SlideShare a Scribd company logo
1 of 48
Version: August 2014 
Training 
2014
Page 2 
Version: August 2014DRUG SAFETYA SHARED RESPONSIBILITY 
Ceuta Healthcare’s responsibilities for our clients’ products
Page 3 
Version: August 2014Agenda 
oBackground information on Pharmacovigilance 
oResponsibilities explained 
oProviding product information 
oAdverse events 
oQuality complaints 
oSpecial Scenario reports/other product related issues to report 
oFalsified Medicines & Counterfeit 
oReporting requirements 
oWhat details and where to report 
oSummary
Page 4 
Version: August 2014 
“Pharmacovigilanceis the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines with a view to: 
oIdentify information about potential new hazards 
oPreventing harm to patients. 
The word is derived from the Greek pharmakon-drug, 
and the Latin vigilare-to be awake or alert, to keep watch.” 
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodPharmacovigilancePractice/Background/index.htm 
What is Pharmacovigilance?
Page 5 
Version: August 2014 
Pharmacovigilance (PV) The process of monitoring, evaluating and improving the safety of medicines. It is carried out by pharmaceutical companies on their products and by government agencies on all medicinal products. Also, the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Useful Definitions 
Medicinal ProductA substance or combination of substances presented as having properties for treating or preventing disease in human beings; or a substance or combination which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis 
Marketing Authorisation (MA) The approval granted by the Regulatory Authority to market a specific product in a particular country 
Marketing Authorisation Holder (MAH) The company named on the Marketing Authorisation for a specific product in a particular country.
Page 6 
Version: August 2014Current Legislation :United Kingdom 
There are several agencies that legislate the pharmaceutical industry. 
Two key organisations are: 
oMedicines and Healthcare Products Regulatory Agency –(MHRA) 
oThe Association of the British Pharmaceutical Industry (ABPI) 
(which Ceuta are an affiliated member of) 
All employees of a company have therefore a legal responsibility to report Adverse Drug Events.
Page 7 
Version: August 2014Role of the MHRA (Medicines & Healthcare regulated Products Agency) 
The MHRA was set up after Thalidomide scare in 1962. Thalidomide was a drug given to pregnant women to combat the symptoms of morning sickness. Their babies were born with severe birth defects. Insufficient trials had been conducted to verify the safety of Thalidomide as a drug –there were minimal regulations and no agency to monitor the effects or safety of drugs. Hence the MHRA was formed. 
oIts main aim is to safeguard public health by ensuring that medicines for human use, sold or supplied in the UK, are of an acceptable standards of safety, quality and efficacy 
oIts main objectives are operating post-marketing surveillance and other systems of reporting, investigating and monitoring adverse reactions to medicines, and taking necessary action to safeguard public health, for example through safety warnings and removing and/or restricting the availability of products. 
oThe MHRA has the power to withdraw a product from the market or suspend production. They can also prosecute a manufacturer or distributor if the law has been broken.
Page 8 
Version: August 2014Background of MHRA Inspections 
Statutory MHRA PV inspections commenced in July 2003 
oThe MHRA aims to inspect all UK Marketing Authorisation Holders (MAH)on a 3 yearly cycle. 
oThis involves routine, periodic system inspections of all training, data capture, monitoring and processing of Adverse Events concerning medicinal products and devices. This also covers the manufacture and distribution processes. 
oTriggered inspections will be performed at the request of the MHRA PV Group if it is believed that an organisation is not working to the set standards of safety and quality.
Page 9 
Version: August 2014Responsibilities of our Clients as a Marketing Authorisation Holder 
Marketing Authorisation Holders are responsible for: 
oMonitoring drug safety throughout drug’s life (from pre-clinical trials to the product is withdrawn from the market or sold to another MAH). 
oImproving drug safety where possible 
oEnsuring optimum quality of the product 
oEnsuring the product is effective and meets specification and labelling 
oAssessing risks and benefits of the medicine 
All of the aboveprotects the patient and ultimately keeps products in the market place 
Please note this applies only to licensed medicinal products and devices
Page 10 
Version: August 2014MHRA outlook of 3rdParty Representation such as outsourcing companies like Ceuta 
oIt is a requirement for the Marketing Authorisation Holder (MAH) to have a Pharmacovigilance (PV) system with procedures in place to support the safety of the products sold.If the MAH chooses to outsource any of the responsibilities then the service provider, (Ceuta), must be able to comply with legislation and guidance.In practice this means that they would need to have a quality management system including documented processes and reporting proceduresin place. 
oFor an outsourced company ,up to date SPCs(Summary of Product Characteristics) must be provided by the MAH to the sales representatives. 
oIn the event of an Adverse Event, the outsourced company must have procedures in place to record and monitorcomplaints and be in a position to reconcileback to the MAH’s safety department. 
oCeuta complies with all of the above.
Page 11 
Version: August 2014Responsibilities of allCeuta Healthcare Employees 
Ceuta employees are seen as an extension of our Client’s own personnel. As we are at the forefront of sales and product enquiries, you may be the 1stpoint of contact for hearing about an adverse event: 
As an outsource company we are responsible for: 
oProviding product information to third parties 
oReporting product issues to the client: 
oAdverse events 
oComplaints on quality of product (defects) 
oSpecial scenario reports including: 
oComplaints on efficacy of product 
oEffects on pregnancy or lactation 
oMisuse and abuse 
oOverdose 
oMaladministration 
oUnexpected benefit 
Version: May 2013
Page 12 
Version: August 2014Providing Product Information 
oAllsalespersonnelarerequiredtohaveaccesstocopiesofcurrentSPCsforthelicensedproductswithintheirportfolio. 
oAnSPC(SummaryofProductCharacteristics)isadetailedlistingofthepharmaceuticalinformationonamedicinewhichhasbeenapprovedbyacompetentauthorityandformspartofaMarketingLicenceorAuthorisation. 
oWhenaskedaboutaproductyoumustrefertoitsSPCasthisholdsapproved,accurateproductinformation.AnelectronicfilecontainingSPCsforalllicensedproductsintheteam’sportfoliowillbeprovidedtosalesstaffbytheirmanagerduringtheirinduction(whereapplicable).Thisshouldbesavedonthedesktoponeachperson’slaptop. 
oSPCupdateswillbesentoutperiodicallyandtheseneedtobesavedinthisfileandtheoldSPCwillneedtobedeleted.ItisvitalthatyouhavethecurrentSPCversioninyourfileshouldyoueverbeaskedforinformation. 
oElectronic copies of SPCs are kept on the Ceuta network V:Common DataPharmacovigilanceSPCs 
oIffurtherinformationisrequired,pleasecontactCustomerServicesatCeutaHeadOffice
Page 13 
Version: August 2014An example of an SPC
Page 14 
Version: August 2014What is an Adverse Event? 
An Adverse Event (AE) is: 
Any untoward medical occurrence, in a patient or clinical investigation subject who has administered a pharmaceutical product, that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product . 
A pre-existing condition which worsened in severity after administration of the product would also be considered as an adverse event. 
Examples of side effects: 
Lip swells after using a product 
Burning sensation in the eye after using a product 
Stomach cramps after using a product 
Hair loss after using a product 
Breathing difficulties after using a product 
Rash develops after using a product 
Feeling of nausea after using a product
Page 15 
Version: August 2014When is an Adverse Event serious? 
An Adverse Event (AE) can be very serious. They can: 
obe fatal 
obe life threatening 
oresults in persistent or significant disability / incapacity 
oresults in or prolongs hospitalisation 
oresult in congenital anomaly / birth defect 
oresult in a serious adverse clinical consequence, including use outside the terms of the SPC (for example, overdoses or abuse) 
obe deemed medically significant (when the reporting health care professional feels the AE is medically significant)
Page 16 
Version: August 2014Product Technical Complaints(Faulty Products & Quality Complaints) 
Quality complaints can present themselves in a variety of forms ranging from packaging design issues to faulty or contaminated medicines. 
