Term paper 2012

AMITY UNIVERSITY

Term paper 2012

POST MARKETING SURVEILLANCE

SUBMITTED TO: BY: Dr. ARCHANA SHARMA AKSHAY LECTURER & MENTOR A4513310010

SUBMITTED

Term paper 2012

AMITY INSTITUTE OF PHARMACY 14 B.PHARMA (2010-

INDEX 1. Abstract 2. Introduction

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ABST&A#T

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Post marketing surveillance (PMS) is the practice of monitoring a pharmaceutical drug or device after it has been released on the market. Since drugs are approved on the basis of clinical trials which involve relatively small numbers of people who have been "controlled" for this purpose - meaning that they normally do not have other medical conditions which may exist in the general population - and post marketing surveillance can further refine, or confirm or deny, the safety of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions.

WH is the directing and coordinating authority for health within the !nited "ations system. #t is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.

INT&ODU#TION

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-ost.Mar/$tin" Sur'$i anc$

$ll conformity assessment procedures %as well as medical device &uality systems' re&uire the manufacturer to possess a post-marketing surveillance %()S' system. $ ()S system should allow a manufacturer %through the company*s procedures' to collect, review and assess all information about the device, and related competitor*s devices, once the device has +, marking and is on the market. +learly, vigilance is a seminal component of ()S, but the topic of ()S has been more globally addressed since the guidance on vigilance was discussed released.

Benefits to a PMS System

,uropean -orum of "otified .odies )edical /evices %".-),/' produced guidance %0.10.1' on ()S. 2he group discussed possible achievements of such a system3 detection of manufacturing problems4 improvement of medical device &uality4 verification of risk analysis4 intelligence of long-term performance4 chronic complications4 performance trends4 performance in different user populations and mechanisms the device may be misused4 feedback on indications for use, instructions for use4 training re&uired for users4 use with other devices4 customer satisfaction and market performance and sustainability4 and identification of incident reports. Here is an example3 $ manufacturer of intraocular lenses collected numerous complaints from users about broken lenses. 2he manufacturer assessed the complaints and deemed them. $fter investigation, it was deduced that the cases in which the lenses were transported were placing increased pressure on the lenses resulting in breakage. 2he specifications were ad5usted, and the situation corrected "thereby reducing breakage, increasing user satisfaction and reducing costs." $ll benefits aside, ()S is a regulatory re&uirement for all manufacturers.

Sources of PMS Data

2here is a reactive and proactive list in the annex of the ,uropean -orum of "otified .odies )edical /evices %".-),/' guidance. (roactive implies the manufacturer is actively engaging in activities to collect information about their devices. 2his is not an exhaustive list of ()S data, and not all may be considered appropriate for the particular medical device3 literature reviews,
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patient registries, customer complaints, customer surveys, expert user groups, user reaction during training programs, media, trade shows, maintenance6service reports, field evaluation, retrieval studies on explants or trade-ins, in-house testing and failure analysis. $lso, if the manufacturer produces similar devices, this should be considered. /on*t forget to perform similar activities for a competitor*s similar devices and to review regulatory authorities* databases on incidents. ()S data is any information obtained about the device once it possesses a +, mark.

Methods of Surveillance
+ontrolled clinical trails Spontaneous or voluntary reporting +ohort studies
+ase 7 controlled studies.

Controlled Clinical trails :

/irectly monitor patients to for the duration of study. -or evaluating the drug8s efficacy and safety. 2hey are often costly. 2o minimi9e bias through such methods as randomi9ation or : double blinding :.

Spontaneous and voluntary eporting :

.y physicians and other health providers and hospitals may act to alert -/$ and pharmaceutical firms to possible adverse drug effects

Cohort studies:
Studies follow a defined group% the cohort' of patients for a given period of time.

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(atients are not randomly assigned and there8s no blinding. #f $/; occurs, $ second group of patients %the controls' with the same medical condition who are not taking the drug or who may be receiving any other alternative treatment.

Case Controlled studies :

These studies identify the patient with the adverse effects to be studied ( the cases ), and compare with the samp e ( the contro s ) drawn from the same cohort that !ive rise to the cases"

More Practical !spects of PMS

2he manufacturer*s ()S procedure should discuss the information that will be collected and obtained as part of the ()S system. 2he ()S procedure also should assign departments or positions as responsible for performing a particular function. $ manufacturer may find it helpful to have a ()S report at the end of the year, as well as a ()S tracking schedule and log. $s an example, the intraocular lens given above. 2his intraocular lens manufacturer attends various trade shows, and their attendance
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and the information obtained could be documented as ()S. 2his information could constitute feedback received from users or information obtained from discussions with users or other manufacturers. $t the end of the year, the intraocular lens manufacturer might compile all the information collected reactively and proactively into a ()S report. $ blog post from a notified body auditor provides insight into a &uestion a notified body auditor may ask to test the effectiveness of a manufacturer*s ()S system. ;oland +ooke, a regulatory services specialist, a notified body, shared the following &uestion he typically asks3 "#f your competitor*s similar device had problems in the field, how would you learn about those problems. 2he response should align with the manufacturer*s PMS procedure" 2he information obtained from a manufacturer*s ()S system should be communicated, at a minimum, annually during a management review meeting-which is top management*s examination of the organi9ation*s &uality management system. -urther, this information also may be incorporated as part of the risk management process.

