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Transcript
1 Therapeutic Drug Monitoring of Donepezil Treatment in Alzheimer’s Disease Patients Alin Kazanjian Northeastern University 2 Abstract Pharmacists pay a vital role in clinical trials and choosing various forms of treatments whether the treatment involves a new drug that is not approved yet or a pre-existing one that is already approved by FDA. They participate in designing a protocol, identifying the nature of treatment, deciding what type of tests must be done on patients to achieve the optimal outcome from medications and ensure the patients don’t get any harm and are safe to be tested on specific drugs. This paper primarily will talk about the significance of therapeutic drug monitoring (TDM) that yields greater results in the effectiveness and safeness of a specific drug. This form of practice is an important aspect in the field of pharmacy because it ensures the patients get the maximum benefits from a drug therapy with very minimal to no toxicity. The aim of this paper is to explore the significance of therapeutic drug monitoring of specific drugs in the field of pharmacy and why I have specifically chosen a journal related to TDM of drug donepezil in patients with Alzheimer’s disease. 3 The name of the journal I have chosen is Therapeutic Drug Monitoring for Patients with Alzheimer Dementia to Improve Treatment with Donepezil which was published on June 2015. It is the Official journal of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT). It is a multidisciplinary and a peer-reviewed journal and is directed to the audience of pharmacists, pharmacologists, toxicologists and drug researchers. This article was written by four German authors. Gudrun Hefner, PHMD. Her major research interests are in therapeutic drug monitoring of various drugs and adverse reactions caused by drug interactions. Anne Brueckner, PhD, graduated from the Creighton University Medical Center, United States. Dr. Christoph Hiemke is a professor interested in drug-drug interactions, drug transport, and clinical and experimental psychopharmacology. He is the managing director of Psiac GmbH, providing an Internet-based drug–drug interaction program for psychopharmacotherapy. Dr. Andreas Fellgiebel, MD, PhD, is interested in Alzheimer’s disease, dementia, neurodegeneration diseases and medical neuroscience. The article drew my attention because it is specifically on patients with Alzheimer’s disease (AD), which is the most common form of dementia. I am very interested in patients with this type of disease and how various treatments help improve patient’s quality of life and become independent as they age. In addition to that, why pharmacists and pharmacologists aren’t able to find a cure for the disease? More than five million Americans have Alzheimer’s disease and is ranked as the sixth leading cause of death in the United States. It is a neurodegenerative disease that is progressive and irreversible which slowly destroys the memory and important mental functions that causes problems with thinking and behavior. Its symptoms develops slowly and 4 eventually worsens over time becoming severe enough to interfere with daily life. It can’t be cured or reversed, however, medications and treatments could only improve its symptoms temporarily. The actual cause of this damage is still unknown and not fully understood. Scientists only believe that it can be caused by a combination of lifestyle, family history, genetic, and environmental factors. Approximately 35 million people suffer from Alzheimer’s disease worldwide and is very common among elderly and is really fascinating why scientists conduct thousands of research on the disease and yet they cannot find the cause and cures for it. I am curious about some of the specific research questions that I would like to find out the answer for them such as why scientists don’t know the actual cause of Alzheimer’s? What is the reason that brain cells fail as we age? Why pharmacists can’t discover a drug that can reverse the disease? How does lifestyle and environmental factors affect the way a person develops a disease associated with dementia? However, very recently, pharmacists were able to find a treatment with a specific Alzheimer drug called donepezil through therapeutic drug monitoring in order to maximize drug treatment. Therapeutic drug monitoring is a clinical practice where it optimizes individual dosage treatments, enhances the efficiency of a drug and helps to identify a decrease in the efficiency of the drug. It also reduces the toxicity and assists with diagnosis. It is a form of practice of specific drug measurements where it maintains a constant concentration medication in patient’s bloodstream. The drugs should have a narrow therapeutic index which is the ratio between therapeutic and toxic medication doses. This means that not all drugs can be used in therapeutic drug monitoring treatment. The purpose of the journal is to find results of whether serum 5 concentrations of drug donepezil are linked to clinical improvements and aim to confirm if therapeutic drug monitoring helps optimize the treatment of Alzheimer’s disease with donepezil. The therapeutic