When a product is suspected or known to be faulty, the MHRA immediately works with manufacturers and wholesalers on the most appropriate and timely action to take. Sometimes this means a product has to be recalled and taken out of the supply chain. 
The action taken is determined by the scale of the threat posed to the public’s health. 
Our clients must be made aware of all defective or product related issues so that they can investigate fully and take the required action.
Page 17 
Version: August 2014Examples of complaints 
oEmpty tube, short measure, contamination 
oDesign issues –too small, not enough 
oBad taste or odour 
oForeign object in the product 
oLack of efficacy (product does not work) 
oMissing tablets 
oBroken / cracked tabs 
oDiscoloured tabs 
oIllegible label 
oMissing patient info leaflet 
In cases of Adverse Events and Product Complaints we need to request for the product to be sent to Ceuta Healthcare Head Office as soon as possible, so that the product can be sent off to be analysed by the client. 
Our FREEPOST address is Ceuta Healthcare, Freepost (BH1571), Bournemouth, BH2 6BF.
Page 18 
Version: August 2014Special Scenarios 
Special Scenario cases are reports where a product has been used outside of the license. These cases include 
opregnancy or breastfeeding (lactation) 
ooverdose 
omisuse 
oabuse 
ooff-label use 
otransmission of infectious agents 
olack of efficacy 
omaladministration 
ounexpected benefit
Page 19 
Version: August 2014Pregnancy and Lactation 
oThis is deemed to be drug exposure via a parent, usually the mother, either at time of conception, at any time during pregnancy, labour and delivery or whilst breast-feeding an infant 
oNot an adverse event, but cases are collected and are followed up to establish whether the pregnancy and the baby are normal 
oCases with and without events are collected and must be reported to the client.
Page 20 
Version: August 2014Overdose 
oOverdose is exposure to a dosage of a medicinal product that is significantly higher than that recommended in the product information and license. 
E.g. if someone takes a one a day tablet three times in a day. 
oReports of overdose with or without adverse events are collected and must be reported to the client
Page 21 
Version: August 2014Misuse 
oDrugmisuseisanexposureresultingfromtheintentionaluseofadruginawaythatisnotrecommendedintheproductinformationorlicence. 
E.g.ifsomeonetakeslaxatives(licensedtoloosenthestool,andtotreatconstipation)tohelpthemloseweight. 
oCaseswithandwithouteventsarecollectedandmustbereportedtotheclient
Page 22 
Version: August 2014Drug abuse 
oDrugabuseisanexposureresultingfromthepersistent,excessiveandintentionalre-currentuseofadrugbyapatientinawaythatisnotrecommendedintheproductinformationorlicense. 
oCasesofdrugabusewithandwithoutadverseeventsarecollectedandmustbereportedtotheclient
Page 23 
Version: August 2014Off-Label Use 
oThe use of medicinal product outside the terms of the licence (ie, ‘off- label’). 
oThe use and/or promotion of medicinal products whose effectiveness and safety for a particular treatment or procedure have not been officially proven or authorised. 
oReports of off-label use with or without adverse events are collected and must be reported to the client
Page 24 
Version: August 2014Transmission of Infectious Agents 
Transmission of an infectious agent (bacteria or other contaminant) via a medicinal product. This could arise from various causes e.g.: 
oContamination of raw materials 
oContamination of products during processing or manufacture 
oCases with and without adverse events are collected and must be reported to the client
Page 25 
Version: August 2014 
Procter & Gamble is recalling Vicks Sinex in the US, UK and Germany 
Procter & Gamble has announced it is recalling 120,000 bottles of Vicks Sinex nasal spray after small traces of bacteria were found in the product. 
Bottles shipped to the US, the UK and Germany are being recalled after traces of the B cepacia bacteria were found at a German plant in Gross Gerau. 
The firm said no illnesses had been reported, but the bacteria can affect people with lung problems. 
It added that consumers who have the medication should no longer use it. 
The consumer products giant stressed the recall was just a precautionary measure, but added that "the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis." 
In the UK, lot 9224028832 of Vicks Sinex Micromist Aqueous Nasal Spray solution in 15ml bottles is being recalled. 
Consumers worried whether they own one of the affected bottles should call 0800 555 515. Example of Transmission of Infectious Agent: November 2009 -Procter & Gamble recalls 120,000 Vicks nasal sprays 
http://news.bbc.co.uk/1/hi/business/8369764.stm
Page 26 
Version: August 2014Lack of Drug Efficacy 
oLack of drug effect is defined as failure to produce the expected pharmacological action for an approved indication. A situation where the drug has not produced the expected outcome. 
oLack of efficacy could be classed as an adverse event: e.g. Lack of efficacy of a drug used to treat a life threatening condition and / or to prevent such: cancer, vaccines etc. 
oCases with and without adverse events are collected and must be reported to the client.
Page 27 
Version: August 2014Maladministration(Medication Errors) 
oMaladministration is the inappropriate prescribing of drugs or medication error: that is the receipt of the wrong drug or the wrong dose of the right drug. 
oE.g. a doctor has prescribed the wrong product or incorrect dosage, or, the pharmacist has dispensed the incorrect product or dosage. 
oThese may or may not lead to adverse events 
oCases with and without adverse events are collected and must be reported to the client
Page 28 
Version: August 2014Example of Medication Error
Page 29 
Version: August 2014Unexpected benefit 
oWhen someone experiences an unexpected benefit that is not indicated in the product license as a result of taking the product. 
(e.g. unexpected hair growth after taking a product for heart problems) 
oThis is not an adverse event, but cases are collected and must be reported to the client.
Page 30 
Version: August 2014Falsified Medicines 
Falsified Medicines are fake medicines that pass themselves off as real, authorised medicines. Falsified medicines may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage – either too high or too low. Since they have not passed through the necessary evaluation of quality, safety and efficacy as required by the EU authorisation procedure, they can be a major health threat . 
Falsified medicines are a major threat to public health and safety and the number are, according to the European Commission, increasing each year. 
Falsified ('fake') medicines and drugs are a major problem for patients, their families and health care providers. The main risk with falsified medicines is with medicines which are targeted at those who are seriously ill. Such medicine may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. 
The main source is from internet sales, marketed by illegitimate or unethical companies. The big problem is that - globally -legislation has been relatively weak. 
There has been concern that over the past few years, more falsified medicines have been entering the supply chain. This includes outright counterfeiting (often involving organised crime) through the use of Active Pharmaceutical Ingredients which are not intentionally fraudulent but which may not have been tested correctly to ensure that they meet agreed specifications.
Page 31 
Version: August 2014 
A falsified medicinal product is defined as any medicinal product with a false representation of: 
oits history, including the records, and documents relating to the distribution channels used 
oits source, including its manufacturer, its country of manufacturing, its country of origin, or its marketing authorization holder 
oits identity, including its packaging and labelling, its name, or its composition as regards to any of the ingredients including excipients and the strength of those ingredientsFalsified Medicines
Page 32 
Version: August 2014What Is a Counterfeit? 
А counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. 
oProduct appears to be a genuine branded item 
oFound in suspicious circumstances 
oDoes not ‘look’ quite right 
oUnusual packaging 
oUnusual colour or appearance 
oHas an unusual smell/texture 
oLack of effect
Page 33 
Version: August 2014 
The International Police Agency, Interpol, has announced a deal with the pharmaceutical industry to crack down on fake drugs. 
Twenty nine of the world's biggest drug companies will provide 4.5m euros ($5.9m; £3.9m) in the next three years to help the response to the problem. 
"A global effort is needed to combat this threat," Interpol said. 
The agency added that the lives of millions of people were put at risk every day because of it. 
