Influencia de diversas variables psicológicas y sociales sobre el procesode interacción cooperativa

“The Good Compounding Practices Applicable to State-Licensed Pharmacies” (14), developed by the National Association of Boards of Pharmacy, discusses eight recommendations. The subparts include (A) general provisions and defi nitions; (B) organization and personnel; (C) drug com- pounding facilities; (D) equipment; (E) control of components and drug product containers and closures; (F) drug compounding controls; (G) con- tinuous quality improvement program; (H) label- ing control of excess products; and (I) records and reports.

Subpart (A), General Provisions, provides two important defi nitions (14):

“Compounding” means the preparation of Components into a Drug product (1) as the result of a Practitioner’s Prescription Drug Order based on the Practitioner/ patient/Pharmacist relationship in the course of profes- sional practice, or (2) for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or Dispensing. Compounding includes the preparation of limited amounts of Drugs or Devices in anticipation of receiving Prescription Drug Orders based on routine, regularly observed prescribing patterns.

“Manufacturing” means the production, preparation, propagation, conversion, or processing of a Drug or Device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis. Manufacturing includes the packaging or repackaging of a Drug or Device or the labeling or relabeling of the container of a Drug or Device for resale by pharmacies, Practitioners, or other Persons.

Subpart (B), Organization and Personnel, discusses the responsibilities of pharmacists and other per- sonnel engaged in compounding. It also stresses that only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of the drug compounding operation.

Subpart (C), Drug Compounding Facilities, describes the areas that should be set aside for compounding, either sterile or not. Special attention is required for radiopharmaceuticals and for products requiring special precautions to minimize contamination, such as penicillin.

Subpart (D), Equipment, states that equip- ment used must be of appropriate design, adequate size, and suitably located to facilitate

Chap03.indd 79

evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution and is capable of tight re-closure.” A hermetic container “is impervious to air or any other gas under the ordinary or customary condi- tions of handling, shipment, storage, and distri- bution.” Sterile hermetic containers generally hold preparations intended for injection or parenteral administration. A single-dose con- tainer is one that holds a quantity of drug intended as a single dose and when opened, cannot be resealed with assurance that sterility has been maintained. These containers include fusion- sealed ampuls and prefi lled syringes and car- tridges. A multiple-dose container is a hermetic container that permits withdrawal of successive portions of the contents without changing the strength or endangering the quality or purity of the remaining portion. These containers are com- monly called vials. Examples of single-dose and multiple-dose products are shown in Figure 3.3.

Dosage forms, such as tablets, capsules, and oral liquids, may be packaged in single-unit or multiple-unit containers. A single-unit container is designed to hold a quantity of drug intended for administration as a single dose promptly after the container is opened (Fig. 3.4). Multiple-unit containers contain more than a single unit or dose of the medication. A single-unit package is termed a unit dose package. The single-unit packaging of drugs may be performed on a large scale by a manufacturer or distributor or on a smaller scale by the pharmacy dispensing the medication. In either instance, the single-unit package must be appropriately labeled with the product identity, quality and/or strength, name of manufacturer, and lot number to ensure positive identifi cation of the medication.

Although single-unit packaging has a particular usefulness in institutional settings, for example, hos- pitals and extended care facilities, it is not limited be developed to ensure drug stability for its

anticipated shelf life.

Different specifi cations are required for parenteral, nonparenteral, pressurized, and bulk containers and for those made of glass, plastic, and metal. In each instance, the package and closure system must be shown to be effective for the particular product for which it is intended. Depending on the intended use and type of container, among the qualities tested are the fol- lowing:

Physicochemical properties •

Light-transmission for glass or plastic •

Drug compatibility •

Leaching and/or migration •

Vapor transmission for plastics •

Moisture barrier •

Toxicity for plastics •

Valve, actuator, metered dose, particle size, •

spray characteristics, and leaks for aerosols Sterility and permeation for parenteral •

containers

Drug stability for all packaging •

Compendial terms applying to types of contain- ers and conditions of storage have defi ned meanings (15). According to the USP, a con- tainer is “that which holds the article and is or may be in direct contact with the article.” The immediate container is “that which is in direct contact with the article at all times.” The closure is part of the container. The container, including the closure, should be clean and dry before it is fi lled with the drug. The container must not interact physically or chemically with the drug so as to alter its strength, quality, or purity beyond the offi cial requirements. An example would be the sorption of lipophilic drugs, such as diaze- pam, to low density plastics resulting in a loss of drug that is available for administration. The problem can be avoided with the use of glass containers.

The USP classifi es containers according to their ability to protect their contents from external conditions (15). The minimally acceptable con- tainer is termed a well-closed container. It “pro- tects the contents from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage, and distribution.” A tight container “protects the contents from contamination by extraneous liq- uids, solids, or vapors, from loss of the article,

and from effl orescence, deliquescence, or

FIGURE 3.3 Injectable products packaged in multiple-dose

(vial) and single-dose (ampul) containers.

Chap03.indd 80

cited for single-unit packaging and unit-dose dis- pensing are positive identifi cation of each dosage unit and reduction of medication errors, reduced contamination of the drug because of its protec- tive wrapping, reduced dispensing time, greater ease of inventory control in the pharmacy or nurs- ing station, and elimination of waste through bet- ter medication management with less discarded medication.

