@tekkare/romulus 0.1.251 → 0.1.253

package/layer/app/oip-drugs/composables/useHeartIntlApprovals.ts

@@ -0,0 +1,661 @@
+/**
+ * Les autorisations et avis etrangers d'une marque, un registre par pays.
+ *
+ * Six agences, six schemas : l'AIFA publie des extraits de Gazzetta Ufficiale,
+ * l'AEMPS des rapports de positionnement, le G-BA des evaluations de benefice
+ * par population, la MHRA un document par molecule qui porte ses produits,
+ * l'EMA un EPAR par medicament, la FDA une pile de soumissions par dossier.
+ *
+ * Tout est ramene ici a un seul objet (le meme que les onglets Alertes, PUT
+ * et Contributions donnent deja a `heart-results-details-record-drawer`) pour
+ * que la carte pays n'ait pas a connaitre six formats.
+ */
+import { ES_INDEX } from "../esIndices";
+import useOipDrugsElastic from "./useOipDrugsElastic";
+
+export interface HeartIntlRecord {
+  key: string;
+  /** Nature du document, telle que l'agence la nomme. */
+  typeLabel: string;
+  icon: string;
+  date: string | null;
+  title: string;
+  excerpt?: string | null;
+  badge?: string | null;
+  badgeTone?: "pre" | "post" | "good" | "warn" | "neutral";
+  status?: string | null;
+  statusTone?: "good" | "bad" | "neutral";
+  url?: string | null;
+  sourceLabel: string;
+  sections: { key: string; label: string; body: string }[];
+}
+
+/**
+ * Les pays du regard international, dans l'ordre de lecture de la fiche.
+ *
+ * `priceSource` et `approvalSource` sont les fiches Directus citees en pied de
+ * carte, comme partout ailleurs dans l'app. L'Italie n'en a qu'une : l'AIFA
+ * publie sous la meme reference ses listes de prix et ses decisions.
+ */
+export const HEART_INTL_COUNTRIES = [
+  {
+    iso: "EU",
+    key: "EU",
+    agency: "EMA",
+    fr: "Union européenne",
+    en: "European Union",
+    priceSource: null,
+    approvalSource: "d5a2cb42-69af-4c6d-8ea7-b318b2538bfd",
+  },
+  {
+    iso: "DE",
+    key: "DE",
+    agency: "G-BA",
+    fr: "Allemagne",
+    en: "Germany",
+    priceSource: "70416855-3761-4085-9664-b01ec4db30dc",
+    approvalSource: "4fa70cd9-7918-47e9-920e-a2059b964519",
+  },
+  {
+    iso: "ES",
+    key: "ES",
+    agency: "AEMPS",
+    fr: "Espagne",
+    en: "Spain",
+    priceSource: "765a7f89-09c3-483a-b6b0-4046738a3bb4",
+    approvalSource: "7cfd0f9c-cdda-44fe-872f-989edd258c16",
+  },
+  {
+    iso: "IT",
+    key: "IT",
+    agency: "AIFA",
+    fr: "Italie",
+    en: "Italy",
+    priceSource: "a91e97d1-b6b2-4f65-98b4-0914d14c4ac0",
+    approvalSource: null,
+  },
+  {
+    iso: "GB",
+    key: "GB",
+    agency: "MHRA",
+    fr: "Royaume-Uni",
+    en: "United Kingdom",
+    priceSource: "6ae4d4c6-a073-4cce-975f-3b255d3dd908",
+    approvalSource: "6ed39046-aa49-4266-bb02-7c3fe339d2b1",
+  },
+  {
+    iso: "US",
+    key: "US",
+    agency: "FDA",
+    fr: "États-Unis",
+    en: "United States",
+    priceSource: "244d86d9-5a81-4560-ba75-d5a8664a2d18",
+    approvalSource: "4c344cfe-94b5-4e25-9241-0f74d04a939b",
+  },
+] as const;
+
+/** Le texte des agences arrive parfois en HTML : on ne veut que la phrase. */
+function clean(value: any): string {
+  if (typeof value !== "string") return "";
+  return value
+    .replace(/ /g, " ")
+    .replace(/<[^>]+>/g, " ")
+    .replace(/\s+/g, " ")
+    .trim();
+}
+
+/** Premiere valeur remplie : la langue du lecteur, puis celle de l'agence. */
+function pick(...values: any[]): string {
+  for (const value of values) {
+    const text = clean(value);
+    if (text) return text;
+  }
+  return "";
+}
+
+/** Un texte long ne tient pas dans une ligne de tableau. */
+function excerptOf(text: string, length = 180) {
+  const value = clean(text);
+  return value.length > length ? `${value.slice(0, length).trimEnd()}...` : value;
+}
+
+/** Une date d'agence, parfois en millisecondes (EMA), parfois en ISO. */
+function asDate(value: any): string | null {
+  if (value === null || value === undefined || value === "") return null;
