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Value-based pricing aligns prescription drug prices to their clinical benefits, leading to lower spending and better health outcomes.…
Value-based pricing aligns prescription drug prices to their clinical benefits, leading to lower spending and better health outcomes.…
Pharmaceutical Quality affects every American. The Food and Drug Administration (FDA) regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMPs. This paper discusses some facts that may be helpful in understanding how CGMPs establish the foundation for drug product quality.
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the “C” in CGMP stands for “current,” requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been “top-of-the-line” to prevent contamination, mix-ups, and errors 10 or 20 years ago maybe less than adequate by today’s standards.
It is important to note that CGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.
A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While CGMPs require testing, testing alone is not adequate to ensure quality. In most instances, testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees …
Pharmaceutical distributors are the intermediary that ships products from manufacturers to pharmacies and other providers. In addition to hospital and chain pharmacies, more than 22,000 independent pharmacies rely on their services on a daily basis, according to the Healthcare Distribution Alliance (HDA).
Distributors handle 92% of pharmaceutical sales in the United States, delivering more than four billion prescription medications safely and quickly. They also save the healthcare system as much as $53 billion annually through logistics and supply chain expertise as well as technological advancements.
Given their critical role in the pharmaceutical ecosystem, choosing the right pharmaceutical distributor for your pharmacy is more important than ever. Here are some criteria worth considering.
1. Distributors must be licensed to be authorized, trading partners.
“Drug diversion, counterfeiting, and the importation of unapproved drugs may result in potentially dangerous drugs entering the drug supply chain, posing a threat to public health and safety,” warns a 2018 report from the HHS. As a result, federal law requires rigorous and consistent standards for state licensing of pharmaceutical distributors to prevent criminal activity.
The FDA advises that prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. Since distributors are often licensed in more than one state, it’s necessary to look for one that has been approved by the licensing agency in your home state. The FDA offers a link to state databases to identify your options.
2. A distributor with the VAWD seal can ensure that the supplies you receive are safe.
The Verified-Accredited Wholesale Distributors (VAWD) program was developed in 2004 to help protect the public from the threat of counterfeit drugs.
“VAWD accreditation helps ensure that the wholesale distribution facility operates legitimately, is licensed in good standing, and is employing security and best practices for safely distributing prescription drugs from manufacturers to pharmacies and other institutions,” says the National Association of Boards of Pharmacy (NABP), which administers the program.
VAWD-accredited distributors have undergone a review of their operating policies and procedures, licensure verification, a survey of their facility’s operations, and screening through the NABP Clearinghouse.
3. A distributor should be well informed about the many laws and regulations that govern the industry.
Primary among them is the Drug Supply Chain Security Act (DSCSA), enacted by Congress in 2013 to create one federal traceability solution for prescription medicines. DSCSA requires pharmacies to transact only with authorized trading partners as defined in the law.
In the recent “Serialization Readiness Survey” conducted by the HDA Research Foundation, distributors report that the majority of independent pharmacies did not understand DSCSA requirements, placing them well behind chain stores, health systems, and hospitals (Fig. 1).
“Distributors have a global understanding of some of the big picture issues, and they should be able to bring it to the corner pharmacy and help them understand it,” says Perry Fri, HDA’s executive vice president of Industry Relations, Membership, and Education, as well as COO of its Research Foundation.
It is a bedrock principle of capitalism that as competition erodes profits on established products, enterprises will invest in innovation to earn higher profits from new products. US law governing prescription pharmaceutical markets abandons that principle and gives every new drug a long-term monopoly that prohibits competition. It also discourages competition between medicines based on comparative price or effectiveness. High prices and slow innovation cycles are the inevitable result and will remain so unless Congress makes fundamental changes in existing law.
According to the Pharmaceutical Manufacturers Association, it takes at least 10 years to develop a new drug. It is no surprise that the typical monopoly period on an existing drug is also 10-12 years. Why rush to bring a new product to market when a monopoly makes it possible to raise the price of the old one with impunity?
Patents covering products other than drugs rarely provide the ability to charge any price. They are normally limited to a specific innovation and do not prevent competition from similar products. There are always many computers, TVs, and smartphones to choose between. Patent litigation also takes years to complete and the vast majority of cases are ultimately settled because the pace of new innovations is often faster than the time it takes to acquire or enforce a patent on an existing innovation. The iPhone supplanted the Blackberry is far less than the 20-year life of Blackberry’s patents.