Christopher Viehbacher, the chief executive of French drugmaker Sanofi, said: "In the case of drug counterfeiting, it can mean the difference between life and death for a patient. 
"It is estimated that 10% of medicines are fake and these figures can go up to 50%, particularly in some poorer countries." 
12 March 2013 Interpol deal to combat fake drugs
Page 34 
Version: August 2014Why collect and report complaints? 
The key reasons that complaints must be reported to clients is for them to: 
oEstablish and monitor the safety profile of product 
oImprove the product 
oEnsure patient safety 
And also because it is a regulatory authority requirement.
Page 35 
Version: August 2014How to Report Adverse Events / Complaints/ Special Scenarios 
oAt Ceuta, we ask you to report allproduct issues to us (not just licensed) 
oThe same process should be used when processing all product complaints, side effects and special scenarios. 
oIn all cases an Adverse Event form needs to be completed 
oField Based Staff –Form located in the library on your desktop 
oHead Office Staff –Form located in the Pharmacovigilance file in common data: V:Common DataPharmacovigilanceDocuments and FormsAdverse Event Form July 2013.docx
Page 36 
Version: August 2014 
Minimum information required to report an adverse event 
Reporter contact details 
Event(s) experienced 
Patient ID (initials, gender, age or age group) 
Suspected drugReporting an Adverse Event 
Please note: available information must be sent even if any of the above criteria are missing
Page 37 
Version: August 2014How to Fill In a Product Adverse Event Form 
Product Details 
Product Name: Please put name of product 
Variant:Cream / Lotion, Flavour etc 
Pack Size:The amount the pack contains 
Batch no: lot/batch number found on packaging 
Quantity taken per dose:How much has the patient taken 
How Often:How Often has the patient taken/used product 
Date started taking:When did the patient first take product 
Date stopped taking:When did the patient stop taking/using product 
Patient Details 
Name: Patients name 
Initials: Patients initials 
Male/Female:Tick box that indicates patients gender 
Date of Birth:Fill in patients date of birth 
Age:Please put a figure here 
Address:Please take the patients address in full 
Tel Number:Please take a contact number for the patient 
Advised to see a doctor:If the patient has seen a doctor please note the name, address and contact number of the doctor 
Gives permission to contact doctor:Please tick if the patient gives you permission for their doctor to be contacted
Page 38 
Version: August 2014Adverse Event Form Continued 
Reporter Details 
Name: Take the name, initials , gender, address and contact number of the person reporting the incident if not the patient. 
Consumer, pharmacist, doctor, nurse, other (specify): Note down the profession of the person reporting (qualifications if a Health Care Professional). 
Event Details: Please put a tick next to the most appropriate explanation. 
Date Event Started: Note the date that the reporter became aware of the incident. 
Date Event Stopped:Note down the date the reporter became aware that the incident ended (if appropriate). 
If a case of pregnancy: Please note the approximate due date 
Additional Information (second page): Describe the event/incident in as much detail as possible including any actions that have already been undertaken.
Page 39 
Version: August 2014ReportingRequirements 
oDuring office hoursplease contact Customer Services immediately after becoming aware of any product related issues and give them all of the details so that they can complete the Adverse Event Form and the report for the incident. 
oANY incidence of an Adverse Event that you hear about out of hours should be reported IMMEDIATELY 
toSound Opinion(Ceuta’s emergency out of hours service provider) on 01793 710454. You are each given a credit size information card to keep in your purse or wallet which contains this information. 
oEven if you think an incident is already being handled it is still your duty to report it 
oAll Adverse Events must be reported to the Client within24hrs from the initial point of contact. 
This means we have 24 hours to report it from when you are first made aware NOT when you first report it. 
oThis allows the client to investigate fully on a timely basis 
oPlease note: some Clients screen notes made post-call on Fieldstrike to ensure no adverse event information is missed. All Adverse Events must be reported immediately as detailed above.
Page 40 
Version: August 2014Reporting responsibilities 
oIn a Newspapers / Magazines / Editorials 
oThrough speaking with Family / Friends / Colleagues 
oPhone call (it does not have to be a face to face conversation) 
oAn overheard conversation about a product issue 
oFrom a Healthcare professional 
If you learn of any adverse event regarding any of our clients products through the following means it is still your responsibility to report this information:
Page 41 
Version: August 2014Report Everything 
oYou do not need to determine the seriousness of any adverse event or quality issue, our clients will do this. 
oJust report everything to the client immediately 
oWe may come back and ask you for more information, so retain details 
oRemember, the clock starts ticking as soon as YOU are notified of the incident
Page 42 
Version: August 2014Training 
oAll new starters are given Pharmacovigilance Training during their induction 
oAll training is recorded by the Training Department and signed training acknowledgement forms are kept on file 
oAll staff are required to complete annualPharmacovigilance Refresher Training which is monitored and delivered by the Training Department 
oPharmacovigilance Training may be delivered by clients intermittently as and when required. All client training is logged by the Training Department at Ceuta
Page 43 
Version: August 2014All staff are given a laminate as an Essential Guide to remind them of their responsibilitiesStaff are also given a credit card size information card giving details of how to report an adverse event should one be reported to them
Page 44 
Version: August 2014Summary 
oReport alladverse events issues and complaints immediately 
oIt is your responsibility until you pass it on, then it is the client’s (the reporting clock starts ticking from the time you become aware of the event) 
oDrug safety is trulya shared responsibility
Page 45 
Version: August 2014 
GOOD DISTRIBUTION PRACTICE (GDP) 
A SHARED RESPONSIBILITY 
Ceuta Healthcare’s responsibilities for our clients’ products
Page 46 
Version: August 2014GDP –Good Distribution Practice 
oGooddistributionpractice(GDP)dealswiththeguidelinesfortheproperdistributionofmedicinalproductsforhumanuse.GDPisaQualitySystem,whichincludesrequirementsforPurchase,Receiving, Storage,Sales(includingExporting)andReturnsofdrugsintendedforhumanconsumption. 
a)Purchase –checks must be done on who we are buying our medicinal products from. 
b)Receiving –checks must be done to ensure for example correct batches are delivered, vehicles are clean and free of infestation,and the labelled storage conditions have been complied with. 
c)Storage –checks must be done to ensure for example that the pick process ensures FEFO, that the warehouse provides necessary security as well as the warehouse being able to maintain temperature levels to support the labelled storage conditions 
d)Sales –checks that customers are bonafide i.e. registered and licenced to receive medicinal products. Also that records are kept to enable recalls to take place if necessary to remove product from the market. When Exporting similar processes must also be followed. 
e)Returns –that any return must pass a number of checks to enable it to be released back to stock and be resold
Page 47 
Version: August 2014GDP –Good Distribution Practice 
oGDPguidelines give tools to help wholesale distributors when conducting their activities and to prevent falsified medicines from entering the supply chain. Compliance with GDP will ensure control of the distribution chain and consequently maintain the quality and integrity of the products. 
oGDPas a Quality System sets out the responsibilities, processes and risk management principles predominantly through the use of Standard Operating Procedures (SOPs).
Page 48 
Version: August 2014GDP –Good Distribution Practice 
oGDPis regulated in the UK by the MHRA and must be complied with for Ceuta to keep its Wholesale Distribution Authorisation (WDA –used to be known as a WDL) 
oThe definition of medicinal products includes THR (Traditional Herbal Remedies), GSL (General Sales List), P (Pharmacy), and POM (Prescription Only Medicines) –all are subject to GDP 
oCeuta has to have a nominated person known as the Responsible Person (RP), this is currently Chris Hoole. Please ask him for further information if needed.

