The pharmaceutical industry covers the development, manufacture, marketing, and distribution of drugs worldwide, and it is among the most heavily regulated sectors anywhere. Those regulations exist to protect the health of the people who take the products.
The US government describes pharmacovigilance as monitoring pharmaceuticals for safety, reducing risk, and improving quality of life for the patient. The European Commission frames it as post-marketing surveillance in the public interest. Regulators in both places can require changes to a drug when a new signal appears.[5]
International Harmonization has not removed the differences between regulatory regimes. The United States applies some of the strictest pharmaceutical safety requirements of any market.[10]
Pharmacovigilance and Drug Safety, The Difference
Drug safety and pharmacovigilance both gather and report adverse drug reactions. Drug safety draws its data from clinical trials and the post-marketing period and reports what it finds, which makes it reactive. Pharmacovigilance looks outward for signals and trends before they surface as reports. The post-marketing environment matters most, because that is where real world conditions apply, and data analytics is what makes better signal detection possible.
What a company needs to know is which hazards attach to its product and how to reduce the risk to users. Clinical trials tell you a great deal about how a product behaves in a controlled population and very little about the rest. Real world variables in how people actually take a medication or use a device affect safety too. A full audit is usually needed to establish where the product stands against global regulatory requirements.
Pharmacovigilance is roughly 170 years old, though it was not called that at the start. It is a structured activity within professional healthcare, with social and commercial consequences, aimed at monitoring the risk and benefit profile of drugs and improving patient safety. Its history runs from the letters and warnings clinicians sent to scientific journals through to the electronic registries in use today, and that path explains both what the field has achieved for human health and what still challenges it.
The processes associated with Pharmacovigilance involve several functions including
- · Collecting and managing safety data
- · Reviewing case reports to detect signals
- · Practicing proactive risk management
- · Communicating with and informing company stakeholders and patients[5]
- The Beginning of Pharmacovigilance
The death of a child in the United Kingdom from chloroform in 1848 pushed the medical community to start warning each other about the dangers of medicines, tonics, elixirs, and formulas. Physicians posted adverse drug reactions and case details to journals read by doctors, druggists, and laboratory scientists. That practice led to commissions set up to investigate incidents, accidents, and deaths connected to medicines, their toxicity, and their purity.
The US Pure Food and Drug Act of 1906 called for contamination free food and drugs, laboratory testing, and factory inspections. It also banned foreign and interstate food containing harmful preservatives or adulterants, and stopped mislabeled food entering the market.[5]
More than 100 deaths from Elixir of Sulfanilamide in 1937 led to the Federal Food, Drug, and Cosmetic Act of 1938. Safety and efficacy data ahead of pre-marketing submission was not required in the US until 1962. In 1966 a pilot study began using in-hospital monitoring to develop epidemiological method.[9]
Those events pushed spontaneous adverse drug reaction reporting into something organized, systematic, and timely.
What Has Changed in Pharmacovigilance?
In the 170 years since the first reports of adverse drug reactions the field has grown enormously. A large global market, product innovation, new technology, and regulatory requirements that keep shifting all complicate drug safety while companies carry the risk management obligation.
Pharmacovigilance covers the safety of pharmaceuticals, vaccines, plasma derived therapies, and medical devices. The people doing it have to keep pace with therapies and technologies that change quickly, and with a regulatory system that changes alongside them.
In practice it means collecting safety data continuously, then assessing, monitoring, and reporting on compounds and medical products that are either in clinical development or already on the market.
The functions involved are numerous and interlinked, and all of them exist to meet a regulatory standard. Shifting global regulation, emerging therapies, new technologies, devices, and pharmaceuticals together make the modern version of this work demanding.
Pharmacovigilant practices are guided by local, regional, and international healthcare systems and regulations.[7]
The Food and Drug Administration oversees approximately 20,000 approved prescription drug products and regulates more than 6,500 product categories for medical devices, on a total budget of 5.9 billion dollars.
regulatory activities involving human drugs accounts for about 33 percent of the FDA’s budget.[3]
New Drugs-Long-term Investment
The Tufts Center for the Study of Drug Development puts the time to bring a new drug to market at 12 to 15 years, at an estimated cost to manufacturers of over $2.6 billion.
