Adverse drug reaction

Post Marketing Surveillance Methods – South Africa

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Post Marketing Surveillance Methods – South Africa

Post marketing surveillance (PMS) is the practice of monitoring a pharmaceutical drug or device after it has been released on the market. PMS is a function of the Medicines Control Council (MCC), the regulatory authority in South Africa. The MCC’s PV Committee was comprised of a pharmacist and six external experts from various. Types – Active safety surveillance, Passive safety surveillance, stimulated reporting, Comparative Observational Studies.


  • Who to Report To – National Adverse Drug Event Monitoring Centre, Registrar of Medicines
  • Route of Notification –. It should be sent by post, or by facsimile
  • Report Format – Adverse reaction report form available from the NADEMC or holders of a certificate of registration may use their in-house report forms.
  • Follow-Up Reports Any follow-up information must be cross-referenced to the unique number assigned by the holder of a certificate of registration. A CIOMS format “initial” report which follows a previous (first) communication from the holder of a certificate of registration must be clearly marked that it is a follow up and linked through the applicant-assigned reference number. The only reliable way to minimize the duplication of reports, submitted by holders of a certificate of registration, in the NADEMC’s ADRI database.

Type of ADR report

Time frame for reporting


South African Reports (spontaneous/published/study):

• Serious (expected and unexpected)

• Non-serious (expected and unexpected)

15 days Annually ADR form, Summary report
Foreign Reports (spontaneous/published/study):

• Serious

On request or relating to specific safety issue As appropriate
Notification of Change in Nature, Severity or Frequency or Risk factors 15 days Detailed report (including publications)
New information impacting on benefit-risk profile of product including international regulatory decisions 3 days Detailed report (including publications)


South Africa is having a legal framework in place requiring that adverse events be monitored both actively and passively.

Post Marketing Surveillance Methods – European Union

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Post Marketing Survelliance Methods – European Union

Objective : Post marketing  safety surveillance program are to assess and quantify known or suspected drug safety issues, identify and characterize potential new risks and risk factors following product marketing, and to monitor medication use patterns.

Types of PMS:-

Active Surveillance: It is defined within the European Commission Volume 9A to be the ongoing, proactive monitoring of product use and potential adverse events (AEs) “To ascertain more completely the number of adverse events in a given population via a continuous organised process.” One objective of active surveillance is to detect safety issues early in the post-marketing environment that were not identified during development, such as rare events or latent onset.

Passive surveillance : It is primarily includes the analysis of spontaneous adverse event reports. Sources for reports include regulatory systems. Passive surveillance often involves assembling a series of cases to examine specific types of events, such as overdose and product re-challenge. This method of safety surveillance is limited by incomplete reporting information (which can impede determination of causality), potential underreporting of events, and unknown parameters for calculation of incidence (denominator and numerator).

Stimulated reporting : It is achieved through direct encouragement of event reporting through communication with potential reporters, such as via a Dear Healthcare Provider Letter. Stimulated reporting can be limited by the same factors as passive surveillance: underreporting,

Comparative observational studies : It  can be analytic, such as case-control studies, or descriptive, including cross-sectional surveys and cohort studies. Observational studies do not recruit participants into a controlled environment, as in a random-controlled trial, but instead observe the outcome of interest (e.g., a specific adverse or other drug event) in a population that already takes the drug compared to a population that does not. These studies are commonly used to identify side effects rather than evaluate treatment effectiveness, and may be used to calculate relative risk, but usually cannot be used to calculate absolute risk.

Data Collection and Analytical Methods: There are many tools and resources available for post-marketing safety surveillance: spontaneous adverse event report databases, large administrative databases (e.g., Medicaid, managed care organizations, insurers), registries, and electronic medical records. In the UK, for example, Prescription Event Monitoring (PEM,) developed in the 1980’s, uses a questionnaire to collect outcomes information from a panel of all physicians who prescribe a new drug. Notably, PEM does not require the clinician to determine whether there is a causal relationship to the product. This reporting also allows for follow-up on events of interest, such as pregnancy or death.

Robust pharmacovigilance system needed to report ADRs: Prof Aziz

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With more and more new drugs coming in the market, it is high time that India needs to adopt robust pharmacovigilance system to report the Adverse Drug Reactions (ADR) both at the primary and tertiary care hospitals in the country. According to Professor Dr S A Aziz, Principal of Deccan College of Pharmacy in Hyderabad, with the patent cliff going off, there are vast numbers of new drugs coming in the markets. In view of this, there is a need for the country to adopt a new working model of pharmacovigilance embedded with the pharmacy practice programme.

As part of this, professor Aziz has proposed a new working model of pharmacovigilance to record the adverse drug reactions at tertiary care hospitals. “Pharmacovigilance plays a crucial role in meeting the challenges posed by the ever increasing range and potency of medicines. Despite of recent implementation of a well structured pharmacovigilance programme in India in accordance with the objectives and recommendations of WHO by CDSCO, India has contributed only 2 per cent of Individual Case Safety Report(ICSR) to the global ICSR database which holds about 10 million ICSR’s. In view of this a new working model of pharmacovigilance is necessary to record and report ADRs,” observed Dr Aziz.

