Packaging of pharmaceutical medications may vary depending on the use and type of substance packaged: prescription drugs, non-prescription (over-the-counter) drugs, and herbals and dietary supplements. Variations of pharmaceutical packaging include blister packs, alternative tamper-evident packaging, bottles, vials, ampules, intravenous bags, and calendar packs.
A blister pack is a form of tamper-evident packaging where an individual pushes individually sealed tablets through the foil in order to take the medication. This form of packaging can also help the individual recall if the previous dose was taken. Calendar blister packaging is a derivation of a blister pack in which the blister is labeled with the date of the month or day of the week. This form of packaging has classically been used for oral contraceptives. Other forms of tamper-evident packaging include seals or specially designed caps.
Child-resistant packaging of oral prescription drugs began with the Poison Prevention Packaging Act in the 1970s.
This act mandated packaging specific household chemicals and most oral prescription drugs in child-resistant packaging, ensuring that at least 80% of children cannot open it in a given time frame. The enactment of the PPPA resulted in an estimated 45% reduction of child mortality due to the consumption of oral prescription drugs. Exceptions to this mandate include a caveat for the elderly and handicapped. With these populations, the individual or prescriber may request non-child-resistant packaging for ease of opening the container. Some over-the-counter (OTC) drugs are also required to be packaged in child-resistant packaging, as mandated by the Food and Drug Administration. OTC drugs that contain active ingredients that were previously only available by prescription are now required to have child-resistant packaging.
Pharmaceutical packaging (or drug packaging) is the packages and the packaging processes for pharmaceutical preparations. It involves all of the operations from production through drug distribution channels to the end consumer.
Pharmaceutical packaging is highly regulated but with some variation in the details, depending on the country of origin or the region. Several common factors can include: assurance of patient safety, assurance of the efficacy of the drug through the intended shelf life, uniformity of the drug through different production lots, thorough documentation of all materials and processes, control of possible migration of packaging components into the drug, control of degradation of the drug by oxygen, moisture, heat, etc., prevention of microbial contamination, sterility, etc. Packaging is often involved in dispensing, dosing, and use of the pharmaceutical product. Communication of proper use and cautionary labels are also regulated. Packaging is an integral part of pharmaceutical product.
Segments of usage
Pharmaceutical packaging can often be thought of by the segment in the distribution system being encountered and by the functions needed by the user of the package.
Packaging requirements are different.
Bulk pharmaceuticals can be shipped to another pharmaceutical company for further processing, to a contract packager for forming unit packs, to international customers, etc.
Bulk shipments might be in fiber drums (with plastic liners), bulk boxes, corrugated boxes with liners, intermediate bulk containers, and other shipping containers.
Smaller bulk packs can be shipped to pharmacies, particularly compounding pharmacies. The liquids or powders can be measured and put into primary packages.
Shipments to medical professionals could be at hospitals, nursing homes, veterinarians, dentists, etc. These packaged pharmaceuticals are intended to be dispensed and administered by professionally trained and certified personnel.
Drugs under prescription control are sent to pharmacies in multi-packs of unit packs or in bottles containing many hundreds of capsules. Typically a pharmacist prepares the final form of the unit pack or places a lower count of capsules in a small bottle for the customer. In a pharmacy, pharmacists are available to answer questions and to ensure that proper documentation is provided. Internet pharmacies mail the prescribed drugs to the customer; boxes or mailing envelopes are used. Child resistant packaging is often required on the unit packs; if requested, a pharmacist is allowed put drugs in a bottle with easy open features.
Over-the-counter drugs are sold in drug stores, grocery stores, and diverse retail outlets. Usually the package needs to have all the usage information available. Packages often need to have tamper resistant features and child-resistant packaging.
Usually the packaging and labeling of dietary supplements, homeopathic drugs, and folk medicines are not regulated. Some producers voluntarily follow the regulations for over-the-counter drugs or regional Pharmacopoeias.
Many pharmaceutical products are sensitive to heat or cold. Controlled distribution systems and sometimes cold chains are required. A mail order or online pharmacy usually ships orders by mail services or by small parcel carrier. The shipment is not temperature-controlled and it may sit in a mail box upon delivery. Conditions can include high or low temperatures outside of the recommended storage conditions for certain products. For example, the USFDA found that the temperature in a steel mailbox painted black could reach 136 °F (58 °C) in full sun while the ambient air temperature was 101 °F (38 °C). Insulated mailing envelopes are sometimes used.
Larger shipments are sent in insulated shipping containers with dry ice or gel packs. A digital temperature data logger or a time temperature indicator is often enclosed to monitor the temperature inside the container for its entire shipment.
Many dry pharmaceuticals are sensitive to moisture. Tablets may become unstable and the drug may degrade. High barrier packaging (including seals) is necessary but, by itself, is often not enough. Shelf life of a moisture-sensitive drug can be extended by means of desiccants. Several types of dessicants are available; the type and quantity need to be matched to the particular drug and package. One common method is to include a small packet of dessicant in a bottle. Other methods of including desiccants attached to the inner surface or in the material have recently been developed.
Counterfeit drugs are a serious problem. People can potentially ingest useless or dangerous drugs without their knowledge. Custom package seals, authentication labels, holograms, and security printing can be valued parts of an entire security system. They help verify that enclosed drugs are what the package says they are. Drug counterfeiters, however, often work with package counterfeiters, some of whom can be sophisticated. No packaging system is completely secure.
Medication packaging includes a document that provides information about that drug and its use. In the US, this information is overseen by the Center for Drug Research and
Evaluation (CDER), a branch of the Food and Drug Administration (FDA). For prescription medications, the insert is technical, and provides information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user - the person who will take the drug or administer the drug to another person. Inserts for over-the-counter medications are also written plainly.
In the US the document is called "prescribing information" or the "package insert" (PI) and layperson's document is called the "patient package insert" (PPI). In Europe the technical document is called the "summary of product characteristics" and the document for end-users is called the "package leaflet".
All aspects of pharmaceutical production, including packaging, are tightly controlled and have regulatory requirements. Uniformity, cleanliness (washdown), sterility, and other requirements are needed to maintain Good Manufacturing Practices.
Product safety management is vital. A complete Quality Management System must be in place. Validation involves collecting documentary evidence of all aspects of compliance.
Hazard analysis and critical control points is a methodology which has been proven useful. Quality assurance extends beyond the packaging operations through distribution and cold chain management; Good distribution practice is often a regulatory requirement. Track and trace systems are usually required.
With a large portion of pharmaceutical packaging being outsourced to contract packagers, additional demand is being placed on specialty areas, i.e. specialty dosage forms.
Packaging types for shipping Medicines
Above are few types of boxes commonly used for shipping the medicines worldwide. Plastic bubble and brown paper is used inside these kraft paper boxes to help medicines maintain usually required safety & damages parameters. Once packed properly inside one brown plastic gumming tape is wrapped all around the package to make it air-proof, water-proof and dust-proof. Over the top of the package, complete details of receiver / customer is pasted to enable the courier / postal services to deliver the same promptly.