APPROACHES TO ENHANCING THE QUALITY OF DRUG THERAPY
A JOINT STATEMENT BY THE CMA ANDTHE CANADIAN PHARMACEUTICAL ASSOCIATION
This joint statement was developed by the CMA and the Canadian Pharmaceutical Association, a national association of pharmacists, and includes the goal of drug therapy, strategies for collaboration to optimize drug therapy and physicians' and pharmacists' responsibilities in drug therapy. The statement recognizes the importance of patients, physicians and pharmacists working in close collaboration and partnership to achieve optimal outcomes from drug therapy.
Goal of This Joint Statement
The goal of this joint statement is to promote optimal drug therapy by enhancing communication and working relationships among patients, physicians and pharmacists. It is also meant to serve as an educational resource for pharmacists and physicians so that they will have a clearer understanding of each other's responsibilities in drug therapy. In the context of this statement, a "patient" may include a designated patient representative, such as a parent, spouse, other family member, patient advocate or health care provider.
Physicians and pharmacists have a responsibility to work with their patients to achieve optimal outcomes by providing high-quality drug therapy. The important contribution of all members of the health care team and the need for cooperative working relationships are recognized; however, this statement focuses on the specific relationships among pharmacists, physicians and patients with respect to drug therapy.
This statement is a general guide and is not intended to describe all aspects of physicians' or pharmacists' activities. It is not intended to be restrictive, nor should it inhibit positive developments in pharmacist-physician relationships or in their respective practices that contribute to optimal drug therapy. Furthermore, this statement should be used and interpreted in accordance with applicable legislation and other legal requirements.
This statement will be reviewed and assessed regularly to ensure its continuing applicability to medical and pharmacy practices.
Goal of Drug Therapy
The goal of drug therapy is to improve patients' health and quality of life by preventing, eliminating or controlling diseases or symptoms. Optimal drug therapy is safe, effective, appropriate, affordable, cost-effective and tailored to meet the needs of patients, who participate, to the best of their ability, in making informed decisions about their therapy. Patients require access to necessary drug therapy and specific, unbiased drug information to meet their individual needs. Providing optimal drug therapy also requires a valid and accessible information base generated by basic, clinical, pharmaceutical and other scientific research.
Working Together for Optimal Drug Therapy
Physicians and pharmacists have complementary and supportive responsibilities in providing optimal drug therapy. To achieve this goal, and to ensure that patients receive consistent information, patients, pharmacists and physicians must work cooperatively and in partnership. This requires effective communication, respect, trust, and mutual recognition and understanding of each other's complementary responsibilities. The role of each profession in drug therapy depends on numerous factors, including the specific patient and his or her drug therapy, the prescription status of the drug concerned, the setting and the patient-physician-pharmacist relationship. However, it is recognized that, in general, each profession may focus on certain areas more than others.
For example, when counselling patients on their drug therapy, a physician may focus on disease-specific counselling, goals of therapy, risks and benefits and rare side effects, whereas a pharmacist may focus on correct usage, treatment adherence, dosage, precautions, dietary restrictions and storage. Areas of overlap may include purpose, common side effects and their management and warnings regarding drug interactions and lifestyle concerns. Similarly, when monitoring drug therapy, a physician would focus on clinical progress toward treatment goals, whereas a pharmacist may focus on drug effects, interactions and treatment adherence; both would monitor adverse effects.
Both professions should tailor drug therapy, including education, to meet the needs of individual patients. To provide continuity of care and to promote consistency in the information being provided, it is important that both pharmacists and physicians assess the patients' knowledge and identify and reinforce the educational component provided by the other.
Strategies for Collaborating to Optimize Drug Therapy
Patients, physicians and pharmacists need to work in close collaboration and partnership to achieve optimal drug therapy. Strategies to facilitate such teamwork include the following.
- Respecting and supporting patients' rights to make informed decisions regarding their drug therapy.
