Improving Prescription Packaging

Improving Prescription Packaging

Can medication packaging be improved? by Howard B. Largent The primary obligation of pharmacy is the service it can render to the public in safegu...

5MB Sizes 0 Downloads 45 Views

Can

medication

packaging

be improved?

by Howard B. Largent The primary obligation of pharmacy is the service it can render to the public in safeguarding the preparation, compounding and dispensing of drugs and the storage and handling of drugs and medical supplies. l

s

o states the APHA Code of Ethics. Remington's Practical Pharmacy 2 has the following to say about the packaging of medicationThe choice of prescription containers is of prime importance to the pharmacist. I n choosing the proper container for prescription medication, the pharma.c ist should ask himself the following questions- .

1. Will the container protect the Community pharmacist and owner of the Menlo Prescription Pharmacy in Menlo Park, California since 1952, Howard B. Largent began his career as an assistant pharmacist more than 40 years ago. After two years as assistant he was registered as a licensed pharmacist. He has also served as a medical representative and as district manager of a pharmaceutical company. During his · duty in the Navy, Largent was a pharmacist's mate in Managua, Nicaragua, Coco Solo in the Canal Zone and on several naval vessels. In addition tQ being a member of A~.hA, he also belongs to service clubs and numerous professional ssociations.

efficacy of the medicine during the time of its intended use? 2. Is the container designed so that medicine can be removed easily by the patient? 3. Is the container the most suitable type for the particular dosage form to be dispensed? 4. Does the container have "eye appeal" and will it appear professional to the patient?

Husa's Pharmaceutical Dispensing 3 provides even· more specific details on the problem of stabilityThe container must be capable of preserving the medicine at least for the period during which it would be used. For this reason, most pharmacists use screw-cap glass or snap-cap plastic containers. Some pharmacists use colored . glass containers for maximum stability;

however, for drugs not affected adversely by light, a clear container has the advantages of revealing the elegance of the preparation and permitting the patient to observe easily the quantity remaining in the container during use.

There is a growing tendency for some pharmaceutical manufacturers to include on the labels of their respective products, packaging and storage information with expiration dates, if applicable. Section 4048 of the pharmacy laws of California provides that the expiration date of a product must be on the prescription label of the drug dispensed. 4 The manufacturer's label may instruct the pharmacist to dispense in amber glass; protect from . light; keep container tightly closed; keep bottle securely closed in a cool, dry place; dispense in moisture-proof container; or protect from sunlight and excessive heat. These instructions and similar warnings, developed as the result of ·years of experience in quality control, are carried on separate strip labels. Today an increasing number of these instructional labels are available as a stock item. These strip labels assist the pharmacist in keeping the patien t informed regarding warning cautions and the c~re and storage of his medication. I am inclined to believe the strip labels are . as , important as the label bearing the physician's directions. Verbal instructions are quickly forgotten, whereas the labels, placed on Vol. NS6, No. 12, December 1966

635

the container serve as a constant reminder t o the patient. T o select the appropriate containers , the practicing pharmacist must consider the effect exposure to the elements has on medication. Temperature, humidity, light and other environmental factors , all influence his selection. Furthermore, the patient's welfare is placed in jeopardy if the medication is not stored under proper conditions after it has been dispensed by the pharmacist. For " dry packaging" of products susceptible t o deterioration from moisture, we encourage the use of desiccator capsules of anhydrous calcium chloride, packets or capsules of silica gel or activated charcoal and predried rayon balls as a stuffer instead of cotton which absorbs and holds moisture. George Archambault, in a very comprehensive review of the subject of packaging, statedThe best authorities on the preservation and storage factors of medications are the monographs in the Pharmacopeia of the United States and the National Formulary. These direct that many of the official med'ications be packaged, stored and preserved in tight, light-resistant containers.

