Among other criteria, the following should be studied:

• •

  To choose those marketed formulations with contents better adapted to usual dosing, with the aim to minimize handling.

• •

  To choose the most adequate and easy-to-use strength (1, 2, 5, 10, 25 mg/ml).

• •

  Not mixing / preparing at the same time formulations of the same medication with different strengths.

• •

  To choose, if possible, and in case of hazardous drug, what appears in Appendix Ia and Ib, which are basically formulations with a design that guarantee their low external contamination. Thus, it is better to select:

  • –

    Vials vs. ampoules.

  • –

    Formulations as solution for immediate use vs. lyophilized formulations.

  • –

    Drugs packaged in breakage-proof polypropylene vs. glass.

  • –

    Certain compounds already pre-charged in syringes ready for administration.

• •

  To select among marketed formulations those with a more efficient sealing of the vial after puncture, because if there is an incomplete sealing when the needle is removed, there will be an increased risk of environmental contamination.

• •

  The presence or not of preservatives will affect the use-by date of the solution from its first use; and therefore it will determine, together with its physicochemical stability, the validity of the remaining fractions after preparing one treatment.

All medications are received at the Pharmacy Unit in the Hospital Intermutual de Levante.

It is recommended to wear synthetic globes (nitrile, polyurethane, neoprene) for the manipulation and distribution of drugs in storage.

When opening the packaging of these drugs, attention should be paid to the presence of any broken packaging; in this case, the person must get adequate protection and follow the rules of action established against spillage.

Hazardous drugs must be stored with caution, in order to avoid any packaging breakage.

The fact that some drugs require low temperature for their storage must be taken into account (there is cold storage for these medications), and/or protection from the light (these must be kept in their original packaging).

Tables 4, 5 and 6 show the recommendations for SPMs to be used in different activities.

• •

  HDs must be prepared by authorized staff, and as far as possible this preparation should be centralized in the Pharmacy Unit.

• •

  In the working areas where medications are administered:

  • –

    The staff must not eat, drink, chew gum or store food.

  • –

    The staff must not use makeup or other cosmetic products that could lead to prolonged exposure in case of contamination.

  • –

    Measures for adequate hand washing will be implemented, as well as working in a sterile area (if necessary), and the adequate SPMs will be used if necessary.

• •

  Any members of staff of reproductive age, and actively trying to conceive, who are handling drugs from List 3, must adopt all prevention measures recommended in this procedure.

• •

  This type of drugs might have restrictions for those professionals in the following situations:

  • –

    Pregnant or breastfeeding women.

  • –

    Staff considered at high-risk (with previous history of miscarriages or congenital malformations, previous treatments with cytostatic agents or ionizing radiations) and cutaneous allergies.

  • –

    Fertile men and women actively trying to conceive.

  • –

    Any of these situations should be reported to the Unit for Occupational Risk Prevention.

• •

  The number of persons handling HDs should be reduced as much as possible, through organization measures and the use of preparations that require the lowest level of handling.

Transportation must be conducted in such a way as to avoid breakages or spillages.

No mechanical transportation systems will be used, such as pneumatic tubes.

In case any drug is not administered, it will be returned to the Pharmacy Unit through the same procedure and in the same packaging as it was delivered to the place of administration.

• •

  Administration will include all techniques required for administering the treatment, regardless of its way of administration; the most frequently used are: intravenous, subcutaneous (SC), topical, intramuscular (IM) and oral.

• •

  Administration will be conducted following the recommendations in the product specifications for each drug, and always according to the Standard Operating Procedures (SOPs) or HIL Guidelines.

Oral Formulations

• •

  The selection of formulation will be conducted by prioritizing whole units (tablets, pills and/or capsules) and oral suspensions. If fragmented formulations are required, these must be prepared at the Pharmacy Unit.

• •

  When oral formulations are handled, direct contact with the drug should be avoided (see Section on SPMs).

• •

  When the medication is supplied in a package, or even packaged in single doses, and it is self-administered by the patient, it will ONLY be handled with single gloves, without any other measure required.

Topical Application

• •

  Creams or other topical formulations must be applied with the SPMs stated. During this technique, handling must be restricted to the lower extent, using a spatula or other application products in order to avoid contact with the product.

Subcutaneous (SC) and Intramuscular (IM) Administration

• •

  It will be preferred to prescribe drugs which are pre-charged and purged with closed drug transfer devices systems. In those cases where purge is required, sterile gauze will be used, soaked in 70° alcohol, to prevent sprays and surface contamination.

• •

  A cloth with an absorbent upper side and a waterproof lower side should be placed under the administration line, with the aim to avoid contamination of bedclothes or the administration chair, in case of spillage.

• •

  Both in SC and IM administration, the needle won’t be unattached to the syringe at any point; the connections must be luer-lock to prevent any accidental disconnection, and discarded as one single piece in the adequate container.