- Promoting knowledge, understanding and acceptance by physicians and pharmacists of their responsibilities in drug therapy and fostering widespread communication of these responsibilities so they are clearly understood by all.
- Supporting both professions' relationship with patients, and promoting a collaborative approach to drug therapy within the health care team. Care must be taken to maintain patients' trust and their relationship with other caregivers.
- Sharing relevant patient information for the enhancement of patient care, in accordance and compliance with all of the following: ethical standards to protect patient privacy, accepted medical and pharmacy practice, and the law. Patients should inform their physician and pharmacist of any information that may assist in providing optimal drug therapy.
- Increasing physicians' and pharmacists' awareness that it is important to make themselves readily available to each other to communicate about a patient for whom they are both providing care.
- Enhancing documentation (e.g., clearly written prescriptions and communication forms) and optimizing the use of technology (e.g., e-mail, voice mail and fax) in individual practices to enhance communication, improve efficiency and support consistency in information provided to patients.
- Developing effective communication and administrative procedures between health care institutions and community-based pharmacists and physicians to support continuity of care.
- Developing local communication channels and encouraging dialogue between the professions (e.g., through joint continuing education programs and local meetings) to promote a peer-review-based approach to local prescribing and drug-use issues.
- Teaching a collaborative approach to patient care as early as possible in the training of pharmacists and physicians.
- Developing effective communication channels and encouraging dialogue among patients, physicians and pharmacists at the regional, provincial, territorial and national levels to address issues such as drug-use policy, prescribing guidelines and continuing professional education.
- Collaborating in the development of technology to enhance communication in practices (e.g., shared patient databases relevant to drug therapy).
- Working jointly on committees and projects concerned with issues in drug therapy such as patient education, treatment adherence, formularies and practice guidelines, hospital-to-community care, cost-control strategies, sampling and other relevant policy issues concerning drug therapy.
- Fostering the development and utilization of a high-quality clinical and scientific information base to support evidence-based decision making.
The Physician's Responsibilities
Physicians and pharmacists recognize the following responsibilities in drug therapy as being within the scope of physicians' practice, on the basis of such factors as physicians' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of pharmacists (see The Pharmacist's Responsibilities). In addition, it is recognized that practice environments within medicine may differ and may affect the physician's role.
- Assessing health status, diagnosing diseases, assessing the need for drug therapy and providing curative, preventive, palliative and rehabilitative drug therapy in consultation with patients and in collaboration with caregivers, pharmacists and other health care professionals, when appropriate.
- Working with patients to set therapeutic goals and monitor progress toward such goals in consultation with caregivers, pharmacists and other health care providers, when appropriate.
- Monitoring and assessing response to drug therapy, progress toward therapeutic goals and patient adherence to the therapeutic plan; when necessary, revising the plan on the basis of outcomes of current therapy and progress toward goals of therapy, in consultation with patients and in collaboration with caregivers, pharmacists and other health care providers, when appropriate.
- Carrying out surveillance of and assessing patients for adverse reactions to drugs and other unanticipated problems related to drug therapy, revising therapy and, when appropriate, reporting adverse reactions and other complications to health authorities.
- Providing specific information to patients and caregivers about diagnosis, indications and treatment goals, and the action, benefits, risks and potential side effects of drug therapy.
- Providing and sharing general and specific information and advice about disease and drugs with patients, caregivers, health care providers and the public.
- Maintaining adequate records of drug therapy for each patient, including, when applicable, goals of therapy, therapy prescribed, progress toward goals, revisions of therapy, a list of drugs (both prescription and over-the-counter drugs) currently taken, adverse reactions to therapy, history of known drug allergies, smoking history, occupational exposure or risk, known patterns of alcohol or substance use that may influence response to drugs, history of treatment adherence and attitudes toward drugs. Records should also document patient counselling and advice given, when appropriate.
- Ensuring safe procurement, storage, handling, preparation, distribution, dispensing and record keeping of drugs (in keeping with federal and provincial regulations and the CMA policy summary "Physicians and the Pharmaceutical Industry (Update 1994)" (Can Med Assoc J 1994;150:256A-C.) when the patient cannot reasonably receive such services from a pharmacist.
- Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development.
Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Care also should be provided in accordance with accepted scientific and ethical standards and procedures.
The Pharmacist's Responsibilities
Pharmacists and physicians recognize the following responsibilities as being within the scope of pharmacists' practice, on the basis of such factors as pharmacists' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of physicians (see The Physician's Responsibilities). In addition, it is recognized that, in selected practice environments, the pharmacists' role may differ considerably.
- Evaluating the patients' drug-therapy record ("drug profile") and reviewing prescription orders to ensure that a prescribed therapy is safe and to identify, solve or prevent actual or potential drug-related problems or concerns. Examples include possible contraindications, drug interactions or therapeutic duplication, allergic reactions and patient nonadherence to treatment. Significant concerns should be discussed with the prescriber.
- Ensuring safe procurement, storage, preparation, distribution and dispensing of pharmaceutical products (in keeping with federal, provincial and other applicable regulations).
- Discussing actual or potential drug-related problems or concerns and the purpose of drug therapy with patients, in consultation with caregivers, physicians and health care providers, when appropriate.
- Monitoring drug therapy to identify drug-related problems or concerns, such as lack of symptomatic response, lack of adherence to treatment plans and suspected adverse effects. Significant concerns should be discussed with the physician.
- Advising patients and caregivers on the selection and use of nonprescription drugs and the management of minor symptoms or ailments.
- Directing patients to consult their physician for diagnosis and treatment when required. Pharmacists may be the first contact for health advice. Through basic patient assessment (i.e., observation and interview) they should identify the need for referral to a physician or an emergency department.
- Notifying physicians of actual or suspected adverse reactions to drugs and, when appropriate, reporting such reactions to health authorities.
- Providing specific information to patients and caregivers about drug therapy, taking into account patients' existing knowledge about their drug therapy. This information may include the name of the drug, its purpose, potential interactions or side effects, precautions, correct usage, methods to promote adherence to the treatment plan and any other health information appropriate to the needs of the patient.
- Providing and sharing general and specific drug-related information and advice with patients, caregivers, physicians, health care providers and the public.
- Maintaining adequate records of drug therapy to facilitate the prevention, identification and management of drug-related problems or concerns. These records should contain, but are not limited to, each patient's current and past drug therapy (including both prescribed and selected over-the-counter drugs), drug-allergy history, appropriate demographic data and, if known, the purpose of therapy and progress toward treatment goals, adverse reactions to therapy, the patient's history of adherence to treatment, attitudes toward drugs, smoking history, occupational exposure or risk, and known patterns of alcohol or substance use that may influence his or her response to drugs. Records should also document patient counselling and advice given, when appropriate.
- Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development.
Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Products and services should be provided in accordance with accepted scientific and ethical standards and procedures.
Auditing Physician Billings
The CMA has developed a set of guiding principles to assist in the formation and modification of provincial/territorial billing audit processes. These principles will ensure that billing audit systems are fair, transparent, effective and timely, and that they uphold their original objectives of ensuring the accountability of public expenditures and educating physicians on appropriate billing practices.
As payments to physicians are made through public monies, the integrity of the payment system is validated through physician billing audits and reviews. Audits and reviews are usually prompted by: billings that appear to be outside of the “norm,” patient complaints, physician complaints or a “focus” on a particular service/area of practice/group of physicians. Each province/territory is responsible for and has in place particular processes and procedures to review physician billings.
Billing audits can be stressful events that, regardless of the audit outcome, have had adverse effects on a physician’s health and practice. Although changes over the years in billing audit practices have occurred, they have not addressed all of the physicians’ concerns. Inadequacies in the existing procedures, such as the lack of a clear decision-making process, established review timelines and options for recourse still remain.
