Pharmaceutical Worker Certification Assessment (Kazakhstan) cheat sheet

Core laws: Law on Public Health and the Healthcare System; Code on Public Health and the Healthcare System (2020, in force from 2021); Law on Medicines and Pharmaceutical Activity regulates registration, circulation, and pharmacy practice.

Licensing of pharmaceutical activity (manufacture, wholesale, retail, storage) is issued by the state licensing authority; a license is required before any pharmaceutical turnover, and annexes list permitted activity subtypes.

State registration of medicines is mandatory before sale; the register (State Register of Medicines) lists registered products, and unregistered medicines are permitted only for named-patient import, clinical trials, or compassionate use with authorization.

The national regulator is the Committee for Medical and Pharmaceutical Control (under the Ministry of Health); it performs pharmacovigilance, inspection, and quality control of medicines.

Pharmacovigilance: marketing authorization holders and healthcare/pharmacy organizations must report adverse drug reactions, serious unexpected reactions, and lack of efficacy to the national pharmacovigilance system within established timelines.

Prescription status, narcotic/psychotropic scheduling, and precursor control are set by ministerial orders; narcotic and psychotropic medicines require special record-keeping, separate storage, and stricter reporting.

Prices of medicines in the reimbursed outpatient list are subject to state regulation (maximum wholesale and retail markups); markups are capped by price band, so the allowed margin falls as the ex-factory price rises.

Advertising of prescription medicines to the public is prohibited; advertising of OTC medicines must not imply guaranteed effect or encourage unnecessary use, and comparative claims require substantiation.

Compliance inspections may be scheduled or unscheduled; unscheduled inspections require grounds defined by the Entrepreneurial Code, and results can lead to suspension of the license or product withdrawal.

Pharmacokinetics: absorption, distribution (protein binding, volume of distribution), metabolism (phase I oxidation/reduction, phase II conjugation), excretion; half-life determines time to steady state (~4–5 t½) and dosing interval.

Bioavailability (F) = fraction of dose reaching systemic circulation; for IV, F = 1. First-pass hepatic metabolism lowers oral bioavailability and is bypassed by sublingual, rectal, or parenteral routes.

Clearance CL = dose rate / plasma concentration; maintenance dose rate = CL × target concentration / F; loading dose = Vd × target concentration / F.

Receptor pharmacology: agonists activate, antagonists block without intrinsic activity, partial agonists produce submaximal response, inverse agonists reduce constitutive activity; potency relates to affinity (EC50), efficacy to maximal response.

Key adverse-effect patterns: aminoglycosides - nephro/ototoxicity; NSAIDs - GI ulceration, renal impairment, fluid retention; ACE inhibitors - dry cough, hyperkalemia, angioedema; statins - myopathy, raised transaminases.

Narrow therapeutic index drugs (digoxin, warfarin, lithium, phenytoin, gentamicin, theophylline) require therapeutic drug monitoring; sampling time depends on distribution phase and dosing interval.

Contraindications and interactions: CYP3A4 inhibitors (macrolides, azoles) raise levels of CYP3A4 substrates; CYP inducers (rifampicin, carbamazepine) lower them; warfarin interacts with many antibiotics and NSAIDs, raising bleeding risk.

Special populations: dose adjustment in renal impairment by creatinine clearance (Cockcroft–Gault), in hepatic impairment by severity class, and in pregnancy/breastfeeding by risk–benefit; pediatric dosing is often weight- or body-surface-based.

Powders: divide bulk drug by geometric dilution to ensure uniformity; weigh on class-appropriate balances; label with total mass and dose per sachet.

Solutions: percentage concentration rules - % w/v = g per 100 mL, % w/w = g per 100 g, % v/v = mL per 100 mL; ethanol dilution uses the mixing rule (cross method) to reach a target strength.

Isotonicity: sodium chloride equivalent (E-value) method - mass of NaCl equivalent = drug mass × E; add NaCl to reach 0.9% total; freezing-point depression method uses Δt = 0.52 °C for isotonicity.

Suspensions and emulsions require a suspending or emulsifying agent, controlled particle size, and shaking instruction; emulsions must be checked for phase separation and creaming.

Ointments and suppositories: bases are lipophilic (hydrocarbon, e.g., vaseline) or hydrophilic (PEG); suppository displacement value corrects the base mass for drug volume.

Sterile compounding requires an aseptic environment (laminar flow or isolator), validated sterilization (autoclave 121 °C, 15–20 min at 1 atm excess), and membrane filtration for heat-labile solutions.

