Older Canadians represent the fastest-growing segment of our population and are the largest users of prescription drugs. Seniors take more drugs than younger Canadians because, on average, they have a higher number of chronic conditions. According to the Canadian Institute for Health Information, in 2012, nearly two-thirds of seniors had claims for 5 or more drug classes, and more than one-quarter of seniors had claims for 10 or more drug classes. The number of drugs used by seniors increased with age.
The use of multiple medications, or polypharmacy, is of concern in the senior population. The risk of drug interactions and adverse drug reactions is several-fold higher for seniors than for younger people. This phenomenon is associated with pharmacokinetic and pharmacodynamics factors in seniors, including changes in renal and hepatic function, increased sensitivity to drugs and, potentially, multiple medical problems. In older persons, adverse drug reactions are often complex and may be the direct cause of hospital admissions for acute care. Cognitive and affective disorders, for example, may be due to adverse reactions to sedatives or hypnotic drugs. Chronic pain is a common issue, and it is important to carry out research into and education for health care providers concerning the unique challenges of managing pain in older adults.
The CMA supports the development of a coordinated national approach to reduce polypharmacy and prevent adverse drug reactions. Prescribers must be vigilant to optimize pharmacotherapy and in reconciling medications, taking into consideration physiological changes as a person ages. Deprescribing should be considered, reducing or stopping medications that may be harmful or no longer be of benefit, seeking to improve quality of life.
There has been considerable interest in determining which factors affect prescribing behavior and how best to influence these factors. Strategies that improve prescribing practices include evidence-based drug information provided through academic detailing; objective continuing medical education; accessible, user-friendly decision support tools available at point of care; and electronic prescribing systems that allow physicians access to their patient's treatment and medication profiles.
The following principles define the basic steps to appropriate prescribing for seniors.
Know the patient.
Know the diagnosis.
Know the drug history. Keep a medication list for each patient and review, update, reconcile and evaluate adherence at each visit. Instruct the patient to bring all prescription and over-the-counter medications, including medications prescribed by other physicians, and natural health products, to each appointment. In some provinces, pharmacists conduct medication use reviews for patients on public drug benefit programs.
Know the history of use of other substances such as alcohol, tobacco, cannabis, opioids and caffeine.
Consider non-pharmacologic therapy, including diet, exercise, psychotherapy or community resources. Continuing medical education in specific non-pharmacologic therapies is valuable. For example, evaluation and management of behavioural and psychological symptoms of dementia should be considered before anti-psychotic therapy. As well, Canadian standardized non-pharmacologic order sets should be developed for the treatment of delirium.
Know the drugs. Critically evaluate all sources of drug information and use multiple sources such as clinical practice guidelines, medical journals and databases, continuing medical education and regional drug information centres. Monitor patients continually for adverse drug reactions. Appropriate drug dosage depends on factors such as age, sex, body size, general health, concurrent illnesses and medications, and hepatic, renal and cognitive function (for example, older people are particularly sensitive to drugs that affect the central nervous system).
Keep drug regimens simple. Avoid mixed-frequency schedules when possible. Try to keep the number of drugs used for long-term therapy under five to minimize the chance of drug interactions and improve adherence.
Establish treatment goals. Determine how the achievement of goals will be assessed. Regularly re-evaluate goals, adequacy of response and justification for continuing therapy. Time to benefit of prescribed medications should be a key consideration when providing care to seniors at end of life.
Encourage patients to be responsible medication users. Verify that the patient and, if necessary, the caregiver, understands the methods and need for medication. Recommend the use of daily or weekly medication containers, calendars, diaries or other reminders, as appropriate, and monitor regularly for compliance. Encourage the use of one dispensary.
The Institute for Safe Medication Practices Canada has developed a program, Knowledge is the best medicine (https://www.knowledgeisthebestmedicine.org), that can be helpful to seniors and their healthcare team manage medicines safely and appropriately.
Approved by the Board on May 28, 2011
Update approved by the Board on March 02, 2019
Position Statement on Prescription Drug Shortages in Canada
The escalation in shortages of prescription drugs in the past few years and the ongoing disruptions to supply experienced in Canada and globally are matters of grave concern to the Canadian Medical Association (CMA) and its members. Drug shortages are having a detrimental impact on the delivery of patient care and treatment and the availability of health care services across the country.
CMA has advocated for a thorough examination of the drug supply system to identify points where we in Canada can influence supply problems. Solutions will have to involve the various players in the drug supply chain, from manufacturers through to healthcare providers and levels of government.
