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CM19.1-4 | Essential Medicine — Practice Quiz
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The 28th edition of the WHO Model List of Essential Medicines (2023) contains how many medicines?
Correct. The 28th edition WHO EML (2023) contains 502 medicines across the core list and complementary list.
The WHO EML (28th ed, 2023) has 502 medicines. India's NLEM 2022 has 384 medicines across 27 therapeutic categories — a distinct national adaptation. Both are regularly revised based on disease burden, efficacy, safety, and cost-effectiveness evidence.
Incorrect. The 28th edition WHO EML (2023) lists 502 medicines. 384 is the count for India's NLEM 2022.
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According to the WHO, essential medicines are those that:
Correct. This is the WHO's formal definition of essential medicines, emphasizing population-level health need, evidence of efficacy and safety, and comparative cost-effectiveness.
The WHO definition (adopted 1977, revised multiple times) centres on four selection criteria: disease prevalence and public health relevance; evidence of efficacy and safety; comparative cost-effectiveness. NLEM inclusion confers neither prescription-only nor OTC status automatically.
Incorrect. The WHO defines essential medicines as those satisfying priority health care needs of the population, selected based on disease prevalence, efficacy, safety, and cost-effectiveness.
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At a Primary Health Centre (PHC), the Medical Officer notes that the government drugs available are entirely from the NLEM 2022 list. The primary purpose of restricting the PHC formulary to NLEM medicines is to:
Correct. The NLEM at PHC level promotes rational use: right drug, right dose, right duration, at the lowest cost — reducing irrational polypharmacy and ensuring equitable access.
WHO's rational use principle — right patient, right drug, right dose, right duration, right price — is operationalised at PHC through the NLEM formulary. DPCO controls prices of listed medicines (Schedule H/H1), but price control is a downstream effect, not the primary purpose of listing.
Incorrect. The core purpose of the NLEM at PHC is to promote rational prescribing and ensure availability of evidence-based, affordable medicines for the population's priority health needs.
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A drug inspector seizes tablets from a licensed manufacturer that contain only 60% of the labelled active ingredient — below the pharmacopoeial standard. According to WHO classification, these tablets are best described as:
Correct. Substandard medicines (also called out-of-specification products) are authorised medicines that fail to meet quality standards or specifications. They may arise from poor manufacturing practice, degradation, or inadequate quality control.
WHO distinguishes three categories: (1) Substandard — authorised, but fail quality standards (poor GMP, degradation); (2) Falsified — deliberate misrepresentation of identity/source/composition; (3) Unregistered/unlicensed — no marketing authorisation. 'Counterfeit' is a legal/IP term, not WHO's preferred technical classification.
Incorrect. Medicines from a licensed manufacturer that fail pharmacopoeial standards are 'substandard' (out-of-specification), not falsified or counterfeit.
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A pharmacist in a rural pharmacy receives a shipment of Artemether-Lumefantrine tablets with an unfamiliar hologram that differs from the manufacturer's authentic sticker, and the batch number cannot be verified on the CDSCO track-and-trace portal. This product is MOST likely a:
Correct. The deliberate misrepresentation of identity (fake hologram, unverifiable batch) indicates a falsified medicine — intentional fraud in composition, source, or identity.
Falsified medicines deliberately misrepresent identity, composition, or source. Red flags: packaging inconsistencies, unverifiable batch numbers (CDSCO track-and-trace), suspect holograms. Artemether-Lumefantrine is a WHO EML antimalarial (core list) — falsification of antimalarials is a documented public health emergency globally.
Incorrect. Deliberate misrepresentation of source/identity makes this a falsified medicine. Substandard medicines come from legitimate manufacturers but fail quality tests.
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Statement 1 (Assertion):
India's NLEM 2022 contains fewer medicines (384) than the WHO EML 28th edition (502).
BECAUSE
Statement 2 (Reason):
National essential medicine lists are adaptations that prioritise locally prevalent diseases and available health system resources, so they may differ substantially from the WHO model list.
Select the correct relationship:
Correct. Both statements are true, and the reason correctly explains why NLEM ≠ WHO EML. National lists reflect local disease burden, available infrastructure, and affordability — the WHO model is a global reference, not a prescription for national adoption.
WHO EML serves as a global reference model. Countries adapt it based on: (1) local disease burden; (2) available health infrastructure; (3) national affordability. India's NLEM 2022 revision added medicines for rare diseases, mental health, and oncology while removing some older molecules — reflecting local priorities.
Incorrect. Both the assertion (384 vs 502) and reason (national adaptation rationale) are true, and the reason correctly explains the difference.
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CLINICAL SCENARIO
A Medical Officer at a PHC serving 10,000 population is calculating annual drug requirements for Oral Rehydration Salts (ORS) sachets. Past consumption data (adjusted for stock-outs) shows 2,400 sachets used last year. The MO estimates a 10% population growth, and wishes to add a 15% buffer stock to prevent stock-outs. The PHC receives medicines quarterly.
Answer the following questions based on the scenario above.
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Using the consumption-based method, what is the TOTAL annual indent (procurement requirement) the MO should place, including buffer stock?
Correct. Adjusted consumption = 2,400 × 1.10 = 2,640. Buffer = 2,640 × 0.15 = 396. Total = 2,640 + 396 = 3,036 sachets.
Incorrect. Step 1: Adjust for growth — 2,400 × 1.10 = 2,640. Step 2: Add buffer — 2,640 × 0.15 = 396. Total = 3,036 sachets.
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Since the PHC receives medicines quarterly, what should be the quantity in EACH quarterly indent request (excluding buffer stock, which is maintained centrally)?
Correct. Growth-adjusted annual = 2,640. Quarterly = 2,640 ÷ 4 = 660 sachets.
Incorrect. Growth-adjusted annual consumption = 2,640 ÷ 4 = 660 sachets per quarter (buffer maintained centrally).
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India's National List of Essential Medicines (NLEM) 2022 is organised into how many therapeutic categories?
Correct. NLEM 2022 contains 384 medicines organized into 27 therapeutic categories.
NLEM 2022 (released September 2022) superseded NLEM 2015. Key changes: 384 medicines (up from 376), 27 therapeutic categories, addition of new molecules for rare diseases, hepatitis C, oncology, and mental health. The NLEM informs public procurement, price control (DPCO), and PHC formulary policy.
Incorrect. NLEM 2022 has 384 medicines across 27 therapeutic categories.
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