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Vocabulary

AF (assessment factor), see under PNEC.

ATC system (anatomic therapeutic chemical classification system) is a classification system for pharmaceuticals used by WHO. The ATC system consists of 14 main anatomical/pharmacological groups, where active substances are classified based on their main therapeutic use. In addition to these main groups, the substances are classified in a hierarchy of four different levels: the second and third levels are usually a therapeutic/pharmacological subgroup, the fourth level is the chemical subgroup and the fifth level the chemical substance. When different pharmaceuticals contain the same active substance but have clearly different indications and are used in substantially different doses, the substances end up in different groups.

Bioaccumulation is the ability of a substance to accumulate in fatty tissue of aquatic organisms. Bioaccumulation is assessed on the partition coefficient (n-octanol/water), usually reported as log Kow (also log Pow) where substances with log Kow ≥ 4.5 are assessed as having a high potential for bioaccumulation (OECD test 107 or 117). However, there is a gray area between log Kow 3.0 and 4.5. If the n-octanol/water partition coefficient indicates that a substance has the potential to bioaccumulate, then the bioconcentration factor (BCF), see BCF, should be determined.

BCF (bioconcentration factor) is the ratio of the concentration in aquatic organisms to the concentration in water at steady state. Different regulations specify different thresholds for BCF. The CLP Regulation states that a substance has a high potential to bioaccumulate when BCF ≥ 500 L/kg. According to the REACH Regulation, a substance fulfills the criterion for bioaccumulation when BCF is > 2 000 L/kg.

CEC (critical environmental concentration) is the calculated concentration of a substance in surface water that is expected to have pharmacological effect in fish. Among aquatic organisms, fish share many target proteins for human medicines. If the ratio of CEC to measured concentration of a substance becomes 1 or less, this indicates that measured concentration can be expected to cause pharmacological effect in fish.

CHMP (Committee for Medicinal Products for Human Use) is the European Medicines Agency's (EMA) Scientific Committee, responsible for producing proposals for EU-wide decisions on centralised procedure for human medicines, such as new marketing authorisation or assessing modifications or extensions ('variations') to an existing marketing authorisation. The formal decisions are made by the EU Commission.

The CLP (classification, labelling and packaging) Regulation contains rules for the classification, labeling and packaging of chemical products.

Cyanobacteria, blue-green algae, are recommended for effects testing of antimicrobials in environmental risk assessments according to the European guidelines for risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 corr 2).

DDD (defined daily dose) is the assumed average maintenance dose per day for a drug used for its main indication in adults. The DDD is a unit of measurement and does not necessarily reflect the recommended or prescribed daily dose (PDD). DDDs are not established for e.g. topical products. In Sweden, 1 gram = 1 DDD is sometimes used for the calculation of topical drugs, which is not based on the amount of active substance. Therefore, DDD for topical drugs cannot be compared to DDD for drugs for internal use.

The detection limit (DL, LOD, LLD) for a chemical analysis method is the lowest concentration at which a substance can be detected.

EC50 (effect concentration) refers to the test concentration of a substance at which 50 % of the animals are estimated to be immobile/dead. Can also be called LC50 (lethal concentration) or IC50 (inhibitory concentration).

ECHA (European Chemicals Agency).

EMA (European Medicines Agency).

Environmental hazard, see Hazard.

Environmental risk, see Risk.

ERA (environmental risk assessment) is an environmental risk assessment that is mandatory for the dossier for the marketing authorisation of human medicinal product.

Hazard expresses the inherent, environmentally harmful characteristics of a pharmaceutical substance, such as resistance to degradation (persistence), ability to accumulate in adipose tissue (bioaccumulation), and its toxicity to aquatic organisms (toxicity). See further under each characteristic.

Hazard ratio, see PEC/PNEC ratio.

Hazard score (previously referred to as the PBT index) is used in the Stockholm Region's Environment and Medicines database and is the sum of the values for persistence, bioaccumulation and toxicity for a substance where each characteristic is assigned a numerical value, 0–3. The sum of the values constitutes the hazard score, 0–9. The higher the value, the greater the substance's danger to the environment.

