(inventarios)

consequences.

Health Canada issues warnings and advisories in the form of press releases, Web site announcements (http:// www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/ index-eng.php), or letters to health professionals.

Priority Review Process

Health Canada has attempted to make lifesaving investi- gational drug therapies available to the population sooner by offering a Priority Review of Drug Submission pro- cess. This policy applies to New Drug Submissions (NDS) or Supplemental New Drug Submissions (S/NDS) and allows for earlier review of drug products for serious, life-threatening, or severely debilitating diseases or con- ditions (e.g., cancer, AIDS, Parkinson’s disease) for which there is no effective drug on the Canadian market.

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the case in the United States.) Advertisements in profes- sional health care journals contain claims and prescrib- ing information. Advertising Standards Canada (ASC) and the Pharmaceutical Advertising Advisory Board (PAAB) review and clear advertisements according to standards set by the Food and Drugs Act. Although the clearance procedure is voluntary, most companies com- ply with the regulations.

E T H I C A L N U R S I N G P R A C T I C E

Ethical nursing practice is based on basic ethical prin- ciples such as beneficence, autonomy, justice, veracity, and confidentiality (see Legal and Ethical Principles: Common Legal and Ethics-Related Terms). The Canadian Nurses Association (CNA) Code of Ethics for Registered Nurses (2008) should be a familiar framework of practice to all nurses and serve as an ethical guideline for nursing care. It is a statement of the ethical values of nurses and of nurses’ commitments to persons with health care needs and persons receiving care. The Code of Ethics is intended Generic drug (and all nonpatented drugs) prices are not

regulated by the PMPRB but are determined provincially. For example, in Ontario, the Ontario Drug Benefit Act and the Ontario Drug Interchangeability and Dispens- ing Fee Act allow the Ontario government to establish generic drug prices for the drugs that it will reimburse. Basically there is a “70/90” rule: a new generic drug is priced at no higher than 70% of the price of the brand name; succeeding generic drugs are priced no higher than 90% of the price of the initial generic drug. Generic and existing or revised drugs do not have to go through the Common Drug Review to receive a listing recom- mendation as new drugs do, but requests are submitted directly to the drug plans.

Drug Advertising in Canada

Drug advertising in Canada is regulated by Health Can- ada. Direct-to-consumer advertising (such as ads in con- sumer magazines and on subways) is restricted to simply giving the names of prescription drugs, but these ads do not make claims for product effectiveness. (This is not

Patient Access to and Costs of Prescription Drugs The twenty-first century in Canada has seen rapid growth in prescription drug use and costs. In 2004, prescription drugs for Canadians cost $562 per capita (not including drugs provided in hospital). Almost half of this cost (approxi- mately $268) was paid directly out of patients’ pockets. Pre- scription drug costs are increasing at 9% annually. In 2006, Canadian pharmacists filled 400 million retail prescriptions. According to the Canadian Institute for Health Information, costs of prescription-only medicines accounted for $25 bil- lion in 2006. The increased costs are attributed not only to the increase in numbers of prescriptions, some of which can be attributed to Canada’s aging population, but also to more costly drugs. Costs of prescription drugs are deter- mined by ingredient costs (manufacturer cost), pharmacy retail mark-up, and the dispensing fee. Dispensing fees are the additional fee pharmacists charge for dispensing pre- scription drugs to patients. Such costs can vary from $2 to over $10, depending on the pharmacy.

Prescription drugs are not covered under the Canada Health Act. Patients must pay for a drug unless the drug is covered by a private drug plan or a federal, provincial, or territorial (F/P/T) drug plan. Most provincial plans provide for the costs of drugs to the poor, the older adult, those with catastrophic drug costs, and those with certain con- ditions (e.g., cancer, HIV/AIDS). The federal government provides coverage for Aboriginal peoples. Each Canadian province and territory has a formulary committee that decides which drugs are listed on a provincial formulary and reimbursed by the drug benefit health plan, which have restricted access, and which are not covered. There is a wide variety of access to prescription drugs across the country: provincial and territorial drug plans vary in eligibility criteria, drugs covered, and financing. Provinces base the decision to list a drug on a variety of factors such

as effectiveness analyses, cost, government priorities, and patient advocacy. Some drugs may be restricted if they require special monitoring or if the cost is high.

