Lecture 7: Food and Drug Regulations + Drug Recalls Flashcards Preview

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1

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

2

Food & Drug Regulations Part C

How is manufacturing regulated as compared to compounding?

- Manufacturing is regulated federally
- DIN, establishment license, notice of compliance
- Compounding is regulated by provincial bodies
- Antifungal cream mixed with menthol and steroid pursuant to a prescription
- F&D Act and its Regulations speak to manufacturing mostly

3

Food & Drug Regulations Part C

a person who is entitled under the laws of a province to treat pts with a prescription drug and is practicing their profession in that province

Practitioner

4

Food & Drug Regulations Part C

describe child resistant packaging
what do our SOPs say?

A package that meets the child test protocol requirements of the Canadian Standards Association
• Cannot be opened by at least 85 per cent of those children prior to a demonstration
• Cannot be opened by at least 80 per cent of those children after the demonstration
• Can be opened by at least 90 per cent of those adults

SOP 7.3: Dispense in child resistant packaging unless requested by patient or there is another reason
Best practice: DOCUMENT if they are not getting child safe package

5

what is a drug that requires a prescription prior to dispensing?

PDL drug

6

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

7

The PDL is split into which 2 lists

1. Products for human use that require a prescription
2. Products for veterinary use that require a prescription

8

Regulations Pertaining to Generic Drugs

what must be same?
what may be diff?

- Generic drugs contain the same medicinal ingredients as the brand name drug, and are considered bioequivalent to the reference product
- Non-medicinal ingredients, like fillers and ingredients that colour the drug, may be different from those of the brand name product.
- generic manufacturer must provide studies showing that the different non-medicinal ingredients have not changed the quality, safety or effectiveness of the generic drug (not same as biosimilars)

9

Regulations Pertaining to Generic Drugs

There must be no more than a ___ difference between
the ____ and _____ of brand name versus generic
products.

20%, AUC, Cmax
Area under the curve = amount of drug available to body to use
Cmax = max conc of drug in system after taking the drug
Tmax = time when Cmax is reached

this is based on international consensus
for bioequivalence, the AUC and Cmax
for the generic drug are compared with that of the brand name drug

10

compare Chemical to Biologic Agents
- appearance
- source
- characterization
- MOA
- immunigenicity

chemical agents:
- small, simple structure
- Synthesized using defined chem rxns
- Fully characterized molecule
- usually well defined single MOA
- rare immunogenicity

biological agents:
- large, complex structure
- mfr in a living system
- challenging to fully characterize
- multiple MOA, less defined
- potential formation of antibodies

11

Part C of F&D Regulations?

who can sell drugs?
SOPs are more detailed instead of Regulations

No person shall sell a prescription drug unless
• (a) they are entitled under the laws of a province to dispense a prescription drug and they sell it in that province under a verbal or written prescription that they received; or
(b) A person may sell a prescription drug to: drug mfr, practitioner, wholesale druggist, pharmacist, Gov Can
- If a person sells a prescription drug as above they shall retain the written order for the drug for a period of at least two years after the day on which the drug is sold

12

Part C of F&D Regulations

Can a pharmacist dispense of animal use?

Pharmacists can dispense for animal use
- Drugs for animal use must be labelled with: For veterinary use only
- 2018, changes to Canadian Food and Drug Regulations
- Increased oversight of antimicrobial use in animals
- Ensuring all meds are important antimicrobials will be sold by prescription only
- Pharmacists that compound antimicrobials for animals, must report sale to Health Canada

13

How does the role and scope of pharm for animals differ for human pts?
what guidelines are changing this?

- Pharmacist must be aware of any gaps in their knowledge and the
limitations of their scope that affect the care of their patient.
- regulated member must deal with pt's owner
- gather info to assess animal
- monitoring plans are created for animals to
avoid, resolve, or monitor drug related problems
- know when to refer

- cannot currently adapt or prescribe for animals - pt is defined as a human under standards
ACP Draft Guidelines for Providing Pharmacy Services for Animals attempting to change this

14

Who regulates labelling on drug bottles and
prescription vials?

Health Canada
Fed legislation doesn’t mention prescription labelling - go to SOPs and ACP, Standard 7.5

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

what are these?
• Name of the patient;
• Name, address, and telephone # of the pharmacy;
• Name of the prescriber;
• A description of the product in English by:
• Generic name, strength and identity of manufacturer (for single entity drug);
• Generic name, strength and identity of manufacturer for combination drugs, or
the BRAND name and strength;
• Name of compounded drugs or ingredients and strength;
• Blood product name
• Instructions for use;
• A unique prescription number;
• Date of the dispense;
• Quantity of the drug dispensed; and
• The number of refills remaining if applicable.

Requirements: SOP (Standard 7.5) for prescription labelling

18

what can a DIN help differentiate? (6)

• Product Name
• Manufacturer’s/Distributor’s Name
• Medicinal ingredient
• Corresponding strength
• Dosage form
• Route of administration

The National Drug Code (NDC) is a unique product identifier used in the United States for drugs intended for human use.

