Archive for the ‘Patient-Centred Care’ Category
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.
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
Pharmacy’s Role in Personalized Medicine
A major concern with personalized medicine is its potential to aid in discrimination. Employers and insurance companies may use sequenced genotypes in determining whether the individual is a suitable candidate to hire or insure. As a result, many individuals may be left without jobs or without private insurance due to their genetic predisposition for certain medical conditions. As such, it is imperative that restrictions are put in place in order to control who is able to access information that is drawn from genotype sequencing. Based on the principles of patient autonomy and confidentiality, patients should be allowed full control over who is able to view their genetic information. Much like any other aspect of medical records, a patient’s genetic records need to be kept confidential if that is the patient’s desire and should not be accessed without their permission. Furthermore, the initiation of all genetic tests should only be done voluntarily and not through coercion or pressure from potential employers.
Given that personalized medicine has a direct effect on medication therapy management, it is natural that pharmacists should be heavily involved. Pharmacists have specialized medication training and are experts in their field, giving them significant knowledge in terms of drug dosing, interactions, contraindications, and both positive and negative effects of medications. This knowledge places pharmacists in the ideal position to take charge in managing new drug technologies and can be utilized in selecting and developing tailored treatments for individual patients based on predictions from their genome. This ultimately increases positive health outcomes such as the elimination of symptoms, the reduction of disease occurrence, and overall survival rates.
Since pharmacists have specialized training in medication management, it would be beneficial for teams of healthcare professionals as well as for patients to have pharmacists work alongside physicians for managing therapy with personalized medications – analogous to how pharmacists work alongside physicians to adjust dosing of warfarin in anticoagulation clinics. Just like how the pharmacists of today can interpret lab values, pharmacists of the future specialized in personalized medication would be able to interpret the genotyping tests and manage personalized medications accordingly.
On the flip side, the cost-benefit of ordering genotyping tests is questionable. Genotyping tests requires time, labour, and resources. While not all medical conditions or medications require genotyping tests, there needs to be some kind of standardized protocol to assess whether particular circumstances demand such a test, and whether such tests are practical given the constraints of current medical technology.
Pharmacists have no place in a dispensary.
Pharmacists have no place in a dispensary. Period.
History of the Profession:
In the past, pharmacists were masters of their domain, they would prepare compounds from scratch, double check their own work, and frequently owned their own businesses. Like many other industries however, in recent decades the profession has changed. As new diseases are discovered, old diseases are better understood, the number of drugs available to treat these have steadily increased. With this increased understanding, and increased availability of drugs, the number of individuals with regular or recurring prescription drugs has drastically increased. This has demanded increases in efficiency and scale of dispensaries in communities. This is not uncommon, the streamlining of professions like pharmacy is akin to the implementation of machines in factories to increase productivity. It only stands to reason then, that as the sheer volume of prescriptions that are written increases, the community pharmacy industry will find ways to improve efficiencies.
What Pharmacists do (Currently):
As it currently stands, community pharmacists have 3 main roles in pharmacy. The first is assessing the appropriateness of therapy for an individual, this cognitive work is unique to our profession, and because of our specialization in training, we are, bar none, the most proficient profession at doing this. Secondly, is counselling the patient on the medication, this is also a unique skill that only pharmacists can perform, as we receive more training and education on doing this than any other profession. Thirdly, is we physically check prescriptions, ensuring that from point of entry, to point of sale, the drug that was prescribed is in the correct bottle, and goes to the correct patient. This portion of our job can be done by anyone who can read a doctor’s writing, and who has enough visual acuity to compare tablets in a stock bottle to those in the dispensed bottle. Pharmacists are no better trained to do this than any technician. Depending on the pharmacy, the third role of pharmacists can easily take up the majority of the pharmacists time, with the time dedicated to assessing therapy and counselling being severely limited. Consider the following: the vast majority of community pharmacies are owned by large corporations, with the minority being privately owned stores. The current business model for community pharmacies is based on the volume of prescriptions dispensed, and not the quality of care. Additionally, most of these large companies are publicly traded companies, which forces huge emphasis on them to cut costs and maximize profits wherever possible.
The problem:
Community pharmacy in general is trending towards a business model wherein they can accomplish selling the most number of prescriptions, at the least cost to themselves. As I already stated, the third role of the pharmacist (technical role) occupies the majority of the pharmacists time in most community pharmacies; and this role is easily replaceable. What we have already begun to see is the training of technicians who will perform the coveted task of “final check” on prescriptions. Simply put, this job is to ensure that correct product is in the correct bottle for the correct patient. Herein lays the problem. Large corporations have the right idea. There is no reason that pharmacists should be performing this role; we are no more proficient checking prescriptions than a technician, and yet we hold monopoly on it, and expect 2x-5x the salary for it. Who can blame these large companies for lobbying to have this power relinquished by pharmacists? From a business standpoint, they can eliminate more than 50% of the pharmacist’s workload in the community pharmacy, by replacing them by equally capable, and much cheaper, technicians.
The flaw of current practice model:
So what does this mean for pharmacists? It means that the fundamental model of community practice is going to change. The problem is that pharmacists exist in a bizarre loophole of how they are financially renumerated. The vast majority of pharmacists in community are in one of two situations. They either work for a pharmacy (private or corporate) or own their own pharmacy. Either situation is faced with the same dilemma. On one hand, the pharmacy in which a pharmacist may work is reimbursed by the volume of prescriptions sold, which are paid for by the government via pharmacare. On the other hand, the pharmacists themselves are paid salary by the pharmacy they work for. Therefore, for pharmacists to protest against the implementation of registered technicians, they are going against their employers best interests.
