by Pharmaceuticals play a vital role in hospitals across the world. Modern hospitals would not be able to function effectively without having access to a wide range of safe and effective pharmaceutical drugs. This article provides an overview of hospital pharmaceuticals, including how they are procured, regulated, and managed within healthcare facilities.
Procurement of Pharmaceuticals
Hospitals purchase pharmaceuticals from licensed wholesale distributors or directly from pharmaceutical manufacturers. The procurement department is responsible for projecting pharmaceutical needs, issuing bids, selecting suppliers, negotiating contracts, and receiving/inspecting shipments. They aim to purchase high quality pharmaceuticals at competitive prices while ensuring continuity of supply.
Due to the large volumes purchased, hospitals are able to negotiate discounts with suppliers. Group purchasing organizations (GPOs) also help smaller hospitals join together to leverage collective bargaining power. The procurement process is tightly regulated to prevent errors, minimize costs, and avoid shortages. Electronic systems help manage pharmaceutical inventories, track usage, and facilitate reordering.
Regulation of Hospital Pharmaceuticals
Hospital pharmacies must strictly adhere to pHospital Pharmaceuticals regulations determined by local healthcare authorities and regulatory bodies. The US Food and Drug Administration (FDA) regulates pharmaceutical approvals, manufacturing, labeling, and distribution. Hospitals are governed by rules on appropriate pharmaceutical storage conditions, inventory management, dispensing procedures, prescription requirements, and waste disposal.
State boards of pharmacy conduct regular inspections of hospital pharmacies to ensure compliance. Non-compliance can result in violations, penalties, and even loss of pharmacy licenses. Regulations are vital to guarantee the safety of hospitalized patients by preventing medication errors, microbial growth, diversion of controlled drugs, and other issues. They also set professional standards for pharmacists and technicians working in hospitals.
Medication Management and Distribution
Once procured, pharmaceuticals must be accurately managed and efficiently distributed within the hospital. Large hospitals may have decentralized or unit-dose packaging systems to reduce the risk of errors during medication administration. Automated dispensing machines are also increasingly used to store and dispense medications near patient care areas.
Electronic medication administration records (eMAR) have mostly replaced paper-based systems to record medication orders, document administration, and reduce transcription errors. Bedside scanning technology further enhances accuracy by verifying the right patient receives the right medication. Barcoding is used during dispensing, transporting, and administering medications to identify and track drugs.
Floor-stock medications for urgent use are secured in crash carts, automated dispensing cabinets and emergency medication kits. Controlled substances have additional safeguards like double-locked storage, perpetual inventory counts and signature logs. Intravenous (IV) admixtures are prepared under certified hazardous conditions by trained pharmacy staff or contractors. Proper transportation within the hospital, labeling and packaging also minimizes risks.
Specialty Pharmaceuticals
The term ‘specialty pharmaceuticals’ refers to high-cost biologic and conventional drugs that treat complex chronic conditions like cancer, rheumatoid arthritis, and multiple sclerosis. Specialty drugs require special handling such as refrigeration due to their fragile molecular structure. They also have unique reimbursement, distribution and adherence challenges compared to traditional medications.
The cost of specialty pharmaceuticals is rising much faster than other drugs. For example, the cost of a new cancer drug rose from around $5,000 per month in the early 1990s to $10,000 or more currently. Spending on specialty drugs is projected to grow over 20% annually in coming years due to biologic approvals, limited competition and price increases. This rapid growth strains hospital budgets and payers’ ability to provide access and coverage.
To cut costs, hospitals may limit specialty drug formularies, steer patients to lower-cost alternatives, or shift dispensing to mail-order specialty pharmacies. Careful therapeutic drug monitoring helps optimize dosing and mitigate waste. Payer negotiations, reference pricing, and risk-sharing agreements also aim to balance affordability with appropriate patient access to life-saving specialty pharmaceuticals.
Cytostatic and Cytotoxic Drugs
Cytostatic drugs slow down or stop the growth of cancer cells and are commonly used for chemotherapy. Even more hazardous are cytotoxic drugs that can kill both cancer cells and rapidly dividing normal cells. Safe handling of these hazardous drugs is critical due to their adverse effects profile and potential reproductive toxicity.
Cytostatic and cytotoxic drugs require containment during preparation, transportation, administration, cleaning and disposal to protect healthcare workers and minimize environmental contamination. Vertical laminar flow hoods with HEPA filters are used to aseptically prepare IV admixtures and oral doses following rigorous decontamination procedures. Negative pressure isolators provide the highest level of protection.
Personal protective equipment including gowns, gloves, respirators and eye protection must be worn appropriately. Spill kits and containment bags are necessary to clean up any accidental release. Sharps containers prevent needlestick injuries from contaminated syringes. Training and competency demonstrations ensure staff use safe practices. Special disposal routes avoid toxic sewer discharge into the environment. Periodic environmental surface testing verifies containment and decontamination effectiveness.
Pharmacy Compounding
The art of pharmacy compounding involves preparing customized medications for patients who cannot use commercially manufactured products. This specialized service is important for pediatric and geriatric patients along with those requiring alternative routes of administration or unique dosage forms.
Compounded preparations use bulk drug substances, ingredients, components or devices to prepare products tailored to individual prescriptions. Common preparations include topical creams and ointments, oral suspensions, sterile intravenous admixtures, and transdermal patches. Examples are metronidazole cream, oxycodone liquid, morphine sulfate infusion or estrogen patch.
Hospital compounding requires adherence to current Good Manufacturing Practices (cGMP) standards set by FDA and USP chapters for cleanrooms, equipment, personnel training, documentation and testing. Beyond USP-NF ingredients, only FDA-approved components may be used in sterile and non-sterile compounds. Strict aseptic techniques and quality control checks help validate sterility and potency prior to dispensing.
Outsourcing compounds to FDA-registered outsourcing facilities relieves in-house workload but shifts responsibility. Regular auditing ensures outsourced products meet quality, accuracy and microbial contamination specifications. Barcoding and electronic order entry reduce risks of errors during prescribing and dispensing of customized formulations.
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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
