Argument by Vaccine Package Inserts . It’s ironic that these antivaccine groupies rail against Big Pharma, as if they are demon reptilians, but the package insert, written by Big Pharma, is considered gospel. Irony abounds. Just spend more than a couple of minutes in discussion in any vaccine “debate,” and you’ll eventually get someone pointing to. Or that it doesn’t work. Orac has recently proclaimed it “Argument by Package Insert”. It is not a document that serves as medical and scientific gospel.
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But it is a document that can help clinicians use vaccines (or frankly, any medication) properly. What is a Package Insert? All of you have probably seen a package insert. Depending on the type of drug, the PI can be 3. Although some people believe it’s written in small fonts on thin paper to make it difficult to read and use, it’s actually done so to save on shipping costs. Yes, if you had to fold up a large font- size package insert and place it in each box that contains a vial or bottle of medication, the shipping weight and volume would make the cost astronomical. And that cost would pass down to consumers.
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In general, package inserts are part of what is called the “labeling” of the drug, which means all the verbiage that pharmaceutical company may say about the drug. It is not just the printing on the vial or box, labelling. Labeling is strictly regulated, because it establishes the claims made about the drug or device, how it is to be used, and other pertinent information. Even what sales reps say to physicians in a sales call is covered by the drug’s labeling. In the USA, the Food and Drug Administration has established. There is very little variance in format or quality of information from one PI to another one even for very different classes of drugs.
Amusingly, the regulations even state the type and size of font used in the PI. Writing. During the Phase I, II and II. Note that there is a lot of consistency between all worldwide pharmaceutical. You are not going to find better information in a European PI, though you’ll get to see the Latvian translation of the PI if that thrills you. In today’s world, part of the purpose of a PI is to protect the pharmaceutical company from legal issues.
If the PI says “do not prescribe this drug to someone who abuses alcohol”, and a physician prescribes it to that type of patient, then the company has some protection from a legal action from the patient or physician. The PI is supposed to give a physician or other prescribing healthcare worker the framework to use the medication properly on a patient. After the Medical and/or Regulatory departments complete the initial draft of the PI, it is usually passed through different departments of the company for further review, correction and approval.
For example, the manufacturing department may not agree with a statement about how the drug or device is manufactured, and it is corrected. Spelling errors are commonly found.
Depending on the company up to 1. PI, and it could take a few weeks before this process is completed to everyone’s satisfaction. And the approval is not a passive one. If a reviewer just signs it without actual review, a future FDA audit or legal issue could place the blame on all reviewers whether they took the time to read it or not. The draft PI is then included with the New Drug Application (NDA). Many times a pharmaceutical company will attempt to add indications.
Pharmaceutical companies may add more information, warnings, indications (or contraindications, meaning uses that may harm the patient if used in particular situations), and other information that can be supported by evidence from scientific investigations. Of course, the pharmaceutical company must resubmit its labeling (including the PI itself) to the FDA for approval of the changes.
Contrary to popular belief (including from an amazing number of physicians), a pharmaceutical company cannot change an indication unless it has a new approval from the FDA. Even making a change that allows a medication to be used on children (a pediatric indication) can take years of clinical trials and regulatory review before a change can be made.
The FDA spends a lot of time reviewing pharmaceutical labeling, because it has the most direct impact on patients’ health. The package insert is necessarily complex and wordy, because it needs to cover a lot of information. To save weight in shipping, and to make it small enough to attach to every individual unit of a product (like a vial, bottle or box), the PI is often printed in tiny fonts on very thin paper. A lot of time is taken by pharmaceutical companies to lay out the document to fit properly. The following list is long, because PI formats are necessarily complex. By regulatory code (in the USA, as required by the FDA), every pharmaceutical package insert (there are different regulations for devices and equipment). For example, a drug that might kill someone if used incorrectly in specific situations.
Physicians and other prescribers need to know this one thing before all else prior to prescribing a medication. Sometimes a medication is perfectly safe, but may cause serious allergic reactions in some people. As far as I was able to determine, there are no Boxed Warnings on any vaccine ever. Because there is simply no evidence that there is any dangerous and deadly reaction to vaccines. Date of US approval.
Description. This section may also contain results of various. However, the pharmaceutical company’s labeling may not discuss this off- label use, even if there is compelling scientific evidence supporting this use, until the FDA approves it. Recently, there have been major fines levied by the US Department of Justice against pharmaceutical companies that push off- label use through subtle advertising or sales rep conversations. Contraindications.
It lists situations in which medication should not be used, for example in patients with certain medical conditions, in children, or other situations. For a physician, this section is as important as the Boxed Warning section.
Warnings and precautions. If the warnings are particularly serious (risk of death, for example), they may be placed in the Boxed Warning section. This section also explains how to use the medication safely, for example stating that “Do not drink alcohol while taking this medication” or other common precautions. It also describes any laboratory tests that may be necessary prior to using the drug. This section is much more important with powerful therapeutic drugs that often have critical side effects. Nonclinical toxicology. This section has little applicability to vaccines, since they have no carcinogenic, mutagenic, or fertility effect, given that the level of the vaccine’s ingredients’ dosage fall far below the lower threshold of the any dose- response test of these issues.
The PI may state some innocuous verbiage such as “no known information” meaning that in the 1. Use in specific populations. Almost all of these side effects are coincidental observations and are rarely of much concern. This section is the favorite of the vaccine denier, because. These are simply observations, not. Not relevant to vaccines. Drug abuse and dependence.
Not very crucial to vaccines. Dosage and administration. Very important for vaccines. Dosage forms and strengths.
This is important information, especially for vaccines, that’s sometimes ignored. Lots of medications, vaccines included, lose potency if they are overheated or frozen. Patient counseling information.
It does not include anything more current, and some PI’s can be over 1. Most published clinical trials were not done for FDA approval, so aren’t included in any PI’s. I used to consider this a defect of the PI, but with easy access to post- marketing clinical trials through Pub. Med and other sources, it’s not too relevant.
References. Again, it is only as current as the date of the package insert (which is listed at the bottom), so it can be way out of date. Note: Europe, Japan, and other countries use slight variations on the FDA requirements, but, in general, they’re pretty much the same. So, that’s a lot of information, but is any of it useful? How does one interpret the information in the PI?
Especially for vaccines, which are not truly a therapeutic drug (it doesn’t cure a disease state, but prevents it), and which has ingredients in levels that are below the level of detection in a dose response study. Learning from vaccine package inserts. The information in a package insert can be used in a manner to help treat a patient.
Vaccine deniers idolize vaccine PI’s as some biblical statement about the dangers of vaccines. Once again, it’s easy to cherry pick information out of a PI if one does not or refuses to.
Knowing this information helps the scientific minded (not a skill set well known in the antivaccine cult) how the drugs work. By understanding this section, you. For example, knowing how immunizations work, you will realize that intramuscular injections are a perfectly scientific method of inducing an immune response, that there is no logical reason to believe an injection would cause a neurological disorder, and other silly myths. But pharmacology is very hard to understand, so most people ignore it. There are very few contraindications in vaccines. But the ones that do exist are quite serious.
Or yeast sensitivity for Gardasil. Physicians are very aware of these issues, as are most places, like pharmacies, that do vaccinations. Warnings. These are adverse events that have evidence supporting their causal association with the drug or vaccine. As opposed to the adverse reactions section, which tends to be abused by vaccine deniers, this section is where solid, repeatable scientific data is located.
The FDA, by regulation, can mandate a change in the PI to include new warnings as evidence arises. Not a single PI for vaccines mentions autism as a “warning.” Not one.