More Related Content

What's hot

mHealth Israel_Rambam Health Care Campus_Miki Halberthal
mHealth Israel_Rambam Health Care Campus_Miki HalberthalmHealth Israel_Rambam Health Care Campus_Miki Halberthal
mHealth Israel_Rambam Health Care Campus_Miki HalberthalLevi Shapiro
 
Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
 
Cooper Pharma corporate presentation by Ayman CHEIKH LAHLOU, CEO, for mHealth...
Cooper Pharma corporate presentation by Ayman CHEIKH LAHLOU, CEO, for mHealth...Cooper Pharma corporate presentation by Ayman CHEIKH LAHLOU, CEO, for mHealth...
Cooper Pharma corporate presentation by Ayman CHEIKH LAHLOU, CEO, for mHealth...Levi Shapiro
 
Clinical research : Drug regulatory affairs and Pharmacovigilance.
Clinical research : Drug regulatory affairs and Pharmacovigilance.Clinical research : Drug regulatory affairs and Pharmacovigilance.
Clinical research : Drug regulatory affairs and Pharmacovigilance.ProfDnyaneshwariJosh
 
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...Siddhartha Dash
 
Presentation re promotion 8 june 2011(2)
Presentation re promotion 8 june 2011(2)Presentation re promotion 8 june 2011(2)
Presentation re promotion 8 june 2011(2)Erik Vollebregt
 
Pharma Uptoday Monthly Magazine - Volume 10 issue Jan 2015
Pharma Uptoday Monthly Magazine  - Volume 10 issue Jan 2015Pharma Uptoday Monthly Magazine  - Volume 10 issue Jan 2015
Pharma Uptoday Monthly Magazine - Volume 10 issue Jan 2015Sathish Vemula
 
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014Sathish Vemula
 
Fda adverse event reporting requirements for otc drugs
Fda adverse event reporting requirements for otc drugsFda adverse event reporting requirements for otc drugs
Fda adverse event reporting requirements for otc drugsComplianceOnline
 
Pharma Uptoday Monthly Magazine volume 4 issue jul 2014
Pharma Uptoday Monthly Magazine volume 4 issue jul 2014Pharma Uptoday Monthly Magazine volume 4 issue jul 2014
Pharma Uptoday Monthly Magazine volume 4 issue jul 2014Sathish Vemula
 
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014Sathish Vemula
 
Discount discount.....research aarkstore enterprise point of care diagnostic...
Discount discount.....research aarkstore enterprise  point of care diagnostic...Discount discount.....research aarkstore enterprise  point of care diagnostic...
Discount discount.....research aarkstore enterprise point of care diagnostic...Neel Terde
 
What’s new in Pharmacovigilance
What’s new in PharmacovigilanceWhat’s new in Pharmacovigilance
What’s new in PharmacovigilanceBruno Moreau
 
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...CRF Health
 

What's hot (18)

mHealth Israel_Rambam Health Care Campus_Miki Halberthal
mHealth Israel_Rambam Health Care Campus_Miki HalberthalmHealth Israel_Rambam Health Care Campus_Miki Halberthal
mHealth Israel_Rambam Health Care Campus_Miki Halberthal
 
Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)
 
Cooper Pharma corporate presentation by Ayman CHEIKH LAHLOU, CEO, for mHealth...
Cooper Pharma corporate presentation by Ayman CHEIKH LAHLOU, CEO, for mHealth...Cooper Pharma corporate presentation by Ayman CHEIKH LAHLOU, CEO, for mHealth...
Cooper Pharma corporate presentation by Ayman CHEIKH LAHLOU, CEO, for mHealth...
 
Clinical research : Drug regulatory affairs and Pharmacovigilance.
Clinical research : Drug regulatory affairs and Pharmacovigilance.Clinical research : Drug regulatory affairs and Pharmacovigilance.
Clinical research : Drug regulatory affairs and Pharmacovigilance.
 
Regulatory affairs
Regulatory affairsRegulatory affairs
Regulatory affairs
 
Committee for orphan medicinal products
Committee for orphan medicinal productsCommittee for orphan medicinal products
Committee for orphan medicinal products
 
Product recall & withdrawal
Product recall & withdrawalProduct recall & withdrawal
Product recall & withdrawal
 
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...
 
Presentation re promotion 8 june 2011(2)
Presentation re promotion 8 june 2011(2)Presentation re promotion 8 june 2011(2)
Presentation re promotion 8 june 2011(2)
 
Pharma Uptoday Monthly Magazine - Volume 10 issue Jan 2015
Pharma Uptoday Monthly Magazine  - Volume 10 issue Jan 2015Pharma Uptoday Monthly Magazine  - Volume 10 issue Jan 2015
Pharma Uptoday Monthly Magazine - Volume 10 issue Jan 2015
 
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014
 
Fda adverse event reporting requirements for otc drugs
Fda adverse event reporting requirements for otc drugsFda adverse event reporting requirements for otc drugs
Fda adverse event reporting requirements for otc drugs
 
Emea
EmeaEmea
Emea
 
Pharma Uptoday Monthly Magazine volume 4 issue jul 2014
Pharma Uptoday Monthly Magazine volume 4 issue jul 2014Pharma Uptoday Monthly Magazine volume 4 issue jul 2014
Pharma Uptoday Monthly Magazine volume 4 issue jul 2014
 
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014
 
Discount discount.....research aarkstore enterprise point of care diagnostic...
Discount discount.....research aarkstore enterprise  point of care diagnostic...Discount discount.....research aarkstore enterprise  point of care diagnostic...
Discount discount.....research aarkstore enterprise point of care diagnostic...
 