In contrast, Federal law prohibits the Food and Drug Administration (FDA) from approving a copy of a new drug for a period of seven to 12 years even if there are no patents. The FDA is also prohibited from approving a generic drug anytime a claim of patent infringement is alleged – a policy that has encouraged many frivolous patent claims just to delay competition. Drug patients also get extensions of up to five years and then an additional six-month extension for conducting studies of the new drug’s suitability for use in children. Collectively, all of these special monopolies prevent competition and keep prices high.
Competition between the many medicines that are usually available to treat the same medical condition could help bring down the price of a new drug that has insignificant value over an old one. A rational consumer would not pay $10 for a medication when their affliction could be relieved for 10 cents. Unfortunately, once a medication is prescribed by a physician, only that medication or an approved generic copy can be legally dispensed even if a lower-cost alternative medicine exists.
In a 1979 study recommending that States enact generic drug substitution laws as a means of lowering prescription drug costs, the Federal Trade Commission stated “the forces of competition do not work well in a market where the consumer who pays does not choose and the physician who chooses does not pay.” The situation is worse today because most patients have drug insurance that pays.
The pharmaceutical industry exploits this market distortion to avoid price …
Staffing and Temp agencies are both parts of a fast-growing industry that provides jobs to over 16 million people every year.
Both types of agencies offer work in all sectors – from industrial to clerical, to healthcare, and more. Their reach is large enough that many job seekers have likely come across a staffing or temp agency at some point during their employment search.
But what are staffing and temp agencies, and what’s the difference between the two?
In a nutshell, both agencies help people find employment. Because of that, they can often seem interchangeable.
However, though the services temp and staffing agencies offer sometimes overlap, the opportunities they provide tend to be very different.
We’ll help clarify what distinguishes them from each other.
Temp agencies staff for exactly that – temporary work. They offer short-term projects, usually lasting one day to one week. And it’s not uncommon for people working with them to be sent out to different job sites every day. Candidates often fill roles doing special projects, seasonal assignments or same-day work.
Temp agencies usually attempt to fill an urgent need for a company. They mostly work with manufacturing or warehouse companies who need extra labor for a short period, such as during the holiday seasons. A majority of the positions temp agencies offer are entry-level and light industrial in nature.
A staffing agency also offers temporary work. But unlike a temp agency, they provide a much wider range of opportunities including longer placements. Positions can be temporary, temp-to-hire, contract, and direct-hire.
Staffing agencies provide many different types of jobs. They work with a wide array of industries, including administrative, light industrial, engineering, technical, and management. Even their shorter assignments can get extended or turn into long-term careers.
Clients of temp agencies have urgent needs to fill open positions. For them, it’s less about the ‘right fit’ and more about ‘right now.’
Since they need to place people fast, a temp agency’s interview process tends to be short and fairly superficial. They want to make sure you can do the job, but their goal is not to place you in a position that’s a perfect match for your skills.
While a temp agency will find you work quickly, it probably isn’t going to be the job of your dreams – …
Health is a fundamental need of every individual in society. Over the years, the pharmaceutical industry has ensured effective drug manufacturing that helps in therapy, treatment and prevention of patient’s life. With the growing number of health disorders on the global level, the pharmacy sector has evolved in producing medicines & drugs that improve quality of living. This is why pharma has gained huge importance in human society.
If you look at the past 50 years data, the industry has been successful in determining the leading causes of many lethal diseases. This has reduced the substantial amount of death rate by life-threatening cardiac ailments over the years. And, there are many such researches that have brought medical care available to improve life expectancy in patients with severe morbidities.
This is the key reason why several countries today have been economically involved in pharmaceutical production of drugs and medicines. Infact, the pharma products manufacturing in India can improve the economic development of the nation. Its performance scale is interlinked to the country’s economic performance as India is recognized as the “Pharmacy of the world.” Countries like the USA, Europe, etc. have invested in either such profitable programmes or have set up production plants in India due to its low price – high production rate.
However, communicable diseases like the coronavirus pandemic can hamper the performance, productivity and development of health systems. As a result, society is affected on a larger scale. Pharma industry at such times becomes crucial in providing drugs and needful resources that can prevent or tackle the situation.