Conclusion on PMS
)anufacturers should understand that a ()S system is a regulatory re&uirement. ()S data is so integral to a manufacturer*s success that the procedures should similarly reflect the manufacturer*s commitment to collecting and reviewing this information.

#ppsala monitoring centre

2he !ppsala )onitoring +entre %!)+' is an independent foundation and a centre for international service and scientific research. #ts priorities are the safety of patients and the safe and effective use of medicines in every part of the world. 2hey meet these priorities by innovative research and development, and by providing data, reference, consultative and training resources to medicines regulatory agencies, health professionals, researchers and the pharmaceutical industry all over the world.

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$unding of #ppsala Monitoring Centre

!)+ receives no permanent funding from any commercial, governmental or other source4 income is derived solely from its own activities and specific, ad hoc pro5ect funding.

%hat is the &ision of #MC

'he vision at #MC is to improve (orld(ide patient safety and (elfare )y reducing the risk of medicines"

)ission Statement
2o achieve !)+*s vision, we will3

lead

the

research

and

development

of tools and

methodologies

for

pharmacovigilance and patient safety

lead and support global pharmacovigilance activities develop effective networks and sustainable pharmacovigilance systems

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apply best practice in communication and networking with stakeholders provide high &uality and cost-effective tools, services and international dictionaries, classifications, and terminologies for pharmacovigilance and patient safety

.uild an effective organisation for the future with open, impartial and ethical values and performance.

&alues
2he aspiration value of !)+ is to give service to the people of the world, especially patients, and to all those who work for their safety and wellbeing. 2he corporate tag-line 'Safeguarding patients' reflects an extension of the previously known focus of the !)+ relating to drug safety towards the end beneficiary. .elow are the operational values guidelines in their daily work and in all collaborations. 2hey will3

provide innovation and leadership in the area of patient safety conduct our operations within WH principles and concepts constantly develop our knowledge and strive for scientific excellence deliver high &uality products and services to all our customers always have a global focus, particularly considering the needs of developing and emerging countries

seek and maintain active collaboration with all stakeholders actively listen to all partners* views whilst maintaining the highest possible level of integrity and impartiality

favour openness and transparency in our communications without sacrificing confidentiality and data security needs

encourage creativity and intellectual adventurousness, amongst !)+ staff and in our relationships
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endeavour to earn trust and respect, by applying the highest ethical and technical standards in everything we do

/efend the position of the !)+ as a uni&ue organisation, balancing income-generation and the public good in its products and services.

&E0IE1 O2 T3E 4ITE&ATU&E

Pharmacovigilance
Set of methods that aim at identifying and &uantitatively assess the risks related to the use of drugs in the entire population, or in specific population subgroups.

Side effect
$ny unintended effect of a pharmaceutical product occurring at doses normally used in man, which is related to the pharmacological proprieties of the drug.

!dverse drug reaction

$ response to a drug which is noxious and unintended, and which occurs at doses normally used in man.

#nexpected adverse drug reaction

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$n adverse reaction, the nature or severity of which is not consistent with market authorisation, or expected from the characteristics of the drug. (redominant element is that the phenomenon is unknown.

ationale for pharmacovigilance

#nformation obtained prior to first marketing is inade&uate to cover all aspects of drug safety3 tests in animals are insufficiently predictive of human safety, in clinical trials patients are selected and limited in number, conditions of use in trials differ from those in clinical practice, duration of trials is limited #nformation about rare but serious adverse reactions, chronic toxicity, and use in special groups %such as children, the elderly or pregnant women' or drug interactions is often not available.

No. o) pati$nts T5p$ o) pati$nts

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$%#'r4",

(harmacovigilance is needed in every country, because there are differences between countries in the occurrence of adverse drug reactions because of differences in3 drug production distribution and use %e.g. indications, dose, availability' genetics, diet, traditions of the people pharmaceutical &uality and composition of locally produced pharmaceutical products 2he use of non-orthodox drugs %e.g. herbal remedies' which may pose special toxicological problems, when used alone or in combination with other drugs.

DIS#USSION AND #ON#4USION

%"*"+" Pharmacovigilance

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W.H. . (harmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. W.H. established its (rogramme for #nternational /rug )onitoring in response to the +ollaborating +entre for

thalidomide disaster detected in ,-.,. 2ogether with the WH 0=1=, 1>? countries were part of the WH (< (rogramme.

