POST 00268 : FAULTY VVMs PROBLEM: EXTENT & SOLUTIONS

Post00268 FAULTY VVMs PROBLEM: EXTENT & SOLUTIONS 26 July 2000 CONTENTS 1. FAULTY VVMs: THE NATURE AND EXTENT OF THE PROBLEM 2. FAULTY VVMs: SUGGESTIONS AND PROPOSED SOLUTIONS Moderators Note: In Post00266, Dianne Phillips. DOH/SA, asked for help with solutions to the managerial, logistics and for health workers in the South Africa Immunization program when faced with some number of faulty VVMs entering the routine immunization cold chain. Technet Forum responses and comments following Technet Forum Post00266, Faulty VVMs, on 13 July 2000 were received as the Moderator set off on travel. Apologies for the delay in posting these clarifications and suggestions. During this period Technet members both in their personal and organizational capacities have continued email discussions to address the issues raised by Diane Phillips, DOH/SA in Post00266. Julie Milstien, ATT/V&B/WHO, has informed the Moderator that: "We now know that this was a relatively small lapse in quality, apparently affecting some 0.1% of VVMs only, and while still serious, it is clearly not a global problem. We also know that the manufacturer was aware of the problem and offered to destroy the consignment, so it was not a case of him issuing a sub-standard product without the knowledge of the programme. "[17 Jul 2000] Many of the key contributions received are posted below under these headings: * Information on the nature and extent of the problem * Suggestions and approaches or alternatives to address the logistics management issue raised by Dianne Phillips, DOH, SA. regards, Allan Bass ____________________________________*______________________________________ 1. FAULTY VVMs: THE NATURE AND EXTENT OF THE PROBLEM * Steve Fields, Lifelines Technology, clarifies the extent and nature of the problem. Out thanks to Steve for the detailed update on the situation and the very good news that "We have also begun supplying the new VVMs for the more stable vaccines". * Hans Everts, WHO/V&B/EPI, adds further clarification and invites country programs to contact him before considering accepting defective VVM labeling. ** The fact that the vaccine with defective VVM labeling has been quarantined by the manufacture will assure all programs that the vaccine they are using is labeled with good VVMs, allowing the delivery of potent vaccines to children. Contributions, comments and additions please: [log in to unmask] or use your reply button ___________________________________________________________________________ Date: Thu, 13 Jul 2000 20:15:42 -0400 From: Steve Fields Subject: re: Post00266 URGENT: FAULTY VVMS To: Technet Moderator Organization: LifeLines Technology, Inc. Dear Allan: I would like to take this opportunity to put into perspective the problem with defective VVM labels. First, it involves one consignment of VVM labels for oral polio vaccine delivered to only one vaccine manufacturer. Some tubes of vaccine (~800,000 tubes) have been labeled with VVMs from this consignment, but they are still in quarantine at the manufacturer's plant. The problem was accurately characterized in Technet Post 00266 as the transfer of part or all of the reactive coating in the center of the VVM to the back of the release liner on the next winding of labels near the core of some rolls. After we were alerted to the problem we added another inspection step in our label finishing process, and no further problems of this kind have been detected. The unused portion of the consignment has been returned to our plant for inspection. The consignment consisted of multiple lots. Our inspection is not yet complete, but we have inspected the lots from which came most of the VVM labels that have been applied to the tubes of vaccine now held in quarantine. Our findings are that 6.5% of the VVM labels contain non- critical defects and 1.4% contain critical defects. The definition of a critical defect is more than 1/3 of the color-changing surface is missing. The part of the color-changing surface that remains in a critically defective VVM will still change color at the proper rate and accurately depict the heat exposure of the vial. The incidence of the entire color- changing surface missing is less than 1/10th of 1%. This is a matter of great importance to us and we are working with the vaccine manufacturer to develop and implement both short-term and long-term solutions to this problem. A senior executive of our Company will visit the vaccine manufacturer next week to assist in the development of a protocol for inspecting the labeled vaccine. Our QA Manager will make a subsequent visit to assist in the actual inspection. We have suggested a design change in the VVM label consisting of the addition of a clear polyester film laminate on top of each VVM