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CDER Year 2000 Information

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CDER Y2K Frequently Asked Questions

  1. What is Y2K?

  1. The year 2000 technology problem was created in the early days of computers when computer memory was expensive and scarce. Instead of using a four-digit code for each year, a two-digit code was used (for example ‘98’ instead of ‘1998’). When the year 2000 (Y2K) comes, programs coded with two-digit years will not distinguish between the years 2000 and 1900. This may cause computers to malfunction.

  1. What should I do to prepare for the Year 2000 as it relates to my pharmacy needs?

  1. The following is a list of prudent steps that you can take to ensure that you and your family are prepared for any medical situation at any time, not just on January 1, 2000.

  1. Make a list of prescription and important nonprescription medications you and your family are currently taking. Include the name of the medication, the family member taking it, the dosage and the prescribing doctor. When you go to a doctor or hospital for medical treatment, you are often asked to list medications you are currently taking. This list will help.

  1. Keep up-to-date on getting refills. It is advisable to get a normal refill of your medication when you have a 5 to 7 day supply of medication remaining. The supply system is resilient and can correct any issue that might arise within 5 to 7 days. This is good practice regardless of Y2K. And remember, if your insurance coverage will change at the end of the year, be sure to tell your physician and pharmacist.

  1. Create a personal health record for you and your family. Document important medical information, including drug allergies, existing medical conditions, past medical treatment and operations, information on any medical devices, physician names and phone numbers and the name and phone number of someone to notify in case of emergencies. You can keep a copy in your home, and perhaps have a copy in your wallet or purse. If you need emergency medical treatment, this information can be very important.

  1. Keep records of your insurance claims. This makes sense the same way keeping copies of your bank statements or tax returns is good financial management.

  1. Carry your current insurance card with you. In order to receive the medications you need, it is important to have evidence of your coverage with you. This is particularly important if you will be covered by a different insurance plan in the new year-make sure you provide this information to your physician and pharmacist.

  1. What is being done so that I will not have difficulty getting my prescription filled during the first few weeks of the year 2000?

  1. Government agencies and organizations within the pharmaceutical industry supply system (including manufactures, distributors, pharmacies, hospitals, physicians, pharmacists, insurers and others) have been working closely together to prepare for the Year 2000 date change and its potential impact on the supply of pharmaceuticals. The President’s Council on Year 2000 Conversion in conjunction with the Veterans Health Administration hosted a Roundtable event on May 17, 1999. The Roundtable brought together 90 supply system representatives from government and industry to make certain that open communication lines exist throughout the supply system, and that contingency plans had been developed, ensuring multiple paths of distribution for pharmaceuticals.

  1. Will I be able to get enough of my medications?

  1. The Year 2000 should not affect your ability to receive your normal supply of medications. Government agencies and organizations within the pharmaceutical industry supply system are taking the necessary steps so that the usual flow of medications will not be disrupted by Y2K problems. The industry typically operates with an average 90-day supply in the distribution system among manufacturers, distributors, and pharmacies. If you have questions about your individual supply, it is recommended that you speak with your doctor or pharmacist.

  1. Do I need to have additional supplies of my prescription medications on hand?

  1. It is advisable to get a normal refill of your medication when you have a 5 to 7 day supply of medication remaining. The supply system is resilient and can correct issues that might arise within 5 to 7 days.

  1. Who, besides my pharmacist and the manufacturer, is involved in providing my medications?

  1. Your prescription medications flow through a very efficient and extensive supply system. The raw materials flow to the pharmaceutical manufacturer who uses them to make the drugs you need. Drug wholesalers and distributors move the drugs from manufacturers to your pharmacy. Finally, the drug product is delivered to you. Companies involved throughout the supply system have been working very hard so that Y2K has minimal impact, if any, on the drug supply. It is important to note that the supply system is a complex web that is not easily broken.

  1. What are drug manufacturers doing to address Y2K issues?

  1. An association of drug manufacturers’ reported in April 1999 that 100% of the companies surveyed-including nearly all of the top 20 research based pharmaceutical firms-have Y2K plans in place and are working diligently to ensure an uninterrupted supply of pharmaceuticals. These companies also have emergency response plans in place so that the supply of medicines to patients should continue to be uninterrupted.

  1. I have heard that Y2K issues may jeopardize information from a patient’s medical records, such as past allergic reactions and adverse drug reactions. What is being done to prevent problems caused by Y2K issues in the databases containing patients’ histories and where can I find the most accurate information about supplies of my medication?

  1. Government, industry, hospitals, and pharmacies have made efforts to test and resolve any potential Y2K issues. They are checking word-processing documents, spreadsheets, databases and systems that test for allergies, duplicate medications, and drug interactions. They are also making every effort to correct or replace existing systems with Y2K compliant hardware and software. Also, many medical records are kept in "paper-copy" and therefore will not be affected by potential computer problems associated with Y2K. If you have questions about your individual medical records, it is recommended that you speak with your doctor or pharmacist.

  1. Do you have a backup plan if something fails at the turn of the century?

  1. Government and organizations within the supply system that manufacture, purchase, distribute, and provide prescription and nonprescription medicines and medical supplies have backup plans in place and will continue to work together to further enhance contingency (backup) planning for Y2K-specific issues throughout the supply system. The pharmaceutical supply system already had well-developed and tested emergency response plans in place to cope with the supply of products following hurricanes, fires, earthquakes, and other disasters. In the unlikely event of a disruption, each part of the supply system will work together and rely on one another to ensure your continued care.

  1. Where can I go for continued updates on Y2K drug-related issues?

  1. You can visit the following web site:

    2. http://www.fda.gov/cder/y2k/

    http://www.y2k.gov/

  2. Or you can call:

For general Y2K information:  888-USA-4-Y2K

For drug-specific questions:  888-INFOFDA

FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DML
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