Why We Are Campaigning on Pharmacogenomics

There are many aspects to safe medicines.

Our current campaign focuses on petitioning the Australian Senate to do more to reduce unsafe medicines by introducing pharmacogenomics. 

Unsafe medicines are a leading cause of death and disability worldwide.

Current Australian prescribing guidelines are outdated as they do not consider the individual's response to medicines before prescribing them. 

Pharmacogenomics is the branch of medicine that predicts an individual's response to medicines. 

The introduction of pharmacogenomics in Australia lags behind the science and world’s best practice.

Our petition calls on the Australian Government to adopt world's best practice. 

We want to see a “no prescribing without pharmacogenomic testing” policy here in Australia. 

That’s why we think the Australian Government should be doing more and why we are asking you to stand with us by signing our petition.

Will you stand with us for safe medicines?
#mylifematters

 

Fact 1: Unsafe Medicines Are A Leading Cause of Death and Disability Worldwide

  • The World Health Organization has identified that unsafe medicines are a major worldwide issue and has announced Medication Without Harm is their current major patient safety initiative.[1]

  • Numerous American, British and Australian studies repeatedly show unsafe medicines to be amongst the top 4 causes of death and disability.[2]

  • In Australia, as many as 5% of hospital admissions are due to unsafe medicines, and a major cause of death and disability. Some studies also show rates as high as 40% for mental health and geriatric beds. [3] [5]

  • A recent Swiss study of people referred to a community nursing service revealed that 41% had medicine errors, 13% required at least one hospitalization or a medical review, and over 60% were preventable.[4]

  • In 2017, the NSW Government Public Accounts Committee Inquiry into the Management of Health Care Delivery in NSW was advised that medication errors are a very big problem in Australia [13]

Fact 2: Current Australian Prescribing Guidelines Are Out-dated

  • Current Australian prescribing guidelines adopt a “one size fits all” model and assume that a person takes one medicine. [6]

  • Medical scientists have known for decades, that any given medicine, is only effective in 60 to 70% of people. Antidepressants and statins have significantly worse outcomes than this. [7]

  • Dr. Allen Roses, of Glaxo Smith Kline, has also stated that "The vast majority of drugs - more than 90 percent - only work in 30 or 50 percent of the people," and that "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 percent of people. Drugs out there on the market work, but they don't work in everybody."
  • Currently, if a person does not have a “normal” response to medicine, a process of trial and error of medicines or doses commences. People also may choose to simply discontinue essential medicines.

  • Australia’s Quality Use Of Medicines Framework requires that the individual person is taken into account when prescribing medicine. 

  • Current practices do not consider how an individual person will respond to the medicine before prescribing them. The only way to consider the individual is through pharmacogenomic testing. 

 

Fact 3: Pharmacogenomics Takes The Guess Work Out of An Individual's Response to Medicines

  • The branch of medicine that predicts an individual’s response to a medicine is called pharmacogenomics.

  • An individual’s genes (and particularly four key genes – CYP2D6, CYP2C19, CYP2C9, and CYP3A4) determine how an individual will respond to medicines.

  • These four genes process approximately 80% of all medicines.

  • They are highly variable between people including specific ethnic groups. Therefore drug response varies significantly.

  • Around 10% of Caucasians are at severe risk of hospitalization, death, and disability if given the "average" dose of certain medicines. 40% need a higher or lower dose to get the desired effects. [8]

  • In other ethnic groups including Asian, Pacific Islanders, and Africans, the risk is significantly higher. Approximately 70% (rather than 10%) are at risk if given the "average" dose. The pharmacogenomic makeup of descendants of aboriginal persons is currently subject to a detailed study. [9]

  • Simplistically, if a medicine does not act as intended, then an individual genetics could explain this difference. 

  • Pharmacogenomic testing enables a doctor to know before prescribing medicine how that person is likely to respond to them and to take the guesswork out of the selection of the medicine and dose.

  • Pharmacogenomics has a life-long application, applies to all medicines a person will take over their lifetime, and does not predict any other aspect of a patient’s health.

 

Fact 4: The Introduction of Pharmacogenomics in Australia Lags Behind Science and World Best Practice

  • The implementation of pharmacogenomics in Australia lags behind the science and world’s best practice.[10]

  • The scientific barriers to implementing pharmacogenomics identified by key stakeholders in 2008 have been removed:

    • Medicine pathways have been mapped.

    • Pharmacogenomic testing is listed with the Therapeutic Goods Administration.

    • An International systemic review of the evidence, including double-blind trials, and guidelines for clinical practice has been developed.

      Of note, The Pharmacogenetic Working Group of the Royal Dutch Association for the Advancement of Pharmacy (DPWG) and the Clinical Pharmacogenetics Implementation Consortium (CPIC) have jointly established international guidelines.[14]

      Pharmacogenomics has been fully implemented into the Dutch prescribing system and is now being implemented across the Economic Union. [15]

      Australia has failed to adopt international pharmacogenomic guidelines into its prescribing system.