In response to this situation, many provinces/territories are reviewing and modifying their existing billing audit process. The CMA and Canada’s physicians believe in an open, accountable and transparent health care financing system. It is for this reason that the CMA has developed this set of principles related to the key components of the audit process to ensure it is fair, efficient, effective and serves the purpose it was originally intended – to ensure the accountability of public funds and to educate physicians on proper billing practices.
Education on proper billing practices:
The audit and review process must be undertaken as an educational exercise. In a fee based system, billing code use and interpretation are complex and can often lead to unintentional errors. If or when inconsistencies occur, the physician must be alerted and provided with the opportunity to explain his/her billing behaviour.
To assist in moving the audit and review process from under a cloud of perceived punishment to that of educational enlightenment, the repayment of any funds shall not commence until the audit and review process is complete and all appeal options have been exercised.
As part of this overall educational framework, it is recommended that all newly licensed physicians be offered an educational program on proper billing interpretations, procedures and practices, and of the audit process itself.
Fair, Transparent and Timely Process:
In order for the audit and review process to be perceived as fair, it must operate at arms length from governments and the Colleges. As a profession, physicians have been granted the privilege of self-regulation by society. Given that medicine is a highly complex art and science, physicians are the only group truly qualified to set and maintain standards and to uphold accountability in matters of professional behaviour.
The billing audit and review process must observe the principles of “Natural Justice” in that the:
audit findings must be both impartial and be seen to be impartial and
physicians affected by the findings must be offered a fair hearing by being given notice in writing of the findings; the opportunity to respond to the findings; all of the information to prepare a response; sufficient time to prepare a response; and an oral hearing if there is a dispute on factual matters or if requested by the physician.
Physicians should be informed that legal counsel and assistance can be retained at any stage of the audit and review process. Physicians should consult with their respective provincial/territorial division or the Canadian Medical Protective Association (CMPA) to see whether such assistance is available, or with lawyers who specialize in this field.
Specific time limits should be adhered to in the auditing and reviewing of a physician’s billings practice, particularly related to when the review period should commence and to the duration of the review period. For example, billings should not be reviewable more than 24 months after the service is rendered and the review period should not be greater than 12 months. These limitation periods recognize that physicians will not be able to recall, with certainty, the vast amount of information contained in a patient’s medical record over the past 10 years – the average length of time in which medical records must be held. It also ensures that audits and reviews are conducted in a timely fashion minimizing undue stress and hardship on the physician and, in light of the health human resources shortage, enabling them to re-focus their attention and energy on taking care of their patients.
Audits and reviews to determine whether there has been any incorrect or inaccurate billing should be undertaken solely by a physician’s peers, and where possible, consisting of physicians from the same specialty and subspecialty and with similar practice type, geography and demography. This peer review group shall consider age-gender distribution and the morbidity of the patients as well as other pertinent matters in arriving at its findings and conclusions.
Any conclusions and/or findings from an audit and review must be prepared in a written report and forwarded, in a timely manner, to the physician and the paying agency. If either party is not satisfied with the findings, they have the option of launching an appeal.
The preferred route would be to pursue and use Alternative Dispute Resolution processes since they tend to encourage a more co-operative climate resulting in fair and appropriate settlements, while avoiding the excessive financial, psychological and procedural costs that can be associated with formal court proceedings.
These guiding principles are the product of an international, provincial and territorial scan of billing audit practices. They have undergone extensive consultation with the provincial/territorial medical associations and national medical organizations.
They should be used to form the foundation of and to guide any reviews or modifications to existing provincial/territorial audit and review processes.
CMA Policy, Medical Professionalism, 2002.
Student Behaviour Guide_Natural.Justice.htm, Dec. 2002
Obesity and Cardiovascular Disease (Update 2004) (Applicable to Canadians aged 20-60 years)
Obesity is a chronic condition that is multi-factorial in origin, complex to treat, and is a major contributor to heart disease, type II diabetes, hypertension, stroke and some cancers. Due to the magnitude of the impact that obesity has on heart disease and stroke, and to the clustering of risk factors for cardiovascular disease that are often found in the obese patient, obesity is recognized as a major risk factor for cardiovascular disease.
The impact of obesity points to the importance of prevention through healthy behaviours including increased physical activity and a healthy nutritional diet beginning early in life, and continuing through all stages of life. Solutions require comprehensive approaches that are both education and environment based, and that target and assist individuals, the family, and communities to engage in healthy lifestyle patterns and behaviours. Solutions also require ongoing research to develop and evaluate comprehensive approaches to obesity prevention, management and treatment, and surveillance data that measures and tracks obesity and its impact in Canada.
The World Health Organization defines obesity as a condition of excessive body fat accumulation to an extent that health may be compromised.
Body Mass Index (BMI) is a widely accepted parameter used to distinguish between obese and non-obese adults aged 20 to 60 years and thus provides information about the subsequent risk of cardiovascular disease.
BMI is calculated by dividing the weight (in kilograms) by the square of the height (in metres).
BMI = weight (in kilograms)
height (in metres) * height (in metres)
A BMI equal to or greater than 30 kg/m2 is classified as obese, while a BMI in the range of 25 to 29.9 kg/m2 is classified as overweight.
Waist circumference (WC) provides an independent prediction of health risks over and above BMI. Increased waist (abdominal) circumference is associated with increased risk of cardiovascular disease, dyslipidemia, type II diabetes and hypertension. As waist circumference increases above 102 cm for men and 88 cm for women, the risks of health-related illnesses increase.
Populations at Increased Risk
Obese individuals with diabetes, hypertension, or dyslipidemias or who are physically inactive are at increased risk of cardiovascular disease, compared to individuals without these conditions.
A BMI between 25 and 29.9 kg/m2 (overweight) is associated with elevated risk of cardiovascular disease, type 2 diabetes, hypertension and dyslipidemia.
Weight gain during young adult life may be one of the most important determinants of future development of cardiovascular risk factors and cardiovascular disease. Adults who gain weight have increased risk of coronary heart disease compared to those with stable weight. Weight gain during adult life may contribute to future development of ischemic heart disease regardless of initial body weight (obese or non-obese).
Canadians of Aboriginal, Chinese, and South Asian (from India, Pakistan, Bangladesh, and Sri Lanka) descent have higher rates of obesity-related chronic diseases (for example diabetes, hypertension and cardiovascular disease).
Individuals with lower socio-economic status have higher rates of obesity than those with higher socio-economic status.
Promotion of Healthy Weights
In April 2002, the Public Health Approaches to the Prevention of Obesity (PHAPO) Working Group of the International Obesity Task Force (IOTF) identified that a comprehensive approach to obesity prevention should:
Address both dietary habits and physical activity patterns of the population
Address both societal and individual level factors
Address both immediate and distant causes
Have multiple focal points and levels of intervention (i.e. at national, regional, community and individual levels);
Include both policies and programs; and
Build links between sectors that may otherwise be viewed as independent.
Research is needed to:
Develop a standard definition and a standard measurement technique for determining obesity in children.
Develop obesity measures for older, ethnic and gender specific populations.
Identify and develop effective primary prevention methods for individuals, families and communities to reduce the prevalence of obesity in all stages of life.
Improve awareness and knowledge about the health effects of obesity and healthy living.
Develop effective primary prevention measures and strategies that are therapeutic, secondary and tertiary in nature.
Identify and track rates of obesity and overweight in Canada.
Assess the effectiveness of obesity prevention and treatment initiatives.
Identify and implement the most effective primary prevention strategies for ethnic populations.
Develop and implement effective healthy public policy for the prevention, treatment, and management of obesity.
Further, the surveillance of obese and overweight Canadians is necessary in order to assess the effectiveness of prevention and treatment initiatives. It is only through the combined action and resources of governments, non-governmental organizations, non-profit and private sectors to develop and implement a comprehensive approach to curb the growing trend of obesity in Canada.
