Measures to manage, reduce and prevent medicines shortages in European countries in 2020
Bibliographic record
Abstract
Abstract Background Several countries have seen an increase in medicines shortages that constitute a major public health threat as they can negatively impact the health outcomes of patients. The study aims to survey measures that European countries apply or consider introducing to address medicines shortages. Methods A questionnaire was sent to the public authorities, as involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network, in 47 countries, thereof 44 countries of the WHO European region. Respondents were asked to report measures in place or being discussed as of the first quarter of 2020. Results Preliminary data from 8 countries (Albania, Austria, Finland, Germany, Italy, the Netherlands, Romania, Sweden; further responses are expected) show that national registers to which manufacturers notify, usually on a mandatory basis, upcoming and existing shortages (including end dates and causes in some countries) are common (all countries but Albania). Medicine reserve supplies that have to be kept for defined medicines exist in Albania and Finland; they are being established the Netherlands and are under discussion in Germany and Sweden. Finland and Italy allow issuing export bans for targeted medicines; this possibility is before implementation in Austria, was planned and then withdrawn in Romania and is under discussion in the other countries (except Albania). Further measures include simplified import permits (with patient information leaflets in foreign language), working groups with relevant stakeholders and financial sanctions for manufacturers in case of non-supply. Conclusions Governments have been reacting to shortages by implementing appropriate measures and adapting existing ones. Actions taken differ with regard to stakeholders addressed, the degree of obligation and the focus (optimising the management of existing shortages vs. prevention of future supply limitations). Key messages A mix of measures to address medicine shortages is applied in European countries. Recently, the number of measures increased, and actions requested from stakeholders tend to have become mandatory.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.000 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".