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1

What is a drug incident and what is an adverse drug event? vs drug error

Drug incident: any event that may cause or lead to inappropriate drug use or patient harm.

Adverse drug event: an unexpected and undesired incident that results in patient harm such as injury, adverse outcome or death.

Drug error: an adverse drug event or a drug incident where the drug has been released to the patient

2

privacy vs confidentiality

To comply with current privacy standards, you need to go beyond just protecting the
confidentiality of personal information you hold; you need to develop and participate in
an ongoing privacy program that addresses
• accountability,
• information flow,
• right of access, and
• security

3

2 types of health info

1. Diagnostic, treatment, and care information—this includes information about
• the physical and mental health of an individual;
• the treatment they are receiving or have received, including information about
health services providers involved in their care;
• organ/tissue donations;
• drugs prescribed;
• health care aids; or
• health care benefits.
2. Registration information—this includes
• demographic information (name, ID, personal health number (PHN), date of
birth, gender);
• location, residency, and how to contact;
• health service eligibility; and
• billing

4

6 Recommended Strategies to Improve Communication

1. Explain things clearly in plain language
- audience, writing (active voice), presentation (main message at top), visual clarity (heading, left just)
2. Focus on key messages and repeat
3. Use a “teach back” or “show me” technique to
check understanding
4. Effectively solicit questions
5. Use patient-friendly educational materials to
enhance interaction
6. Communicate numbers effectively

5

What are the Twelve education skills? (1-3)
Provide the correct amount and type of information

1. Assess patient's starting point
○ "How much do you know about ibuprofen already? It would be helpful for me to understand what you know and fill in the gaps."

2. Asks patients what info would be useful
(Least used skill usually and from our class)
○ What else would you like to know?

3. Chunk and check
○ Give a piece of info then ask. "Does that make sense?"
○ Give explanation at appropriate times
○ Now i will show you how do this part
○ Don’t do too many teach backs
○Don’t talk at once for too long

■ avoid premature advice or reassurance

6

What are the Twelve education skills? (4-8)
Aiding Accurate Understanding

4. Organizes explanation
○ Uses explicit categorization or signposting

5. Uses repetition and summarizing

6. Language
○ no jargon. Be clear e.g., “for fluid retention”....still that is not plain language. “For extra water in the body”

7.Use visual methods of conveying information

8. Check patients understanding (teach back)

7

What are the Twelve education skills? (9-12)
Incorporates patient's perspective

9. Relates explanations to pt's illness framework
○ “I can see why you thought this was an allergy. I think it may be an side effect and let me explain..”
○ Pt understand conditions and drugs differently

10. Provide opportunities and encourages participation
○ “I am glad you asked”

11. Picks up and responds to verbal and nonverbal
cues
○ "You look unhappy-is that about the new pill?"

12. Elicits patient's beliefs, reactions, and feelings
○ "How that news has left you feeling...."

8

What are 7 questions to ask in Kleinman's Explanatory Model?

● What do you call this problem? -> Name
● What do you believe is the cause of this problem? -> Cause
● What course do you expect it to take? How serious is it? -> Serious
● What do you think this problem does inside your body? -> Action
● How does it affect your body and your mind? -> Affects
● What do you most fear about this condition? -> Fear
● What do you most fear about the treatment? -> Fear Tx

9

What is D.I.V.E.R.S.E.?

what does it stand for?

tool that can be used to develop a personalized care plan incorporating a client’s values and beliefs, and to explore diverse cultural values and beliefs.

- Explore pt cultural values/beliefs
- Not used all the time

Demographics
Ideas
Views
Expectations
Religion
Speech
Environment

10

What is L.E.A.R.N.?

when is it not used?

Communication tool that can be used to improve communication, enhance awareness of personal and
cultural beliefs, and help determine acceptable care plans.
- “Approach to build a care plan”
- For negotiating the care plan, collaborative

Not used in crisis response situations, enhances patient centered care

Listen with empathy
Explain your thoughts and perceptions about problem.
Acknowledge, discuss, and incorporate the differences and sim
Recommend treatment.
Negotiate agreement.

11

name 5 steps on how to communicate numbers

1. Simplify numbers
2.Avoid using descriptive words - fraction, percent, odds (better)
3.Use standardized numeric definition
4.Use visual aids
5.Use more than one method

(extra: Chronic meds may often work for less than 50% of the population)

12

Food and Drug Act

How many parts and schedules?

2 Parts and 4 Schedules
Part I (foods, drugs, cosmetics, devices)
Part II (administration and enforcement - power for Health Minister)

13

Food and Drug Regulations
- 7 parts

which parts are important for pharmacy?

A: administration
B: food production and food safety
- Baby food, Alcohol, Flavourings, Dairy pdts
C: drugs and defines rules for dispensing and mfr
- Raw materials to pdt
- applies to manufacturers not pharmacists
D: Vitamins, Minerals, AA
- most moved to NHP Regs
E: Artificial sweeteners - cyclamate and xanthine sweeteners
G: Controlled drugs
J: Restricted drugs

C, G are important for pharmacy

14

The drug will be listed on the PDL if: (4)

• Drug requires supervision of a practitioner for the diagnosis, treatment or prevention of a disease or disorder
• Drug requires monitoring
• Level of uncertainty associated with the use of the drug or effect
• Level of harm associated with drug use and can be mitigated by practitioner supervision

15

Part C of F&D Regulations

What requirments are needed in inner and outer labels for drugs? (Principal Display Panel)
what abbreviations are used as symbols in packaging? (4)

On the Principal Display Panel (C.01.004 (1)) - part of a food label that is most likely to be displayed to the customer when for sale
• Name of Drug (Proper and/or common name)
• Standard (CSD)
• “Sterile” if required by regulations
• Upper left corner must contain symbol as relevant:

Pr = PDL list
C = controlled drugs
N = narcotics
T/C = benzodiazepines, targeted substances

16

Part C of F&D Regulations

What requirements are needed in inner and outer labels for drugs on any panel? (5)

what additional requirements MUST an outer label have?

what to do with small packages?

• Name and Address of Manufacturer
• Lot Number
• Directions
• List of Medicinal Ingredients
• Expiry Date

• Net quantity
• List of preservatives for parenteral use
• Mercury or salts used

• Specific requirements if the package is too small to contain all the Inner Label Requirements
• The Outer Label must comply with regulations.

17

Part C of F&D Regulations

What are cautionary statements?
Statements for:
- ASA and Salicylates for children;
- ASA and salts for internal use;
- Hyoscine (Scopolamine) and salts;
- Phenacetin;
- Boric Acid or Sodium Borate

ASA and Salicylates for children:
• The drug should not be administered to a child less than 2 years except on advice of physician

ASA and salts for internal use;
• Drug should not be administered to children or teenagers who have chicken pox or manifest flu symptoms before a physician or pharmacist is
consulted about Reye’s syndrome, which statement shall also refer to the fact that Reye’s syndrome is a rare and serious illness

Hyoscine (Scopolamine) and salts;
• Drug not to be used in people with glaucoma, or where blurring of vision or pressure pain in eye occurs

Phenacetin;
• CAUTION: May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician.

Boric Acid or Sodium Borate
• The drug should not be administered to child less than 3 years of age

18

When should you write “To be kept out of reach of children”?
When should you write “There is enough drug in the package to seriously harm a child” (entire package quantity)

• Salicylic acid and salts
• ASA or salts
• Acetaminophen

• More than 1.5 g of salicylic acid
• More than 2g of ASA
• More than 3.2g of acetaminophen
• More than eq. of 250mg elemental iron
• More than eq. of 120 mg fluoride ion