Archive for the ‘Personalized Medicine’ Category
comments on the current pharmacy practice and personalized medicine
WHY PHARMACIES SHOULD ALL BE OWNED/OPERATED BY PHARMACISTS
1. Corporations create an environment incompatible with pharmacy practice
Large surface stores are modelled on high volume sales, low profit margins, simple products and low consumer interaction. Pharmaceutical care, on the other hand, centers around the needs of individual patients as well as complex and potentially dangerous technologies (i.e. pharmaceutical drugs). Selling warfarin in a one-stop location next to the toilet paper, chocolate and big screen televisions subconsciously conveys to the patient that their prescription is like any other consumer good; it should be cheap and it should be fast. This practice endangers the safety of the patient by trivializing the risks associated with pharmacotherapy and the information provided by the pharmacist during pharmaceutical counselling.
Additionally, the corporate environment imposes on the pharmacist unattainable goals which compromise pharmaceutical care. The performance of employed pharmacists is not assessed on their merits as good healthcare providers but rather on the number of prescriptions processed in any given day. Under such circumstances, medication review, pharmacovigilance, pharmaceutical counselling and continuation of care are set aside in order to maximize sales per hour.
2. Corporations are inflexible entities
Pharmaceutical needs of individual patients are varied and unique. A given patient may require a compounded medicine, a veterinary product, a brand name medication, a prescription delivered after hours or simply social interaction. Such characteristics are incompatible with the inflexible large corporation model of chain-assembled goods. The real-life result is that patients are routinely refused pharmaceutical care, or referred elsewhere, due to high cost-to-profit ratios and time constraints. As pharmacy students, many of us have witnessed or heard about the atypical patient which the pharmacy staff would rather avoid servicing.
3. Private enterprise stimulates quality of service and innovation
Pharmacy is unavoidably linked with consumerism. When corporate monopolies are removed, free enterprises in a competitor-rich environment must rely on a distinctive edge other than simple price differentiation. Individual pharmacies must then fight for the satisfaction and loyalty of patients (aka consumers) or die. As a result, business-wise entrepreneurs emerge and thrive by offering better and newer services/goods (i.e. quality care, medication review, disease specialization, compounding, injection services, etc) and enrich the environment and practice. Eventually, these become standard practices until the next great innovation perpetuating the cycle of innovation and enterprise.
4. Pharmacy ‘store-in-stores’ erodes pharmaceutical care and commodotizes the pharmacy
Pharmacies located within grocery stores, department stores, etc. relegate the service to merely another aisle or service counter in the store, allowing the service to decrease at the pharmacy without being acted on by the consumer. Because of the added convienience of shopping while a perscription is filled the lack of service may be overlooked as an opportunity cost of the convienence. As this happens, a decrease in care creaps into society and overall negatively affects both patient care and the profession.
Personalized medicine differs from the modern medicine that we know of in that it is completely tailored to every individual patient. The medicine that is practiced today in hospitals and other care facilities revolves around treatment decision made based upon guidelines, and studies, all of which look at the impact on a representative group of our population. The fact is, everyone is different! This raises the question: can every person be treated the same way with the same results? No. Every person is different and everyones response to different treatments and medication is different. This is why the concept of personalized medicine was developed. Imagine having your genome sequenced so that we are able to predict which diseases you are at risk for. Also, it would be possible to determine which enzymes are more prevalent in your body, allowing us to determine the perfect dose of medication to use.
Should Pharmacists be involved?
Of course pharmacists should be involved. While doctors spend their time determining diseases patients are at risk for, or what type of a certain disease a patient has, pharmacists can work on the best way to treat that patient based on their “personalized” information.
What should they be doing?
Pharmacists can play a role in determining the exact dosing of medications depending on a person’s CYP enzymes for example. By doing so, they will eliminate almost all adverse effects, allowing for better patient compliance and better efficacy.
by: group 22.
Personalized Medicine, Pharmacogenomics, and the Pharmacist
As we move away from the paternalistic ethos of medicine, we approach a unique way of incorporating patient-centered care: personalized medicine. Whereas the current approach of health care is largely based on trial and error of therapy and monitoring for the patient’s response, personalized medicine makes health care a truly individual experience by tailoring it the patient’s genetic makeup. The goal of personalized medicine is to optimize and deliver the best possible outcomes for each person by integrating advanced knowledge of disease at a molecular level with the individual’s unique genetic and environmental factors. As we gain deeper insights and understanding of current and new disease states, it is important that there are specialized treatments at our arsenal to properly provide patient-centered care.
One of the interesting developments in personalized medicine is pharmacogenomics. The mapping of the human genome just over a decade ago has breathed new life into the area of therapeutics, giving rise to the new and exciting field of pharmacogenomics. This new area of research can potentially give us new insights into what drugs do to our bodies as well as how our bodies respond at the molecular level. Pharmacogenomics integrates genomics with existing knowledge in pharmacokinetics and pharmacodynamics, and seeks to develop personalized treatment based on the patient’s unique genome. This entails collecting information on the patient’s genome, and looking for unique genetic traits and deviations in particular genes. These genes typically code for enzymes and proteins crucial in the mechanism of action of the drug, and thus greatly affect the metabolism of the medication, and its effect on the individual as a whole. Contrary to the belief of some people, various individuals do not metabolize drugs in the same way. Some may have an allele resulting in a lower than normal level of metabolism of a drug, while others may have a genotype resulting in a completely non-functional enzyme. This can seriously affect the way a patient responds to a medication, and the dose required to achieve a desired effect. If we can tailor the dose and regimen of the drug according to the patient’s genetics, we can help to deliver the more effective drug therapy, and avoid unwanted adverse effects.
