Safety and Ethics
2.3 Legal Foundations and National Guidelines
There are many federal and provincial laws, as well as national guidelines, that have been established to protect public health and safety. This section will explain how Health Canada and provincial/territorial nursing governing bodies protect the public from medication harm.
Health Canada Health Products and Food Branch
To protect the public, the Health Products and Food Branch (HPFB) of Health Canada is responsible for regulating, evaluating and monitoring the safety, efficacy, and quality of therapeutic and diagnostic products available to Canadians. These products include drugs, medical devices, disinfectants and sanitizers with disinfectant claims. [1] Some of the ways that the HPFB protects the public health regarding medications include: enforcing an official drug approval process based on evidence-based research; issuing safety warnings for medications with serious adverse reactions; and regulating over-the-counter (OTC) medications. Each of these actions is further explained below.
Developing New Drugs
Canadian consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. Drug companies conduct extensive research and work to develop and test a drug and follow the Development and Approval Process of Drugs by Health Canada.
Health Canada Approval: What it Means
Health Canada approval of a drug means that data on the drug’s effects have been reviewed by the HPFB, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.
The HPFB reviews all new drug submissions and all the information about the drug captured during the development process (quality, preclinical and clinical) and evaluates the risks of the drug versus its benefits to the Canadian population. More specifically, HPFB reviews information regarding the drug’s manufacturing, packaging and labelling, as well as information about the drug’s therapeutic claims and side effects. What doctors and clients will be told about the drug will also be reviewed, through the drug’s monographs and information sheets. All drugs allowed to be sold in Canada are reviewed to ensure that they meet the requirements of the Food and Drugs Act and its Regulations.[2] Once these requirements are met, the drug developer/sponsor receives a Notice of Compliance, confirming the dossier’s compliance with the Food and Drugs Act and its Regulations.
Safety Warnings
The HPFB posts a database of safety alerts, public health advisories, press releases and other notices related to therapeutic health products. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada.[3] In the United States, if a safety problem surfaces, Black Box Warnings are issued by the FDA and appear on a prescription drug’s label. The purpose is to call attention to serious or life-threatening risks.
Levofloxacin is an antibiotic that received FDA approval (the US equivalent of HFPB). However, after the drug was on the market, it was discovered that some clients who took levofloxacin developed serious, irreversible adverse effects such as tendon rupture. The FDA issued a Black Box Warning with recommendations to reserve levofloxacin for use in clients who have no alternative treatment options for certain indications: uncomplicated UTI, acute exacerbation of chronic bronchitis, and acute bacterial sinusitis.
A nurse is preparing to administer medications to a client and notices that levofloxacin has been prescribed for the indication of pneumonia. There is no other documentation in the provider’s notes related to the use of this medication.
What is the nurse’s best response?
Note: Answers to these activities can be found in the “Answer Key” sections at the end of the book.
Drug Schedules Regulation
Because controlled substances have a greater chance of being misused, there are additional laws and procedures that must be followed when working with these medications. The federal government administers some regulations regarding controlled substances. Most controlled substance regulations, however, come from the provincial governments through the provincial Drug Schedules Regulation under the Pharmacy Operations and Drug Scheduling Act (PODSA). Nurses also have the authority to administer, dispense, and compound certain medications under the Nurses (Licensed Practical) Regulation, the Nurses (Registered) and Nurse Practitioners Regulation, and the Nurses (Registered Psychiatric) Regulation. It is important that nurses are aware of their standards of practice and regulations related to their licensing and regulation.[4]
Scheduled Medications
The Drug Schedules Regulation under the Pharmacy Operations and Drug Scheduling Act places all substances that are regulated under existing federal law into one of five schedules. Scheduled medications are based on a substance’s medical use, the potential for misuse, and safety or dependence liability.
| Schedule | Definition | Examples |
|---|---|---|
| Schedule I (Prescription) | Schedule I drugs require a prescription for sale and are provided to the public by a pharmacist following the diagnosis and professional intervention of a practitioner. The sale is controlled in a regulated environment as defined by provincial pharmacy legislation. | Most medications
Atenolol Ciprofloxacin Enoxaparin Tylenol #3 (Codeine + Acetaminophen) |
| Schedule IA (Triplicate/Duplicate Prescription Program) | Drugs which may be sold by a pharmacist to a practitioner or on the prescription of a practitioner in accordance with Bylaw 5 (31) (6) of the bylaws to the Pharmacists, Pharmacy Operations and Drug Scheduling Act.
This bylaw aims to reduce inappropriate prescribing of selected controlled drugs and to prevent forgeries. Prescriptions for the controlled drugs specified in the program must be written on the duplicate prescription pad specially developed for this purpose. |
Fentanyl
Morphine Oxycodone Hydromorphone |
| Schedule II (Professional Service Area) | Drugs which may be sold by a pharmacist on a non-prescription basis and which must be retained within the Professional Service Area of the pharmacy where there is no public access and no opportunity for clients self-selection. | Diclofenac (when sold as single ingredient)
Dimenhydrinate (Gravol) |
| Schedule III (Professional Products Area) | Drugs which may be sold by a pharmacist to any person from the self-selection Professional Products Area of a licensed pharmacy. | Acetaminophen > 650mg
Hydrocortisone < 1% Lactulose |
| Schedule IV (Prescription by Pharmacist) | Drugs which may be prescribed by a pharmacist in accordance with guidelines approved by the Council. | Emergency contraceptives (Norgestrel, Progestin) |
| Unscheduled (Non-pharmacy Sale) | Drugs which may be sold by a non-pharmacist to any person. | Acetaminophen < 650mg, in pack sizes less than 50 units
TUMS |
Many problems associated with drug misuse are the result of legitimately made controlled substances being diverted from their lawful purpose into illicit drug traffic.
