Drug Shortages Analysis

Introduction

You have 48 hours to complete this assignment, but we recommend you don’t spend more than 1 or 2 hours on it. Remember it’s just a rough draft! Please bring to your interview the 1 pager and any accompany notes (if any).

Description of the Data

The data from Drug Shortages Canada and the Drug Product Database needs some explanation.

DPD Data

DRUG_CODE A unique code to identify a drug product.
PRODUCT_CATEGORIZATION Category of drug.
CLASS The class identifies whether the drug is for human use, veterinary use or used as a radiopharmaceutical or a disinfectant.
DRUG_IDENTIFICATION_NUMBER The Drug Identification Number (DIN) is the 8 digit number located on the label of prescription and over-the-counter drug products that have been evaluated by the Therapeutic Products Directorate (TPD) and approved for sale in Canada.
BRAND_NAME This is the brand name approved by Health Canada, under which the drug product may be marketed.
DESCRIPTOR The description field displays important product information that might differentiate between two identical products (i.e. same product formulations with or without preservative) or to indicate specific characteristic of a product (i.e. single use syringe).
PEDIATRIC_FLAG Indicates whether or not a pediatric drug product.
ACCESSION_NUMBER NA
NUMBER_OF_AIS The number of active ingredients.
LAST_UPDATE_DATE The date this record was last updated.
AI_GROUP_NO The Active Ingredient Group (AIG) Number is a 10 digit number that identifies products that have the same active ingredient(s) and ingredient strength(s). For more information see: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/terminology.html
CLASS_F The class identifies whether the drug is for human use, veterinary use or used as a radiopharmaceutical or a disinfectant. (French)
BRAND_NAME_F Brand name of the drug (French).
DESCRIPTOR_F Description of product in terms of format, dosage etc… (French)

DPD Status

DRUG_CODE
CURRENT_STATUS_FLAG
STATUS The statuses listed below are a direct representation of the status available in DPD Online Query and the description of each status can be found here: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/terminology.html
HISTORY_DATE
STATUS_F
LOT_NUMBER
EXPIRATION_DATE

Drug Shortages Data

Report ID
Drug Identification Number The Drug Identification Number (DIN) is the 8 digit number located on the label of prescription and over-the-counter drug products that have been evaluated by the Therapeutic Products Directorate (TPD) and approved for sale in Canada.
BRAND_NAME This is the brand name approved by Health Canada, under which the drug product may be marketed.
Report Type
Brand name
Company Name
Common or Proper name
Ingredients
Strength(s)
Packaging size
Route of administration Indicates the part of the body on which, through which or into which the product is to be introduced (e.g. oral, topical, intramuscular, rectal). A product can have more than one route of administration (e.g. intravenous, intramuscular, intra articular).
Shortage status
Dosage form(s)
ATC Code

Anatomical Therapeutical Chemical (ATC) Classification System is used as a tool for drug utilization research in order to improve quality of drug use.

In the ATC classification system, the drugs are divided into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutical properties.

For more information see:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/terminology.html
ATC description
Anticipated start date The anticipated start date of the drug shortage.
Actual start date The actual start date of the drug shortage.
Estimated end date The estimated end date of the drug shortage.
Actual end date The actual end date of the drug shortage.
Reason The reason for the shortage.
Date Created The date the record was created.
Date Updated The date the record was updated.

Scenario

We’ve provided you with an extract from Drug Shortages Canada and Drug Product Database (DPD).

First, filter out any shortages that were not true shortages, hint: check the Shortage status column in the Drug Shortages Canada data set.

Part 1: Research

Using your favorite data analysis tools, identify and present the following (use tables and other visualizations as you see fit):

  1. What is the distribution of reasons for drug shortages, can you tell me the raw numbers and the proportions?
  2. How many drug shortage reports were filed by each company? Present your results in descending order (most reports to least reports).
  3. What is the distribution of reasons for shortages for the top three companies as found in b)?
  4. What is the distribution of shortages for drugs, by type of drug?
  5. Which companies tend to not provide sufficient notice of drug shortages? Hint: use the Anticipated and Actual Start Date Columns from the Drug Shortages data set. What is the distribution?
  6. Which companies fail to provide anticipated start dates for drug shortages?
  7. Which companies tend to not provide accurate estimates for how long drug shortages will last? Hint: use the Estimated and Actual End Date columns from the Drug Shortages data set. What is the distribution?

Part 2: Take Action

Which company should we send inspectors to? Take into consideration the types of drugs they produce and their track record of providing accurate notice.

For the company you want to inspect, provide a table that includes:

  1. Drug Brand Name (i.e. the drugs the company produces),
  2. ATC Description,
  3. Mean difference between anticipated start date and actual start date (in days).
  4. Mean difference between estimated end date and actual end date (in days).
  5. Number of years each drug has been on the market.

Solution

Part 1: Research

a) Reasons for Shortages

What is the distribution of reasons for drug shortages, can you tell me the raw numbers and the proportions?

b) Identifying Offendors

How many drug shortage reports were filed by each company? Present your results in descending order (most reports to least reports).

c) Offendor’s Reasons for Shortages

What is the distribution of reasons for shortages for the top three companies as found in b)?

d) Types of Drugs and Shortages

Use ATC Description for the following question.

What is the distribution of shortages for drugs, by type of drug?

e) Drug Shortage Notice

Which companies tend to not provide sufficient notice of drug shortages? Hint: use the Anticipated and Actual Start Date Columns from the Drug Shortages data set.

Positive numbers mean the shortage started after the anticipated date. Negative numbers mean the shortage happened before the anticipated start date.

From this table, we can see that

  1. Alk-Abello Inc.
  2. Natco Pharma Inc. and
  3. Sanofi-Aventis Inc.

are the worst offenders for having drug shortages that start sooner than anticipated.

f) No Notice

Which companies fail to provide anticipated start dates for drug shortages?

The worst offenders for not providing notice of a drug shortage.

  1. Teva Canada Limited
  2. Apotex Inc. and
  3. Sandoz Inc.

g) Estimated Shortage End Dates

Positive numbers mean the actual end date was after the estimated end date. Negative numbers mean the shortage ended before the estimated shortage end date.

From the table below, we can see that

  1. Taylor Pharmaceuticals
  2. McGuff Pharmaceuticals Inc. and
  3. Teva Pharmaceuticals Inc.

are the worst offenders for having drug shortages that last longer than anticipated.

Part 2: Take Action

Which company would you send inspectors to? Use the data analysis from the previous steps or any other analysis to justify your choice.

Teva

I’d send inspectors to Teva.

Teva Pharmaceutical Industries Ltd., also known as Teva Pharmaceuticals, is a global pharmaceutical company with headquarters in Tel Aviv, Israel.

Teva is an offender on multiple fronts. They have the highest number of shortage reports. Most of their shortages (750 out of 845) fall into the category of “Disruption of the manufacture of the drug” which I think requires deeper investigation. Furthermore, Teva failed to provide any warning of shortages for 826 out of 845 shortage reports.

Additionally, Teva makes antidepressants and antipsychotics which are listed above as two of the most common types of drugs to have shortages.

Final Table

For the company you want to inspect, provide a table that includes:

  1. Drug Brand Name,
  2. ATC Description,
  3. Mean difference between anticipated start date and actual start date (in days).
  4. Mean difference between estimated end date and actual end date (in days).
  5. Number of years the drug has been on the market.