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Importance of Pharmacovigilance
| 작성자 | 류재린 | 카테고리 | 전문가 인사이트 |
|---|---|---|---|
| 작성일 | 2016-07-06 | 조회수 | 2,051 |
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Importance of Pharmacovigilance
- 글 Ghadeer M. Qawasimi
- GPKOL 위원
학력사항
- 2001 University of Jordan, Analytical Toxicology in Forensic Medicine
경력사항
- 2012-현재 Jordan Food and Drug Administration(JFDA), Pharmacovigilance Department & Rational Drug Use Department
- 2009-2012 JFDA, Drug Registration Department
- 2008-2009 JFDA, Research and Development Laboratories
- 2005-2008 Al-Wafi Drug Store, Drug Registration Department
세부 전문분야 및 컨설팅 내용
- 중동지역, 요르단 인허가
Thalidomide Disaster
Thalidomide first entered the German market in 1957 as an over-the-counter remedy, based on the maker’s safety claims. They advertised their product as “completely safe” for everyone, including mother and child, “even during pregnancy,” as its developers “could not find a dose high enough to kill a rat.” Around this time, Australian obstetrician Dr.
William McBride discovered that the drug also alleviated morning sickness. He started recommending this off-label use of the drug to his pregnant patients, setting a worldwide trend. In 1961, McBride began to associate this so-called harmless compound with severe birth defects in the babies he delivered. The drug interfered with the babies' normal development, causing many of them to be born with phocomelia, resulting in shortened, absent, or flipper-like limbs.., by March of 1962, the drug was banned in most countries where it was previously sold. The tragedy surrounding thalidomide and Kelsey’s wise refusal to approve the drug helped motivate profound changes in the FDA. By passing the Kefauver-Harris Drug Amendments Act in 1962, legislators tightened restrictions surrounding the surveillance and approval process for drugs to be sold in the U.S., requiring that manufacturers prove they are both safe and effective before they are marketed. Now, drug approval can take between eight and twelve years, involving animal testing and tightly regulated human clinical trials.
Pharmacovigilance Definition:
Pharmacovigilance (PV or PhV) also known as Drug Safety, is a pharmacological science that is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. A new medicine must pass three hurdles before its approval by the national drug regulatory authority.
Sufficient evidence is required to show the new drug to be:
- Of Good Quality
- Effective
- Safe for the purpose or purposes for which it is proposed.
As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). 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.
Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority. Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients.
Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance. Within the last decade, there has been a growing awareness that the scope of pharmacovigilance should be extended beyond the strict limits of detecting new signals of safety concerns. Globalization, consumerism, the explosion in free trade and communication across borders, and increasing use of the Internet have resulted in a change in access to all medicinal products and scientific information on them.
These changes have given rise to new kinds of safety concerns such as:
- Illegal sale of medicines and drugs of abuse over the Internet
- Increasing self-medication practices
- Irrational and potentially unsafe drug donation practices
- Widespread manufacture and sale of counterfeit and substandard “medicine”
- Increasing use of traditional medicines outside the confines of the traditional culture of use
- There are differences among countries (and even regions within countries) in the occurrence of ADRs and other drug-related problems.
- This may be due to differences in e.g.:
- Diseases and prescribing practices.
- Genetics, diet, traditions of the people.
In addition to other factors that increases the need for a system to follow up the safety of the medicines in a country, such as:
- Drug manufacturing processes used which influence pharmaceutical quality and composition.
- Drug distribution and use including indications, dose and availability.
- The use of traditional and complementary drugs (e.g. herbal remedies) which may pose specific toxicological problems, when used alone or in combination with other medicines.
Data derived from within the country or region may have greater relevance and educational value and may encourage national regulatory decision-making. Information obtained in one country (e.g. the country of origin of the drug) may not be relevant to other parts of the world, where circumstances may differ. Therefore, drug monitoring is of tremendous value as a tool for detecting ADRs and specifically in relation to counterfeit and substandard quality products. ADR monitoring is to help ensure that patients obtain safe and efficacious products. In addition, the results of ADR monitoring have also a very important educational value.
There is a need for a reconsideration of pharmacovigilance practice in the light of the lack of clear definition of boundaries between:
- Food
- Medicines (including traditional medicines, herbal medicines and ‘natural products’)
- Medical devices
- Cosmetics
Increasing public expectation of safety in relation to all of these adds another dimension of pressure for change. National pharmacovigilance centers are in no position to address all these safety concerns on their own, but they are especially able to detect and anticipate the impact of such problems on the safety of patients. Through strong links with the national drug regulatory authority as well as to other countries, National Centers are in a position to influence decision-making on drug and other health-related policies.
The purpose of pharmacovigilance concerns have been widened to include:
- Herbals
- Traditional and complementary medicines
- Blood products
- Biologicals
- Medical devices
- Vaccines
Many other issues are also of relevance to the Pharmacovigilance science:
- Substandard medicines
- Medication errors
- Lack of efficacy reports
- Use of medicines for indications that are not approved and for which there is inadequate scientific basis
- Case reports of acute and chronic poisoning
- Assessment of drug-related mortality
- Abuse and misuse of medicines
- Adverse interactions of medicines with chemicals, other medicines, and food
The Specific Aims of Pharmacovigilance:
- To improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.
- To improve public health and safety in relation to the use of medicines.
- Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.
- Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
Pharmacovigilance has developed and will continue to develop in response to the special needs and according to the particular strengths of members of the programs and beyond.
The Pharmacovigilance Reporting System:
The primary source of the information on a suspected adverse reaction(s) is the person who reports the facts.