label to protect the printed matter, including the VVM; thus, eliminating the possibility of a recurrence of this problem. Samples of this label construction are currently being evaluated by the vaccine manufacturer. The newer VVMs for the more stable vaccines all contain this film laminate which results in a much more durable label. Both myself and my colleague Dr. Ted Prusik (973) 984-6002 will be available to answer any questions about this problem. Sincerely yours, Steve Fields President & CEO LifeLines Technology, Inc. (973) 984-6001 --- Date: Fri, 14 Jul 2000 17:16:10 -0400 From: Steve Fields Subject: re: Post00266 URGENT: FAULTY VVMS To: Technet Moderator Organization: LifeLines Technology, Inc. Dear Allan: Further to my message of yesterday, I would like to clarify another issue raised by Dianne Phillips. There is no shortage of Type D VVMs for oral polio vaccine. The one manufacturer who detected the presence of defective VVMs in one consignment is currently out of VVM labels because they returned the consignment and they have not yet approved the proposed design change, i.e., the addition of the polyester film laminate. We continue to make normal deliveries to other vaccine manufacturers. We have also begun supplying the new VVMs for the more stable vaccines. Again, as best as we can determine, the problem reported in post 00266 is an isolated incident. Sincerely, Steve Fields President and CEO LifeLines Technology, Inc. --- From: [log in to unmask] Date: Fri, 14 Jul 2000 , Tue, 25 Jul 2000 15:21:28 +0200 To: Subject: RE: FWD: re: Post00266 URGENT: FAULTY VVMS Dear Allan, At this stage of polio eradication and just before the introduction of VVM on all vaccines, it is crucial the confidence in the VVM is maintained. We have in the mean time made the appropriate steps to get the full picture of the issue related to faulty VVM in South Africa. At this stage there are a number of points to be made: 1) 2.1 billion of doses of OPV were used this year. We have absolutely no indication of a quality problem of the VVM 2) from the various messages it is obvious nobody has made an effort to hide the problem. All relevant partners were made aware of the problem, which could therefore easily be contained and corrected, without faulty VVM appearing in the field, except in the case of South Africa. 3) South Africa decided to accept the faulty VVM for fear of not getting any vaccine at all. Although we still have to be careful with OPV, we are definitely out of the period of acute crisis. Before deciding to accept bad VVM we therefore strongly recommend countries to get in touch with us first. I am sure that in case this problem exceptionally occurs a solution can most likely be found together with the partners in industry and UNICEF. Hans Everts Technical Officer EPI WHO Geneva Tel: 00 41 33 791 3683 ____________________________________*______________________________________ 2. FAULTY VVMS: SUGGESTIONS AND PROPOSED SOLUTIONS Debie Kristensen, PATH, Jens Pake, WHO/V&B, Garry Presthus, WHO, Anthony Battersby, FBA Analysts, and Carla Lee, US CDC have kindly commented and made some suggestions to Dianne. * A vial of vaccine with a defective VVM should be handled as if it were a vial without a VVM, and should be used first, and before its expiry date. At higher levels of the cold chain the management of problematic vials is relatively straight forward. At the immunization service delivery level the identification of problematic vials and their management is more difficult. If a program does, for any reason accept vaccines with defective VVMs, it must have a clear plan to manage the vaccines and effective mechanisms in place to do so prior to taking delivery of such a vaccine. Anthony Battersby makes the point that "NO country should use defective VVMs, the implications for the future use of VVMs are too serious." Contributions, comments and additions please: [log in to unmask] or use your reply button ___________________________________________________________________________ From: "Kristensen, Debra" To: Technet Moderator , [log in to unmask] Subject: RE: Post00266 URGENT: FAULTY VVMS Date: Thu, 13 Jul 2000 22:16:15 -0700 Dear Dianne, Allan, and All: I just want to add a few comments to those made by Steve Fields of LifeLines. If we weren't experiencing a shortage of OPV, this problem may never have come into the public eye. The vaccine manufacturer and LifeLines identified batches of VVM labels with a small percentage of defects through their internal quality control processes. Unfortunately the VVM labels had already been placed on tubes of OPV and it seems that re-labeling is not an option. So the vaccine manufacturer placed the tubes in quarantine. The vaccine manufacturer and LifeLines have worked diligently to ensure that the problem