As we make the momentous shift toward an exciting new era of pharmacogenomic research, it is important to always relate it back to the concept of personalized medicine. Pharmacogenomics has already made an impact on cancer research and treatment. For example, an individual can be tested to see what levels of certain proteins they have in their body. If they then have a high level of a certain growth factor protein (breast cancer) which can be the cause of a tumour, treatment can be individualized based on the levels of this growth factor. Treatment in the future will also aim to just target this molecular pathway to minimize or even eliminate side effects which are quite undesirable in cancer treatment. This is just one example of how having the ability to tailor one’s medication regimen to his / her genetic map opens the gate to a much broader spectrum of medication options for an individual, especially those suffering from complex conditions and chronic illness. The conventional therapy we are currently accustomed to, while effective, may carry more cost over benefit with consideration of their side effects, complexity and rigid regimen. The knowledge that we will be able to introduce medications with minimized adverse reactions reassures the success rate of a medication therapy. Physicians will be able to take a closer look at the patient’s physiological and genetic profile and determine the best fit for their patient. Bacterial resistance may no longer be an area of concern, and hospitalized cases of serious drug reactions will no longer be a fear at the back of our minds. With personalized medicine, we are able to carry out a “best-fit” strategy as opposed to a “trial-and-error” system, elevating patient adherence and healthcare credibility. This is an exciting area in medicine as well as pharmacy. Imagine a day where we no longer see shelves of “top 40 drugs” on the pharmacy counters, instead having specially-formulated medications tailored to each patient. Not only will the most effective assessment be made for our patients, we, as pharmacists, will be able to exercise our knowledge and training to its fullest potential.
Another interesting aspect of personalized medicine is finding new and innovative ways to deliver treatment to patients in ways that maximize adherence. Medicine can be individualized through diversifying routes of deliveries in order to suit the individual differences and needs, and minimize side effects. For instance, it is a common practice to give oral antidepressants, gabapentin, and other oral medications for relieving pain. However, if formulated properly, the drugs can be incorporated into topical, transdermal creams to specifically target the site of pain through skin instead of systemic oral medications, thus reducing systemic side effects. The topical application not only decreases the side effects but may also increases compliance and convenience for patients. Another type of personalized medication includes using a patient’s own body fluids and parts to treat the patient’s condition. Autologous eye drop for treating dry eye is a good example which is effective and safe for the patient since it is a sterile ophthalmic solution extracted from a patient’s own blood serum. There are only four pharmacists in Canada who make the personalized drop for patients, which brings us to think how much more pharmacists can do for patients and expand the scope of practice.
Personalized medicine holds great promise for the future. If this process is made more cost effective/more readily available, this could reduce the amount of adverse drug reactions and related hospitalizations. This is advantageous to the patient, healthcare professionals and the taxpayers who help support the medical system. It will also allow us to provide more effective care for patients. If medical professionals know in advance how well a drug will work in a patient, they can help ensure that the patient in question receives optimal care at the lowest cost possible. If this up-and-coming idea of personalized medicine were to become more widespread, perhaps pharmacists would have the chance to establish their role in clinical decision-making. Pharmacists are in the ideal position to incorporate genetic testing into the role of drugs in therapy. We are the drug experts; furthermore, we are also very knowledgeable about the body’s various responses to these compounds. Pharmacists have the education required to interpret genetic tests and recommend appropriate drug therapy accordingly. The growth of personalized medicine would see the pharmacist being able to function within his/her full scope of practice and the patients receiving better health care.
Despite all the benefits patients may receive from “personalized medicine,” it may take a while before this idea can be fully implemented into the current health care system. As our profession embraces this new idea, many challenges await us. Money, time, patient’s acceptance, and the collaboration of different health care professionals are all potential barriers that we have to overcome in order to achieve this goal. We, as pharmacists, have a big role in introducing this new concept to patients, and explaining the purpose and benefits of doing so. Having the patients understand and acknowledge our care for them, will motivate us and the whole health care team to strive for this rather new but exciting and rewarding idea.
Stephanie Ho, Lingsa Jia, Caitlin Lang, Sarah Lee, Greg Ouellette, Megan Tromposch, Ken Wong, Tian Zhang
Translating the Prescription Encoded in Your DNA: A Personalized Approach to Drug Therapy
Traditionally, doctors would prescribe a standard dose of medication for a patient with a particular disease, with the hope that the drug would have the same therapeutic and safety profiles in their patient as it did in the average patient. However, for most drugs, there are always the unlucky few who experience a diminished therapeutic effect or a dangerous toxic effect that is not seen in the general population. Now that genomic research has shown that patient variations in drug response can be predicted based on their genetic sequence, all it takes is a genetic test to determine whether a patient would be expected to respond “normally“ to a drug, or experience an exaggerated adverse effect or a subtherapeutic effect. Dubbed personalized medicine, the process of testing an individual for known gene variations allows pharmacists to determine if the patient has a different form of the enzyme that metabolizes the drug, the protein that transports the drug, or the receptor to which the drug acts on. Based on these results, the pharmacist can predict how the patient will respond to normal doses of the drug, and can adjust the medication dosing accordingly.For example, a patient who possesses a variation of the enzyme metabolizing drug A, which causes the patient to metabolize or break down the drug slower than normal, will have more of drug A build up in their body due to the inability to metabolize the drug as effectively as the normal patient. If a pharmacist knows that the patient has the genotype that gives rise to this slow metabolizing enzyme, the pharmacist can give the patient a lower-than-normal dose of drug or recommend that the drug be administered less frequently to the patient so that the patient does not experience toxic effects from the unusually high buildup of the medication in his or her body.
