Friday, October 31, 2014
December 19, 2011 Update: Radiation Found in Infant Formula Minimize

Rx-360 Considers Recent Radiation Finding in Infant Formula

 

Rx-360 quickly convened its Japan Supply Chain Working Group to discuss the recent news that Tokyo-based food manufacturer, Meiji, had detected cesium 134 and cesium 137 from the Fukushima Daiichi fallout in some of its baby formula.  Although testing found levels well below the Japanese government limits, the company is offering to replace cans at customers' request.  Rx-360's Japan Supply Chain Working Group met to assess the situation and share current information and any bio-pharmaceutical experiences related to this occurrence.  The Working Group found that no additional precautions are being established or developed by member companies beyond the comprehensive and focused risk mitigation approaches put in place by many companies earlier in the year to address the initial earthquake/tsunami.  At this time, it is the Working Group's opinion that further precautions are not necessary based on experiences of and data from individual member companies who continue to monitor and screen products and materials in their supply chains and have not found any radiation levels beyond background levels. 

  

Japan Earthquake, Tsunami and Nuclear Power Plant and the Impact to the Pharmaceutical Supply Chain Minimize

Japan Earthquake, Tsunami and Nuclear Power Plant and the Impact to the Pharmaceutical Supply Chain

Please join us in support of those in Japan who, after suffering tremendous natural disasters, are now faced with an array of catastrophic after-effects. 

As you know, Rx-360 represents a global community of members worldwide, including many in Japan.  Please do what you can to provide support for our friends and colleagues in Japan.   Rx-360 has added several links to our web page that you can use to provide such support.

Japan is a vital link in the pharmaceutical supply chain and includes many suppliers, pharmaceutical manufacturers, healthcare providers and patients.  In order to minimize the impact of recent events in Japan to the pharmaceutical supply chain, Rx-360 has assembled a small panel of experts to evaluate the situation and recommend best practices to the pharmaceutical community.  This group begins meeting this week, and as they develop and share best practices, the larger Rx-360 community will be apprised via our Web Page, Flash Reports, Linkedin, Twitter and Facebook pages.
This Rx-360 expert group will try to answer the following questions to assure a reliable supply of critical and safe medicines for the patients we serve:
  • Share Best Practices on How to Identify Japan-Pedigree Materials
    • What/Who
    • Existing Inventory
    • Secondary Sourcing
    • Supplier Activities
    • How to Address a Raw Material Shortage
       
  • Trapping & Screening of Incoming Shipments for Radiation
    • Supplier
    • Japan Government During Exportation
    • Other Governments During Importation
    • Carrier
       
  • Detecting & Handling of Contaminated Materials
    • Use of Qualified Consultants
    • Staff Precautions
    • Sterilization
       
  • Science-based perspective on radioactive contaminants
    • Radiation vs Loose Surface Contaminates
    • Implications to Raw Material Characteristics
However, in the interim, the US Customs and Border Protection has published the following:  

U.S. Customs and Border Protection is monitoring developments in Japan carefully and is specifically assessing the potential for radiological contamination associated with the ongoing impact of the earthquake and tsunami to Japan’s nuclear facilities.

Out of an abundance of caution, CBP has issued field guidance reiterating its operational protocols and directing field personnel to specifically monitor maritime and air traffic from Japan.

No aircraft entering the United States has tested positive for radiation at harmful levels. To address radiological and nuclear risks, CBP employs several types of radiation detection equipment in its operations at both air and sea ports, and uses this equipment, along with specific operational protocols, to resolve any security or safety risks that are identified with inbound travelers and cargo.

In the air environment, CBP frontline personnel are equipped with Personal Radiation Detectors (PRDs) that can detect the presence of radiological materials, and all airports have more sensitive Radiation Isotope Identification Devices (RIIDs) to determine both the presence and type of radiation encountered.

Travelers who manifest signs of radiation sickness are referred to health authorities and provided appropriate treatment.

At seaports, and in its international mail and express consignment facilities, CBP continues to use sensitive, large-scale Radiation Portal Monitors (RPM) and scans all maritime cargo and express consignment and mail arriving from Japan.

CBP maintains similar protocols for identifying and resolving radiation alarms in these operations and will deny entry to contaminated cargo and mail.

CBP will continue to evaluate the potential risks posed by radiation contamination on inbound travelers and cargo and will adjust its detection and response protocols, in coordination with its interagency partners, as developments warrant.

Please share this e-mail with your colleagues. 

  

Points to Consider Minimize

Points to Consider in Assessing Risk Related to Japan Situation

These Points to Consider have been prepared by Rx-360 as a tool that companies (both drug/device manufacturers and suppliers) can use to guide their development of assessing risk related to the situation in Northeast Japan.  This list is not comprehensive and does not itself constitute a risk assessment method – it provides potential considerations for companies developing their own risk assessments.  Note also that any questions (including these) should not necessarily be sent “carte blanche” to suppliers or manufacturing sites without first understanding the relevant details of those sites (e.g., where are they located? what materials are manufactured there?, or how materials are transported within or out of Japan).  Any risk assessment questionnaires sent to suppliers should ask focused questions that address, and if possible, identify, the specific materials/products of concern.

