Role of the Nurse in Drug Therapy

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Role of the Nurse in Drug Therapy

• Deb Fraser Askin

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What is a drug

• According to Health Canada, a drug is
• Any substance manufactured, sold or represented
  for use in
• Diagnosis, treatment or prevention of a disease,
  disorder or abnormal physical state or its
  symptoms
• Restoring, correcting or modifying organic
  function
• Disinfection in premises where food is made

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So, what is a drug

• Over-the-counter stuff
• Herbs
• Samples
• Cosmetics anything sold for use in cleaning
  improving or altering the complexion, skin, hair
  or teeth

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Why do drugs need to be regulated?

• Protection of the public
• Case Study 15-yr-old Vanessa Young
• Bulimia sufferer
• Prescribed Prepulsid after 3 mo., Vanessa had
  cardiac arrest
• Prepulsid linked to 80 deaths by March 2000
• Health Canada issued warning Feb 25, 2000
• American doctors warned 5 weeks prior

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How are drugs regulated?

• 1884- Adulteration Act
• First regulation of how drugs could be modified
• 1920 amendments in 1950- Food and Drug Act
• Control of manufacture and sale of all drugs
  except narcotics, also food, cosmetics and some
  medical devices
• http//www.hc-sc.gc.ca/

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How are narcotics regulated?

• 1908- Opium Act
• Cocaine and morphine added in 1911
• 1961- Narcotic Control Act
• Controls manufacture, distribution and sale of
  narcotics
• 1996- Controlled Drugs and Substances Act
• Replaced narcotic act
• Addresses regulation of all controlled drugs and
  substances

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Proposed Changes

• Health Canada now developing regulation to
  address natural products such as herbal
  preparations
• Health claims for food substances currently
  restricted.

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Drug Standards

• Canadian Formulary and British Pharmacopoeia set
  standards for drug strength, quality, purity,
  packaging, safety, labelling and dosage form

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Accepted standards

• Purity- how much other stuff (fillers, binders,
  preservatives) can be added to drugs
• Potency- concentration of active drug in a
  preparation
• Bioavailability- ability of drug to be released
  from its dosage form
• Safety

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How is the act enforced?

• Responsibility of Health Protection Branch
• Enforce drug legislation
• Receive applications for approval of new drugs
• Does an extensive investigation
• Assign DIN numbers
• Now the drug can be sold in Canada under limited
  release
• Once safety data available, released for general
  sale

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What is a DIN number

• DIN number indicates that the drug has been
  approved for sale in Canada
• Can be found on the drug label
• Applies to all substances which manufacturers
  want to market as a drug
• ie) herbs
• When something has a DIN number sales regulations
  apply ie) need a pharmacist on site

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Provincial regulations

• Responsible for medical, nursing and pharmacy
  acts
• Determine schedules which dictate which drugs are
  sold without prescription and which are held
  behind the counter
• Provincial Pharmacare program determines which
  drugs will be paid for

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NAPRA

• National Association of Pharmacy Regulatory
  Authorities
• Goal is to develop national consistency
• What drugs go on what schedules
• How are various prescriptive issues handled

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Institution Policies

• Must conform to national and provincial
  regulations
• For example around safe storage of narcotics,
  counting and control measures

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Provincial Acts

• Pharmacy Act
• Controls the licensing of pharmacists and
  pharmacies
• Currently dictate that med orders can only be
  accepted from doctors, dentists and vets
• Medical act
• Sets out that physicians are the only ones who
  can provide a medical diagnosis

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New Nurse Practice Act

• Contain provisions for nurses on a special roster
  to
• Order and receive diagnostic tests
• Prescribe medication
• Perform minor invasive procedures

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What is the next step for nurses?
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Drug Regulations and the Practicing Nurse

• Must know the drug regulations as they pertain to
  your practice
• Must know what is required in a medication order
• Must carry out safe and ethical practice with
  respect to drug administration

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Issues in Administration of Controlled Substances

• Narcotics are stored in a locked cabinet
• Keys are issued according to unit policy
• Drug counts are performed at change of shift
• Discrepancies are reported immediately
• Special records are required each time a narcotic
  is dispensed

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Special Access Programs

• Some drugs are released as investigational or
  under special circumstances
• Approval from Health Canada must be obtained to
  order these drugs
• ie) Synagis
• E coli vaccine under investigation was released
  for the people of Walkerton

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Adverse Drug Events

• What is an adverse reaction
• Undesirable effects from health products
• May occur immediately or years later
• Range from minor rashes to life-threatening
  events
• Manufacturers are required to pass on any
  information they obtain when bad things happen to
  people taking their drugs

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Adverse Drug Events

• Suspected reactions are voluntarily reported by
  patients, health care professionals
• National reporting coordinated by Health Canada

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Drug Advertising

• Why dont we see Viagra commercials on Canadian
  TV stations?
• Health Canada prohibits advertising to the
  general public of any food, drug, cosmetic or
  device for the treatment or cure of any diseases
  listed on schedule A

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Schedule A

• Alcoholism
• Alopecia
• Anxiety
• Arthritis
• Asthma
• Cancer
• Depression
• Diabetes

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Schedule A

• Disorders of menstrual flow
• Gout
• Heart disease
• Hypertension
• Obesity
• Sexual impotence
• Ulcers
• Tumors and on and on

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Purpose of banning advertising?

• Prevent fraud
• Prohibit advertising for cures where no cures
  exist
• Prohibit advertising of self-treatments when
  self-treatments arent safe
• Encourage people to seek medical attention

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Drug errors

• US study in 2002
• More than 40 potentially harmful drug errors each
  day in an average hospital
• Errors in one of five doses in a typical 300 bed
  hospital
• Most common- wrong time or missed doses
• 7 of errors were potentially harmful

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Drug Errors

• Most common causes
• Ignoring the 5 rights
• Drug
• Dose
• Person
• Time
• route

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Essential elements of a drug order

• Patient name and identifying numbers
• Wt- if a child
• Drug- careful about confusing names
• Ie morphine and meperidine
• Dose (and dose per kg if a child)
• Route
• Frequency

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Clear as mud
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Drug Errors

• Trailing zeros
• 5.0 mg
• .5mg
• Wandering decimal places- most common error in
  children and potentially most serious

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Look A-likes??
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More information

• ISMP- institute for safe medication practices
• www.ismp-canada.org