Should pharmacists be involved and if so, what should they do?
So what kinds of activities would a pharmacist be undertaking in order to offer pharmacogenetics services?
The scope of pharmacy practice is expanding to provide the community with patient-centred care. Pharmacists are now conducting medication reviews and providing more comprehensive counselling services. As an extension, pharmacists can have an active role in providing pharmacogenetic services to patients. Tasks would include conducting critical appraisal of evidence for new technologies and treatments, collaborating with medical laboratories to interpret biological test results (e.g., drug levels in the blood or genetic sequencing information), and making appropriate recommendations to physicians about any changes to drug therapy based on those test results. Pharmacists will also be counselling patients on their personalized drug therapy to ensure they receive optimal benefit from their medication, and understand the rationale behind the recommended drug and dosage regimen.
What does this mean for practicing pharmacists and students?
Some form of clinical case-based learning workshops will have to be developed for practicing pharmacists to familiarize themselves with the requirements associated with providing pharmacogenetics services. Existing undergraduate courses concerning genetics will have to be reviewed; modifications will have to be made to prepare future pharmacists.
Is personalized medicine viable?
written by Lucky Group 13
Introduction
Personalized drug therapy is being billed as the new era of pharmaceutics. Clinical pharmacogenetics allow clinicians and pharmacists to identify the safest and most effective drug and dosage for each patient. They can do this by studying the individual genetic polymorphisms that will affect the patient’s drug response and therefore the efficacy and toxicity of the administered drug. Ideally, this will prevent adverse effects and promote optimal dosing of drugs based on the patient’s genetic profile. In reality, there are many different issues surrounding the implementation and viability of personalized medicine, and these have limited its use in the current health care system.
Privacy Issues
In order to efficiently implement pharmacogenetics as a personal medicine service, there needs to be a method of collecting and storing people’s genomic and genetic information efficiently and accurately. Genome mapping of individuals may be something that can be done during the already recommended pre-screening tests, or following the quick blood test that they are already preforming post-birth. These records can become an addition to an individual’s medical records, just as weight, height, and drug allergies are commonly seen. They can be safely and confidentially stored as any medical records, and used only with patient consent or by the patient’s health care team. When viewing collection of genetic information to be like this, there exist no additional privacy concerns aside from existing ones with conventional medical records.
However, genetic information of an individual may be considered a more sensitive private information. We understand that genomic information can be extremely useful in tailoring medical therapy and improving patient health care, but it can also be a means to discrimination. Discrimination against a patient’s predisposition to certain diseases or ailments when it comes to providing health insurance, employment, relationships, etc; anything! This type of discrimination is a realistic threat, as there are laws that were made to protect individuals from the discrimination that can come from their genomes, e.g. Genetic Information Nondiscrimination Act, and Health Insurance Portability and Accountability Act. However, we need to remember that a person’s actual outcome (phenotype) would not only be based on the genotype – the DNA characteristics – but also on the environment.
For personalized medication to be viable, we would have to make sure the public understands the concept, as well as participants are aware they are entering under full consent, so to lower the amount of privacy issues.
Public opinion
Before pharmacogenomics can be implemented as the new gold standard of pharmaceutical care, it must convince not the practitioners or legislators of its merits, but the public at large. One only needs to go as far as topics like stem cell treatments and abortion guidelines to see the power public opinion holds over the development and implementation of health care practices, and pharmacogenomics without a doubt will experience similar controversy.Implementation of pharmacogenomics on a large scale involves sequencing a patient’s genome as part of building the patient profile, and using that information to to tailor drug therapy and minimize side effects. Genomics intrudes upon the topic of human genetic engineering with the concept of sequencing a patients genome to personalize treatments such as gene therapy. The foundation of the concept is identifying human genetic deficiencies and compensating by introducing foreign genetic material. It is not too difficult to envision the transition from compensating to improving. This raises the question of whether or not the sequencing of genomes should be restricted to patients with hereditary diseases. If genome mapping is not regulated and made accessible to all, will there be a future where patients undergo unnecessary gene therapy to boost the activity of an enzyme functioning at reduced capacity they naturally have?This is just one situation. Another controversial topic can be whether or not sequencing should be allowed before birth: the comparatively simple idea of determining the gender of a fetus is already a hotly debated topic where the ethical concern lies with the issue of selective abortions. Health care is a multidisciplinary field and the developments in one practice can have far reaching consequences on other disciplines. Pharmacogenomics faces a daunting challenge as its core concept of genome mapping presents so many opportunities, and just as many controversies
Cost-Benefit Considerations
As with any new technology and ideas, cost is a major concern that comes to one’s mind. How much is it going to cost to implement this new health care service? What about the training process involved for health care professionals to be able to offer this service? Are patients going to be able to afford it? Who is going to fund this service? Is it going to be covered by PharmaCare or Medicare? Looking past the cost of personalized medicine, there are clear benefits to it with the obvious being improved health care outcomes and increased quality of care for patients. The bottom-line is that one needs to carefully consider the costs and benefits of personalized medicine before a decision is made to accept or reject this service.
