in term of time. The correct choice of a topic for research is critical and in most instances dictates the ease with which the proposal will be written. Thorough research is required to be able to choose a topic with great relevance to society today. Choosing a practical topic which involves the day to day activities is a good place to start. The objectives and hypothesis set again should have a value to them such that after completion of the project the recommendation made can be integrated into the system. Read More