Because of discrepancies in drug coverage among F/P/T drug plans, the Common Drug Review Directorate was established in 2002 at the Canadian Coordinating Office for Health Technology Assessment. An independ- ent advisory body, the Canadian Expert Drug Advisory Committee (CEDAC), has members from all jurisdictions except Quebec. CEDAC makes evidence-informed recom- mendations regarding the listing of drugs to the F/P/T formularies. This process is intended to provide equal access to all drugs, reduce duplication between formu- laries, and streamline the review process for new drugs. However, the drug plans make the decision on which drugs will make the final formulary listing.

In 2002, Roy Romanow, the head of the Romanow Commission, presented a report, Building on Values: The

Future of Health Care in Canada, which recommended

extensive changes to protect the long-term sustainability of the Canadian health care system. One recommenda- tion was to establish a national pharmacare program. One aspect of the national program would be the Catastrophic Drug Transfer Program (CDTP), under which the federal government would assist the provinces to cover those who have extremely high drug costs. In addition, a national for- mulary administered by a National Drug Agency would be formed in an effort to control costs and to evaluate safety and cost-effectiveness of all new and existing prescrip- tion drugs. Romanow also recommended a review of the Canadian patent legislation regarding new prescription drugs and better access to generic drugs. A full discussion of the report is available at http://www.hc-sc.gc.ca/hcs-sss/ hhr-rhs/strateg/romanow-eng.php.

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E T H N O C U L T U R A L C O N S I D E R A T I O N S

Because the health care system overall emphasizes cure, prescribed drugs tend to be a major part of a patient’s therapeutic regimen. The Canadian health care system often advocates a “one-size-fits-all” treatment approach. However, Canada is an ethnoculturally diverse nation, thus a more multicultural, holistic approach to alterations in health status could help in meeting the needs of such a diverse patient population. According to the 2006 Canada Census, the Canadian population was 31,612,897 (as of August 2009, the population was 33,716,731); of this total, 16.2% were members of a visible minority (Statistics Can- ada, 2006). Canada’s minority population is ethnocultur- ally diverse, with some groups being more so than others. Population growth among Canada’s visible minority was five times the rate of growth of the total population between 2001 and 2006. The three largest self-identified visible minorities, accounting for approximately two- thirds of the visible minority population, are South Asian (e.g., East Indian, Pakistani, Sri Lankan), Chinese, and Black. These groups are followed in population size by Filipino, Latin American, and Southeast Asian (Vietnam- ese, Cambodian, Malaysian, Laotian). Aboriginal people account for 3.8% of Canada’s total population. It is esti- mated that by 2017, one in every five Canadian residents will be a member of a visible minority.

The new and expanding field of ethnopharmacology (the study of the health beliefs and practices of differ- ent ethnocultures) holds much promise for understand- ing the specific impact of ethnicity on drug effects and responses. It is hampered, however, by the lack of clarity in terms such as race, ethnicity, and ethnoculture. Although some researchers have used the term Hispanic to encom- pass groups as diverse as Puerto Ricans, Mexicans, and Peruvians, other researchers have used it to denote a specific racial group. This lack of clarity in terminology and lack of consistency in the use of terms in research raises questions about the validity of the data collected. One thing is certain, however: it is impossible to know a patient’s genotype simply by looking at the patient or at the patient’s health care history and documentation. for nurses in all contexts and domains of nursing practice

and at all levels of decision making. Developed by nurses for nurses, it can assist nurses in practising ethically and working through ethical challenges that arise in their practice with individuals, families, communities, and public health systems.

These ethical principles and codes of ethics ensure that the nurse is acting on behalf of the patient and with the patient’s best interests at heart. As a professional, the nurse has the responsibility to provide safe nurs- ing care to patients regardless of the setting, person, group, community, or family involved. Although it is not within the nurse’s realm of ethical and professional responsibility to impose his or her values or standards on the patient, it is within the nurse’s realm to provide information and to assist the patient in facing decisions regarding health care.