+  if (typeof value === "number") return new Date(value).toISOString().slice(0, 10);
+  return String(value).slice(0, 10);
+}
+
+/** Le benefice supplementaire du G-BA : une bonne et une mauvaise nouvelle. */
+function benefitTone(label: string): "good" | "bad" | "neutral" {
+  const value = label.toLowerCase();
+  if (!value) return "neutral";
+  if (value.includes("not proven") || value.includes("no added") || value.includes("lesser"))
+    return "bad";
+  if (value.includes("non-quantifiable") || value.includes("non quantifiable")) return "neutral";
+  return "good";
+}
+
+export default function useHeartIntlApprovals() {
+  // Les index APPROVAL_* passent par la cle ES dediee : le proxy du layer la
+  // choisit, a condition de les interroger un par un (jamais en multi-index).
+  const { queryCustomElastic } = useOipDrugsElastic();
+  const { locale } = useI18n();
+
+  const records = ref<Record<string, HeartIntlRecord[]>>({});
+  const isLoading = ref(false);
+
+  const en = () => locale.value === "en";
+
+  /** L'EPAR europeen : un document par medicament autorise. */
+  async function loadEma(brand: string): Promise<HeartIntlRecord[]> {
+    const res = await queryCustomElastic({
+      index: ES_INDEX.APPROVAL_EU_EMA,
+      customQuery: {
+        size: 10,
+        _source: [
+          "product_label",
+          "ema_product_number",
+          "medicine_status",
+          "marketing_authorisation_date",
+          "european_commission_decision_date",
+          "therapeutic_indication",
+          "inn_common_name",
+          "company",
+          "atc_code",
+          "url",
+          "is_orphan_medicine",
+          "is_conditional_approval",
+          "is_biosimilar",
+          "is_generic",
+          "is_advanced_therapy",
+          "is_additional_monitoring",
+        ],
+        query: { match_phrase: { product_label: brand } },
+        track_total_hits: true,
+      },
+    });
+
+    return (res?.results ?? []).map((doc: any, index: number) => {
+      const flags = [
+        doc.is_orphan_medicine && (en() ? "Orphan" : "Médicament orphelin"),
+        doc.is_conditional_approval && (en() ? "Conditional" : "AMM conditionnelle"),
+        doc.is_biosimilar && (en() ? "Biosimilar" : "Biosimilaire"),
+        doc.is_generic && (en() ? "Generic" : "Générique"),
+        doc.is_advanced_therapy && (en() ? "ATMP" : "Thérapie innovante"),
+        doc.is_additional_monitoring && (en() ? "Additional monitoring" : "Surveillance renforcée"),
+      ].filter(Boolean) as string[];
+
+      return {
+        key: doc.ema_product_number || `ema-${index}`,
+        typeLabel: "EPAR",
+        icon: "Certificate",
+        date: asDate(doc.marketing_authorisation_date ?? doc.european_commission_decision_date),
+        title: pick(doc.product_label) || brand,
+        excerpt: excerptOf(doc.therapeutic_indication),
+        badge: doc.ema_product_number || null,
+        status: pick(doc.medicine_status),
+        statusTone: /authorised/i.test(doc.medicine_status || "") ? "good" : "bad",
+        url: doc.url || null,
+        sourceLabel: "EMA",
+        sections: [
+          {
+            key: "indication",
+            label: en() ? "Therapeutic indication" : "Indication thérapeutique",
+            body: clean(doc.therapeutic_indication),
+          },
+          {
+            key: "identity",
+            label: en() ? "Marketing authorisation" : "Autorisation de mise sur le marché",
+            body: [
+              doc.inn_common_name && `${en() ? "INN" : "DCI"} : ${doc.inn_common_name}`,
+              doc.company && `${en() ? "Company" : "Laboratoire"} : ${doc.company}`,
+              doc.atc_code && `ATC : ${doc.atc_code}`,
+              flags.length && `${en() ? "Status" : "Statuts"} : ${flags.join(", ")}`,
+            ]
+              .filter(Boolean)
+              .join("\n"),
+          },
+        ],