LOEC (lowest observed effect concentration) is the lowest statistically significant concentration of a substance at which effects are observed.

Log Kow, see Bioaccumulation.

Log Pow, see Bioaccumulation.

LOQ (limit of quantification) for a chemical analysis method is the lowest concentration that can be quantitatively determined with satisfactory safety.

MEC (measured environmental concentration) is the measured concentration of a substance.

MIC (minimal inhibitory concentration) is the lowest concentration of a antibiotic required to inhibit bacterial growth.

NOEC (no observed effect concentration) is the highest test concentration of a substance where no effect is observed. In some cases, there is only data for LOEC and then an approximate NOEC value can be obtained by dividing the value for LOEC by 2.

OECD (Organisation for Economic Co-operation and Development) guidelines for testing chemicals is a collection of the most relevant, internationally agreed test methods used by authorities, industry and independent laboratories to identify and characterize potentially hazardous properties of a substance/chemical.

PBT index, see Hazard score.

PBT and vPvB substances are substances with particularly environmentally hazardous properties, PBT (Persistent, Bioaccumulative and Toxic) and vPvB (very Persistent and very Bioaccumulative) according to the regulatory guideline.

PEC (predicted environmental concentration) is the calculated concentration of a substance in the environment.

The PEC/PNEC ratio is used to calculate the environmental risk, i.e. toxic risk to the aquatic environment, and is based on the ratio between estimated concentration of a pharmaceutical in Swedish water systems when used to the present extent or expected use for newly approved pharmaceuticals in Europe (= PEC), and the concentration that is predicted to be safe for aquatic organisms and plants (= PNEC).

Persistence is the ability of a substance to resist degradation in the aquatic environment. Persistence is assessed based on criteria for degradability according to OECD's test guidelines (test 301, 308) or corresponding other degradability tests.

PNEC (predicted no effect concentration) is the highest concentration of a substance that is considered safe for animals and plants living in a particular environment. PNEC is calculated based on toxicity tests (NOEC/EC10 or LC50/EC50/IC50) with algae, crustaceans and fish divided by a safety factor (assessment factor, AF [EMEA/CHMP/SWP/4447/00 corr 2]).

The Precautionary principle (Environmental Code, chapter 2, 3 §) is adopted and means that actions can be taken when scientific evidence about an environmental or human health hazard is uncertain but there are grounds for suspecting that a product or production causes unacceptable effects on human, animal and plant health or on the environment. The precautionary principle is included in the EU's statutory requirement and is applied in all member states.

Reach (registration, evaluation, authorisation and restriction of chemicals) is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be caused by chemicals.

Recipient is a water system that receives emissions of for example purified wastewater.

Reduction in wastewater treatment plants of a substance refers to concentration reduction through separation and/or degradation in effluent compared to influent water.

The Risk (environmental risk) relates to the likelihood of toxic effects on aquatic organisms, i.e., a comparison between exposure and toxicity. Exposure can either be based on the current use of a pharmaceutical substance or on the expected use for a newly approved pharmaceutical. The risk depends on how much of a pharmaceutical we use and how much reaches nature. An increased or decreased use of a pharmaceutical could mean a change in risk. In recent years, risk assessments have been carried out based on measured levels in the environment of several pharmaceuticals

Toxicity (ecotoxicities) is a substance's potential to poison aquatic organisms. Toxicity for aquatic organisms is assessed based on the results of toxicity tests on species from three different trophic levels in the food chain: algae, crustaceans and fish (OECD Test Guidelines for acute toxicity 201, 202 and 203, or equivalent). Test guidelines for chronic toxicity (NOEC) are the OECD Test Guidelines 201, 210 and 211. Data for the most sensitive organism is used in the assessment.

The Wise list is the Stockholm Region Drug and Therapeutics Committee's recommended essential pharmaceuticals in primary care, specialized outpatient and inpatient care. The recommendations are based on scientific documentation regarding efficacy and safety, pharmaceutical effectiveness, cost-effectiveness and environmental aspects. For comparable medical effects and safety, cost and environmental assessment should be weighed together and the most advantageous alternative is recommended.

Senast ändrad 2019-03-15