Production plants are known to manufacture a varied range of pharmaceutical products in India like generics, medications, supplements, medical devices, etc. These are produced as per certain guidelines and global policies as they drive the access to improve healthcare and medical facilities on the whole. Moreover, the innovations in this sector also helps in saving money by generating vaccines & improved medicines.
Many manufacturing plants in India are driven by immensure workforce, highly knowledgeable technicians and manpower ability. This enablement not just derives profitable income for the nation but also significantly contributes to the nation’s GDP. Manufacturing goods & services that are worth billions, the nation’s workforce efficiency is what attracts huge investments from corporate companies across the globe.
Further, establishment of new plants becomes resourceful in generating employment and reducing societal poverty on a growing scale. Labor employment has opened job opportunities for various categories of people. Skillful manufacturers, dealers (distributors), wholesalers, and retailers or small scale workers are some of them. Certain pharma product manufacturers in India are also responsible to evaluate and train individuals to acquire creative skill sets supporting the value chain. This learning ground enhances productivity of many individuals, helping them earn better to meet their basic necessities of living.
Every new innovation, research and development promotes highly skilled job openings and increases scientific knowledge amongst the industry workers. This stimulates capital formation, engines economic growth and supports newer development cycles for the …
Over the past 30 years the recruitment sector has gone through a major evolution. At the start of my career, I used filing cabinets, card boxes, fax machines, and I even hand delivered CVs! Without the internet, as a recruiter you were only as good as your relationships and your ability to identify and clearly define a job opportunity and seek out the right candidates.
Today networking on social media, job boards and smart phone use is commonplace. Technology provides the tools that offer easy and direct access to detailed information about large numbers of candidates and job opportunities, globally, from your desk or smart phone.
The sector has grown immensely due to increased economic activity and the rise in social recruiting. The sector now generates sales of £299bn globally but, even though associated salaries have increased fourfold, there has been no change in the actual fee income generated per recruiter in the last 30 years.
When I started out, a good month for a recruiter hit the £10K mark. As someone who has started, developed and successfully sold recruitment businesses, I know that this £10K figure is what good looks like today too. Despite the increase in tools and resources available to recruiters today, how is it possible that billings have remained on par with what I achieved 30 years ago?
Today the market is becoming increasingly competitive, jumping from 90 recruitment agencies in 1985 to around 20,000 today in the UK alone. Of these 20,000 recruitment businesses in the UK, around 70% will never get above 10 heads or generate more than £0.05m in gross profit. Behind the success of the agencies that do thrive is a solid foundation of talented recruiters. Agency leaders need to prioritise investment in their recruiters and make sure they have access to the necessary training in order to become great at what they do.
An air of confidence is critical to excel in any sales role, but you have to find the right balance between demonstrating confidence in your service without coming across as arrogant. The key to gaining this confidence is knowledge.
The consistent billers in my own recruitment firms all have one thing in common… they are really good listeners. Having a full picture of your client and candidate’s desires will enable you to meet their expectations more effectively.
Recruitment is a people business. As a recruiter your interactions with candidates and clients must always be tactful and professional across all platforms; email, face-to-face, and of course on social media too.
Recruiters in a buoyant market will typically be working on a high number of job briefs with several clients and juggling the process with lots of candidates too. Time management skills and the ability to juggle multiple projects will help you to keep on top of your tasks and get more done.
Recruitment is very competitive and target driven, therefore …
How do you develop a loyal customer base as a pharmacy? By gaining their trust, offering them superior service, and truly caring about their well-being. To do all of this, however, you’ll need to rely on your supplier. More than perhaps any other industry, the supplier you choose as a pharmacy can make a big impact on how successful you are as a business.
That’s why, when you’re starting out or looking to expand your operations, it’s essential that you sit down to consider which supplier works best for you. There is a range of factors you’ll need to look at, and it’s not always an easy decision to make. If you focus on seeking out the following seven core values, you’ll find a partner to help your business flourish.
Although it may seem obvious, checking for supplier accreditation is often overlooked in the haste to get the business up and running. Accreditation is a good indication of supply reliability, product authenticity,1 and regulatory compliance, so, if you’re looking to build a dependable long-term connection, making sure they’re accredited is a vital first step.2
Not all accreditation is equal, either, so it’s also important that you find out what your pharma supplier is accredited for and who they’re accredited by, and double-check with the relevant authorities to avoid any problems down the line. This is especially true if they’re supplying you with controlled substances such as Schedule II – V drugs. For that, you should confirm that they’re certified by the DEA.
