Complementary OTC Drugs

Question 1

What are examples of NHP?

Answer 1

Under the Natural Health Products Regulations, natural health products (NHPs) are defined as:
* Vitamins and minerals
* Herbal remedies
* Homeopathic medicines
* Traditional medicines
* Probiotics
* Other products like amino acids and essential fatty acids
Certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes

Question 2

Why are NHP used?

Answer 2

Used and marketed for a number of health reasons:
* prevention or treatment of an illness or condition
* reduction of health risks
* maintenance of good health
* Must be safe to use as over-the-counter products and do not need a prescription

Question 3

What is your responsibility as a midwife re: NHP (4)?

Answer 3

1) Provide evidence, efficacy, risks, and benefits of proposed NHP, so client can make informed choice.

2) Realize we have power in the convo - so don’t sway.

3)Respect client’s autonomy to use or decline NHP.

4) Document NHP convos.

Question 4

What are the risks of NHP (5) ?

Answer 4

1.Manufacturing problems
* Contamination, incorrect ingredients or dosage (heavy metals, contain synthetic drugs (less likely in Canada), doses are weird)
2.Unproven claims
* Using wrong products for serious conditions, delayed treatment
3.Not enough information for people to make an informed choice
* Incorrect instructions or no warnings, not many clinical studies (not lucrative to run them :()
4.Interaction with prescription drugs or other natural health products
* Reduced or enhanced effects, including side effects or overdose (ex/ Ca supplements can interfere w ABX)
5.Unwanted side effects
Any substance that has an effect on the body has the potential to be a risk to health

Question 5

How many Canadians have had adverse rxns w natural health products?

Answer 5

12%

Question 6

How many Canadians who experienced unwanted side effects of NHPs reported?

Answer 6

41%

Question 7

How can we minimize the risks of NHP (5) ?

Answer 7

1. Carefully weigh potential benefits vs potential risks
   
   2. Assess ALL therapies (interactions) (prompt when asking about meds, any NHPs?)
   3. Use approved products
   4. Follow instructions on product label
      Report unwanted adverse reactions

Question 8

Questions to ask when taking NHPs?

Answer 8

Why take this product?
What are the benefits or results that are desired from this product?
Is this the best product or approach to achieve those results, or are there better alternatives?
What is the evidence that supports the safety and effectiveness of this product? [this is an area lacking, although some ayurvedic TCM products have been used forever, so we know that at least they aren’t having adverse effects]
What are the risks associated with taking this product?

Question 9

Who does quality control of NHPs?

Answer 9

Natural and Non-prescription Health Products Directorate (NNHPD) ensures ready access to natural health products that are safe, effective and of high quality

Question 10

What does the quality control of NHPs in Canada look like (3)?

Answer 10

1. Assessment of all natural health products for safety and efficacy before they are sold in Canada
   
   2. Ensures proper manufacturing (site licensing, good manufacturing practices)
   3. Post-market monitoring to make sure that NHP Regulations are being followed
      excludes compounded products (made by compounding pharmacies)

Question 11

How are NHPs licenced in Canada?

Answer 11

NHP health claims, as well as efficacy & safety, must be supported by standards of evidence

*Modern health claims (peer reviewed research, clinical trials) vs traditional medicines (traditionally used)
* 3 tier system: high level of certainty (existing monograph ingredient), medium level (ie. combo of ingredients), low level (previously unlicensed claims for serious conditions, new ingredients/combos, sig safety concerns)

Question 12

Where can you find info on NHPs?

Answer 12

Health Canada Licensed Natural Products Database

Question 13

How are NHPs labelled?

Answer 13

Specific requirements to allow safe & informed choices
Eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM)
Safe and effective when used according the instructions on the label; they’ve been reviewed and approved by Health Canada

Question 14

What are the categories of NHPs and what do they mean (4)?

Answer 14

Unsafe - good research has shown adverse outcomes
Likely safe - been used for a long time
Insufficient evidence- we don’t have enough info
Possible Unsafe - studies that show it could be possibly unsafe, but there’s poor research.

Question 15

What was the take-away from the systematic review on NHPs?

Answer 15

• Not enough information to recommend the safe use of herbal products during pregnancy & postnatal period
• Most herbal products are recommended and used on the grounds of tradition, historic or anecdotal evidence
• Use of herbal products and adverse events to these products are generally under-reported to health care providers
  Reports of severe adverse events such as perinatal stroke, severe hyponatremia, and lead poisoning for some products

Question 16

What are the general recs of supplementation in pregnancy (with doses) (4)?

Answer 16

• Multivitamin with folic acid Folic acid 0.4-1 mg/day; 4 mg/day if high risk
• Calcium age 14-18 = 1300 mg/day; age 18+ = 1000 mg/day
• Vitamin D3 400-1000 IU/day (max 4000)
• Canadian Pediatric Society: consider 2000IU during winter months
  Iron RDA is 27 mg/day in pregnancy (HC recommends 16-20 mg in supplement) (max 45 mg)

Question 17

Moderate risk folic acid amount?

Answer 17

1 mg for 3 months pre-conception & first 12 weeks of pregnancy; then 0.4-1 mg for pregnancy & 4-6 weeks

Question 18

High risk folic acid amount?

Answer 18

4 mg for 3 months pre-conception & first 12 weeks of pregnancy; then 0.4-1 mg for pregnancy & 4-6 weeks

Question 19

Reasons moderate risk folic acid intake (5)?

Answer 19

Personal or family history of other folate-sensitive congenital abnormalities
Family history of NTD in first- or second-degree relative, Maternal diabetes,
Teratogenic medications that inhibit folate
Maternal GI malabsorption condition (Celiac, gastric bypass, EtOH overuse)

Question 20

Reasons high risk folic acid intake?

Answer 20

Personal NTD history or a previous NTD pregnancy

Question 21

Meds that inhibit folate (2)?

Answer 21

Dihydrofolate reductase inhibitors
Anticonvulsants (

Question 22

Calcium Interactions (3) ?

Answer 22

Decreased iron absorption (space by 2 hours)
Decreased absorption of tetracycline & quinolone antibiotics
Watch for “antacid” interactions (calcium carbonate - Tums)

Question 23

Vit d Interactions?

Answer 23

Calcium: potential risk of hypercalcemia due to increased absorption

Question 24

Iron Interactions?

Answer 24

Decreased calcium absorption
Decreased absorption of tetracycline & quinolone antibiotics

Question 25

Iron Adverse Effects?

Answer 25

Abdominal pain, constipation, diarrhea, gastrointestinal irritation, nausea, and vomiting

Question 26

Ginger Dose

Answer 26

50-1950 mg daily for up to 3 weeks
Common dosing: 250 mg four times daily

Question 27

Ginger Interactions?

Answer 27

• May increase stomach acid production and work against effects of antacids, H2RA, PPIs
• Increase risk of bleeding
  Warfarin, heparin, clopidogrel, NSAIDs

Question 28

Pyridoxine (Vitamin B6) Dose?

Answer 28

25 mg every 8 hours for 72-96 hours
Lower doses also help for nausea, but might not work as well for preventing vomiting

Question 29

What cohosh is not good for the midwife’s brew?

Answer 29

Blue cohosh