What Is Drug Safety And Pharmacovigilance

What is drug safety in pharmacovigilance?

Pharmacovigilance Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and / or unexpected. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.

All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period of time.

The from t he first joint meeting of WHO Global Advisory Committee on Vaccine Safety and WHO Advisory Committee on Safety of Medicinal Products is now available. An integrated WHO Pharmacovigilance team was established in 2020, to combine work related to the safety of medicines and vaccines within the Department of Regulation and Prequalification (RPQ).

Following this transformation WHO convened a joint meeting with both the Advisory Committee on Safety of Medicinal Products (ACSoMP) and the Global Advisory Committee on Vaccine Safety (GACVS) for the first time on 14–16 June 2022. The conclusions from the second joint meeting of the WHO GACVS and the WHO ACSoMP, 14-16 December 2022, are now available ( and ).

The meeting discussed various topics including mpox (monkeypox) vaccines and safety surveillance, safety monitoring of pregnant and breastfeeding women, active safety surveillance of molnupiravir, hallucinations reported with delamanid in children, dolutegravir exposure at conception, emergency use protocol for tecovirimat, the use of sodium valproate in women and girls of childbearing potential as well as a gaming approach to risk and safety communication. The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities. Thrombotic Thrombocytopenia Syndrome (TTS) has emerged as a new adverse event following immunization in individuals vaccinated with COVID-19 non-replicant. The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities. The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities. The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and legal actions taken by regulatory authorities. This is a master protocol, which was approved by the WHO Ethics Review Committee (ERC) on 09.03.2022 (protocol ID; CERC.0155. It will be used by study. The WHO Pharmacovigilance team strives to ensure safer use of medicines and vaccines throughout the life cycle of the products. Among our activities we are:

Developing norms, standards and guidelines.Providing credible safety and regulatory information on medicines.Appointing and convening global advisory committees of experts to review and provide guidance on the safety of and, Hosting global networks such as the (PIDM) to promote pharmacovigilance in countries.Establishing and maintaining to provide technical support to countries in pharmacovigilance.Countering vaccine-misinformation about vaccines through the, which facilitates the access to reliable information on vaccine safety.Providing training programmes to build and strengthen the capacity of national safety surveillance systems for medicines and vaccines,Developing innovative methods and tools to generate new evidence on the safety of medicinal products

: Pharmacovigilance

What is the difference between drug safety and pharmacovigilance?

Difference between Drug Safety and Pharmacovigilance Drug Safety & Pharmacovigilance are receiving more attention than any these days. “Drug Safety and Pharmacovigilance” is not a single term. There is a slight difference between “Drug Safety” and In short, we can say one is reactive, and the other is proactive.

Drug Safety Pharmacovigilance
With the Drug Safety design, data collected at clinical trials and in the post-marketing environment is examined and reported. Crucial data is highlighted, and regulatory agencies use this information to decide which drugs will be registered and reimbursement authorities to decide reimbursement. These choices include weighing up the risk vs. benefit of different treatment options, i.e., for the service that the patient receives from the medicine, what are the likely chances in terms of side effects. The Pharmacovigilance model takes drug safety to the next level. The term ‘vigilance’ links to ‘being vigilant,’ i.e., proactively considering the environment, and identifying signals and trends, with an enhanced focus on the post-marketing environment. The conditions of use have changed. Patient compliance is variable, and inclusion/exclusion criteria are not as tight as in controlled trial settings.

Within the Pharmacovigilance model, larger and more complex datasets are being analyzed. It generates considerable insight into how drugs are performing in the real world. Valuable data is being developed on how medicines are completing inpatient sub-populations and across disease states.

The Pharmacovigilance model concentrates on establishing signal detection systems and uses advanced data analytics to proactively monitor the entrance of new medicines to large patient populations. Real-world evidence is collected, collated, analyzed, and turned into penetration which is then being used during regulatory, reimbursement, and commercial discussions on strategic competitive benefits.

The two words Drug Safety and Pharmacovigilance can be used conversely – the same primary role is being performed. But Pharmacovigilance is more encompassing and more strategic. Feel free to share this article with your colleagues. This not only shows that you have the expertise needed for the job or the project, but certifications also showcases your dedication towards what you do, giving credible proof that you have full fledged knowledge on the topic.