Considerations of Potential Risk

1.    What products and materials are manufactured and/or sourced from Japan? 

2.    Was the product or material made and shipped out of Japan prior to the March 11-13 events?

3.    From whom do you obtain these products or materials (suppliers, re-packagers, contractors, own or partnering facilities)?  Where in Japan are these facilities located?  Include all of the physical facility locations (mfg, storage, distribution, etc.) where your materials are handled.

4.    Are any of these facilities

·         Located in a government established radiation evacuation zone?

·         In parts of Japan damaged by the Tsunami or earthquake?

·         Were subjected to water or earthquake or tsunami damage?

·         Currently or were subjected to power or other utilities outages?

·         Currently or were subjected to harmful radiation exposure?

·         Currently or were subjected to any disruptions in normal manufacturing operations since March 11-13 events?

Considerations of Potential Impact

5.    How much inventory of these items do I have on hand or are confirmed incoming?  Do they expire?

6.    Do I have alternate source(s) for these products or materials?  How long until alternate sources can on boarded?

7.    Are any of your materials or products transported through parts of Japan where the product or material could be adversely affected by conditions (radiation, earthquake, Tsunami)? 

8.    Were storage conditions anywhere in the supply chain in Japan adversely impacted from physical damage, water, power outages, or radiation? 

9.    Did earthquake damage, tsunami damage, power outages, or radiation leakage from the reactors impact materials or products from these facilities in Japan?

Considerations for Mitigation

10.  If any material or product was damaged or impacted are there plans to try and salvage this?  What will be done and is it appropriate? 

11.  What risk mitigation steps were taken or are being taken relative to the above risks?

12.  Is documentation related to mitigation activities complete and auditable?

13.  What are the suppliers to your suppliers doing to assess and mitigate risk?  Is their assessment and risk mitigation appropriate?

Companies should carefully consider the need for this question/consideration based on supplier location, materials manufactured, etc.

 

 

  

Information Related to Radiation Minimize

Rx-360 has developed this webpage to provide information related to the Fukushima Daiichi power plant situation in the Futaba district, Fukushima Prefecture, Japan, and general radiation information.  The compiled links below provide daily monitoring information as well as basic educational information regarding radiation in the environment.
 

I. Monitoring Information 

  • Tokyo Metropolitan Government to implement Random radiation Check at the Port of Tokyo, Yokohama and Kawasaki.  Please see below for more specifics on radiation checks at ports:
     
    http://www.mlit.go.jp/common/000143409.pdf 
    http://www.mlit.go.jp/common/000143417.pdf 
    http://www.mlit.go.jp/common/000143418.pdf
  • Japan Ministry of Education, Culture, Sports, Science and Technology MEXT.  Provides data for all prefectures of Japan including fallout data for I-131 and Cs-137, drinking water data for I-131 and Cs-137, and radiation dose rates. http://www.mext.go.jp/english/

  • Nuclear Safety Division, Ministry of Education, Culture, Sports, Science and Technology Disaster Prevention Network for Nuclear Environments.  Provides real time monitoring/data.  http://www.bousai.ne.jp/eng/

  • WIDE Project.  Provides compiled monitoring information from various prefectures in Japan.  http://eq.wide.ad.jp/index_en.html

  • Nuclear and Industrial Safety Agency, Japan. Provides monitoring information of various areas in Japan.  http://www.nisa.meti.go.jp/english/

  • International Atomic Energy Agency (IAEA).  Daily updates on situation at power plant and surrounding environment.  http://www.iaea.org/

  • U.S. Dept of Energy aerial survey results and context (updated regularly):  http://www.slideshare.net/energy/radiation-monitoring-data-from-fukushima-area-03252011?from=share_email
     
  • United Nations International Civil Aviation Organization (ICAO).  Press Release, 14 April, on current situation on travel and transport to and from Japan.  Contains links to Japan Ministry of Land, Infrastructure, Transport and Tourism regarding monitoring of radiation levels in Japanese ocean ports and airports. Click here to view or download the ICAO Press Release.

II.        Educational Information on Radiation in the Environment

III.        Food and Customs Information

IV. To Learn About Japanese Power Outages

V. FDA Current Thinking on Medical Products (scroll down to “Questions about Medical Products”)

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm247403.htm

 

 

VI. EMA Current Thinking on Medical Product

http://bit.ly/lXgT6Y
 

 

  

International Regulatory Information Related to Japan Situation Minimize

 

EU/EUROPE

Statements/Expectations

Documents

      
 
 
 
 
 
 
 
 

EMA

Letters sent from IMB, MHRA:

Dear Marketing Authorisation Holder:

 

Re: Radiation leak from the Daiichi Fukushima nuclear power plant: Impact on medicinal products supplied to EU from Japan

 

Following the radiation leak from the Fukushima Daiichi nuclear power plant in Japan after the earthquake and tsunami of 11 March 2011, EU authorities and Member States have been monitoring its possible impact on medicines manufactured in Japan. This includes an assessment and evaluation of the risk for possible radioactive contamination. Account has been taken of the limits set for food in Regulation (EU) No 297/2011 as amended by Regulation (EU) No 351/2011.