Drug shortages are not a problem confined to Canada. In the United States the number of drug shortages from 2006 to 2010 grew by more than 200 per cent.1 In 2011, 251 shortages were reported to the FDA. 2 Canada has not had an accurate record of the number of drugs in short supply over past years but in April 2013 253 drugs were listed on the industry sponsored Canadian Drug Shortage Website.3
Factors that influence the occurrence of a drug shortage can occur at any stage of the drug supply chain and any disruptions can ripple through the system.
Figure 1 Drug supply chain in Canada4 [See PDF]
There are many causes that can lead to a drug shortage. Disruptions in the supply of an active or key ingredient contribute to drug shortages and this is exacerbated when the active ingredient is produced by a single raw material supplier. If the supplier is unable to meet demand than all manufacturers relying on that supply become vulnerable to disruptions. The sourcing of raw materials from outside of North America, primarily China and India, whose safety and regulatory standards may not be stringently enforced can result in regulatory authorities closing down facilities thereby impacting supply of active ingredients or necessitating a lengthy search for a new supplier.
Additional manufacturing issues contributing to shortages can include complex manufacturing processes like those used to make sterile injectables, changes in product formulations, problems in the production process or regulatory enforcement of good manufacturing processes, limited capacity, an unexpected surge in demand, regulatory delays in product approvals and business decisions. 5
Shortages may also be due to factors outside the manufacturers control such as various interruptions in the normal delivery of medicines through the pharmacy supply chain and distribution network6. Just in time inventory management practices can lead to a reduction of available drug inventories. In addition procurement strategies that lead to sole source contracts for bulk purchases has been identified as the single most avoidable cause of drug shortages. 7
Disruptions in the supply of medications have the potential to impact patient care, patient health and the efficiency of the overall health care system.
Among the impacts of drug shortages are:
- delays in access to needed medication;
- delays or disruptions to clinical treatment;
- delayed or cancelled surgeries,
- loss of therapeutic effectiveness when an appropriate alternate therapy is not available;
- increased risk of side effects;
- increased non-compliance when changes in medication make it confusing and harder to comply with a new medication regime particularly for those on long term therapy.8
Any and all of these situations can result in a disruption to clinical stability and deterioration, particularly in patients with complex problems. Drug substitution can also result in unintended consequences. In 2010 an Institute of Safe Medication Practices survey of 1800 US health professionals revealed that in one year drug shortages caused over 1000 incidents involving negative side effects or medical errors. 9 In many instances shortages can lead to an increase in the use of the health care system, be it in physician or emergency room visits or treatments.
A CMA survey of physicians in September 2012 found that 66% of respondents indicated that drug shortages have gotten worse since 2010 and 64% stated that the shortages have had consequences for their patients or practice. Similarly, the results of the 2012 Canadian Pharmacists Association (CPhA) survey of pharmacists found that over 91% of pharmacists indicated that patients had been inconvenienced by shortages and 51% indicated that patients' care had been compromised.10
Drug shortages also have an impact on the practices of physicians and pharmacists. Sixty seven percent of the respondents to the CMA survey stated that drug shortages do have an impact on their practice most notably by increasing time spent on research or consultation with health professional colleagues to source alternative medicine, increase in length of patient visits due to medication substitution concerns, and increase in time spent on forms such as insurance claims. Seventy six percent of hospital pharmacists and 76 percent of community pharmacists also report an impact on their workload and practice.11
Since as early as 2005, the CMA has supported a comprehensive strategy and adequately resourced system for monitoring domestic drug supply. In response to a Health Canada consultation in October 2005 on a report entitled "Developing a Drug Supply Network" CMA recommended that Canada needs such a system to identify shortages and respond quickly to remedy them, and to ensure that policy and regulatory decisions are founded on accurate and reliable knowledge.
In March 2011 this position was reinforced in communication with the Government of Canada stating that Canada needs a sustainable, adequately resourced process to identify shortages, rapidly communicate them to health professionals and respond quickly to resolve them.
1. The Canadian Medical Association supports an investigation into the underlying causes of prescription drug shortages in Canada.
2. The Canadian Medical Association recommends the creation of a monitoring unit to track drug production disruptions in Canada and abroad.
The communication of information to health professionals once a shortage occurs, or is expected, is critical to their ability to make patient centered decisions and provide continuity of optimum care. CMA has participated on a Multi Stakeholder Working Group on Drug Shortages that has had the pharmaceutical industry and health professional organizations working together to establish a national drug shortage reporting website. CMA provided key input on the needs of needs of physicians to ensure that information required to provide optimum care when managing a drug shortage such as product information including name, manufacturer, formulation, strength, package size, expected duration of shortage, notification that shortage is resolved as well as automatic alerts and search and sort functionality was included on the website.
