Ceuta Pharmacovigilance Presentation 2014

Version: August 2014
Training
2014

Version: August 2014DRUG SAFETYA SHARED RESPONSIBILITY
Ceuta Healthcare’s responsibilities for our clients’ products

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

“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?

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.

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.

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.

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.

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

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.

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

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

Version: August 2014An example of an SPC

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

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)

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.

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.

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

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.

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

Version: August 2014Misuse
oDrugmisuseisanexposureresultingfromtheintentionaluseofadruginawaythatisnotrecommendedintheproductinformationorlicence.
E.g.ifsomeonetakeslaxatives(licensedtoloosenthestool,andtotreatconstipation)tohelpthemloseweight.
oCaseswithandwithouteventsarecollectedandmustbereportedtotheclient

Version: August 2014Drug abuse
oDrugabuseisanexposureresultingfromthepersistent,excessiveandintentionalre-currentuseofadrugbyapatientinawaythatisnotrecommendedintheproductinformationorlicense.
oCasesofdrugabusewithandwithoutadverseeventsarecollectedandmustbereportedtotheclient

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

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

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

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.

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

Version: August 2014Example of Medication Error

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.

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.

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

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

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

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.

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

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

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

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.

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.

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:

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

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

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

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

GOOD DISTRIBUTION PRACTICE (GDP)
A SHARED RESPONSIBILITY
Ceuta Healthcare’s responsibilities for our clients’ products

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

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).

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.

Ceuta Pharmacovigilance Presentation 2014

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