In addition to these .official sources, many phannacists look to the pharmaceutical manufacturer as a knowledgeable source of information . If the manufacturer's label on his product reads, "Keep Tightly Closed," we accept this recommendation and convey such information to each patient using this particular medication. The manufacturers of prescription containers should also be considered as an ~mportant source of information and ma terial. For example, a comprehensive report entitled Combined Reference Index has been prepared by the prescription container department of the Armstrong Cork COIf1pany. This excellent 81 -page document, compiled from data in the Pharmacopeia of the United States XVI, National Formu~ry XI .and the A merican Drug Index 1964, reports that 565 monographs designate the drug as one to "Preserve in Light-R'e sistant Containers." Monographs of 872 official titles make the designation, "Preserve in Tight Containers," and monographs of 380 official titles make the designation, "Preserve in Tight, Light-Resistant Containers." Another Armstrong , brochure lists the percentage of harInful light rays stopped by prescription bottles of various colors. Clear o'r colorless glass stopped 38 percent of these rays; commerci'al blue, 41 percent; emerald green, 59 ' percent; and Armstrong amber,' 98 percent. The u.s. Phar636

oo~

UlZ:r:

..... ~

::t: ."

::l ::E

C> 0::

.... c..> .... ~

~

C> 0::

Name of Product ·

a...

.

Vl<\!)

~

~

c... >a:::

~ ~

-' <:> <:>

~ ;:::

i!:

~

=

~

..... <:> ....a::: ...,

~

~

gUl::J

u~::E

>-...JO ...Ja.c: j:...Ju. \!)Ol-Ou I-UUl fu<5

UlZC: ~_a.

"''''

~ffi~ ~~~

al81U

........ ..

~~E ~

",

="'~
,.:---1I '!c o

I~

is 1.

~

X

X

I sopti ne Hyoscine

X

X

Benadryl Kapseal s

X

X

X

Dil ant i n Kapseal s

X

X

X

X

X

X

X

Lincoci n Capsul es V Cillin K Ped . Susp . (Reconstituted ) 125 Phenerg an (Amps., Tabs)

Phenaphen Capsule s

X

2 weeks i f re -

X

frig

X

Carbri tal Kapseals Reserpine USP Tabs

I

! "''''''''' e:o.... 1 :.1 i L ...__ ..

Stoxil Ophthalmic

Equagesic Tablets

.

X X

X X

X

The random sa mpling above shows in structions which appearon th e labels of stock packages which the manufacturer sends to th e pharmacist or recommends be used with a medication . In the sa mples of products listed all instructions are not induded.

maco peia lists as harmful those light rays between 2,900 and 4,500 angstrom units; the new USP XVII expresses this in terms of millimicrons as. 290 to 450 (the angstrom unit is ten times a millimicron) . Sir William Osler, during one of his famous lectures to graduating students of medicine, admonished, " Listen to what the patient is saying, he is giving you the diagnosis." It is my belief that this logic m ay be applied appropriately to recipients of medication . The more information a pharmacist has, the more intelligently he can select the proper container and supplementary strip labels. . Containers for medication to be used away from home should differ from conventional containers. If the patient is taking a trip, the pharmacist:;before selecting a container should determine the mode of transportation the patient will use, the climate at his destination and enroute, the frequency of dosage prescribed by the physician and the number of medication doses required by the patient away from home. If the patient is to be gone only for a day, should it not be incumbent on the pharmacist to provide a container for the midday dosage? Otherwise the patient is left to find his own particular

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

container and the likelihood of his making a proper selection is slim. It is true tha t the physician on occasion may consider these logistics, but very frequently it is the pharmacist's responsibility to calculate not only required amounts but also the most appropriate t ype of container. Therefore , the pharmacist should consider not only the container for the patient at home, but also for the patient away from home. Sublingual tablets nitroglycerin for the patient who has angina pectoris is a good specific example. Many pa tien.ts carry their tablets in an amazing . variety of containers which they have chosen and which do nothing to protect the medication against deterioration by light, moisture, or high temperature. Experience with these patients and their exotic containers had led me to a study of tight, light resistant containers and the best method of controlling the potency of the medication with minimum deterioration. * *1 wish to thank the following firms for assistance in this study-Armstrong Cork Company, Prescription Container Dept., Lancaster, Pa.; Becton . Dickinson & Company, Rutherford, New Jersey; K leen·Stik Products, Chicago, Illinois a nd Los Angeles, California ; Owens Illinois G lass Company, Toledo, 'Ohio; PaperMate Compan y. Chicago, Illino is. and P hen ix Box and Label Company, Kansas City. Missouri.

