Surveillance and monitoring for vaccine safety

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1 9 Surveiance and monitoring for This chapter describes the process of monitoring in the UK and the reporting of adverse events foowing immunisation (AEFIs) (see Chapter 8). It aso describes the mechanism for the reporting of suspected defects in vaccines or in the devices used for the administration of vaccines. A vaccines are extensivey tested for quaity, safety and immunogenicity and/or efficacy before being icensed and used routiney. As not a side effects may have been identified prior to icensing, particuary if they occur very rarey, carefu surveiance is required throughout their use. Important information on is routiney coected through the Yeow Card scheme and from other sources, incuding medica iterature, post-marketing safety studies, epidemioogica databases and other wordwide organisations. Surveiance and The Medicines and Heathcare products Reguatory Agency (MHRA) has responsibiity for monitoring the safety of a marketed medicines (incuding vaccines) and medica devices. Suspected adverse events foowing the use of vaccines, medicines and medica devices shoud be reported to the MHRA. The Yeow Card scheme The Yeow Card scheme is a vountary reporting system for suspected adverse reactions (ADRs) to medicines, which incudes vaccines. AEFIs that are suspected to be vaccine-induced shoud be reported as ADRs via the Yeow Card scheme. An ADR is an unwanted or harmfu reaction foowing the administration of a medicine, vaccine or combination of vaccines. The ADR may be a known AEFI (see Chapter 8), or it may be previousy unrecognised. Spontaneous reports of suspected ADRs are received from UK doctors, pharmacists, dentists, coroners, nurses, midwives, heath visitors and patients. There is aso a statutory requirement for pharmaceutica companies to report to the MHRA serious suspected ADRs associated with their products. 65

2 Surveiance and Reports of suspected ADRs submitted through the Yeow Card scheme are entered onto a computer database operated by the MHRA. The reporter receives an acknowedgement and is suppied with a unique registration number. Reports of suspected ADRs are reguary reviewed, and appropriate investigation and action is initiated if a possibe probem is identified. Information reating to the MHRA and the Yeow Card scheme can be found on the MHRA website (www.mhra.gov.uk) and at Information on individua patients and reporters submitted to the MHRA is confidentia. The five regiona monitoring centres of the Commission on Human Medicines (CHM) work in conjunction with the MHRA in coecting data on ADRs and faciitating oca ADR reporting (see end of chapter). Surveiance and Which ADRs to report The success of the Yeow Card scheme depends on eary, compete and accurate reporting of suspected ADRs. A Yeow Card shoud be submitted when a causa association is suspected between the product administered and the condition experienced by the patient. The MHRA encourages reporting of suspected ADRs even if there is uncertainty as to whether the vaccine payed a causa roe. A suspected ADRs occurring in chidren shoud be reported. Newy icensed vaccine products are subject to enhanced surveiance and are given back triange status (indicated by an inverted triange t on the product information). For such products, a serious and non-serious suspected ADRs shoud be reported, for both aduts and chidren. For vaccines that have been marketed for two years or more, ony serious suspected ADRs shoud be reported. This appies to a serious reactions, whether or not such reactions have previousy been recognised with the suspected vaccine. Serious reactions that shoud be reported incude those that: are fata are ife-threatening are disabing or incapacitating resut in or proong hospitaisation are medicay significant ead to congenita abnormaities. 66

