Pharmacy preparation labelling

A pharmacy technician is an individual who assists in pharmacy activities that do not require the professional judgment of a pharmacist. For example, pharmacy technicians may accept orders from patients, prepare labels, enter drug information into the pharmacy s computer system, and retrieve medications from inventory. As pharmacists assume an increasing number of clinical roles, pharmacy technicians are taking more and more responsibility for distributive functions in pharmacies in all settings. 

At Leeds Teaching Hospitals NHS Trust in England, the Pharmacy department has a catalogue of authorised pharmacy preparations, which is periodically reviewed to ensure that other more suitable options are not available. Each of the approved preparations on the catalogue have been reviewed by a group of senior technicians and pharmacists to ensure that they have a sound evidence base and are backed by an authorised preparation instruction and agreed label. 

Informing the patient about the nature of pharmacy preparations is not yet common practice in many countries. In the UK patient leaflets on this topic are available [88]. They explain both the preparation in the pharmacy and off label prescribing of licensed medicinal products. Both situations have in common that physician and pharmacist will of course act according to disease-specific professional guidelines or following a documented risk assessment. 

The influence of ethanol on the responsiveness can especially be a problem for all ages. Pharmacy preparations should be labelled with a warning indication as it is directed for licensed products. Guidelines concerning the content of ethanol and how to deal with in high-risk groups... 

Worked Example. A regional supplier of pharmacy preparations routinely prepares an oral solution of noscapine hydrochloride. The label claim is 100 % and the standard deviation of the spectrophotometric determination for the release decision, o = 0.8 %, is known from historic data. The limiting quality levels for this product have been fixed at LQL = 86 % with a consumer s risk, a, of about 5 %, and the AQL is set to 95 % with a producer s risk, p, of about 10 %. 

The label of any medicine meant for dispensing should contain an expiry date, stating month and year, and storage conditions (see Sect. 37.3). This applies to licensed medicines as well as pharmacy preparations. 

Uniform labels of good constant quality are very important for pharmacy preparation. Quality control of incoming labels, both printed or unprinted, should equal the requirements for containers described in Sect. 24.5. 

When a medicine is developed, the requirements of the patient are translated into an actual product (see Chap. 17). The qualitative and quantitative composition are chosen, as well as the pharmaceutical dosage form, the preparation method, the container and the accompanying information for the patient. Pharmacy preparations should have a pharmacotherapeutic as well as technically sotmd product design. Formulation, preparation method, container and labelling have to meet the relevant requirements. 

The Pharmacy Practice Order (Apothekenbetrieb-sordnung) in Germany demands, besides die name of the owner, the initials of the person who has dispensed the medicine on the label, or the name of the supervising pharmacist [7]. In Croatia and the Czech Republic this applies for the label of pharmacy preparations. In the UK it is good practice to write the initials of the pharmacist and those of the dispenser if they are different, but this is not law. 

Usually the date the medicine is dispensed will appear on the label. It is important to notice that this date may be different from the date it is actually delivered to the patient The date can be used as an instrument for tracing a dispensed medicine, but in most of the national legislation a batch number is required for pharmacy preparations... 

In naming pharmacy preparations with more than one active substance, it will in practice not always be possible to foUow the rules about the name and the strength. If for instance 0.1 % triamcinolone acetonide is added to ketoco-nazole cream, the name on the label for the patient would probably be 0.1 % triamcinolone in ketoconazole cream, simply because the full name would not fit. 

The expiry date of pharmacy preparations depends on the date of preparation, the conditions under which the preparation is made, the type of container and the storage conditions. It should always be part of the label of stock preparations. In practice, it will not always be necessary for the patient to know this expiry date, as long as the beyond-use date lies before the expiry date, and the container is opened shortly after dispensing. Most important for the patient is that the label is clear and unambiguous on the maximum period of storage. 

First, FDA has been conducting continuing research into how much and what kind of information patienfs gef about their prescriptions from pharmacies and physicians offices. Dafa from fhe lasf four patient surveys that have been conducted since 1992 are on FDA s website at www.fda.gov/cder/ddmac/research.htm. FDA has also completed research on how men and women perceive benefits and risks in patient labeling as a fxmc-tion of how the information is commxmicated. FDA hopes to use these data to better communicate prescription medication information and is preparing papers for publication based on e data from this study. 