does not occur again. In fact, they have already identified the probable solution which is lamination of the label. Now the difficulty is how to best utilize the quarantined batches of OPV. In an ideal world, this vaccine would be sent to countries that have not yet been able or don't plan to conduct VVM training. There are plenty such countries, including all of Latin America. Has the idea of exchanging consignments been completely ruled out? That would be a great solution so that the countries receiving these vials would not have to risk losing long term health worker confidence in VVMs in their essential effort to ensure that the quality of this OPV is maintained. If this vaccine must go to S. Africa (and maybe other countries that have conducted VVM training), they must be prepared for the arrival of some vials that may not have readable VVMs. I would not suggest using VVMs on other vials as a proxy for the vials with unreadable VVMs as we have found the proxy idea to be problematic elsewhere, as it is unlikely that any 2 given vials have received identical heat exposure. This is especially the case in a country like S. Africa where the multi-dose vial policy for OPV is used. One solution might be to ask health workers to treat vials with unreadable VVMs exactly as they treated vials before the VVMs arrived. When in doubt, throw it out. Hopefully the 250,000 vials could go to specific districts so that only these districts are trained on the issue. The trick is, as you say Dianne, to get the correct message out to health workers. I am not sure I fully understand the plastic bag idea Dianne. Did you mean for the bags to be labeled with VVMs and transported within boxes of OPV until the boxes are broken down? If this is so, then why would the discard date need to be written (since the VVM on the bag should provide an accurate picture of heat exposure incurred - as long as the vials within are always kept together)? If this is not so, what did the health workers do before VVMs were available to ensure that the OPV was not kept out of the freezer for more than 6 months? I want to get this message off today, but will continue to mull ideas over and will hope that a consignment exchange might be possible. All the best, Debbie Kristensen Technical Officer Program for Appropriate Technology in Health (PATH) 4 Nickerson Street, Seattle, WA 98109-1699 USA Telephone: (206) 285-3500; Fax (206) 285-6619 E-Mail: [log in to unmask]; PATH Web Site: http://www.path.org --- From: [log in to unmask] Date: Fri, 14 Jul 2000 16:22:34 +0200 To: Subject: Faulty VVMs Dear Steve, Thank you very much for your points of clarification. I agree, that a vial having a critically defective VVM should be handled as a vial without a VVM, and be used first. Regards Jens Pake --- From: [log in to unmask] Date: Thu, 13 Jul 2000 15:18:33 +0200 To: Subject: Re:Post00266 URGENT: FAULTY VVMS Diane, I just received the message below. As I used to work in Botswana (Smallpox early 70's) Southern Africa is still a special place for me. I worked for many years in EPI so I have some ideas on your problem. 1. What did you do before V.V.M ..existed? If it worked then do the same thing again. 2. If you are getting a new fresh stock of OPV with an expiry date 18- 24 months hence and you will use the vaccine in the next 6 to 12 months there is not much risk it will loose it's potency unless left in the sun.? 3. The longer you store the vaccine at central or regional level in known safe conditions and the faster it is used at site the less risk you have. (The so called FAST chain) 4. Warn people to be extra careful due to the problem you have, or decide not to warn them which may cause confusion. 5. All of the above is nothing more or less than common sense I am sure you have plenty. Do not put too much trust in gadgets. Good Luck, Garry Presthus WHO Geneva --- Date: Fri, 14 Jul 2000 13:34:16 -0400 From: Anthony Battersby Subject: Post00266 URGENT: FAULTY VVMS To: Technet Moderator , Dear Dianne, Remembering the long discussion that ensued following the "VVMs in boiling water" episode. I suggest that you tell the manufacturer to re-label the vials without any VVMs at all. The potential for misunderstanding is enormous if there are VVMs which are apparently good but have an instruction over-riding the VVM. It should not take the manufacturer long to re-lable. You can then revert to the previous procedures that you followed before VVMs were in use. NO country should use defective VVMs, the implications for the future use of VVMs are too serious. I suspect that there would be some very tricky legal problems if it was known that DoH had knowingly issued OPV with faulty labels, especially if there were a problem such as VAPP. Cheers Anthony --- From: "Lee, Carla" To: "'Dianne Phillips'