3 Surveiance and However, a reporter can aso state that a case is serious for any reason other than those outined here. When submitting a Yeow Card, the vaccine brand name and batch number shoud be provided. If the brand name is unavaiabe, the active ingredient or antigen type shoud be ceary identified, e.g. pneumococca conjugate vaccine shoud be ceary distinguished from pain pneumococca poysaccharide vaccine. It is important to give as much information as possibe about the nature, timing and severity of the suspected ADR, if the patient was hospitaised, what treatment was given and the outcome. Information about other factors, such as immunisation history, concomitant vaccines, underying disease, aergies or famiy history, shoud be provided whenever possibe. The provision of additiona information, such as test resuts or reevant hospita correspondence, is aways hepfu. Any further information, incuding where subsequent investigations impicate another possibe cause for the condition, shoud be sent to the MHRA to hep in the assessment of the suspected ADR. The Yeow Card registration number, provided to reporters on acknowedgement of receipt of the Yeow Card, shoud be quoted. The MHRA may aso contact the reporter directy if specific information on a suspected ADR is required. Surveiance and Deciding whether to report a suspected ADR It is a matter of cinica judgement whether a suspected ADR shoud be reported or not. Athough a reaction might occur in cose tempora association with an immunisation, often it can be very difficut to assess whether there is a causa ink. If there is any suspicion that the reaction is vaccine-induced, an ADR shoud be reported. Many suspected ADRs are actuay medica conditions that have occurred spontaneousy and coincidentay. The probabiity that a vaccine has caused an ADR may be increased if there is bioogica pausibiity for the event. For instance, pyrexia iness occurring five to ten days or parotid sweing occurring three weeks after meases, mumps and rubea (MMR) immunisation woud be consistent with the incubation periods for meases or mumps viruses. On the other hand, pyrexia occurring ess than three days after MMR vaccination is unikey to be caused by the immunisation, and an underying infection is a more ikey expanation. 67

4 Surveiance and Where to get Yeow Cards Yeow Cards can be downoaded from the MHRA website (www.mhra.gov.uk) and reports can be submitted eectronicay (www.yeowcard.gov.uk). Yeow Cards are aso avaiabe in the back of the British Nationa Formuary (BNF), the BNF for Chidren, the Nurse Prescribers Formuary, the Association of the British Pharmaceutica Industry Compendium of Data Sheets and Summaries of Product Characteristics and MIMS for Nurses. Yeow Cards can aso be obtained by caing the nationa Yeow Card information service ( ) or by writing to the MHRA or one of the five regiona centres (see contact detais at the end of the chapter). Surveiance and Causaity assessment of potentia new signas Yeow Cards are important in generating possibe new signas of safety concerns. When assessing whether a signa generated by Yeow Cards or from other sources is vaccine-induced, a of the avaiabe evidence is considered. Causaity assessment often depends on factors that incude bioogica pausibiity an excess of events in a specified post-immunisation period compared with background rates and aboratory evidence. Forma epidemioogica studies are required to strengthen or refute an assessment of causaity. Where a causa association is demonstrated, the eve of risk shoud be quantified and the risk factors estabished. For exampe, by inking computer records of hospita admissions and MMR immunisation, a positive association was found between MMR and idiopathic thrombocytopenic purpura (ITP). One case of ITP, attributabe to vaccine, occurs for every 32,000 doses administered (Mier et a., 2001). Using a simiar method, the hypothesis that ora ive poio vaccine was associated with intussusception was rejected (Andrews et a., 2001). Matters reating to are kept under constant review. The CHM and the Joint Committee on Vaccination and Immunisation (JCVI) are independent, expert scientific committees that advise the Government. The CHM advises on the safety, quaity and efficacy of medicines and vaccines, 68

5 Surveiance and and the JCVI provides expert advice on immunisation poicy. These committees examine carefuy any new evidence that reates to, and make recommendations on the subsequent use of a vaccine or the impementation of the immunisation programme. Action foowing evidence about If the avaiabe evidence supports a causa association between a vaccine and a reported ADR, the CHM or JCVI may give recommendations for action. These wi take into account an assessment of the baance of benefits of vaccination versus the risks. Reguatory action may be taken by the MHRA on the recommendation of the CHM. This coud invove withdrawa of a vaccine but woud more often invove an amendment to a vaccine icence (marketing authorisation) in order to ensure that it is used more safey and effectivey. Such amendments may incude restrictions on usage, refinement of dosage instructions or the introduction of specific recommendations or warnings in the Summary of Product Characteristics (SPC). Surveiance and Where further evidence to reject a causa association between a vaccine and a condition becomes avaiabe, action may incude the remova of previous restrictions or a change to the SPC. Defective vaccines and batch probems Defects in medicina products may incude errors in the packaging, abes or eafets, or other product fauts, such as particuate contamination of a vaccine. If heathcare professionas suspect that a vaccine is defective, they shoud not use the product but contact the Defective Medicines Report Centre (DMRC) of the MHRA (see contact detais at the end of the chapter). The DMRC assists in the investigation of defective medicines and co-ordinates any action that may need to be taken. When submitting reports on suspected defective medicina products to the DMRC, the foowing information shoud be provided: brand/non-proprietary name name of the manufacturer/suppier strength and dosage form product icence number batch number(s) expiry date(s) 69