What’s new in Pharmacovigilance
What’s new in PharmacovigilanceWhat’s new in Pharmacovigilance
What’s new in Pharmacovigilance
 
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
 

Similar to Ceuta Pharmacovigilance Presentation 2014

TGA presentation: Postmarket Monitoring
TGA presentation: Postmarket MonitoringTGA presentation: Postmarket Monitoring
TGA presentation: Postmarket MonitoringTGA Australia
 
pharmacovigilance pdf (1)
pharmacovigilance pdf (1)pharmacovigilance pdf (1)
pharmacovigilance pdf (1)Prasad Bhat
 
Pharmacovigilance pdf (1)
Pharmacovigilance pdf (1)Pharmacovigilance pdf (1)
Pharmacovigilance pdf (1)Prasad Bhat
 
3..Post marketing surveillance.pptx
3..Post marketing surveillance.pptx3..Post marketing surveillance.pptx
3..Post marketing surveillance.pptxKrishnapriyaVH1
 
Fda med watch
Fda med watchFda med watch
Fda med watchSridhar S
 
Postmarket monitoring of therapeutic goods in Australia
Postmarket monitoring of therapeutic goods in AustraliaPostmarket monitoring of therapeutic goods in Australia
Postmarket monitoring of therapeutic goods in AustraliaTGA Australia
 
Dossier on drug safety
Dossier on drug safetyDossier on drug safety
Dossier on drug safetyLanre Suleiman
 
Dossier on Drug Safety.
Dossier on Drug Safety.Dossier on Drug Safety.
Dossier on Drug Safety.Lanre Suleiman
 
Safety monitoring and reporting of adverse events of medical devices national...
Safety monitoring and reporting of adverse events of medical devices national...Safety monitoring and reporting of adverse events of medical devices national...
Safety monitoring and reporting of adverse events of medical devices national...Vivek Nayak
 
W hite Paper On Medical Devices
W hite Paper On Medical DevicesW hite Paper On Medical Devices
W hite Paper On Medical DevicesAllisonBooth
 
Strategy for enhanced marketing authorization final docx
Strategy for enhanced marketing authorization final docxStrategy for enhanced marketing authorization final docx
Strategy for enhanced marketing authorization final docxFasika Alemu
 
6 Game-Changing Tips to Deal with Risk Management and Drug Safety Audit
6 Game-Changing Tips to Deal with Risk Management and Drug Safety Audit6 Game-Changing Tips to Deal with Risk Management and Drug Safety Audit
6 Game-Changing Tips to Deal with Risk Management and Drug Safety AuditDarwin Jayson Mariano
 
Medicines and Healthcare products Regulatory Agency(MHRA)
Medicines and Healthcare products Regulatory Agency(MHRA)Medicines and Healthcare products Regulatory Agency(MHRA)
Medicines and Healthcare products Regulatory Agency(MHRA)TMU
 
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...Until ROI
 
Volume 9 A Guidelines On Pharmacovigilance[1]
Volume 9 A Guidelines On Pharmacovigilance[1]Volume 9 A Guidelines On Pharmacovigilance[1]
Volume 9 A Guidelines On Pharmacovigilance[1]siddharthchachad
 
Pharmacovigilance Basics for fresher's as well as experience candidates
Pharmacovigilance Basics for fresher's as well as experience candidatesPharmacovigilance Basics for fresher's as well as experience candidates
Pharmacovigilance Basics for fresher's as well as experience candidatesJonaid Ali
 
post marketing surveillance OF DRUG PRODUCTS
post marketing surveillance OF DRUG PRODUCTSpost marketing surveillance OF DRUG PRODUCTS
post marketing surveillance OF DRUG PRODUCTSPrakashGoudanavar
 
Regulatory Authorities for Pharmaceuticals - TGA,MHRA,MCC
Regulatory Authorities for Pharmaceuticals - TGA,MHRA,MCCRegulatory Authorities for Pharmaceuticals - TGA,MHRA,MCC
Regulatory Authorities for Pharmaceuticals - TGA,MHRA,MCCSanket Shinde
 

Similar to Ceuta Pharmacovigilance Presentation 2014 (20)

TGA presentation: Postmarket Monitoring
TGA presentation: Postmarket MonitoringTGA presentation: Postmarket Monitoring
TGA presentation: Postmarket Monitoring
 
pharmacovigilance pdf (1)
pharmacovigilance pdf (1)pharmacovigilance pdf (1)
pharmacovigilance pdf (1)
 
Pharmacovigilance pdf (1)
Pharmacovigilance pdf (1)Pharmacovigilance pdf (1)
Pharmacovigilance pdf (1)
 
3..Post marketing surveillance.pptx
3..Post marketing surveillance.pptx3..Post marketing surveillance.pptx
3..Post marketing surveillance.pptx
 
Fda med watch
Fda med watchFda med watch
Fda med watch
 
Health Canada Progressive Licensing - Professor Peivand Pirouzi
Health Canada Progressive Licensing - Professor Peivand PirouziHealth Canada Progressive Licensing - Professor Peivand Pirouzi
Health Canada Progressive Licensing - Professor Peivand Pirouzi
 
Postmarket monitoring of therapeutic goods in Australia
Postmarket monitoring of therapeutic goods in AustraliaPostmarket monitoring of therapeutic goods in Australia
Postmarket monitoring of therapeutic goods in Australia
 
Dossier on drug safety
Dossier on drug safetyDossier on drug safety
Dossier on drug safety
 
Dossier on Drug Safety.
Dossier on Drug Safety.Dossier on Drug Safety.
Dossier on Drug Safety.
 
MHRA.pptx
MHRA.pptxMHRA.pptx
MHRA.pptx
 
Safety monitoring and reporting of adverse events of medical devices national...
Safety monitoring and reporting of adverse events of medical devices national...Safety monitoring and reporting of adverse events of medical devices national...
Safety monitoring and reporting of adverse events of medical devices national...
 
W hite Paper On Medical Devices
W hite Paper On Medical DevicesW hite Paper On Medical Devices
W hite Paper On Medical Devices
 
Strategy for enhanced marketing authorization final docx
Strategy for enhanced marketing authorization final docxStrategy for enhanced marketing authorization final docx
Strategy for enhanced marketing authorization final docx
 
6 Game-Changing Tips to Deal with Risk Management and Drug Safety Audit
6 Game-Changing Tips to Deal with Risk Management and Drug Safety Audit6 Game-Changing Tips to Deal with Risk Management and Drug Safety Audit
6 Game-Changing Tips to Deal with Risk Management and Drug Safety Audit
 
Medicines and Healthcare products Regulatory Agency(MHRA)
Medicines and Healthcare products Regulatory Agency(MHRA)Medicines and Healthcare products Regulatory Agency(MHRA)
Medicines and Healthcare products Regulatory Agency(MHRA)
 
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...
 
Volume 9 A Guidelines On Pharmacovigilance[1]
Volume 9 A Guidelines On Pharmacovigilance[1]Volume 9 A Guidelines On Pharmacovigilance[1]
Volume 9 A Guidelines On Pharmacovigilance[1]
 
Pharmacovigilance Basics for fresher's as well as experience candidates
Pharmacovigilance Basics for fresher's as well as experience candidatesPharmacovigilance Basics for fresher's as well as experience candidates
Pharmacovigilance Basics for fresher's as well as experience candidates
 
post marketing surveillance OF DRUG PRODUCTS
post marketing surveillance OF DRUG PRODUCTSpost marketing surveillance OF DRUG PRODUCTS
post marketing surveillance OF DRUG PRODUCTS
 
Regulatory Authorities for Pharmaceuticals - TGA,MHRA,MCC
Regulatory Authorities for Pharmaceuticals - TGA,MHRA,MCCRegulatory Authorities for Pharmaceuticals - TGA,MHRA,MCC
Regulatory Authorities for Pharmaceuticals - TGA,MHRA,MCC
 

