Psychological Aspects of Pharmaceutical Dosage Escalation - Assignment Example

1.Bazerman, M. H. (200 I) Judgement in Managerial Decision-Making, Chichester, Wiley. The Potential Dangers of Escalation in the Pharmaceutical Industry Contents List: 1. Frugal Ideology in Pharmaceuticals A. Escalation as a Danger B. Ephedra : An example of Escalation Dangers in Pharmaceuticals 2. Strategic Thinking and Decision Making Regarding Escalation A. Strategies for Circumventing Escalation Dangers B. Conclusion C. Suggestions for Making the Right Decisions in Matters of Escalation Abstract: In the Pharmaceutical Industry; we are positioned to be one of the most profitable industries in the world. The reason for this is that we provide a product which is not in most cases, optional. One can live without cosmetics, name brand clothing or even a home, but the ill do not recover without pharmaceuticals. For those who are below the poverty line, the government provides certain programs which allow those who are of little or no financial means, to obtain the medications they require. This often results in little to no damage to our bottom line as ultimately, someone is paying for the product that we provide. The inverse to the industrial super-power of pharmaceuticals is the risk factor associated with the product. Not only that, products are not created and then released onto the market. They are subject to extensive and costly clinical trials which ultimately hinge on FDA approval. The expectations which precede FDA approval are high and ultimately dictate that each and every product that we produce, must provide a benefit(s) which far outweigh any risks. In many cases, this is difficult enough to gauge, and dosage is paramount to this equation. The escalation factor involved with multiple medications, presents a number of bug ticket risks and potentially catastrophic results. Strategically speaking, as pharmaceutical professionals, we must align ourselves with methods for reducing and eliminating such risks. Terms of Reference: Clinical Trials- Are used prior to the release and use of medication. They serve to test a medication’s potency and possible side effects. Dosage Increase- Refers to the gradual or sudden increase of a medication with the intent of increasing ot enhancing it’s efficiency. Dosage Increase Testing- Is used to test the propensity of a medication to have either beneficial qualities in higher dosages as well as what type of side effects may arise under such conditions. Ephedra-A pharmaceutical marketed for it’s stimulant qualities containing the botanical ingredient ephedrine. Ephedrine- A naturally occurring substance found in botanicals which is used for its stimulating properties, in some medications. It is also considered to be relatively unsafe for human consumption. Introduction: As a pharmaceutical professional, it is paramount to understand and comprehend the dangers of escalation concerning medication dosages. Like most industries, the health care industry included; pharmaceutical companies have a bottom line goal and that is to turn over profit in a safe and legal way while offering a product which is in demand due to need; by the public. Avoiding the expense and media exposure of a lawsuit is very much apart of this larger picture making extra precautions in all areas, a frugal and wise agenda. Specifically, the topic of dosage is fundamental to both profit margins and public safety as well as product efficiency. Certainly; when presenting pharmaceuticals post clinical trials, the matter of suggested dosage is important for product effectiveness as well as for product approval. It makes sense to outline a recommended dose which most accurately fit’s the criteria of safety as well as effectiveness. When isolating cases of pharmaceutical dosage escalation, the drug known as ephedrine can be used as a prime example of the type of damage dosage escalation is capable of. This is not only on a patient level of course but also on a corporate level. In previous decades, the drug known as Ephedra (main ingredient ephedrine) was commonly used in allergy medicines and cold medicines as well as for the purposes of weight loss. Ephedrine, like most of the main ingredients in commercial pharmaceuticals, is a stimulant much like methamphetamine which is found in various botanicals. Because of its propensity to cause people to lose weight, it became quite prevalent in the U.S. in the 80’ and 90’s as a weight loss drug. Ephedrine however, acts to affect the central nervous system, raises the blood pressure and effects heart rate and other cardiac functions; naturally it causes weight loss as a result. When it became clear that patients who were taking Ephedra not only for the cosmetic purposes of weight loss but also in greater amounts, it lost its approval status in the U.S as well as in other countries. It is not as heavily controlled here in the UK but is still covered under the terms of the Misuse of Drugs Act. We can consider the cases of drugs such as Ephedrine on a global level, as various factions of the pharmaceutical industry market products worldwide. The incidents of drug misuse followed by damaging media coverage are centrifugal to frugal thought for the entire industry and not just one company in specific. Even extending beyond the economic and production aspects of cautionary dosage suggestions; one should consider the element of humanity involved with the process of ensuring saef pharmaceuticals for the general public. In the process of finding and marketing new and improved pharmaceuticals, it our job as pharmaceutical professionals to avoid releasing or suggesting use of any medication which could be potentially harmful outweighing its possible assets. Concurrently, we must also avoid rash decisions or the making of waves by increasing a suggested dosage; without primarily ensuring the fact that such a recommendation is integral to patient care with profit margins trailing as a distant, secondary reason. Though “liberal use” or application of certain products can be safely suggested in the open market, it is beyond reason to utilize this particular strategy in pharmaceuticals, to sell more product. Conclusion: The very nature of pharmaceuticals renders an inherent need for conservative decision making and protocol. By looking at examples of pharmaceuticals which have in the past; become issues of health and safety, we can gleam a lesson in frugal decision making conducive not only to patient safety and effectiveness but also to the overall professional and financial health to this and any pharmaceutical company. The bar has been set for the elimination of any and all plausible doubt surrounding the release of health promoting medications, which means that there is simply no longer any room for acceptable risk. Ultimately, the need for dosage increase studies exists prior to any drug’s public release. Suggestions: Certainly there are danger management strategies which can be adopted to prevent or reduce some of the risks associated with escalating doses. First and foremost, it is important to establish the clinical trials necessary to accurately test and approve a new medication. Let us assume that a new medication has been tested and is presumably ready for introduction into the healthcare field, for use under a specific dose relative to effectiveness and safety. It is wise to consider the results from clinical trials based on a conservative allowance for side effects or adverse effects. If the occurrence of such effects are considerably minimal to non existent and the medication is feasibly more efficient in an elevated scale; escalation testing is the next priority. Dose escalating studies are often performed after a drug is already in use. Implementation of such studies however, prior to its release may serve to resolve any quarries about the effectiveness of said drugs prior to their overall approval. These studies will also provide a possible platform for which to identify possibly unforeseen side effects or potential dangers. The expense of such studies is more of an expectable risk than the potential fallout which could occur after the fact, when the drug is already being widely prescribed. It is then soundly suggested that as integral players on the front lines of pharmaceutical ingenuity and circulation; we act with extreme caution in the arena of dosage escalation by implementing such tests in all possible cases, prior to a drug’s approval and use. This not only ensures the maximum amount of safety possible to potential patients but also serves to protect this pharmaceutical company from the professional and legal recourse of drugs which render catastrophic results in dosage escalation after their release. By setting a criteria for any drug which receives our seal of approval and claims a certain level of safety; we ultimately act overall on the side of caution. References: Bazerman, M. H. (200 I) Judgement in Managerial Decision-Making, Chichester, Wiley. Craig R. 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