 

The responsibility for ensuring the quality, safety and efficacy of medicinal products lies with the Marketing Authorisation Holder. Therefore, to safeguard public health, the National Competent Authorities of the Member States and EMA (for Centrally Authorised Products), invite the Marketing Authorisation Holder to complete and submit the attached declaration for each product partially or totally manufactured in Japan including active substances and intermediates, with reference to the maximum levels set for iodine-131, caesium-134 and caesium-137 in Regulation (EU) No 297/2011 as amended by Regulation (EU) No 351/2011.

 

Our records show that you hold a marketing authorisation(s) for medicinal product(s) manufactured or partially manufactured in Japan, and in particular, in one or more of the following prefectures: Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Yamagata, Niigata, Nagano, Yamanashi, Saitama, Tokyo and Chiba.

 

I would therefore appreciate a completed declaration by mid-day 11 May 2011 with a timeframe for the provision of further information at that time, if appropriate.

 

Please note that Marketing Authorisation Holders should inform the relevant National Competent Authorities or EMA, where relevant, if there is likely to be a shortage of supply of product as a result of the disruption caused by recent events in Japan. 

 

Announcement on EMA website:

 

EMA Document

France

The Afssaps, via the Leem, seeks the Marketing Authorizations holders who have drugs containing active substances, excipients, synthetic component… from animal or vegetal origin coming from Japan and that may presented a radioactive contamination risk, in order that they answer to the following questions:

1.   Do the pharmaceutical products for which you are MA holder have any  active substance, excipient, synthetic component… from animal or vegetal origin coming from Japan? (YES / NO)

If YES:

- Identify the pharmaceutical products : name, dosage, pharmaceutical form, MA number

- Identify the raw material concerned and its role (active substance, excipient…)

2.   Are these raw materials coming from Japan susceptible to have been or to be contaminated by the radioactivity, depending the production sites and the importation date in France (YES / NO – Precise)

3.   What are the measures took or to be taken in place in order to control a potential contamination?

 

French Document

EC

Corrigendum to Commission Implementing Regulation (EU) No 351/2011 of 11 April 2011 amending Regulation (EU) No 297/2011 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station

 

EC Document

Spain

 Declaration of the Manufacturers Related to the Safety of Medical Devices
 Manufactured in Japan and Exported after 11 March 2011 and Destined for
 Use in the European Union.  [The declaration refers to medical devices
 coming from only certain prefectures]
 Ministerio de Sanidad, Política Social e Igualdad http://www.msps.es/en/home.htm

 Spanish
Document

ASIA

Statements/Expectations

Documents

Singapore

Due to the recent developments and events in Japan, and the fact that a number of the current and proposed Drug Substances manufacturer are located in Japan, please address the following questions:

·         What has been done to reduce the risk of contamination of your products by your company/ DS manufacturer?

·         What measures do you have in place before you restart the manufacturing process after the recent event in Japan?

·         Has the quality control system been updated to take into account the spread and increase in radioactivity level?

·         Does your company pro-actively test your products for radioactivity?

·         What baseline measures will you be taking if one of the ingredients used in the manufacturing process is found to be contaminated with radioactive substances?

·         Are there any documentation that can be provided to assure the safety of the product in terms of radioactivity levels, for example, certificate of testing?

 

None Available 

Australia

 Letter sent to individual companies outlining expectations for declaring the
 quality and safety of materials coming from Japan.

 

Australian
Document

MIDDLE EAST

Statements/Expectations

Documents

Egypt

Dear Company Chairman,  We would like to inform you that the technical committee for drug control decided, at its meeting on the 31st of March 2011, to ban any import of drugs and pharmaceutical raw materials from Japan for the next 6 months effective from the above date. At the end of the duration the situation will be re-evaluated by the committee and that is to eliminate any potential hazardous radiation.

 

Technical Committee OfficerHead of Central Administration for Pharmaceutical Affairs

 

Dr. Nesreen HanafiDr. Ashraf Bayoumi

 

Egyptian Document

NORTH AMERICA

Statements/Expectations

Documents

US (FDA)

 

Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Returned and Salvaged Drug Products

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm252324.htm

 

FDA questions/answer website on radiation and medical products

http://www.fda.gov/newsevents/publichealthfocus/ucm247403.htm

 

FDA radiation testing method for foods:

http://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM248262.doc

 

 

Q/A addressing improper storage conditions such as those resulting from natural disaster, toxic fumes or radiation.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm252324.htm#1

 

None Available 

 

 Letter To Foreign and Domestic Medical Device and Component 
 Establishments That May Be Affected by the March 2011 Japan 
 Earthquake and Tsunami

 

 Letter outlines FDA concerns and recommendations regarding potentially affected medical
 devices and components

 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm257527.htm

 

 US FDA
CDRH Document

 

  

 

2009 © Rx-360