Accessibility & Practicality
We have talked about how personalized medicine will allow health care practitioners to provide almost perfect therapy, with treatment as individualized as the patient, but should we make this accessible to everyone? Currently, to a certain extent, personalized medication is utilized in certain cancers and autoimmune disease but how practical it would be in treating common illnesses such as hypertension or depression is still quite vague. Therefore, is it really necessary to make it more publicly accessible than it is now? Is the cost, labour, and resources that are required to map a genome for a single person worth it, just to prevent someone from getting nausea from their narcotics? We can always restrict the access to designated patients who meet certain criteria, but to whom? Even with the lack of labour and resources that are required to implement personalized medication currently, there are lots of issues that needs to be clarified and set before this can be made accessible to the general population.
Change can be difficult
The profession of pharmacy, one could argue, has evolved slowly over the past few decades, as evidenced by pharmacists still underappreciated or negatively portrayed as overpaid pill counters. Current pharmacists may not be comfortable with breaking the status quo (and maybe the general public do not want to see this status quo broken either). It can be difficult to step outside our comfort zone to embrace new technologies and services such as personalized medicine, especially if they were never trained or educated in these areas when they were in school. Pharmacies may need to invest in new technology and staff training and education, neither which will come free of charge. Pharmacies and pharmacists will want to see a return on their investments. The current business model might not be ideal, but let’s hope the Blueprint for Pharmacy paves the way for personalized medicine.
Since we are striving for “patient-centered” care, the idea of personalized medicine must also be embraced by the general public, or it may never take off to the extent to which it is hoped.
It may take a while to educate the average Joe on health issues and dispel myths in general, let alone explain what personalized medicine is and how it may benefit them. Just ask the anti-vaccine camp who still doubts the benefits of vaccinations and herd immunity and/or views vaccines as a form of government control or cause of autism.
It will take quite some time before the science of personalized medicine matures and the knowledge base of human genetics is sufficient to be utilized in drug research and therapy for a broad range of disease states.
And It may take many more years before personalized medicine becomes mainstream and widely adopted by both the general public and health care professionals for whatever reason, be it indifference, reluctance, skepticism, fear, or money.
Bottom Line/Conclusion
There are lots to be done in the process of working towards a world of personalized medicine. Genome mapping would allow us to provide a new level of personalized care to each patient and could greatly benefit some individuals, however it may be unnecessary and overly expensive to be provided to everyone as the average member of our population may see no benefit. Pharmacogenomics also presents us with a wealth of new ethical issues that we would need to learn how to deal with regarding patients privacy and right to confidentiality, as well as potential discrimination and use of the technology for the wrong reasons. It would be an expensive and slow transition and implementing the accessibility for all patients is questionable. In order to continue down this path towards personalized medicine for all, more research is required and we will need to come up with concrete methods to protect our patients and their privacy.
What is personalized medicine? Should pharmacists be involved, and what should they be doing?
On Jan 31, 2012, the federal government pledged a sum of $67.5 million for furthering research into the field of personalized medicine.
Proponents of personalized medicine say it is likely to change the way drugs are developed, how medicines are prescribed and generally how illnesses are managed. They say it will shift the focus in health care from reaction to prevention, improve health outcomes, make drugs safer and mean fewer adverse drug reactions, and reduce costs to health-care systems.
From the CBC article ‘Personalized medicine’ gets $67.5M research boost
So, what is personalized medicine and how significant is it to have garnered such a considerable sum from the reserves of our government?
What is Personalized Medicine?
Personalized medicine involves individualizing a patients’ drug therapy based on the patient’s genome and their therapeutic needs. This idea explores new avenues of pharmaceutical care as it involves tailoring the right medication, dose, and regimen, for the patient, as per the more traditional roles of pharmacy and medical practice with a genetic twist: Not every drug may be suitable for a patient because not every patient has the right genes involved in metabolizing the drug. For patients who have a variant gene for the metabolism of specific drugs, they could metabolize the drug too slowly and thus be at a higher risk for drug toxicity, or they could metabolize a drug too quickly and not be able to achieve therapeutic effects in the body. Because of the complexity and variation in the human genome, it is hard to determine a drug therapy that is suitable for every individual. Personalized medicine would therefore be very beneficial to patients as it can ensure safe and effective drug therapy, and in turn improve patient compliance.
So how does personalized medicine compare to the more traditional form of medication management? The conventional form of medication management in most clinical settings involves the following steps:
- Look for an appropriate drug with minimal side effects and drug interactions
- Deliver drug and wait
- Observe for efficacy and side effects of the drug as they appear
- Conduct lab tests and measure/interpret drug concentration and other relevant parameters
- Individualize therapy based on the info gathered.
With the above steps, finding the appropriate medication is little more than trial and error. With personalized medicine, clinicians can start to individualize therapy even before the administration of the first drug. Each individual responds differently to a drug since no one has the same number of metabolizing enzymes, drug targets or drug transporters in their body. By analyzing the genome of patients, these unique constituents will come to light. Clinicians can then respond accordingly by either altering concentration of the drug or choosing a different one altogether.
Should Pharmacists be Involved?
