Tag Archives: pre-packaged medicines

Repackaging Rules | Proficient Rx

Repackaging Rules Are Rules For A Good Reason

If you received medication covered in dust, you would be concerned. If you received your medication and were told they were handled by a staff member who has the flu, you would be outraged. If you received the wrong medication, or the wrong dose of medication, you would not stand for it. All these scenarios are risky for you and for your patients. This is why repackaging rules are set into place, to protect you both.

Repackaging of medication comes with even stricter rules for sanitation purposes and for overall safety than normal medicine. The laws can make you feel comfortable and secure that your patients will not be harmed when you prescribe the medications they need to meet their health goals.

Keep reading to learn about some of the repackaging rules that are in place for everyone’s protection. First, let’s understand what it means to repackage a product.

What is Repackaging?

Medication you order is created by a manufacturer. This manufacturer places the newly created medicine in an original package. This packaging will not be the final packaging. Instead, the medicines are shipped to a repackaging company.

The repackaging company removes the medicine from its original packaging and puts into a safer, more convenient form of storage. For instance, your medicine may arrive at the repackaging company in a single container. They may then be removed from the single container and placed in individual blister packs, separating them into single doses. This is considered repackaging for convenience.

The Federal Drug Administration enforces strict repackaging rules when it comes to repackaging any product. Furthermore, the facility must be licensed and certified as an approved site for repackaging. The FDA sets forth such strict guidelines to maintain safety for consumers and to protect you from any malpractice.

Below are a few of the repackaging rules a repackaging facility must follow to pass FDA inspection.

Container Safety Rules

With both unit-dosing and multiple-dosing packaging, repackaging rules and regulations must be met and approved before they can be distributed to you or your patients.

The containers used must be damage free, even from minor damages that consumers may not even notice.  Containers must maintain protection from light that can reduce the effectiveness of medicine. It must also protect from temperature damage when stored correctly.

Containers must also keep the medicine dry, must stay sealed, yet also be easy to open by the patient while at the same time hard to open for children. After all these are in place, the containers must still pass inspection with extensive documentation available to support its safety.

Labeling Rules

Labeling and relabeling medicines follow good manufacturing processes set forth by the FDA and The World Health Organization.

The new container must contain specific labeling information. The label must state accurate drug names, dosage, instructions, and who to contact in case of emergency. The manufacturer information should also be included.

The physician will place additional information to include your practice contact information, date of dispensing and any other warnings for the client.

Keeping good records is required. Repackaging companies must keep quality records for at least one year after the date of being repackaged.

Repackaging rules state records must include the date of repackaging, prescription name, physician who will be dispensing the medicine, and drug name. The strength of the drug must be listed, as well as the quantity.  These steps must be verified and signed by an authority figure in the repackaging company.

Regulations are now including the serialization of medicines to make them easily traceable, especially when repackaging controlled substances.

Quality Control Safety Processes

Quality control involves all the actions a company takes to make sure medicines are pure, safe and compliant with all laws and regulations.

Quality control can prevent counterfeiting of drugs. With online sales of counterfeit medicines rising, this is an important safety measure. Prevention of counterfeit drugs can literally save your patients’ lives.

When your patients are safe, your practice is more secure. You do not have to fear liability issues. Good repackaging companies will be excited to tell you all the safety tests they have passed. They will want you to know they strive for perfection in every area, from sorting to labeling to shipping.

Additional Repackaging Rules

There are repackaging rules and regulations to cover every step of the process. Other than those listed above, repackagers must also meet strict environmental control clean room regulations. These ensure medications are safe from cross-contamination, dust, dirt and any other particles that could affect the drug.

Clean rooms help provide this healthy environment during the manufacturing of pharmaceuticals. Clean rooms focus on the air in the facility where drugs are manufactured. If the air is clean, everything else in the facility will be cleaner.

A clean room is defined as the space used to contain an area that needs to be free of particles that could potentially contaminate a product. They are also used to control temperature and pressure.