    • The American Food and Drug Administration now incorporates pharmacogenomic information, including testing recommendations and actionable prescribing recommendations, on some drug "labels" where the international guidelines suggest pharmacogenomics is important for its efficacy and to avoid toxicity. [11]

      Australia has failed to adopt pharmacogenomic guidelines into its drug labeling regulations.

  • Our petition calls upon the Australian Government to implement pharmacogenomics by:

    • Conducting a review, independent of entrenched interests, of the world's best practice, 

    • Identify and fund research into any significant gaps,

    • Reimburse pharmacogenomic testing on Medicare, and

    • Educate the consumer and the healthcare provider on pharmacogenomics.
       

Fact 6: No Prescribing Without Pharmacogenomics

  • The central tenant of the ethical practice of medicine is to do no harm.

  • We consider it to be unethical to prescribe certain medicines without pharmacogenomic testing as to do so exposes the person to a high risk of avoidable harm with some medicines.

  • The risk is not "niche" but is 1:10 for Caucasians and considerably higher in Asian, Pacific Islander, and African populations. The risk to aboriginal persons is not yet known. 

  • A pharmacogenomic test has a lifelong application and has an application to most medications a person is likely to be prescribed throughout their life.

  • A key platform of the Australian Government’s Reform is "Precision Medicine”. Precision medicine focuses on disease prevention and early intervention, particularly through pre-medication. 

  • Whilst this initiative will consider pharmacogenomics it does not meet the consumer’s needs for safe medicines as it fails to address all the medicines a person may take over their life.

  • For example, in June 2018, the Therapeutic Goods Administration issued a warning, that a significant number of medications cause severe adverse reactions including suicide. These medications are not linked to disease processes, including anti-depressants, attention deficit hyperactivity disorder medications, seasonal allergy medicines, smoking cessation medicines, and acne medicines. [12]

  • Furthermore, there are actionable recommendations for pharmacogenomics now, that will not be altered by precision medicine, which carries considerable scientific and ethical challenges.

  • Delaying the implementation of pharmacogenomics even further puts lives at risk whilst waiting for the science around precision medicine to catch up. It puts the science of medicine before the safety of people.

  • Australian's are dying and becoming disabled whilst waiting for precision medicine science to catch up.
     

 

Will you stand with us for safe medicines?
#mylifematters

 

 

[1] http://www.who.int/patientsafety/medication-safety/medication-without-harm-brochure/en/

[2] Lazarou, Jason, Bruce H. Pomeranz, and Paul N. Corey. "Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies." Jama 279.15 (1998): 1200-1205, Starfield, Barbara. "Is US health really the best in the world?." Jama 284.4 (2000): 483-485., Kohn, Linda T., Janet M. Corrigan, and D. John Doyle. "To err is human: building a safer health system." Canadian Medical Association. Journal 164.4 (2001): 527., Null, Gary, et al. "Death by medicine." Journal of Orthomolecular Medicine 20.1 (2005): 21-34., Pirmohamed, Munir, et al. "Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients." Bmj 329.7456 (2004): 15-19.

[3] Wilson, Ross M., et al. "The quality in Australian health care study." Medical journal of Australia 163.9 (1995): 458-471.

[4]  Elliott RA , Lee CY , Beanland C , Vakil K , Goeman D . Medicines management, medication errors and adverse medication events in older people referred to a community nursing service: a retrospective observational study. Drugs Real World Outcomes 2016; 3: 13–24.

[5] Day, Richard O., Leone Snowden, and Andrew J. McLachlan. "Life‐threatening drug interactions: what the physician needs to know." Internal medicine journal 47.5 (2017): 501-512. Beijer HJ , de Blaey CJ . Hospitalisations caused by adverse drug reactions (ADR): a meta‐analysis of observational studies. Pharm World Sci 2002; 24: 46–54. Kongkaew C , Noyce PR , Ashcroft DM . Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother 2008; 42: 1017–25.

[6] Australian Centre for Health Research, Improving the Quality Use of Medicines in Australia, Realising the Potential of Pharmacogenomics, October 2008.

[7] Deloitte, 2007, Targeted Therapies: Navigating the Business Challenges of Personalised Medicine, Deloitte Centre for Health Solutions, p 6.

[8] Australian Centre for Health Research, Improving the Quality Use of Medicines in Australia, Realising the Potential of Pharmacogenomics, October 2008.

[9] Australian Centre for Health Research, Improving the Quality Use of Medicines in Australia, Realising the Potential of Pharmacogenomics, October 2008.

[10] https://acola.org.au/wp/pmed/

[11] https://cpicpgx.org/guidelines/ and https://www.pharmgkb.org/guidelines

[12] https://www.tga.gov.au/publication-issue/medicines-safety-update-volume-9-number-2-june-2018#a2