#nternational /rug )onitoring, !ppsala, WH promotes (< at the country level. $t the end of

2he aims of (< are to enhance patient care and patient safety in relation to the use of medicines4 and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

'he /eed of pharmacovigilance

nce put onto the market, a medicine leaves the secure and protected scientific environment of clinical trials and is legally set free for consumption by the general population. $t this point, most medicines will only have been tested for short-term safety and efficacy on a limited number of carefully selected individuals. #n some cases as few as @== sub5ects, and rarely more than @===, will have received the product prior to its release. -or good reason, therefore, it is essential that new and medically still evolving treatments are monitored for their effectiveness and safety under real-life conditions post release. )ore information is generally needed about use in specific population groups, notably children, pregnant women and the elderly, and about the efficacy and safety of chronic use, especially in combination with other medicines. ,xperience has shown that many adverse effects, interactions %i.e. with foods or other medicines' and risk factors come to light only during the years after the release of a medicine.

!ims of pharmacovigilance
2he principal aims of pharmacovigilance programmes are3

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A 2o improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions4 A 2o improve public health and safety in relation to the use of medicines4 A 2o contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective %including cost-effective' use4 A 2o promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public.

Partners involved in pharmacovigilance

(a) 0Pharmacovigilance in national drug policy

2he provision of good &uality, safe and effective medicines and their appropriate use is the responsibility of national governments. 2he establishment of a national medicine regulatory agency and a designated centre for the study of adverse reactions are central to the achievement of these functions. )ultidisciplinary collaboration is of great importance4 in particular, links need to be forged between various departments of the ministry of health and also with other stakeholders, such as the pharmaceutical industry, universities, nongovernmental organi9ations %"B s' and those professional associations having responsibility for education on rational use of medicines and pharmacotherapy monitoring. Cey elements of pharmacovigilance in national drug policy A ,stablishment of national pharmacovigilance systems for the reporting of adverse events, including national and, if appropriate, regional pharmacovigilance centres. A /evelopment of legislation6regulation for medicine monitoring. A "ational policy development %to include costing, budgeting and financing'.
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A +ontinuing education of health-care providers on safe and effective pharmacotherapy. A (rovision of up-to-date information on adverse reactions to professionals and consumers. A )onitoring the impact of pharmacovigilance through process indicators and outcome.

()) 0Pharmacovigilance in clinical practice

Safety monitoring of medicines in common use should be an integral part of clinical practice. 2he degree to which clinicians are informed about the principles of pharmacovigilance, and practise according to them, has a large impact on the &uality of health care. ,ducation and training of health professionals in medicine safety, exchange of information between national pharmacovigilance centres, the coordination of such exchange, and the linking of clinical experience of medicine safety with research and health policy, all serve to enhance effective patient care. $ regular flow and exchange of information in this way means that national pharmacovigilance programmes are ideally placed to identify gaps in our understanding of medicine-induced diseases.

0Pharmacovigilance in disease control pu)lic health programmes

2he monitoring of medicine safety in countries where there is no regulatory or safety monitoring system in place, or in remote areas with little or no health care surveillance or infrastructure, has been identified as a matter for concern. 2he problems are especially apparent in situations that involve the use of medicines in specific communities, for example, for the treatment of tropical diseases such as malaria, leishmaniasis and schistosomiasis, and for the treatment of H#<6$#/S and tuberculosis. #n some settings several disease control initiatives involving the administration
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of medicines to large communities are being implemented within the same population with little knowledge of, or regard to, how these various medicines could interact with each other. (harmacovigilance should be a priority for every country with a public health disease control programme.

!)out /ational Pharmacovigilance Program (/PP):

2he "ational (harmacovigilance (rogram was officially inaugurated by the honorable Health )inister /r. $nbumani ;amadoss on 0> "ovember, 0==? at "ew /elhi. +entral /rugs Standard +ontrol rgani9ation %+/S+ ' initiated a well-structured and highly participative "ational in a (harmacovigilance (rogram which is build on the structure recommended by WH

document titled as :Safety )onitoring of )edicinal (roducts 7 Buidelines for Setting up and ;unning a (harmacovigilance +entreD. 2he )ain focus of "ational (harmacovigilance (rogram was to collate, analy9e and archive adverse drug reaction data for creating healthy environment for the ;egulatory $uthorities to analysis the drugs to be marketed in #ndia. "ational (harmacovigilance (rogram is a three layered structure consisting of peripheral, regional and 9onal centers8. 2hese are monitored by an apex body i.e. "ational (harmacovigilance $dvisory +ommittee and the "ational (harmacovigilance +entre which are based at the +entral /rugs Standard +ontrol rgani9ation, "ew /elhi. 2he > tier structure report the serious, unexpected $dverse /rug ;eactions to the "ational (harmacovigilance +entre directly so as the regulators to act on it promptly.

Conclusion:
2he basic advantage of "ational (harmacovigilance (rogram is unrecogni9ed, unidentified adverse drug reactions can be directly reported to regulators wherein the actions concerned with can be immediately implemented. However, the under reporting scenario needs to be improvised by creating the awareness for spontaneous reporting. "ot only doctors but other healthcare providers, vi9., pharmacists and nurses should actively participate in the program. 2hey should start reporting adverse events to help ensure that our country receive safe drugs.

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