That timeline covers years of clinical study and FDA evaluation intended to establish that a drug is safe and effective in the people who take it. After US approval, further studies are required for populations the clinical trials did not cover.
Novel drugs are those that represent some advance in treatment. They count as novel because their active ingredients have not been approved in the United States before.
The FDA's Center for Drug Evaluation and Research approved more than 50 novel drugs in its most recent annual report, covering a range of medical conditions.[2]
The field has changed substantially over the past decade as the pharmaceutical industry has grown. Tighter regulatory requirements, reporting and compliance systems that differ by market, and new technology for data collection and signal detection have all raised the level of trained resource organizations need in-house.
Many companies still struggle to attract and keep qualified in-house PV staff, which limits how far the function can scale.
The hard part is running pharmacovigilance economically while satisfying regulators across markets, adopting new tools, and deciding which functions can reasonably be automated.[6]
Outsourcing when you need PV people
What outside PV support usually covers
· A single point of contact for PV and regulatory requirements
· Coverage across the U.S., Europe, Middle East, Asia, and Australia when programs span more than one region
· Clinical and post-marketing PV support across multiple national reporting regimes
Handling the regulatory complexity well frees time and resources, which lets a company concentrate on how its products are actually used and put earnings back into developing new ones.
Why companies look outside for PV capacity
Outsourcing reduces the cost for small to medium sized pharmaceutical companies experiencing
- · Rapid and unexpected increase in workload
- · Temporary lack of specialty trained staff resources
Qualified PV personnel perform a range of functions that include
- · Creating and Maintaining the PV system files
- · Updating and Maintaining a database of safety information
- When outsourcing PV is usually the right call
- · You do not have time to run a full interview process for qualified candidates
- · Regulatory deadlines will slip without immediate help
- · Processes and paperwork start to drift if PV roles stay vacant
- · You lack the time to onboard and train new permanent hires
- · You need someone who can pick up where another PV professional left off
Glassdoor puts the average time to hire a candidate at about 24 days. Screening and interviewing consume time that carries a direct cost to the business.
Every day a position stays open is a day of work not being done. It also wears on the people covering the gap, and that has its own effect on output.
Third party resources bring established expertise in pharmacovigilance processes and in the technology behind them. They work inside these systems daily and know how they behave.
Reasons to work with outsourced talent
- · Top performers in their area of expertise
- · Frees up management to focus on core capabilities
- · Core competency in their specialty
- · Mixed capabilities and experiences with other life science companies
- · Investment in customer’s approach
- · Knowledge from performing similar services for other companie
Goals moving forward
- What Drives Changes in the Roles and Focus of Pharmacovigilance?
- · Regulator’s heightened focus on timely and accurate reporting of adverse events
· Drug corporation’s fear of paying hefty fines for insufficient or untimely reporting to regulatory agencies
· Increased focus by regulators on adverse events that originate outside of clinical trials and traditional help lines
· Outside patient assistance programs
· Social media accounts and specially sponsored websites
Why Outsourcing Makes Sense-The Move Towards Proactivity and Resource Efficiency
Because of regulatory changes, pharmaceutical operating models must now include greater focus on core capabilities including:
· Case Management for Adverse Events
Business Strategy for Future Growth
· Develop a benefit-risk profile for specific products
· Identify at-risk patients/users
· Global coverage that must include knowledge of specific regulatory frameworks
· Strict and clear governance to include company-wide crisis management processes
Why Companies are Using Alternate Delivery Models
Efficiently Managing the PV Delivery Model Through Outsourcing
Outsourced staff give an organization room to pursue growth while the safety and compliance framework stays in place around the product.
Internal Optimization-Trained in-house personnel work on activities of highest value.
Technology-Investing in new tools can speed up pharmacovigilance work and increase effectiveness for pharmaceutical organizations.
Consolidation-Creating a single unit of shared services increases staff efficiency, reduces redundancy, and makes for centralized control of Pharmacovigilance.
Outsourcing as a way to scale PV
Bringing in a third party for some or all of pharmacovigilance operations gives you access to specific expertise that is difficult to build internally.
These methods are cost effective and increase efficiency overall.
Internal resources, external expertise, and outside providers can all be cost efficient, but a company may not want to trade transparency, control, and service levels for that saving. The usual answer is to keep certain core functions in-house and place the rest outside. That starts with an honest read of where the gaps actually are.
