Hospital Pharmacy had gradually got to back drop due to industrial growth in pharmaceuticalformulations. Many preparations like customized compounded preparations of cough mixtures,antidiarrheal mixtures, and Extemporaneous preparations were abundant. In its place fixed dosecombinations (FDCs) came with a prominence. In this course, Pharmacist in worldwide forgottenthe compounding and art of making medicines based on individual prescriptions.
Thecompounding is considered a highly skillful area of practice. Pharmacist thinks of the patientrequirement, and makes the formulations as per the palatability and safety of the patients intoconsideration. The Fixed Dose Combinations (FDCs) might have able to match with the hugedemand of the patients, and able to provide medicines for the mass. FDCs which are usually unitdoses having shelf life of 2 to 3 years as expiry date determined by the accelerated stabilitystudies. There are some issues and drawbacks with the fixed dose preparations which need to bediscussed in the era of Pharmacovigilance and patients safety.
The major complaint of fixed dosepreparations/Unit dose is gross philosophy that is “One Cap Fits All”. As per the fixed dose,patients are administered medicines without considering the serious implications of wrong doses.A dose of medicines is to be determined based on patients body weight/surface area/age of thepatients.
All drugs are known to act better, when that concentration is within the therapeuticwindow. However, by ignoring this fact prescriber has to order the administration of drug toevery patient. If the patient is under weight or having a less body surface area comes underspecial population. There can be severe implications if the patients are administered with theprinciple of one cap fits all (1, 2, and 3).Another serious practice is crushing of the fixed dose in order to optimize the dose suitable topatient requirement.
We see a many time in Medical shops, Nursing Stations or in the wards ofHospital tablets are being broken for the sake of optimizing the dose, this is unscientific andillegal in judging the dose of the drugs for a particular patients in the ward. It is usually to findthe practices in the sittings like retail pharmacy/hospital wards and in homes. The risk evolved inthe purpose of reducing the dose of the medicine is improper handling and illegal. Sometimes thefixed dose may be formulated as sustain release or control release, when the tablets are broken itloses its design, purpose and property. Hence, it is very improper, irrational to crush a unit dosefor the purpose of optimizing the dose. Important issue of fixed dose is the addition of overage tocompensate for degradation during storage.
Hence, to compensate such a loss during storageseveral excipients like pharmaceutics aids and preservatives are added to the formulations. Theseexcipients may be causing health problems on patients. However, in freshly compoundedformulations which are made suitable in terms of dose requirements which are possible incompounding a prescription based formulation. The drugs with cumulative effects which are tobe used over a long period of time need to be prepared customized request, one may argue thatFDCs are better over compounded formulation as; they are not manufactured as per GoodManufacturing Practice (GMP) requirements. There are already GMP guidelines available forpreparation of Extemporaneous preparations by compounding preparations in hospitals (4, 5, and6).
In table 1 adverse effects due to excipients used in FDCs with their ADRs.Adverse effects of Excipients in Drug Formulations (7)Excipients Uses Adverse effectsMethyl and PropylPara-hydroxy benzoatesAntimicrobial preservative Hypersensitivity reactions likepruritus, asthma and delayedurticarial, maculopapular rashBenzyl Alcohol, SodiumBenzoate and Benzoic AcidAntimicrobial preservative;disinfectant; solventFatal syndrome characterized bygasping and metabolic acidosisPropylene Glycol Vehicle in oral andParenterals preparationsseizuresEthanol solvent and preservative CNS depressants, sedation anddrowsinessSweeteners (Sucrose andSorbitol )To mask the bitter taste ofthe medicament.Dental caries, osmotic diarrhoea,gas, bloating and stomach crampsLactose Inert Filler or diluents intablets and capsules or togive bulk to powdersDiarrhoea or gastrointestinaldisturbances in lactose or galactoseintolerant in infantsImportance of Optimized DoseIn the Era of industrialized pharmaceutical manufacturing, it is not so easy to optimize the dosefor each individual patient.
However, one can try to do justice by some interventions likeadapting in the dosage form into a solution, and then administrating the appropriate volume ofdose in tablet/capsule contain the concentration of 500mg per unit dose. In case we are supposeto administer 300mg of the drug, and then a solution of 50ml containing 500mg of drug may beprepared. Administration of 30ml will be somewhat approximately equivalent to 300mg andanother 20 ml may be discarded. There are various criteria to be met to use this technique drugmust be soluble in water.
The excipients and other things insoluble additives can be separated bydecanting or simple filtration. Drug should be palatable in terms of taste, odor etc.Individualization of drug therapy may not be an important in day-to- day health problems likeresolution of joint pains, itching and other issues like fever etc. However, if the patient conditionis serious and the drug in use has a narrow therapeutic window it becomes very important toadminister precise dose in such circumstances, one can adapt the principles of compounding. Theunit dosage should be weighed and documented. The label claim shall indicate the amount ofdrug per unit weight of tablet/capsule.
The inert diluents like lactose, starch, cellulosederivatives, and magnesium stearate which are suitable can be mixed with the crushed tablet.Appropriate calculated required quantity can be dispensed. For doing all these, there is arequirement of separate license for compounding under the D&C Act along with retail pharmacylicense (8).
Patient safetyProvision of Patient safety is a broad concept of assuming the responsibility of preventing thepatients by the injuries inflicted while undergoing treatment. Patient safety varies for differenthealth care professionals, and usually integrated with patient safety principles for Doctors andNurses. Pharmacist being experts in drugs, doses and Adverse Drug Reactions (ADRs) arefocused on ensuring each and every patient safety and doesn’t suffer due to wrong drug dose orany ADRs. There is a need for the hospital pharmacy department to keep constant vigilance onday-to- day transactions of prescriptions and dispensing.