Production equipment must meet exacting standards that can meet both long-run and short-run production needs. The equipment must be at a regulated speed and fully-automated. It must be state-of-the-art and use custom software.

The software used in repackaging must constantly be modernized to create the most efficient processes.

All parts of the production process must be set up to offer the fastest times with computerized controls that are developed to count tablets, sort, package, seal and label.

Everything is not about computers, software and equipment. The staff that are present, must abide by strict regulations too.

Personnel must undergo training, environmental safety and what to do in case of accidents or contamination issues. Personnel are required to wear specific protection clothing while in the lab. They have guidelines to follow when dressing and undressing.

They must know how to keep the room clean with the implementation of steps established to avoid contamination, from changing air filters to monitoring air flow.

Knowing the many repackaging rules and regulations can offer you confidence in your decision to dispense medicines at the point of care. You can know that your patients are receiving the safest product available to help them obtain better health.

 

 

 

 

Medication Re-packer | Proficient Rx

Benefits of Working with a Trusted Medication Re-packer

There are over 100 steps involved in the production of repackaged medicines. DEA and FDA guidelines are strictly followed when creating medicines to be used by physicians who are dispensing at point of care, and especially checking on the process used by the medication re-packer as well.

Therefore, you should avoid randomly picking a repackaging company. Instead, do your homework to find the best. When you work with the best re-packager, you will reap the numerous benefits they have to offer.

A medication re-packer will give your medications a bar code, customize a label for you, allow you to choose packaging and do all of this for minimal costs. Using a medication re-packer has shown to decrease waste of medication by patients. It has also shown to streamline how your office functions due to the superior software technology you receive.

A medication re-packer can make it easy for you to keep track of inventory and needed refills. And all of these can help you better track patient outcomes. It gives you more time to focus on the important aspects of your practice like spending more time with patients and helping them reach health goals.

Below are some other benefits discussed in more detail.

Product Preparation

Temperature can change the structure and effectiveness of a medicine quickly. Repackaging facilities take extra measures to make sure medicines are kept at temperatures conducive to keeping the potency and form intact.

Medicines are susceptible to degradation. To prevent this and any loss of potency, repackaging companies do whatever they can to make sure packaging provides adequate barriers to the drugs but are also easy to use by the patient.

Companies use the best materials to protect drugs while also keeping the cost reduced. They ensure both primary and secondary packaging meets the standards set forth by governmental agencies.

Correct labeling is important in all medication production, especially when done by a medication re-packer. The label, even though small, contains a large amount of information. Repackaging facilities know just how vital this information can be.

Product Safety

Repackaged medicines are stored and packaged in a clean, safe environment. The rooms are temperature controlled and have added security to protect the medicines. Monitoring is controlled with the use of state of the art computerized technology.

Repackaging facilities are held to higher standards than pharmacies. How often do you see pharmacists cleaning their counter tops when filling prescriptions? Germs transferred from a pharmacist’s counter to a medicine can cause adverse reactions. Plus, it is just unhealthy.

There are specific standards a medication re-packer company must follow when it comes to preparing bottles, multi-unit or individual unit packages. The containers must be better than the original container from the manufacturer.

The new containers must take into consideration moisture, light, vapors, sealants and compatibility with the drug itself.

Repackaging of controlled substances makes them safer for you, the physician, and for the patient. Controlled substances, and all other repackaged medicines, are coded and labeled. Meaning, they are traceable all the way back to the manufacturer.

This provides all people involved with a security that if a medication is stolen or misused, it can be tracked to verify where the medicine originated and for whom or what it was intended.

Product Environment

For prepacking medication, temperature, humidity and air pressure are all crucial factors and must be heavily monitored. Using a clean room is essential. If you find the prepacking company you work with is not using a clean room, it is time to switch to one who does.

Your patients can be affected by any time of facility contamination, even it is with the smallest particles. Therefore, prepacking companies take extra steps to follow classification guidelines. Clean rooms help companies remain compliant with Good Manufacturing Practices.

