The to different care settings. From the
current and future roles and relationships between community pharmacy, hospital
pharmacy and personalised medicines
The personalised medicines for the individuals started with the discovery
of the DNA double helix in the 1950s. It was then followed up by identification
of the genetic code and DNA sequencing. The very first personalized medicine
was Herceptin for the patients with excessive expression of the HER2 receptor 1
.Through the completion of the human genome project with the goal of
mapping of all the genes, which make up human being, scientists obtained useful
information about the structure, organization, and function of the human genes.
As all human beings are different from each other, healthcare professionals can
use this information as an instruction for dealing with the disease at the
individual level 2.
personalisation of medicines important?
Personalisation of medicine helps healthcare professionals to help each
patient from prevention to treatment to management. For example, it helps to
distinguish responders from non-responders and exclude the high-risk group from
both clinical trials and therapy groups. From another point of view,
personalisation of medicine not only helps to improve the patients’ outcome, by
improving their quality of life, the method of administration and the
prevention of disease, but also it can have a significant role in the
improvement of efficiencies in the healthcare system. This can be achieved by
focusing on prevention and earlier intervention, instead of treatment.
journey as a platform for personalisation of medicine:
When we are
considering a patient’s journey between community and hospital pharmacy, there
are different points where the patient and healthcare professional can engage
in personalised medicine, whether it be primary or secondary care.
Communication among healthcare professionals is important, especially when a
patient is transferred to different care settings. From the pharmacist’s
perspective, this relates particularly in term of ensuring a patient has
understood the changes made to their medication, had opportunities to ask
questions and has otherwise received the support required to enable good and
journey is important to understand between community and hospital pharmacy as
it allows us to realize where pharmacists may face challenges, and
opportunities where personalised medicine can have a role in enhancing patient
care. Current examples of personalised medicine are limited in both the
community and hospital settings. However, with drug research developing and as
our knowledge of health conditions expands, there is more opportunity for
personalisation of medicines happen in the community pharmacy?
few examples of personalised practice in the community, there are more to the
monitoring or pre-diagnosis process. Some community pharmacies offer INR
testing thus patients do not need to visit a surgery frequently, for example,
day Lewis and some boots stores. Other examples of medicines personalisation in
the community pharmacy include the H. Pylori test for the stomach ulcer,
providing personal medical devices like Insulin pens, where doses can be
adjusted according to individual requirements and other enhanced services like
MUR (medical use review) and NMS (new medical services).
One of the
other areas where medicine personalisation can happen in the community pharmacy
is the improvement of unintentional non-adherence. An essential step to
overcome non-adherence is changing the treatment strategy. This strategy is
shifting from one size fit everyone to personalised medicine. It can be a guide
for the development of the better therapeutic relationship between patients and
healthcare professionals. In this method, the patient will be treated based on
their specific characteristics, desires, needs, expectations, abilities, fears,
etc. In addition to this unique personal requirements, medical history,
co-morbidity, family and personal history may also play important roles in
patient’s response to treatment.
personalised medicine can help to improve adherence in both long and
short-term. For example, in the short term personalisation of medicine,
providing written counselling in addition to the oral one can significantly
improve the adherence of specific patient groups like dementia and patients
with language difficulty. Examples of long-term medical personalisation are
using alternative packaging and compliance aids (liquid formulation like
suspension instead of solid formulation like tablets for patients with
dysphagia). Overall, changing and simplifying the medicine’s dosage and dosing
regimen can significantly improve adherence for polypharmacy patients. Another
way to improve adherence is suggesting recording their medicine-taking and
encouraging them to monitor their conditions 3. The acronym for
patient centred adherence in the community pharmacy is SIMPLE: Select
medications respecting the patient’s preference and Simplify the regimen;
Increase knowledge; Modify negative patient’s attitudes and behaviour; Provide
person-centred pharmacotherapy and motivational interviewing; Leave paternalism
and empower patients to self-manage their medical condition; and Evaluate
adherence regularly 4 56.
can hospital pharmacists involve in medicines personalisation?
terms, a hospital pharmacist has a greater role in medicine personalisation in
compare to community pharmacy. Few current examples include the test for HER2
receptor levels before starting Herceptin treatment for breast cancer. There
are 4 tests, the most common one is IHC (Immunohistochemistry). The IHC test
gives a score of 0 to 3+, which indicates the amount of HER2 receptor protein
in tumours (Table 1). If a tumour scores 0 to 1+, it’s called “HER2
negative.” If it scores 2+ or 3+, it’s called “HER2 positive”. If the
patient is “HER2 positive” another test, which is called FISH
(Fluorescence in situ hybridisation), will do. It helps to identify the level
of expression of HER2 gene. Only patients with excessive HER2 gene expression
will be treated with Herceptin 7.
About 13 years ago, researchers discovered a direct
relationship between the cell growth and differentiation with the stimulation
of the epidermal growth factor receptor (EGFR), which normally overexpressed in
lung cancer cells. They tried to develop an EGFR receptor antagonist to
antagonise the stimulatory signal and subsequently stop cellular growth.
The first responder patient group tended to be
Asian, female non-smokers, and younger than the average patient age. By testing
lung tumours for mutations in EGFR, and K-Ras gene, doctors can identify
patients who have the best chance of responding to certain personalized
therapies. The drugs developed for these tumour weak spots are Tarceva
(erlotinib)( (Figure 1 shows the survival rate of the patient with and without
the overexpression of EGFR to the Erlotinib), Erbitux (cetuximab), Iressa
(gefitinib), and Gilotrif (afatanib) for EGFR and Xalkori (crizotinib) for ALK.