• •

  After the injection, extraction will be conducted with gauze soaked in 70° alcohol, to prevent any drug reflux or dripping.

• •

  During administration, individual protection equipment must be used (see Section on SPMs). Eye and respiratory protection will only be necessary if there is a reasonable risk of splashing, or if the patient’s conditions could cause a potential accidental disconnection.

Intravenous Administration

• •

  It is recommended to implement closed drug transfer devices systems. This task must be conducted at preparation, so that no connection or disconnection are required during drug administration.

• •

  The system will be disposed of as one single piece in the specific container, the drugs used must not be disconnected.

• •

  The staff involved in this technique should be trained to ensure an adequate use of closed systems, in order to achieve an optimal performance and reduce to the lowest extent any risk of dripping, spillage, or spray.

• •

  During administration, individual protection equipment must be used (see Section on SPMs). Eye and respiratory protection will only be necessary if there is a reasonable risk of splashing, or if the patient’s conditions could cause a potential accidental disconnection.

Spillage

• •

  The worker must be protected with a waterproof lab coat, goggles or screen with lateral protection, shoe covers, and 2 pairs of gloves, one made of thick rubber and another one of non-powdered latex. In case the spillage has occurred outside the BSC, a FFP3-type mask for respiratory protection will also be used. These will be worn in the following order: shoe covers, lab coat, mask, first pair of gloves over the coat, second pair of gloves, and goggles or screen.

• •

  The spillage will be absorbed with cellulose or an absorbing cloth (dry if liquids and wet if dry powder) before proceeding to cleaning it. If there are rests of glass, these will never be collected with the hand, but with tweezers (or a collecting brush), and they will be placed in a small rigid container for sharp / cutting objects.

• •

  The dry surface must be cleaned afterwards with cellulose soaked in 70° alcohol. The area will be cleaned 3 times with soap and water or detergent cleaner / bleach, finally rinsing it with plenty of water, always going from the less contaminated to the most contaminated areas.

• •

  The protection equipment must be removed in this order: first pair of gloves, shoe covers, second pair of gloves, mask, lab coat and goggles. Everything should be discarded, except if eye-glasses are used; tweezers can be re-used after being carefully washed with soap and water (hands should be protected with a clean pair of gloves in order to conduct this procedure).

• •

  All waste generated, as well as the materials used, will be treated as contaminated materials at the time of disposal.

Accidental exposure

• •

  If there is direct contact of the drug with the skin: The affected area will be immediately washed with soap and water, during approximately 10 minutes. If the skin appears irritated, it should be examined by a specialist.

• •

  If the drug splashes the eyes: rinse the affected eye with water or isotonic solution during at least 15 minutes, and then consult the specialist.

• •

  In case of accidental ingestion, it is necessary to see a doctor immediately.

• •

  In any of these cases, it will be reported to the Occupational Health area of the Prevention Unit to enable the specific pharmacovigilance.

Drug waste must be treated in the Group III or Group IV containers, according to the current procedure for waste management.

Potential exposure to HDs in each of the activities described will depend on the set of preventive measures adopted; therefore, the potential exposure and its level must be established according to the risk evaluation conducted in each specific case.

The extent of the risk will depend on:

• •

  The toxicity inherent to each medication.

• •

  The level of exposure, associated with:

  • –

    Workload.

  • –

    Handling conditions.

• •

  Environmental protection.

• •

  Protection materials.

• •

  Handling technique, involving procedures, training and periodical assessment.

  • –

    Time of exposure.

  • –

    Stage of the process. There is higher risk in preparation and accidental spillage, though protection measures should include all stages of the process.

  • •

    Characteristics of the handler (reproductive age, simultaneous exposure to other agents, etc.).

Another important aspect to be taken into account is the potential ways of penetration of these substances into the body, which are:

• a)

  Inhalation of sprays and micro-drops emitted during the preparation of the hazardous drug solutions for administration, when vials are broken, while purging the system, etc.

• b)

  Through direct contact, by penetration of the medication through the skin or mucosa.

• c)

  Orally: ingestion of food and drinks, contaminated cigarettes.

• d)

  Parenterally: through direct introduction of the medication by accidental needle sticks or cuts caused by vial breakage.

The worker exposed should be qualified, aware of the risks taken if exposed to these drugs without an adequate protection, as well as of the conditions required for patient safety.

Thee requirements about the use of Individual Protection Equipment according to each medication have been stated in previous sections of this protocol (Appendix II and III).

The SPM specifications for each activity are not the object of this document.

With general application, and according to Articles 18 and 19 of the Law for Prevention of Occupational Risks13, workers must receive adequate information and training about the risks derived of the presence of any hazardous chemical agent present in their working place, as well as about the prevention and protection measures to be adopted. In particular, the training of staff working with bio-hazardous drugs is a key aspect to prevent occupational risks.