What is the meaning of drug safety?

ESTIMATION OF INITIAL SAFETY AND TOLERABILITY – Drug safety refers to the frequency of adverse drug effects (i.e., physical or laboratory toxicity that could possibly be related to the drug) that are treatment emergent—that is, they emerge during treatment and were not present before treatment, or they become worse during treatment compared with the pretreatment state.

An adverse drug effect is distinguished from an adverse event (or experience), which refers to any untoward experience that occurs while a patient is receiving the medication, whether or not it is attributable to the drug. The seriousness of an adverse event dictates how quickly it must be reported to regulatory agencies and to others who may have ongoing experimental protocols.

A serious adverse event is defined as one that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

Investigators conducting pharmaceutical industry–sponsored studies should be aware that companies may have their own, more strict definition of serious adverse events. The term severity is distinguished from serious in that severity refers to the intensity of a specific event, whereas serious refers to the outcome or consequences of the event.

Drug tolerability refers to how well subjects are able to tolerate overt adverse drug effects. Read full chapter URL: https://www.sciencedirect.com/science/article/pii/B978141606581410007X

What are the 4 aims of pharmacovigilance?

3. EU Pharmacovigilance – objectives – aims – tasks – Following the above definition of pharmacovigilance, according to the EMA the underlying objectives of the applicable EU legislation for pharmacovigilance are:

preventing harm from adverse reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure;


promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public.

Specific aims of pharmacovigilance are to:

Maintain a robust monitoring system for new safety issues. Implement effective approaches to minimise risk, Install procedures for rapid decision making and triggering actions in case of (immediate) safety concerns Improve patient care and safety in relation to the use of medicines and all medical and paramedical (services that support medical work, such as nursing, first aid, radiography) interventions. Improve public health and safety in relation to the use of medicines. Contribute to the assessment of benefit, risk, and effectiveness (including cost- effectiveness ) of medicines. Secure the accessibility of information about the safety of medicinal products to patients, healthcare professionals and the public. Promote understanding, education and training in pharmacovigilance and its effective communication to the public. Monitor impact of measures and activities and ensure continuous improvement of pharmacovigilance system

The above list incorporates what the WHO calls the general objectives. Pharmacovigilance is therefore an activity contributing to the protection of patients’ and public health. Main pharmacovigilance related tasks: The pharmacovigilance process can be broken down into the following key tasks:

Assessing the known and potential risks of each medicine before marketing and developing plans to collect data and minimise those risks ( risk management planning ); (See lesson 2 on risk management)Collecting and managing data of possible adverse reactions (ADR); (see section 2 below on ADRs) Signal detection and management – analysing the data (reports of suspected adverse reactions) to identify ‘signals’ (any new or changing safety issue); (see section 1.5 on Signals)Routine benefit – risk monitoring of medicines via periodic safety update reports (PSURs).

Europe-wide reviews and evaluation of important safety and benefit – risk issues and decision on whether and which (regulatory) action to take; e.g., PhV referrals (in a referral procedure, the EMA is requested to conduct a scientific assessment of the safety concern for the EU).

Acting to protect public health (including regulatory action). Managing information on products under additional monitoring, and products that have been withdrawn.Identifying and reducing the risk of medication errors before and after the authorisation of a medicine.Assessing and co-ordinating studies after marketing through post-authorisation safety studies and post-authorisation efficacy studies, Carrying out inspections to ensure company pharmacovigilance systems comply with good pharmacovigilance practice. Communicating in a clear, effective and timely manner about safety -related issues to relevant stakeholders. Interacting with and engaging key stakeholders, including patients, healthcare professionals, the pharmaceutical industry, other parts of the regulatory system (including international regulators), academia, the media, and wider civil society Monitoring performance of the system and its components, including compliance with legal obligations and standards.Continuous development and improvement of systems (including IT infrastructure), guidelines and standards, and promotion of research to address knowledge gaps.

Is pharmacovigilance the key to drug safety?

Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. It is a key public health function. The EU pharmacovigilance system is one of the most advanced and comprehensive in the world and represents a robust and transparent instrument to ensure a high level of public health protection throughout the EU.

What is pharmacovigilance in one word?

Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the ‘collection, detection, assessment, monitoring, and prevention’ of adverse effects with pharmaceutical products.

Why is pharmacovigilance is so important in drug industry?

Why Pharmacovigilance is an Essential Part of the Drug Lifecycle Pharmacovigilance is the lifeblood of the pharmaceutical industry. Without it, there would be no reliable way for researchers to assess the overall safety and efficacy of a drug. Simply put, this process is necessary to ensure that every drug on the market is both beneficial and safe for widespread use – a level of protection that has unfortunately proven necessary to guard against,

Pharmacovigilance, as defined by the World Health Organization, “is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine related problem.” Its methods are essential for thoroughly testing clinical drugs, lessening the risk of undesirable side effects, and improving patient safety.

As clinical trials are by necessity restricted to a limited sample size, unwanted side effects sometimes emerge only in later stages, when a drug is released to a larger population. Pharmacovigilance extends to cover post-market use, so that patient reactions to each drug can be continually monitored for improved safety – which in turn also improves public trust.

Drug Safety Drug safety monitoring is crucial throughout all stages of the drug development lifecycle. As different drugs pose different dangers, monitoring and understanding the science behind adverse drug reactions can greatly increase the safety of new and future medicines. Pharmacovigilance is applied to both the pre-market research/development stage and the post-market real-world use stage of drug manufacturing.

In the pre-market stage, researchers are tasked with closely monitoring and analyzing adverse drug reactions wherever they appear, across all three phases of a clinical trial. This part of the clinical research process plays a major role in determining whether a given drug is safe for distribution.

Post-market pharmacovigilance is conducted through a combination of spontaneous and solicited reports. When a patient has an adverse drug reaction, healthcare professionals or patients can submit a spontaneous report describing these effects to the relevant regulatory authority. This is called a spontaneous report and is considered a passive form of monitoring.

Solicited reports are conducted through a pre-planned process by hospitals, pharmacies, and physicians, and are aimed at monitoring adverse reactions caused by drugs. Although each drug goes through rigorous procedural analyses before being authorized and released to the public, some drugs may nevertheless have unexpected side effects.

  1. That is why it is vital for pharmaceutical companies and specially contracted research organizations to faithfully adhere to the pharmacovigilance process – continuing to closely monitor any adverse events that may occur, even after a drug is made available for wide release.
  2. Signal Management When adverse reactions are found, researchers will then conduct further investigation by following the signal management procedure, to identify whether there are new risks associated with the medicinal product or whether known risks have changed.

This procedure can be broken down into various parts, including signal detection, signal validation, analysis & prioritization, assessment, recommendation for action, and exchange of information. Signal detection can come from spontaneous reports, active monitoring systems, and interventional studies (clinical trials).

When a signal is detected, its validity must be evaluated by taking into account the strength of the evidence, clinical relevance, and previous awareness of the association. Through analysis and assessment, researchers can propose a recommended action by prioritizing patient safety within a risk-benefit balance framework.

Lastly, the pharmacovigilance physician will communicate the details to regulators. The outcome of the signal assessment may also be communicated to the public, especially healthcare professionals and patients, to inform them about new or changed risk assessments.

Patient Safety Pharmacovigilance is designed to safeguard patients from adverse events while enabling the detailed exchange of information among healthcare professionals. Although doctors and researchers do not intend to put patients in harm’s way, unfortunately a percentage of drugs and medications do carry a risk of incurring harmful side effects.

Effective pharmacovigilance practices therefore ensure that risks and adverse events are identified as soon as possible, preventing and minimizing any damage that may befall current or future patients. Ultimately, the analysis and dissemination of this information sets the foundation for success and overall patient safety in future trials.

The value of pharmacovigilance is largely a product of its thorough, detail-oriented focus. The process enables in-depth monitoring throughout all stages of the drug development cycle, with findings analyzed and categorized according to clear sets of guidelines. Data collection is enhanced through two types of reports that permit timely identification of current and potential risks in medicinal products.

Safety information is then shared to help minimize the adverse effects of drugs, and ultimately safeguard patient wellbeing. Pharmacovigilance is essential to any drug development process – though its true value in society extends even further. This process provides the foundation of trust on which the entire pharmaceutical industry depends, as researchers protect the interests of public health and safety.