The drug information is available at the finger tips. However, the willingness to serve using thisinformation requires motivated and dedicated Pharmacists. The flow of prescriptions anddispensing should be under vigilance. Wherein, the drugs prescribed are questioned regarding theindications, and the prescribed dose should match with the recommended dose and other issuespatients’ complaints regarding something unusual experience during treatment. The scanning ofprotocol would ensure identification of any injuries due drugs, and optimize the medicationswhich will be effective but not injuries to the patients.
It is mammoth task the hospitalpharmacist have to perform the routine rotation of the staff would eliminate the boredom andbecome more productive. The drug information services would be an advantage for providingintegrated patient safety services. The services of poison information, hematology informationsystem shall be an added advantage. The patient safety issues arising in the wards can bereported to the hospital pharmacy by ward round of Doctors, Nurses and Pharmacy students.
The special preparations like ointments with individualized dose such as eye lotions, mixtures,and tinctures required for the treatment of the patients ordered by the therapeutic team can beprepared on extemporaneous bases. Here, the Good Manufacturing Practice guidelines ofHospital Pharmacy can be adapted for quality medicines. As the medicines are prepared based ona prescription order are likely to be consumed immediately, these preparation do not contain anypreservatives and no need of adding overage to compensate for degradation during storage.
It isnot possible to prepare every prescription medicines however; some selected medicines whichare not manufactured by the industry can be prepared and supplied by the hospital Pharmacy (9,10).Basel statements on the future of Hospital PharmacyIn 2008, 68 th annual congress of International Pharmaceutical Federation (FIP) HospitalPharmacy section successfully develop hospital pharmacist consensus statement focusing on thevision of hospital pharmacy practice in future years. The survey consist of 75 questionsexploring various aspects the overreaching statements include the safe judicious, efficacious,appropriate cost effective of treatment. The important points include procurement of medicinesby the hospital pharmacy. The influence of clinical pharmacy practice on prescribing theprescription medicines.
Preparation and distribution of medicines in a cost effective manner and quality adaption ofpreparations, administration of medicines mandates five rights which are right patient, rightmedicine, right dose and right time. The pharmacy services should try to reinforce these points.Further special safety considerations for inject able medicines, infusion devices, chemotherapyof cancer, and prevention of wrong route of administration medicines, pediatrics, drugadministration in intensive care and implementation of bedside barcode assisted drugadministration. The role and responsibility of pharmacist during monitoring of medicationtherapy is reviewed with a focus on safety, efficacy and economic use of medicines.
The clinicalpharmacy practice provides opportunities to measure more definitive outcomes such as mortalityand morbidity and disease specific clinical outcomes. However, the hospital pharmacy servicesare developed on activities costs, work load and quality of services. Finally the Basel statementmakes provision for allocation of resources for development of skill orientated training forhuman resources (11, 12).
The roles of Hospital PharmacistThe social expected behavior pattern is usually determines the role and responsibilities ofhospital pharmacist. There is a need to review the primary role of hospital pharmacist who islikely to act as patient educators, advocators, mangers, collaborators, and scholars for newpharmacist intern. The pharmacists are expected to help the Patients, Doctors and Nurses in thematter of drug, doses and safety of the patients.Traditional roleThe roles of the Hospital Pharmacist can be classified as traditional roles and specializationservices roles.
The tradition role of Hospital pharmacist includes the filling of prescriptions,compounding or mixing the drugs as per the prescription. Planning and monitoring the patientdrug schedules. Preparing and maintaining the health records which can be shared with Doctorsand Nurses for the purpose of treatment. Determination regarding the success of prescribedmedications and advising the patients on how to use the medications during and after theirhospital stay. The emerging role of hospital pharmacist which are nick named as clinicalpharmacist are suppose to indulge in case studies with an intent of appropriate advise withPhysicians regarding which drug suits the present patient conditions. These pharmacists make goon rounds with Doctors recommending the appropriate medications to be prescribed and theyalso identify untreated health condition by oversight.
They also are engaging in dischargemedication counseling. They also specialize in the areas of nuclear pharmacy (Radioactive drugfor diagnosis and treatment), Pain management, pediatrics, oncology and psychiatrics. In figure 1the various roles of Hospital Pharmacy are given for quick reference of the readers (13, 14).Dispensing Purchase Teaching, Statistics CompoundingInventory control Research, ReportControlOutdoor Inpatients MedicalPatients Surgical Bulk Large SmallLaboratory Supplies volume volumeParenterals ParenteralsFigure 1. Shows the role of Hospital Pharmacist (15, 16)ConclusionRaise and fall and raise are the distinct feature of Hospital Pharmacy is developed during the preindustrial era. The traditional roles of the pharmacist were became the core concepts of practiceof hospital pharmacy such as the skills of compounding, dispensing and patient counseling hasreached its zenith which gradually got eroded due to development of industrial pharmacy andavailability of manufactured fixed dose combinations.
For example, unit doses ready to useformulations had curtailed the compounding the practice of pharmacist. Instead of that thedispensing was converted into retail trade medicines and is classified into over the counterproducts and prescription only products. The difficulties and rigidity of the current system ofmedicines has made the pharmacist to go back to the compounding and learn all the skills andetiquettes of the art of the compounding. In the era of Biotherapeutics, where medicines are tooexpensive and highly sensitive to storage conditions.
These characteristics are compelled the allstakeholders to act wisely and switch to the concepts of quality use of medicines. Here elaborateunderstanding of the drugs and patients features of the drug in question. Hence, we can expectthe hospital pharmacist serving the patients with the Good Manufacturing Practices armed withskills of compounding, dispensing and patient counseling.