Use cases

Screen literature hits for case reports and safety findings

Reads each hit's title and abstract for article type, product mention, a patient, an adverse effect and safety findings. It never judges causality.

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Example · A case report of severe low sodium after starting the drug, in an older man

Our products (active substances and brand names): ostaverin (Ostavel 20 mg and 40 mg film-coated tablets)

Article title: Severe symptomatic hyponatraemia within two weeks of starting ostaverin in an older man: a case report

Abstract

Background: Hyponatraemia is a recognised complication of several drugs used in older adults, but reports with newer agents are few. Case presentation: A 71-year-old man with hypertension and type 2 diabetes, living independently, was started on ostaverin 20 mg once daily by his general practitioner. His other medicines, unchanged for more than a year, were amlodipine and metformin. Twelve days later he was brought to the emergency department by his daughter with confusion, unsteady walking and two falls at home. Serum sodium was 118 mmol/L, down from 139 mmol/L three months earlier. Urine osmolality and urine sodium were inappropriately high and he was clinically euvolaemic; thyroid and adrenal function were normal. He was admitted, ostaverin was stopped and fluids were restricted. Sodium rose to 131 mmol/L over four days and his confusion resolved. He was discharged on day six without ostaverin, and sodium was 137 mmol/L at follow-up two weeks later. Conclusions: The timing, the absence of other causes and the recovery after withdrawal suggest ostaverin-induced inappropriate antidiuresis. Clinicians should consider checking sodium within the first weeks of treatment in older patients.
  1. Is there enough text in the title and abstract to screen the article?Yes97%
  2. What kind of article is this, from its title and abstract?Single case report100%
  3. How does one of our products appear in the article?Given, and linked to an unwanted effect100%
  4. Does the abstract say the product the patients received was made by a company other than ours?No87%
  5. Does the abstract describe an unwanted effect in a person who received one of our products?Yes97%
  6. Does the text refer to a specific person who had the problem?Yes99%
  7. Which special situation does the text describe, if any?Use in children or older people100%
  8. Does the text mention death, a life-threatening event, a hospital admission, lasting disability or a birth defect?Yes98%
  9. Does the article report a safety finding across a group of people who received one of our products?No94%
  10. Where should this literature hit go for reading?Case intake100%

These are real answers stored from one run on this example.

The prism behind it

Screen literature hits for case reports and safety findings10 questions

Fields

  • Our products (active substances and brand names)
  • Article title
  • Abstract

Context

Working definitions of a pharmaceutical company's drug safety literature team. Each text is the title and abstract of one hit from the weekly searches of published medical literature that the company runs for its own products. It is read so that the safety team reads the likely individual case reports and group safety findings first, and every hit it excludes keeps a recorded reason. Nothing here decides whether a case is valid or reportable, whether it is serious, whether the product caused the event, or whether the event is expected: drug safety staff decide all of that from the article. Our products are the active substances and brands in the products field. Several companies may market the same active substance. When an article names only the active substance, treat the product as possibly ours unless the article says it came from another company. An unwanted effect is any harmful or unintended medical occurrence in a person who received a product, whether or not the authors link it to the product. It includes symptoms, abnormal test results, hospital admission and death. Special situations are collected even when no harm is described: exposure during pregnancy or breastfeeding; use in children or older people; overdose, misuse or abuse; a medication error; lack of effect; use for a condition, age group or dose outside the approved use; and exposure of a carer or worker who handles the product. An individual case needs an identifiable reporter, an identifiable patient, a suspect product and a suspected adverse reaction. For a published article the first author, or the corresponding author where one is named, is the reporter.

Questions

  1. Is there enough text in the title and abstract to screen the article? Yes / No

    Read the title and the abstract. Yes: The abstract describes what the article studied or reports, clearly enough to judge the questions that follow. No: The abstract is missing, cut off, only a title, or too short to tell what the article reports, so the full text is needed.

  2. What kind of article is this, from its title and abstract? Choice

    Read the title and the abstract. Choose the kind of article. A letter or conference abstract that describes patients one by one counts as a case report or case series.

    • Single case report Describes one patient and what happened to them.
    • Case series Describes a few patients one by one, each with their own course.
    • Clinical trial An interventional study that assigns patients to treatments and reports group results.
    • Observational study A cohort, case-control, registry or database study that reports group results.
    • Review or meta-analysis Summarises or pools the results of other studies.
    • Non-clinical Laboratory, cell or animal work with no patients.