Choosing a repacking facility that has their clean room tested and approved through a certification process means they will have the airflow in their facility tested for visualization, volume and velocity to make sure they meet standards for repacking medications.

This means you can stress less about the quality of your medications.

Compliant with Laws

The Federal Drug Administration (FDA) sets forth Current Good Manufacturing Practices (cGMPs) that all laboratories must follow to ensure safety when dealing with pharmaceuticals. These are the minimum requirements to pass inspection.

If repackaging companies fail to adhere to the regulations, they are warned, inspected and eventually shut down and prevented from operating. Repackaging companies are expected to provide documentation and visual proof that all regulations are being met.

The World Health Organization sets forth dispensing guidelines that must be followed by the physician and practice staff. Repackaging companies make it easy for doctors to comply with these guidelines, which cover the entire process from writing the prescription to handing medicine to the patient.

Quality Control

There are multiple quality control processes involved to ensure safety for patients. Keep reading to find out more about how safety is increased by quality control of repackaged medications.

Repackaged medications undergo quality control processes that prevent counterfeiting.

Drugs are registered, making it many times harder for counterfeit criminals to manufacture and deal the product.

The containers used at the repackaging company must prove to be better than the original container from the manufacturer.

The new containers must abide by moisture, light, vapors, and sealant regulations.Repackaging companies are experts in containers and the standards set forth for protecting medicine.

Repackaging of narcotics and other controlled substances has very strict quality control processes. Controlled substances are coded and labeled. Meaning, they are traceable all the way back to the manufacturer.

Repackaging facilities must follow strict guidelines when it comes to keeping their environment clean. Pharmacies are not held to the standards repackaging facilities are required to follow. From room temperature to how often and with what counters are cleaned.

Because of the many quality control processes of repackaging facilities, you can feel confident prescribing repackaged medication to your patients because they go above and beyond ordinary standards.

Working with a trusted medication re-packer is essential when dispensing medications at the point of care. A good medication re-packer allows you to be an even better physician.

 

Brand Name vs. Generic Drugs | Proficient Rx

Is There a Real Difference Between Brand Name and Generic Drugs?

A drug is any therapeutic agent, other than food, used to treat a physiological condition. Prescribing drugs to patients is quite common and no matter what the issue, there seems to be a medicine available for treatment in either the form of brand name or generic drugs.

A drug has three names including its chemical name, brand name and generic name. There are five steps a drug must go through to be approved for sale and consumption.

It must be submitted to the Federal Drug Administration (FDA) as a new chemical entity. Then it must apply for a patent. Following this a generic and brand name version are created. The FDA then reviews it and approves or rejects the new drug.

When writing a prescription, you choose either brand name or generic versions of a drug.

Currently, generic drugs account for close to 90 percent of prescribed drugs. This saves your patients and insurance companies billions of dollars.

Many of your patients have questions about the differences between generic medicines and brand name medicines. Because patients are not aware of the pharmaceutical values within both generic and name brand medicines, it is your job to provide them an answer to their question.

Knowing the differences, between generic drugs and brand name drugs will help you explain them to your patients. Below are similarities and differences between the two.

Active Ingredients

The Federal Drug Administration requires both generic drugs and brand name medicines have the exact same active ingredients.  Active ingredients are biologically active. They are also known as bulk actives, active substances or active pharmaceutical ingredients.

Inactive Ingredients

The FDA does not require brand name and generic drugs to have the same inactive ingredients. These do not change the affect of the medicine or the active ingredients. They may be known as filler agents.

Inactive ingredients are important even though they do not produce any therapeutic effects. They are considered fillers, binders or coating. They can also be flavoring, coloring or stabilizers.

Strength

Strength is the amount of the active ingredient in each dose of the medicine. Federal law requires both generic and brand name medicines to be comparable in strength. Meaning, per dose, they have the same amount of active ingredients.

