Final Exam- the basics :) Flashcards
What is the MOA of COCs? (7 marks)
COCs made of estrogen and progestogen (2 marks)
Estrogen suppresses FSH and prevents follicle development (2 marks)
Progestogen inhibits the LH surge and endometrial proliferation. It also causes cervical mucus thickening. (3 marks)
List 3 types of contraception drugs/devices (1.5 marks; 0.5 mark each)
COC
Progestogen only tablet
vaginal ring
IUDs : Copper, Levonorgestrel..
Condoms (female or male)
Define complimentary medicines (6 marks)
Medicines containing herbs, vitamins, minerals, nutritional supplements, homeopathic or certain aromatherapy preparations. (5 marks) They also contain at least one active ingredient in schedule 14 of the regulations (1 mark).
What are listed complimentary medicines? (5 marks)
CMs with low risk ingredients in acceptable amounts and can be used in listed TGA medicines (2 marks). They are assessed for quality not safety (1 mark), the therapeutic indications are restricted to health maintenance and enhancement (2 marks)
What is the difference between assisted listed medicines and listed complimentary medicines? (2 marks)
Assessed listed medicines will be included in the ARTG following successful premarket assessment of
efficacy evidence by the TGA
What are registered complimentary medicines? (5 marks)
CMs which are high risk due to their ingredients (1 mark), the TGA individually assesses these for safety, quality and efficacy (3 marks) and therapeutic claims are based on evidence (1 mark)
What are the three principles to support indications and claims about therapeutic goods?
sponsors must hold adequate evidence to support all
claims they make about a product, claims must be true and valid and the claims must not lead to unsafe or inappropriate use of the product.
What is traditional evidence for CMs? (4 marks)
evidence showing a therapeutic use based on extensive history of use (2 marks) It must have evidence demonstrating use for 3 generations (75+ years) in it’s home tradition (2 marks)
What is scientific evidence for CMs
provided secondary to human data (1 mark) and can involve RCTs, cohort studies and case control studies (1 mark)
True or false : All CMs are required to be manufactured under the Good Manufacturing Practice
True
Do L# or R# CMs have theraeputic claim restrictions?
L# (registered CM’s)
What are some examples of contraceptive injections and implants, and how do they work?
Depo-Provera (injection) and Nexplanon (implant). They release progestin to prevent pregnancy by suppressing ovulation and thickening cervical mucus
What is the primary mode of action for spermicides, and how are they used?
Spermicides are chemical agents that immobilize or kill sperm. They are available in various forms, such as creams, gels, or foams, and are applied to the vagina before intercourse
What is the rhythm method of contraception based on, and how is it practiced?
relies on tracking a woman’s menstrual cycle to determine fertile and infertile days. Couples avoid intercourse or use protection during fertile periods.
What are the key differences between hormonal and non-hormonal intrauterine devices (IUDs)?
Hormonal IUDs release hormones (e.g., levonorgestrel) to prevent pregnancy, while non-hormonal IUDs (copper IUDs) create an inhospitable environment for sperm.
What is a diaphragm, and how is it used for contraception?
dome-shaped barrier device that is inserted into the vagina before intercourse, covering the cervix to prevent sperm from entering the uterus
What is the Lactational Amenorrhea Method (LAM), and when is it typically used?
natural contraceptive method used during exclusive breastfeeding to prevent pregnancy, relying on the suppression of ovulation by breastfeeding.
How do combined oral contraceptives (COCs) and progestogen-only contraceptives work, and what are the primary differences between them?
COCs contain both oestrogen and progestogen and work by suppressing ovulation and thickening cervical mucus. Progestogen-only contraceptives, such as the mini-pill, primarily thicken cervical mucus and inhibit fertilization, with no oestrogen component
What are the three primary mechanisms of action of Combined Oral Contraceptives (COCs)?
COCs work by inhibiting ovulation, reducing the receptivity of the endometrium to implantation, and thickening cervical mucus to form a barrier to sperm.
What are some commonly reported adverse effects of COCs?
breakthrough bleeding, breast enlargement and tenderness, headache, fluid retention, and chloasma (skin hyperpigmentation).
What are some less common but potentially serious adverse effects associated with COCs?
allergies, hypertension, jaundice, pancreatitis, and an increased risk of conditions such as liver, cervical, and breast cancer, stroke, and venous thromboembolism (VTE).
How might COCs interact with hepatic enzymes and what are some examples of inducers of these enzymes?
COCs can be affected by hepatic enzyme inducers like rifampicin, phenytoin, and carbamazepine, potentially reducing their contraceptive effectiveness.
What are the contraindications for using COCs?
- less than 6 weeks postpartum, – smoker over the age of 35 who smokes more than 15 cigarettes per day, having complicated valvular heart disease, a history of venous thromboembolism (VTE), ischaemic heart disease, a history of cerebrovascular accident, uncontrolled hypertension (above 160/100mmHg), current breast cancer, diabetes with retinopathy, neuropathy, or nephropathy, severe cirrhosis, and liver tumours.