This discovery helped doctors to differentiate between responders and
non-responders and make a precise therapeutic design based on a tumour’s
genetic profile. This approach helped doctors to use the precision therapies
along with traditional treatment for better patient survival 8.
When the medicine has been selected, it can be
tailored further to individual’s needs. For example, Tarceva (erlotinib)’s
normal dosage is 150 mg once daily, however, if a patient taking a potent
inducer of CYP3A4, dosage can be increased to 300?mg daily, if well tolerated
for more than 2 weeks, further increase to 450?mg daily could be considered
with close monitoring. Or dose adjustment may be necessary if smoking started
or stopped during treatment 9.
An example of how the personalisation of medicine
minimises the risk of side effects can be seen for Abacavir, an antiviral
medicine for HIV. During the first 6 weeks of the Abacavir (ABC) treatment,
there is a risk of development of hypersensitivity reaction (HSR). Studies
showed the impact of ethical background on the development of ABC HSR. For
example, white patients with the risk of 5%-8% are more likely to develop
hypersensitivity reaction in comparison to the black patients with the risk of
2%-3%. The major reason for the
development of HSR is the presence of the major histocompatibility complex
(MHC) class I allele HLA-B*5701. Patients with the specific genetic background,
like Indians, need to screen for this allele’s present with a skin patch test
(SPT) before treatment initiation. Skin patch tests can easily detect the
presence of this allele and gathered information can be used for personalised
safe medicine 10.
A similar example is the use of methotrexate, used
to treat conditions where there is some kind of ‘over-activity’ in the body, which
is causing problems such as cancer, Ra, Psoriasis. In this example, dose and
frequency are calculated according to the condition, the patient’s weight and
height, age, renal impairment, and concomitant use of another anti-folate drug
(e.g. trimethoprim) 11.
personalised medicine deliver in the community?
To deliver a
personalised medicine in the community, two potential models can be suggested:
GP testing and pharmacy testing. In the first model, GP testing, during the
diagnostic stage GP do the genetic tests. These genetic tests are carrying in
the same way as temperature monitoring. Then, GP makes a therapeutic decision
based on the results of these genetic test. Then, community pharmacist needs to
have enough knowledge and information to clinically check and dispense the
genetically informed prescription. In this method, in addition to checking for
normal drug-drug interaction, the pharmacist also check for with gene-drug
interactions as a part of clinical checking.
One of the challenges for implementation of this model is lack of
availability of the technology that supplies accurate genetic test results
quickly in order that genetic testing can be carried out during a patient’s
the second model pharmacist carrying out the genetic testing. After issuing the
prescription to the GP, the genetic test will perform by the pharmacists in the
community pharmacy and the results of the tests will combine with all other
patient’s background and genetic information and as a result, right medicine,
with the right dose will be given to the right patient at the right time.
However, to obtain this goal, pharmacists need to learn how to analyse genetic
information like SNPs (single-nucleotide polymorphisms) and relate them to the
patient’s abilities to metabolize, transport, or respond to certain drugs. This
approach will result to tailor dosing regimen from standard to individual ones.
And finally, by minimising the risk of side effects, patients will receive the
safest and most effective therapy
model also faces some challenges. First of all, how the pharmacist with the
heavy load of works, can do genetic testing for all of their patients. Then,
the technology, which enables the pharmacist to use swabs and get the results
within the few minutes need to develop. And lastly, pharmacist need to educate
how to have a proper communication with their patients to explain everything
clearly and be able to answer all of their patient’s questions 12.
community pharmacists think?
To assess the interest of community
pharmacist to provide the medicine personalisation service in their community pharmacy,
American Pharmacy Services Corporation (APSC) run a survey. Nearly 75% of the
pharmacists liked the idea of implementation of this service in their pharmacy.
However, half of them think they do not have enough knowledge and understanding
of the concept and they require further training. As a result, the future plan
will be focusing on education of pharmacist by buildout of comprehensive
training programme 13.
programmes running recently for the involvement of pharmacists, as medical
experts, in the field of medicine personalisation. For example, PRIME
programme, which was led by Drs. Lisa McCarthy and Beth Sproule, was run for
the pharmacists training and is now supporting the process of working with the
patients and optimise their therapy regimen within their communities. The main
focus of the project was training the community pharmacists as personalised
medicine experts and apply their knowledge to the practice. Right now, the
PRIME pharmacists trying to identify the patients, who can be suitable for the
initial part of the study 14.
pharmaceutical companies do for medicine personalisation?
patent from GlaxoSmithKline offers the promise of simplifying the pill burden
for patients and at the same time offers the chance of customising medicines at
the point of dispensing in response to a prescription from a physician. For
example, The Polypill combines 3 antihypertensive and 1 cholesterol-lowering
drug at variable doses aiming to improve adherence. 86% of people given the
four-in-one polypill were compliant with their medicine, compared to only 65%
of those who received the standard treatment consisting of four individual
medicines. This idea can be further explored for other drug combinations 15.
medicine is the future of both community and hospital pharmacy. Currently, most
of medicine personalisation happen
in the hospitals. In the community pharmacies, they are more to the monitoring
or pre-diagnosis process. But before further implementation of personalised
medicine happens, we need to think about how fast, and how far, we should move
to a personalised NHS.
What will be its impact on pharmacies and what must be in place to allow us to
move forward, and finally, who needs to work with whom to make this happen?