File Name: compendium of pharmaceuticals and specialties 2017 .zip
Featured Books and Ebooks. Featured Databases. Suggested Websites. Contact Us.
The Canadian Paediatric Society gives permission to print single copies of this document from our website. For permission to reprint or reproduce multiple copies, please see our copyright policy. See below for a list of all authors and endorsing organizations. Paediatr Child Health 24 5 — Executive Summary. In Canada, policies governing medication approval and reimbursement are based largely on adult standards, and the evaluation of new medicines employs adult return-on-investment benchmarks.
Research funding for adult diseases is often prioritized over that for childhood illnesses. Canada lags other countries in implementing regulatory and research-related reforms that take the unique characteristics of children and youth into account.
To ensure that children and youth have timely access to safe, effective medications, including child-friendly formulations, the federal government must pursue paediatric-focused reforms that consider their unique health needs throughout the drug life cycle. Regulatory reform must be guided by principles of fairness and equity, always recognizing that children deserve the same standards of drug safety, efficacy, availability, and access as adults.
Paediatric experts must drive evidence-informed change within Health Canada, and across reimbursement agencies, through the establishment of a permanent, appropriately funded Expert Paediatric Advisory Board. Reforms must ensure the proactive collection and review of paediatric evidence and enable the application of paediatric-sensitive standards and benchmarks across all regulatory and reimbursement decision-making.
Finally, the government must fully support evidence-informed paediatric prescribing and establish a stable, national infrastructure for paediatric drug research and clinical trials. Children have a right to receive the highest standards of health care, including optimal treatments for disease [ 1 ].
Yet children and youth continue to be under-represented in medication research [ 2 ] [ 3 ] , regulation, and commercial product development [ 4 ]. Policies governing the development, approval, and reimbursement of medicines are generally designed for adult populations and often neglect the unique characteristics of children and youth.
Research funding for adult diseases tends to be prioritized over childhood illnesses because the capacity for, feasibility of, and expected commercial benefit from adult-focused research is presumed to be greater [ 5 ] - [ 7 ]. New medicines are often evaluated and brought to market based on principles of adult physiology and adult return-on-investment benchmarks, without consideration for the developing child [ 8 ].
Moreover, many commonly prescribed paediatric medications must be extemporaneously compounded, because child-friendly formulations e. Both off-label prescribing and compounding are associated with significant risk, including adverse reactions and efficacy concerns [ 14 ] [ 15 ].
In a landmark report in , the Standing Senate Committee on Social Affairs, Science and Technology [ 10 ] made the first significant effort to understand the extent and effect of off-label medication use in Canada, highlighting children as a vulnerable population. That same year, the Council of Canadian Academies published a multidisciplinary expert panel report exploring the state of pharmacotherapy for children in Canada [ 16 ].
They concluded that:. This commitment provides a unique occasion to rectify long-term, systemic shortcomings and to strengthen and streamline the safety and availability of paediatric medications for the future. To fully realize this opportunity, regulatory reform must be guided by fundamental health care values, including fairness and equity, to ensure that children and youth receive equitable consideration and attention.
Expert paediatric leadership must drive evidence-informed change within Health Canada and across reimbursement decision-making bodies. Policies and processes must enhance paediatric data-gathering and utilization. Finally, the unique needs of children and youth must be considered throughout the drug life cycle. Children deserve the same high standards of drug safety, efficacy, availability, and access as adults. Health Canada has exclusive authority to approve medications for sale in Canada [ 18 ].
Their mandate includes new chemical entities, review of products originating in other jurisdictions but new to the Canadian market, and new indications or formulations for medications already available in Canada. Strict, rigorous regulations ensure the safety and efficacy of medicines approved for sale, with a product label that accurately outlines appropriate use. Similar to regulatory regimes in comparable international jurisdictions, the process of preparing a submission to Health Canada can be lengthy and expensive.
Submissions require data summarizing clinical safety and efficacy in the target population, manufacturing process information, quality standards, and non-clinical studies that support safe human use [ 19 ]. Health Canada may also request additional information that requires additional studies. While such standards are in place to protect the health of all Canadians, current policies have unintended negative implications for children and youth. Current regulatory norms are based on available data for adult populations, which stem from large patient pools and a stable, well-funded clinical trial infrastructure.
At present, parallel trials in paediatric populations may not be feasible, due to low disease prevalence e. Policy reform and focused, sustained investment are needed to effectively overcome these barriers. Perceived procedural complexity and the inherent uncertainty of success are additional disincentives.
While some accommodations, incentives, and alternative pathways exist [ 22 ] , they are limited in scope, poorly understood, and rarely used. Most importantly, Health Canada does not require manufacturers to submit paediatric data unless a specific paediatric indication is being pursued.
