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CM19.1-4 | Essential Medicine — Graded Quiz
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The concept of essential medicines was introduced by WHO in:
Correct. WHO launched the essential medicines concept in 1977 with the first Model List of Essential Medicines.
The WHO Expert Committee on Essential Medicines first met in 1977 and produced the inaugural list of 208 essential medicines. The list is now revised biennially; the 28th edition (2023) contains 502 medicines.
Incorrect. WHO introduced the essential medicines concept in 1977 with its first Model List.
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India's National List of Essential Medicines (NLEM) 2022 contains:
Correct. NLEM 2022 has 384 medicines across 27 therapeutic categories.
NLEM 2022: 384 medicines, 27 categories — released September 2022. NLEM 2015 had 376 medicines. WHO EML 28th ed (2023): 502 medicines. Distinguish these two lists — a common exam trap.
Incorrect. NLEM 2022 contains 384 medicines. 376 was the NLEM 2015 count; 502 is the WHO EML 2023 count.
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Which of the following is NOT a criterion used in selecting medicines for the WHO Essential Medicines List?
Correct. Country of manufacture is irrelevant to WHO EML selection. The criteria are disease burden, efficacy, safety, and cost-effectiveness.
WHO EML selection criteria are strictly evidence-based and population-need based — they never include geographic origin, patent status, or manufacturer nationality. This ensures global applicability.
Incorrect. Country of manufacture is NOT a selection criterion. The WHO criteria are: disease prevalence, efficacy evidence, safety profile, and comparative cost-effectiveness.
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WHO defines rational use of medicines as prescribing the right medicine, at the right dose, for the right duration, to the right patient, at the right price. Which additional component completes this definition?
Correct. The WHO rational use definition includes: right medicine, right dose, right duration, right patient, right price, and available at the right time (accessibility component).
WHO's rational use framework (Nairobi Conference, 1985) has six 'rights': right patient, right drug, right dose, right route, right duration, right time. Availability is integral — a medicine that is correctly prescribed but unavailable fails rational use.
Incorrect. The accessibility dimension of rational use includes availability 'at the right time' — medicines must be available when needed to be truly rationally used.
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The key feature that distinguishes a FALSIFIED medicine from a SUBSTANDARD medicine is:
Correct. Falsified medicines involve deliberate misrepresentation (fraud). Substandard medicines are authorised products that fail quality specifications — the failure may be unintentional.
WHO GSMS definitions: Substandard = authorised product failing quality standards; Falsified = deliberate misrepresentation of identity/source/composition. 'Counterfeit' is a legal/IP term. All three categories harm patients but require different regulatory responses.
Incorrect. The defining difference is intent and origin: falsified = deliberate fraud; substandard = quality failure (often unintentional) in an authorised product.
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In India, the apex regulatory body responsible for approval of new drugs and oversight of medicine quality (including detecting substandard and falsified medicines) is:
Correct. CDSCO under the Ministry of Health and Family Welfare is India's apex drug regulatory body — it approves new drugs, regulates clinical trials, and enforces quality standards under the Drugs and Cosmetics Act 1940.
Key regulatory agencies: CDSCO — drug approval and quality enforcement; NPPA — price control under DPCO; ICMR — biomedical research; NMC — medical education. Falsified/substandard medicines are reported to state drug controllers and CDSCO via the pharmacovigilance system.
Incorrect. CDSCO is the apex drug regulator in India. NPPA controls prices; ICMR conducts research; NMC regulates medical education.
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The method for calculating drug requirements at a PHC that is based on past drug utilization adjusted for morbidity patterns is called the:
Correct. The consumption method uses historical drug utilization data (adjusted for stock-outs and morbidity trends) to forecast future requirements.
Three main drug quantification methods: (1) Consumption method — past use data + adjustments; easiest but perpetuates irrational use. (2) Morbidity method — disease incidence × standard treatment protocols; most rational but requires complete data. (3) Service level method — based on patient load. PHC most commonly uses the consumption method.
Incorrect. Using past consumption data adjusted for morbidity/stock-outs is the 'consumption method'. The morbidity method uses disease prevalence and standard treatment protocols instead.
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A PHC Medical Officer is preparing an annual drug indent for Cotrimoxazole tablets (WHO EML, NLEM 2022). She adds 15% buffer stock to her calculated requirement. The PRIMARY purpose of this buffer stock is to:
Correct. Buffer (safety) stock is maintained to protect against supply chain variability — delayed deliveries, transportation disruptions, or unexpected disease outbreaks causing demand surges.
Buffer stock (typically 10-25% of annual consumption at PHC level) is calculated as: Buffer = Annual requirement × Buffer %. It covers the 'lead time' (time between order placement and receipt) and demand variability. Cotrimoxazole (sulfamethoxazole+trimethoprim) appears on both WHO EML and NLEM 2022 for respiratory and urinary infections.
Incorrect. Buffer stock primarily protects against supply-chain delays and demand surges, not expiry losses or revenue generation.
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