When a potential customer comes to you, you need to have what they need on hand. To those in need of medical supplies, everything is urgent, and almost all people will simply go to another pharmacy instead of waiting days or weeks for an order to be delivered. Once they go to another pharmacy, of course, they probably won’t return.
Any supplier you choose needs to be able to provide you with a broad inventory, as well as multiple options for each product or drug so you can pass that choice on to your customer. While having multiple suppliers to widen your range is fine, the fewer suppliers you have, the better.3 It’s far easier to keep track of stock and avoid inventory gaps when you only have to deal with one or two suppliers.
In any business, and with any supply chain, there are always going to be occasional delivery hiccups. When we talk about reliable delivery, what we mean is that these disruptions are not only kept to a minimum but also that they are resolved quickly and honestly so it doesn’t affect your pharmacy.
That means a fast turnaround on orders, full delivery tracking, the use of a reliable delivery company, and open communication about order status, delivery problems, and any missing, damaged, or returned items.4 As well as that, if there is a problem, your pharmaceutical exporter should go the full …
Staffing agencies have proven their worth. With almost $90 billion in annual revenue, the staffing industry employs about 3 million workers daily. These companies play an important role in meeting the growing demand for skilled, qualified employees in the U.S.
Close the gaps on your team with insider information: Download your Hiring Guide.
A: You could, but there’s no guarantee you’ll save money, and you won’t likely save time. Some parts of your business are worth seeking outside expertise; a staffing firm that specializes in the type of position you are looking to fill is one of them.
A: The advantage of using a staffing agency is that you have the ability to adjust your workforce as needed. Most staffing service arrangements are simple – you can let them know you no longer need the temp employee’s services. But, many businesses find that some of their temp employees are valuable enough to hire on permanently.
Contact us for more information.…
Pharmaceuticals have been used to treat illnesses for thousands of years. The early days of medication included plants and herbal remedies to treat a variety of diseases and traumas. Today, the long and complex journey to demonstrate the safety and efficacy of a compound and bring it from the laboratory into the hands of patients in need, is a multi-billion-dollar global industry.
Pharmaceutical companies continually strive towards innovative new treatments that help people live longer and healthier lives. These therapies are developed, manufactured, marketed and distributed around the world by pharmaceutical companies every day. Here, we look at some of the key contributions of the industry, and the reasons why pharmaceutical companies are so important to patients, society and the life sciences industry:
The pharmaceutical industry has greatly contributed to the increase in life expectancy for men and women across the world. It has been reported that pharmaceutical advancements accounted for 73% of the total increase in life expectancy between 2000 and 2009, across 30 developing and high-income countries. In 1900, global life expectancy was just 32 years; thanks to advancements in medicines, this has more than doubled and today the average life expectancy stands at 72 years.
Japan and Hong Kong have the highest average life expectancy, with people living to 85 years old on average. Pharmaceutical innovation has not just benefited richer nations, developing countries have also been positively impacted and global inequality in life expectancy is starting to decrease.
Disease eradication is the ultimate goal when developing treatments, as this benefits ecosystems on a global level. To date, the World Health Organization (WHO) has declared smallpox as the first – and so far only – human disease to be eradicated globally.
There are 7 diseases that are almost eradicated, including: measles, rubella, polio, guinea worm and lymphatic filariasis (elephantiasis). Eradication is extremely hard to achieve as it requires a vaccination and a true global effort.
Although many pharmaceuticals do directly cure conditions, they can also be used to manage pain, symptoms or side-effects of other treatments, helping to relieve discomfort. A study by the WHO showed that individuals who live with persistent pain are four times more likely to suffer from depression, anxiety and twice as more likely to have difficulty working than those who do not suffer with pain. By providing treatments to manage pain, symptoms and side-effects, pharmaceutical companies can improve patients’ quality of life, allowing them the freedom to live healthier and more fulfilled lives.
By preventing disease, vaccines not only help to save millions of lives, they save money too. Vaccines are widely accepted as a cost-effective public health intervention, reducing healthcare spending and prevent productivity loss, curbing the wider impact on the economy. According to the WHO for every $1 the US spends on childhood vaccinations, over $10 in disease treatment costs is saved.
In the US, 50 years ago, the average hospital stay was 8 days. With innovation and greater access to medicine, patients have the potential to recover …