Since the early 1960s, medication compounding is the significant function of the pharmacist. However, the role of the pharmacist is quickly changing from compounding medications to dispersing already compounded medications.
Oct. 10, 2012 – How did a single pharmacy in Massachusetts put 13,000 people in 23 states at risk of deadly fungal meningitis?
New England Compounding Center (NECC) is a compounding pharmacy. It has now recalled the 2,410 different drugs it sold in all 50 states. Fungal contamination of at least one product – single-shot syringes filled with a steroid preparation – is responsible for the meningitis outbreak.
This raises serious questions about compounding pharmacies, which make some 3% of drugs dispensed in the U.S.
Various diseases can be treated with different drugs and medication, however, for this medicine to work efficiently, the ingredients and constituents of the medication need to be mixed correctly in the right quantity and dosage.
What is Compounding Pharmacy?
Pharmacy compounding is the art and science of medication preparation for patients. It involves the process of preparing a medication for a patient in the right quantity and dosage. It consists of the mixing of various ingredients that comprises a prescription in the order and format prescribed by a medical practitioner or doctor.
Compound medications are often done by a licensed pharmacy, licensed medical practitioner. Often they are produced by an outsourcing company, under the supervision of a licensed pharmacist or medical practitioner.
Why Do We Need Compounding Pharmacy Pharmacists?
In this new technological age, the various drugs produced by pharmaceutical companies are delivered enmass and in generalized specifications. However, some diseases and individuals need specific and different dosages and compositions for a medication to work for them.
Compounding pharmacies provide the pharmacists and medical practitioners needed to meet the specific and unique needs of these groups of patients. A compounding pharmacy is the solution to the dilemma of the bad taste of drugs, missing prescriptions, increased allergies to specific medications, and hating the form of drugs.
Our bodies develop different thresholds and tolerances to drugs and dosages; I practice the treatment of specific diseases for some individuals. The dosages and consistuants of some medicines needs to be adjusted to meet the unique demands of their bodies and disease requirements. The “one size fits all” approach used by the various pharmaceutical companies in this 21st century would not meet the requirements of this group of individuals that need medications made in a unique dosages and compositions to function.
The latest insurgency of the compounding pharmacy has given medical practitioners the ability to meet the needs of specific patients that need medications with :
- Particular strength
- Distinct and unique dosage
- Particular flavours
- Specific ingredients previously removed due to contra-indication, side-effects, complications, or allergies.
- A young child may need a small, liquid dose of a drug made only in adult-dosage tablets.
- A person may be allergic to one of the ingredients in the commercial version of a drug.
- In such cases, a compounding pharmacy would make the proper dosage and form of the drug, without any offending ingredients.
In recent years, the role of compounding pharmacies has expanded, says David Miller, RPh, CEO of the International Academy of Compounding Pharmacists (IACP), the trade group representing the compounding industry.
“In the last two to three years there has been an upsurge in an old function of compounding pharmacies, to step in on a local basis to fulfill drug shortage issues,” Miller says. “What we have seen is on a large scale, important drugs being in shortage and not for short periods as before. Now it’s in the months-to-years range. So compounding pharmacies are being looked to on a larger scale as we try to address drug manufacturing problems.”
How Many Compounding Pharmacies Practice Advanced Compounding Services?
According to the IACP, there are 56,000 community-based pharmacies in the U.S. About half of them directly serve local patients and doctors.
Some 7,500 compounding pharmacies specialize in what the IACP calls “advanced compounding services.” Some 3,000 of these pharmacies make sterile products. The tainted steroid shots produced by NECC were supposed to have been unproductive.
Who Ensures the Safety of all Compound Pharmaceutical Drugs?
The FDA traditionally regulates drug manufacturers. But states regulate pharmacies.
There are 3 primary government agencies that regulate compounding pharmacies:
- State boards of pharmacy ensure that stores follow state regulations for pharmacy practice.
- The FDA regulates “the integrity of the drugs” and the active pharmaceutical ingredients from which they are made.
- The Drug Enforcement Administration regulates compounding pharmacies’ handling of controlled substances.
- The independent Pharmacy Compounding Accreditation Board (PCAB) offers its official seal of approval to pharmacies that voluntarily pass strict inspections and other rigid requirements. Miller says some 180 compounding pharmacies have this stringent PCAB accreditation. The NECC, the company at the heart of the fungal meningitis outbreak, was not PCAB accredited.
- But there’s a grey area. As some compounding pharmacies get larger, they begin to act like small drug manufacturers. So when does a large compounding pharmacy regulated by a state pharmacy board become a little drug manufacturer regulated by the FDA?
A 1997 law extending the FDA’s authority over compounding pharmacies was mostly struck down by a 2002 Supreme Court decision. Later in 2002, the FDA issued guidance in which it says it can regulate compounding pharmacies under certain circumstances. These include:
- Making drugs before a doctor has prescribed for them, except in “insufficient quantities.”
- Making drugs with commercial-scale manufacturing or testing equipment.
- Making drugs for resale to individual patients.
- Making drugs commercially available in the marketplace or copying FDA-approved drug products.
However, this guidance is not an official FDA regulation and does not have the force of law.