Even under the most ideal conditions there is always the problem of patient failure. Failing to have potent nitroglycerin tablets easily accessible at the time of an attack could be extremely serious for the patient. The tablets might be located too late to be effective. Not only could this happen, it actually has happened. JT A, my good friend and former neighbor, was seated in his living room engaged in conversation with his brother when he developed chest pains and pressure. He asked for his tablets. His brother raced upstairs but there was a delay in locating the tablets. When he found the tablets he ruphed back downstairs to JT ... '. too late! On my way home after the funeral services, I resolved to find a container that would be convenient to carry and instantly available to the patient when the occasion demanded instant relief. This container ·not only had to provide availability but also had to preserve the potency of the nitroglycerin. This container I thought should be available in every pharmacy for all patients with a diagnosis of angina pectoris. This happened many years ago and since that time I developed the Jay-Tee tube through the process of trial and error. Dedicated to the memory of my friend, the tube is an assembly of components which may be carried in the pocket like a fountain , pen. If directions are followed, the potency of sublingual tablets nitroglycerin may be maintained with a minimum loss by deterioration. The J ay-Tee tube is not recommended ' for long term storage of ni troglycerin. The Jay-Tee tube and assembly components, however, are not commercially available. Until a unit like this is available, a small amber glass "tight container" with screw cap and liner, such as the manufacturer of sublingual tablets nitroglycerin uses, should be employed as a substitute. A small label, to size, can be provided by a printer. One "tight container" suitable for lots of less than 100 tablets is Armstrong's amber glass capsule vial #39-A. Another possibility is the Owens Illinois Glass Company's amber glass capsule vial, three-dram size, or its 19X50 mm amber vial in 15-425 finish with black molded c,ap, P.V. Liner, available on special order. The stability of sublingual tablets nitroglycerin depends primarily on the conditions under which they are stored. The main cause of decreased potency is volatilization of the nitrogly~rin which occurs when the tablets are subjected to adverse storage conditions. Sublingual tablets nitroglycerin stored in bottles which are frequently opened for dispensing purposes, should be protected as much as possible from atmospheric moisture. The time that

These are typical containers which may be used for the storage of nitroglycerin tablets. They not only give protection from light but also prevent unnecessary exposure to the atmosphere. The container below is manufactured by Owens-Illinois and the one above by Armstrong Corp.

container which cannot be tightly closed, they will lose their potency more rapidly through volatilization of the nitroglycerin. A word of caution is particularly important in relation to the pharmacist's ethical attitude toward the attending physician and his fellow pharmacists. Part of the pharmacist's responsibility is to advise the patient about the packaging, storing and transporting of medication. The function of the physician is to diagnose and prescribe and that of the pharmacist is to dispense. Any reference to symptoms or treatment should be referred to the attending physician for an answer. We must bear in mind the patient is already apprehensive; therefore we must be on guard against adding anything to increase the anxiety by explaining that with certain additional care, his medication becomes more dependable. Again, what we say may not be as important as the-inferences drawn by the patient. Criticism of a fellow pharmacist regarding his packaging methods should be avoided since none ' of us ate "without sin." The physician should be made aware of the advantages to be gained by the proper selection of prescription containers. In principle, it makes little difference whether the medication supply is intended for one week, one month, or one year. We must be motivated by the premise that if there is a better way of doing things, we should do it. Our reward is the gratitude of a satisfied and happy patient. When a pharmacist dispenses sublingual tablets nitroglycerin, his instructions to the patient should be1~

the bottle is allowed to remain open should be kept at a minimum and the cap should be securely tightened each time after some of the sublingual tablets have been removed. When properly stored in a tight container in a cool, dark location, sublingual tablets nitroglycerin will retain their potency for up to five years. An amber · glass prescription vial with screw ' cap and liner affords more protection than a clear plastic vial with snap cap. If the sublingual tablets are dispensed in a container such as a pasteboard or plastic box, which is permeable to moisture vapors, or in a

Your prescription bottle, labe'led with directions for use, should remain at home, stored in a dark, cool and dry place. If prolonged storage or high temperatures are anticipated, refrigeration of the bulk of the tablets would be desirable. In this case, however, the bottle should be allowed to warm up to room temperature before it is opened to avoid moisture inside the bottle. 2. Keep your prescription bottle tightly closed. A small supply of tablets may be transferred to a small amber glass vial which should be kept within easy reach atalltimes. 3. Sublingual tablets nitroglycerin should act within one or two minutes. Loss of potency should be suspected if there is failure to ' obtain relief after one or two doses, especially if the tablets have been exposed to extremely high temperature and moisture. Some patients, experienced in taking nitroglycerin, describe a tingling sensation or heat at the end of the tongue when the tablet Vol. NS6, No. 12, December 1966