Incompatibilities: check for chemical (redox, hydrolysis, precipitation), physical (immiscibility, salting out), and therapeutic incompatibility before compounding; adjust vehicle or separate administration.

Quality of compounded forms: organoleptic check, uniformity of mass (deviation limits by dose form), volume deviation limits, and documented calculation double-check by a second person.

Primary metabolites (carbohydrates, proteins, lipids) vs secondary metabolites (alkaloids, glycosides, terpenoids, phenolics) - the latter drive most pharmacological activity.

Alkaloids: nitrogen-containing, basic, extracted by acid–base partitioning; examples - morphine (Papaver somniferum), atropine (Atropa belladonna), caffeine (Coffea), quinine (Cinchona), vincristine (Catharanthus roseus).

Cardiac glycosides (Digitalis purpurea/lanata, Strophanthus): positive inotropy via Na+/K+-ATPase inhibition; narrow therapeutic index, require standardized assay and careful dosing.

Essential oils: volatile terpenes obtained by steam distillation; examples - menthol (Mentha), thymol (Thymus), eucalyptol (Eucalyptus); stored in tightly closed containers away from heat and light.

Tannins (gallotannins, condensed) are astringent, bind proteins; used externally for mucosal inflammation; incompatible with alkaloids and heavy metals (precipitation).

Quality indicators of raw materials: moisture content (limit prevents mold), total ash (mineral residue), extractive substances, and absence of foreign matter or heavy metals; identity by macroscopy and microscopy.

Collection and storage rules: harvest at the phase of maximum active-substance content, dry rapidly at controlled temperature, store in dry, ventilated, dark conditions; essential-oil and glycoside raw materials are heat- and light-sensitive.

Standardization: raw material and extracts are assayed to a declared content of marker or active substance, so batches deliver reproducible pharmacologic effect.

Qualitative analysis identifies identity (functional groups, IR fingerprint, melting point); quantitative analysis measures content (titrimetry, spectrophotometry, chromatography).

Titrimetry: acid–base, redox, complexometric (EDTA), and precipitation methods; content % = (V × C × equivalent mass × 100) / sample mass, corrected for titer.

Spectrophotometry: UV absorbance follows Beer–Lambert law A = ε × c × l; linear range and calibration curve are required for valid quantification.

Chromatography (HPLC, GC, TLC): separation by differential distribution between mobile and stationary phases; key validation parameters are specificity, linearity, accuracy, precision, LOD/LOQ, robustness.

Impurity control: related substances are limited by pharmacopoeial tests; heavy metals, residual solvents, and microbial limits are also specified.

Pharmacopoeial requirements: identity, assay (usually 95–105% of label claim), uniformity of dosage units, dissolution/disintegration, sterility for parenterals, and stability-indicating methods.

Stability testing: accelerated (40 °C/75% RH) and long-term studies define shelf life and storage conditions; degradation follows zero- or first-order kinetics, with t90 as the shelf-life criterion.

Instrumental and chemical methods must be validated and calibrated; reference standards and documented sample chain of custody are required for a defensible result.

Pharmacy economics: turnover = revenue from sales; gross margin = revenue − purchase cost; markup % = (retail price − purchase price) / purchase price × 100.

Inventory accounting: FIFO and average-cost methods; stock turnover ratio = cost of goods sold / average inventory; low turnover signals slow-moving stock and expiry risk.

Stock management: minimum/maximum levels, reorder point = average daily demand × lead time + safety stock; ABC analysis prioritizes high-value items.

Narcotic, psychotropic, and precursor medicines require subject-quantitative accounting, separate storage, and periodic reconciliation with the register.

Pharmaceutical supply chain: manufacturer → wholesale distributor → pharmacy; cold-chain products require validated transport and temperature logging; recalls follow a documented procedure.

Pricing in the reimbursed list: regulated maximum wholesale and retail markups applied to the registered ex-factory price; the pharmacy must keep price records for inspection.

Staffing and workflow: separation of dispensing and cashier functions, prescription verification before dispensing, and documented refusal for invalid prescriptions.

Financial documents: invoices, waybills, and acceptance certificates must match the delivered batch; discrepancies are recorded and reported to the supplier.

Good Pharmacy Practice (GPP/FIP) requires the pharmacist to assess the patient's problem, verify the prescription, counsel on use, and follow up on outcomes rather than merely sell a product.