Pharmacists definitely have a role in personalizing medicine for patients as part of their expanding scope of practice. Because pharmacists are drug experts, they are ideal candidates in optimizing patient health through personalizing medication for patients. However, the path to implementing personalized medicine is lengthy and requires a lot of work. Pharmacists would first need to be trained and educated on how to interpret results of genomic tests and utilize the results to determine a drug therapy that would best fit the patient. Pharmacists will then need to keep up with the rapidly evolving research behind personalized medicine. Moreover, in order for personalized medicine to be a role of the pharmacist, pharmacists need also be involved in the promotion of personalized medicine so that it becomes a necessary component in their practice.
It is also important to note the role that the patient plays in his or her own health care. The patient is the one who makes the final decision regarding their health at the end of the day. Before including personalized medicine as a part of the pharmacist’s scope of practice, we must be confident that we as pharmacists will be able to educate patients about the significance of their genes in relation to the success of their drug therapy. Education is key in making sure that patients have all the information they need in order to make an informed decision.
What Should They Be Doing?
With a lack in formalized education in pharmacogenetics, it is not surprising that the majority of respondents reported their understanding of pharmacogenetics as fair or poor (83%). Only 17% of respondents rated their understanding of pharmacogenetics as excellent, very good or good. Those participants who rated their knowledge as either excellent or very good were associated with the highest mean scores on knowledge assessment, which helps validate this perception as being accurate. One encouraging statistic was that those with less than 10 years of practice experience demonstrated the highest scores on pharmacogenetic knowledge assessment, which may represent the increased focus of pharmacogenetics in the pharmacy curricula across the nation, as well as the increased amount of information on pharmacogenetics over the past decade. Of note, this group of practitioners with less than 10 years of experience also had the highest level of interest in further pharmacogenetics education.
-From the article Knowledge of Pharmacists Regarding Pharmacogenetic Testing
Pharmacists hold a critical position in the success of genome-based medication therapy. In many institutions, the role of pharmacists in the implementation of personalized medication program has already been confirmed. Pharmacists in these institutions are specially trained in pharmacogenomics and they utilize their expertise to make appropriate decisions in optimizing patients’ drug therapies.These pharmacists obtain and interpret genomic test results for certain medications, such as those for cancer, prior to administering the medication. The test results tell the pharmacist whether the patient has variant alleles that put them at a higher risk for severe toxicities. Armed with this information, both patient and pharmacist can work together to make the right decisions about the patient’s treatment. Thus, not only does pharmacist involvement in personalized medicine help ensure the safety of the population, it also has the potential to save costs. Although at its infancy, pharmacogenomic concepts have already been successfully applied in some hospitals to date, and in the future, personalized medicine will ideally be able to extend past hospital care and into the community.
Arthur L, Sarah L, Nicole T, Alana W, May W, Christopher Y, Mohan Z,
Personalized Medicine in Canada
Personalized medicine will change the way many medications are prescribed in Canada. Prior genome sequencing and testing will allow medical professionals to assess the efficacy and safety of medications on an individual basis before initializing treatment. This optimization of drug therapy will lead to better health outcomes and prevent vast amounts of money spent on treating adverse effects of medications that could have been predicted and prevented through a personalized medicine approach. In addition, genetic investigation into diseases such as cancer, will enable us to predict which drugs will be effective and put them into use more quickly.
Recently, the federal government of Canada has announced they will be investing $67.5 million into personalized medicine. This move signals that health care administrators and government staff also believe many great things can come from implementing a system of personalized medicine into our current practices.
As pharmacy students, many of us can see the benefits to both patients and the eventual reduction in health care costs through avoiding the use of drugs that wont work, and reducing adverse effects. However, many Canadians see this as not only a waste of money, but also an invasion of privacy. Ideally we want every Canadians DNA to be collected, tested and interpreted prior to them becoming sick, but before this can happen, laws surrounding access to this information need to be developed.
The role pharmacists play in personalized medicine has yet to be established, however, given pharmacists’ expert knowledge of pharmacokinetic and pharmacodynamic drug properties and role in patient-centered care, we believe our profession is well positioned to take a central role in implementing and maintaining personalized medicine in Canada.
By: Sam Nolan, Angel Chan, Maryn Dempster, Raman Dhaliwal, Youna Choi, Valerie Webber and Kate Lafreniere
Personalized Medicine – Students’ Perspectives
Despite the many positive opportunities for patients, there are potential pitfalls to the implementation personalized medicine as well. Pharmacists, with their expertise in pharmacogenomics, are in an excellent position to invigilate this process and to ensure that patients have equal access to optimal therapies regardless of their genetics. – KC
Meals can be custom-made at restaurants because the customer may have allergies or is a vegetarian. Now think about extending that concept into designing a medication therapy specifically for one patient. The idea of personalized medicine revolves around the heightened ability to tailor a treatment option according to the patients’ genes. The ideal outcome is being able to catch potential adverse drug reactions before administration of the medication and ultimately increase the overall effectiveness of the drug therapy. However, as personalized medicine is slowly being developed, there still remains various factors that may hinder the process of bringing the concept to general practice.
By genotyping a patient’s DNA, trained pharmacists with the help of lab technicians are able to examine the appropriateness of certain medications even before giving it to the patient. This would help greatly reduce the need for trial and error, thereby minimizing the risk of side effects and shorten the time required to correct ineffective treatment. The fundamental principle of personalized medicine appears to be promising, but the drawbacks and barriers should also be carefully considered.
