Pharmaceutical Worker Certification Assessment (Kazakhstan) flashcards
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- State registration of medicines
- Mandatory authorization before a medicine may be sold in Kazakhstan; the product is entered in the State Register, and unregistered use is limited to defined exceptions such as clinical trials or named-patient import.
- Pharmacovigilance reporting duty
- Marketing authorization holders and healthcare organizations must report suspected adverse drug reactions, serious unexpected reactions, and lack of efficacy to the national pharmacovigilance system within established timelines.
- Regulated medicine price markups
- For reimbursed outpatient medicines, the state caps wholesale and retail markups applied to the registered ex-factory price, with the allowed margin decreasing as the price band rises.
- Bioavailability (F)
- The fraction of an administered dose that reaches systemic circulation unchanged. For intravenous administration F equals 1; oral bioavailability is reduced by incomplete absorption and first-pass hepatic metabolism.
- Volume of distribution (Vd)
- The apparent volume relating the amount of drug in the body to its plasma concentration. A large Vd indicates extensive tissue distribution; Vd is used to calculate loading doses.
- Loading dose formula
- Loading dose equals Vd multiplied by the target plasma concentration, divided by bioavailability F. It rapidly achieves therapeutic concentration, while maintenance dosing depends on clearance.
- Narrow therapeutic index drugs
- Drugs such as digoxin, warfarin, lithium, phenytoin, and gentamicin, where small concentration changes cause toxicity or loss of effect, so therapeutic drug monitoring is required.
- ACE inhibitor adverse effects
- Dry persistent cough, hyperkalemia, hypotension, and angioedema. Angioedema and bilateral renal artery stenosis are contraindications; potassium and renal function require monitoring during therapy.
- Geometric dilution
- A compounding technique for mixing a small amount of potent drug with an equal volume of diluent, then repeatedly doubling the mass to achieve uniform distribution throughout the final powder.
- Sodium chloride equivalent method
- An isotonicity calculation: multiply the drug mass by its E-value to obtain the NaCl equivalent, then add NaCl to bring the total to 0.9 percent of the solution volume.
- Suppository displacement value
- The number of parts of drug that displace one part of base. It corrects the calculated base mass so the mold is filled exactly when the drug is incorporated.
- Terminal sterilization parameters
- Saturated steam at 121 degrees Celsius for 15 to 20 minutes at about one atmosphere excess pressure is a standard autoclave cycle; heat-labile solutions require membrane filtration instead.
- Alkaloid definition
- A basic nitrogen-containing plant secondary metabolite, usually extracted by acid-base partitioning. Examples include morphine, atropine, caffeine, quinine, and vincristine from their respective plants.
- Cardiac glycosides
- Plant glycosides from Digitalis and Strophanthus that inhibit sodium-potassium ATPase, increasing intracellular calcium and contractility. They have a narrow therapeutic index and require standardized assays.
- Total ash value
- The residue remaining after incineration of plant raw material. It indicates mineral content and contamination with soil or foreign matter; pharmacopoeias set upper limits.
- Essential oil storage
- Volatile terpene-rich oils must be kept in tightly closed, filled containers, protected from light and heat, because evaporation and oxidation degrade their composition and potency.
- Beer-Lambert law
- Absorbance equals molar absorptivity times concentration times path length. It underpins UV spectrophotometric assay, valid only within the calibrated linear concentration range.
- Chromatographic validation parameters
- Specificity, linearity, accuracy, precision, limit of detection and quantitation, robustness, and system suitability demonstrate that an analytical method is suitable for its intended purpose.
- Accelerated stability testing
- Storage at elevated temperature and humidity, commonly 40 degrees Celsius and 75 percent relative humidity, predicts degradation and supports shelf-life assignment together with long-term data.
- Assay acceptance range
- Pharmacopoeial content limits for most finished products are typically 95 to 105 percent of the label claim, determined by a validated, stability-indicating analytical method.
- Reorder point
- The stock level triggering a new order: average daily demand multiplied by lead time, plus a safety stock buffer covering demand variability and delivery delay.
- Stock turnover ratio
- Cost of goods sold divided by average inventory value. A low ratio indicates slow-moving stock, tying up capital and increasing the risk of expiry losses.
- Subject-quantitative accounting
- Mandatory item-by-item recording of narcotic, psychotropic, and precursor medicines, with separate storage and periodic reconciliation of register entries against physical stock.
- Pharmaceutical care process
- The pharmacist identifies actual or potential drug-related problems in indication, effectiveness, safety, or adherence, then intervenes, documents the action, and follows up on the patient outcome.
- Prescription screening checks
- Verify legal validity, prescriber details, patient identity, dose against age, weight and renal function, interactions, contraindications, therapeutic duplication, and quantity limits before dispensing.
- Antimicrobial stewardship
- Prescribe and dispense antibiotics only for confirmed or likely bacterial infection, at the correct dose and duration, to preserve efficacy and limit selection of resistant organisms.
- Live attenuated vaccine contraindications
- Live vaccines such as measles, mumps, rubella, and BCG are contraindicated in severe immunosuppression and generally in pregnancy, because replication may cause disease in the host.
- Vaccine cold chain
- Most vaccines are stored at 2 to 8 degrees Celsius with continuous temperature monitoring; freeze-sensitive adsorbed vaccines must not be frozen, and excursions require documented assessment.
- Herd immunity
- Indirect protection of unvaccinated individuals when a sufficient proportion of the population is immune, reducing transmission; the threshold varies by pathogen and is high for measles.
- Adult basic life support
- Check responsiveness and breathing, call for help, give chest compressions at 100 to 120 per minute, 5 to 6 cm deep, with a 30 to 2 compression-to-ventilation ratio, and apply an AED.
- Anaphylaxis first-line treatment
- Intramuscular adrenaline 0.3 to 0.5 mg of the 1:1000 solution into the anterolateral thigh, repeated after 5 to 15 minutes if needed, with emergency services called and the patient positioned supine.
- Patient confidentiality
- Patient information may be disclosed only with informed consent or when required by law; records must be stored and transmitted securely, and casual discussion of cases is prohibited.