Table 2.

Dimensions and sub-dimensions framework for assessing patient safety risks associated with medications procured over the internet tailored to ophthalmic preparations.

Dimensions of risk assessment		Sub-dimensions focusing on the risk factors specific to the evaluated drug class
INTRINSIC RISKS	1. General pharmaceutical risk	1.1. Dosage form
		1.2. Complexity of application
	2. Therapeutic risk	2.1. Mode of action
		2.2. Systemic absorption
		2.3. Altered absorption (Indication including damaged eye)
		2.4. Narrow therapeutic index (NTI)
		2.5. Special patient group (Pediatric indication)
	3. Risk of microbiological contamination	3.1. Single-dose vs. Multi-dose or Antimicrobial filter
		3.2. Preservative content
		3.3. API is an antibiotic
EXTRINSIC RISKS	4. Augmented demand for online purchase	4.1 Limited access (drug shortage, prescription requirement)
		4.2. Misuse potential (off-label indications, illegal use)
RISK OF COUNTERFEITING	5. Unregistered/unlicensed: Medical products which have not undergone evaluation and/or approval by the National or Regional Regulatory Authority (NRRA) for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation	5.1. Based on preliminary evaluation whether the drug product is unregistered, investigational, or withdrawn.
	Falsified1: Medical products deliberately/fraudulently misrepresent their identity, composition or source.	Determined only by physical examination or by the verification of the serialized product.
	Substandard1: Also referred to as, “out of specification”, these are authorized medical products which fail to meet either their quality standards or specifications, or both.	Only complete analytics can assess safety risk.

¹Risk of falsification and substandard quality cannot be integrated in the pre-purchase assessment, as such properties are undeterminable without physical and analytical examination. Accordingly, complete counterfeit risk assessment can be performed following actual purchase and delivery of products.