+      } satisfies HeartIntlRecord;
+    });
+  }
+
+  /** G-BA : une evaluation par population de patients. */
+  async function loadGba(brand: string): Promise<HeartIntlRecord[]> {
+    const res = await queryCustomElastic({
+      index: ES_INDEX.APPROVAL_DE_GBA,
+      customQuery: {
+        size: 100,
+        _source: [
+          "benefit_assessment_id",
+          "case_reference",
+          "valid_from",
+          "patient_group_en",
+          "patient_group_de",
+          "indication_en",
+          "indication_de",
+          "added_benefit_en",
+          "added_benefit_de",
+          "added_benefit_reason_en",
+          "evidence_certainty_en",
+          "endpoint_mortality_en",
+          "endpoint_morbidity_en",
+          "endpoint_quality_of_life_en",
+          "endpoint_adverse_events_en",
+          "comparator_en",
+          "comparator_de",
+          "procedure_type_en",
+          "is_orphan",
+          "icd10_gm",
+          "url",
+        ],
+        query: { match_phrase: { brand_name: brand } },
+        sort: [{ valid_from: { order: "desc", unmapped_type: "date" } }],
+        track_total_hits: true,
+      },
+    });
+
+    return (res?.results ?? []).map((doc: any, index: number) => {
+      const benefit = pick(doc.added_benefit_en, doc.added_benefit_de);
+      const endpoints = [
+        ["Mortality", "Mortalité", doc.endpoint_mortality_en],
+        ["Morbidity", "Morbidité", doc.endpoint_morbidity_en],
+        ["Quality of life", "Qualité de vie", doc.endpoint_quality_of_life_en],
+        ["Adverse events", "Effets indésirables", doc.endpoint_adverse_events_en],
+      ]
+        .filter(([, , value]) => clean(value))
+        .map(([labelEn, labelFr, value]) => `${en() ? labelEn : labelFr} : ${clean(value)}`)
+        .join("\n");
+
+      return {
+        key: `${doc.benefit_assessment_id ?? index}`,
+        typeLabel: en() ? "Benefit assessment" : "Évaluation du bénéfice",
+        icon: "Scales",
+        date: asDate(doc.valid_from),
+        title:
+          pick(doc.patient_group_en, doc.patient_group_de) || pick(doc.indication_en),
+        excerpt: excerptOf(doc.indication_en || doc.indication_de),
+        badge: doc.is_orphan
+          ? en()
+            ? "Orphan drug"
+            : "Médicament orphelin"
+          : pick(doc.procedure_type_en) || null,
+        badgeTone: doc.is_orphan ? "warn" : "neutral",
+        status: benefit || null,
+        statusTone: benefitTone(benefit),
+        url: doc.url || null,
+        sourceLabel: "G-BA",
+        sections: [
+          {
+            key: "population",
+            label: en() ? "Patient group" : "Population de patients",
+            body: pick(doc.patient_group_en, doc.patient_group_de),
+          },
+          {
+            key: "indication",
+            label: "Indication",
+            body: pick(doc.indication_en, doc.indication_de),
+          },
+          {
+            key: "benefit",
+            label: en() ? "Added benefit" : "Bénéfice supplémentaire",
+            body: [
+              benefit && `${en() ? "Extent" : "Ampleur"} : ${benefit}`,
+              clean(doc.added_benefit_reason_en) &&
+                `${en() ? "Reason" : "Motif"} : ${clean(doc.added_benefit_reason_en)}`,
+              clean(doc.evidence_certainty_en) &&
+                `${en() ? "Certainty of evidence" : "Certitude des preuves"} : ${clean(doc.evidence_certainty_en)}`,
+            ]
+              .filter(Boolean)
+              .join("\n"),
+          },
+          {
+            key: "endpoints",
+            label: en() ? "Endpoints" : "Critères de jugement",
+            body: endpoints,
+          },
+          {
+            key: "context",
+            label: en() ? "Procedure" : "Procédure",
+            body: [
+              doc.case_reference && `${en() ? "Case" : "Dossier"} : ${doc.case_reference}`,
+              clean(doc.comparator_en || doc.comparator_de) &&