Many hospitals with unit dose systems strip- package oral solids (Fig. 3.5). Such equipment seals solid dosage forms into four-sided pouches and imprints dose identifi cation on each package at the same time. The equipment can be adjusted to produce individual single-cut packages or per- forated strips or rolls of doses. The packaging materials may be combinations of paper, foil, plas- tic, or cellophane. Some drugs must be packaged in foil-to-foil wrappings to prevent the deteriorat- ing effects of light or permeation of moisture. The packaging of solid dosage forms in clear plastic or aluminum blister wells is perhaps the most popu- lar method of single-unit packaging (Fig. 3.6).

Oral liquids may be dispensed in single units in paper, plastic, or foil cups or prepackaged and dispensed in glass containers having threaded caps or crimped aluminum caps. A number of

FIGURE 3.4 Single-unit packaging, including patient cup

and blister packaging of single capsule. (Reprinted with per- mission from Lacher, BE. Pharmaceutical Calculations for the Pharmacy Technician. Baltimore, Maryland: Lippincott Williams & Wilkins, 2008.)

to them. Many outpatients fi nd single-unit packages a convenient and sanitary means of maintaining and using their medication. Among the advantages

FIGURE 3.5 Strip packaging equipment capable of produc-

ing 50 packages per minute. Seals solid dosage units in a variety of wrapping materials and labels each package simul- taneously. (Courtesy of Packaging Machinery Associates.)

FIGURE 3.6 Commercial blister packaging of pharmaceuticals.

Chap03.indd 81

chemical makeup of the various glasses; types I, II, and III are intended for parenteral products, and type NP is intended for other products. Each type is tested according to its resistance to water attack. The degree of attack is determined by the amount of alkali released from the glass in the specifi ed test conditions. Obviously, leaching of alkali from the glass into a pharmaceutical solution or preparation could alter the pH and thus, the stability of the product. Pharmaceutical manufacturers must use containers that do not adversely affect the composition or stability of their products. Type I is the most resistant glass of the four categories.

Today, most pharmaceutical products are packaged in plastic. The modern compact-type container used for oral contraceptives, which contains suffi cient tablets for a monthly cycle of administration and permits the scheduled removal of one tablet at a time, is a prime example of contemporary plastic packaging (Fig. 3.6). Plastic bags for intravenous fl uids, plastic ointment tubes, plastic fi lm–protected suppositories, and plastic tablet and capsule vials are other examples of plastics used in pharmaceutical packaging.

The widespread use of plastic containers arose from a number of factors, including the following:

Its advantage over glass in lightness of weight •

and resistance to impact, which reduces trans- portation costs and losses due to container damage

The versatility in container design and con- •

sumer acceptance

Consumer preference for plastic squeeze •

bottles in administration of ophthalmics, nasal sprays, and lotions

The popularity of blister packaging and unit- •

dose dispensing, particularly in health care institutions

The term plastic does not apply to a single type of material but rather to a vast number of materials, each developed to have desired features. For hospital pharmacies package oral liquids for

children’s use in disposable plastic oral syringes with rubber or plastic tips on the orifi ce for clo- sure. In these instances, the nursing staff must be fully aware of the novel packaging and special labeling used to indicate that they are not for injection. These oral syringes are designed so they will not accept a needle. Other dosage forms, such as suppositories, powders, ointments, creams, and ophthalmic solutions, are also commonly found in single-unit packages provided by their manufacturers. However, the relatively infrequent use of these dosage forms in a given hospital, extended care facility, or community pharmacy does not generally justify the expense of purchas- ing the specialized packaging machinery necessary for the small-scale repackaging of these forms.

Some pharmaceutical manufacturers use unit- of-use packaging; that is, the quantity of drug product prescribed is packaged in a container. For example, if certain antibiotic capsules are usually prescribed to be taken four times a day for 10 days, unit-of-use packaging would contain 40 capsules. Other products may be packaged to contain a month’s supply.

Many pharmaceutical products require light- resistant containers. In most instances, a con- tainer made of a good quality of amber glass or a light-resistant opaque plastic will reduce light transmission suffi ciently to protect a light- sensitive pharmaceutical. Agents termed ultravi- olet absorbers may be added to plastic to decrease the transmission of short ultraviolet rays. The USP provides tests and standards for glass and plastic containers with respect to their ability to prevent the transmission of light (15). Containers intended to provide protection from light or those offered as light-resistant containers must meet the USP standards that defi ne the accept- able limits of light transmission at any wavelength between 290 and 450 nm. A recent innovation in plastic packaging is the coextruded two-layer high-density polyethylene bottle, which has an inner layer of black polyethylene coextruded with an outer layer of white polyethylene. The con- tainer provides light resistance (exceeding amber glass) and moisture protection. It is increasingly being used in the packaging of tablets and capsules.

The glass used in packaging pharmaceuticals falls into four categories, depending on the chemical constitution of the glass and its ability to resist deterioration. Table 3.3 presents the

TABLE 3.3 CONSTITUTION OF OFFICIAL