For instance, if each Tylenol pill has 500mg, all generic versions of Tylenol must have 500mg of strength.

Effect

The effect of a drug refers to the change created when the medicine is taken. The effect produces a result in the patient.

The FDA requires that generic drugs produce the exact same effects as the brand name drug. Meaning, it must be comparable in results the patient will see when taking the medicine. Side effects may also be comparable.

Testing

Both generic drugs and brand name medicines must undergo and pass the same testing methods.

Clinical trials are performed in which the FDA oversees every step. The clinical trials involve humans taking a medication to see if it is safe and effective. There are usually three phases of testing.

If the medicine proves to have more benefits than side effects or negative reactions, it is approved for sale and consumption.

How You Take It

Generic drugs and brand medicines must be available in the same forms for consumption as brand name drugs. Meaning, if a brand name medicine is created in liquid form, so must the generic brand. If pill form is how a brand name drug is created, the generic version must also be in pill form.

Typical ways of taking a medicine include orally, inhalation, liquid, tinctures and by injection.

Packaging

Prepackaged medications provide the safest form of distribution. Many doctors and pharmacies are choosing prepackaged medications due to the precise labeling and ease of use. Those who are not using prepackaged medications may notice differences between generic and name brand packaging.

The labeling, however, must be the same. This includes warning labels. However, only brand name medicines are required to update their warning labels each time a new risk or side effect is discovered.

Expiration Dates

Expiration dates can be misleading. An expiration date does not mean the drug is no longer any good after that date. It simply means that is the date a manufacturer can guarantee the full benefits of the medicine.

Even though a medicine has an expiration date, it can sometimes still be effective for months, even years, after that date.

According to the FDA, generic and name brand drugs can have different expiration dates. However, both drugs are required to be effective up until that expiration date.

This means a brand name can expire in one year and a generic version of the same medicine can expire in six months. But both must provide quality effectiveness until these dates arrive.

Price of Generic Drugs Vs. Brand Name

Brand name medicines are required to go through multiple and repeat studies on both animals and humans. This gets very expensive for the manufacturing companies. Therefore, the cost of a brand name medicine is much higher than that of a generic brand.

On top of this, the brand name manufacturers spend millions of dollars in production.

Generic drugs are not required to be involved in repeat studies or testing. This allows them to keep costs low.

Price differences between generic and brand name drugs can be massive. Brand names can range from 25 to 75 percent higher than generic brands. Therefore, insurance companies often require patients to use generic versions of a drug.

Take the time to explain these differences to your patients. When patients do not understand something about their healthcare, rather than ask questions, they may decide to just stop taking the medicine.

Especially when it comes to paying higher prices for medicine, patient choose to forego their medicine. If there is no generic version, explain to your patient the necessity of the medicine for their health.

Prepackaged medication allows for ordering only the number of pills your patient needs and no more. This may help your patient continue their medicine even if the cost is higher. Do what you can to help them improve their health. Sometimes a little bit of knowledge can go a long way in helping you reach that goal.

 

Prepackaged Medication | Proficient Rx

How to Streamline Office Practices with Prepackaged Medication

A recent study of 35,000 patients nationwide found that the number one complaint among patients is customer service received in the physician’s office. Even more staggering, nineteen of every twenty patients surveyed reported disorganized operations and poor communications made them post harsh reviews.

Patients are happy with the clinical treatment they receive. What makes them unhappy is how the practice is being run. What should be the easiest functions are turning out to be where patients are showing dissatisfaction.

The good news? This problem is very fixable. Streamlining office practices can be done quickly, ensuring the office operates more effectively. Below are a few of the ways your office can use prepackaged medication to streamline practices.

What is Prepackaged Medication?

Many physicians are wisely choosing to dispense medications at the point of care. They do this by using prepackaged medications. Prepackaged medications are ordered from an office dispensing company, who after receiving medicines from the manufacturer, use extreme safety measure to properly package medications.