What are the 5 rights of drug safety?

The Five Rights: A Destination Without a Map As we have discussed in previous columns, errors in drug administration pose a great risk to patients. Most health care professionals, especially nurses, know the “five rights” of medication use: the right patient, the right drug, the right time, the right dose, and the right route—all of which are generally regarded as a standard for safe medication practices.

Yet many errors, including lethal mistakes, have occurred even when health care professionals were confident that they had verified these “rights.” Why does this happen? First, although these criteria are the goals of safe medication practice, they offer little guidance to health care practitioners on the appropriate way to ensure drug safety.

For instance, how does a pharmacist identify the right patient when the patient’s name and room number on an order copy are blurred and the physician’s signature is illegible? Whom should the pharmacist call for follow-up? How does a home-care nurse in an assisted-living facility identify the right patient if name bracelets are not used? Can the nurse depend on verbally questioning the patient? Unfortunately, relying on accurate information from patients has led to errors, for instance, when patients misunderstood a name or when they were confused.

Without adequate systems in place to help practitioners achieve the goals of the five rights, errors are likely. The five rights, as stated, focus on the performance of individuals and do not reflect the fact that drug safety is a culmination of efforts of professionals from several disciplines; the responsibility for accurate drug administration lies with multiple individuals and reliable systems.

Some of the factors contributing to a medical team’s failure to accurately verify the five rights, despite their best efforts, include:

poor lighting. inadequate staffing patterns. poorly designed medical devices. handwritten orders. trailing zeroes (e.g., 2.0 vs.2) or using a decimal point without a leading zero (e.g.,,2 instead of 0.2). Misinterpretation of such an order can result in a 10-fold dosing error. ambiguous drug labels. lack of an effective independent double-check system for high-alert drugs.

Nurses, for example, cannot verify the identity of the patient if they have no way of knowing whether patients are actually who they say they are or whether the name on a patient’s armband is accurate. They can only verify two unique identifiers assigned to the patient upon admission to the facility—a process that the organization deems to be sufficient to confirm that the identity of the patient—before they administer medications.

reading the label requesting an independent double-check if required questioning orders for drugs and doses that are illegible or that appear unsafe using bar-code technology if it is functional

Organizations consider these procedural rules to be sufficient to verify the right drug and the right dose. Thus, the duty of the health care practitioner is not so much to achieve the five rights but to follow the procedures designed by the organization to produce these outcomes.

If the procedural rules cannot be followed because of problems within the system, health care practitioners also have a duty to report the matter so that it can be fixed. Although some might think that this distinction is minor, it is helpful to consider the following. If we hold individuals accountable for achieving the five rights, we should then give them the authority to design their own systems for achieving these outcomes.

After all, how can we hold individuals accountable for situations and events that are not under their control? However, because organizations typically decide on the processes that are necessary for achieving the five rights, staff members who follow these procedures should not be held individually accountable for undesirable outcomes.

  1. Improvements must be made in the systems themselves, not in the individual’s practice or behavior.
  2. The five rights are not a behavioral model for achieving medication safety; they are goals for which organizations must accept responsibility and design fail-safe ways so that the goals can be achieved.

Of course, the five rights are not the final word in medication safety. Unfortunately, managers often simply admonish health care practitioners who make an error for not following the five rights without recognizing or addressing the human factors and causes of the error originating within the system.

Likewise, regulatory agencies often penalize health care professionals if they cannot verify the five rights; such actions perpetuate the belief that individuals should be blamed. The five rights should remain as medication-use goals, but we must help practitioners achieve these goals by establishing strong support systems that encourage safe practices.

The reports described in this column were received through the ISMP Medication Errors Reporting Program (MERP). Errors, close calls, or hazardous conditions may be reported on the ISMP Web site () or communicated directly to ISMP by calling 1-800-FAIL-SAFE or via e-mail at,

Why is drug safety important?

Drug safety is an important aspect of healthcare, and healthcare providers have a responsibility to ensure that the drugs they prescribe are safe and effective for their patients. Adverse events and drug interactions can result in serious harm to patients and can also lead to increased healthcare costs.

What are the responsibilities of drug safety?

