The General Guidelines Provided by the Saudi Food and Drug Authority - Research Paper Example

 Suspension of the drug Avandia in Saudi Arabia Introduction: The drug Avandia which was used in the treatment of Diabetes Mellitus 2 was recently suspended in Saudi Arabia for a period of six months because of the element of risk associated with it, as a cause of heart failure. In association with this move, the Saudi Food and Drug Authority which was responsible for this move, has also taken steps to circulate information publicly on the dangers of the drug and the Ministry of Health has offered some tentative guidelines on the drug for those who are treating patients on the drug and pharmacists issuing the drug, on the manner in which the drug is to be handled. This research study proposes to undertake an examination of the problem associated with the use of the Avandia drug in Saudi Arabia. It proposes to use the survey method to gather information from pharmacists on the extent of their knowledge about the use of the drug. The context of this study is therefore the post surveillance atmosphere of the suspension of the drug Avandia and whether or not the Saudi FDA policies and programs have been effective in educating pharmacists and medical professionals about the dangers of potential dangers associated with Avandia. Research Questions: This research study proposes two specific questions to be answered in the context of this study., which are provided below: (a) When assessing the post marketing surveillance on the drug Avandia, how knowledgeable are pharmacists on the developments occurring with the drug? (b) How effective has the Saudi Food and Drug Authority been in educating medical personnel about the drug Avandia? Literature Review: The drug marketed as Avandia is named rosiglitazone, and has been a popular drug used for the treatment of diabetes. The drug has been found to double the long term risk of heart failure and it also increases the long term risk of a heart attack by 42 percent (Science News, 2007). This result first emerged when the results of short term trials using the drugs showed a 43% increase in the long term rate of heart attacks. The controversy over the use of the drug emerged when the 21st May issue of the New England Journal of Medicine published an article in 2007 about the drug Avandia and the dangers it poses due to the potential risk of heart disease. Glaxo-Kline, the Company which manufactured the drug, then pulled out all the stops to turn the tide of public opinion which had turned against the drug with the publication of the article. The figure below, shows the position of the stocks of GSK (GlaxoSmith Kline) the manufacturer of Avandia in the Arabian business market and it may be clearly noted how the stocks have dropped sharply just after 2007 when the report mentioned above was first released. Figure: (source: http://www.reuters.com/article/idUSLDE62L1M320100322) A medical monitoring group IMS Health, carried out studies after the initial controversy about the drug and found that while the drug used to rake in amounts such as $4.5 million in sales prior to the report, such impressive sales figures dropped substantially and there was a 16% drop in the issue of prescriptions for the drug (www.arabianbusiness.com). The safety of the drug as a means to treat the disease Type 2 Diabetes Mellitus was evaluated by the Saudi Food and Drug Authority. They examined the evidence arising out of clinical trials, meta analyses and observational studies, all of which showed that there are serious risks to the cardiovascular system when using the drug. The summary of the findings from the report can be set out as follows: (a) The benefits arising from the drug in the treatment of Diabetes Mellitus 2 are outweighed by the risks associated with its use, such as myocardial infarction and congestive heart failure, as well as posing an increased risk of fractures (b) In addition to the risks associated with the use of the disease as identified above, there are safer alternatives available for the treatment of Diabetes Mellitus available in Saudi Arabia. On the basis of these two findings, the report concluded that the use of the drug be suspended for a period of six months until further investigations could be carried out, since the risks arising out of the disease outweighed the benefits and it was not the only drug available to treat the disease. Three different products containing rosiglitazone are Avandia, Avandamet and Avandaryl and the study took all of these products into account in determining whether or not rosiglitazone products should be allowed in the country. Saudi Arabia was the first country to take the initiative to regulate the use of the drug in the country by taking the drastic step of suspending the use of the drug in the country for six months. This decision in effect means that the detailing and advertising of the drug is banned, with those patients who are currently still taking the drug needing to be referred back to their doctor for a consultation (www.reuters.com). According to a news report about the Arabian business scene, there were a stream of requests from patients who were anxious to change their medication and according to Dr. Essop Solomon, internist at Saud Specialist Hospital, these patients were all concerned about the risk of heart attacks. As the report reveals, in the absence of clear cut evidence, physicians were unsure about how to respond and were divided in their responses. According to the physician Solomon, the solution to the problem was to prescribe rosiglitazone and to change the existing patients who were still on the drug to other agents, because he believed in the principle of not causing any harm to patients (www.reuters.com). While the decision has been clear cut for some doctors, it has been less clear for other doctors, who have been placed in a quandary and are not quite sure what to do in the case of patients who are still on the drug. Avandia has been one of the major drugs used to treat diabetes because it is very effective in lowering the glycated haemoglobin (AIC); as a result physicians are reluctant to totally discard the use of the drug. Since local health ministries have offered very little direction and the drug was