Several primary sources, such as healthcare professionals and/or a consumer, may provide information on the same case. In this situation, all the primary sources ‘details, including the qualifications, should be provided in the case report, with the ―Primary source(s) section repeated as necessary in line with the ICH-E2B(R2) guideline. In accordance with the ICH-E2D guideline, Medical documentations (e.g. laboratory or other test data) provided by a consumer that support the occurrence of the suspected adverse reaction, or which indicate that an identifiable healthcare professional suspects a reasonable possibility of causal relationship between a medicinal product and the reported adverse event, are sufficient to consider the spontaneous report as confirmed by a healthcare professional.
If a consumer initially reports more than one reaction and at least one receives medical confirmation, the whole report should be documented as a spontaneous report confirmed by a healthcare professional and be reported accordingly. Similarly, if a report is submitted by a medically qualified patient, friend, relative of the patient, the case should also be considered as a spontaneous report confirmed by a healthcare professional.
Health Professionals
The success or failure of any spontaneous reporting system depends on the active participation of reporters. Although limited schemes for reporting by patients have been initiated recently, health professionals have been the major providers of case reports of suspected ADRs throughout the history of pharmacovigilance.
Originally physicians were the only professionals invited to report as judging whether disease or medicine causes a certain symptom by exercising the skill of differential diagnosis. It was argued that accepting ADR reports from physicians only, would ensure high quality information and minimize the reporting of unrelated, random associations. Studies have shown, however, that different categories of health professionals will observe different kinds of drug related problems. Only by inviting reports from all professionals involved in the care of patients will it be possible to detect the full spectrum of complications related to pharmaceutical treatment.
If, for example, only general practitioners contribute to the pool of information, medicines used primarily by specialists will not be covered. To get a representative picture of the reality, all sectors of the healthcare system would need to be involved, such as public and private hospitals, general practitioners, nursing homes, retail dispensaries, and clinics for traditional medicine. Wherever medicines are being used there should be a readiness to observe and report unwanted and unexpected medical events.
There are other aspects of drug safety that have been rather neglected until now, which should be included in monitoring latent and long-term effects of medicines.
These include:
- Detection of drug interactions
- Measuring the environmental burden of medicines used in large populations
- Assessing the contribution of ‘inactive’ ingredients (excipients) to the safety profile
- Systems for comparing safety profiles of similar medicines
- Surveillance of the adverse effects on human health of drug residues in animals, e.g. antibiotics and hormones
Risk and Crisis Management:
The importance of an efficient system for dealing with drug safety risks and crises has become increasingly evident in recent years. Drug safety issues tend rapidly to take on international significance. The speed with which information spreads in the modern world means that drug safety concerns are no longer confined to individual countries. Often the media and general public are informed at the same time as, or even before, the national regulatory authority. When crises arise, whether they are real or perceived, local safety issues or concerns arising abroad, regulatory authorities are expected to meet them openly, efficiently, thoroughly and rapidly. Many national authorities have identified the need for developing an organizational plan for managing risks and for communication and action during crises. Regulators themselves often react under duress in a drug safety crisis within a legislative or administrative framework that is inadequate or excessively restrictive. There should be clear yet flexible operating procedures so that their response is not delayed, unnecessarily complicated, or unduly cautious (undue caution may result in removal of a product from the market even when there may be no justification and a more thoughtful and less drastic response would be appropriate).
In such circumstances, the greater the disparity in safety information between the pre-registration evaluation and the real situation in practice, the greater is the likelihood that the regulatory response will be inappropriate. When crises arise, the regulatory authority has powers to suspend registration, impose special conditions, or severely restrict use to certain patients or prescribers. The authority may require manufacturers to change the product information in a specified manner. These decisions are normally communicated by drug alerts, general letters to doctors and pharmacists, press statements, through websites, newsletters and journal publications, depending on the type and urgency of the message and those who are being addressed.
Health professionals are more likely to identify and report important ADRs if they have confidence in their ability to diagnose manage and prevent such reactions. National pharmacovigilance centers and training institutions play a central role in this by encouraging inclusion of the principles and methods of pharmacovigilance and the study of iatrogenic disease at undergraduate and postgraduate levels in schools of medicine, pharmacy and nursing. Pharmacology curricula should give a higher priority to the study of the safety of medicines. This would lead to an enhanced awareness of the balance between the benefits and harms of medicines. An integrated approach to therapeutic decision-making might be encouraged. Excessive and irrational drug use contributes to adverse reactions. The misuse of medicines is largely caused by the poor quality and inaccessibility of drug information available to practitioners.
These problems are worsened by:
- Aggressive and inaccurate marketing and advertising
- Uninformed patient use and their demands for the latest medicines
- Lack of accurate drug information
Indicators of inappropriate drug use can be obtained from spontaneous reports of ADRs. Case examples may serve as useful teaching tools for improving the safe use of medicines. In some countries an overwhelming volume of information (as opposed to effective communication of critical information) can serve as a deterrent to rational use. Medication errors and ADRs are well documented in hospitalized and non-hospitalized patients, and they contribute substantially to morbidity and mortality. They also contribute to the number of hospital admissions and are known to occur in the community setting. Many are predictable and preventable. This suggests considerable opportunity for minimizing the risks of ADRs through rational use, monitoring and follow-up. Early detection is important, particularly in hospitals where systems for detecting ADRs and medication errors will save lives and money. Such systems might be linked to institutional, regional or national pharmacy and therapeutics committees so that information can be used to educate professional staff in safe drug use.
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