target for the Alzheimer’s disease is Acetylcholine-esterase (AChE). However, current AD treatments show that this target is only limited to symptomatic therapies. The drug donepezil (approved in 1996 by FDA) is an inhibitor for Acetylcholine-esterase but it can only improve the symptoms of patients associated with AD because it inhibits AChE only by 20% – 40 %. Higher dose of donepezil (23 mg/day orally) was developed and proven to inhibit the target up to 80% (serum concentrations of 50 and 75 ng/mL). However, moderate side effects were associated with higher doses of the medication such as bradycardia, gastrointestinal disturbances and weight loss. According to the article, clinical assessment was carried through different methods to collect data. The first method was the measurement of concentration of donepezil in serum (blood) that was held through high-performance liquid chromatographic with spectrophotometric detection and the second was the measurement of patient improvement after 1 week of the treatment. The evidence were provided through the Clinical Global Impression scale (CGI) which involved both measuring the clinical improvement of drug treatment (CGI-I) where the scores ranged from 1 = very improved to 4 = unchanged and measuring the severity of illness (CGI-S) which scaled from 1 = not ill to 7 = extremely ill. The results were found that serum concentration of donepezil was 50ng/mL can be recommended for maximum clinical benefits. It was shown that below this dosage, equivalent to 5 and 10 mg/d, could be used to enhance treatment of donepezil 6 through therapeutic drug monitoring. In conclusion, the tests showed that therapeutic drug monitoring can be used to optimize donepezil treatment with patients of Alzheimer’s disease. The writers argued about the use of TDM for various drugs. This practice has been a variable tool for antidepressants, mood-stabilizing drugs, antipsychotics and anticonvulsants. However, for anti-dementia drugs, TDM has never been used in a clinical practice for the treatment of Alzheimer’s disease or other forms of dementia. Gathering some evidence about the treatment of dementia with TDM suggests that this practice can be used for donepezil medication dose titration so that the patients with AD can obtain maximal therapeutic benefits and avoid tolerability and safety problems since undesirable effects have been reported to different donepezil dosage forms. The collected data by the writers suggested that the serum concentration of donepezil should be 50 ng/mL so that it can be correlated with clinical improvement which was the case when the serum concentrations were analyzed. The patients with this concentrations did receive a “very much improvement” indicating that TDM does have the potential to improve dementia patients with donepezil to receive therapeutic outcomes. One of the top pharmacist’s priorities is to ensure the patient’s safety when it comes to testing a new drug or an already existing one on them. That’s why pharmacists are the key members of all the health care team when it comes to drug therapy monitoring because they have the appropriate knowledge and skills to embrace this role to provide significant improvements. They are medication experts, healthcare professionals always rely on pharmacists for advice on medication errors, adverse side effects and drug-drug interactions and most importantly testing 7 drugs on patients. They enhance knowledge and patient care and move science forward. In the field of pharmacy, it is very important to know what forms of treatments must be used when testing patients with new or pre-existing medications because people’s response to medications can be complex and severe reactions may occur. For this reason, pharmacists review their patient’s record during drug therapy monitoring, they communicate with the prescribers to identify and resolve any problems may occur related to drug therapies such as adverse drug events. Therefore, pharmacists have an essential role in clinical trial processes and clinical assessments. They design the drug therapy protocol and indicate the appropriate dosage to use so that patients get the optimal outcome of the medication. Clinical assessments are vital to test the efficiency and the safety of an existing medication specifically through therapeutic drug monitoring. This practice is known to provide effective pharmacologic therapy though producing the maximum benefit of a drug which can remain longer period of time within the patients and have almost no toxicity that could cause harm to patients. This is why therapeutic drug monitoring in the field of pharmacy is essential enough to figure out an effective medication against a disease without any dangerous toxic actions involved to improve patients’ quality of life and hopefully find exceptional cures which is one of the pharmacists’ priorities. 8 References 1. Hefner, Gudrun. Brueckner, Anne. Hiemke, Christoph. Fellgiebel, Andreas. March, 2015. Therapeutic Drug Monitoring for Patients with Alzheimer Dementia to Improve Treatment with Donepezil. 2. Kang, Ju Seop. Lee, MinHo. March 6, 2009. Overview of Therapeutic Drug Monitoring 3. Therapeutic Drug Monitoring. Vol. 37. June 2015.