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Official websites use. Share sensitive information only on official, secure websites. Correspondence: Dr. Box , Riyadh, , Saudi Arabia, yazeed ksu. Drug shortages are a serious and complex issue in any healthcare system. We conducted this study because the prevalence of drug shortages in Saudi Arabia is largely unknown, while there have been reports of shortages. To explore the prevalence and characteristics of drug shortages as well as identify strategies to minimize their impact on patient care and safety in large hospitals. The European Association of Hospital Pharmacists drug shortage questionnaire was administered to survey pharmacists about drug shortages in their hospitals. Percentages of drug class shortages, characteristics, and strategies to minimize impact on patient care and safety across each hospital sector. A significantly higher percentage of pharmacists from MOH-affiliated medical cities The relatively high reported rates of drug shortages in some hospitals should encourage health policymakers to address this serious public health problem. Drug shortages are a global problem and a major threat for any health care system as shortages negatively affect the health of patients, potentially increasing the risk of medication errors, and imposing an economic burden on patients, providers, and health care systems. The number of reported drug shortages has increased worldwide over the last decade. The root causes of drug shortages vary across different countries. The primary objectives of this study were to explore the prevalence and characteristics of essential drug class shortages as well as to identify determine the different strategies used to minimize the impact of drug shortages on patient care and safety in large hospitals in the city of Riyadh. The secondary objective was to explore different proposed policy solutions to drug shortages from the perspective of the hospital pharmacist. A questionnaire based cross-sectional study was conducted in 10 large hospitals in the city of Riyadh selected to represent the main sectors of healthcare. Participants were practicing pharmacists at the hospitals. We used the European Association of Hospital Pharmacists EAHP drug shortage questionnaire, which consists of 27 questions about the prevalence and duration of drug shortages, the classes of drugs in shortage, type of drugs in shortage e. The EAHP drug shortage questionnaire was distributed to pharmacists in the hospitals. Convenience sampling was used due to constraints on time and resources. The minimum sample size was estimated to be 88 participants at an alpha of 0. The questionnaire was explained to pharmacists who agreed to participate. Statistical significance was determined at an alpha of 0. All statistical analyses were performed using SAS version 9. Data collection started in January and ended in May The participants were distributed in the three hospital sectors as follows: 29 The majority of the participants were female Most of the participants Pharm as their highest educational degree. More than 50 percent of the participants reported working in their hospitals for more than 2 years. Participants were mostly pharmacists working in outpatient or inpatient pharmacies Values are number percentage. Number of pharmacists within each sector. Table 2 shows the responses to questions about drug shortages in the three hospital sectors. The percentage of participants who reported that drug shortages in their hospitals compromise the quality of patient care, was significantly higher in the MOH-affiliated medical cities Similarly, a significantly higher percentage of participants from MOH-affiliated medical cities More than 50 percent of participants reported that drug shortages usually last for less than a month. The longest duration of drug shortages that most participants The majority of the participants A significantly higher percentage of participants from non-MOH hospitals Similarly, a significantly higher percentage of participants from non-MOH hospitals The vast majority of participants Table 3 shows the frequency of reported drugs in shortage for different drug classes across the three hospital sectors. A significantly higher percentage of participants from MOH-affiliated medical cities Likewise, a significantly higher percentage of participants from MOH-affiliated medical cities Moreover, participants from MOH-affiliated medical cities reported a significantly higher percentage A significantly higher percentage of respiratory drugs Endocrine, antimicrobial, and pediatric drugs were reported to be in shortage among Table 4 shows the different reported strategies to minimize the impact of drug shortages on patient safety and care. More than 70 percent of participants reported that they either 1 informed prescribers about the drugs in shortage and recommend therapeutic alternatives or 2 created new communication systems and tools to alert prescribers and other hospital staff about drugs in shortage and the need to replace them with therapeutic alternatives. Approximately 18 percent of participants reported substituting drugs in shortage without consulting prescribers or patients. Forty percent of participants reported reassigning staff work profiles and job descriptions to include dealing with drug shortages as one of their employed strategies to minimize the impact of drug shortages on patient care. Only 5. Strategies used to minimize the impact of drug shortages on patient safety and care by hospital sector. Table 5 shows policy solutions proposed by participants. Although multiple studies have explored the prevalence and root causes of drug shortages in the United States and Europe, 2 , 7 , 8 , 10 , 13 very few studies have been conducted addressing this serious problem in healthcare systems in the Middle East. Although some medical cities belong to the MOH, they enjoy more autonomous governmental funding channeled through the MOH. The third category included hospitals that receive funding from other governmental entities such as the Ministries Of National Guard And Interior. The findings of this study show the high prevalence rates of drug shortages of major drug classes in three hospital sectors in Saudi Arabia. The percentage of participants from MOH-affiliated medical cities who reported that drug shortages in their hospitals compromised the quality of patient care, was the highest compared to participants from other hospital sectors. A higher percentage of participants from MOH-affiliated medical cities reported that they encounter drug shortages in their hospitals more frequently than participants from the other hospital sectors. Generic drugs are cost effective alternatives to many of the highly priced branded drugs, and their shortage makes the drug shortage problem even worse. This indicates that the drug shortage problem in the MOH-affiliated medical cities is more prevalent and serious compared to MOH and non-MOH hospitals, and emphasizes the importance of carrying out a thorough investigation into this issue to minimize any impact on patient safety and care. Fortunately, most participants, regardless of the hospital sector, reported that drug shortages usually last for less than a month. Although pharmacists should know the different sources of drugs, most participants e. This may be attributable to poor communication between the pharmacists and pharmacy managers or directors of pharmaceutical care services in their hospitals. Cardiac drugs such as beta blockers and renin-angiotensin blocking agents were reported to be in shortage by more than one third of participants. The drug shortage prevalence of such an important class of drugs is alarming given the huge impact of these drugs on controlling serious medical conditions such as hypertension and heart failure, where shortages could lead to unfavorable consequences such as higher rates of hospitalizations and mortality if left untreated. Participants reported a range of different strategies to minimize the impact of drug shortage on patient safety and care. Changing the formulary by adding therapeutic alternatives or deleting backordered medications may negatively affect the pharmacy budget and patient care if the alternatives are not as effective as the drugs in shortage. Devoting more staff time to manage the drug shortage problem is an issue that many hospitals are struggling with, and the Saudi hospitals are no exception. The findings of this study have multiple practical implications. Addressing drug shortages cannot be resolved using institutional level solutions, 1 , 3 and therefore require national and sometimes require the engagement of international health and regulatory bodies. The participants proposed multiple policy solutions to this serious healthcare issue such as clarifying the role that pharmaceutical manufacturers play regarding their responsibility in drug shortages, and creating a comprehensive database of drugs in shortage under the oversight of the SFDA and the MOH. However, there are other solutions and recommendations that were reported in the literature and used in different countries to address this issue. FDA, in collaboration with the American Society of Health-System Pharmacists ASHP , to trigger an advance notice of drug shortages in different healthcare institutions to minimize the impact on patient care is one of the workable recommendations of the program. FDA of any potential drug shortage at least three months in advance to enable the FDA to act swiftly to minimize its impact on patient care. Therefore, supporting generic drug manufacturers in the country is important for a multitude of reasons. First, strengthening the local production of essential generic drugs, such as cardiac and antineoplastic medications, will create hundreds if not thousands of jobs, and will ensure supplies of these essential drugs. Therefore, when certain drugs go off-patent many generic drug manufacturers scramble to enter the market. As more drug manufacturers enter the market the prices of generic drugs decrease until they reach a point where the profit margin is not high enough for certain generic companies to keep manufacturing these drugs. Although this study is the largest to our knowledge in Saudi Arabia that explores the prevalence of drug shortages and the proposed policy solutions, it has several limitations. First, the study may suffer from the limitations of convenience sampling. Fourth, the participants were asked about the shortage of anatomical therapeutic classes of drugs rather than specific drugs so it is hard to determine which drugs are in shortage. Fifth, there may be other reasons behind drug shortages, which were not reported in the study due to its design. Sixth, the study included an uneven number of participants from the three hospital sectors. Finally, although pharmacists are believed to be the most knowledgeable healthcare providers about drugs and their availability, the inclusion of other healthcare providers such as nurses and physicians would have made the findings more robust and representative. Therefore, it is hard to generalize the findings of this study to other cities and hospitals in Saudi Arabia. Suggestion for future studies include implementing a mixed methods approach, whereby different themes regarding drug shortages can first be identified using qualitative research methods, and then a questionnaire could be developed to examine the prevalence and root causes of drug shortages quantitatively. As a library, NLM provides access to scientific literature. Ann Saudi Med. Find articles by Yazed Sulaiman AlRuthia. Find articles by Hadeel AlKofide. Find articles by Bander Balkhi. Find articles by Ahmed Alghamdi. Find articles by Albandari AlNasser. Find articles by Areej Alayed. Find articles by Maali Alshammari. Find articles by Danah Alsuhaibani. Find articles by Asma Alathbah. Pharm 22 Open in a new tab. No 8 Occasionally e. A number of days e. Generic 21 Less than an hour 7 Never 0 0. I do not know 18 Conflict of interest The authors have declared that no competing interests exist. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Highest educational degree. Length of time in the workplace. Pharmacy manager e. Do drug shortages compromise the quality of patient care in your hospital? How often does your hospital experience drug shortage? How long do drug shortages usually last in your hospital? A number of weeks e. What was the longest drug shortage duration that you recall in your hospital? Which type of drugs is commonly in shortage? In an average week in your hospital, how much time staff working time do you estimate is diverted because of drug shortage problems? How often do you provide a therapeutic equivalent or near equivalent medicine, without major disruption to their treatment? Which category of external supply does your hospital most frequently encounter problems with sourcing specific required medicines? Unlicensed drugs suppliers e. Inform prescriber and recommend an alternative drug. Investigate when supply will be restored and plan stock accordingly. Attempt to source the medicine from an alternative supplier including another hospital. Change the formulary based on the information provided. Reassign staff work profiles and job descriptions e. Create new communication systems and tools to alert prescribers and other hospital staff about the presence of shortages and the need to substitute replacement therapies. Readjust budget plans due to additional expenditure caused by shortages e. Cancel practice improvement and development initiatives due to resources having to be reassigned to dealing with the shortages problem. Greater legal clarity about the responsibility of drug manufacturers. High level investigation into the root causes of drug shortages led by the Saudi FDA. A national annual report on drug shortages by the Saudi FDA.
Saudi Arabia's War on Drugs and Foreign Influence
Riyadh buying Heroin
A doctor's prescription less than six months old in the name of the patient with the following information:. The person importing the prescription medications will be held personally responsible for its lawful use and agrees to limit its usage to the intended patient only. The amount of allowable prescription medicine to be cleared for import shall for the duration of the visit or one month's supply, whichever is shorter. The prescription medications must remain valid for use during the clearance period and satisfy the following conditions:. Should the physician confirm such need, a medical file for the patient should be opened at the medical facility before a prescription can be issued. The prescribed drug must then be dispensed by a local pharmacy, if available. If the prescription medications or its medically acceptable replacement is not available in the local market, the medical facility prescribing the medication may request permission from the Saudi Food and Drug Authority to import the medication from a pharmaceutical distributor. If the prescription medication is used through injection, the clearance process should be completed on behalf of the patient by and under the supervision of a local medical institution. The cleared prescription medications should then be registered in the record of the medical institution for personal use in accordance with its medication management policy. Should the quantity of the cleared medication exceed the medical need of the patient, unused medication must be disposed of in a proper manner. With the exception of the conditions provided for under subsections a , b and c of Sections 5 and 6 , all other conditions shall similarly apply to those patients who are travelling outside the Kingdom of Saudi Arabia. Request to import prescription drugs must be filed with the branch of the Saudi Food and Drug Authority at the port of entry to which the drugs will arrive. Drugs that are for personal use will be cleared for import into the Kingdom of Saudi Arabia provided the following conditions are met: a. The prescription medications in question must be accompanied either: i. A doctor's prescription less than six months old in the name of the patient with the following information: medical diagnosis; generic name of the prescription drug, dosage and dosage form; drug usage instructions and prescribed duration of use; and official seal of the health care provider. Copy of patient identification document. The prescription medications must remain valid for use during the clearance period and satisfy the following conditions: a.
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