With prepackaged medications, you only order and pay for medicines you need, no extras. The medicines are separated and labeled for easy use.

StreamlineComputer Capabilities

The software program that accompanies prepackaged medication sets your office staff up for streamlining success. It makes the entire process of prescribing, filling, and even billing simple and accurate.

The software program is installed by the company’s technician, who is also available around the clock for technical support.

With this software, you simple enter the data on a patient, print a label to adhere to the prepackaged medicine, and deliver to your patient. And with a push of a button, you can send a claim directly to the insurance company. It really is that simple.

Streamline the Prescription Process

In just a few minutes, patients can receive their filled prescriptions and begin treatment immediately. This is not the case when they are required to go to the pharmacy. At the pharmacy patients usually wait an hour or longer to receive their order.

Prepackaged medications can be streamlined for quick delivery because there is no compounding, mixing, or sorting that needs to be completed. The medicines are ready before the patients even need them.

You and your staff simply enter the prescription information into the computer. Next you print the label, retrieve the prepackaged medicine from the locked cabinet, adhere the label and deliver package to your patient.

Just a few steps to complete the entire process, improving operations to be organized and simple.

Streamline Claims Submissions

In-office dispensing of prepackaged medications makes it easy to streamline communication with insurance companies. The software technology that accompanies prepackaged medication is set up to include direct contact with the claims departments of all insurance companies.

There are no more copying insurance cards and faxing to insurance companies. All information is entered into the computer data bank. With a simple click of a button, your office billing staff can send claims directly to the claims department.

Furthermore, payments can be made from the insurance company directly to your account. This means you no longer must wait on checks in the mail. You can receive direct payments in a timely manner.

Streamline the Refill Process

Ordinarily, when a patient needs a prescription refill, they are instructed to call into the physician’s office, speak into a recording stating their name, date of birth, the prescriptions needing refilled and contact information.

When the nurse or other office staff has time to review the recordings, they do so and then consult the doctor to renew the prescription. They then contact the patient to pick up their refill prescription. Or, they send the renewal directly to the pharmacy.

The nurse then contacts the patient to tell them their refill has been renewed.

With prepackaged medication, once the data has been entered in the software, you will be alerted to any refills that need to be renewed. Notifications will automatically be sent to your office staff via the computer system.

This system is also in place for renewing medicines you keep in stock. The software will notify you when your supply of prepackaged medications is running low. It can also send a re-order request to the dispensing company.

Before you know it, your replacement supply arrives, and you can restock.

Prepackaged medications systems offer many benefits to physicians who dispense medications at the point of care. Each benefit helps you stay organized for efficiency and accuracy when caring for your patients.

Pre-Packaged Medicines | Proficient Rx

5 Reasons Pre-Packaged Medicines are Safest

Pre-Packaged Medicines contribute greatly to the healthcare industry. It contributes how much money is saved and wasted. It contributes to patients adhering to their plans and can prevent accidental overdoses.

Packaging of medicine also can aid in errors made by doctors and pharmacists.

Below are five ways the use of pre-packaged medicine can provide safer use among patients.

1. Patients Take Medicine as Prescribed

Reports state that patients do not take their medicine as prescribed. One of the main reasons they do not do this is because they forget if they have taken their dose for the day. Even if they use pill organizers, it can be confusing.

The cost in America of not taking medicines as prescribed is close to $300 billion.

It has been reported that at least ten percent of the American population is on five or more medications. This can be very overwhelming for those trying to stick to a regimen that works. Patients often forget which medicines are best taken in the morning and which at night.

They forget which medicines may interact if taken together and which are best when combined.

Pre-packaged medicines eliminate this confusion. Your patients will be able to tell if they have taken the correct dose, providing safety and reducing the fear of overdose.

2. Prevents Accidental Overdose

When patients do not have an effective system of tracking the medication they have taken throughout the day, they may accidentally take too much of their medicine.