Ceuta Pharmacovigilance Presentation 2014

  • 1. Version: August 2014 Training 2014
  • 2. Page 2 Version: August 2014DRUG SAFETYA SHARED RESPONSIBILITY Ceuta Healthcare’s responsibilities for our clients’ products
  • 3. Page 3 Version: August 2014Agenda oBackground information on Pharmacovigilance oResponsibilities explained oProviding product information oAdverse events oQuality complaints oSpecial Scenario reports/other product related issues to report oFalsified Medicines & Counterfeit oReporting requirements oWhat details and where to report oSummary
  • 4. Page 4 Version: August 2014 “Pharmacovigilanceis the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines with a view to: oIdentify information about potential new hazards oPreventing harm to patients. The word is derived from the Greek pharmakon-drug, and the Latin vigilare-to be awake or alert, to keep watch.” http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodPharmacovigilancePractice/Background/index.htm What is Pharmacovigilance?
  • 5. Page 5 Version: August 2014 Pharmacovigilance (PV) The process of monitoring, evaluating and improving the safety of medicines. It is carried out by pharmaceutical companies on their products and by government agencies on all medicinal products. Also, the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Useful Definitions Medicinal ProductA substance or combination of substances presented as having properties for treating or preventing disease in human beings; or a substance or combination which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis Marketing Authorisation (MA) The approval granted by the Regulatory Authority to market a specific product in a particular country Marketing Authorisation Holder (MAH) The company named on the Marketing Authorisation for a specific product in a particular country.
  • 6. Page 6 Version: August 2014Current Legislation :United Kingdom There are several agencies that legislate the pharmaceutical industry. Two key organisations are: oMedicines and Healthcare Products Regulatory Agency –(MHRA) oThe Association of the British Pharmaceutical Industry (ABPI) (which Ceuta are an affiliated member of) All employees of a company have therefore a legal responsibility to report Adverse Drug Events.
  • 7. Page 7 Version: August 2014Role of the MHRA (Medicines & Healthcare regulated Products Agency) The MHRA was set up after Thalidomide scare in 1962. Thalidomide was a drug given to pregnant women to combat the symptoms of morning sickness. Their babies were born with severe birth defects. Insufficient trials had been conducted to verify the safety of Thalidomide as a drug –there were minimal regulations and no agency to monitor the effects or safety of drugs. Hence the MHRA was formed. oIts main aim is to safeguard public health by ensuring that medicines for human use, sold or supplied in the UK, are of an acceptable standards of safety, quality and efficacy oIts main objectives are operating post-marketing surveillance and other systems of reporting, investigating and monitoring adverse reactions to medicines, and taking necessary action to safeguard public health, for example through safety warnings and removing and/or restricting the availability of products. oThe MHRA has the power to withdraw a product from the market or suspend production. They can also prosecute a manufacturer or distributor if the law has been broken.
  • 8. Page 8 Version: August 2014Background of MHRA Inspections Statutory MHRA PV inspections commenced in July 2003 oThe MHRA aims to inspect all UK Marketing Authorisation Holders (MAH)on a 3 yearly cycle. oThis involves routine, periodic system inspections of all training, data capture, monitoring and processing of Adverse Events concerning medicinal products and devices. This also covers the manufacture and distribution processes. oTriggered inspections will be performed at the request of the MHRA PV Group if it is believed that an organisation is not working to the set standards of safety and quality.
  • 9. Page 9 Version: August 2014Responsibilities of our Clients as a Marketing Authorisation Holder Marketing Authorisation Holders are responsible for: oMonitoring drug safety throughout drug’s life (from pre-clinical trials to the product is withdrawn from the market or sold to another MAH). oImproving drug safety where possible oEnsuring optimum quality of the product oEnsuring the product is effective and meets specification and labelling oAssessing risks and benefits of the medicine All of the aboveprotects the patient and ultimately keeps products in the market place Please note this applies only to licensed medicinal products and devices
  • 10. Page 10 Version: August 2014MHRA outlook of 3rdParty Representation such as outsourcing companies like Ceuta oIt is a requirement for the Marketing Authorisation Holder (MAH) to have a Pharmacovigilance (PV) system with procedures in place to support the safety of the products sold.If the MAH chooses to outsource any of the responsibilities then the service provider, (Ceuta), must be able to comply with legislation and guidance.In practice this means that they would need to have a quality management system including documented processes and reporting proceduresin place. oFor an outsourced company ,up to date SPCs(Summary of Product Characteristics) must be provided by the MAH to the sales representatives. oIn the event of an Adverse Event, the outsourced company must have procedures in place to record and monitorcomplaints and be in a position to reconcileback to the MAH’s safety department. oCeuta complies with all of the above.
  • 11. Page 11 Version: August 2014Responsibilities of allCeuta Healthcare Employees Ceuta employees are seen as an extension of our Client’s own personnel. As we are at the forefront of sales and product enquiries, you may be the 1stpoint of contact for hearing about an adverse event: As an outsource company we are responsible for: oProviding product information to third parties oReporting product issues to the client: oAdverse events oComplaints on quality of product (defects) oSpecial scenario reports including: oComplaints on efficacy of product oEffects on pregnancy or lactation oMisuse and abuse oOverdose oMaladministration oUnexpected benefit Version: May 2013
  • 12. Page 12 Version: August 2014Providing Product Information oAllsalespersonnelarerequiredtohaveaccesstocopiesofcurrentSPCsforthelicensedproductswithintheirportfolio. oAnSPC(SummaryofProductCharacteristics)isadetailedlistingofthepharmaceuticalinformationonamedicinewhichhasbeenapprovedbyacompetentauthorityandformspartofaMarketingLicenceorAuthorisation. oWhenaskedaboutaproductyoumustrefertoitsSPCasthisholdsapproved,accurateproductinformation.AnelectronicfilecontainingSPCsforalllicensedproductsintheteam’sportfoliowillbeprovidedtosalesstaffbytheirmanagerduringtheirinduction(whereapplicable).Thisshouldbesavedonthedesktoponeachperson’slaptop. oSPCupdateswillbesentoutperiodicallyandtheseneedtobesavedinthisfileandtheoldSPCwillneedtobedeleted.ItisvitalthatyouhavethecurrentSPCversioninyourfileshouldyoueverbeaskedforinformation. oElectronic copies of SPCs are kept on the Ceuta network V:Common DataPharmacovigilanceSPCs oIffurtherinformationisrequired,pleasecontactCustomerServicesatCeutaHeadOffice
  • 13. Page 13 Version: August 2014An example of an SPC
  • 14. Page 14 Version: August 2014What is an Adverse Event? An Adverse Event (AE) is: Any untoward medical occurrence, in a patient or clinical investigation subject who has administered a pharmaceutical product, that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product . A pre-existing condition which worsened in severity after administration of the product would also be considered as an adverse event. Examples of side effects: Lip swells after using a product Burning sensation in the eye after using a product Stomach cramps after using a product Hair loss after using a product Breathing difficulties after using a product Rash develops after using a product Feeling of nausea after using a product
  • 15. Page 15 Version: August 2014When is an Adverse Event serious? An Adverse Event (AE) can be very serious. They can: obe fatal obe life threatening oresults in persistent or significant disability / incapacity oresults in or prolongs hospitalisation oresult in congenital anomaly / birth defect oresult in a serious adverse clinical consequence, including use outside the terms of the SPC (for example, overdoses or abuse) obe deemed medically significant (when the reporting health care professional feels the AE is medically significant)