In stark contrast to leading international jurisdictions, Health Canada does not actively request paediatric evidence, even when use among children and youth can be readily anticipated, or when paediatric data exist and such data have been submitted to other foreign regulators.
This passive standard can be considered regulatory neglect, leaving prescribers with limited options and uncertain of how best to modify adult medications to treat children and youth [ 23 ]. While estimates vary by jurisdiction, practice setting, and speciality, off-label prescribing for paediatric patients is high [ 24 ] - [ 26 ] , particularly in infants [ 27 ] , children receiving intensive care [ 28 ] , and children being treated for mental illness [ 29 ].
Given the cost, complexity, and uncertainty associated with current regulatory processes, there are tacit incentives to adhere to minimum requirements for file submissions. Systemic barriers to commercializing new paediatric drugs or new indications for existing medications, even when they have been approved for paediatric use for decades in trusted markets elsewhere, are significant.
The current framework fuels off-label prescribing and endangers children. When a commercially available child-friendly formulation e. Caregivers may also be advised by a health care provider to compound a medication at home to facilitate administration. Quality controls for compounded products are weaker than for commercially prepared products [ 33 ]. Consequently, their stability, potency, uniformity, chemical purity, microbial sterility, and bioavailability are less certain, and significant concentration-related or dosing errors can occur [ 34 ].
Because compounded medicines often have an unpleasant taste [ 35 ] , adherence can be a challenge. And importantly, the manipulation of prescribed but potentially hazardous substances, such as chemotherapeutic agents, can pose significant risk to both patients and family members. In many cases, paediatric formulations that are commercially available in places like the US and EU are simply not marketed in Canada because of the complex and cumbersome regulatory and reimbursement environment, commercial limitations inherent to a small market, and existing practice norms.
Medications for children in Canada deserve the same regulatory protections as medications for adults, and barriers to the commercialization of child-friendly formulations should be eliminated. Under the current regulatory framework, a significant number of medications for rare diseases have not been nor are likely to be submitted for Health Canada approval.
This gap has created a disproportionate dependency on the federally supported Special Access Programme SAP , designed to facilitate access to essential medications not marketed in Canada. The SAP review process is cumbersome, time-consuming, case-based, and only accessible by patients for whom no other therapeutic option exists [ 36 ].
The evolution of new drug pricing practices has stimulated interest in regulatory approval for selected rare disease medications [ 37 ] [ 38 ]. However, the unintended effects of approving new, sometimes costly medications to replace SAP-accessible options include flooding the market with therapeutics that, in some cases, cost much more but only confer marginal therapeutic benefit compared with older, less expensive products. Ensuring that new drug submissions are reviewed in accordance with current clinical care standards is essential to protect against predatory pricing or practices that have evolved in other jurisdictions.
Regulatory approval by Health Canada does not guarantee eligibility for reimbursement under public or private drug plans. Public reimbursement status involves four independent steps:.
This process is designed to optimize procurement controls and help sustain the public health system. However, the current, complex reimbursement assessment system often has the unintended consequence of jeopardizing access to medications and child-friendly formulations for Canadian children and youth. Their unique needs are not systematically considered, nor are paediatric-specific standards and benchmarks routinely employed. No public reimbursement entity, at any government level, is required to consider the unique attributes of paediatric patients.
HTA and pricing negotiations are based on approved indications, which often address the adult population exclusively. Their assessments rely on principles, benchmarks, and price-to-volume ratios based on adult norms, often involving large patient populations with common conditions.
They do not usually consider characteristics specific to paediatric populations, which include limited labelling, small market size, lack of clinical and cost-effectiveness data needed to ensure reimbursement, the need for child-friendly formulations, and the shared social benefits of providing quality care for children [ 41 ].
Such factors can compromise paediatric-sensitive HTAs for all medications, but become more pronounced when evaluating medications for conditions that primarily or exclusively impact children. Reforming the HTA and pricing processes in parallel with regulatory improvements will optimize health care and outcomes for paediatric patients. Health Canada should have a comparable mandate [ 42 ]. In Europe, the Paediatric Regulation came into force in , with the aim of increasing the development and availability of safe, effective medicines for children [ 43 ].
Central to this initiative is the Paediatric Investigation Plan PIP [ 44 ] , a mandatory component for all drug submissions to provide paediatric data in support of paediatric indications when use in children can reasonably be expected. The PIP requirement applies to new drug submissions and those for new indications, formulations, or routes of administration.
