The pharmaceutical industry, a significant sector of our economy, works to develop, produce, and market a variety of pharmaceutical drugs for use as medications. The scope of these medications covers everything from itchiness to end-stage cancer drugs. The companies may deal in brand name or generic medical devices and medications. To keep the public safe, the federal and state governments subject the companies and products to various regulations and laws that govern the processes of patenting, testing, safety, efficacy, and marketing.
THE GLOBAL PHARMACEUTICAL INDUSTRY
Europe and the United States house the leading pharmaceutical corporations. On sales from prescriptions alone, Pfizer, based in NYC, is the world leader. Sales during 2016 reached almost $53 billion. Other leaders in the U.S. include Merck, Johnson & Johnson (one of the world’s most widely recognized labels), and AbbVie. The big five out of Europe are AstraZeneca and GlaxoSmithKline in the U.K., Roche, and Novartis in Switzerland, and Sanofi in France. As a global sector, the massive importance of the industry is undeniable. Total revenue worldwide in 2014 surpassed one trillion USD for the first time in history. The biggest portion of these revenues come from North America, due in most part to the U.S. holding a large leadership role.
The largest portion of revenue from the pharmaceutical industry comes from patented, branded medicines. In 2016, over $16 billion in global revenue was generated by the anti-inflammatory drug, Humira. Drugs for cancer, or oncologics, continue to lead revenue numbers among the therapeutic drug classes. Global revenue was just shy of $79 billion in 2015. Dependence on research and development is more important in the pharmaceutical industry than in any other sector. The majority of new substances introduced in pharmacology trace their roots back to the United States. It is vitally important for new drugs to be invented regularly to combat losses from patent protection. An excellent example of this is the most commonly prescribed drug in the United States, Lipitor. Used to combat high-cholesterol, it is the all-time best-selling prescription medication and earned Pfizer $81 billion by 2012. When their patent expired, rather than lose an estimated 80% of sales, Pfizer made an unprecedented move, working with prescription process companies and insurers to cut a deal that would make Lipitor available for the same price as the expected generic versions.
HUMBLE BEGINNINGS
Local apothecaries were the beginning of today’s modern pharmaceutical industry. During the early 1800s, botanical drugs were dispensed frequently, especially quinine and morphine for pain. In the later part of the century, the development of synthetic chemical methods started the growth in pharmacology science, allowing scientists and researchers to create new drugs and structurally change the composition of each discovery. By the mid-1800s, apothecaries began to step away from their traditional role as dispensaries and focus on manufacturing drugs for wholesale. Pharmaceutical industry giants such as Eli Lilly, Merck, Upjohn (currently part of the Pfizer Group), Abbott Laboratories, Burroughs-Wellcome (currently under the umbrella of GlaxoSmithKline), and Hoffman-La Roche got their start as local apothecaries.
PHARMACEUTICAL PRODUCT LABELING
One of the most crucial aspects of dispensing any pharmaceutical product is ensuring it is labeled correctly. The U.S. Food and Drug Administration (FDA), compiled a sequence of regulatory steps in the 1970s and set them in place to ensure all labeling on prescription drugs is concise and clear. Every label needs to be in compliance with federal and state regulations. All necessary information must be clearly and correctly conveyed regarding proper product storage, a method of administration, and dosage instructions. Label quality is of high importance because it relates to how the patient perceives the product’s value. If they believe the product is inferior due to shoddy labeling, there could be dangerous implications on the patient’s prescribed regimen compliance and their proper use of the medication. Regulations currently in place by the FDA require labels to incorporate extensive product, safety, and quality information. It would be difficult to imagine what the pharmaceutical industry would be like without these regulations. Medicines and other drugs produced by manufacturers would be of no use to anyone if they were labeled incorrectly.
LABEL INFORMATION REQUIRED BY LAW
Many pharmacies work with their label supplier to pre-print their phone number, address, and name on their prescription labels to save time. The following eight pieces of information must also appear on the label as per regulations:
- The full, legal name of the patient.
- The name of the medical professional prescribing the medication.
- The initial date of dispensing.
- The serial number of the prescription.
- Complete usage directions and any applicable warnings.
- The beyond-use date (or expiration date).
- The name of the dispensing pharmacist.
- The name and strength of the drug (in compound prescriptions the active ingredients must be listed).
An auxiliary label containing the statement, “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed” is also needed for controlled substances under schedules II, III, and IV. Recommended label information included the allowable number of refills and either the volume of the product or total dosing units dispensed.
PROPER FORMATTING FOR LABELING OF PHARMACEUTICALS
In general, most labels on prescription drugs follow the same format so that it is easy for the patient to recognize quickly where the important information is. An example is shown below: Bayside, Queens, NYC 11361 891-0046 Rx # 987654 - Dr. No Name Jerry Cann - 4/4/04 Take two tablets every three to four hours as needed for pain. Acetaminophen 500 mg, Codeine sulfate 20 mg/tablet (#60) 0 refills; Discard after 4/30/04 Dispensed by C. Yulater R.Ph.
GENERAL LABELING GUIDELINES TO FOLLOW
To ensure labels are concise and understandable by all patients, there are some guidelines used when printing actual prescription labels.
- Do not use abbreviations For example. "Take one tablet three times a day," instead of "Take one tab three times."