still available in the market around January 2008, and the data presented in the New England Journal of Medicine report was inconclusive, many doctors were unsure of how to deal with the situation in so far as the drug was concerned. Dr. Masri, one of the doctors who was unsure about whether or not to use Avandia, has pointed out that patients have a right to know and it is the responsibility of doctors to give them that choice, but the lack of guidance from the Ministry of Health has compounded the problem ( www.reuters.com). The findings from the literature review above may be summarized as follows: The catalyst for the controversy about the drug Avandia has arisen from a report published in the New England Journal of medicine which showed that the drug posed a significant long term risk for cardiovascular problems. Since the data was inconclusive and an inadequate amount of guidance has been provided by the Ministry of Health, most pharmacists and doctors have been placed in a position where they are unsure of how to deal with patients and their anxieties about the drug. Methodology: The proposed methodology in this study is qualitative, because the objective of the research study is to determine whether or not physicians, pharmacists and other medical personnel are finding the levels of available guidance from the Ministry of Health to be adequate or not. This would involve an assessment of subjective opinions of these personnel to some extent; therefore a qualitative approach seems to be the best suited. For purposes of analysis of the data however, it would be helpful to collect it in a numerical format; therefore a Likert style questionnaire is proposed to be used, which ranks the subjective responses of the participants on a scale of 1 to 5. This study will distribute the questionnaire to at least 30 medical personnel, including pharmacists and doctors, in order to collect their responses in a numerical format that could be statistically analyzed to determine responses to variables and also evaluate correlations between them. The questionnaire would contain sample questions as follows: (a) How informed are you about the long term implications of using the drug Avandia? 1. Very Informed 2. Informed 3. Indifferent 4. Not informed 5. Not at all informed. (b) How would you rate the levels of information available to you from the report published in the New England Journal of Medicine? 1. Very good 2. Good 3. Indifferent 4. Bad 5. Very bad (c) How would you rate the levels of information available to you from the Ministry of Health? 1. Very good 2. Good 3. Indifferent 4. Bad 5. Very bad (d) How effective has the Saudi Food and Drug Authority been in providing information about Avandia? 1. Very effective 2. Effective 3. Don’t know 4. Not effective 5. Not at all effective (e) How effective has the Saudi Food and Drug Authority been in providing guidelines to medical personnel about the dangers associated with Avandia? 1. Very effective 2. Effective 3. Don’t know 4. Not effective 5. Not at all effective (f) How effective has the Saudi Food and Drug Authority been in providing guidelines to medical personnel about how to deal with patients who are on the drug? 1. Very effective 2. Effective 3. Don’t know 4. Not effective 5. Not at all effective (g) How effective has the Saudi Food and Drug Authority been in providing guidelines to medical personnel about how to provide information to patients about the drug? 1. Very effective 2. Effective 3. Don’t know 4. Not effective 5. Not at all effective The sample questionnaire above would be expanded in order to include more questions that will test the extent of knowledge that pharmacists and medical personnel have about the drug Avandia and the dangers associated with it. Based upon an assessment of the results from this questionnaire, it is also proposed to develop an open ended questionnaire which can take up a more detailed and thorough examination of the views that participants have about the drug, its use, its dangers and how patients who are already on the drug are to be counselled. Conclusions: Based upon the findings from the literature review, it appears that the general guidelines provided by the Saudi Food and Drug Authority may not adequately address the need for knowledge that pharmacists and doctors need to have on how to deal with patients who are currently on Avandia. They may be aware of the suspension of the drug for the six month period, hence they have enough guidance about not prescribing the drug for diabetes patients. But for those patients who are already on the drug, both doctors and pharmacists may not be aware of exactly how they are to be counselled; how their drug requirements are to be met or which drugs to substitute in the place of Avandia. In the absence of strong, clear guidelines from the Saudi Food and Drug Authority and the Ministry of Health, pharmacists who may have stocks of the drug may continue to dispense the drug to patients already on it. The guidelines provided by Government authorities in Saudi Arabia may therefore need to be more comprehensive and pervasive if it is to be effective in ensuring that the ban on the drug is enforce. At present, these guidelines are sketchy at best and may be inadequate to effectively address the problem of ensuring that existing stocks of the drug are destroyed and that patients already on the drug are intimated about its dangers while doctors and pharmacists are provided instructions on suitable alternative drugs. References: “Avandia – the aftermath”, Arabian Business.com, 20 January, 2008; Retrieved April 12, 2010 from: http://www.arabianbusiness.com/508668-avandia---the-aftermath “Debate Renewed: Diabetes drug ups heart risk”, Science News, September 15, 2007, Vol 172. Jones, Liz, 2010. “Saudi Arabia to review Avandia”, Fierce Pharma, March 22, 2010; Retrieved April 11, 2010 from: http://www.fiercepharma.com/story/saudi-arabia-to-review-avandia/2010-03-22 “Saudi Food and Drug Authority suspends the authorization of Rosiglitazone”, 23 March, 2010; Retrieved April 12, 2010 from: http://www.worldpharmanews.com/content/view/1160/32/ “Saudi Arabia suspends Glaxo diabetes drug Avandia”, Retrieved April 12, 2010 from: http://www.reuters.com/article/idUSLDE62L1M320100322 Read More