Postmarketing surveillance

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Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions. [1]

Contents

Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases. [1] These data are reviewed to highlight potential safety concerns in a process known as data mining.

National implementation

Canada

Health Canada is the regulatory body which approves drugs, and it has a division called "Marketed Health Products Directorate" (MHPD) which coordinates Canadian postmarketing surveillance. [2]

European Union

The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for medical device post-market surveillance (materiovigilance). The concept of post market surveillance is linked to the concepts of vigilance and market surveillance. A manufacturer of medical devices is required to report incidents (serious adverse events) to the national competent authority of the member state the company resides in. The Medical Device Regulation (EU) 2017/745 (MDR) provides in §2 the following definition of post-market surveillance:

‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

Further requirements on PMS are given in §83 of the MDR; §84 details PMS Plan requirements and references Section 1.1 of Annex III of the MDR; §85 details the PMS report, while §86 describes the contents of the Periodic Safety Update Report (PSUR).

Similar provisions on Post-Market Surveillance are found in the European regulation on in vitro diagnostic medical devices (IVDR). [3] [4] [5]

The MDCG Guideline 2023-3 "Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices" provides furter clarification on the topic. [6]

United Kingdom

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) jointly operate the Yellow Card Scheme, which was one of the first examples of a pharmacovigilance scheme, aimed at mitigating adverse drug reactions (ADRs).[ citation needed ]

United States

Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system of passive surveillance called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. [7] The FDA also conducts active surveillance of certain regulated products. For example, the FDA may monitor safety and effectiveness of medical devices through either a Post-Approval Study [8] or through a 522 Postmarket Surveillance Study. [9] With respect to regulation, two terms are defined: Postmarketing requirements are studies and clinical trials that sponsors are required to conduct and postmarketing commitments are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statue or regulation. [10]

See also

Related Research Articles

<span class="mw-page-title-main">Food and Drug Administration</span> United States federal agency

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.

<span class="mw-page-title-main">Medical device</span> Device to be used for medical purposes

A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complication is similar to adverse effect, but the latter is typically used in pharmacological contexts, or when the negative effect is expected or common. If the negative effect results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not an adverse effect. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects occur only when starting, increasing or discontinuing a treatment. Adverse effects can also be caused by placebo treatments . Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen. Adverse effects of medical treatment resulted in 142,000 deaths in 2013 up from 94,000 deaths in 1990 globally.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose

  1. Results in death
  2. Is life-threatening
  3. Requires inpatient hospitalization or causes prolongation of existing hospitalization
  4. Results in persistent or significant disability/incapacity
  5. May have caused a congenital anomaly/birth defect
  6. Requires intervention to prevent permanent impairment or damage

Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.

<span class="mw-page-title-main">Essure</span> Permanent birth control method for women

Essure was a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. Essure was designed as an alternative to tubal ligation. However, it was recalled by Bayer in 2018, and the device is no longer sold due to complications secondary to its implantation. The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction. Although designed to remain in place for a lifetime, it was approved based on short-term safety studies. Of the 745 women with implants in the original premarket studies, 92% were followed up at one year, and 25% for two years, for safety outcomes. A 2009 review concluded that Essure appeared safe and effective based on short-term studies, that it was less invasive and could be cheaper than laparoscopic bilateral tubal ligation. About 750,000 women have received the device worldwide.

EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.

The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities and the members of the medical device industry” whose goal was the standardization of medical device regulation across the world. The representatives from its five founding members were divided into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. Founded in 1992, the GHTF was created in “an effort to respond to the growing need for international harmonization in the regulation of medical devices."

<span class="mw-page-title-main">FDA Center for Devices and Radiological Health</span>

The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of electromagnetic radiation, such as cellular phones and microwave ovens.

<span class="mw-page-title-main">Research on Adverse Drug Events and Reports</span>

Research on Adverse Drug Events and Reports (RADAR) is a pharmacovigilance team of 25 doctors who receive calls about possible adverse drug reactions (ADR) and investigate. RADAR is based at Northwestern's Feinberg School of Medicine. RADAR is led by Dennis West. Though it was without funding for its first four years, RADAR has raised about $12 million through grants from the National Institutes of Health, the American Cancer Society and other such institutions. Its work has identified safety problems with 33 drugs. Adverse drug events are a serious health problem.

The following outline is provided as an overview of and topical guide to clinical research:

The FDA Adverse Event Reporting System is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in health care delivery. The system interacts with several related systems including MedWatch and the Vaccine Adverse Event Reporting System. FAERS replaced legacy AERS system in Sep 2012.

Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report any adverse event caused by the device to MedWatch program for reporting significant adverse events or product problems with medical products.

<span class="mw-page-title-main">Regulation (EU) 2017/745</span> Political regulation

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.

Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.

<span class="mw-page-title-main">Federal Service for Surveillance in Healthcare</span>

Federal Service for Surveillance in Healthcare (Roszdravnadzor) is the federal service of the Russian Federation that exercises control and supervision functions in the field of health care. Until 2012, it was called the Federal Service for Surveillance of Health and Social Development and was subordinate to the Ministry of Health and Social Development of the Russian Federation, then from 2012 to 2020 it was shifted to reporting directly to the Government of the Russian Federation, and from 2020 again made subordinate to the Ministry of Health of the Russian Federation.

A custom-made medical device, commonly referred to as a custom-made device (CMD) or a custom device, is a medical device designed and manufactured for the sole use of a particular patient. Examples of custom-made medical devices include auricular splints, dentures, orthodontic appliances, orthotics and prostheses.

References

  1. 1 2 McNeil JJ, Piccenna L, Ronaldson K, et al. (2010). "The Value of Patient-Centred Registries in Phase IV Drug Surveillance". Pharm Med. 24 (5): 281–288. doi:10.1007/bf03256826. S2CID   19091146. Archived from the original on 2012-07-07. Retrieved 2011-06-17.
  2. ↑ "Post-marketing Pharmacosurveillance in Canada". Health Canada. 2005. Archived from the original on 2010-09-28. Retrieved 2010-07-27.
  3. ↑ IVDR - 2017/746
  4. ↑ Zippel, Claus; Bohnet-Joschko, Sabine (2017). "Post market surveillance in the german medical device sector - current state and future perspectives". Health Policy (Amsterdam, Netherlands). 121 (8): 880–886. doi:10.1016/j.healthpol.2017.06.005. ISSN   1872-6054. PMID   28697849.
  5. ↑ "Post-Market Surveillance and Vigilance: MDR vs IVDR". citemedical.com.
  6. ↑ MDCG Guideline 2023-3
  7. ↑ "Post-marketing Surveillance". U.S. FDA/CDER. 2004.
  8. ↑ "Post-Approval Studies". U.S. FDA/CDRH. 2014.
  9. ↑ "522 Postmarket Surveillance Studies". U.S. FDA/CDRH. 2014.
  10. ↑ FDA. "Postmarketing Requirements and Commitments: Introduction". Food and Drug Administration .
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