For new chemical entities, the PIP is negotiated early Phase 1 or 2 in the development of a product. For existing entities, a PIP is negotiated as soon as any new indication or dosage is sought. For products with no foreseeable paediatric use e. The standing Paediatric Committee PDCO , a scientific committee responsible for coordinating EMA activities around paediatric medicines, reviews and approves each PIP, and determines the studies to be conducted as part of the proposal.
PIP requirements are binding on the manufacturer [ 44 ] [ 45 ]. The PeRC is granted authorities through:. At present, the US is pursuing legislation to expand requirements for assessing medication use in paediatric populations, especially for medications used to treat paediatric cancer patients [ 48 ].
This landmark work shows how government regulations can ensure safer, more effective paediatric medications. Fundamental to both the EU and US frameworks are close, coordinated, relationships among regulators, research funders, clinical leaders, and industry [ 49 ].
At the centre of each model is a standing committee of paediatric experts, mandated to lead and oversee process, foster stakeholder relationships, and drive change. Central to their effectiveness is a proactive paediatric data-gathering approach to support appropriate labelling, indications, and formulations [ 51 ] - [ 53 ]. The EPAB would:. The Board should include leadership from clinical, academic and administrative domains, with capacity to rapidly assemble ad hoc expert panels when specific questions arise.
Public, parent, and patient engagement should be deliberate to assist with both priority-setting and decision-making. Deliberations must be transparent, with an online annual report showing progress toward specific goals and measurable objectives. View larger version. Clear, paediatrics-specific guidance on regulatory and reimbursement processes must be disseminated to all stakeholders. Along with appropriate HTA review, these reforms will lower barriers, costs, and uncertainty, and draw more paediatric submissions to Canada.
Regulatory proposals associated with Bill C have been slow to emerge, but key reforms must include empowering the Minister of Health to:. These powers align with key initiatives designed to improve access to safe, effective paediatric medications and should be leveraged appropriately. Efforts to modernize and streamline regulatory processes will remain limited unless the HTA agencies also embrace parallel reforms. Reform-related activities should be guided by paediatric experts who also advise and liaise with federal pricing bodies.
This role best belongs to the EPAB, who would be mandated with aligning regulatory, HTA, and reimbursement policy standards and processes.
The Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals , more commonly known by its abbreviation CPS ,  is a reference book that contains drug monographs and numerous features which help healthcare professionals prescribe and use drugs safely and appropriately. The CPhA is a nonprofit organization that advocates for pharmacists in Canada. CPS is also available online by subscription at www. Most of the drug monographs in CPS are provided by manufacturers, though numerous monographs—usually for drugs which are available as generic brands— are written by CPhA editorial staff and peer reviewed. It is the most comprehensive list of current brand and generic drugs in Canada, and also includes discontinued products.
Home List. Revise Search. House of Commons. Professional Patient or Public 68 Recommended 15 Featured 0. Search Options. Advanced search tips. Search Clear Form.
Giving you the confidence to deliver innovative pharmacy services and optimal drug therapies for your patients. For more than half a century, our publishing department has specialized in medication therapy management. The Canadian standard for drug monographs contains thousands of products, including monographs for drugs, vaccines, natural health products and medical devices, approved by Health Canada. It includes the most current, evidence-based therapeutic information and non-prescription therapy for most common conditions, with cross-referenced drug tables and algorithms. It features critical updates such as warnings, advisories, and drug shortages; and useful tools such as medical calculators, Clin-Info, Pill Identifier and Lexi-Interact drug interaction checker. Fully searchable drug and therapeutic content is updated weekly to ensure you have the most current drug information, including Health Canada advisories.
Как только он оказался там, его сразу же увлек за собой поток молодых людей. - А ну с дороги, пидор! - Некое существо с прической, больше всего напоминающей подушечку для иголок, прошествовало мимо, толкнув Беккера в бок. - Хорошенький! - крикнул еще один, сильно дернув его за галстук. - Хочешь со мной переспать? - Теперь на Беккера смотрела юная девица, похожая на персонаж фильма ужасов Рассвет мертвецов.
Наклонился и осмотрел пальцы левой руки. Лейтенант следил за его взглядом. - Ужасное уродство, правда. Но не искалеченная рука привлекла внимание Беккера.
Вы получите оба экземпляра, - прозвучал голос. - Мой и мистера Танкадо. Нуматака закрыл трубку ладонью и громко засмеялся. Однако он не смог удержаться от вопроса: - Сколько же вы хотите за оба экземпляра. - Двадцать миллионов американских долларов. Почти столько же поставил Нуматака.
The Canadian Paediatric Society gives permission to print single copies of this document from our website.Reply
Backgrounders are academic detailing tools to assist pharmacists in supporting drug stewardship and are supplemented by online, interactive webinars.Reply
Jump to navigation.Reply