QPPV.COM KNOWLEDGE ASSESSMENT

Knowledge Assessment: Controlled Access and Controlled Distribution of Medicines in the EU

Test your understanding of the concepts covered by Controlled Access and Controlled Distribution of Medicines in the EU: Non-Pregnancy Risk-Minimisation Approaches and Member State Implementation.

Question 1 of 10Pass mark: 80%

Question 1 of 10 What is the appropriate QPPV position when a distributor performs eligibility checks on behalf of the MAH?

The MAH has no further responsibility because the activity is outsourced. The distributor becomes the regulatory decision-maker for the product. The MAH retains oversight responsibility and should define contractual responsibilities, data, performance requirements and escalation pathways. The activity can be excluded from the quality system because it is commercial.

Question 2 of 10 Which statement best distinguishes a controlled access programme from a controlled distribution system?

A controlled access programme focuses on eligibility conditions before prescribing, dispensing or supply, whereas a controlled distribution system focuses on ensuring that the required supply pathway is followed. A controlled access programme applies only to hospital medicines, whereas a controlled distribution system applies only to community medicines. A controlled access programme concerns product quality, whereas a controlled distribution system concerns adverse reaction reporting. A controlled access programme is a routine measure, whereas a controlled distribution system is always an additional risk-minimisation measure.

Question 3 of 10 Why might administration be restricted to authorised treatment centres?

Because all centrally authorised medicines must be administered in hospitals. Because the product may require specialised equipment, trained staff or immediate management of serious reactions. Because community pharmacies are never permitted to dispense biological products. Because treatment-centre restrictions eliminate the need for product monitoring.

Question 4 of 10 Which conclusion about non-pregnancy CAP/CDS measures is most accurate?

They are limited to preventing fetal exposure. They may address eligibility, diagnostic confirmation, specialist use, administration setting, monitoring, medication errors, misuse, diversion or supply-chain risks. They are applicable only to medicines with a narrow therapeutic margin. They are alternatives to product information and routine prescribing controls.

Question 5 of 10 Which item is most useful in an implementation matrix for demonstrating the link between an EU objective and national execution?

The product's global advertising expenditure. The national mechanism, operational evidence and accountable owner for each control element. Only the name of the Member State. A list of all adverse events reported for the product, without reference to the control.

Question 6 of 10 What is the principal transferable lesson from the YESCARTA and STRIMVELIS examples?

All advanced therapies must be dispensed through community pharmacies. The technical characteristics and treatment process may require qualified centres, specialised handling and appropriate clinical infrastructure. Advanced therapies do not require adverse-event monitoring once administered in a centre. A centre-based pathway is justified solely by the product's commercial value.

Question 7 of 10 When does a required laboratory test function as an access control rather than merely as clinical monitoring?

When the test is listed in the product information, regardless of how results are used. When the result is required before supply or continuation and an unacceptable result prevents or changes the treatment decision. When the test is performed by a hospital laboratory rather than a community laboratory. When the test is repeated at least monthly.

Question 8 of 10 During an inspection, which evidence chain would provide the strongest demonstration of CAP/CDS governance?

A copy of the educational material alone. The approved safety rationale, control design, national procedures, records of actual operation, deviation management and effectiveness evaluation. Annual sales data without information about eligibility or distribution channels. A list of registered healthcare professionals without evidence of dispensing or prescribing checks.

Question 9 of 10 Which indicator would best evaluate whether a restriction to authorised prescribers is working?

The number of educational leaflets printed. The percentage of authorised prescribers who completed optional training. The proportion of prescriptions issued by authorised versus unauthorised prescribers, including detected exceptions. The total annual sales volume without reference to prescriber status.

Question 10 of 10 Which scenario most directly supports restricting prescribing to registered healthcare professionals?

The medicine has a high marketing budget. The medicine requires specialist diagnosis and clinical judgement to initiate safely. The medicine is available in more than one pack size. The medicine is supplied in a recyclable package.

Knowledge Assessment: Controlled Access and Controlled Distribution of Medicines in the EU

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