Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

NHP > Midterm 2 - Safety > Flashcards

Midterm 2 - Safety Flashcards

(64 cards)

Start Studying
1
Q

What did a case study of black cohosh show?

A

5-6 people show liver toxicity.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is the purpose of HPLC?

A

HPLC can identify the different compounds present in an extract and quantify the amount of each compound present in an extract by measuring the area of the peaks corresponding to each compound in the chromatogram.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What does the comparison of HPLC do?

A

By comparing the chromatograms (the output of the HPLC analysis) of different extracts, you can determine which compounds are present in each extract, their relative amounts, and identify any differences or similarities between the extracts. Help to compare natural extracts, drugs in the market, and “supposed” extracts.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What did HPLC do for Saint John’s?

A

Identified active principles including hyperforin (more clinically active) and hypericin.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Why is DNA barcoding rarely used in NHP?

A

Very expensive and there is a lot of confusion in results. It is not validated as well.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What were the 5 case reports on black cohosh in Canada?

A

Indicated hepatic adverse reactions associated with the use of black cohosh products.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What were the results of the 5 case reports on black cohosh in Canada?

A

3 “possible:” potentially because of black cohosh, but person taking other medications as well
1 “probable”
1 “unassessable”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What did scientists do with the 5 case reports on black cohosh in Canada?

A

One case of “probable” was analysed further with authenticity of product involved in the hepatic AR. HPLC was used.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What were the plants used in the HPLC black cohosh?

A

Black cohosh from nature, other acetaea species, powdered black cohosh extract, and lab samples of it.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What did comparison of black cohosh (nature) and the extract show?

A

HPLC showed that all the correct marker compounds were the present and absent in both.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What did comparison of black cohosh (nature) and the lab samples show?

A

Two compounds were matched, but one was present that wasn’t in the black cohosh (cimifugin) and another absent only in the lab samples (cimiracemoside C).

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What was the controversy was Kava?

A

In 2002/4, an adverse event reporting in Europe showed more than 12 people taking Kava developed hepatoxocity and liver failure (other drugs actually have much higher numbers).

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What was the problem with Kava?

A

Associated with the substitution of the traditional root product with bark by manufacturers.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What is the suspect toxin in Kava?

A

Pipermethystine

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What is pipermethystine enhanced by?

A

P450 inhibition

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What was PC-SPES (HOPE) supposed to do?

A

Claimed to induce castrate serum levels of testosterone and a reduction in prostate specific antigen.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What did chemical analyses of PC-SPECS show?

A

Natural compound plus added chemical ingredients such as DES, warfarin, and indomethacin.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What were the ADR of PC-SPECS?

A

Breast tenderness/enlargement, loss of libido and erectile dysfunction, deep vein thrombosis and 2 cases of severe bleeding.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

What undeclared pharamecuticals found in TCM?

A
  1. Caffeine = energetic
  2. Diclofenac = anti-inflammatory
  3. Valproate = mood stabilizer

AND MANY MORE

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What did Ayurvedic medicine show?

A

Some used to increase vigor (physical and mental health) had heavy levels of lead, mercury, arsenic, and palladium.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What is type A acute toxicity?

A

Adverse health effects occurring after a single or short-term exposure. They are pharmacologically predictable and dose dependent.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Give examples of type A acute toxicity.

A

Wild garlic = hypotension and rashes
Yohimbe = hypertension and anixety
Goldenseal = vomiting, diarrhea

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

What did aristolochoic acid show in rats?

A

Kidney hyperinflammation and toxicity.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

What is type B acute toxicity?