Roles & Responsibilities of Drug Safety Associate or Pharmacovigilance Associate A Drug Safety Associate is a professional who works in the field of pharmacovigilance within a pharmaceutical, biotechnology, medical company or life sciences consulting firm.

Reviewing and evaluating adverse event reports (AERs) to determine if they meet regulatory reporting requirements. Entering and maintaining adverse event information in safety databases Narrative writing Communicating with healthcare professionals and other stakeholders to gather additional information about adverse events Assisting in the preparation of safety reports to be submitted to regulatory agencies Monitoring safety literature to stay current on the latest safety information related to the company’s products Collaborating with other departments such as clinical research, regulatory affairs, and pharmacovigilance to ensure compliance with safety regulations and guidelines Participating in the development and implementation of safety policies and procedures Reviewing and assessing the safety profile of new and existing products Participating in the development and execution of risk management plans Communicating with regulatory authorities, healthcare professionals, and other stakeholders on safety-related issues.

Drug Safety Associates are crucial in ensuring that drugs and medical devices are safe for use, and that any safety issues are quickly identified and addressed. They play a key role in maintaining public trust in the healthcare system by ensuring that the medications and devices that people rely on are safe and effective.

What is rule of 3 pharmacovigilance?

The rule of three means that you need three times as many subjects to observe an event when you assume that the adverse event of interest does not normally occur in the absence of the medication.

Which skill is more important in pharmacovigilance?

Communication Skills – Pharmacovigilance jobs demand excellent communication skills, no matter what the role or level of the position. The information you provide needs to be clear and precise so that users can understand it. Many jobs in this sector involve working with different teams of people, so as well as written communication skills, verbal communication skills need to be excellent.

  1. You’ll need to be able to work well as part of a team, and be adept at working cross functionally with other departments.
  2. Increasingly, foreign language skills are sought by pharmaceutical companies seeking to fill pharmacovigilance jobs, so if you possess skills in another language, this could put you at an advantage.

Computer literacy is also normally demanded by employers. If you think you have got what it takes to work in pharmacovigilance, browse our selection of jobs and get in touch today to speak to one of our advisers to kick-start your new career.

Is pharmacovigilance a Phase 4?

Phase IV – Phase IV trials are also known as postmarketing surveillance trials. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (e.g., the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials).

  • Safety surveillance is designed to detect any rare or long-term adverse effects in a much larger patient population over a longer time period than was possible during phase I–III clinical trials.
  • Harmful effects discovered by phase IV trials may result in a drug being withdrawn from the market or restricted to certain uses.

In this phase, further indications of drugs might be determined. For topical drugs, trials may include skin studies for irritation (primary and cumulative applications), allergy (repeated insult patch testing (RIPT)), pharmacokinetics and bioavailability (dermatopharmacokinetic), phototoxicity, and photoallergy.

The US Food and Drug Administration Guidance for Photosafety Testing states that “photoirritation and photoallergy studies in humans should be considered for all drug substances and formulation components that absorb UVB, UVA, or visible radiation (290–700 nm) and are directly applied to the skin or eyes, or significantly partition to one of these areas when administered systemically.” If the drug passes the initial safety tests, then its safety is evaluated more rigorously against a placebo within larger efficacy trials.

Safety testing for cosmetics includes usually cumulative irritation, RIPT, phototoxicity, photoallergy, and exaggerated use or home use studies. Skin reactions that develop under these skin tests, with a comparison to the controls where applicable, are the bases for conclusions on safety.

Who controls pharmacovigilance?

Abstract – Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC.

Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators.

The Central Drugs Standard Control Organization has notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in the year 2015, other drugs are under monitoring for regulatory interventions. Key words: Adverse drug reaction reporting, patient safety, Pharmacovigilance Programme of India The burden of adverse drug reactions (ADRs) in the global scenario is high and accounts for considerable morbidity, mortality, and extra-cost to the patients.

In England, 0.9% of the total hospital admissions were due to ADRs during the year 1999–2008. ADRs are common in Australian healthcare system also and they contribute to 1% of hospital admissions. In the United States of America, ADRs contribute 3.4%–7% of hospital admissions. The percentage of hospital admissions due to ADRs in certain countries is 10% or more.