Drug Diversion
Drug diversion involves the transfer of any legally prescribed controlled substance from the individual for whom it was prescribed to another person for any illicit use. The most common drugs diverted from the health care facility setting are opioids. Tampering is the riskiest and most harmful type of diversion.
In some cases, drug diversion can occur by health care providers. Substance misuse by nurses is often unidentified, unreported, and untreated; nurses may continue to practice where their impairment may endanger the lives of their clients. BCCNM has established a professional and ethical responsibility to report a colleague’s suspected drug use. For more information about drug diversion in nurses visit BCCNM Duty to report: Narcotic diversion and substance abuse impairing practice.
Prescription Monitoring Programs (PMP)
In addition to drug diversion programs, prescription monitoring programs (PMP) have been established in several provinces to address prescription drug misuse, addiction, and diversion[5]. A PMP “collects information about prescription and dispensing of controlled substances for the purposes of monitoring, analysis and education. In Canada, it is the responsibility of the provincial institutions to organize, maintain and run such programs”. [6] By providing valuable information about controlled substance prescriptions that are dispensed in the province, it aids healthcare professionals in their prescribing and dispensing decisions. The PMP also fosters the ability of pharmacies, healthcare professionals, law enforcement agencies, and public health officials to work together to reduce the misuse and diversion of prescribed controlled substance medications.
Proper Drug Disposal
Health Canada Guidelines allow users to dispose of controlled substances in a safe and effective manner. A Johns Hopkins study on sharing of medication found that 60% of people had leftover opioids they hung on to for future use; 20% shared their medications; 8% would likely share with a friend; 14% would likely share with a relative; and only 10% securely locked their medication.[7] Health Canada also has a Take Back Program in all provinces and territories that allows anyone to return unused medication at any time (see figure 2.3). Additionally, needle disposal bins (yellow bins) are given through pharmacies for people on injectable medications.
A nurse is providing discharge education to a client who recently had surgery and has been prescribed hydrocodone/acetaminophen tablets to take every four hours as needed at home. The nurse explains that when the post-op pain subsides and the medication is no longer needed, it should be dropped off at a local pharmacy for disposal in a collection receptacle. The client states, “I don’t like to throw anything away. I usually keep unused medication in case another family member needs it.”
- What is the nurse’s best response?
A nurse begins a new job on a medical-surgical unit. One of the charge nurses on this unit is highly regarded by her colleagues and appears to provide excellent care to her clients. The new nurse cares for a client that the charge nurse cared for on the previous shift. The new nurse asks the client about the effectiveness of the pain medication documented as provided by the charge nurse during the previous shift. The client states, “I didn’t receive any pain medication during the last shift.” The nurse mentions this incident to a preceptor who states, “I have noticed the same types of incidents have occurred with previous clients but didn’t want to say anything.”
2. What is the new nurse’s best response?
Note: Answers to these activities can be found in the “Answer Key” sections at the end of the book.
Attributions
- “Clinical Reasoning and Decision-Making Activity 2.3a” was adapted from Daily Med by U.S. National Library of Medicine, which is the public domain.
- Health Canada. (2015). How Drugs are Reviewed in Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugs-reviewed-canada.html ↵
- SPharm-Inc. (2019). The Drug Review and Approval Process in Canada. https://spharm-inc.com/wp-content/uploads/2019/02/drug-regulatory-and-approval-process-in-canada_infographic.pdf ↵
- HPFB. (2020). Advisories, Warnings and Recalls – Drugs and health products. https://www.canada.ca/en/health-canada/services/drugs-health-products/advisories-warnings-recalls.html ↵
- BCCNM. (2020). Practice standard for all BCCNM nurses: Medication. https://www.bccnm.ca/RN/PracticeStandards/Lists/GeneralResources/RN_PS_Medication.pdf ↵
- Canadian Center on Substance Abuse. (2015). Prescription Monitoring Programs in Canada: Best Practice and Program Review. https://campusmentalhealth.ca/wp-content/uploads/2018/03/CCSA-Prescription-Monitoring-Programs-in-Canada-Report-2015-en1.pdf ↵
- Furlan, A. D., MacDougall, P., Pellerin, D., Shaw, K., Spitzig, D., Wilson, G., & Wright, J. (2014). Overview of four prescription monitoring/review programs in Canada. Pain research & management, 19(2), 102–106. https://doi.org/10.1155/2014/634171 ↵
- U.S. Department of Justice - Drug Enforcement Administration. (2017, December 13). Federal regulations and the disposal of controlled substances. https://www.deadiversion.usdoj.gov/mtgs/drug_chemical/2017/wingert.pdf#search=drug%20disposal ↵
The strongest warnings issued by the Federal Drug Association (FDA) that signify a drug carries a significant risk of serious or life-threatening adverse effects.
classification tool for drugs, substances, and certain chemicals that are used to make drugs. Defined by medical use, potential for misuse, and safety or dependence liability.
The transfer of any legally prescribed controlled substance from the individual for whom it was prescribed to another person for any illicit use.
Collects information about prescription and dispensing of controlled substances for the purposes of monitoring, analysis and education
The science of preparation of drugs.