Personalized Medicine and The Pharmacist

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.

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:

1. Look for an appropriate drug with minimal side effects and drug interactions
2. Deliver drug and wait
3. Observe for efficacy and side effects of the drug as they appear
4. Conduct lab tests and measure/interpret drug concentration and other relevant parameters
5. 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,  

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:

1. Pharmacists move out of dispensaries.
2. Legislation passed requiring prescriptions to be signed off by both a Physician and Pharmacist before getting filled at a dispensary.
3. Pharmacies (dispensaries) no longer need pharmacists, and only employ technicians.
4. 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:

1. 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.
2. 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.
3. 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