- Always use words in place of numbers. For example, “Take two capsules every day,” not “Take 2 capsules every day.”
- When articulating quantities, it is essential the patient is familiar with the prescribed unit, and they are likely to have a device at home appropriate for measuring it properly. For example, “Take one tablespoon every six to eight hours,” not “Take 15 ml every six to eight hours.” In certain circumstances, an exact volume may be critical for the safety of the patient, such as 1.5 ml. When this happens, the pharmacist is responsible for providing the patient with a measuring device properly calibrated for the volume unit.
- When the prescription is not intended to be used orally, the administration route needs to be specified. For example, “Apply cream liberally to affected area.”
- When it comes to the dispensing of bulk medications, like creams, suspensions, solutions, ointments, or emulsions, a percentage is used to express the strength of the active ingredients. For example, Hydrocortisone cream 2.5% is commonly seen on prescription labels.
LABELING GONE WRONG
Even when labels are correctly done, problems arise often. When it comes to following the instructions printed on medication labels, only 33% of people do it correctly according to studies. There are 66% of Americans who never bother to take any of the medications they are prescribed, and of these, almost 50% do not fully understand the directions.
Not only are these numbers astounding, but they can have fatal consequences. Many people subscribe to the theory that “two is better than one” and take twice the number of prescribed drugs. While this may only result in some nausea if you are lucky, when it comes to controlled drugs, there is a real danger that you may die. Over 1.3 million Americans suffer some type of injury from a prescription error every year. When patients pick up a prescription from their pharmacy, they are trusting that the information they are receiving is accurate and will keep them safe from harm. They need to believe the drug they are being given is going to make them feel better. The pharmacist is the only link between the person who prescribed the medication and you. As such, they are your only line of defense. It is no secret the healthcare system in America is overworked and understaffed. Doctors are human, and they do make the occasional mistake, especially when they are nearing the end of a 48-hour ER rotation. A good pharmacist notices when something doesn’t seem right in dosing or strength and contacts the doctor to confirm it. However, with the constant pressure to fill pharmaceutical prescriptions as quickly as possible, errors do occur. Pharmacy staff rushing to get medications done are eventually going to miss something. Whether it is stocking a drug that has expired or incorrectly labeling a bottle, the results could be catastrophic, including poisoning, overdose, toxicity, or death.
REPERCUSSIONS
Even with the best prevention, some errors you can never see coming. Consider a doctor who prescribes an antibiotic for a child who has never had them before. If they have an allergic reaction, either uncomplicated or severe, there was no way to predict this outcome. Medical malpractice suits are the dread of every physician, but not every mistake is automatically a malpractice case. If the doctor were to prescribe an incorrect medication or dosage and the patient suffered no ill effects, there is no legal case for malpractice. They would very likely lose the patient though, and since there is a good chance the patient will caution others from going to this doctor, their reputation and organization could be negatively impacted.
Pharmacies fill billions of prescriptions annually. The most common mistakes made in the pharmacy include failing to identify drug allergies or interactions, giving prescriptions to the wrong patient, confusing drugs that look or sound similar and getting the label right but the contents wrong. Pharmaceutical products save lives but only when they are prescribed, dispensed, and used correctly. One trend making this easier is the increase in the use of electronic prescriptions. This eliminates the problem of the illegible scrawl doctors are so famous for with handwritten prescription. The evolution in barcode technology is also working to reduce the number of mistakes in dispensing, along with advances in software to flag allergy issues or possible drug interactions. The FDA is also taking steps to reduce mistakes originating from drugs that look or sound the same. Packaging and new drug names from manufacturers are being analyzed and rejected if the potential exists for confusion with drugs currently on the market.
WHAT YOU CAN DO
Every time you go and pick up a prescription, don’t just pay for it and leave. Take the time to open the bag at the counter and look at it. Ask any questions you may have and confirm that what you have is what is supposed to be there. Just because your name is on the outside of the bag’s label, the containers inside the bag may be labeled with someone else’s name. Most people are too busy to take the time and accept the pharmacist’s offer of counseling before they leave the store. This can end up being a critical mistake. Not only does the pharmacist inform you of the crucial information relating to the drugs, but it also presents a second opportunity to catch any mistakes. Don’t be shy to ask exactly what the drug is for and how it works. Find out how long you need to take it and the exact way it needs to be taken. Also, ask about any potential side effects and interactions with other medications you may already be on. It is always a good idea to carry an updated listed of your current prescriptions and dosages so you can easily discuss any issues with a pharmacist or physician. If you catch an error in your pharmaceutical prescription, it is essential you make the pharmacy aware of their mistake. By doing this, you will give them the opportunity to document the mistake, determine the mistake’s source, take steps to correct the error, and prevent the same thing from happening to someone else in the future.
FINAL THOUGHTS
The importance of pharmaceutical products of all types being properly labeled can never be overstated enough. Almost everything has potential side effects, even innocuous over-the-counter (OTC) drugs like Tylenol or Benadryl. Too many people never take the time to read OTC labels for their safety information. Did you check the bottle the last time you bought Aspirin? There are laws in place to make sure you receive all the information you need to make an informed decision – it is up to you to read it. With the potential hazards that exist, taking the extra few minutes to be certain you understand your medication and how to take it is critical. Carefully read everything, confirm that you understand it properly, and always ask questions. It could honestly save your life!