The nurse also has the right to refuse to participate in any treatment or aspect of a patient’s care that violates the nurse’s personal ethical principles. However, this should be done without deserting the patient, and in some facili- ties the nurse may be transferred to another patient care assignment only if the transfer is approved by the nurse manager or nurse supervisor. The nurse must always remember, however, that the Code of Ethics and profes- sional responsibility and accountability require the nurse to provide nonjudgemental nursing care from the start of the patient’s treatment until the time of the patient’s discharge. If transferring to a different assignment is not an option because of institutional policy and because of the increase in the acuteness of patients’ conditions and the high patient-to-nurse workload, then the nurse must always act in the best interest of the patient while remaining an objective patient advocate.

It is always the nurse’s responsibility to provide the highest quality nursing care and practice within the professional standards of care. The CNA Code of Ethics, the ICN Code of Ethics for Nurses, standards of nursing practice, federal and provincial codes, ethical principles, and the previously mentioned legal principles are read- ily accessible and provide nurses with a sound, rational framework for professional nursing practice.

Common Legal and Ethics-Related Terms

Autonomy: Self-determination and ability to act on one’s own; implications include promoting a patient’s deci- sion-making process, supporting informed consent, and assisting in decisions or making a decision when a patient poses harm to himself or herself.

Beneficence: The doing or active promotion of good; implications include determining how the patient can best be served.

Confidentiality: The duty to respect privileged informa- tion about a patient; implications include not talking about a patient in public or outside the context of the health care setting.

Justice: Being fair or equal in one’s actions; implications include the fair distribution of resources for the care of the patient and determination of when to treat.

Nonmaleficence: The duty to do no harm to a patient; implications include avoiding doing any deliberate harm while rendering nursing care.

Veracity: Duty to tell the truth; implications include tell- ing the truth with regard to placebos, investigational new drugs, and informed consent.

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must also be aware that some patients use alternative therapies, such as herbal and homeopathic remedies, that can inhibit or accelerate drug metabolism and therefore alter a drug’s response.

In reference to specific drug therapy and a patient’s response, the important concept of polymorphism is critical to understanding how the same drug can result in differ- ent responses in different individuals. Drug polymorph- ism refers to the effect of a patient’s age, sex, size, body composition, and other characteristics on the pharmaco- kinetics of specific drugs. For example, why does a Chi- nese patient require lower doses of an anti-anxiety drug than a White patient? Why do Black patients respond differently to antihypertensives than do White patients? Factors contributing to drug polymorphism may be loosely categorized into environmental factors (e.g., diet and nutritional status), ethnocultural factors, and genetic (inherited) factors. For example, a diet high in fat has been documented to increase the absorption of the agent griseofulvin (an antifungal agent). Malnutrition with defi- ciencies in protein, vitamins, and minerals may modify the functioning of metabolic enzymes, which may alter the body’s ability to absorb or eliminate a medication. The ever-changing national demographics require the

nurse to be ethnoculturally competent while administering holistic and individualized nursing care involving both nonpharmacological and pharmacological therapies. To ensure this competence, the nurse must be up to date in basic knowledge of the nursing process and in the art and science of professional nursing practice. Acknow- ledgement and acceptance of the influences of a patient’s ethnocultural beliefs, values, and customs is necessary to promote optimal health and wellness. Some related terms and examples of ethnocultural influences are presented below in Ethnocultural Implications: Ethnocultural Terms Related to Nursing Practice, and Ethnocultural Implica- tions: Common Practices of Select Ethnocultural Groups.

Influence of Ethnicity and Genetics

Medication response depends greatly on the level of the patient’s adherence to the therapy regimen. Given mul- tiple ethnocultural factors, adherence may vary accord- ing to the patient’s ethnocultural beliefs, experiences with medications, personal expectations, family expecta- tions, family influence, and level of education. Adher- ence is not the only issue, however. Health care providers

Ethnocultural Terms Related to Nursing Practice Ethnicity: Ethnic affiliation based on shared ethnoculture, genetic heritage, or both.

Ethnoculture: An integrated system of beliefs, values, and customs that are associated with an ethnically dis- tinct group of people and are generally handed down from generation to generation.