A pediatric patient was presented to the emergency room (ER) experiencing seizures for which 150-mg Cerebyx (fosphenytoin anticonvulsant) IV was ordered. The pharmacy technician took the call for Cerebyx and delivered three 10-mL vials of Cerebyx 50-mg PE (phenytoin sodium equivalents) per mL to the ER as a floor stock transaction. A nurse misread the 50-mg PE/mL on the 10-mL container label, making the assumption that the entire vial contained 50 mg PE. The contents of all three vials were prepared for administration. Instead of 150 mg PE, the patient was administered ten times the intended dose, or 1,500 mg PE. The patient later died. The ER staff only discovered the error after the patient s blood phenytoin levels were returned from the laboratory. 

The plant with the pretty yellow flowers was christened St. John s wort because it begins to bloom around June 24, the purported birthday of St. John the Baptist. Until a couple of years ago, Hypericum perforatum grew on our roadsides in virtual obscurity, but today preparations made from the plant jostle for our attention on the shelves of pharmacies and health food stores. Relieves insomnia, neuralgia and nervous tension, one label boldly declares, while another sedately promises to make you feel your best. Sounds intriguing. 

A pharmacist checks the technician s work, reviewing the label against the medication order and the dose that has been prepared. The drug is labeled and dispensed. In the institution, the nurse receives the drug and compares the medication and pharmacy label against the copy of the physician s order, as well as the handwritten transcription made earlier in the MAR. 

Salts, artificial A mixture of the more important chemical salts naturally present in several of the well-known mineral springs of Europe. These are properly labeled artificial, notes Remington s Practice of Pharmacy (1926), and if used to prepare effervescent salts or mineral waters they should be sold only as an imitation of the genuine. 

In another reported incident, a pharmacist ordered the 10 g vials of cefazolin sodium but received the 1 g vials in error. Intending to reconstitute and then divide the 10 g vials into Ig doses, a pharmacy technician inadvertently reconstituted the 1 g vials and proceeded to divide the total solution of each vial into ten 100 mg doses. Some of the prepared 100 mg doses of cefazolin sodium were administered to patients instead of their scheduled 1 g doses. No adverse effects to the patients were reported. The pharmacist felt the error occurred, in part, because the vials are identical in size and have similar labels. 

By default, a certain software program printed teaspoonful for any syrup preparation when a numerical figure was not followed by a specific measure, such as ml, for the dose. A prescription for Viml albuterol syrup every 6 h for a 9 week-old infant was presented to the pharmacy, and the pharmacist entered Vi into the computer but did not enter ml. Therefore, by default, the label printed /i teaspoonful every 6h if needed for wheezing. The child was administered the overdose and was consequently admitted to the hospital emergency room for observation. Fortunately, the child was released with no permanent damage. 

Once the label(s) has/have been generated, the item(s) may be dispensed. There are many items which may be prescribed via an NHS prescription form and it is important that pharmacists and pharmacy technicians ensure that the correct item(s) are being supplied. Remember, within community pharmacy, if a drug is prescribed using a proprietary name, the proprietary product must be supplied. However, if a drug is prescribed by its generic name, in most cases, any generic or proprietary equivalent may be supplied. (The exception to this is for some sustained-release preparations where the release properties of different brands may vary.)... 

In most Spanish hospitals, there is just one delivery a day, in the afternoon, because in many hospitals doctors see patients between 8 a.m. and 3 p.m. However, the number of visiting hours is increasing and pharmacy working procedures may have to adapt to the new situation. Parenteral admixtures and nutritional preparations, if chemically stable, are generally prepared for each patient in a centralized unit (described later), labeled, and... 

Local laws may define preparation in a pharmacy as the complete or partial manufacture of medicinal products or the packaging or labelling of them. As a result, a pharmacy comprises premises in which medicines are prepared, stored, and dispensed, or just stored to be dispensed. 

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