  • 16. Page 16 Version: August 2014Product Technical Complaints(Faulty Products & Quality Complaints) Quality complaints can present themselves in a variety of forms ranging from packaging design issues to faulty or contaminated medicines. When a product is suspected or known to be faulty, the MHRA immediately works with manufacturers and wholesalers on the most appropriate and timely action to take. Sometimes this means a product has to be recalled and taken out of the supply chain. The action taken is determined by the scale of the threat posed to the public’s health. Our clients must be made aware of all defective or product related issues so that they can investigate fully and take the required action.
  • 17. Page 17 Version: August 2014Examples of complaints oEmpty tube, short measure, contamination oDesign issues –too small, not enough oBad taste or odour oForeign object in the product oLack of efficacy (product does not work) oMissing tablets oBroken / cracked tabs oDiscoloured tabs oIllegible label oMissing patient info leaflet In cases of Adverse Events and Product Complaints we need to request for the product to be sent to Ceuta Healthcare Head Office as soon as possible, so that the product can be sent off to be analysed by the client. Our FREEPOST address is Ceuta Healthcare, Freepost (BH1571), Bournemouth, BH2 6BF.
  • 18. Page 18 Version: August 2014Special Scenarios Special Scenario cases are reports where a product has been used outside of the license. These cases include opregnancy or breastfeeding (lactation) ooverdose omisuse oabuse ooff-label use otransmission of infectious agents olack of efficacy omaladministration ounexpected benefit
  • 19. Page 19 Version: August 2014Pregnancy and Lactation oThis is deemed to be drug exposure via a parent, usually the mother, either at time of conception, at any time during pregnancy, labour and delivery or whilst breast-feeding an infant oNot an adverse event, but cases are collected and are followed up to establish whether the pregnancy and the baby are normal oCases with and without events are collected and must be reported to the client.
  • 20. Page 20 Version: August 2014Overdose oOverdose is exposure to a dosage of a medicinal product that is significantly higher than that recommended in the product information and license. E.g. if someone takes a one a day tablet three times in a day. oReports of overdose with or without adverse events are collected and must be reported to the client
  • 21. Page 21 Version: August 2014Misuse oDrugmisuseisanexposureresultingfromtheintentionaluseofadruginawaythatisnotrecommendedintheproductinformationorlicence. E.g.ifsomeonetakeslaxatives(licensedtoloosenthestool,andtotreatconstipation)tohelpthemloseweight. oCaseswithandwithouteventsarecollectedandmustbereportedtotheclient
  • 22. Page 22 Version: August 2014Drug abuse oDrugabuseisanexposureresultingfromthepersistent,excessiveandintentionalre-currentuseofadrugbyapatientinawaythatisnotrecommendedintheproductinformationorlicense. oCasesofdrugabusewithandwithoutadverseeventsarecollectedandmustbereportedtotheclient
  • 23. Page 23 Version: August 2014Off-Label Use oThe use of medicinal product outside the terms of the licence (ie, ‘off- label’). oThe use and/or promotion of medicinal products whose effectiveness and safety for a particular treatment or procedure have not been officially proven or authorised. oReports of off-label use with or without adverse events are collected and must be reported to the client
  • 24. Page 24 Version: August 2014Transmission of Infectious Agents Transmission of an infectious agent (bacteria or other contaminant) via a medicinal product. This could arise from various causes e.g.: oContamination of raw materials oContamination of products during processing or manufacture oCases with and without adverse events are collected and must be reported to the client
  • 25. Page 25 Version: August 2014 Procter & Gamble is recalling Vicks Sinex in the US, UK and Germany Procter & Gamble has announced it is recalling 120,000 bottles of Vicks Sinex nasal spray after small traces of bacteria were found in the product. Bottles shipped to the US, the UK and Germany are being recalled after traces of the B cepacia bacteria were found at a German plant in Gross Gerau. The firm said no illnesses had been reported, but the bacteria can affect people with lung problems. It added that consumers who have the medication should no longer use it. The consumer products giant stressed the recall was just a precautionary measure, but added that "the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis." In the UK, lot 9224028832 of Vicks Sinex Micromist Aqueous Nasal Spray solution in 15ml bottles is being recalled. Consumers worried whether they own one of the affected bottles should call 0800 555 515. Example of Transmission of Infectious Agent: November 2009 -Procter & Gamble recalls 120,000 Vicks nasal sprays http://news.bbc.co.uk/1/hi/business/8369764.stm
  • 26. Page 26 Version: August 2014Lack of Drug Efficacy oLack of drug effect is defined as failure to produce the expected pharmacological action for an approved indication. A situation where the drug has not produced the expected outcome. oLack of efficacy could be classed as an adverse event: e.g. Lack of efficacy of a drug used to treat a life threatening condition and / or to prevent such: cancer, vaccines etc. oCases with and without adverse events are collected and must be reported to the client.
  • 27. Page 27 Version: August 2014Maladministration(Medication Errors) oMaladministration is the inappropriate prescribing of drugs or medication error: that is the receipt of the wrong drug or the wrong dose of the right drug. oE.g. a doctor has prescribed the wrong product or incorrect dosage, or, the pharmacist has dispensed the incorrect product or dosage. oThese may or may not lead to adverse events oCases with and without adverse events are collected and must be reported to the client
  • 28. Page 28 Version: August 2014Example of Medication Error
  • 29. Page 29 Version: August 2014Unexpected benefit oWhen someone experiences an unexpected benefit that is not indicated in the product license as a result of taking the product. (e.g. unexpected hair growth after taking a product for heart problems) oThis is not an adverse event, but cases are collected and must be reported to the client.
  • 30. Page 30 Version: August 2014Falsified Medicines Falsified Medicines are fake medicines that pass themselves off as real, authorised medicines. Falsified medicines may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage – either too high or too low. Since they have not passed through the necessary evaluation of quality, safety and efficacy as required by the EU authorisation procedure, they can be a major health threat . Falsified medicines are a major threat to public health and safety and the number are, according to the European Commission, increasing each year. Falsified ('fake') medicines and drugs are a major problem for patients, their families and health care providers. The main risk with falsified medicines is with medicines which are targeted at those who are seriously ill. Such medicine may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. The main source is from internet sales, marketed by illegitimate or unethical companies. The big problem is that - globally -legislation has been relatively weak. There has been concern that over the past few years, more falsified medicines have been entering the supply chain. This includes outright counterfeiting (often involving organised crime) through the use of Active Pharmaceutical Ingredients which are not intentionally fraudulent but which may not have been tested correctly to ensure that they meet agreed specifications.
  • 31. Page 31 Version: August 2014 A falsified medicinal product is defined as any medicinal product with a false representation of: oits history, including the records, and documents relating to the distribution channels used oits source, including its manufacturer, its country of manufacturing, its country of origin, or its marketing authorization holder oits identity, including its packaging and labelling, its name, or its composition as regards to any of the ingredients including excipients and the strength of those ingredientsFalsified Medicines
  • 32. Page 32 Version: August 2014What Is a Counterfeit? А counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. oProduct appears to be a genuine branded item oFound in suspicious circumstances oDoes not ‘look’ quite right oUnusual packaging oUnusual colour or appearance oHas an unusual smell/texture oLack of effect
  • 33. Page 33 Version: August 2014 The International Police Agency, Interpol, has announced a deal with the pharmaceutical industry to crack down on fake drugs. Twenty nine of the world's biggest drug companies will provide 4.5m euros ($5.9m; £3.9m) in the next three years to help the response to the problem. "A global effort is needed to combat this threat," Interpol said. The agency added that the lives of millions of people were put at risk every day because of it. Christopher Viehbacher, the chief executive of French drugmaker Sanofi, said: "In the case of drug counterfeiting, it can mean the difference between life and death for a patient. "It is estimated that 10% of medicines are fake and these figures can go up to 50%, particularly in some poorer countries." 12 March 2013 Interpol deal to combat fake drugs