How to Identify a Compound Pharmaceutically Manufactured Drug
The NECC has taken down its website and issued a statement: “For the foreseeable future, NECC staff and professionals will be singularly focused on providing full cooperation with relevant public agencies and carrying out this recall professionally and expeditiously.”
Regular pharmacies do not fill drug prescriptions for compounded drugs. If your doctor writes you order for a compounded medication, you must fill it at a compounding pharmacy.
If you receive medicines at a clinic, hospital, or doctor’s office, ask whether the medication came from a compounding pharmacy. It would also be a good idea to ask whether that store has PCAB accreditation.
Are Compounded Drugs Approved by FDA?
Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective and made by Federal quality standards. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed.
State boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs by the conditions of section 503A of FDCA/ although FDA retains some authority over their operations. However, outsourcing facilities that register under section 503B are regulated by FDA and must comply with CGMP requirements and will be inspected by FDA according to a risk-based schedule.
Is it Safe to Use a Compounded Drug?
Drug safety cannot be generalized. Just like any other drug, most compounded drugs could be manufactured under low quality due to lack of strict control and regulation s by FDA, and because some of the major constituents of the drug have been altered.
The safety of any drug cannot be generalized; it depends on the individual production company, the quality of the product manufactured, and the quality of the prescription. All these factors combined determine if a drug is safe or not, whether it is bought from a compounding pharmacy or standard pharmacy.
Compounding Pharmacies Facing New Guidelines by the FDA
Compounding pharmacies are facing new guidelines by the FDA through a new act called the Compounding Quality Act.
What is a Compounded Drug Outsourcing Facility?
Primarily compounds drugs for outsourcing. An outsourcing facility is a company or compounder located in a specific location with a primary aim of compounding drugs and medications. These facilities functions in compliance with the rule and guidelines contained in section 503B of FDCA.
THEY REGISTER USING ELECTRONIC DRUG REGISTRATION SYSTEM or sending an email to the FDCA company.
However, animal drug compounding is not covered under the drug quality and security act (DQSA).It includes only drugs compounded for humans.
What is the Difference Between a Compound Pharmacy and a Standard Pharmacy?
- Perfect dosage: Most standard or corner pharmacies produce drugs with a generalized dosage. A compound pharmacy can manufacture a drug with a dosage that matches your BMI, and exclude side effects and adverse reactions.
- A form of medication: A standard or corner pharmacy produces drugs in a unique way (oral, topical, injection), but a compound pharmacy gives you the opportunities to pick the form you want the drug to be. What if you don’t like the taste of drugs, a compound pharmacy can make your medicine in gel or cream. They make medication to suit your taste and comfort. This also eliminates the problem of hating or missing your pills. Compound pharmacy manufactures the drugs in a way to make you love it and take it consistently.
- Pediatrics medication: One of the most significant fears of all parent is to see their child react badly to a particular medication. Most corner and standard pharmacies do not produce different drugs for your kids. A compound pharmacy can manufacture drugs in a way to make administration more straightforward. They can make it in powder form that you can quickly mix with your kid’s food or favorite beverage. Simplicity is one of their primary advantages.
Compounding Pharmacy Future Growth Prospects
The future of compounding pharmacy is bright. There is a high probability compounding pharmacies will replace standard and corner pharmacies. We live in an era where everyone wants something tailored to their specifications. A compound pharmacy gives people that opportunity to choose how their medications should look and taste.
With the slowdown in world economic growth, the Compounding Pharmacy industry has also suffered an inevitable impact. However, it has still maintained relatively optimistic growth over the past four years. Market analysts believe that in the next few years, compounding pharmacy market size will be further expanded. We expect that by 2021, the market size of the compounding pharmacy industry will reach $11.2 million.
What Kind of Drugs Require a Compounding Pharmacy?
Different types of drugs require compounding pharmacy. Especially if some modifications, such as avoiding ingredients that cause allergy or changing the taste, is needed.
The most frequently compounded drugs include topical and oral pain relievers, dermatological pills, hormone replacement medications, and thyroid functioning drugs.
Why do These Drugs Require a Compounding Pharmacist?
Sometimes a drug needs modification.These drugs require a compound pharmacist if the general dosage or specification of a particular drug needs to be modified. For example, if some ingredients of a medicine cause an allergic reaction in an individual, or if little children have difficulties in swallowing some medications.
Is it a Good Idea to Use an Online Compounding Pharmacy?
If doctor prescribed recommended pharmacy. Just like purchasing drugs from a standard or corner pharmacy, the safety of buying a drug from a compounding pharmacy depends on the prescription from your doctor and the quality of production by the compounding company.
However, buying from an online compounding has some benefits which include:
- Cheap cost
- It saves time spent on queuing in standard pharmacy
- It helps you to request for your specific need in a medication
Can Any Doctor Prescribe a Compound Prescription?
Only licensed doctors, nurse physicians, veterinarians are permitted to prescribe or order a compounded drugs. However, the mixing of the drug can just be done by a trained and licensed compounding pharmacist in a well controlled and safe environment.
Are you tired of missing your medications due to bad taste? Do you always react or have an allergy to specific essential drugs? Do your children skip medicine, and there is nothing you can do about it? Compounded medications by licensed compounding pharmacies are the solution to your dilemma. To get the best service and products. Find the nearest compounding pharmacist near you.
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