+                `${en() ? "Comparator" : "Comparateur"} : ${clean(doc.comparator_en || doc.comparator_de)}`,
+              Array.isArray(doc.icd10_gm) && doc.icd10_gm.length && `CIM-10 : ${doc.icd10_gm.join(", ")}`,
+              doc.valid_from && `${en() ? "Valid from" : "En vigueur depuis"} : ${asDate(doc.valid_from)}`,
+            ]
+              .filter(Boolean)
+              .join("\n"),
+          },
+        ],
+      } satisfies HeartIntlRecord;
+    });
+  }
+
+  /** AEMPS : les rapports de positionnement therapeutique (IPT). */
+  async function loadAemps(brand: string): Promise<HeartIntlRecord[]> {
+    const res = await queryCustomElastic({
+      index: ES_INDEX.APPROVAL_ES_AEMPS,
+      customQuery: {
+        size: 100,
+        _source: [
+          "detail_id",
+          "report_date",
+          "report_english_title",
+          "report_spanish_title",
+          "illness_english_label",
+          "illness_spanish_label",
+          "atc2_code",
+          "atc2_english_label",
+          "atc2_spanish_label",
+          "version",
+          "pdf_url",
+          "tekkare_pdf_url",
+        ],
+        query: { match_phrase: { brand } },
+        sort: [{ report_date: { order: "desc", unmapped_type: "date" } }],
+        track_total_hits: true,
+      },
+    });
+
+    return (res?.results ?? []).map((doc: any, index: number) => ({
+      key: doc.detail_id || `aemps-${index}`,
+      typeLabel: en() ? "Positioning report (IPT)" : "Rapport de positionnement (IPT)",
+      icon: "FileText",
+      date: asDate(doc.report_date),
+      title:
+        pick(doc.report_english_title, doc.report_spanish_title) || brand,
+      excerpt: pick(doc.illness_english_label, doc.illness_spanish_label),
+      badge: doc.version ? `v${doc.version}` : null,
+      status: null,
+      url: doc.tekkare_pdf_url || doc.pdf_url || null,
+      sourceLabel: "AEMPS",
+      sections: [
+        {
+          key: "title",
+          label: en() ? "Report" : "Rapport",
+          body: pick(doc.report_english_title, doc.report_spanish_title),
+        },
+        {
+          key: "titleEn",
+          label: en() ? "Spanish title" : "Titre espagnol",
+          body: pick(doc.report_spanish_title),
+        },
+        {
+          key: "illness",
+          label: en() ? "Condition" : "Pathologie",
+          body: [
+            pick(doc.illness_english_label, doc.illness_spanish_label),
+            doc.atc2_code &&
+              `ATC : ${doc.atc2_code} (${pick(doc.atc2_english_label, doc.atc2_spanish_label)})`,
+          ]
+            .filter(Boolean)
+            .join("\n"),
+        },
+      ],
+    }));
+  }
+
+  /** AIFA : un extrait de Gazzetta Ufficiale par decision. */
+  async function loadAifa(brand: string): Promise<HeartIntlRecord[]> {
+    const res = await queryCustomElastic({
+      index: ES_INDEX.APPROVAL_IT_AIFA,
+      customQuery: {
+        size: 100,
+        _source: [
+          "opinion_id",
+          "decision_date",
+          "has_code",
+          "brand",
+          "molecule",
+          "company",
+          "atc5_code",
+          "nature_of_request",
+          "nature_of_request_en",
+          "indication",
+          "indication_en",
+          "essential",
+          "essential_en",
+          "aifa_url",
+          "tekkare_pdf_url",
+          "tekkare_pdf_url_en",
+        ],
+        query: { match_phrase: { brand } },
+        sort: [{ decision_date: { order: "desc", unmapped_type: "date" } }],
+        track_total_hits: true,
+      },
+    });
+
+    return (res?.results ?? []).map((doc: any, index: number) => ({
+      key: doc.opinion_id || `aifa-${index}`,
+      typeLabel:
+        pick(doc.nature_of_request_en, doc.nature_of_request) || "AIFA",
+      icon: "Stamp",
+      date: asDate(doc.decision_date),
+      // La nature tient deja la colonne « Nature » : l'objet, c'est l'indication.