The establishment of the Canadian drug shortage website marks an improvement in the management of drug shortages but significant issues remain. Of great concern are drugs that are 'single sourced'. When there are shortages of single sourced medications there are no clear substitutes. Related to this are the unintended consequences of sole sourcing products from one manufacturer to secure a lower price. This introduces a vulnerability to the marketplace if the sole supplier experiences production disruptions. The 2011 production stoppage at a Sandoz facility in Quebec due to regulatory compliance issues and a subsequent fire in the plant resulted in a scramble to find alternate sources of many essential medications. The CMA supports the development of strategies at the provincial/territorial and federal level to discourage single source purchasing decisions. The inclusion of incentives or penalties for guaranteed supplies, or a contingency plan for supply disruptions should be inserted into purchase contracts. We must be extremely careful not to exacerbate supply problems while trying to address cost issues.
3. The Canadian Medical Association calls for a review of the supply processes in place for drugs and equipment considered essential for medical practice.
4. The Canadian Medical Association supports strategies to discourage single-source purchasing decisions for prescription medications.
Advance notice, by manufacturers to Health Canada, of expected drug shortages can provide a window of opportunity for the manufacturer and regulators to work together to resolve production problems or identify alternate supply. We are encouraged by recent initiatives by Health Canada to collect information on planned discontinuances from manufacturers.
5. The Canadian Medical Association calls for the establishment of a legislative framework requiring pharmaceutical companies to provide advance notice of production stoppages and any forecast disruptions in the drug supply.
Because of the complexity of the drug supply system, to effectively identify the situations that lead to drug shortages and find Canadian based solutions that can decrease the incidence of shortages or mitigate their impact requires the involvement and cooperation of all players in the process. CMA has consistently asked the government of Canada to work with the provinces and territories, the private sector and health professionals to address this potentially dangerous threat to the lives of Canadian patients.
6. The CMA supports the provinces and territories in their efforts to prevent drug shortages.
We are heartened by actions of Health Canada in 2012 to bring together representatives of industry, federal, provincial and territorial governments and health professional associations in a Multi Stakeholder Steering Committee on Drug Shortages to respond to the need for the mitigation of drug shortages. We trust that processes can be put in place and supported by key players to allow Canada to respond in a coordinated, transparent and accountable fashion to future or actual drug shortages.
Drug Shortages represent an ongoing worry for physicians. The impact on patients, health professionals and the health care system can be significant. Substantial progress has been made since 2011 in terms of gathering and sharing drug shortage information and improving our understanding of the drug supply processes but much still remains to be done. Although complex and challenging, ongoing attention to the issue is required to ensure that Canadians can count on a secure supply of medication into the future.
The CMA will continue to represent the best interests of patients and physicians to ensure that Canada's health care system delivers on patient-centered care.
1 DRUG SHORTAGES FDA's Ability to Respond Should be Strengthened, Statement of Marcie Cross, Director, Health Care, United States Government Accountability Office, Testimony before the Committee on Health, Education, Labor, and Pensions, U.S. Senate, December 15, 2011.
2 FDA is asking the public to send in ideas for combatting drug shortages, FDA Voice, Feb. 13, 2013, U.S. Food and Drug Administration, available at http://blogs.fda.gov/fdavoice/index.php/tag/drug-shortages/ (accessed 2013 April 2).
3 Canadian Drug Shortages Database available at http://www.drugshortages.ca/drugshortages.asp (accessed 2013 April 5).
4 Drug Supply In Canada: A Multi-stakeholder Responsibility, Report of the Standing Committee on Health, 41st Parliament, First session, June 2012.
5 Drug Supply Disruptions, Environmental Scan, Canadian Agency for Drugs and Technologies in Health, Issue 17, March 2011.
6 Canadian Drug Shortages Database available at http://www.drugshortages.ca/drugshortages.asp (accessed 2013April 5).
7 Drug Supply In Canada: A Multi-stakeholder Responsibility, Report of the Standing Committee on Health, 41st Parliament, First session, June 2012.
8 Prescription Drug Shortages, E Panel Survey, Canadian Medical Association, December 2010.
9 Drug Shortages, Recommendations of the Working Group on Drug Shortages, Ordre des Pharmaciens du Québec, March 2012.
10 Impact of Drug Shortages, Member survey, Canadian Pharmacists Association, October 2012.
11 BACKGROUNDER - DRUG SHORTAGES SURVEY, Canadian Pharmacists Association, Canadian Society of Hospital Pharmacists, Canadian Medical Association, January 2013, available at http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Media_Release/2013/Backgrounder-Drug-shortages_en.pdf ( assessed 2013 April 2).
Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association
By 2015, e-prescribing will be the means by which prescriptions are generated for Canadians.
e-Prescribing is the secure electronic creation and transmission of a prescription between an authorized prescriber and a patient's pharmacy of choice, using clinical Electronic Medical Record (EMR) and pharmacy management software.