Accidental overdoses occur mainly with those who are taking prescription pain medicines. In fact, just in the United States, around 60,000 people accidentally overdosed on prescription medications such as opioids in 2016.

Patients on pain medications may not be thinking clearly due to the effects of the medication. This can lead them to abuse their medicines, which can ultimately lead to accidents.

With pre-packaged medications, patients don’t have to think about their dose or count how many pills are left in their bottle. This will allow for improved outcomes.

3. Improves Patient Outcomes

When patients accidentally misuse their medications, or forget to take them altogether, they have poor outcomes. Meaning, their health suffers and conditions worsen.

With  pre-packaged medications, patients do not have to wonder if they have taken their medicines or not. The packaging tells them. This system keeps a person on track with their medicine schedule, allowing them to experience the full benefits of the medicines prescribed to them.

Calendarized blister packaging is becoming very popular. It has shown great improvements in patient outcomes. With specific dates on the packaging, patients know exactly when to take their medicine. Instructions are also provided as to when to call for refills.

As reported by the National Center for Biotechnology Information, a study showed pre-packaged medicines with reminders had a positive effect on both patient adherence and outcomes.

Another study found that patients with diabetes benefited from pre-packaged medicines in keeping their blood pressure down and their glycemic levels in a healthy range.

Pre-packaged medicines can also eliminate errors with dispensing medicines that sound alike and look alike.

4. Reduces Pharmacist and Doctor Errors

You are human. You make mistakes. Dispensing medicines is one area where you want to make as few mistakes as possible. Pre-packaged medicines can help with this, especially when it is the doctor dispensing the medication directly.

If you work in a hospital, you know just how complex the medication systems can be. The more people involved with a prescription, the more room for error. There are many reasons for these errors, from lack of training to environmental stress.

Pre-packaged medicines can reduce all of the reasons, especially with simply getting them mixed up.

There are many medications that sound alike and look alike. When you are busy and in a rush, the two can be mixed up. Your patients trust you to know that you are giving them the right medication. They trust you so much that they will take their medication without hesitation, even if it appears different.

This is why you have to take every precaution necessary to ensure your patient’s safety.

A very recent example took place in England, where a pharmacist prescribed propranolol instead of prednisone to a patient. That patient died. In his trial, the pharmacist admitted the medicines were next to each other on the shelf and their packaging was similar.

Devastating events like this can be reduced and even eliminated with pre-packaged medication.

5. Pre-Packaged Medicines are Becoming Smarter

The packaging of medicine is constantly being reviewed and tested and upgraded. Pre-packaged medicines are currently child-resistant and elderly friendly. However, they are constantly being improved for patient safety.

Current designs are being tested to add a smart element to the packaging. One that can connect with technology such as a smart phone to enable reminders for patients to take their medications on time. Smart apps and programs are showing much progress in this field.

The materials used for packaging are child-resistant but are not hard for the elderly to open. They are sensitive to helping medicines remain the right temperatures also.

Patients often store their medicines at the wrong temperatures, causing them to lose effectiveness. Pre-packaging materials are able to protect the longevity of the medicines so the effectiveness remains strong.

All these Reasons benefit the patient the most, not the pharmaceutical companies.

Currently, the way medicines are packaged benefits the pharmaceutical companies the most, not the patient.

Pharmaceutical companies have been known to create packaging that forces you, as the doctor, to waste medicine. For instance, a patient may need 30 miligrams of a medicine that only comes in 20 miligram packaging.

You must use a full and another half of the medicine to give a patient the correct dose. What happens to the rest? It is thrown away. But the manufacturers of the product have doubled their profits.

This is an unfair practice that can harm the patient and the industry. When the goal focuses on money rather than properly treating the patient, errors can be made. Prepackaged medications can help solve this issue.

By investing in the use of pre-packaged medicines, you are putting your patients care as the top priority. You are helping them take their medicines as prescribed, which helps them improve their quality of life.

 

Learn More about our prepackaged medication services or contact us today to determine how we can best meet your needs!