The new working model will adopt new software called Vigilflow. The voluntary and professionally identified drug reactions are recorded in blue and red forms respectively. Later this will be sent to well qualified and trained clinical pharmacists for further reviewing and prepare a detailed report which will be uploaded into the Vigilflow software.

Up on uploading into the Vigilflow software, an ICSR is generated which will be submitted to the Indian Pharmacopoeia Commission (IPC) and National Coordination Center (NCC) which will further assess the ICSR and send it to the world health organization Upsala monitoring center (WHO-UMC) which will further assess the clinical pharmacological aspect of the case history and the quality of the documentation of the observation. Based on its assessment it will provide information on drug safety to WHO headquarters in Geneva. This information will further propagated to regulatory bodies and researchers.

Apart from this, the ICSRs uploaded in the Vigilflow are also made available on Vigilbase where information is recorded in structured hierarchical form to allow for easy and flexible retrieval and analysis of the data.

“If we can adopt such a robust pharmacovigilance programme embedded in to the pharmacy practice in the healthcare centers, we can not only help develop safer drugs, but can also improve the quality of healthcare in the country,” opined the professor.

Source : 1

Special cell in CDSCO to coordinate with agencies like ICMR for monitoring studies

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The Union health ministry has constituted a special Cell in the Central Drugs Standard Control Organisation (CDSCO) to coordinate with research agencies like ICMR for monitoring several studies to enable CDSCO for continued evaluation of drugs marketed in India and to take regulatory actions.

Dr Ramkishan, deputy drugs controller of India (CDCSO HQ); Somnath Basu, assistant drugs controller of India (CDSCO HQ); and M Balakumar, drugs inspector (CDCSO HQ) are the members of the Cell which will coordinate with research agencies like ICMR for the conduct of various studies.

According to sources, the members of the Cell will coordinate with research agencies such as ICMR for the conduct of specific studies for the post-marketing surveillance of drugs, rational use of medicines, drug utilisation studies, adverse drug reaction monitoring, etc that would enable CDSCO for continued evaluation of drugs marketed in India and to take regulatory actions on continued use of such drugs in the country.

The health ministry’s decision to constitute a cell in this regard is based on the recommendations of the Prof Ranjit Roy Chaudhury committee which in its reports had said that the CDSCO may need information continuously on post-marketing surveillance of drugs,  rational use of medicines, drug utilisation studies and adverse drug reaction monitoring, etc.

It will be useful if a research unit is created within the CDSCO. This unit would initiate and sponsor studies in these areas to be able to get the needed information to help in decision making, the report had recommended.

The ministry had constituted an expert committee in February last year under the chairmanship of Prof Ranjit Roy Chaudhury to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. After much deliberations, the committee submitted its recommendations in September, 2013, recommending sweeping changes in all these sectors.

 Source: PharmaBiz

CDSCO issues guidelines on pharmacovigilance requirements for biological products

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The Central Drugs Standard Control Organization (CDSCO) has issued guidelines on pharmacovigilance requirements for biological products. These guidelines are intended for the guidance of the Market Authorisation Holders (MAHs) i.e. manufacturers and importers of biological products.  The procedure set out to facilitate the industry to submit the documents as per the requirements of Drugs & Cosmetics Act and Rules.

The guideline is intended to assist in planning pharmacovigilance activities, especially in preparation for the early post-marketing period of vaccines and biotechnology-derived products.  The main focus of this guideline is a safety specification and pharmacovigilance plan that might be submitted at the time of licence application. The guideline describes a method for summarising the important identified risks of a drug, important potential risks, and important missing information, including the potentially at-risk populations and situations where the product is likely to be used that have not been studied during pre-approval.

The guideline has been developed to provide the guidance to all the stakeholders including the Marketing Authorisation Holders on the coordinated activities of the various departments within the Ministry of Health and Family Welfare to work together and enhance the pharmacovigilance of vaccines.

This guidance document has been prepared in line with the recommendation of the NRA assessment 2012 to provide guidance for the MAH to perform specific safety study throughout the product life-cycle and to define the roles and responsibilities of all the stakeholders namely CDSCO, IPC, Immunisation Division, MAH, private and public practitioners and outlines the Risk Minimization Action Plan. This could provide guidance to the manufacturers and importers of vaccines in the country to strengthen their ADR monitoring and pharmacovigilance department to ensure patient safety.

Risk assessment during product development should be conducted in a thorough and rigorous manner; however, it is impossible to identify all safety concerns during clinical trials.  Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with co-morbid conditions and those being treated with concomitant medical products. Therefore, post-marketing safety data collection and risk assessment based on observational data are critical for evaluating and characterising a product’s risk profile and for making informed decisions on risk minimisation.

This guidance document focuses on pharmacovigilance activities in the post-licensure period. This guidance uses the term pharmacovigilance to mean all scientific and data gathering activities relating to the detection, assessment, and understanding of adverse events. Pharmacovigilance principally involves the identification and evaluation of safety signals. In this guidance document, safety signal refers to a concern about an excess of adverse events compared to what would be expected to be associated with a product’s use. Signals can arise from post-marketing data and other sources, such as preclinical data and events associated with other products in the same pharmacological class.

Source: PharmaBiz