19

Part C of F&D Regulations

what drugs can be advertised?

If a person advertises a prescription drug to the general public, the person shall not make any representation other than with respect to the brand name, the proper name, the common name and the price and quantity of the drug.
• For example, metformin is a drug on the PDL. You can only advertise:
• Metformin
• 500 tablets
• $29.99/500 tablets

- cannot reference its use or benefits
- cannot make claims to treat, prevent, cure any Schedule A diseases of DFA (Sch A prevention claims are now permitted by regulation of OTCs and NHPs)
- Exception: Does not apply to information provided to clinicians in scientific journals

20

Part C of F&D Regulations

Can advertising of over the counter drugs, vaccines, natural health products and medical devices be advertised to the general public beyond name, price and quantity?

Yes

Cannot say that these items can treat or cure any disease listed on Schedule A.
Can say that these items prevent the diseases listed in Schedule A.

USA: Direct to Consumer Advertising (DTCA) regulated by FDA, allow for direct advertising of prescription drugs along with New Zealand
- FDA only regulates ads for presc drugs

21

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

mandated by public health to be put on pdts

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

22

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

23

Food & Drug Regulations Part C: Drug Recalls
what are the 2 main steps?

Step 1: Health Hazard Evaluation conducted by
Manufacturer
Step 2 (Recall Notification): Notify the Health Protection
Branch

24

Food & Drug Regulations Part C: Drug Recalls

what info is step 1 needed for recall process?
Health Hazard Evaluation conducted by Manufacturer

Gather, correlate and evaluate all known information on the nature and extent of the reputed health risk.
• Whether any disease or injuries have already occurred from the use ofnthe product.
• Assessment of hazard to various segments of the population, e.g., children, surgical patients, etc., who are expected to be exposed to
• Assessment of the degree of seriousness of the health hazard to which the population at risk
• Assessment of the likelihood of occurrence of the hazard.
• Assessment of the consequences (immediate or long-range) of occurrence of the hazard.
• Will also be conducted by Health Protection Branch scientists

25

Food & Drug Regulations Part C: Drug Recalls

what info is step 2 needed for recall process?
recall notification: Notify the Health Protection
Branch

info needed:
• name of the recalled product and, where applicable, the identifying model designation, serial number, code, lot number and any other means of identification.
• total quantity of the recalled product originally in his possession.
• total quantity of the recalled product that had been distributed up to the time of the recall.
• Area of the distribution of the recalled product by province and, if exported, by country.
• The quantity of the recalled product still in his possession.
• The reason for initiating the recall.

26

Food & Drug Regulations Part C: Drug Recalls

What are the 3 types of recall?

Type 1: Exposure or use will cause serious adverse effect or death.
Type 2: Exposure or use of will cause temporary adverse effect and the chance of a serious consequence is remote.
Type 3: Exposure or use of will not cause an adverse effect.

- Pharmacists should report this to Health Canada which may trigger recall after investigation for suspected ADR
- Must be reported within 15 days for mfr
- Encouraged for HCPs and publics to report to MedEffect

27

what is a pharmacist';s role in recalls?

Subscribe to the Canadian Adverse Reaction Newsletter (CARN)
• Quarterly publication providing information about adverse reactions and safety alerts to health care professionals,

MedEffect e-Notice, a free e-mail service that distributes CARN, as well as e-mail notices of all issued advisories, warnings and recalls.

Comply with recall process as communicated by Health Canada and Drug Manufacturer

28

Food & Drug Regulations Part C: Importation

Can presc drugs be imported for pts? what requirements must be met?

Unapproved importation is illegal and there is a high risk of counterfeit drugs
If a Registered Pharmacist wants to import a drug for
patient use, then the following must be met:
• A Drug Identification Number (DIN) for each product
• Importer must hold a Drug Establishment Licence (DEL) and also must be a practitioner, a drug manufacturer, a wholesale druggist or a registered pharmacist.
• The foreign manufacturing site must be listed on the Importer’s DEL

29

Importation of Prescription Drugs for Personal Use

How much can visitors to Canada bring for their use?

A single course of treatment or a 90-day supply based on the directions for use, whichever is less, of a prescription drug.
• The drug must be for the individual’s own personal use, for the use of a person for whom they are responsible and with whom they are travelling,.

The drug must be shipped/carried in one of the following:
• Hospital or pharmacy dispensed packaging
• Original retail packaging
• Have the original label affixed to it which clearly indicates what the health product is and what it contains

30

Importation of Prescription Drugs

Can Canadian residents import presc drugs?

• Importations of prescription drugs by Canadian residents are not permitted by mail or courier
• However, to continue therapy Canadian residents returning to Canada may be permitted to bring with them a single course of treatment or a 90-day supply based on the directions for use, whichever is less, of a prescription drug.
• Rules that are applicable to visitors apply to Canadian residents returning to Canada