Term paper

Term paper 2012

AMITY UNIVERSITYPOST MARKETING SURVEILLANCE

SUBMITTED TO: SUBMITTED BY:

Dr. ARCHANA SHARMA AKSHAYLECTURER & MENTOR A4513310010AMITY INSTITUTE OF PHARMACY B.PHARMA (2010-14)INDEX

1. Abstract

2. Introductiona) Definition of PMS

b) Benefits of PMS

c) Sources of PMS

d) Methods of surveillance

(i) Controlled Clinical trails

(ii) Spontaneous or voluntary reporting

(iii) Cohort studies

(iv) Case controlled studies

(e) Practical aspects of PMS

(f) Conclusion of PMS

3. Uppsala monitoring Centre

a) Definition

b) Funding

c) Vision

d) Mission statement

e) Values

4. Review of the literature

(a) Pharmacovigilance

(b) Side effects

(c) Adverse drug reactions

(d) Unexpected ADRs

(e) Rationale of pharmacovigilance

5. Discussion and conclusiona) WHO pharmacovigilance

b) Need of Pharmacovigilance

c) Aims of pharmacovigilance

d) Partner involved in pharmacovigilance

e) Conclusion6. References ABSTRACT

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.

WHO is the directing and coordinating authority for health within the United Nations system. It 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.

INTRODUCTIONPost-Marketing SurveillanceAll conformity assessment procedures (as well as medical device quality systems) require the manufacturer to possess a post-marketing surveillance (PMS) system. A PMS 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 CE marking and is on the market. Clearly, vigilance is a seminal component of PMS, but the topic of PMS has been more globally addressed since the guidance on vigilance was discussed released.

Benefits to a PMS SystemEuropean Forum of Notified Bodies Medical Devices (NB-MED) produced guidance (2.12.1) on PMS. The group discussed possible achievements of such a system: detection of manufacturing problems; improvement of medical device quality; verification of risk analysis; intelligence of long-term performance; chronic complications; performance trends; performance in different user populations and mechanisms the device may be misused; feedback on indications for use, instructions for use; training required for users; use with other devices; customer satisfaction and market performance and sustainability; and identification of incident reports.

Here is an example: A manufacturer of intraocular lenses collected numerous complaints from users about broken lenses. The manufacturer assessed the complaints and deemed them. After investigation, it was deduced that the cases in which the lenses were transported were placing increased pressure on the lenses resulting in breakage. The specifications were adjusted, and the situation corrected "thereby reducing breakage, increasing user satisfaction and reducing costs." All benefits aside, PMS is a regulatory requirement for all manufacturers.

Sources of PMS DataThere is a reactive and proactive list in the annex of the European Forum of Notified Bodies Medical Devices (NB-MED) guidance. Proactive implies the manufacturer is actively engaging in activities to collect information about their devices. This is not an exhaustive list of PMS data, and not all may be considered appropriate for the particular medical device: literature reviews, patient registries, customer complaints, customer surveys, expert user groups, user reaction during training programs, media, trade shows, maintenance/service reports, field evaluation, retrieval studies on explants or trade-ins, in-house testing and failure analysis. Also, if the manufacturer produces similar devices, this should be considered. Don't forget to perform similar activities for a competitor's similar devices and to review regulatory authorities' databases on incidents. PMS data is any information obtained about the device once it possesses a CE mark.Methods of Surveillance Controlled clinical trails Spontaneous or voluntary reporting Cohort studies Case controlled studies.Controlled Clinical trails :

Directly monitor patients to for the duration of study. For evaluating the drugs efficacy and safety. They are often costly. To minimize bias through such methods as randomization or double blinding . Spontaneous and voluntary Reporting :

By physicians and other health providers and hospitals may act to alert FDA and pharmaceutical firms to possible adverse drug effectsCohort studies: Studies follow a defined group( the cohort) of patients for a given period of time. Patients are not randomly assigned and theres no blinding. If ADR occurs, A 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 sample ( the controls ) drawn from the same cohort that give rise to the cases.More Practical Aspects of PMSThe manufacturer's PMS procedure should discuss the information that will be collected and obtained as part of the PMS system.

The PMS procedure also should assign departments or positions as responsible for performing a particular function. A manufacturer may find it helpful to have a PMS report at the end of the year, as well as a PMS tracking schedule and log. As an example, the intraocular lens given above. This intraocular lens manufacturer attends various trade shows, and their attendance and the information obtained could be documented as PMS. This information could constitute feedback received from users or information obtained from discussions with users or other manufacturers. At the end of the year, the intraocular lens manufacturer might compile all the information collected reactively and proactively into a PMS report.

A blog post from a notified body auditor provides insight into a question a notified body auditor may ask to test the effectiveness of a manufacturer's PMS system. Roland Cooke, a regulatory services specialist, a notified body, shared the following question he typically asks: "If your competitor's similar device had problems in the field, how would you learn about those problems.

The response should align with the manufacturer's PMS procedure.The information obtained from a manufacturer's PMS system should be communicated, at a minimum, annually during a management review meeting-which is top management's examination of the organization's quality management system. Further, this information also may be incorporated as part of the risk management process.

Conclusion on PMSManufacturers should understand that a PMS system is a regulatory requirement. PMS 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.Uppsala monitoring centreThe Uppsala Monitoring Centre (UMC) is an independent foundation and a centre for international service and scientificresearch. Its priorities are the safety ofpatients and thesafe and effective use of medicines in every part of the world. They 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.

Funding of Uppsala Monitoring Centre

UMC receives no permanent funding from any commercial, governmental or other source; income is derived solely from its own activities and specific, ad hoc project funding.

What is the Vision of UMC

The vision at UMC is to improve worldwide patient safety and welfare by reducing the risk of medicines.Mission StatementTo achieve UMC's vision, we will:

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

apply best practice in communication and networking with stakeholders

provide high quality and cost-effective tools, services and international dictionaries, classifications, and terminologies for pharmacovigilance and patient safety

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

ValuesThe aspiration value of UMC is to give service to the people of the world, especially patients, and toall those who work for their safety and wellbeing. The corporate tag-line 'Safeguarding patients' reflects an extension of the previously known focus of the UMC relating to drug safety towards the end beneficiary. Below are the operational values guidelines in their daily work and in all collaborations. They will:

provide innovation and leadership in the area of patient safety

conduct our operations within WHO principles and concepts

constantly develop our knowledge and strive for scientific excellence

deliver high quality 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 UMC staff and in our relationships

endeavour to earn trust and respect, by applying the highest ethical and technical standards in everything we do

Defend the position of the UMC as a unique organisation, balancing income-generation and the public good in its products and services.

REVIEW OF THE LITERATURE

Pharmacovigilance

Set of methods that aim at identifying and quantitatively assess the risks related to the use of drugs in the entire population, or in specific population subgroups.Side effectAny unintended effect of a pharmaceutical product occurring at doses normally used in man, which is related to the pharmacological proprieties of the drug.

Adverse drug reactionA response to a drug which is noxious and unintended, and which occurs at doses normally used in man.Unexpected adverse drug reaction

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

Rationale for pharmacovigilance

Information obtained prior to first marketing is inadequate to cover all aspects of drug safety: 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 Information 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.EfficacyPost marketing

No. of patients100-1000