Ethnocultural competence: The ability to work with patients with proper consideration for the ethnocultural context, which includes patients’ belief systems and val- ues regarding health, wellness, and illness. It also involves learning about patients of distinct ethnicity and their specific responses to treatment, including drug therapies.

Ethnopharmacology: The study of the effect of ethnicity on drug responses, specifically drug absorption, metab- olism, distribution, and excretion (i.e., pharmacokinetics; see Chapter 2) as well as the study of genetic variations to drugs (i.e., pharmacogenetics).

Race: Often defined as a class of individuals with a com- mon lineage. In genetics, a race is considered to be a population having a somewhat different genetic compos- ition or gene frequencies. Race is also used to refer to geographic origins of ancestry.

Common Practices of Select Ethnocultural Groups

Ethnoculture Common Practices

African Practise folk medicine; employ “root workers” as healers Asian Believe in traditional medicine

Hispanic View health as a result of good luck and living right, and illness as a result of doing a bad deed; use heat and cold as remedies

European Hold traditional health beliefs; some still practise folk medicine Aboriginal Believe in harmony with nature; view ill spirits as causing disease

Filipino Believe in and practise traditional and Western medicine; illness results from an imbalance in the body South Asian Believe dietary imbalance is a source of illness

Western Show increased participation in health care; demand more explanation about diseases and treatment, as well as the prevention of diseases

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individual and whether the forces are balanced; balance produces healthy states. Yin represents the female and the negative energies of darkness and cold; yang represents the male and the positive energies of light and warmth. Beliefs in yin and yang must be respected by all who participate in the care of Chinese patients. Other common health practices of Asians include acupuncture, use of herbal remedies, and use of heat. All such beliefs and practices need to be con- sidered—especially when the patient values their use more highly than the use of medications. Many of these beliefs are strongly grounded in religion. The Asian and Pacific Islander racial–ethnic group also includes Thais, Vietnam- ese, Filipinos, Koreans, and Japanese, among others.

Some Aboriginals believe in preserving harmony with nature or keeping a balance between the body and mind and the environment to maintain health. Ill spirits are seen as the cause of disease. The traditional healer for this ethnoculture is the medicine man, and treatments vary from massage and application of heat to acts of purification. “Smudging” is a common ceremony used to cleanse the body spiritually and physically. An herb such as sage or sweetgrass is burned and the smoke is rubbed or brushed over the body.

Some South Asian individuals follow a variety of traditional health practices. Illness is seen as an imbal- ance in the body humours, bile, wind, and phlegm, and treatment is seen to restore these imbalances. Treatment may consist of home remedies, dietary regimens, pray- ers, rituals, and consultation with hakims, veds, babajis, pundits, homeopaths, and jyotshis.

Some Hispanic individuals view health as a result of good luck and living right and illness as a result of bad luck or committing a bad deed. To restore health, these individuals seek out a balance between the body and mind through use of cold remedies or foods for “hot” illnesses (of blood or yellow bile) and hot remedies for “cold” illnesses (of phlegm or black bile). Hispanics may use a variety of religious rituals for healing (e.g., lighting of candles), which may also be practised by adherents of other religions and belief systems.

It is important to remember that these beliefs vary from patient to patient. Therefore, the nurse should As indicated above, genetic factors also influence how

different racial or ethnic groups respond to drugs. Some European and African patients are slow acetylators and metabolize drugs at a slower rate, which results in ele- vated drug level concentrations. Some Japanese and Inuit patients are more rapid acetylators and metabolize drugs more quickly, which leads to decreased drug concentra- tions. The Chinese, Japanese, Malaysians, and Thais are poor metabolizers of debrisoquine; therefore, drugs such as codeine are likely to be more effective at lower dosages in these individuals than in a European person. Several major drug classifications are relatively well researched with regard to differential responses in different ethno- cultural groups; these are outlined in Table 4-2.

Individuals throughout the world share many com- mon views and beliefs regarding health practices and medication use. However, specific ethnocultural influ- ences, beliefs, and practices related to medication admin- istration do exist. Awareness of ethnocultural differences