+      title:
+        excerptOf(doc.indication_en || doc.indication, 120) ||
+        pick(doc.nature_of_request_en, doc.nature_of_request) ||
+        brand,
+      excerpt: [doc.molecule, doc.company].filter(Boolean).join(" · ") || null,
+      badge: doc.has_code ? `GU ${doc.has_code}` : null,
+      url: doc.tekkare_pdf_url_en || doc.tekkare_pdf_url || doc.aifa_url || null,
+      sourceLabel: "AIFA",
+      sections: [
+        {
+          key: "indication",
+          label: "Indication",
+          body: pick(doc.indication_en, doc.indication),
+        },
+        {
+          key: "essential",
+          label: en() ? "Decision" : "Décision",
+          body: pick(doc.essential_en, doc.essential),
+        },
+        {
+          key: "context",
+          label: en() ? "Reference" : "Référence",
+          body: [
+            doc.molecule && `${en() ? "Molecule" : "Molécule"} : ${doc.molecule}`,
+            doc.company && `${en() ? "Company" : "Laboratoire"} : ${doc.company}`,
+            doc.atc5_code && `ATC : ${doc.atc5_code}`,
+          ]
+            .filter(Boolean)
+            .join("\n"),
+        },
+      ],
+    }));
+  }
+
+  /**
+   * MHRA : l'index tient un document par molecule, les marques sont dans ses
+   * produits. La marque est donc cherchee dans le tableau imbrique, et chaque
+   * produit retenu devient une ligne.
+   */
+  async function loadMhra(brand: string): Promise<HeartIntlRecord[]> {
+    const res = await queryCustomElastic({
+      index: ES_INDEX.APPROVAL_UK_MHRA,
+      customQuery: {
+        size: 10,
+        _source: ["molecule", "last_indication"],
+        query: {
+          nested: {
+            path: "products",
+            query: { match_phrase: { "products.brand": brand } },
+            inner_hits: { size: 50 },
+          },
+        },
+        track_total_hits: true,
+      },
+      allAnswer: true,
+    });
+
+    const hits = res?.hits?.hits ?? [];
+    const rows: HeartIntlRecord[] = [];
+
+    for (const hit of hits) {
+      const molecule = hit._source?.molecule ?? "";
+      const products = hit.inner_hits?.products?.hits?.hits ?? [];
+      for (const product of products) {
+        const source = product._source ?? {};
+        // L'indication vit dans les PDF du produit ; a defaut, celle que le
+        // document porte pour la molecule entiere.
+        const pdf = (source.pdfs ?? []).find((entry: any) => clean(entry?.indication));
+        const indication = pick(pdf?.indication, hit._source?.last_indication);
+
+        rows.push({
+          key: `${source.product_code ?? source.brand ?? ""}-${product._nested?.offset ?? rows.length}`,
+          typeLabel: en() ? "Marketing authorisation" : "Autorisation de mise sur le marché",
+          icon: "Certificate",
+          date: asDate(source.last_approval_date),
+          title: pick(source.product_label, source.brand) || brand,
+          excerpt: excerptOf(indication),
+          badge: source.atc_code || null,
+          status: pick(source.status) || null,
+          url: pdf?.pdf_source_url || null,
+          sourceLabel: "MHRA",
+          sections: [
+            { key: "indication", label: "Indication", body: indication },
+            {
+              key: "context",
+              label: en() ? "Product" : "Produit",
+              body: [
+                molecule && `${en() ? "Molecule" : "Molécule"} : ${molecule}`,
+                source.manufacturer && `${en() ? "Manufacturer" : "Fabricant"} : ${source.manufacturer}`,
+                source.product_code && `${en() ? "Licence" : "Licence"} : ${source.product_code}`,
+                source.last_update_date &&
+                  `${en() ? "Last update" : "Dernière mise à jour"} : ${asDate(source.last_update_date)}`,
+              ]
+                .filter(Boolean)
+                .join("\n"),
+            },
+          ],
+        });
+      }
+    }
+
+    return rows.sort(
+      (a, b) => new Date(b.date || 0).getTime() - new Date(a.date || 0).getTime(),
+    );
+  }
+
+  /**
+   * FDA : un dossier par marque, et sa pile de soumissions. L'index repete la
+   * meme soumission autant de fois qu'elle porte de PDF : une ligne par couple
+   * date + soumission suffit.