When looking at the practicality of personalized medicine in the community, the chances of having a variant allele or mutation in a single gene in a pool of wild type individuals are quite rare. Consequently, the usefulness of this concept of tailoring medications may not be of great interest to pharmaceutical companies who look toward making drugs that are safe and effective for a larger population. Furthermore, the process involved in decoding a patient’s genotype and then analyzing possible mutations and variants is a time-consuming process for pharmacists and lab technicians alike. This would then come down to how these professionals should manage their time from other duties, as well as the method of reinbursement for their work.
Personalized medicine is a prospective beginning to taking advantage of new understandings of the human genome and cutting-edge technology in science. However, it is essential to look at the practicality of the concept and how it can extend its use to benefit not just a small group of patients. Pharmacists being the central expert in medication use, can serve as one of the leaders in developing this new area of patient-orientated care. —Ying (Joane) Tang
Orphaned illnesses can sometimes be neglected in pharmacogenetic research, where funds are often doled to find cures for illnesses affecting large populations. The ethics of this matter comes down to “quantity of treatment outcomes” rather than improving the quality of life of select individuals, as research companies try to maximize the number of people who can benefit from treatment. Some rare genetic, fatal illnesses afflict only a few in a million, and these patients are unfortunately unrepresented in the research sector where pooling billions and billions of dollars for a potential miracle cure that would only benefit a select number of individuals would be unlikely. These patients find comfort instead in online chat rooms where another patient from halfway across the world might happen to share the same genetic point mutation as them, and through collective blogging, derive meaning through their chronic illness experience.
This points to the idea of striking a balance between social support and biomedical treatment. The term “personalized medicine” conveys a sense of comfort and emotional support for patients, but for patients who know nothing about the molecular workings of DNA and gene-directed therapy, or what we can call the “scientific connotation” of personalization, this term might only be illusory. Educating the public about what personalized medicine really is, through an introduction to the basics of DNA and genetics, would dispel these myths for patients who may otherwise feel deceived or disappointed about the treatment they actually receive. At the same time, social support for rare genetic illnesses that remain unrepresented in research for a cure would be greatly appreciated. As pharmacists, we can certainly seek a balance between the two connotations of “personalized medicine” – the knowledge behind its technology, and the empathy we exude in caring for our patients. -GC
Ethical issues regarding personalized medicine.
Personalized medicine has many limitations and challenges regarding policy (ie. how to implement new technologies) and science problems (technical problems). Although it’s probably going to be a challenge to come up with an optimal solution that satisfies many people, I think that these can be resolved by proposing a solution and considering the appropriateness and reasoning. But ethical issues are very tricky in nature in that there’s a dilemma and both sides have pros and cons for justification.
1. Protection of patient privacy is going to be the most important and challenging thing that must be done for individualized medicine. Everybody agrees that patients have the right to keep their health information from other people but how far does that right extend? For example, personalized medicine facility may have collected information regarding what diseases one has (or at risk of having those diseases) based on one’s genotype and gene expression. How do we keep that information private and how do we determine the extent of applying that knowledge to medical procedures such as diagnosis and profiling? Is it okay for that individual to have automatic access to all his genetic information once it has been decoded? What about privacy from other family members? Once one learns of his/her genetic risk of a disease, he/she may infer relative’s risks. Is that fine?
2. Cost issues are also a significant ethical issue in the world of personalized medicine. Many people do not have health insurances (in the case of US) or they have insurances that only cover the basic things. How do we provide access to personalized medicine to everybody? It’s probably unlikely for personalized care to be equally accessible to everybody due to this problem. Provision of this type of care will likely to be stratified similar to US’s traditional medical care and universal access is denied. In that case, is it right that due to cost issues, some people have more comprehensive information about their genetic make-up, while others have limited amount of information they can get access to? – TK
Personalized Medicine: A SWOT analysis
Pharmacogenetics is the study of how a person’s genetics will influence their response to a drug. Polymorphs in a person’s genes may cause differences in efficacy, risk of toxicity or risk of side effects with drug therapy between patients. Pharmacogenetic testing involves testing a person’s genes for specific polymorphs and tailoring their drug therapy to their specific characteristics. Using the SWOT analysis tool we will look at the strengths, weaknesses, opportunities and threats (SWOT) of pharmacists leading the way in the future of the emerging field of pharmacogenetics.
Pharmacists have a variety of strengths that would make them useful in the implementation of personalized medicine, another name for pharmacogenomics. Pharmacists are often called the most accessible healthcare providers, as any patient can walk in to speak with a pharmacist. Pharmacists therefore are able to develop relationships with the patients and establish trust. If pharmacists were to be involved in pharmacogenomics, this would allow the patients to see us take on a more clinical role and therefore improve the patient’s views of the role of the pharmacist. This also will help to extend and improve upon the relationship between the pharmacist and the patient through more through and insightful interactions. Additionally, through Pharmanet the pharmacists already have access to the patient’s medication history allowing us to give unique insight and details on the patients past drug therapies. Pharmacists are known among other health-care providers as the drug experts. Pharmacists are trained to have an extensive knowledge of drugs and pharmacologic therapies. This strength makes the pharmacist a very useful player for the implementation of pharmacogenomics. The information we could provide to a team of healthcare professionals could be helpful in gathering information to make therapeutic decisions for the patient.