Health Information Technology (HIT) is an enabler to support clinicians in the delivery of health care services to patients. The Canadian Medical Association (CMA) and the Canadian Pharmacists Association (CPhA) each have identified e-prescribing as a key tool to deliver better value to patients. The integration of HIT into clinics and health care facilities where physicians and pharmacists provide care is a priority for both associations1.
As part of its Health Care Transformation initiative, the CMA highlighted the need to accelerate the introduction of e-prescribing in Canada to make it the main method of prescribing. In its policy on optimal prescribing the CMA noted that one of the key elements was the introduction of electronic prescribing. The CPhA, as part of its Blueprint for Pharmacy Implementation Plan, highlights information and communication technology, which includes e-prescribing, as one of five priority areas.
We applaud the ongoing efforts of Canada Health Infoway, provinces and territories to establish Drug Information Systems (DIS) and the supporting infrastructure to enable e-prescribing. We urge governments to maintain e-prescribing as a priority and take additional measures to accelerate their investments in this area.
It is our joint position that e-prescribing will improve patient care and safety. e-Prescribing, when integrated with DIS, supports enhanced clinical decision-making, prescribing and medication management, and integrates additional information available at the point of care into the clinical workflow.
The following principles should guide our collective efforts to build e-prescribing capability in all jurisdictions:
* Patient confidentiality and security must be maintained
* Patient choice must be protected
* Clinicians must have access to best practice information and drug cost and formulary data
* Work processes must be streamlined and e-prescribing systems must be able to integrate with clinical and practice management software and DIS
* Guidelines must be in place for data sharing among health professionals and for any other use or disclosure of data
* The authenticity and accuracy of the prescription must be verifiable
* The process must prevent prescription forgeries and diversion
* Pan-Canadian standards must be set for electronic signatures
Benefits of e-Prescribing
A number of these benefits will be realized when e-prescribing is integrated with jurisdictional Drug Information Systems (DIS).
o Improves patient safety and overall quality of care
o Increases convenience for dispensing of new and refill prescriptions
o Supports collaborative, team-based care
o Supports a safer and more efficient method of prescribing and authorizing refills by replacing outdated phone, fax and paper-based prescriptions
o Eliminates re-transcription and decreases risk of errors and liability, as a prescription is written only once at the point-of-care
o Supports electronic communications between providers and reduces phone calls and call-backs to/from pharmacies for clarification
o Provides Warning and Alert systems at the point of prescribing, supporting clinician response to potential contraindications, drug interactions and allergies
o Facilitates informed decision-making by making medication history, drug, therapeutic, formulary and cost information available at the point of prescribing
* Health Care System:
o Improves efficiency and safety of prescribing, dispensing and monitoring of medication therapy
o Supports access to a common, comprehensive medication profile, enhancing clinical decision-making and patient adherence
o Increases cost-effective medication use, through improved evidence-based prescribing, formulary adherence, awareness of drug costs and medication management
o Improves reporting and drug use evaluation
While evidence of the value of e-prescribing is established in the literature, its existence has not fostered broad implementation and adoption. In Canada, there are a number of common and inter-related challenges to e-prescribing's implementation and adoption. These include:
* Improving access to relevant and complete information to support decision-making
* Increasing the level of the adoption of technology at the point of care
* Focusing on systems-based planning to ensure continuum-wide value
* Integrating e-prescribing into work processes to gain support from physicians, pharmacists and other prescribers
* Increasing leadership commitment to communicate the need for change, remove barriers and ensure progress
* Updating legislation and regulation to support e-prescribing
Enabling e-Prescribing in Canada
CMA and CPhA believe that we can achieve the vision that is set out in this document and address the aforementioned challenges by working collectively on five fronts:
* Health care leadership in all jurisdictions and clinical organizations must commit to make e-prescribing a reality by 2015
* Provinces and territories, with Canada Health Infoway, must complete the building blocks to support e-prescribing by increasing Electronic Medical Record (EMR) adoption at the point of care, finishing the work on the Drug Information Systems (DIS) in all jurisdictions and building the connectivity among the points of care and the DIS systems
* Pharmacist and medical organizations in conjunction with provinces, territories and Canada Health Infoway must identify clear benefits for clinicians (enhancing the effectiveness of care delivery and in efficiencies in changing workflows) to adopt e-prescribing and focus their efforts on achieving these benefits in the next three years
* Provinces, territories and regulatory organizations must create a policy/regulatory environment that supports e-prescribing which facilitates the role of clinicians in providing health care to their patients
* Provinces and territories must harmonize the business rules and e-health standards to simplify implementation and conformance by software vendors and allow more investment in innovation.
1 Health Care Transformation in Canada, Canadian Medical Association, June 2010; Blueprint for Pharmacy Implementation Plan, Canadian Pharmacists Association, September 2009