+   */
+  async function loadFda(brand: string): Promise<HeartIntlRecord[]> {
+    const res = await queryCustomElastic({
+      index: ES_INDEX.APPROVAL_US_FDA,
+      customQuery: {
+        size: 10,
+        _source: [
+          "applno",
+          "appltype",
+          "drug_name",
+          "molecules",
+          "drug_company",
+          "drug_description",
+          "dailymed_indication",
+          "approvals.action_date",
+          "approvals.submission",
+          "approvals.supplement_categories_approval_type",
+          "approvals.url",
+        ],
+        query: { match_phrase: { drug_name: brand } },
+        track_total_hits: true,
+      },
+    });
+
+    const rows: HeartIntlRecord[] = [];
+
+    for (const doc of res?.results ?? []) {
+      const seen = new Set<string>();
+      for (const approval of doc.approvals ?? []) {
+        const key = `${doc.applno}-${approval.action_date}-${approval.submission}`;
+        if (seen.has(key)) continue;
+        seen.add(key);
+
+        rows.push({
+          key,
+          typeLabel: pick(approval.supplement_categories_approval_type) || doc.appltype || "FDA",
+          icon: "Stamp",
+          date: asDate(approval.action_date),
+          title: `${pick(doc.drug_name)} ${approval.submission ?? ""}`.trim(),
+          excerpt: excerptOf(doc.dailymed_indication),
+          badge: doc.appltype ? `${doc.appltype} ${doc.applno}` : null,
+          url: approval.url || null,
+          sourceLabel: "FDA",
+          sections: [
+            {
+              key: "submission",
+              label: en() ? "Submission" : "Soumission",
+              body: [
+                approval.submission && `${en() ? "Submission" : "Soumission"} : ${approval.submission}`,
+                approval.supplement_categories_approval_type &&
+                  `${en() ? "Type" : "Nature"} : ${approval.supplement_categories_approval_type}`,
+                approval.action_date &&
+                  `${en() ? "Action date" : "Date de décision"} : ${asDate(approval.action_date)}`,
+              ]
+                .filter(Boolean)
+                .join("\n"),
+            },
+            {
+              key: "product",
+              label: en() ? "Product" : "Produit",
+              body: [
+                doc.molecules && `${en() ? "Molecules" : "Molécules"} : ${doc.molecules}`,
+                doc.drug_company && `${en() ? "Company" : "Laboratoire"} : ${doc.drug_company}`,
+                doc.drug_description && `${en() ? "Form" : "Forme"} : ${doc.drug_description}`,
+              ]
+                .filter(Boolean)
+                .join("\n"),
+            },
+            {
+              key: "indication",
+              label: "Indication",
+              body: clean(doc.dailymed_indication),
+            },
+          ],
+        });
+      }
+    }
+
+    return rows.sort(
+      (a, b) => new Date(b.date || 0).getTime() - new Date(a.date || 0).getTime(),
+    );
+  }
+
+  /**
+   * Les six registres pour une marque. Un registre en echec (droits, index
+   * indisponible) laisse sa carte vide ; les cinq autres restent lisibles.
+   */
+  async function load(brand: string) {
+    if (!brand) return;
+    isLoading.value = true;
+
+    const safe = async (key: string, run: () => Promise<HeartIntlRecord[]>) => {
+      try {
+        return [key, await run()] as const;
+      } catch (error) {
+        console.error(`[useHeartIntlApprovals] ${key}`, error);
+        return [key, [] as HeartIntlRecord[]] as const;
+      }
+    };
+
+    const answers = await Promise.all([
+      safe("EU", () => loadEma(brand)),
+      safe("DE", () => loadGba(brand)),
+      safe("ES", () => loadAemps(brand)),
+      safe("IT", () => loadAifa(brand)),
+      safe("GB", () => loadMhra(brand)),
+      safe("US", () => loadFda(brand)),
+    ]);
+
+    records.value = Object.fromEntries(answers);
+    isLoading.value = false;
+  }
+
+  return { records, isLoading, load };
+}