  • 34. Page 34 Version: August 2014Why collect and report complaints? The key reasons that complaints must be reported to clients is for them to: oEstablish and monitor the safety profile of product oImprove the product oEnsure patient safety And also because it is a regulatory authority requirement.
  • 35. Page 35 Version: August 2014How to Report Adverse Events / Complaints/ Special Scenarios oAt Ceuta, we ask you to report allproduct issues to us (not just licensed) oThe same process should be used when processing all product complaints, side effects and special scenarios. oIn all cases an Adverse Event form needs to be completed oField Based Staff –Form located in the library on your desktop oHead Office Staff –Form located in the Pharmacovigilance file in common data: V:Common DataPharmacovigilanceDocuments and FormsAdverse Event Form July 2013.docx
  • 36. Page 36 Version: August 2014 Minimum information required to report an adverse event Reporter contact details Event(s) experienced Patient ID (initials, gender, age or age group) Suspected drugReporting an Adverse Event Please note: available information must be sent even if any of the above criteria are missing
  • 37. Page 37 Version: August 2014How to Fill In a Product Adverse Event Form Product Details Product Name: Please put name of product Variant:Cream / Lotion, Flavour etc Pack Size:The amount the pack contains Batch no: lot/batch number found on packaging Quantity taken per dose:How much has the patient taken How Often:How Often has the patient taken/used product Date started taking:When did the patient first take product Date stopped taking:When did the patient stop taking/using product Patient Details Name: Patients name Initials: Patients initials Male/Female:Tick box that indicates patients gender Date of Birth:Fill in patients date of birth Age:Please put a figure here Address:Please take the patients address in full Tel Number:Please take a contact number for the patient Advised to see a doctor:If the patient has seen a doctor please note the name, address and contact number of the doctor Gives permission to contact doctor:Please tick if the patient gives you permission for their doctor to be contacted
  • 38. Page 38 Version: August 2014Adverse Event Form Continued Reporter Details Name: Take the name, initials , gender, address and contact number of the person reporting the incident if not the patient. Consumer, pharmacist, doctor, nurse, other (specify): Note down the profession of the person reporting (qualifications if a Health Care Professional). Event Details: Please put a tick next to the most appropriate explanation. Date Event Started: Note the date that the reporter became aware of the incident. Date Event Stopped:Note down the date the reporter became aware that the incident ended (if appropriate). If a case of pregnancy: Please note the approximate due date Additional Information (second page): Describe the event/incident in as much detail as possible including any actions that have already been undertaken.
  • 39. Page 39 Version: August 2014ReportingRequirements oDuring office hoursplease contact Customer Services immediately after becoming aware of any product related issues and give them all of the details so that they can complete the Adverse Event Form and the report for the incident. oANY incidence of an Adverse Event that you hear about out of hours should be reported IMMEDIATELY toSound Opinion(Ceuta’s emergency out of hours service provider) on 01793 710454. You are each given a credit size information card to keep in your purse or wallet which contains this information. oEven if you think an incident is already being handled it is still your duty to report it oAll Adverse Events must be reported to the Client within24hrs from the initial point of contact. This means we have 24 hours to report it from when you are first made aware NOT when you first report it. oThis allows the client to investigate fully on a timely basis oPlease note: some Clients screen notes made post-call on Fieldstrike to ensure no adverse event information is missed. All Adverse Events must be reported immediately as detailed above.
  • 40. Page 40 Version: August 2014Reporting responsibilities oIn a Newspapers / Magazines / Editorials oThrough speaking with Family / Friends / Colleagues oPhone call (it does not have to be a face to face conversation) oAn overheard conversation about a product issue oFrom a Healthcare professional If you learn of any adverse event regarding any of our clients products through the following means it is still your responsibility to report this information:
  • 41. Page 41 Version: August 2014Report Everything oYou do not need to determine the seriousness of any adverse event or quality issue, our clients will do this. oJust report everything to the client immediately oWe may come back and ask you for more information, so retain details oRemember, the clock starts ticking as soon as YOU are notified of the incident
  • 42. Page 42 Version: August 2014Training oAll new starters are given Pharmacovigilance Training during their induction oAll training is recorded by the Training Department and signed training acknowledgement forms are kept on file oAll staff are required to complete annualPharmacovigilance Refresher Training which is monitored and delivered by the Training Department oPharmacovigilance Training may be delivered by clients intermittently as and when required. All client training is logged by the Training Department at Ceuta
  • 43. Page 43 Version: August 2014All staff are given a laminate as an Essential Guide to remind them of their responsibilitiesStaff are also given a credit card size information card giving details of how to report an adverse event should one be reported to them
  • 44. Page 44 Version: August 2014Summary oReport alladverse events issues and complaints immediately oIt is your responsibility until you pass it on, then it is the client’s (the reporting clock starts ticking from the time you become aware of the event) oDrug safety is trulya shared responsibility
  • 45. Page 45 Version: August 2014 GOOD DISTRIBUTION PRACTICE (GDP) A SHARED RESPONSIBILITY Ceuta Healthcare’s responsibilities for our clients’ products
  • 46. Page 46 Version: August 2014GDP –Good Distribution Practice oGooddistributionpractice(GDP)dealswiththeguidelinesfortheproperdistributionofmedicinalproductsforhumanuse.GDPisaQualitySystem,whichincludesrequirementsforPurchase,Receiving, Storage,Sales(includingExporting)andReturnsofdrugsintendedforhumanconsumption. a)Purchase –checks must be done on who we are buying our medicinal products from. b)Receiving –checks must be done to ensure for example correct batches are delivered, vehicles are clean and free of infestation,and the labelled storage conditions have been complied with. c)Storage –checks must be done to ensure for example that the pick process ensures FEFO, that the warehouse provides necessary security as well as the warehouse being able to maintain temperature levels to support the labelled storage conditions d)Sales –checks that customers are bonafide i.e. registered and licenced to receive medicinal products. Also that records are kept to enable recalls to take place if necessary to remove product from the market. When Exporting similar processes must also be followed. e)Returns –that any return must pass a number of checks to enable it to be released back to stock and be resold
  • 47. Page 47 Version: August 2014GDP –Good Distribution Practice oGDPguidelines give tools to help wholesale distributors when conducting their activities and to prevent falsified medicines from entering the supply chain. Compliance with GDP will ensure control of the distribution chain and consequently maintain the quality and integrity of the products. oGDPas a Quality System sets out the responsibilities, processes and risk management principles predominantly through the use of Standard Operating Procedures (SOPs).
  • 48. Page 48 Version: August 2014GDP –Good Distribution Practice oGDPis regulated in the UK by the MHRA and must be complied with for Ceuta to keep its Wholesale Distribution Authorisation (WDA –used to be known as a WDL) oThe definition of medicinal products includes THR (Traditional Herbal Remedies), GSL (General Sales List), P (Pharmacy), and POM (Prescription Only Medicines) –all are subject to GDP oCeuta has to have a nominated person known as the Responsible Person (RP), this is currently Chris Hoole. Please ask him for further information if needed.