  3. How does one of our products appear in the article? Choice

    Read the title, the abstract and the products field. Treat an active substance on our list as ours unless the abstract says it came from another company. If a product appears in more than one role, choose the one highest in the list.

    • Given, and linked to an unwanted effect People received our product, and the authors describe an unwanted effect or special situation that may be linked to it.
    • Given, with no unwanted effect linked People received our product as a studied treatment, and the abstract links no unwanted effect or special situation to it.
    • Comparator or background treatment Our product is the comparator, a concomitant medicine or background treatment, and the unwanted effects are linked to something else.
    • Mentioned only Our product is named, for example in the background or discussion, but nobody in the article received it.
    • Not mentioned None of our products appears in the title or abstract.

  4. Does the abstract say the product the patients received was made by a company other than ours? Yes / No

    Read the abstract and the products field. Yes: The abstract names another company, or a brand that is not on our list, as the source of the active substance the patients received. No: The abstract names one of our brands, names no source, or none of our active substances appears.

  5. Does the abstract describe an unwanted effect in a person who received one of our products? Yes / No

    Read the abstract and the definition of an unwanted effect in the context. Count effects in single patients and in groups, whether or not the authors blame the product. Yes: At least one person who received one of our products had an unwanted effect. No: No unwanted effect is described in anyone who received our products, or none of our products was given.

  6. Does the text refer to a specific person who had the problem? Yes / No

    Read the abstract. Count a patient described by age, sex, initials, or their own course of illness and treatment, such as "a 71-year-old man", rather than group results or percentages. Yes: The abstract describes at least one specific patient who had the unwanted effect or special situation. No: The abstract gives only group results, or describes no unwanted effect or special situation.

  7. Which special situation does the text describe, if any? Choice

    Read the abstract and the list of special situations in the context. Choose the special situation the abstract describes with one of our products. If it describes more than one, choose the one it says most about. A special situation counts whether or not any harm is described.

    • None The abstract describes none of the special situations in the context.
    • Pregnancy or breastfeeding The patient, or the partner of a male patient, is pregnant or breastfeeding while exposed to the product.
    • Use in children or older people The patient is a child or an older person, or the abstract reports use in children or older people, and it does not say the use is outside the approved use.
    • Overdose, misuse or abuse More than prescribed was taken, the product was used for a purpose it was not given for, or it was shared with someone else.
    • Medication error A wrong dose, a wrong product, or a missed or incomplete dose because of how the product was handled or a device problem.
    • Lack of effect The product is said not to work, or to have stopped working.
    • Use outside approved use The abstract says the product is used for a condition, age group or dose outside its approved use.
    • Occupational exposure A carer, nurse, pharmacist or other worker was exposed while handling the product.

  8. Does the text mention death, a life-threatening event, a hospital admission, lasting disability or a birth defect? Yes / No

    Read the abstract. Does it mention, for a person who received one of our products, death, a life-threatening event, admission to hospital or a longer hospital stay, lasting disability, a birth defect, or the authors calling the event serious? This sets priority in the queue only; it is not a seriousness assessment. Yes: The abstract mentions at least one of these. No: The abstract mentions none of these.

  9. Does the article report a safety finding across a group of people who received one of our products? Yes / No

    Read the abstract. Count a higher or new rate of an unwanted effect, a new risk factor, an interaction, or a safety result in a group, such as a trial, cohort or pooled analysis, even when no single patient is described. Yes: The abstract reports a safety finding across a group exposed to one of our products. No: The abstract reports no group safety finding for our products, or reports only on single patients.

  10. Where should this literature hit go for reading? Choice

    Read the title, the abstract and the context as a whole. Choose the route that fits the most important thing in the abstract. A person reads every hit sent to case intake or signal review and checks a sample of the rest.

    • Case intake A specific patient had an unwanted effect or special situation after possibly receiving one of our products: a possible individual case.
    • Signal review A group safety finding for one of our products, with no single patient described.
    • Full text needed The abstract suggests safety information about our products but is too short or unclear to route.
    • No safety content for our products None of our products was given, the product came from another company, or no unwanted effect or special situation with our products is described.

Lens columns

enough_to_judge, enough_to_judge_probability, article_type, article_type_probability, our_product_role, our_product_role_probability, other_company_product, other_company_product_probability, adverse_reaction_described, adverse_reaction_described_probability, identifiable_patient, identifiable_patient_probability, special_situation, special_situation_probability, seriousness_words, seriousness_words_probability, aggregate_safety_finding, aggregate_safety_finding_probability, screening_route, screening_route_probability

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