631

To help pharmacists tell their story better, many pamphlets describing the importance and effectiveness of glass containers are available from the manufacturers of prescription containers.

is placed under the tongue. Further investigation is required before this method can be used routinely by all patients as an index of potency. Under certain conditions, there might be slight loss of potency if the medication is even allowed to stand temporarily in an open bottle. Under less than ideal conditions, a loose cap on the bottle or vial may cause more rapid deterioration. Experience will tell you how many taQlets to carry in the tube or vial. 4. Ideally, the tablets should be stored in brown (amber) glass, with a screw cap closure with liner. Storage of the prescription bottle at home should be in a cool dark place which is dry and free from

r

medI-Q Answers

(Answers to MedI-Quiz on page 628) 1. 2. 3. 4. 5. 6. 638

(C) (A) (D) (C) (D) (B)

7. 8. 9. 10. 11.

(B) (A) (C) (D) (B)

sunlight and excessive heat. A plastic or cardboard container is not ideal for storing or transporting sublingual tablets nitroglycerin. Keep a supply of potent tablets within easy reach, both day and night. 5. These instructions are intended to supplement, rather than supplant, instructions issued by your physician for your own specific condition. Of necessity, these are generalizations regarding the packaging and storage of sublingual tablets nitroglycerin. Regarding treatment, follow your physician's specific instructions and cou nsel. Overcome fear with knowledge. 6. Carry an emergency medical identification card and perhaps a signal device. Be prepared for the emergency that may never happen. 7. While needs of the patient with angina pectoris may vary from time to time, the requirements of one patient will differ from another. Remember the best source of medical information is your physician.

The subject of proper packaging is a challenging one which should tax the ingenuity of the pharmacist. To disregard the importance of proper containers and instructions to the patient on storage is to limit the usefulness of products sensitive to light, moisture and temperatur e.

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

Our particularizing on sublingual tablets nitroglycerin has served as an example of the many medicaments which merit special consideration when a prescription container is selected. Adapting a receptacle according to the individual requirements of the patient does require innovation and careful decision. Providing a container that has been selected for size is not sufficient. A container that is useful in the home is one factor; how the patient can follow his doctor's directions away from home is no less important. Thus the pharmacist must ascertain whether the patient understands orders. If the patient is left to his own devices and permitted to select his own container for the away-from-home dosage, his choice may be less than ideal and as a result his medication may deteriorate unknown to him. It is, therefore, incumbent upon the practicing pharmacist to determine the needs of the patient through careful inquiry at the time the patient presents his prescription order to the pharmacist. The pharmacist must look to the pharmaceutical manufacturer's suggested packaging information on the product label because it is from the manufacturer's quality control laboratory that these special instructions originate. This authoritative information must be relayed to the patient by every means at the pharmacist's command-strip labels, supplementary memorandums and verbal instruction. A loyal and grateful patron will be the reward for personalized efforts in the patron's behalf. " Can prescription medication packaging be improved?" We wi111eave the answer to the judgment of the reader. A comparison of the methods of today's pharmacist with those of his predecessor of a past generation shows prescription packaging has improved, not only functionally but also in appearance. How many of our readers can recall the round, cardboard containers and handwritten directions of the pharmacist of another era. For the majority of capsules and tablets of the day, these may have been adequate, but not for the greatly improved products of today's pharmaceutical research. • references 1. 2.

3.

4. 5.

6.

APHA Code of Ethics. Martin, Eric W. , Remington's Practice of Pharmacy, (1961). Cooper, Benjamin F., Jr., "Handling of Prescriptions," Mack Publishing Co., 599 (1959). Pharmacy Laws of Calif. and Administrative Rules of Board of Pharmacy, Sec. 4048, 14 (Oct. 1, 1963) . Archambault, George F., "Standards for Prescription Containers," Amer. J. Hosp. Pharm., 20, 358(Aug. 1963). Combined Reference Index, Armstrong Cork Co., Prescription Container Dept., Lancaster, Pa.