6 Surveiance and nature of the defect an account of any action aready taken. Where the defect is noticed after the vaccine has been administered, advice on the management of that patient shoud be sought from a oca immunisation ead or heath protection unit. Adverse reactions to a vaccine may aso resut from a defective batch of vaccine (programme-reated AEFI) and shoud be reported to the MHRA. Surveiance and Defective medica devices Medica devices and equipment are items used for the diagnosis and/or treatment of disease, or for monitoring patients, as we as aids for daiy iving. This covers a wide range of products used every day in primary and acute care settings, in residentia or nursing settings or in the patient s own home, and by schoo nurses. Exampes of devices reevant to the immunisation programme incude needes and syringes, vias or ampoues. Additiona information and exampes of categories of medica devices can be found on the Devices information part of the MHRA website (www.mhra.gov.uk). The MHRA assesses a reports of adverse incidents invoving medica devices and, where appropriate, instigates an investigation, corrective actions and design changes to reduce the risk of recurrence. Defects in medica devices may occur because of: design or manufacture probems poor user instructions and training inappropriate oca modifications inadequate maintenance unsuitabe storage and use conditions. A defective medica device may cause unexpected or unwanted effects invoving the safety of patients, device users or other persons. Any adverse incident invoving a medica device shoud be reported, especiay if the incident has ed to or coud ead to: death or serious injury medica or surgica intervention or hospitaisation unreiabe test resuts (and risk of misdiagnosis). 70

7 Surveiance and Minor fauts and discrepancies shoud aso be reported, as these can hep to demonstrate trends or highight inadequate manufacturing or suppy systems. Exampes of incidents invoving immunisation equipment which shoud be reported incude: needes that break in use needes that eak or disconnect at the hub bocked needes barbed or bunt needes syringe tips, fanges or pungers that break in use contaminated products missing components visibe damage (cracked syringe barres, etc.). How to report an incident Defective devices and adverse incidents shoud be reported at the eariest opportunity, foowing any oca incident-reporting poicies. Adverse events invoving immunisation equipment (rather than the vaccine itsef) shoud be reported to the medica devices Adverse Incident Centre (AIC) at the MHRA. If in doubt, contact the MHRA about the most appropriate reporting route. Surveiance and Where possibe, reports shoud be submitted eectronicay using the medica device onine reporting system on the MHRA s website (www.mhra.gov.uk). This provides an immediate acknowedgement and MHRA reference number for each report, and aso aows you to e-mai a copy to others within your organisation. However, if necessary, forms may be downoaded from the website or obtained from the AIC and can be e-maied or faxed to AIC (see contact detais at the end of the chapter). Detaied information on reporting adverse incidents with medica devices can be found on the MHRA website, from the AIC or from your oca Medica Device Liaison Officer. 71

8 Surveiance and Contact detais Yeow Card reports: Pharmacovigiance Group Medicines and Heathcare products Reguatory Agency Market Towers 1 Nine Ems Lane London SW8 5NQ Surveiance and Defective medicines: The Defective Medicines Report Centre Medicines and Heathcare products Reguatory Agency Room 1801, Market Towers 1 Nine Ems Lane London SW8 5NQ Te: (weekdays 9am to 5pm) or (outside norma working hours) Defective Devices/Adverse Incident Centre: Adverse Incident Centre Medicines and Heathcare products Reguatory Agency 2/2G Market Towers 1 Nine Ems Lane London SW8 5NQ E-mai: Fax: Incident hotine: Text phone:

9 Surveiance and References Andrews N, Mier E, Waight P et a. (2001) Does ora poio vaccine cause intussusception in infants? Evidence from a sequence of three sef-controed cases series studies in the United Kingdom. Eur J Epidemio. 17(8): BNF for Chidren Mier E, Waight P, Farrington CP et a. (2001) Idiopathic thrombocytopenic purpura and MMR vaccine. Arch Dis Chid. 84(3): Surveiance and 73

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