Pharmaceutical care: identify actual or potential drug-related problems (indication, effectiveness, safety, adherence), then intervene and document.

Rational use of medicines: correct medicine, correct dose, correct duration, correct route, and correct patient; avoid unnecessary antibiotics and polypharmacy.

Prescription screening: check dose against age/weight/renal function, interactions, contraindications, duplication, and legal validity (date, prescriber, signature, quantity).

Counseling core content: dose and timing, with or without food, duration, missed-dose guidance, key adverse effects, storage, and when to seek medical help.

Antimicrobial stewardship: complete the prescribed course for confirmed bacterial infection, avoid use for viral illness, and report adverse reactions; adherence reduces resistance selection.

Self-medication limits: OTC recommendations must respect age, pregnancy, comorbidity, and existing therapy; refer to a physician when red flags are present.

Documentation and adverse-event reporting: record interventions and report suspected adverse drug reactions to the national pharmacovigilance system.

Epidemiological triad: agent, host, and environment; transmission routes are airborne/droplet, fecal–oral, contact, vector-borne, and blood-borne.

Chain of infection control: eliminate the agent, block transmission (hand hygiene, disinfection, PPE), and protect the host (immunization, prophylaxis).

Immunization types: live attenuated (measles, mumps, rubella, BCG) - contraindicated in severe immunosuppression and pregnancy; inactivated, toxoid, subunit, and mRNA/vector vaccines.

Vaccine storage: most vaccines require +2 to +8 °C cold chain; live vaccines are heat- and light-sensitive; freeze-sensitive vaccines (e.g., adsorbed toxoids) must not be frozen.

Cold chain monitoring: continuous temperature logging and a vaccine vial monitor or threshold indicator; excursions require assessment and documentation before use.

Herd immunity thresholds vary by pathogen (e.g., ~95% for measles, lower for some others); high coverage protects those who cannot be vaccinated.

Healthcare-associated infection prevention: hand hygiene before and after patient contact, aseptic technique for sterile compounding, and disinfection of surfaces and equipment.

Post-exposure prophylaxis: for needlestick or mucosal exposure, immediately wash, report, and follow protocol for hepatitis B immunoglobulin/vaccine and HIV post-exposure prophylaxis within the recommended window.

Basic life support sequence: check responsiveness and breathing, call for help, start chest compressions at 100–120/min, depth 5–6 cm, ratio 30:2 with ventilations, use AED as soon as available.

Anaphylaxis: intramuscular adrenaline into the anterolateral thigh at the standard adult dose (0.3–0.5 mg of 1:1000), repeat after 5–15 min if needed, call emergency services, position supine with legs raised.

Hypoglycemia in a conscious patient: oral fast-acting carbohydrate; if unconscious, do not give orally - call emergency services and follow protocol for parenteral glucose.

Fainting (vasovagal syncope): lay the patient supine, raise the legs, loosen tight clothing, ensure fresh air, monitor recovery; do not give oral fluids until fully conscious.

Seizure first aid: protect the patient from injury, do not restrain and do not put anything in the mouth, time the seizure, call emergency services if it lasts over 5 minutes or recurs.

Bleeding and wounds: apply direct pressure with a clean dressing; for needlestick injuries, wash with soap and water, do not squeeze, report immediately and follow post-exposure protocol.

Patient safety in the pharmacy: distinguish look-alike/sound-alike names, double-check high-risk medicines, label clearly, and use an independent second check for compounded or high-risk preparations.

Emergency kit: the pharmacy should maintain accessible first-aid supplies and an emergency plan with documented staff training and periodic drill.

Ethical principles: beneficence, non-maleficence, autonomy (informed consent), confidentiality, and justice - applied to dispensing and counseling decisions.

Pharmacist duty to the patient overrides commercial interest: refuse to dispense a falsified or invalid prescription and report it through the defined channel.

Confidentiality: patient data may be disclosed only with consent or where law requires it; storage and transmission of records must be secure.

Communication: use plain language, confirm understanding by teach-back, avoid jargon, and address health literacy and language barriers.

Conflict of interest: gifts or inducements that influence prescribing or dispensing recommendations must be disclosed or declined.

Quality and safety standards: documented standard operating procedures, incident and near-miss reporting without blame, and root-cause analysis to prevent recurrence.

Medication error prevention: read-back for verbal orders, clear labeling, separation of look-alike products, and verification of patient identity and dose before handover.

Professional competence: continuing education and self-assessment maintain knowledge; practicing outside one's competence requires referral to a qualified colleague.