It is worth checking that a third party can execute these functions to the standard required. Outsourcing pharmacovigilance moves responsibility for drug safety functions onto that provider, in part or in full depending on the arrangement, and which functions transfer varies by company.
Critical activities include
- · Creating Risk Management plan
- · Preparing ideas for Risk Evaluation Mitigation Strategy
- · Creating/submitting critical and timely PV reports
- Benefits of a Good PVO Program
- · Convert fixed costs to workload dependent costs
- · Reduce staff needed to recruit, interview, hire, and train
- · Instant access to experts, multi/hybrid talent
- · Increased flexibility and capacity
- · Increased efficiency and Return On Investment
Global outsourcing addresses: talent shortages, regulations that keep changing, and a company’s desire to invest in technology.
Safety in Outsourcing Pharmacovigilance
A first time marketing authorization holder often lacks the experience and the resources to absorb everything that comes with getting a product to market.
Trust in this sector is hard to rebuild once it has gone, which is the argument for hiring pharmacovigilance staff who are properly trained and properly vetted.
Organizations are likely to lean further on outsourced staff for pharmacovigilance, which helps with high volume and complex regulatory demands while adding scalability to the business.[4]
FDA’s Regulatory Authority, New Parameters
Drugs are used in a real market where patients have comorbidities and take other prescriptions, over-the-counter medicines, and supplements. A drug's risk-benefit profile changes after approval, which is why monitoring has to continue once the product is in general use.[9]
Post-marketing surveillance has limits everywhere. Many doctors and other clinicians are not well trained in using the spontaneous ADR reporting system. Some in the field expect a shift toward more patient-centered pharmacovigilance.
The Future of Pharmacovigilance
Artificial intelligence and predictive analytics will play some part in where this goes next. Regulators will need computer models that help them judge risk and benefit once a product has moved into real world use.
While spontaneous reporting will still be needed in post market surveillance of products, newer methodologies and innovation with signal detection will be key.[1]
1Alomar, M., Tawfiq, A. M., Hassan, N., & Palaian, S. (2020, August 10).
Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: Current status, challenges and the future
. Therapeutic advances in drug safety. Retrieved October 26, 2021, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7418468/.
2Center for Drug Evaluation and Research. (n.d.).
New drug therapy approvals 2020
. U.S. Food and Drug Administration. Retrieved October 26, 2021, from
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2020.
3Commissioner, O. of the. (n.d.).
. U.S. Food and Drug Administration. Retrieved October 26, 2021, from
https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance.
4Edwards, B. (2008, February).
How should you safely outsource pharmacovigilance to an Indian contract research organization?
Indian journal of pharmacology. Retrieved October 26, 2021, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3038519/.
5Fornasier, G., Francescon, S., Leone, R., & Baldo, P. (2018, August).
An historical overview over pharmacovigilance
. International journal of clinical pharmacy. Retrieved October 26, 2021, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132952/.
Pharmacovigilance in crisis: Drug safety at a crossroads
. Clinical therapeutics. Retrieved October 26, 2021, from
https://pubmed.ncbi.nlm.nih.gov/29605513/.
7Kugener, V. F., Freedland, E. S., Maynard, K. I., Aimer, O., Webster, P. S., Salas, M., & Gossell-Williams, M. (2021, August).
Enhancing pharmacovigilance from the US experience: Current practices and future opportunities
. Drug safety. Retrieved October 26, 2021, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8123099/.
8Laxminarayan, R., B, C. M., G, V. T., Arjun Kumar, K. V., Wahl, B., & Lewnard, J. A. (2021, August 13).
SARS-COV-2 infection and mortality during the first epidemic wave in Madurai, South India: A prospective, active surveillance study
. The Lancet. Infectious diseases. Retrieved October 26, 2021, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8363227.
Read "The future of drug safety: Promoting and protecting the health of the public" at nap.edu
. National Academies Press: OpenBook. (n.d.). Retrieved October 26, 2021, from
https://www.nap.edu/read/11750/chapter/7.
10Talbot, J. C., & Nilsson, B. S. (1998, May).
Pharmacovigilance in the pharmaceutical industry
. British journal of clinical pharmacology. Retrieved October 26, 2021, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1873545/.