Despite such strengths we already possess, pharmacists also have weaknesses that must be addressed before these strengths can be utilized effectively. First, it is our weakness that pharmacists, as a group, do not possess a strong bargaining power in the government compared to other health care professionals such as physicians or nurses. This bargaining power is of critical importance in emerging field of pharmacogenomics and personalized medicine because pharmacists and the government must negotiate to establish a solid reimbursement method. At the moment, pharmacists are not reimbursed properly for a variety of services they offer such as over-the-counter medication counselling services. This is primarily due to not having an established reimbursement method. Pharmacists must take initiative to build this foundation in the field of pharmacogenomics and personalized medicine so that their work will be fully appreciated monetarily by the government.
In addition to our lack of strong bargaining power, pharmacy schools currently do not offer adequate training to pharmacy students or licensed pharmacists to work in field of pharmacogenomics and personalized medicine. Such lack of knowledge and skills must be addressed as soon as possible. Otherwise, we will face threats from other professionals or graduates from other faculties for our place in personalized medicine. We must prepare ourselves for the future and be proactive so that not only us, but also the general public will find us useful and relevant in the health care system.
There are many opportunities for pharmacists to be involved in pharmacogenomics. With the aging population of the baby boomers comes an increased demand for medical services and provides an opportunity for pharmacogenomics to become part of the health care system As the new regulated technicians start to practice in the community, pharmacists are constantly on the lookout to expand their scope of practice to a more clinical role. Pharmacists should take advantage of this new technology that is quickly developing before another profession does. Pharmacists are perfectly positioned to perform pharmacogenetic counseling sessions with patients. They are already sitting down with patients to do medication reviews in community and hospital pharmacies therefore pharmacogenomics counseling could be fit into those sessions. During medication management counseling sessions, pharmacists are already reviewing a patient’s full medication history therefore it seems natural to explain how their genetic makeup may influence their drug therapy. Pharmacogenetic counseling sessions have already been tested in a couple of hospitals therefore the protocol must simply be expanded into other hospitals and potentially extended into the community. Community pharmacist can receive lab tests online and meet with the patient in the community for a review of the results.
Pharmacist face and will face a variety of threats in the field of personalized medicine. As mentioned in weakness section, other graduates or professionals with background in biochemistry, genetics and bioinformatics could easily adapt their knowledge and skills to expand their scope of practice. In fact, they already have more extensive knowledge than pharmacist in such topics as genetics. If they take additional training about medications, they can easily replace us in the field of personalized medicine.
Another threat we can predict is the cost of the personalized medicine. This field is currently expensive. Having a pharmacist to analyse the data will only add to this already high cost. Therefore, we must find out way to work efficiently and find a cost-saving measure. Otherwise, the public and the government will not invest in the field of personalized medicine. Another solution to this potential threat is to prove that our work is unique and valuable to patients and to the health care system. We must prove that our work is actually cost-saving at the end of the day by, for example, reducing and/or preventing side effects. Unless we prove ourselves to be useful amongst these threats, we will not be able to exploit all the opportunities that we are given.
In conclusion there are many considerations that must be taken into account when assessing the pharmacist’s role within the realm of personalized medicine. We are educated to be the drug care experts, so it seems natural that we will be involved in personalized medicine. As the field of pharmacogenomics begins to expand, pharmacists will need to work with other healthcare providers to continue putting patient care above all. This blog post looked at the ways pharmacists will be able to help with personalized medicine, and the hurdles we would have overcome to provide optimal patient care in this field.
Jessica Beach, In Whang , Stacey Tkachuk, Jason Tan, Ryan Teo, Agnes Wu, Michelle Shih
Personalized Medicine – the newest iteration of an ongoing trend in medicine
I see personalized medicine as a natural extension of the application of basic science to medicine. I don’t believe it’s a new phenomenon, but just the latest iteration in targeting the basis of disease. A hundred years ago and before, the practice of pharmacy included many “cure-alls”. These remedies purported to help with hair loss to gout and everything in between and thus were not even personalized to the disease state of the patient, let alone standardized or adjusted for dose and regimen or even ingredients. As science progressed and the underlying causes of some of these diseases became better understood, the “cure-alls” were replaced by drugs targeting the causes (or at least specific symptoms) of diseases. Pharmacokinetics could be viewed as another form of personalized medicine that allows for dose adjustment of a drug for physiological factors in a given patient with a given disease. The newest pharmacogenetics tests that have been trialed for metabolic and other enzyme variants are essentially extensions and refinements of pharmacokinetics that aim to adjust drug dose (or guide alternative drug choice) based on the genetic factors that underlie some of those physiologic factors that were the basis for pharmacokinetic monitoring in the first place. Other physiological factors, such as renal failure, are often environmental rather than genetic but there are already tests available to distinguish these. For this reason, I see pharmacogenetic testing by pharmacists for the purposes of determining metabolic enzyme profiles (really, an extension of PK monitoring) as a very logical extension of the trend of refining drug therapy that has been going on for hundreds of years as our knowledge of the basis of disease and drug response to disease increases. It has the potential to minimize patient suffering and maximize therapeutic efficacy with little additional cost as genotyping becomes ever faster and cheaper. With the support of genetic counsellors, already in place, this may be extended even further in scope and in predictive value into the development of future disease states (although this raises other ethical issues). Identifying susceptibilities of infectious organisms or diseases such as cancer through genetic testing is also a very exciting area. (Written by Robyn)