Principles For Providing Information About Prescription Drugs To Consumers
Approved by the CMA Board of Directors, March 2003
Since the late 1990's expenditures on direct to consumer advertising (DTCA) of prescription drugs in the United States have increased many-fold. Though U.S.-style DTCA is not legal in Canada1, it reaches Canadians through cross-border transmission of print and broadcast media, and through the Internet. It is believed to have affected drug sales and patient behaviour in Canada. Other therapeutic products, such as vaccines and diagnostic tests, are also being marketed directly to the public.
Proponents of DTCA argue that they are providing consumers with much-needed information on drugs and the conditions they treat. Others argue that the underlying intent of such advertising is to increase revenue or market share, and that it therefore cannot be interpreted as unbiased information.
The CMA believes that consumers have a right to accurate information on prescription medications and other therapeutic interventions, to enable them to make informed decisions about their own health. This information is especially necessary as more and more Canadians live with chronic conditions, and as we anticipate the availability of new products that may accompany the "biological revolution", e.g. gene therapies.
The CMA recommends a review of current mechanisms, including mass media communications, for providing this information to the public. CMA believes that consumer information on prescription drugs should be provided according to the following principles. 2
Principle #1: The Goal is Good Health
The ultimate measure of the effectiveness of consumer drug information should be its impact on the health and well-being of Canadians and the quality of health care.
Principle #2: Ready Access
Canadians should have ready access to credible, high-quality information about prescription drugs. The primary purpose of this information should be education; sales of drugs must not be a concern to the originator.
Principle #3: Patient Involvement
Consumer drug information should help Canadians make informed decisions regarding management of their health, and facilitate informed discussion with their physicians and other health professionals. CMA encourages Canadians to become educated about their own health and health care, and to appraise health information critically.
Principle #4: Evidence-Based Content
Consumer drug information should be evidence based, using generally accepted prescribing guidelines as a source where available.
Principle #5: Appropriate Information
Consumer drug information should be based as much as possible on drug classes and use of generic names; if discussing brand-name drugs the discussion should not be limited to a single specific brand, and brand names should always be preceded by generic names. It should provide information on the following:
* indications for use of the drug
* side effects
* relative cost.
In addition, consumer drug information should discuss the drug in the context of overall management of the condition for which it is indicated (for example, information about other therapies, lifestyle management and coping strategies).
Principle #6: Objectivity of Information Sources
Consumer drug information should be provided in such a way as to minimize the impact of vested commercial interests on the information content. Possible sources include health care providers, or independent research agencies. Pharmaceutical manufacturers and patient or consumer groups can be valuable partners in this process but must not be the sole providers of information. Federal and provincial/territorial governments should provide appropriate sustaining support for the development and maintenance of up-to-date consumer drug information.
Principle #7: Endorsement/ Accreditation
Consumer drug information should be endorsed or accredited by a reputable and unbiased body. Information that is provided to the public through mass media channels should be pre-cleared by an independent board.
Principle #8: Monitoring and Revision
Consumer drug information should be continually monitored to ensure that it correctly reflects current evidence, and updated when research findings dictate.
Principle #9: Physicians as Partners
Consumer drug information should support and encourage open patient-physician communication, so that the resulting plan of care, including drug therapy, is mutually satisfactory.
Physicians play a vital role in working with patients and other health-care providers to achieve optimal drug therapy, not only through writing prescriptions but through discussing proposed drugs and their use in the context of the overall management of the patient's condition. In addition, physicians and other health care providers, and their associations, can play a valuable part in disseminating drug and other health information to the public.
Principle #10: Research and Evaluation
Ongoing research should be conducted into the impact of drug information and DTCA on the health care system, with particular emphasis on its effect on appropriateness of prescribing, and on health outcomes.
1 DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, "information-seeking" advertisements for prescription drugs, which may provide the name of the drug without mentioning its indications, or announce that treatments are available for specific indications without mentioning drugs by name, have appeared in Canadian mass media.
2 Though the paper applies primarily to prescription drug information, its principles are also applicable to health information in general.