What this results in is two bodies lobbying the college of pharmacists for conflicting changes to the territory of physically checking prescriptions. The pharmacists want to protect their monopoly in this area, and the companies who own the pharmacies want to employ skilled technicians to do it for cheaper. The result is a profession which is at war with itself. When pharmacists are involved in selling prescriptions, they are inescapably stuck in a tug-of-war between good business vs good healthcare.
What is the solution?
Get pharmacists out of the dispensary.
As I already stated, the majority of the pharmacists work currently is performing the “final check” on prescriptions. Pharmacist should not be doing this for 3 main reasons:
1) Technicians can do the exact same job for cheaper (like it or not).
2) Being responsible for the “final check” ties pharmacists inexorably to the current business model which requires high volume of prescription sales. This generates the conflict of interest between pharmacists and the employers.
3) This is not what they are trained for, and is an inefficient use of pharmacists as a resource. In current practice the two roles we are actually trained for: Therapy assessment and Counselling, are SECONDARY to checking prescriptions. Pharmacists are the experts at counselling, and therapy assessment, NOT physically checking prescriptions. Perhaps more importantly however, is the fact that because of current business models, these important skills of pharmacists are woefully underutilized. Were pharmacists able to provide adequate therapy assessment and counselling to every patient, the adherence to medications, quality of life, and savings to healthcare system would be extraordinary.
How do we accomplish this?
It is a simple as passing legislation which mandates that “before any prescription can be filled, it must be signed by both a physician (prescriber) AND pharmacist (assessed proper therapy)”. One such model of this would place the pharmacist in the medical clinic, right across the hall from the physician. For instance: A patient comes in, sees the physician, gets diagnosed with a strep throat, the doctor writes a prescription for antibiotics, and the patient leaves, walks across the hall to the pharmacist. The pharmacists takes the prescription, assesses the appropriateness of it, evaluates the patients other medications, and then counsels the patient on the antibiotics right then and there. After counselling, the pharmacist signs off on the prescription, which the patient can take to any dispensary, and have filled. At this point the prescription has been assessed for appropriateness and the patient has been counselled. The patient goes to a pharmacy, and the technicians which work there count the correct number of tablets from the correct bottle, perform a final check, and dispense it to the correct patient.
With this model, pharmacists are now able to perform the job they are trained to do, and because they are situated in the same geographic location as the prescribing physician, they are much more apt to communicate as a team, resulting in better healthcare.
There are many different possible models of payment for pharmacists with this model.
- The first options is that pharmacists could have a billing account like physicians do, and be renumerated different amounts depending on task which they performed. Assessing new therapy can be billed at X, whereas doing an entire medication review could be billed at Y… etc..
- Alternatively, the pharmacist could be paid a salary, much like nurses and other staff in a medical clinic are. For instance, the physician has a billing number which he bills for all patients that he sees. Out of the money he is renumerated, he pays the wages of any associated staff at the clinic. Pharmacists could be paid in the same manner that nurses at the clinic would be; hourly or monthly etc. This may require adjustments to the amounts that physicians can bill for, but these are small details in the grand scheme of things.
The net result is that the government will be paying pharmacist’s wages instead of community pharmacies. This removes any conflict of interest between pharmacists providing thorough care to patients, and the rush to sell as many prescriptions as possible.
How would we finance this?
Easy.
Change the dispensing fee on prescriptions from $10 per prescription, to $1. Dispensaries are no longer providing the cognitive services that used to be fulfilled by pharmacists, so this professional fee no longer applies. This makes dispensaries much more like any business which sells goods, where the profit is due to mark-up on the drug costs.
This means that all the money that the government would have paid for dispensing fees, is now available to fund pharmacists. The same amount of money that the government had set aside for cognitive service before will now be available to pay pharmacists! The only difference is that now, without the burden of the technical work they previously were buried under…. pharmacists will be able to provide much more time, and much better care to each and every patient.
A functional model of practice for pharmacists:
What would happen:
- Pharmacists move out of dispensaries.
- Legislation passed requiring prescriptions to be signed off by both a Physician and Pharmacist before getting filled at a dispensary.
- Pharmacies (dispensaries) no longer need pharmacists, and only employ technicians.
- The professional fee on each dispensed prescription is drastically reduced, and the money is reallocated to paying pharmacists directly (in their medical clinic setting).
Who this is good for:
- The patient. Pharmacists will have SUBSTANTIALLY more time to counsel patients, develop a therapeutic relationship, and assess their current therapy completely, on a much more regular basis. Results in better medication adherence, decreased risk of complications from diseases, and improved quality of life.
- The taxpayers/government. The amount of money available to pay pharmacists after cutting the amount of professional fee currently reimbursed will pay for pharmacists salaries, so the net cost is the same. In addition, by providing much better care, the pharmacists will be able to reduce the number of hospital admissions every year, and prevent many medication related complications with any patient’s health, resulting in substantial savings.
- The community pharmacies. These businesses will no longer have to employ pharmacists. They can save substantial amounts of money by employing completely capable technicians to do the entire technical role of dispensing a prescription. Whether or not these savings are balanced with the loss of revenue due to not receiving dispensing fees however, remains to be seen.
In summary:
As a pharmacy student, I am in an impossible situation. I am less than halfway through training for a profession which is in very dire straights. If it doesn’t extricate itself from its current entanglement with business, it will die. This will be a huge loss to the healthcare system, patients, and the pharmacists. Currently, many practicing pharmacists are either too complacent, or too busy trying to stay afloat with the onslaught of prescription volume they see at work, to address this overarching problem. As a student, I hardly have the time to think of solutions for our profession’s problem. However, the frightening reality is; that unless we make these changes, and soon, the profession might very well go down a path from which there is no return.
Jordan S, Pavan M, Erik M, Jonathan C, Justin T, Jieun K, Maggie C