Pharmacists and Personalized Medicine
Personalized medicine is in part due to the new innovation in pharmaceutics and medicine. Pharmacogenomics plays a big role in the future of such endeavour. As pharmacist, we are the safe guard of drug delivery and we are also the most accessible of all the health care professionals. In addition, in one of our classes, pharmacists are the most trusted people in the society. So, with all of these, what am I trying to get at? Well, as pharmacists, we are going to be a walking encyclopedia of drugs, or so I hope. New innovations in pharmacogenomics can allow us to see if an individual has some sort of characteristic that might affect the pharmacokinetics and pharmacodynamics of drug therapy. Some of these characteristic may include warnings if the individual is a fast/slow metabolizer of particular substrates of a particular enzyme. We can prevent adverse effects of drugs before the effects can even manifest. For example, if a person is a slow metabolizer of a drug secondary to the allele combination that he/she has for the drug’s enzyme, then there is a risk of toxicity and adverse reactions. As pharmacist, we can further contribute to the safeguard of drug safety. As we are the one of the most accessible health care professional, we can start counselling people if they have genetic conditions that might affect drug delivery. Also, since we are the most trusted people in the community, the patient will must likely listen to our advice and be more knowledgeable about their condition. In Canada, we have public health care which means that pharmacists have to lobby with the government to enable new programs that will correlate with the advances in pharmacogenomics. Knowledge in pharmacogenomics can enable pharmacist to be creative and develop a new niche for the profession; however, we have to be careful about overlapping with doctors’ duties. We don’t want them to feel that we are stealing some of their duties. We want to ensure inter-professional dynamics within the health care community. Also, in the past, pharmacists have shown to be not-the-best for lobbying. We have to advocate for ourselves to survive the shifts and changes within pharmacy (ie. technician regulation, lower generic rebates). If we are not creative about finding new roles, we might be left in the dust and lose our profession. In addition, we have to lobby for compensation for new roles that we might have to do. We cannot offer our services for free because then, our profession is not being recognized.
I think the idea of having pharmacists in charge of clinical pharmacogenetics service, in addition to the clinical pharmacokinetics service that most hospital pharmacist currently undertake, is a brilliant way of expanding pharmacist’s scope of practice. Clinical pharmacogenetics service (i.e. personalized medicine) “matches” individuals with drugs that are safest and most effective for the particular individual, based on his/her genotype. And as drug experts, we are in the perfect position to bring this concept from the research setting to practice. As Tim mentioned above, with changes happening so quickly around us, such as pharmacy technician regulation, reduction in generic rebate, and robotic dispensing machines, it feels as if what we do as a profession is slowly losing its “value” in the healthcare system. Although I initially see this as a negative change to the profession, I now see this as a necessary force in transforming pharmacy into a better, more useful, and more sustainable profession in the near future. Along with the plethora of advantages this change may result in (e.g. potential reduction/capping of the increasing healthcare costs and patients receiving safer and more effective drug therapy), this transformation will also allow us to practice, in the future, using the full extent of our knowledge, which I am excited about. I feel that the technical work that many pharmacists still perform hides what we can fully offer to the public. By making ourselves even more accessible than we are now, such as actively promoting medication management and clinical pharmacogenetics/ pharmacokinetics services, we can increase the public’s awareness of what pharmacists are capable of and contribute more in helping our society achieve better health outcomes (e.g. reducing hospitalization rates due to easily preventable adverse drug reactions).
When patients are given the same drug at the same dose, each patient responds to the drug differently. A big part of this is because each patient differs in their genetic makeup. For instance some patients are “poor metabolizers” while others are “extensive metabolizers” due to the differences in the genes encoding metabolizing enzymes. As a result, each patient may require a specific therapeutic regimen or specific drug therapy based on his or her genetics. Personalized medicine is medical treatment tailored to an individual’s genetic makeup. By sequencing an individual’s genome, it allows us to accurately predict which patients are more susceptible to disease, which ones will respond positively to treatment, and which ones will experience adverse effects. In doing so, doctor’s can select drug therapy that is more “personalized” to the patient’s genetic code. The initial role of a pharmacist in personalized medicine is to become educated in the field of pharmacogenomics. Since pharmacists are the drug experts, they are best suited to educate both patients and other health care professionals on pharmacogenomics and its significance in drug therapy. Pharmacists will need to be able to interpret pharmacogenomic data and be able to use this information to ensure optimal drug dosing. Ultimately, pharmacists will play a major role in developing “personalized” drug therapies based on a patient’s genome.
Moreover as we look to the future, the cost of sequencing the genome has gone down drastically in the past 10 years. The first successful sequencing of the human genome cost hundreds of millions of dollars. According to genome.gov as of October 2011 it costs approximately $8,000 to sequence a human genome. Considering that the average cost just 3 years prior was $10,000,000 this is definitely a step in the right direction for the implementation of a clinical pharmacogenomics service in the future as the trend is expected to continue. (http://www.genome.gov/images/content/cost_per_genome.jpg)
In fact, the speed at which the costs are going down are exceeding the expectations based on Moore’s law and this could allow genomic sequencing to be as routine as other lab tests in the near future. This will take personalized medicine to a literal sense, individualized care and therapeutic decisions based on a patients own unique genetic make up.
(1) Wetterstrand KA. DNA Sequencing Costs: Data from the NHGRI Large-Scale Genome Sequencing Program Available at: www.genome.gov/sequencingcosts. Accessed [date of access].
Group 8: Stephanie Hsieh, Rakesh Dewan, Godwin Cheung, Harman Toor, Kendra Stewart, Timothy de la Torre, Kuldeesh Grewal