India, with a current population of 1.27 billion, is the fourth largest producers of pharmaceuticals in the world with more than 6000 licensed manufacturers and over 60,000 branded formulations in the market. Studies revealed that ADRs are leading to hospitalization and constitute a significant economic burden on patients in India.

  • A study showed that hospital admissions due to ADRs accounted for 0.7% of total admissions and deaths due to ADRs accounted for 1.8% of total admissions in a territory referral center in South India.
  • Therefore, medicines safety monitoring is an essential element of healthcare and for high-quality medical care.

Since safety monitoring of medicines as an integral part of clinical practice, the Ministry of Health and Family Welfare (MoHFW), Government of India launched the nationwide Pharmacovigilance Programme of India (PvPI) in the year 2010 to inspire confidence and trust among patients and healthcare professionals with respect to medicines safety.

What is the difference between clinical trials and pharmacovigilance?

The Role of Pharmacovigilance in Clinical Trials Clinical trials are used everywhere to discover a chemical or biological compound’s safety and efficacy concerning its actions on marks or a known disease process. Pharmacovigilance drives with clinical trials that provide data on the risks and advantages of the drug.

  1. Tries to discover whether the benefits exceed the risks; if they do, drug manufacturers take steps to obtain approval to market the new drug.
  2. Trials are strictly monitored by an investigator and the pharmaceutical company involved in developing a medicinal product.
  3. However, the process also benefits from an independent review by drug safety firms.

Pharmacovigilance matches this process; to provide an extra security level to assure those safe & effective products touch patients. As part of the global healthcare, drug developers, manufacturers, pharmaceutical systems, and investigators are responsible for implementing the best possible care for the patients and consumers worldwide.

Phase I, II, and III clinical trials are needed before a drug company can apply for a new medicine’s market authorization. They are responsible for the research’s conduct and then feed it back to the sponsor (the pharma company). During clinical trials, the analyst gathers and analyzes serious adverse events (SAEs), finding whether the drug in question caused the SAEs.

If they conclude that the adverse side effects were causal, they are categorized as adverse drug reactions (ADRs). The analyst gives this data to the pharmaceutical company responsible for the drug’s R&D (research and development). It is imposed by the pharmaceutical company’s in-house PV team, and the patient files undergo medical review.

  • The PV team fixes if the drug is effective and safe to advance to the next stage of clinical research or to submit an application to the regulatory authority for approval to go to market.
  • If approved, the drug company may conduct Phase IV clinical trials to produce additional data on the efficiency and safety profile.

These studies help provide data in a less controlled environment, representing how patients are using the drug.

How do you determine the safety of a drug?

Therapeutic Index The Therapeutic Index (TI) is used to compare the therapeutically effective dose to the toxic dose of a pharmaceutical agent. The TI is a statement of relative safety of a drug. It is the ratio of the dose that produces toxicity to the dose needed to produce the desired therapeutic response. For example, if the TD50 is 200 and the ED50 is 20 mg, the TI would be 10. A clinician would consider a drug safer if it had a TI of 10 than if it had a TI of 3 (Figure 1). Figure 1. A higher value on the Therapeutic Index indicates a more favorable safety profile (Image Source: ORAU, ©) However, the use of the ED50 and TD50 doses to derive the TI may be misleading about a drug’s safety, depending on the slope of the dose-response curves for therapeutic and toxic effects. The graph in Figure 2 shows the relationship between effective dose response and toxic dose response. The shaded area represents the doses at which the substance produces an effective dose response while the toxic dose response remains below the TD50. The slope of a curve shows how dose increases result in responses to the effective or toxic dose. Figure 2. Relationship between effective dose response and toxic dose response (Image Source: NLM) Because of differences in slopes and threshold doses, low doses may be effective without producing toxicity. Although more patients may benefit from higher doses, that is offset by the probability that toxicity will occur. Figure 3. Comparison of the toxicity of two substances (Image Source: NLM) For some substances, a small increase in dose causes a large increase in response, which is seen in Toxicant A’s steep slope. For other substances, a much larger increase in dose is required to cause the same increase in response, as indicated in Toxicant B’s shallow slope.

What is safety and efficacy?

EFFICACY AND SAFETY. Efficacy and safety are separate concepts; they can be measured and discussed as. distinct properties of a medical technology. Efficacy is defined in terms of a benefit; safe- ty, in terms of a risk.