A

Refers to substances or mixtures that cause serious adverse health effects, including death, following a single or short-term exposure. Unusual reactions not predicted on the basis of pharmacological and generally not dose dependent.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Give examples of type B acute toxicity.
Yohimbine = bronchospasm, lupus-like syndrome Kava = hepatoxicity
26
What does enhancement of conventional drug levels occurs by herbs?
Inhibition of phase 1 metabolism of drugs and or phase 2 metabolism. Stimulation of p450.
27
What does reduction of conventional drug levels occurs by herbs?
Interaction causing up regulation of phase 1 metabolism through inhibition of p450.
28
What does grapefruit and seville orange enhance?
Increases the serum levels of antihistamines, calcium channel blockers, and cyclosporine.
29
Is grapefruit good for medication users?
No, they are potent inhibitors of drug metabolism acting at level of small intestine (first pass) and liver.
30
What does hyperforin do?
Enhance catabolism of Saint John's, so the substance breaks down quicker and is able to act faster.
31
Is St.John's wort an enhancer or reducer?
It reduces plasma levels of drugs.
32
What does SJW reduce?
IDV-anti HIV is reduced below therapeutic levels, indicating a negative interaction as this drug that decreases the amount of HIV in the blood is actually being decreased.
33
What does hyperforin induce?
Cype450 and clears drugs.
34
What are botanicals regulated as drugs called in Europe?
Phytomedicines based on 20+ monographs.
35
How long have botanicals been regulated in Canada? As what?
Since 2004 as NHP with over 100 monographs recoginzing many traditions.
36
What are botanicals regulated as drugs called in Australia?
Complementary and Alternative Medicines, electronic registration and random policing.
37
What are botanicals regulated as drugs called in USA?
Dietary supplements without any medicinal claims.
38
What are botanicals regulated as drugs called in Hong Kong and China?
TCM
39
Crude drug
Not an isolated pure product
40
What were crude drugs replaced with?
Single entity drugs (pure isolated compounds).
41
When did herbal medicine use increase in Canada again?
1998
42
What were the regulations of 1998 Canada and NHP?
These traditional and other products should be legalized as over the counter therapeutics if: a) if safe and of good quality b) if traditional evidence of use for 50 years is available or scientific evidence of efficacy is supplied for new products
43
When was the NHP Act passed?
2000
44
Premarket approval in Canada
Applicants must apply for a license before selling and are issued a license to sell in the form of an NPN# or DIN-HP# for approved products
45
Monograph
A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.
46
How many monographs can a product conform to?
120+ ex. 50 years of safe use or review of literature for vitamins
47
When NHPs are put out in Canada, what do they look for?
Active post market "pharmacovigalence" for adverse reaction reports and rapid assessment and response (warning or withdrawal) or reported ARs.
48
What are the weaknesses of OTC drugs?
Don't track what other medications patients are using.
49
What happened with NHPs before 2000 in Canada?
Vitamins regulated as drugs with DINs and few guidelines for traditional medicines.
50
What must happen for product licensing?
1. Basics = ingredients (medicinal and non, brand name, recommended conditions of use) 2. Safety, quality, and efficacy info is required for license by one or two routes 3. Attestation of Good Manufacturing Practices 4. Labelling regulations must be followed
51
What two routes can you do to obtain safety?
1. Follow an approved NHPD monograph 2. Submit other data to support the safety, quality, and health claims
52
What is needed for standards of evidence for safety?
1. Amount of data required to support the safety claim 2. Additional toxicology data could be required (intended use and duration) 3. Totality of evidence considered for safety and claim assessments 4. Information required is proportionate to the risk associated with the product
53
What can support a safety claim?
Monograph and company will follow the guidelines for suitable formulations and doses (license issued in 60 days).
54
What can support a safety claim (no monograph)?
History of traditional use, and evidence from scientific literature OR clinical data for newer products.
55
What are the claims for standards of evidence for efficacy?
1. Structure/function (compounds and what they do) 2. Risk reduction (anti-ox/in) 3. Treatment/cure
56
What do new NHPs in Canada usually require?
Clinical validation
57
What does the clinical trial protocol approval provide?
- clear and transparent requirements for conducting human clinical trails with NHPs - methods to ensure the safety of trail participants - a means to test new products without a long history of traditional use - ensure effective and complete ethical review
58
What is the purpose of labelling?
Allows the user to make a choice and have assurance of the product's safety, quality, and claim.
59
Once a product is approved for sale in Canada, what is placed on it?
NPN or DIN-HM (homepathic).
60
What must the adverse reaction reporting system do in Canada?
- regulations require product licence holders to monitor all adverse events associated with product - serious and unexpected adverse reactions must be reported to Health Canada - system has a well developed protocol for detecting "signals"
61
What is low in numbers in Canada regarding NHP?
Underreporting of AR.
62
What are problems of NHP in the market regulated by?
Health Protection Food Branch Inspectorate
63
What does Health Protection Food Branch Inspectorate investigate?
Substitution, contamination, and check for unlicensed products.
64
When does Health Protection Food Branch Inspectorate investigate?
Reactive monitoring, so only once an accident is reported.

NHP (4 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions