On 23 May 2017, the report ‘Upholding the clinical promise of precision medicine’
was launched at the International Pharmaceutical Federation’s Pharmaceutical Sciences World Congress 2017 in Stockholm.
Produced by the QuintilesIMS Institute — a global organisation that brings the public and private sectors together to strengthen the role of information in advancing healthcare across the world — the report lays out a framework for understanding the challenges and opportunities presented by systems therapeutics and, specifically, precision medicines.
The use of precision medicine has increased steadily since 1977 but continues to present challenges associated with clinical decision-making, health system diagnostics, patient privacy, big data and cost implications.
Murray Aitken is executive director of the QuintilesIMS Institute and co-author of the report. He was previously senior vice-president of Healthcare Insight and led QuintilesIMS Health’s thought leadership initiatives worldwide. Before that, he served as senior vice-president of corporate strategy from 2004–2007. Before QuintilesIMS Health, Aitken had a 14-year career with McKinsey & Company, where he was a leader in the pharmaceutical and medical products practice from 1997–2001.
Aitken is also editor of HealthIQ, a publication focused on the value of information in advancing evidence-based healthcare, and serves on the editorial advisory board of Pharmaceutical Executive.
Why must pharmacists be prepared for precision medicine?
Pharmacists must be prepared for some unique challenges associated with precision medicin. Among these challenges is the safety of these medicines. Therapies included in our analysis showed that 41% were associated with black-box warnings for serious adverse events (which are issued by the US Food and Drug Administration to medical professionals) that can require specialised monitoring by trained clinicians. Precision medicine tends to be applied in serious, degenerative diseases (e.g. cancers) where providers and patients are prepared to accept risks in order to slow or halt disease progression. Patient outcomes will hinge, however, on safety as well as efficacy, and patient monitoring and support during therapy is a key component of realising the value of these therapies.
What are the implications if they are not prepared?
If pharmacists are not prepared for precision medicine, then they will not be prepared to provide pharmacology-specific advice to their patients. Only pharmacists have the full pharmacological view of the patient — and therefore, it is vital they are educated and understand the emerging group of precision medicines.
To reach the full potential for patient value from systems therapeutics, side effects of the medicines must also be monitored and managed to ensure patient satisfaction and adherence for optimal effect. Pharmacists, along with other healthcare stakeholders, can play a major role in pharmacovigilance.
If pharmacists are not prepared for precision medicines, then they will not be prepared to provide pharmacology-specific advice to their patients
What role will pharmacists play and at what stage?
Pharmacists provide value to clinical decisions for precision medicines because they understand and can manage patients’ entire drug profile. Pharmacists are also point-of-care references for dosing and administration and can advise on potential side effects. In the United States, these medicines may also be distributed by pharmacists through specialty pharmacies, which can provide assistance to patients navigating reimbursement issues, or have insight into manufacturer rebate or patient assistance programmes. Pharmacists provide value to patients at the point they access their medicine and also after patients start taking their medicines.
Precision medicine is definitely not a new thing. In fact, it has been making an impact on the health landscape for many years
Where are we with precision medicine and what is its impact on healthcare currently?
Precision medicine is definitely not a new thing. In fact, it has been making an impact on the health landscape for many years, particularly in the field of oncology, around breast cancer, melanoma and blood cancers. The dramatic decrease in the cost and time it takes to perform genomic sequencing will continue to contribute greatly to the increasing development of precision medicine. Another noteworthy advance around precision medicine is in the growing understanding and acceptance that the ‘one-size-fits-all’ approach to medicine is costly and ineffective because many patients will not respond to first-line therapies and receive care that is not beneficial. Development of precision medicine to get the right dose to the right patient at the right time has the potential to provide savings to healthcare systems.
The ‘one-size-fits-all’ approach to medicine is costly and ineffective because many patients will not respond to first-line therapies and receive care that is not beneficial
What can the UK pharmacy profession do to prepare for precision medicine?
Precision medicine is invariably used within complex disease areas, such as oncology, or in areas with smaller, highly specialised patient populations, such as rare diseases. Multiple interacting factors such as age, gender, comorbidities, polypharmacy, management of side effects and evolving scientific literature must be incorporated to provide holistic care for the patient.
There are some obstacles to overcome when it comes to precision medicine. Specific challenges for pharmacists include keeping up to date with the latest scientific findings around precision medicine, as well as educating patients on these drugs, including the risk of adverse events due to drug–drug interactions, polypharmacy and comorbidities. For example, carbamazepine is a first-line anticonvulsant agent with global regulatory approval for epilepsy and mood disorders, but use of the drug is complicated by a risk of serious adverse, immune-mediated drug reactions. Although pharmacogenetic testing is available to stratify patients into high-risk groups, uptake of the test has not been widely adopted in certain European populations. In this case, the pharmacist could notify patients of the potential for pharmacogenomic testing around carbamazepine in order to avoid serious side effects.
How do we garner public support and trust in terms of getting them to consent to having their genetic data looked at?
We consider precision medicine as a medical treatment that is personalised to the characteristics of each patient by stratifying individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. Eligibility for precision medicine hinges on the ability to use predictive biomarkers to identify the correct patients for the medicines. Although the use of next-generation sequencing (NGS) techniques is on the rise, routine clinical practice remains an important milestone. NGS enables the sequencing of a human genome, or specific areas of interest, quickly and accurately compared with historical sequencing that takes much longer and can only analyse smaller segments of DNA.
Already a number of countries have invested in precision medicine initiatives that involve the widespread genetic screening of large populations, such as the All of Us
precision medicine initiative in the United States, which seeks to recruit 1 million participants to share their genomic and other personal health data, and the UK’s 100,000 Genomes Project
. Pharmacists may provide a role as a liaison between the patient and the science behind NGS, describing to the patient how the data will be used to select a precision medicine to help to treat their disease or to avoid potentially serious side effects. As trusted professionals who most frequently interact with the public regarding medicines and pharmacology, pharmacists are the perfect healthcare professionals to provide information, perspective and understanding on the role that genetic data can play in advancing healthcare for individuals and the population overall.
Pharmacists are the perfect healthcare professionals to provide information, perspective and understanding on the role that genetic data can play in advancing healthcare for individuals and the population overall
What do you think the impact of Brexit will be on progress of precision medicine and research in the UK and Europe?
We decline to respond to this question due to the level of uncertainty around the process and impact of Brexit.
 QuintilesIMS Institute. Upholding the Clinical Promise of Precision Medicine. Available at: http://www.quintilesimsinstitute.org/en_GB/thought-leadership/quintilesims-institute/reports/upholding-the-clinical-promise-of-precision-medicine-current-position-and-outlook (accessed August 2017)
 Genomics England. The 100,000 Genomes Project. Available at: https://www.genomicsengland.co.uk/the-100000-genomes-project/ (accessed August 2017)